[This Transcript is Unedited]
Hubert H. Humphrey Building
200 Independence Avenue, SW
Room 505A
Washington, D.C.
Proceedings by:
CASET Associates, Ltd.
10201 Lee Highway
Fairfax, Virginia 22030
Agenda Item: Call to Order and Welcome and Introductions
DR. COHN: Good morning. I want to call this meeting to order. This is the first day of two days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics.
The committee is the main public advisory committee to the U.S. Department of Health and Human Services on National Health Information Policy.
I am Simon Cohn, Chairman of the Subcommittee. I am the National Director for Health Information Policy for Kaiser Permanente.
I want to welcome subcommittee members who are here, other staff and, obviously, others in attendance. I also want to welcome those listening in on the internet.
As always, I want to remind everyone in the room to speak clearly and into the microphone, so that those on the internet can hear our deliberations.
We have a lot to cover over the next couple of days, next two days, specifically. The Medicare Modernization Act of 2003 calls on the Secretary of HHS to adopt standards for e-prescribing, and the NCVHS has been directed to develop such standards recommendations. This is the first formal public hearing on e-prescribing standards by the subcommittee and NCVHS.
The hearing today is intended to provide background to the subcommittee and others in attendance on the state of e-prescribing and assure that we all have a common understanding of the legislative language directing our work.
We are thankful to have Karen Trudel from CMS, who will begin after introductions and other business from the subcommittee, by discussing the Medicare Part D Benefit and how it all - the legislative language and how it all relates to our work.
We are also pleased, hopefully, to be able to welcome Jonathan Teich, who I think we'll see in a little while, who'll be talking about the state of e-prescribing. We'll hold formal introductions for when he arrives.
After lunch, we continue with a discussion of e-prescribing standards. We have Lynne Gilbertson, who is Director of Standards Development for NCPDP, and Bob Beckley, who is on the NCPDP Board, who'll be talking about that.
And then we move on to a discussion of federal perspectives on e-prescribing from the FDA, VA, DoD, and, I believe, and others.
Obviously, I want to thank personally both Maria Friedman, our chief staff; Jeff Blair, our Vice Chair, for his tremendous work in terms of putting today together, as well as Steve Steindel. I think without all of their work, we would not have a session such as we are going to have today.
I want to emphasize that this is an open session. Those in attendance are welcome to make brief remarks, if you have information pertinent to the subject being discussed. We will also have time at the end of the afternoon for brief comments by those in attendance.
Finally, for those on the internet, we will welcome email and letter comments as issues come before the subcommittee.
In addition, be aware that we will have a number of other hearings on the subject of e-prescribing this year and into next.
With that, let's have introductions around the table and then around the room. As always, for those of you on the National Committee, I would ask if you have any conflicts of interest related to any issues coming before us today, would you please so indicate during your introduction?
Maria.
MS. FRIEDMAN: Maria Friedman, Centers for Medicare and Medicaid Services, lead staff of the subcommittee.
MR. BLAIR: Jeff Blair, Vice President, Medical Records Institute; Vice Chair of the Subcommittee on Standards and Security.
Not aware that I have any conflicts of interest.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the subcommittee and liaison to the full committee.
DR. WARREN: Judith Warren, University of Nebraska - excuse me - University of Kansas, School of Nursing. (Laughter). I know. I know. You can tell the history.
DR. STEINDEL: Well, we beat >um.
DR. WARREN: Yeah.
DR. STEINDEL: All of those states are so flat, it's hard to tell where one stops and one begins.
DR. WARREN: That's right. That's right.
AUDIENCE: Oohh.
DR. FITZMAURICE: But very fine states they are. (Laughter).
Michael Fitzmaurice, Agency for Healthcare Research and Quality, staff to the subcommittee and liaison to the National Committee.
MS. GRAHAM: Gail Graham, Department of Veterans Affairs, staff to the subcommittee.
MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services.
MR. SCANLON: Jim Scanlon, HHS, Executive Staff Director for the full committee.
DR. GREENBERG: Marjorie Greenberg, NCHS, CDC and Executive Secretary to the committee.
MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina, member of the committee; and neither Kansas nor Nebraska are in the final four - (laughter).
DR. HUFF: Stan Huff with Inter-Mountain Healthcare and the University of Utah in Salt Lake City.
I have potential conflicts if we talk about ICD-10, PCS or HL-7 or LOINK(?). I'm a cochair of LOINK. I'm a vocabulary cochair at the HL-7 and a previous contractor with 3M some years ago.
MS. SQUIRES: Marietta Squires, CDC, NCHS and staff to the subcommittee.
MR. MANTOOTH: Mark Mantooth(?), Office of General Counsel, HHS.
MR. PIETRO: James D. Pietro(?), legal assistant, Buchanan Intersol(?).
MR. MURRAY: Tom Murray, American Medical Association.
MR. GILBERG: Anders Gilberg(?), the American Medical Association.
MS. MC KENNAN: Barbara McKennan, Astrasynica(?) Pharmaceuticals.
MR. BECKLEY: Bob Beckley with SureScripts and NCPDP Board member.
MS. GILBERTSON: Lynne Gilbertson, NCPDP.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, staff to the committee.
MR. HOKE: Mike Hoke(?), Strategic Health Solutions.
MS. BRADFORD: Alicia Bradford, Consolidated Health Informatics Initiative.
MR. POLLARD: Michael Pollard, Medco Health.
MS. MC ALLISTER: Lane McAllister, Rx Hub.
MS. WALKOFF: Sheila Derryberry-Walkoff(?), Mayer, Brown, Rowe and Mah(?).
MR. RATHERMICK: Phil Rathermick(?), Express Scripts.
MS. BERN: Terry Bern, Rx Hub.
MR. BUSOWITZ: Roy Busowitz(?), NACDS.
SPEAKER: (Inaudible), Clarity.
MS. AKASKI: Irene Door Akaski(?), American College of Surgeons.
MS. HICKS: Brenda Hicks, Centers for Medicare and Medicaid.
MR. PERRINI: Michael Perrini(?), Pfizer.
MS. BODGETT: Holly Bodgett(?) - Centertech(?) and former Kansas resident. (Laughter).
MS. FORD: Cheryl Ford, Consolidated Health Informatics.
MR. MARTIN: Ross Martin with Pfizer and a Connecticut resident. (Laughter).
MS. ECKERT: Karen Eckert, Medispan, part of Walters - Health.
MS. MONACO: Carol Monaco, American Osteopathic Association.
SPEAKER: (Inaudible), Veterans Affair.
SPEAKER: Jorge - (inaudible) - CMS.
MR. PETERSON: Matt Peterson, Fox Kaiser.
MR. HAUSNER: Tony Hausner, CMS.
MS. THOMAS: Steel(?) Thomas, the Pink Sheet.
MS. TOWNSEND: Jessica Townsend, HUSA(?).
MR. NOMAN: Mike Noman(?) Health Resources and Services Administration, HHS.
DR. BRAITHWAITE: Bill Braithwaite, independent consultant in Washington, D.C.
MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics, CDC.
MR. GORDON: Mark Gordon, American College of Physicians.
MR. HEINBERG: Gary Heinberg(?), law firm Akin, Gump.
MS. KING: Mary Lou King, Office of General Counsel, HHS.
MR. HUTCHINSON: Kevin Hutchinson, CEO SureScripts.
MR. WEINBERGER: Michael Weinberger, Johnson and Johnson.
SPEAKER: Alice - (inaudible) - Johnson and Johnson Healthcare Systems.
MS. MARON: Barbara Maron(?), American College of Emergency Physicians.
MR. HODGE: Richard Hodge(?) of Innis(?) Pharmaceuticals.
MS. FIGMAN-LUKE: Marilyn Figman-Luke, America's Health Insurance Plans.
DR. COHN: Well, if we're going to stay like this, we will have to find a larger room. (Laughter).
Jeff, before we have Karen start, would you like to make some introductory remarks for today?
MR. BLAIR: Sure.
The day has been set forth - the agenda was set forth by Maria Friedman, and I wanted to acknowledge the work that Maria has done in creating the agenda for today.
The objective of today is to give the subcommittee an introduction and overview to the landscape in which we will be looking at selecting standards for e-prescribing. We wanted to have an understanding of the different medical domains and models that might be effecting e-prescribing.
The way the day is breaking out is that Karen Trudel will first be giving us an overview of the law itself, and then Jonathan Teich, from the e-Health Initiative, will be giving us kind of a perspective on the industry per se.
After lunch, we will have Lynne Gilbertson and Bob Beckley begin to review what the standards are that are being in use today and how they apply.
And then we'll be getting a look at the requirements for e-prescribing from a federal perspective with FDA and DoD and VA.
I would like to indicate for all of those of you in attendance that this is really the introductory session. This is the kind of first step into this arena for the subcommittee, and we have a work plan, which is a 15-month work plan which leads to final recommendations to the Secretary by June of 2005, with interim recommendations by November of 2005, and the essence of the way we have pulled this out is we are going to be looking to hear from all of the different users of e-prescribing during May and July and August and find out how they feel about e-prescribing standards from the standpoint of is it meeting their needs, are there gaps, are there additional standards that need to be enhanced or created, and then, in September, we'll be reviewing all of that information with the standards developers and the terminology developers to see if there are plans to address the gaps, and then we will be creating, in September, October and November, the interim recommendations to the NCVHS which we hope will be passed in November and sent on to the Secretary.
And then during the first quarter of 2005, we'll begin to look at electronic signatures related to e-prescribing, and any other remaining issues that didn't have time to be resolved during the 2004, leading up to our final recommendations in June 2005. So I think that that gives you an idea of where we are going.
A copy of that work plan has been distributed to all staff and subcommittee members, and, of course, it is open to the public. So you are free to get yourself a copy of that, and that, at least, will wind up letting you see where we are going and where our priorities are.
Simon, that is all, I think, I would have to say for introductions. You or Maria may have further guidance.
DR. COHN: No, I think we'll let Karen lead off today.
Agenda Item: Issues Related to the Medicare Part D Benefit and E-Prescribing
DR. COHN: Karen we are glad to have you join us. Would you like to start?
I understand we still don't have an LCD projector, but I think everyone should have copies of your presentation materials.
MS. TRUDEL: Right. Right.
I am going to try to cover three things, and I'll do it as quickly as possible, because there are plenty of people that I think a lot of us are more interested in listening to than myself.
The first will be what is required by the law? What functionalities we are talking about with respect to electronic prescribing, to talk in more detail about the timetable for the electronic prescribing requirements, and, third, to talk about some other considerations that I personally have identified in terms of making sure that e-prescribing requirements are implementable easily inside the larger Part D benefit. So those are the things that I'll talk about.
First of all, let's talk about applicability. The electronic prescription program is applicable to eligible individuals within the Part D benefit, the voluntary prescription drug benefit program in Medicare. E-prescribing, very unlike HIPAA, is - well, not unlike HIPAA, really. It is voluntary for the providers, so that a provider does not need to submit prescriptions electronically, but if he does, then needs to use the standards. So that any prescription that is transmitted electronically does have to use the standards.
The objectives that are set out in the law for e-prescribing are, first of all, patient safety, second of all, quality of care, and, third, efficiencies in the delivery of care which obviously includes cost savings.
In terms of design criteria, there was a responsibility that there be no undue administrative burden on providers, pharmacies or pharmacists, and that the standards be compatible with HIPAA and health IT standards generally, and that they permit electronic exchange of labeling and drug-listing information as maintained by the FDA and the National Library of Medicine.
The specifics of the e-prescribing requirements go well beyond the basic prescription that is a transaction that is when you look at the full scope of what is required in e-prescribing, that part of the transaction is relatively uncomplex.
But the legislation goes forward and requires that we build in eligibility information, which includes formularies, and, in fact, the legislation permits tiered formularies and requires us to work with the United States Pharmacopeia to develop a model of categories and classes for formulary development.
It requires that we be able to provide to the prescriber drug information, including the patient's history and related medical history, and in terms of related medical history, it states that the Secretary is to adopt standards specifically to do this, that the standards would be as effective as specified by the Secretary and it is clear that this particular provision of medical history, because it has such a link to electronic health record would be on a separate, but not necessarily unrelated time line.
The standards that are needed are, obviously, messaging, vocabulary, knowledge representation, so that the data that is provided back to the prescriber is provided in a meaningful way that is clinically useful at the time of the prescription; and electronic signatures, clearly, there is a link to signatures with prescriptions.
In terms of links to ongoing initiatives, this, obviously, does relate to the FDA's physician labeling and electronic drug listing regulations, National Library of Medicine's RxNorm and the FDA's structured product label, and, as I said, one of the requirements of the law, the design criteria, does say that it must permit electronic exchange of labeling and drug listing information.
So what will the e-prescribing standards cover? In addition to enabling transmission of basic pharmacy prescription data to and from doctors and pharmacies, including the e-label, it will also cover transmission of data about the patient's drug utilization history, possible interactions, information about the drug plan, including formulary and cost sharing, and lower-cost, therapeutically-appropriate alternatives, and the standards must comply with the HIPAA privacy rules.
The statute specifically requires that messaging that is unrelated to appropriate prescribing, such as marketing, will not be permitted.
The NCVHS's role is very clearly stated in the law, and that was to make recommendations to the Secretary on e-prescribing standards in consultation with a specific group of constituencies, including physicians, hospitals, pharmacists and pharmacies, PBMs, state boards of pharmacy and medicine, federal agencies and other electronic prescribing experts. This, clearly, is one of the reasons that these hearings are going to take a period of time.
What the law requires, in terms of e-prescribing by participating prescription-drug plans or PDPs, is that within a year of promulgation of the final standards, prescriptions for covered Part D benefits that are transmitted electronically must be transmitted according to the standards, and the PDPs must issue a card that enrollees - or other mechanism of identification - that enrollees can use to access their prescription drug plan. The card will use formatting standards developed in consultation with the NCPDP, and I believe that that is probably outside the scope of this committee's work right now, but just stating it to provide some context.
The law does require a pilot project once the Secretary has adopted or announced the initial standards. Those standards will be pilot tested. The pilot will run from January 2006 through December of that year, and it will be completed prior to the promulgation of the final standards. The law says that a pilot is not needed if there is already adequate industry experience with whatever standards the Secretary is planning to adopt.
And there will be voluntary participation in the pilot plan via agreements.
There will be an evaluation and a report to Congress no later than April 1, 2007.
The law also provides a safe harbor. The Secretary, in consultation with the Attorney General, will develop safe harbors under anti-kickback and physician self-referral laws. That will permit hospitals, plans, PDPs, others to provide physicians with non-monetary remuneration, whether that is software or technology services training, whatever, in order to make them able to participate in e-prescribing.
The time lines for these provisions appears to be quite liberal, but really is not. The hearings, clearly, will be NCVHS hearings, will go on through September of 2005 - actually, I think it's June. The Secretary will announce the initial standards in September of 2005. As I said, the pilot program begins in January and runs through December of 2006. The report to Congress, April of 2007. The announcement of final standards via regulation, a year later, April 2008, and the standards to be implemented, a year after that, April of 2009.
The critical challenge that I think we all are facing is to assure that e-prescribing standards can be successfully integrated into the Medicare Part D implementation.
Some of the things that I am concerned about is assuring that the electronic prescribing standards are consistent and workable with the claim and eligibility standards that will be used to actually submit claims from pharmacies to the PDPs to make sure that the data content is consistent, that we are able to maintain information from the prescription all the way through to the end of the process consistently.
I'm worried about interoperability. There is an ability for more than one PDP per region, and, in fact, that is expected, and since patients can, obviously, select their physician and they are able to select their pharmacy under Part D, that means that all pharmacies and all prescribers are going to have to be able to do business with a number of different PDPs, which brings interoperability issues, technology issues and that is the concern that we need to address.
Let's talk for a moment about what is in Part D. The coverage includes most FDA-approved drugs and biologicals. It uses the Medicaid coverage decisions definitions. There are a few exceptions. Part D includes other items that aren't normally considered covered - smoking cessation agents, vaccines and insulin, insulin-related supplies, such as syringes, needles, alcohol swabs and gauze, but not lancets and test strips.
Excluded from Part D - and this is the most important thing in terms of scope - are the drugs that are currently covered under Medicare Parts A and B. That means that, for instance, drugs that are prescribed and dispensed from an outpatient hospital pharmacy are not covered under Part D. Oral drugs that are currently covered under Part B of Medicare, like EPO, are not covered under Part D. So we are not talking about a hospital pharmacy environment. We are talking strictly about a prescriber to retail pharmacy environment.
Other items excluded from Part D are agency use for anorexia, weight loss or gain, agents to promote fertility, symptomatic relief of cough and colds, prescription vitamins, et cetera, non-prescription drugs, out-patient drugs, for which the manufacturer is seeking to require associated testing or monitoring services and barbiturates and benzodiazepines.
That concludes my remarks. Are there any comments or do you have any questions I can answer?
DR. HUFF: So forgive me if I'm naive, but would IV medications that were to be administered at home be covered under this plan? So if a physician prescribed an IV to be given or a home health service - drugs given through a home health service, would those be covered under this?
MS. TRUDEL: If it is covered under Part B of Medicare, it's not covered under Part D.
DR. COHN: Stan, did that answer your question or is that something you need to keep as an issue to explore further?
DR. HUFF: I don't know what's covered under Part B, so - (laughter).
DR. COHN: That's why I was asking you the question whether -
MS. TRUDEL: My best guess would be that this would very likely be covered Part B services.
DR. COHN: But I think that that is an issue that we need to be very clear about what is Part B, though. Of course, it does beg the question of we certainly don't want to live in a world where we know exactly what is happening with Part D covered services but don't know anything about any Part B drugs that the patient may be administered or otherwise getting. So there needs to be some way to handle both.
MR. BLAIR: Karen, there's two different references in the law. One is to medication history, which is a little more clear, but the other one is to patient history, and I couldn't find very much of an explanation of what was meant by patient history. Do you have any insights on that?
MS. TRUDEL: I would agree that the statute isn't particularly clear in defining any one of those things, but medication history, to me, is exactly what it seems to be, the patient's current and previous history of prescriptions, including any allergies. That seems a little bit easier to quantify.
I think there's a lot to discuss with respect to medical history, because there is a lot of medical history that is relatively irrelevant to prescribing, and I think there are some questions there about what are the pieces of information that are most germane to quality as it relates to prescriptions and to medications. So I think that is open for some discussion in terms of both relevance, the availability of those pieces of data, how those pieces of data might be gotten to the prescriber, and any privacy implications also relating to that. I think there are a lot of open issues there.
Kelly, do you want to add anything to that?
MS. CRONIN: Not right now.
MS. TRUDEL: Okay.
DR. STEINDEL: Karen, I am equally confused as Jeff and I think everyone else is about the statement, patient history, and I do think it is something that we need to define better, but one thing that I might want to ask is, coming from the laboratory community, where in Medicare they were charged with giving - quote, unquote - diagnosis codes for patient history for the reason why a laboratory test is done, would that suffice for patient history? That is a question that I know you can't answer, but I'm posing it like to the subcommittee as something to explore.
DR. FITZMAURICE: It seems to me that there is a large task involved, not just with e-prescribing, but also with getting some of the Medicare databases in shape so that they can be accessed in real time for the e-prescribing.
Are there plans being made to make things like eligibility tables, coinsurance and deductible tables made available to prescribers or to pharmacies in real time from the HIPAA database, from the Medicare databases, and would this be accomplished by the web or does everyone have to have a secure line directly to Medicare?
I realize that is a technical detail, and you could probably say, well, they are working it out, but is there discussion of this and how to make these databases available to the industry?
MS. TRUDEL: Definitely. There's definitely a clear understanding that much of the retail pharmacy world is doing its business real time, and, clearly, that is something that they are thinking about in terms of how do you implement the payment part of -
DR. COHN: Michael, can I just clarify? Because my reading of the legislation is a little different than yours. I hadn't heard that this was a transaction between a pharmacy and CMS, but more between a pharmacy and a prescription drug plan which needed to be responsible for all of those things, but I didn't think of that as a responsibility of CMS.
DR. FITZMAURICE: Well, I'm thinking of the business rules and what makes the electronic community work better and faster and smarter, and what information might a doctor want - eligibility, coverage, drug formulary -
DR. COHN: Yes, but that is all from a prescription drug plan.
DR. FITZMAURICE: And then the pharmacy, when filling it, would certainly want to know how much should the patient be charged when the patient walks out. That's not part of the e-prescribing from the physician to the pharmacy, but it's part of making the whole system working better.
MS. TRUDEL: And, again, I think what we are talking about here is not necessarily people querying Medicare databases directly, but how to make data appropriate through the transaction available to the people who need it at the time that they need it. So I would go farther than to say real-time access to Medicare databases. What I think we are trying to do is to make sure that the appropriate data is available to the right people at the right time.
MS. CRONIN: I think it is important to also know that there are private organizations that are already providing this information, such as ARC(?), Hub and SureScripts, which we'll be learning about through the hearings over the next several months, and I don't know that we know enough at this point, in terms of what kind of data we are going to be getting from the PDP sponsors, once this is implemented. So I think, in the short term, we'll probably be looking to learn from what is already existing in the private sector to make it work.
DR. COHN: Michael, you had a followup question. I'm sorry.
DR. FITZMAURICE: Yes. Karen, you mentioned that you wanted to make sure that the e-prescribing is consistent with the claims and the eligibility standards or the files. Is there also work being undertaken to look at the data content of the existing files to make sure that the definitions are known and consistent, so that when the standards are developed for e-prescribing that the elements we have in common we can pull from those definitions?
MS. TRUDEL: That is definitely part of the work that we need to do, but, again, we are at the very beginning stages of a lot of it.
MR. REYNOLDS: Along the same lines - and I know we keep talking about the same subject, but if you think of the flow of this whole process, it would appear that the Medicare system would be the only one that would have most of this medical history, and it will be key, I think, to this committee, and I appreciate your comments and I'll be looking forward to hearing what that is, but if it is not in the Medicare system, then it would appear that more information would have to be gathered than is currently dealt with between the pharmaceutical situation and the drug store and the physician, and so I think that is going to be, Simon, key to really understand that early on, because that can change dramatically, the whole gathering of information and the whole flow of information that the industry is dealing with currently.
MS. TRUDEL: Right. And, again, I think one of the things that it will be interesting to learn about is the extent to which some of the pilots and demonstrations that are ongoing actually use medical history to inform the prescriber and which pieces of information - rather than the entire health record, which pieces of information are deemed to be the most pertinent.
MR. BLAIR: Karen, maybe you could provide the subcommittee with some help on this topic. As you know, when we have been working on our plan, which was based on Section E of the Medicare Prescription Drug Improvement and Modernization Act, we identified the requirements, both the contextual requirements and the standards requirements, and prioritized those and figured those were the things we needed to address.
It was clear that electronic signatures was important, and so we added that to the work plan, but were unable to locate in the law - in that section at least - any references to a requirement for electronic signatures. I am assuming that it must be someplace else in the law, but it would really be helpful if we could get some help in locating where electronic signatures is referenced in the law and what the requirements for electronic signatures are related to the prescribing.
DR. COHN: I was going to try to answer that one, and Karen may want to chime in, actually, to it.
I've read the legislation, somewhat painfully, but - and, of course, you don't remember every aspect of it, but I don't believe that there is actually any reference to electronic signature, digital signature or anything else in the Medicare Modernization Act. Actually, the references to electronic signature actually come from the HIPAA legislation, and, obviously, were never implemented as a standard.
I think the reason - and, Karen, I'll let you join in on this one, but I think the reason that we have all been talking about the electronic signature is more related to the issues of any sort of narcotic prescription or any other -
SPEAKER: Controlled drugs.
DR. COHN: B controlled - thank you - controlled drugs, that they are sort of a common-sense issue related to the fact that whatever we do with e-prescribing needs to be sturdy enough to enable us to do that, so a clinician, physician who is practicing medicine wouldn't have to do something different when it comes to prescription-controlled medication.
Karen, do you have any further comment?
MS. TRUDEL: No, that is absolutely right. There is no requirement in the MMA for electronic signatures for prescriptions. So what we are really tracking back to is any kind of requirements in the DEA's law and regulations, and we will need to work with them fairly closely on that.
DR. COHN: Other comments or questions on this part?
Oh, I'm sorry. Steve.
DR. STEINDEL: Yes. Isn't there some requirement for signatures from the e-prescribing laws at the state level?
MS. TRUDEL: Some state laws do require that, yes, definitely, and, again, it can depend on whether you are talking about a controlled substance or not, but in terms of is there anything in the MMA itself, the answer is no.
DR. COHN: Other questions or comments?
Okay. I think we bookmark a couple of issues, and, obviously, we are just at the very beginning, but, clearly, this issue, I think, that Stan brought up earlier about Part B, and probably even - for that matter - a little bit about Part A, about what medication is covered and how those relate to the Part D benefit, just to make sure that whatever we do has some extensibility off into those areas. Obviously we heard, I think, a fair amount of questioning relating the application to medical history information which will be something I'm sure we'll be continuing to mull over as we go through a number of hearings, and then I think just sort of a general realization that we are just at the beginning of our process here as opposed to midway through.
Now, our next speaker is Jonathan Teich. I don't believe that he is here yet, so what I am going to suggest is that we take our 15-minute break now and we will reconvene, hoping we will find him - have him join us, or, otherwise, modify the agenda when we return.
MR. REYNOLDS: Could I ask one quick question before we -
DR. COHN: Harry.
MR. REYNOLDS: So are we, in fact, adding electronic signature to our task -
DR. COHN: Well, we'll be talking about that this afternoon. We'll be reflecting on our work plan.
(9:48 a.m.)
(10:18 a.m.)
Agenda Item: State of the Art E-Prescribing
DR. COHN: Well, Jonathan, we are very pleased to have you here.
I was going to sort of introduce you as being from Partners Healthcare in Boston, but I understand you have recently taken on a new role as Chief Medical Officer for Health Vision - is that correct? - so welcome and congratulations.
I understand that you are presenting basically for the e-Health Initiative today in your role working with them around sort of the future and the art of e-prescribing.
DR. TEICH: That is correct.
DR. COHN: Okay. Well, welcome, and thank you for joining us.
DR. TEICH: Thanks, Simon.
I think handouts are circulating as we talk.
We were doing a lot of scrambling to get the handouts as well as the projector, I think, all appear at the same time, and we had a race to see which one would get here first, and I think both arrived at the same time. The lesson I think we can take from that is that nowadays there is so much technology that it serves as its own backup. We can have handouts. We can have projectors. I can give you each a small thumb drive that has the presentation on it. There's the times when you had to have a few extra transparencies with you, just in case everything kind of hit the fan are now past us.
Thanks for the introduction, Simon.
I speak, indeed, for the Foundation for E-Health Initiative, and also for about 75 persons, some of whom are in this room, from pretty much every possible sector of the prescribing process - physician groups, patient groups, some of the information brokers that are involved, drug companies, pharmacy representatives, PBMs and many others who joined with me over the past 12 months to create the E-Health Initiative's Rapid Acceleration of Electronic Prescribing Project, which we will describe in the context of this talk, and all these people have worked very hard to look at every possible aspect - what are the things necessary in terms of standards, in terms of incentives, in terms of appropriate design criteria, in terms of usability and in terms of data exchange - all the things that are necessary to take these prescribing devices and make them serve the greater needs of safety and quality, improved cost profiles and much better communication and data exchange.
So this morning I was asked to give something of an Electronic Prescribing 101 talk, talking about - really giving a background of what electronic prescribing is, talking about some of the many different aspects of it that I think people don't quite realize, and then going on to talk about some of the areas that we have worked in in our project, particularly in areas of how can one improve the process, what is necessary from a policy standpoint to grease the skids, so that manufacturers can make better products, so that physician groups can use them better, that pharmacists can be able to make much better use of the whole piece of information, all in the name of better patient care.
So the first thing that is worth saying is that we are talking Electronic Prescribing 101, and when we say electronic prescribing, we are looking at pretty much any system that uses a computer to assist in creating a prescription in one way or another.
The definition of electronic prescribing has been debated in great part among our people because there are so many new aspects to it right now. Electronic prescribing includes not only using a computer to make a prescription, it also includes being able to get that prescription sent over to a pharmacy, whether it be a brick-and-mortar pharmacy or a mail-order pharmacy. It includes all the aspects of what we call clinical decision support, all the different things that use alerts and reminders and various other kinds of complaining to get you to do the right thing to prevent safety errors, all of the different things that are involved with integration with the electronic health record as well.
So we will talk about some of these different levels. We will spend some time talking about the promise of electronic prescribing that we can tell from existing studies, the potential for it and what is necessary to make this really work in the most optimal fashion. What is the barrier right now? Why is it that only a small percentage of physicians right now are actually using this? What are some of the things that we and you can all do to get past this?
Actually, if you'll excuse me for one moment. I see a couple of slides have been hidden, and I am going to take the time to get them all unhidden, so that what I show you matches what is in your books, and so that I am not surprised either.
So this gives you a simple look at one aspect of electronic prescribing.
As Simon mentioned, I do several things, so I'll get my own disclosure out. I am a physician at Brigham and Women's Hospital and Assistant Professor at Harvard Med, worked developing the Brigham and Women's computerized order entry systems and some of their clinical decision support and electronic medical record systems for about 10 years, and then, not quite so recently, Simon, actually, about four years ago, went to help in the formation of Health Vision, which is a company that produces various kinds of clinical information systems across the secure internet as well as community systems. So I am not only the speaker for the group, I am also a client - (laughter) - and, as I mentioned, our group comprises many people from public sector, private sector, commercial and academic, and, really, one of the things I would like to thank the Health Initiative for is their uncanny ability to get people into a room who possibly may be at each other with knives and hammers if they were finding each other in a different room, and somehow getting everyone to check their egos at the door and being able to work together on a community project like this.
So this is an electronic prescribing application, and, in this case, it shows you a couple of typical aspects. This is what a doctor might see when they go to write a prescription.
Up on the top, I see the patient's existing medications and I can manage them. I can renew them. I can change them. I can discontinue them. I can print out patient educational materials, whatever else needs to be done. If I get a renewal request from my pharmacy, I can see that and send that back out to the pharmacy. If I get some new information from my payer that tells me the patient has changed medications and the patient has allowed me to see that, I can see that as well.
So I can manage medications up at the top.
Down at the bottom, I can simply - I can choose from some of my favorite prescriptions or I can choose any particular drug name that is in my dictionary and write a prescription about that.
The fact that there is a favorites list gives you one hint of some of the work that we have done, because, from a physician standpoint, what this has to be is fast. In terms of what a doctor does during their day, speed, speed usability, cost profile and then probably speed are their top five or six criteria. So anything I can do to, for example, have their most common prescriptions appear quickly will make their lives better and will make them much more likely to adopt this technology.
Having chosen the medication - in this case, baby aspirin - I have what amounts to a prescription form here. So these things have all been pre-filled because the dictionary knows pretty much that baby aspirin typically gets prescribed in this way - one capsule a day for a month - and all I really have to do - if this looks okay to me - is say, done, and that prescription is now out and ready to go to the pharmacy in one paper or electronic form.
There are some other things up here that are worth noticing. Up near the top there are a couple of lesser drug interactions, really moderate alerts telling me that some of the other drugs that the patients take may interact with this, and this is listed here on this form, because they are actually possibly lesser importance or they are listed as moderate. I'll show you in a second what it looks like when you get a really big, Harry, please pay attention to this alert.
Down at the bottom, I have a couple of various kinds of options, so I can choose to add this to my favorite list. I can print out do not substitute or whatever is required by the different states. Each state has their own particular wording for this, which dries the manufacturers of these products crazy, and which we'll talk about a little later on. I can print out information for the patients or for myself.
So starting from core prescribing, I have now layered on some clinical decision support. I have layered on some extra information. I have layered on the ability to send this directly over to my pharmacy and many other possibilities.
This is a major alert, and, really, one of the last things I'll need to show in the basic introduction. In this case, this says that two things have gone on. Number one, up at the top, it says the patient is being prescribed aspirin, but the patient already takes another nosteroidal anti-inflammatory agent, in this case naproxen, and so while it is possible to give a patient both aspirin and naproxen, one should do it with care, and so it is worth making sure that we know this.
Secondly, down at the bottom, it says there is a major drug interaction because this patient also takes warfarin, also known as coumadin, a serious blood thinner, and aspirin also is a blood thinner, so very, very few people should be on both of those together. So the fact that the system knows that this patient already takes warfarin puts it in position to give me a resounding alert when I ask it to order aspirin. This is a large part of the promise of electronic prescribing. Many, many errors of this form happen every day in this country. There are numbers to support this, and having alerts like this has been shown, in many instances, to lessen, by a significant amount, the number of such errors, and the number of adverse events that come from them.
DR. COHN: Jonathan, could I just ask a question, just in the interests of full disclosure -
DR. TEICH: Sure.
DR. COHN: - since I see this appears to be a product that looks like you have probably been involved developing?
I just was trying to figure out whether or not - is this a specific e-prescribing application or is this a module within a larger application, and, if so, is this practice management software, is this electronic health record? What is this?
DR. TEICH: Sure. Absolutely, Simon. This is a - this happens to have been developed by us, but it is typical. You will find this in many - I just happen to have more easy access to those slides. There are a number of major vendors, manufacturers that produce these things. In this case, this happens to be a desktop application in the setting of a larger electronic medical or electronic - electronic medical record. So as I see down the side here, you'll notice I can also look up patient's lab results. I can look up reports. I can send out charge coding. I can do problemless management. So, in this case, this application is integrated within a full-scale electronic medical record, and, shortly, when we start talking about the different levels of sophistication of electronic prescribing, that will become very important, because, in fact, the more supplemental information I get, the more I am able to provide more and more active support to the physician, the pharmacist and everyone else.
Clinical decision support, as I mentioned, is really active participation in guidance, in routing, in feedback, tells me where to send this, what to do with it. There is safety-based clinical decision support, which I just showed you, passive kinds, such as asking for a reference to be displayed or active kinds like what just happened. The computer actively looked at the order and said, I better tell you about this. This was a reactive alert, in that it reacted to something I had done, the ordering of aspirin. There are also proactive support. For example, I may start with the program and say, my patient has ulcers, colitus. What should I prescribe, and it might give me a list of various kinds of typical medications or even typical drug regimens that would be appropriate for this.
There is also reimbursement-based clinical decision support. In the electronic prescribing world, that typically revolves around formulary issues where I know that my patient's payer will support one drug of a given class over another, and if I happen to order the more expensive one or the less desired one, as far as the formula is concerned, it will at least let me know that and let me know the others that are in the class.
There is also just-in-time information, the ability to actually pull up patient reference material, physician reference material, any other kind of things that are germane to the process right at the time when I am ordering, and all these things. There's a whole science and a whole skill behind all of these. Certainly, people have learned over the years the best ways to show this so that it has the least impact on making life harder and the most impact on making sure people actually see the alerts when they are needed and not when they are not.
Electronic prescribing also takes the form of hand-helds, and you have probably heard quite a bit about that. This is a screen from a hand-held device, which shows an electronic prescribing application.
In response to Simon's question, this one is a standalone application. It is not, at this point, part of an integrated record. Typically, the prescribing applications today that are on PDAs, handheld devices like this, are often purely prescribing and prescription-management applications. Although, there are some now which start to include integration of results and electronic health records as well.
The choice of using one or the other has a lot to do with the logistics of the physician's day, and it may be that if a doctor is roaming around, going to several different exam rooms, it is maybe more convenient to have one of these things that they can go with and travel quickly or to have a wireless laptop, such as this, a little bit heavier.
If the doctor tends to work from an office-based practice and uses one place, they may find it more desirable to use the desktop, which has a little bit easier input, but both of them do essentially the same thing and can run off the same kinds of data, and this is really included to show you that both of these occur, and many programs now in many states are supplying physicians based on payer support with devices just like this to be able to both write prescriptions and to send them out appropriately.
Active prescribing support means you can go a little bit farther than just warning someone when I ordered a drug to which the patient is allergic or a drug that interacts with something else.
The active prescribing support refers to the fact that these things can guide care to a little bit higher degree. It can look at a patient's list of diseases from a problem list. If it is part of an electronic medical record or if it is connected to a larger electronic health record, it can look at the patient's problem list and realize that this patient, for example, has hyper-cholesterolemia, but is not on a statin, so it can give you that kind of proactive guidance.
It can know that you are on some sort of disease-management protocol, so a patient who is on a diabetes protocol, it can tell you that the patient's hemoglobin A1C, the chief marker, has been elevated, and that perhaps there should be an increase in the patient's drug regimen and will give some suggestions about that.
So as well as giving you just sort of one-for-one, you-do-this-I-tell-you-it's-bad kind of feedback, these systems, as they get more sophisticated, can start talking about entire protocols of management.
From the pharmacy side, we can send you a reminder that this patient is due for a renewal, and if the patient hasn't come in for a renewal and quite some time has passed, perhaps the patient is having trouble complying with his prescriptions, perhaps he is not able to afford them or take them in the right way, so perhaps a reminder can come out that says, gee, based on what I gave your patient, she should have had a refill right about now, but, in fact, it's two months later and she still hasn't done it. Maybe you'd like to check into this.
So there's a variety of ways that you can get supplemental information, subject, of course, to patient permissions about confidentiality and privacy in allowing you to do this, that really can make this do much, much more as you sleep and it thinks and gives you some extra advice.
These things do not set plans of care. They do not make diagnoses for you. They are not like an expert consultant that tells you what you should be doing with your patient.
We like to think that they are more like a really, really meticulous medical student who doesn't quite know exactly what to do, but says, boy, that number is really high. I'd better tell somebody - (laughter) - and that is probably the best way in which these things work.
Communication has also become a significant part of the electronic prescribing world, and here I am showing just a few of the various transactions that go on among the physician, the patient, the pharmacy, the health plan.
From physician to pharmacy, obviously, we want to send a prescription that can be sent in by paper. It can be faxed. It can be phoned in, and, more and more, it can be done through an electronic communication, which makes a lot of things easier.
The pharmacy can call back because they found something wrong with the prescription or they can send you reminders because renewals are due.
The patient can request renewals. Currently, they do this by walking into the doctor's office and saying so. More and more, patients are being allowed to do this, to some extent, on line, using public internet sites that their doctors provide.
Patient to the pharmacy, again, presenting script, requesting refills, having the pharmacy tell the patient they are due for a refill.
All these different chains of communication, claims and approvals that go to the health plan. Health plans now have the ability, in some cases, to combine and aggregate a patient's medication regimen from many, many different physicians, and be able to supply that in one lump, so that you get an organized view of what the patient is taking, regardless of how many doctors and nurses they are seeing.
So all these different communication channels go on every day, and over the past - especially over the past 24 months, there has been a great deal of activity in trying to make these things work much better, trying to make them much more universal and to set standards, some of which you'll hear about from myself and others later today about making these things universal, so that one system can talk just as well as another one can.
At a higher level, once you have gone past basic prescribing, clinical decision support, extra information, communication, now we talk about the issue of integration with the entire electronic health record.
Here, we look at the medications on the right there in context. This is a patient summary, and the patient shows - this is what I would look up when I first see the patient and want to get an overview of what is going on. Here is the patient's problems. There's their procedures. This patient had a flu shot. Patient's recent laboratory tests. Patient's allergies over here. Recent visits, and their medications.
So, again, here is the medication application in context of an entire health record, and, again, there is yet more value to be obtained here, because, now, I have access to the patient's problem list. I have access to allergies. I have access to laboratory results, which may tell me that that hemoglobin A1C is too high or that INR is too low and that I have to adjust medications accordingly.
So, in many cases, the more information we can get, the better we are able to help the physician, the patient, everyone else support this.
In our work, we established this pyramid.
The e-Health Initiative's report on electronic prescribing is going to be coming out officially in a presentation in this town on the 14th of April, and you are seeing some advanced notice of some of these things, some of the findings that we've got.
This pyramid really indicates several different things. It shows where you would like to get to and how you can get there. So at the different stages are the different levels I talked about - basic prescription entry, checking allergies and formularies, being able to manage the entire medication profile, being able to have extensive connectivity and being able to be connected to electronic medical record applications. All of these are possible. There is no question that, as you go to higher levels, you get more benefits, and, in fact, if you look at some of the work done by Center for Information Technology leadership in Boston, who have done analysis of value of these, the curve actually gets kind of steep as you go higher and higher. So, in fact, you get more than just a linear level of benefit increase as you go up.
At the same time, we recognize that there are practices in one context or another that want to start small or have to start small, do not have access to some of these features. So we would like to make it possible for people to get in at a variety of different levels, and perhaps this could be not only a statement of value, but also a statement of a ladder pathway, so that in places in the country where, in fact, connectivity is not very good, where electronic medical records are not widely used or where, for cost reasons, they are not ready for it just at that time, people can start out with something which gives them a significant amount of benefit and then be able to have a pathway to go to higher and higher levels as well.
So all these are important. If one was considering defining an electronic prescribing application, I think that it would include all of these things, and, in our steering group, when we met about this, there was a great deal of debate, and we did really reach the conclusion that all of these comprise electronic prescribing, but, again, value goes up as you go up the chain.
The promise of electronic prescribing has a lot to do with the different kinds of things it can prevent, the different kinds of things it can support, quality, safety, cost, pictures.
Much of the information in electronic prescribing comes, right now, from the inpatient sector, as we have much more data on how medication ordering goes in the inpatient, order-entry environment.
Computerized physician order-entry systems have had significant impact inside the hospital in preventing adverse events, in supporting better use of drugs of all kinds, and, in fact, in supporting better drug utilization as well.
This data from our work at Brigham and Women's shows the impact of an inpatient prescribing system, and, in this case, what we are looking at is before order entry went into place, about two percent of all orders for medications had what the pharmacist considered an overdose. It was an excessive dose, too much narcotics, too much lasix, whatever it might be.
Immediately after putting in a computerized system, which didn't have very much clinical decision support at the time, but which had simply dose guidance, that number dropped by a factor of four down to 0.5 percent. Significant number of fewer errors, and we noticed a significant number of corresponding adverse events that went with that, and then, with additional improvements to the system over the years, the number went down even farther.
So, clearly, the ability of the system, simply by telling you what the right dose is, to be able to help you along, is very important.
If you look at how many doctors work - particularly younger doctors - when they are looking for a dose for a drug, they know the patient is supposed to be on amoxacylin. I don't really know how much amoxacylin, so I'll go look in this little book, and it says, oh, you know, sometimes it's 500. So I think, okay, I'll write down 500. There is sometimes a culture of people who want to make sure they get an answer and aren't quite sure whether it is the right answer, but getting an answer is sometimes better, so sometimes people jump the gun on that, and having something like this, which gives you a better, more sophisticated guidance is very important.
In addition, the ability to promote appropriate drug use can be very powerful. This shows an intervention which fostered the use of a recommended formulary-based H2 blocker, essentially an antacid.
There were several different kinds available, and because of formulary reasons - in this case, it was cost-based - the hospitals, pharmacy and therapeutics committee recommended using one instead of the other, the favorite one was only getting about 15 percent of the prescribing share, until a simple intervention went into place inside the order-entry system, which said, we really would like you to use this, and, as you can see, almost immediately, the number went up to 85 to 90 percent.
Fortunately, not every intervention gets this kind of almost sheep-like compliance. We do want people to be thinking about their interventions. The doctor is supposed to make the last choice, but it is important - very often, they didn't have a problem with this. There was no real difference to them, but since this thing was presented to them at the right moment, they remembered it and were able to do it, and, again, there's that medical student, again. They present the information to you at the right time. You probably already learned it, but because it is there when you are prescribing, you can do this.
There is less data right now on the impact of ambulatory prescribing systems, because they are so new. There is, however, an increasing body of studies which shows that this is going to make a difference.
Again, this is work from CITL.
Savings from preventable adverse drug events in the office. Two million adverse drug events - according to extrapolations - can be prevented using IT in the ambulatory practice, accounting for - if you divide it by the number of visits - about $4 per member per year.
In addition, there's about 10 percent average rate of overused medications that are medically unnecessary, possibly about three to five percent under use of necessary ones. When you average it all out, you get about $35 to $70 per member per year from overuse and under use. So from a financial picture, you are not only saving money from preventable adverse drug events, you are saving money from overuse and under use of medications to the tune of somewhere between $40 and $75 per year per member. Part of the difficulty comes with who that savings actually passes onto.
So we talk about the promise. We can see this thing can make costs better. We can see this can make safety better. We can see that it can promote quality through proactive interventions. We can see that it can make communication better and allow us to keep better overall integrated records - things aren't lost in between different physicians - so that patients don't get as many medications from different physicians, so that patients, in fact, who are trying to abuse the system have a harder time going to different physicians and getting the same medication, but there are still significant barriers.
Doctors are concerned about several different things. Right now, penetrans of electronic prescribing in the physician community in this country is - depending on which study you read and how you define it - somewhere between five percent and 18 percent, so definitely not a majority. It has been growing, primarily due to many payer-sponsored programs and pharmacy-sponsored programs that are actually pushing these devices out at little or no cost to physicians.
You have heard probably about many of those in different areas. There is one up in my area - there are two up in my area right now from two different payers, from Blue Cross and from Tuft's in Massachusetts, and all this is applying costs - there's a problem in that that cost-free basis for physicians may not be a sustainable thing, and they may have to be paying for it after the trial is over. So there is some concern about that.
But from a doctor's side, what are they concerned about? Why don't they go into this? They are concerned about cost. They are concerned about the fact that they have to buy it, that they have to install it, that they have to pay various kinds of costs, possibly, for connectivity, if they need to, and they are concerned, even more, as I mentioned, about speed, about time.
When you first start using these systems, like any other piece of technology, it takes a little bit longer. We have been able to show in the inpatient environment that that time extension goes away after about four to six weeks, but during that time, you have some decreased productivity. You do not currently have any kind of direct reimbursement for using direct prescribing on an electronic basis. There is not an RVU attached to it, and there is really no reimbursement right now for costs and for resources.
The safety improvements have to be completely documented. There has to be really kind of a bandwagon, a swell of support, in much the same way that has been happening on the inpatient side. Those improvements need to be demonstrated clearly, and they need to be fully publicized.
And since it is not considered the standard of practice since one isn't, in some sense, required or expected to do this, then, there is a need to say, well, maybe somebody else should be first.
Obviously, several things have happened to change that. Certainly, the passage of the Medicare bill last year has gotten a lot of people to notice things. It did not include a mandate, which was fine with many folks, but it did include various kinds of expectations about how payment will be going on and how demonstrations will go on, so that, in fact, people are starting to see that this is coming.
There are laws in a couple of states. Florida has a law mandating legible prescriptions, which, if - I believe if I was a Florida physician probably is the same thing as mandating electronic prescriptions. California has laws mandating information technology in one kind or another. So there has certainly been a groundswell of various kinds of things on the policy side as well that have started to make this standard of practice.
There has been a cost issue in that, in many cases, hospital systems have been desiring to provide this technology out to their physicians in their community, but haven't been able to do so because of potential anti-kick-back laws.
Over the past two days, we noticed that CMS has put in an NPRM of an exception to this specifically for community-based health information technology, which we applaud because as the CMS notice itself said, we don't think this constitutes any kind of potential for abuse. We think it constitutes a great potential for improving care and for extending the community out. So those may be some potential incentives that have already happened that are bringing this forward.
So in our steering group, when we looked at the different kinds of members of the prescribing chain - to the pharmacist, to the PBM, to the manufacturer of systems, to the manufacturer of drugs - it came to be clear that while there are some barriers in all different steps, probably the largest barrier right now is in the physician's office.
There are various positive economic directions for most of the other people in the chain to be able to use this. So from a business model, the pharmacist probably gets some certain benefits because of better clerical support, because of better record keeping, less transcribing they have to do, the ability to do things like promote refills. From the standpoint of the vendor, obviously, it is useful because they can get more systems out. From the standpoint of the payer, the ability to do advanced compliance with formulary is a cost benefit to them.
So, really, we were concerned primarily about physicians and the fact that it is the physicians who need to have the appropriate usability and design issues, as well as the appropriate incentive issues.
So from a doctor's side, carrots and sticks. There need to be proven - Safety quality improvement, as I mentioned, it has to be easy and fast to use, and there have to be some kind of financial balance sheet one way or another that makes some kind of sense, and whether that comes in the way the cost picture goes or some other things that we'll talk about later in this hour, certainly, that is probably one of the things that physicians look at as they look at their barely-breaking-even kind of day.
The e-Health Initiative and the Foundation for e-Health Initiative, as you are aware, is a pair of connected non-profit groups that are in the project of trying to combine different forces, different stakeholders in many, many different ways to work on policy issues, to work on better planning issues and to do anything possible to try and create a much-better-connected healthcare community through electronic information technology.
There have been projects from eHI on to connecting for health. Many of you are familiar with this in terms of standards and tools for interconnectivity among different hospitals and different health plans and different health providers within a community and even nationwide. There's been - the newer aspect now has been a grant program that has been able to support various communities in developing these connected health systems.
eHI has developed the Electronic Prescribing Project. This was founded about a year ago, and, again, as I mentioned, this is this multi-stakeholder group devoted to the rapid adoption of computerized prescribing, and, more particularly, to the rapid adoption of the benefits of computerized prescribing, and so we have all these people working on this to try and create a unified voice for practical and workable incentives, and one of the good things about having all these people in the room is that we hope that the findings that we are talking about today and publishing on the 14th are such that no stakeholder can say, hey, you forgot to consult us when you made these.
Looking at design input, so we can get useable and fast systems, making sure that the manufacturers know at least how to set a floor under themselves for good design and to support demonstration projects that build some momentum and awareness, confirm the value and help identify the best practices, many of which are coming through the connecting communities project.
The electronic prescribing group has a steering group of about 35 persons - again, a number of you are in this room - and under the steering group, we had several different discussions. We looked at chief guiding principles. We looked at the core issues that are going to make it important. We looked at the major things that we needed to say so that people outside had a common voice on what electronic prescribing is and should be, and, as I'll get to in a moment, we established two different areas in incentives and in design implementation.
I have mentioned the stakeholders several times, but now you have a paper copy of that.
The first thing the steering group did was look at guiding principles, and, as you can imagine, with this many people, different kinds of stakeholders in the room, it was a very animated discussion, but, really, these are the primary things which came out. These are the guiding principles that have to come out to make electronic prescribing both workable, adoptable and of high value.
Number one, obviously, there needs to be implementable and useable systems. They have to be something you can put into your practice or your pharmacy. They have to be something that you can easily use and that handle the different kinds of work conditions that you want.
Number two, it has to work in a variety of different practice settings. Many of us who are in the group tend to be fortunate enough to come from larger academic areas or places where they allow us time to go and have these discussions, but we have to realize that there's small practices, large practices, rural, urban, many, many different flavors, which have different criteria to them. So when you develop these systems, when we develop things like the pyramid, we have to understand that different practice settings will have different kind of capabilities and we need to be able to support all of those to one degree or another.
Number three, there are areas where standards are very important. In some cases, standards have been well adopted and well established. In other cases, there are certain standards which are not yet well established and which are causing some concern, including state-to-state variations of prescribing standards, as well as standard dictionary forms for different kinds of medications at the doctor level.
Number four, we want to encourage the creation of appropriate incentives and appropriate education to support electronic prescribing.
And, number five, definitely placed here so as to be not least, that electronic prescribing needs to encourage the physician-patient relationship and has to encourage choice. There can be nothing in the computer that suddenly tells you, hey, why don't you go over to Joe's pharmacy, even though you really want to use Jane's pharmacy. Why don't you use Payer Y, even though Payer X is doing the following.
We do not want to make electronic prescribing a tool for advantage. We need to make it a tool for opportunity, and the choice of what to do and where to go to get drugs dispensed needs to reside clearly in the hands of the patient and the physician or other practitioner.
So there are a couple of key objectives.
Design and implementation. That group was established to develop and widely disseminate general design and implementation techniques to two different groups in particular:
Providers, so that they could understand what it is that they should be expecting.
To manufacturers, who have come to us and told us that they have good designers, but they would love to have some common tools to work with and have some common information that has worked elsewhere, so that they can make the best design quicker, so that they don't all have to do the same R&D.
To encourage development of excellent tools, that has to support the workflow of the physicians that have to support patient safety and that is able to educate both patients and their own care givers. That group was established and many of those findings are what we are doing right now.
The incentives group was chartered to identify and promote the adoption of financial incentives, regulatory incentives and any other kinds of incentives that could present compelling forces to generate accelerated adoption, to enhance cost effectiveness and to increase value to all parties that are involved in the use of prescription medications.
I am going to talk a little bit about some of the design issues that are germane to some of the things that the NCVHS requested of me in this particular talk.
The Design and Implementation Group looked at the different stages of prescriptions and prescription writing and prescription management and set up six different subgroups that looked at various different aspects.
The Incentive Group particularly worked on two different areas, pay for performance and education.
On the Design Group, the work that has come out has essentially been geared in imperatives. All of this is supported by about a 100-page report, with a number of different specific examples, specific worksheets, and, in some cases, how-to guides for getting some of this done, but, certainly, there is a usability imperative, and I have mentioned this several times, so you know it probably is important.
Obviously, speed and convenience, easy implementation and - I don't think I meant to write speed twice, but I think you get the idea at this point. You have to support the actual models of prescribing. We can say, well, a prescription is something written by a doctor. Well, that is not necessarily true. In most states, nurse practitioners and midwives can write prescriptions of various kinds. Obviously, when I include doctors, I include both D.O.s as well as M.D.s and dentists, and, in many practices, there's different kinds of work flow. Sometimes, someone who is not fully authorized to write a prescription may generate the initial prescription, have it go to the doctor for signing. So we think about a Level 2 user like a nurse who can do that, perhaps even a Level 3 user, who might be a medical student or a resident who needs to write things that can't go forward until the doctor signs it.
So you have to actually support the kinds of workflow that actually goes forth in a real provider office, and some of the applications that are out there right now do not do this, and so when we looked at our design criteria, we wanted to make sure that people knew what it was that makes prescribing actually work in a real practice and to make sure that all the manufacturers, as well as all the providers, had an expectation that they could do some of these things.
It needs to be accessible in all places where prescription writing is needed. Prescriptions are written in your receiving office. Prescriptions are written in the exam room. If you consider it to be ambulatory practice to include emergency and urgent care, prescriptions are written there, and, very often, prescriptions are written or generated from your home, when someone calls you up or when your office calls you or perhaps you had a different practice that day. So there is remote writing as well, something which is very well fostered by electronic prescribing, something which is, in fact, very hard to do in the paper world.
We know that people are worried about making processes harder, worried about if I have to sign into a computer, it'll take longer. If I have to type something, it'll take longer. There's much less techniphobia than there was when I started in this business 15 years ago, but, certainly, there is still some skittishness.
So to balance out some of these things, one has to make some things easier. Refills are much easier to do when you already have an electronic list of the patient's existing medications. Most prescribing applications that are out there in the market right now can do refills of about 10 different medications in about 10 different seconds, and that is much different than a patient who comes in for their annual checkup and says, well, doctor, I'm here. Here are my 13 medications. I need all of them renewed; and, by the way, this is a 10-minute visit, and it takes me about 9-1/2 minutes to write all those things out longhand. So it is important to be able to have this kind of tool. So that is clearly an advantage.
Favorite medications, as I showed you on the first screen is an advantage, being able to do certain kinds of things like split prescriptions. Very often, a physician will want to write a patient for a long-term medication that is going to be given out by mail order. The patient wishes to do mail order because of convenience and cost issues, but, at the same time, it is going to take a week or more for that mail-order prescription to get there, so the doctor splits it. They give the patient a paper prescription for the first week's worth, and then send something off to the mail order. There are applications now which support that, so that in one flick of a button you can actually send both of those things out.
So you have to look at the workflow that goes on in the office, support the things that work better, the things that you can gain advantage of, and then try and make those better.
Obviously, there is a great deal of efficiency gained - and this has been demonstrated already by several studies - from a reduction in pharmacy call backs, because the prescription has been checked, to some extent, beforehand, and, also, more and more now because the call back happens on an instantaneous basis, so I don't have to wait until a patient arrives at the pharmacy before the pharmacist is able to have their say. The pharmacist sees it right away.
So many, many different processes can be made easier. These have to get into the regular flow of all products that are out there so people can make use of this and like the systems they are doing.
Safety, we have mentioned several times, but since this is really the fundamental good goal coming out of this, we care a great deal about it. Obviously, supporting safe care through proactive and reactive guidance, being able to facilitate, as I just mentioned, instantaneous order feedback and compliance initiatives from the pharmacy, being able to have both basic and advanced clinical decision support, being able to comply with guidelines and help promote the appropriate use of medications for patients who should or should not be on them, and, again, obviously, being able to instantaneously provide educational materials.
Prescribing applications in the computer can have instant access to the appropriate questions and answers. You may think about as you are prescribing a drug, gee, can I use this in pregnancy, and instead of having to go off to a reference book, the answer may be one button away on the screen. So safety imperatives must be part of all prescribing systems.
Reimbursement imperatives come from various things like formulary support, and this includes the ability to display that certain medications are favored or not favored, on or off formulary, have higher copays, that alternatives choices are not only available, but are instantaneously displayed on the screen, that the reasons for the alternatives can be displayed, that drugs which require prior approval can get so right away, instead of after three different phone calls back and forth to your pharmacist, that drugs that are approved only for limited use can be encouraged and enforced to do so in that way. All these things happen through what amounts to relatively basic logic, but stuff that can be included in every system.
Prevention of overuse and under use, as I mentioned, the cost correlates of safety, the fact that preventing adverse events, in its own sense, not only makes people healthier, but also saves money because of all the extra testing that is not needed, the extra care that is not needed.
Substantial financial savings are possible, and, again, as I mentioned, these tend to be right now, not generally directed right at the physician, and so there is, in some sense, an incentive imbalance that needs to be worked out.
And then, finally - actually, not finally, but next - connectivity. Connectivity provides a bunch of different benefits, as I mentioned earlier on, but just to list them again, the potential for access to a complete medication regimen, including things you get from multiple practitioners and things that you may even have yourself enlisted on your own personal health record.
The ability to enhance efficiency for all, as you can see, quickly, how to renew medications that go across different practices, the ability to have that connectivity that can enhance anonymous aggregated data for research, so that we know what drugs are having what effect on what problems, so we know the prevalence of use of various things, so we know the prevalence of various kinds of adverse events, and also for things like public health surveillance, because the enhanced use of certain medications at a time may indicate that there is an enhanced problem going on in that community. If I suddenly see a lot of people using flu vaccines and anti-flu medications in a community, that may indicate that there's some sort of epidemic going on locally that may be a public health concern.
Two-way communication is very important, obviously, and connection to inpatient systems is equally valuable.
We want people to be able to have medications in the inpatient setting, be able to transfer them readily into the ambulatory setting, because, believe me, they are not, most of the time. There is a great deal of disconnect in going from the ambulatory care into the hospital, getting the right medications and then getting them turned back into ambulatory medications on the way back. That is a significant source of omissions, a significant source of new interactions and a significant source of errors.
We want you to be able to have your ambulatory record, your inpatient record, your home record, be available to all your practitioners, even if I use a system made by one company, you use a system made by another company, you use a system made by a third. So the ability to have not only data standards, but also operability standards and connection standards, so that these systems can all talk to each other makes life much, much better. Some of these things are now accelerating rapidly. Some of them are still very much in their infancy.
And then protection for the patient. Some careful reuse of this data is important and valuable - as I mentioned, safety, public health surveillance. There are other concerns, whereby getting aggregated data is going to make a big difference to the state of public health in this country. At the same time, I did say anonymized and I did say aggregated, and one has to be very cautious about this to make sure that provider and patient worries about data being sold and used inappropriately, or, simply, significant violations of patients'privacy and confidentiality have to be protected.
I don't see this as a significant technical barrier. I think that these tools are well in place at this point. Certainly, a lot of the momentum generated by HIPAA compliance work over the past several years has generated a lot of work in this area. So it is not a technical barrier, but it is something that has to be done correctly, and there have to be guidelines for its use. And, again, the choice of pharmacy must also be protected.
And then, finally, in terms of the general specific areas that the design group has worked on, standards and regulatory concerns. I know we are going to hear some more from NCPDP later on.
There's a number of places, in particular, where varied standards - that is sort of an oxymoron, I guess - make development difficult for manufacturers, make it expensive for providers.
I have a book on my desk which is about 150 pages thick which contains the prescription form requirements of the various states and territories, and there are 50 states and six or seven territories that are listed, and that makes 57, and there are about 65 different variations on the theme, including some that happen within a state.
Most of these things are states that are doing pretty much exactly the same intent and same philosophy, but one state actually requires you to say dispense as written, if you don't want a substitution. Another one requires you to say the words, do not substitute. Another one requires no substitution permitted, and each of these must be different. So if you are a manufacturer of a computer system, you have to keep track of these 57 different rules and be able to keep them up to date. Some require the name to be on the top. Some require the name to be on the bottom.
So, in many cases, some of these things are simply formulaic and are simply arrived differently because people arrived at them differently through state boards. It would certainly make life a lot easier and probably make adoption smoother and probably less expensive if there were a way to somehow reconcile some of these differences.
Formulary conventions are problematic right now. The world of electronic supply and delivery of formulary information is relatively new. There are some companies out there now that do brokerage and that they maintain the formularies of several different payers and they provide this in a computer file. So a prescription application can say - when I type out Nexium, it'll say, well, this patient is from Connecticut and uses Aetna, and in Connecticut, the Aetna plan would rather use X drug instead of Nexium, but in a different state, a different plan, they might rather use Nexium instead of something else. So that is okay to have different formularies, but the data conventions right now are in their infancy and it's not so much that you have to deal with the different formularies as that you have to deal with the different brokerages and different standards, and that is something which needs to be improved.
Drug dictionaries. When you write prescriptions, you are using some basic dictionary of drugs. They come from various companies like First Data Bank, Multa-Medispan(?). There are about six different providers of these, and the physicians need to use them so that they can, obviously, pick drugs, so that if they misspell a drug, they can see it quickly. So if I want to write amoxacylin, it says amoxacylin, and not what the pharmacist wants to see, which is the 45 different packages of amoxacylin.
Right now, the coding systems are favoring pharmacists and work very well for pharmacists, but at the doctor level, it is sometimes difficult to be able to select and convey a drug at your level when what I really want to see is amoxacylin capsules and move on from there.
There is work that has gone on at the NLM, the RxNorm project, which is really trying to provide a solution to this, and we look forward to rapid completion and adoption of things like that.
So there are places where standards need to be continued to be updated, where being able to put various kinds of codes into a script standard message or an HL7 message need to be taken care of, and some of these things are things that we have been pushing for in our group as well.
So from a development standpoint, there's a number of different things that are needed to make these things more useable, to make them more connectable, to make them less expensive, to make them easier to generate the benefits that we care so much about.
I am going to talk somewhat about the incentive program, as my last major topic. As I mentioned, we established a large incentive - as well, comprised of the same stakeholders, and they really looked at many, many different categories of potential incentives for their potential impact and for their potential feasibility, and they looked - as you can see in your handouts - about different kinds of economic incentives, whether it be malpractice reform, whether it be handoffs from the pharmacies in exchange for better data, whether it be internal policy things, like credentialing, all of which had to be done, obviously, without generating any kind of kickback concerns.
Public policy incentives. We were concerned about these three acts. As I mentioned, there has been various kinds of progress in at least two of them so far that are making a significant difference to us, and the ability of various kinds of patient safety incentives, like accrediting groups. Jayco(?) is now including some of these techniques. The Leap Frog Group and other sorts of business consortia have been working hard to try and put out various recommendations and try and use their influence to make this standard of care.
Error reporting projects, such as those coming out of CMS itself, as well as things coming out of premier and other large groups, and, again, purchaser and consumer education plans, so that people realize what these benefits are and realize that, in fact, they probably do want to have some of these things, because it makes a big difference, so that purchasers and consumers, the patients, can put a little bit of extra pressure and incentive, saying, I would really rather have a physician that uses one of these systems, because I know it is going to make my healthcare better.
The group rated various of these tools in terms of their impact. Some of the things which came up very high included pay-for-performance programs. As I am sure most of you are aware, pay-for-performance programs are a growing body of programs in which purchasers are providing indirect and sometimes direct reimbursement for the maintenance and achievement of various kinds of care criteria, like the appropriate measurement of hemoglobin A1C in all diabetics or, even better, the appropriate maintenance of low hemoglobin A1Cs in all diabetics, appropriate use of eye examinations and foot examinations and so on.
So that right now, there are a number of projects - I think it is getting past the stage of a pilot - where providers can see direct reimbursement in exchange for providing better care. Certainly, electronic prescribing is one of the key initiatives in many current pay-for-performance programs.
Direct reimbursement for utilization of information is happening through a number of indirect channels. The idea of pharmacies defraying costs certainly has a high impact, although there was a concern with feasibility on those.
Transaction fees, again, high impact balance with some concern about making sure that we are not simply incentivizing people to write for more prescriptions. And various other ones.
And when this came out, these high potential incentives came out of the impact multiplied by the feasibility.
Number one, economics, specifically, reimbursement for utilization of the electronic prescribing in the form of resource value units in the form of actual credits that one can give. Just as one documents various kinds of medical decision making, so one can document the use of electronic prescribing and be able to use that as an RVU-based item.
Pay for performance is certainly one that has been favored, and there have been some work inside our document about having specific pay-for-performance guidelines.
Having third parties be involved - payers, pharmacies, transaction brokers - in terms of not so much incentivizing specific individual prescriptions, but in terms of looking at aggregated defrayed costs and trying to figure out how that financial incentive can be moved up and down the chain.
And, again, the Medicare Act, Stark relief, these things were written before some of these things occurred. The Medicare Act's impact is still not known. Many of you folks are helping us make that impact, and, certainly, it is well known to the people in our incentives group that this is probably going to be one of the big drivers in helping this to be adopted and helping this kind of safety benefit to come out to the entire country.
So, in general, from a policy standpoint, there are a number of things that have to be done.
Certainly, we want to promote standards-based systems. We want to promote appropriate codes, so that people don't have to do multiple different levels of development, supporting multiple different manufacturer standards. We want to have the rapid development of state bridging standards, where possible, so that these things can be unified, all in the name of making it possible to develop these things one time and not 57 times.
There needs to be a floor of good system criteria. Many of the imperatives that I listed earlier on in this talk talk about things which all systems should have in one form or another, and should be able to demonstrate they should have, and should be able to show it in a way that is clearly available to those that are going to purchase these systems.
We want to promote collectives, like ourselves, that do common research and mutual education of such criteria.
Some of the things that go on, providing learning centers, so that both providers and manufacturers can get together and see new things as they come out, perhaps learn from each other, all without suppressing the natural forces of competition and independent innovation, but giving people a piece of groundwork that they can use to build upon.
We clearly want policy to support quality as probably the most important single goal through measurable clinical decision support, and whether that means that incentives are provided for the use of clinical decision support itself or whether incentives are provided for the actual ability to measure different kinds of outcomes, they need to be ones which are readily easy to measure, but the ability to provide some kind of supports that people have that extra incentive to support quality, all providers want quality, but they understand the realities of their own business, of their practice as well, and any ways to support this, encourage it are going to be well rewarded and increase adoption and increase quality.
And we also want to state that electronic prescribing - this whole project - talks about one particular application, but it is important to realize that there is an entire model available here for design, usability, incentives, policy that applies not just to prescribing. It applies to the entire world of electronic health records. It applies to necessary things for the development and furtherance of the national health information infrastructure.
We see electronic prescribing as not just a standalone application, but as a collective part of an electronic record, and we see some of the techniques and brainstorming that was done over the past year as possibly useable and utilizable for these other applications as well. So we really encourage you folks to help us all out with this.
Ambulatory prescribing has substantial potential. We have seen, now, studies that came out recently. You know, 10 to 20 percent of all Medicare patients have some sort of adverse drug events every year. It has substantial potential, and compared to some more expensive systems, like full-flown inpatient CPOE, it may be easier to implement, because of the lower incremental costs.
Usability and incentives are needed to provide adoption and clinical decision support. Communication and data integration are needed to promote quality, and standardization makes it easier, makes it cheaper, makes it more portable, makes it more compatible.
And we do hope that electronic prescribing will be able to - the migration step to having high-quality, high-value electronic health records throughout the whole country.
That's my talk. Thank you for that, and I'll take any questions.
DR. COHN: Okay. Jonathan, thank you. I expect the committee does have - there's really a time for questions and discussions.
I actually wanted to start with one myself here.
Thank you for, I think, a very illuminating conversation about e-prescribing.
I guess, as I am thinking about all of this, and I am just curious about your thoughts, I mean, you mention this as a model for NHII and things like this. I guess I am sort of wondering whether this is really the wedge for NHII, only because I am having a hard time imagining - I mean, this feels like one of the main pieces of an NHII, and I guess - so I am curious about whether that is consistent with your view or not, number one.
And number two is - and I asked this question earlier about this as a module versus this as a free-standing unit, but, from your view, as we move into the later part of the first decade of the 21st Century, do you think that there's actually a reasonable business case for having just a single module that is e-prescribing or is anyone who is going to be looking at these going to be logically wanting to bundle this as part of practice management systems, EHRs or other things, just because of the efficiencies of scale there? So two questions.
DR. TEICH: Sure. Once I get past three facts, I have to write them all down.
DR. COHN: Sure. First of all, the question was is this -
DR. TEICH: No, I got them. I got them.
DR. COHN: - the wedge, and then other question is -
DR. TEICH: I got it.
DR. COHN: - modules versus other pieces.
DR. TEICH: Yes. Certainly, one of the things I have learned from having feet in both academic and business worlds over the past four or five years is that the drivers have a lot to do with what gets publicized and what people think other people are doing.
Right now, electronic prescribing is a hot topic. It's a hot topic because of certain key studies that have been now coming out showing error-prone prescribing, because of the publicity attendant on those studies that have been given in the news media, and it is hot because payers have gotten on the bandwagon and said, well, let's start supplying some test projects. So it's hot because there are a number of well-regarded and well-publicized projects out there saying, electronic prescribing is good and we are going to test this in Boston. We are going to test this in Oakland. We are going to test this in Seattle, and the reason I am using that publicity example is to say that the same should probably be true of electronic health records in general.
Certainly, yes, to me, electronic prescribing has its best potential as a module. It is available as a stand-alone application, and, again, just like that pyramid, there are things you can do at a lower level, but that pyramid fits inside a larger pyramid, says, you know, as you go up in electronic prescribing, so you can go up in sophistication of electronic records in general, and, again, with each of those different additions, you gain sometimes a little bit, sometimes a lot more safety and quality.
So, to me, there's no question that a), you can use electronic prescribing, basically standalone, but once you have done that, you have now done patient identification, you have now done system login, you have now done registration, you've done basic connectivity. So you have done a lot of the infrastructure that you are going to need to do electronic health records. You know, in the work that we do in my own company, we certainly have been able to leverage applications on top of a core infrastructure.
So once you have done one thing, then, in fact, you might have your wedge. It may be that in getting electronic prescribing rolled out, if we do it skillfully, we will have not only that application, but also the tools to promote the infrastructure for many other applications, problem management, disease-management tools and so on.
Jeff, you have a question?
MR. BLAIR: Yes. Jonathan, could you help me understand - it appears to me as if some of the early e-prescribing systems that are out on the market today, some of them appear to be physician- or electronic-health-medical-record-centric and/or with a practice management system. Whereby, they get their eligibility information from the practice management system, their electronic health record system is able to supply medication history, patient history, possibly even formulary information, and they could work with a network to pharmacies and pharmacists. So that is one model that appears to be out there.
There is another model which appears to be out there, whereby the formularies and the eligibility benefits are checked by a pharmacy-benefit manager who is creating a network, and, in that model, I wonder whether the physician has the same freedom to be able to prescribe the drugs that the physician feels is most appropriate, especially if a pre-existing condition or authority is required and how fast that could get back.
And then there is a third model that appears to me which is - I would think of as pharmacy-centric, and the implications of these different models, in terms of who is the source of the data, who controls the data and how do you challenge the data during the prescription process.
I am trying to understand the implication for standards, because our role is what e-prescribing standards are needed. How does this effect our understanding of what standards are needed for e-prescribing?
DR. TEICH: That's a great question, Jeff, and I think I will try and answer in a couple of different ways.
First of all, you are correct. Actually, most electronic prescriptions that are written today are, in fact, written through existing electronic medical record applications. So while the standalone systems and the handheld systems are getting the most newspaper buzz and have some of the most kind of glitter around them, certainly most of these things right now come from integrated applications that have been in place for five to 10 years.
You are really asking whether it makes a difference who has provided the application and who has directed the adoption of the application, as far as what one does with it and what I feel compelled or somehow pressured to do with it, certainly, from the standpoint of the payer and the PBM that is associated, they have a primary goal, I imagine, to help deliver drugs very well and to help provide information and also to manage costs by providing the drugs that work well for their payment model.
Where PBMs have provided systems and where they are backing them, you sometimes see, in current practice, that there are such things as targeted alternatives that appear.
Targeted alternative means that as I go into a drug, it may say, well, if you are ordering a drug for - if I am ordering a drug for ulcers, colitis, they say, well, we recommend you use this particular drug. So it'll actually say it up front. When it is listing the drugs by indication, it'll say, you know, here's a really good one and here's five others. You might see that. You don't see what I think would be the more egregious thing, which says, you know, gee, I would like to prescribe Drug A, and have it come up and say, gee, why don't you prescribe Drug B, because we think it's a nicer drug? So that doesn't really happen very much. What you do see, obviously, is the existence of a formulary, and the fact - I'm not here to challenge the existence of a formulary. I think they have their significant values in various ways, but, certainly, it is imperative, as long as there is a formulary, to make people aware of it, but not to make it overly difficult to continue with the choice that the physician and the patient have, and, again, it all comes down to choice.
The same thing is true of networks that are being provided now by pharmacies or by pharmacy networks that come from - you know, SureScripts certainly is pushing some things out, and that is getting a lot of physicians to adopt these, and, certainly, Kevin from SureScripts is over here and is a member of our steering committee and was not only an agreer to, but also one of the chief proponents of making sure that total choice is preserved in the physician-patient relationship.
So I think the answer is can I make technology such that it constrains what I can do and such that it overly influences what I do and puts the drug they want in big black letters and puts the ones that they don't want in tiny little yellow letters? Yes, that is possible. We haven't seen people being quite so crass, but I do think that it is probably necessary to incorporate in whatever kind of procedures you do the fact that that choice must be preserved. So by whatever means necessary, we want to make sure that the axis of prescribing and prescribing choice rests with the provider and the patient, subject to at least being able to see all the information that is available on cost and other issues.
Does that answer your question?
MR. BLAIR: Yes, in part, and only try to bring it down to a particular standard here.
It is my understanding that if a preauthorization is required or a physician to override the guidance of the formulary, that that happens to be one of the standards that is not yet in place yet, and that that would be a gap. Is that your understanding, too, that that would need to be a standard that needs to be developed?
DR. TEICH: There is - in fact, I should probably ask someone from NCP to be on this more than myself. There are a variety of transactions that go across in the messaging standards that are more than simply the sending of the prescriptions, as you are aware, and some of them include eligibility requests and various kinds of compliance. Someone may check me if there is a specific one for gaining immediate prior approval. I don't know if anyone can answer that for me.
Bob Beckley is one of the people who has designed the NCPDP standards.
MR. BECKLEY: There is prior authorization capability within this crib standard that can work two ways.
If the prescriber is aware of a prior authorization prescribing - writing a prescription, then that can be forwarded at that time, so when the pharmacy gets it, they can immediately dispense it and have the prior authorization.
If it is not caught at the time the physician writes the prescription, when the pharmacy goes to adjudicate the prescription, the message comes back, prior authorization required. There is an electronic transaction again. You don't have to go to paper or telephone to query the doctor indicating that a prior authorization is needed, please obtain one and resubmit, and then the pharmacy can proceed with dispensing - getting a prescription paid for, adjudicated and dispensing the prescription. So it has been taken into account in the standard to message back and forth electronically. Proactive is much better than having to go back later and ask for it, though.
DR. TEICH: Thanks, Bob, and that is clear to me now also. I realize that is the case. When I prescribe, I can see the prior authorization is flagged, so I can generate the necessary work myself, and, as Bob mentions, if I don't, and if it happens to be going instantaneously to the pharmacy, they are going to see it, and you can be sure that they are going to send me back some information on it.
I saw a question in the back?
SPEAKER: I just wanted to make sure I understood all parts of your question, because I think Bob was referring to the communication between the pharmacist and the physician about the prior authorization or existence of it, but not the communication between the physician and the payer who has to give that prior authorization clearance, and that is not currently part of the script standard.
DR. TEICH: Right. I think that is correct. Yes, I think the actual authorization transaction itself, I think, is not yet in the standard.
DR. COHN: Yes, and I think Bob is actually nodding his head, as I understand, so - okay.
DR. FITZMAURICE: You talked about some standards that were needed, desirable. You mentioned RxNorm as one of them.
If you were to put a top five standards that are needed to make this work, what are the areas of standardization that you would like to see done first to make e-prescribing work? Are we talking vocabulary here? Are we talking about classifying NDC codes? What would make it work?
DR. TEICH: The top five standards. Well, let me give them to you in desirability, which may not be the same as feasibility, because some are more complex than others, but, certainly, I think that the two that come to mind immediately is number one would be a prescriber-level vocabulary, so I think that is probably very, very high up, because I think that, right now, as people will know, when I send a prescription along, the script standard will handle NDC codes which can be adapted, more or less, from the prescription level, but sometimes there are some difficulties in sort of getting that mapping to be done, and what happens, more often than not, I am informed, is that it comes in as a piece of text that says, you know, amoxacylin, which has to be hand carried. So you gain a potential source of error in that transcription and you lose some potential for feedback and data gathering.
So I would say that that is certainly one of them, plus the fact that if I could do that and if I could normalize it across the current providers of these dictionaries, then I wouldn't be worried that when I went from one dictionary provider to another I would have slightly different allergy warnings and slightly different interactions and something that used to be permitted was now not permitted.
So one of the things I care about is where there are standards that have been established in - not silos, but in manufacturer-specific context, I would love to bring those back together. So that is probably first.
I think second is the overall issue of the different prescribing forms required by the states. Certainly, in terms of things that we see on a weekly basis, we try and build these out. We'll provide a practice in Maine with a prescription application, then we'll go to provide one to a practice in New York, and it turns out the prescription has to be different, and then we go to the Midwest, to Minnesota, and the prescription is different there.
DR. FITZMAURICE: Are you talking about different information or just different locations -
DR. TEICH: It is really a matter of - most of it is different locations and different forms. There are a couple of things that are more substantial than that, but a large part of it is simply being able to put the right words on the right form in the right place.
So those are two. There are certainly a number of other communications transactions that should happen, that should go forward. We just mentioned one of them. So we really want to get every possible eligibility piece together.
Those are the ones that come to top of mind, and then if I look at my cheat list over here, I think probably the ability to have formularies come through a standard form right now. There are three or four major suppliers, brokers of formula information. Some of them are independent. Some of them come through the payers, and they are providing information, but they are providing them in different formats, and, along with that, is that we don't have a unique identifier for payers in the first place. The ability to have some sort of numeric or coded value for the payers and the plans themselves means that when I go from practice to practice I have to take the words that they have been using for Blue Cross/Blue Shield Preferred Health of Texas and be able to translate that to my master list, when the next people over in the next town call it Preferred Health Blue Cross Texas Blue Shield.
DR. FITZMAURICE: So would the HIPAA unique health-plan identifiers help out on this?
DR. TEICH: I think that has to be a - that or something that goes along with it, would probably be a significant -
DR. FITZMAURICE: You won't have it for years, but -
DR. TEICH: It's a big deal and it causes a lot of - those things that I have mentioned cause a lot of hassle at the time of implementation, at the time I bring up a new practice, and if I go into a new practice and say, here's your application, we are ready to go, and I say, wait a minute. This isn't how I say this. This isn't how I say that, it costs time and it costs productivity, and it starts getting people cranky.
DR. FITZMAURICE: Thank you.
DR. COHN: It's actually the first time I've heard somebody recently bring up the health plan idea in a business case recently. So thank you for reminding us that that is one of the unmet HIPAA regs.
MR. BLAIR: Jonathan, can you help us understand a little bit better the areas that get involved with drug-to-drug interactions, drug-to-allergy checking, drug-to-patient-weight-and dosage-forms checking?
There's two aspects that I would like to have a better understanding of. One of them is that it appears that a lot of those functions within the acute-care center are referred to as clinical decision support, and within the ambulatory sector, they appear to be referred to as drug utilization review. Are they the same things or are they different? Is it just different terminology?
And the second question related to these are if they are different and the drug testing, for example, is being putting forth, our expectation for these, in terms of the requirements for clinical specificity, is that executed with the same level of specificity in the ambulatory sector as has been the expectation in the acute-care center? Is there a difference?
DR. TEICH: Every time Jeff asks a question, I have to write a lot of notes, because he asks so many good things at once.
Let me take a couple of these. Clinical decision support versus drug utilization review. Here's how I define them - and I think this is probably a reasonably general standard.
Clinical decision support is probably a super set. Clinical decision support is all the different things that one can do to alter, promote, remind, educate and in one way or another give extra information to the physician or pharmacist or payer, all the different things that we can do so that primarily at the time of doing a certain transaction they have every piece of information that is necessary to do it right and that if they see all that information and still do a little bit wrong, they have some more information to help them possibly make the best decision. So it's just that. It is information, whether it's active or passive, that helps support the making of the best decision, and that decision could be a safety issue. It could be a cost issue. It could be a patient convenience issue. It could be a logistical issue. So CDS is - most people think of CDS as alerts and reminders, and that is probably a pretty good basis, but it's alerts, it's reminders, it's guidelines, it's proactive things, and it probably also includes those alerts necessary to support drug utilization review.
To me, drug utilization review really deals with exactly those words, with the appropriate utilization of drugs themselves, with not taking a drug that is supposed to be given for one month and overusing it, with not using drugs outside of their proper indications, with not using drugs that are going to breed excessive bacterial resistance for an infection when something better would do.
I wouldn't consider, for example, an allergy warning to be an example of drug utilization review, but I would consider a formulary warning to be such, and I would consider a warning that says there is a more appropriate drug than what you have ordered based on certain patient characteristics to probably be an example of drug utilization review.
So, to me, that is a subset, and I invite anybody else that wants to to correct that or amend that definition one way or the other, because I just came up with it off the cuff. In fact, I'll take amendments before I go to the next part of your question.
Okay. So move to next.
As far as the B in our report, there's a large table of many, many different kinds of clinical decision support interventions. What is involved with them, which one of them, according to our group, seems to be most necessary at the basic core and which ones are also important, but should be added incrementally or can be added incrementally, and, certainly, some of the things you mentioned is that some of these are dictionary bound. Allergy checking and drug interaction checking are dictionary bound. I don't know if Drug A interacts with Drug B unless the same person who provided my drug ordering dictionary has also provided an interaction table that says that these things interact with those things.
Again, among the different manufacturers - and I have had intimate work with probably four different manufacturers of these - they are pretty close, and I would say they are probably about maybe between 90 and 92 percent identical, but there's a couple of differences here and there. So, presumably, most of those are insignificant. I have never found a place where I found one where a real big one has been missed, but I think that in terms of ambulatory versus inpatient, it is probably just as specific. They are probably just as complex, and, in fact, it is probably even more complex.
One of the things about ambulatory care is that I've got a bunch of other medications. On inpatient care, I'm giving the stuff that I'm used to giving in the pharmacy of my hospital. Ambulatory care, I've a patient who is taking my medications and medications from a psychiatrist that they see in another town and medications from an orthopedic specialist somewhere else, and who takes St. John's Wort at home and various other kinds of over-the-counter medications and who drinks a lot of grapefruit juice, which itself has a lot of drug interactions. So, in many ways, the fact that there's so many sources of data I might not know, there's such a wider range of medications that can be used and also that I have so much less controlled an environment in ambulatory care than I do inside a hospital are all reasons why, in fact, there are probably more ways to have errors occur in ambulatory care, not to mention compliance. If a patient doesn't take the medication or takes them too much, that'll happen.
I=m an emergency physician when I practice and I see a lot of the results of these. I see a lot of people who come in with adverse drug events, primarily from kumadin, in fact, but from many other things. I've had patients who were prescribed theopholin for asthma and then they got more sick, so their doctor told them to increase the dose, and that was fine, but then they got even more sick, so they increase the dose by themselves, and then, after that, they started getting a little shaky and got an upset stomach, as theopholin will do, and then they said, well, gee, I have an upset stomach. I better go to my medicine cabinet and take some of this tagamet I have, which is an antacid, an H2 blocker, which happens have a significant drug interaction with theopholin, and this patient comes to me with a heart rate of about 200, about to lose their life.
So you can see that there are many things that the non-controlled environment does to make these things harder in the ambulatory care area, but I think the dictionaries need to include alternative medications, foreign medications and so on to be able to handle this properly.
MR. BLAIR: Thank you.
MS. CRONIN: Jon, I'm just wondering if you would comment on the need and the feasibility of having standards that would allow for the differentiation or severity rating of drug interactions?
DR. TEICH: Sure. The simple answer to this is we certainly had better.
If I were to show you every drug interaction warning that was available in the pharmacy drug compendium or even more so in the PDR, you would be spending a great deal of time dissecting the warnings for each and every drug that you order.
There needs to be some kind of parsimony - some kind of restrictions in the way that interactions are displayed, simply to avoid saturating them. If you display every single warning, then, what is going to happen is people will develop weariness and will ignore every single warning, including the most important ones. So you have to be careful how many different things you throw at a practitioner at a time.
Now, most of the major providers of dictionaries do, in fact, allow them to have different levels. One manufacturer provides Levels 1 through 9, one has minor, moderate and major. In general, whenever I have been involved in the development of a system - whether academically or commercially - we have, in general, given people the choice, and almost always they choose to show only the major ones.
My own laboratory did a study about five years ago where we looked at all the ones that we didn't show and figured out how many errors would have come from them, and over about 150,000 medications, we found one. So, certainly, that one error that would have happened was probably offset by the many, many more errors that would have happened if people were forced to see so many warnings that they didn't see the ones they wanted.
So the answer is yes. We need to have a breakdown, especially among drug interactions, and I think this is something which is not very standardized. I think this is one which is probably more done by feel and by local pharmacy expert choice more than anything else, and I'm not quite sure - really, we haven't addressed the issue of how one would approach that, Kelly, but I think that you are absolutely right. That is one of the ones that would be very important to have.
MS. CRONIN: Yes, I just heard that in terms of user preference and potential barrier to adoption is - you know - having people just inundated with these pop-ups, and they'll eventually just switch off the function if it really irritates them and takes up too much time.
But, at the same time, if there is a lack of evidence base to have a systematic way of categorizing these, then how do we handle it?
But then, again, you don't want, perhaps, a small firm that is under resourced to be coming up with their own categorization scheme that really is very divorced from any level -
DR. TEICH: There was a paper - a commentary that Lucian Leap(?) wrote, I think, a couple of years ago, which - along with several other people - which said we want to have evidence for everything, but we can't practically get evidence for everything tomorrow. So we have to make some good guesses, too, and I think that probably applies here. I think that it would take a humongous amount of research to try and develop exactly which one of these things were - you know, the project that we did, plus many, many more like it.
So I think there has to be some room for saying let's get a good guess together, but I think that good guess could be a consortium good guess, instead of an independent good guess, and you could get your first data and your Medispan and your - together and say, why don't you guys make a good guess together? And I think they can do that without upsetting their competitive advantage over each other.
How are we doing on time?
DR. COHN: Well, we've got a couple of more questions here, and, Jon, I would comment, the private pharmacists also have had a fair amount of experience with these drug interactions. My understanding is that generally there are very few medications that you can prescribe together that don't have some sort of an interaction, and I am sure you and I have had the same issue there.
MR. REYNOLDS: Jonathan, thank you. Excellent presentation.
DR. TEICH: Thanks, Harry.
MR. REYNOLDS: One point that you didn't hit on was the related medical history around the bill, and with all the work that you have done, surely - and including the HR that you showed us - surely, you have thought about that some. Could you give us some insight on what - if you were defining what that ought to be, what it is?
DR. TEICH: Are you talking about medication history in particular -
MR. REYNOLDS: I'm talking about - in the bill, it talks about related medical history.
DR. TEICH: Oh, yes, yes, yes. Yes, that refers, I believe, to the other pieces of information that are necessary to make prescribing, in particular, and also all health care, to be better, since you are looking for those pieces of information that are necessary to make records complete and also to support the kind of clinical decision support that you can support.
Underlying that pyramid that I showed, there's a couple of tables in our report which talks about the fact that, at the lowest level, if one had just a standalone application with nothing else - which very few people do nowadays - you would at least be able to check drug doses. That wouldn't be patient specific, but you would be able to say, here are the typical doses given for this drug.
To the next level, if I can catch key pieces, and they include allergies, which is patient specific, patient's age, obviously and sex, those are things which are easy to catch and which tend to drive quite a bit.
The next level above that is having the patient's other medications, because that is what generates both the drug interactions, the therapeutic duplications and so on - and I'll put a placeholder there, because there's various ways to supply that - and then above that are access to things like problem list, which certainly is a major driver. So that is a big step, because diabetics can only get certain things. People with hypertension can only get certain things. People with ulcer disease can only get certain things.
It is even more complex in the infant world, when you have to worry not only about the size of the baby, but also the various problems they are going through.
So being able to capture problem list. There's - trying to think of what else comes to mind. Recent procedures are important. So I think that - the typical aspect - if you look at the front screen of most electronic medical record products, they have problems in medications and allergies and sometimes health-maintenance issues and recent visits, something like that, and those are there by consensus, but those are there for a reason. Those tend to be the first things you want to look at, and those tend to be the things that drive others.
So in terms of the required history elements, I think those are some of the most important.
I did want to mention - I think I mentioned briefly, but not completely, that there's work right now going on where the complete medication history can be supplied, not just by you asking the patient or not just by the patient putting it in themselves, but also by collecting claims which have come form a variety of different sources, and being able to aggregate that back into a message which may come from the payer channel that says, here's all the claims this patient has made for medication. So you have a pretty good sense of what they have filled.
So there's a couple of ways, but problem lists can be collected, either by hand - as many are - or by ICD9 codes that have come out of various previous visits. Allergies usually are connected by hand one way or the other. Procedures can come from ICD and CPT codes - so many of these things can be collected indirectly with reasonable specificity, through automatic sources.
Does that answer your question?
MS. CRONIN: Actually, I sort of have a related question.
In the one diagram that you had in your presentation, on page 6, with communication, all of that information, I am imagining, is probably mapped out in your more thorough report, but that is something that I think would be very useful to the committee moving forward is to know exactly how that information is going to be exchanged across the various parties.
And you also mentioned in your presentation that you think guidance is necessary to assure the appropriate sharing of data. Is that a specific recommendation that you would make to the committee?
DR. TEICH: Second question first, yes, it is. There is - I don't think anybody wants to reveal private information. I don't think anybody wants to be malicious about any kind of untoward use of information, but I think that, in the heat of battle, it is sometimes possible to go over a line without realizing it. So I think it is important that we make sure that we are preserving individualization of data for privacy, not for every circumstance. Just as HIPAA gives emergency openings, so we need to have those as well, but the ability to make sure that confidentiality is protected, and, certainly, the ability to put some fairly useful and real guidance about the use of selling of data.
There is some benefit to be able to have organizations in the private sector that protect data and make use of it, so that people can share it for quality reasons for one purpose or another. I support the purpose of that in general, but it does have to have certain kinds of safeguards, which I think a good company would not have a problem with, but it is probably worth having them there to make sure that things don't go over there and so people can actually stay clear of them.
As far as the various kinds of communication standard, am I right, Simon, that we have a presentation from NCPDP later today?
DR. COHN: Yes.
DR. TEICH: I think you'll probably learn as much from there as I can possibly tell you about, because these folks have worked on it quite a bit longer and in much more detail.
MR. BLAIR: I am assuming this is the last question, so it's -
DR. TEICH: Yes. Oh, yes.
MR. BLAIR: - it's sort of to ask for a summary, and the summary that I would ask for is, given what you have shared with us, do you have a list of message format standards, identifiers, terminologies that you think national standardization in those areas should be considered high priorities that we should focus on?
DR. TEICH: The B
MR. BLAIR: It sounds like you have a report coming out.
DR. TEICH: I don't know if that's a summary.
MR. BLAIR: Yes, I think you have a report coming out, don't you? (Laughter).
MR. BLAIR: Yes, yes. I think I may have to refer you to the report for some of that.
The summary is ambulatory prescribing is good - (laughter) - and that it can be better in a variety of different ways, and, yes, we have done a fair amount of work on the particular kinds of standards that we think are important, and, again, I mentioned some of them in response to Mike's question, and I think that if I were to try and remember them right now, I would probably do disservice to some. So I will say that in a couple of weeks, when the report comes out, we'll have this in a much more comprehensive form than I could probably give you off my cuff right now. So let me dodge the last question.
DR. COHN: Well, Jon, I really want to thank you for coming, and I think this has been very valuable for the subcommittee and for, obviously, others in attendance.
I actually hadn't realized that your report was coming this quickly, so we are obviously delighted. We'll be looking forward to it, obviously, middle of April, and I suspect once we see it, we probably will have additional questions, so, hopefully, we can call upon you for some of your expertise in the future as we move forward in this.
DR. TEICH: Sure. Thank you.
DR. COHN: Thank you very much.
Now, the committee will take a lunch break. We will reconvene at 12:50 for afternoon session.
(11:50 a.m.)
(12:58 p.m.)
Agenda Item: E-Prescribing Standards
DR. COHN: Well, this afternoon, we delve further into e-prescribing standards. We are delighted to have Lynne Gilbertson, who is Director of Standards Development for the National Council for Prescription Drug Plans, and Bob Beckley, who is on the Board of Trustees for NCPDP and has worked for SureScripts, and I am looking at your title here, you're Vice President for SureScripts.
Obviously, want to thank you both for joining us, and, Lynne, are you up first?
MS. GILBERTSON: No, actually, Bob is going to start and I'm just going to chime in.
DR. COHN: Okay. Thank you.
MR. BECKLEY: She's color commentator.
MS. GILBERTSON: Yes.
DR. COHN: Okay.
MR. BECKLEY: First of all, we would like to thank you for allowing us to present today.
Wanted to give you a little background on the two of us. Lynne Gilbertson and I, we have been members of - before she was an employee of NCPDP, we have been members of NCPDP since around 1988-89 time frame and were both involved in the very beginning of what is called the SCRIPT Standard from NCPDP. We started working on that project back in the mid >90s. I played a role - I was cochair of that workgroup, and I played a role in writing that standard. Lynne is the author of the original implementation guide, which is about a hundred-and-something pages, and so we have quite a bit of history of watching this grow.
One of the interesting things about this standard versus many other standards, many standards - whether they are X-12 or NCPP(?) Standards, HL-7 - they are developed based upon a current business need or practices that are already in progress, proprietary standards that need to be merged so that everyone can utilize them.
NCPDP saw electronic prescribing coming many years ago, and a standard was developed in kind of like what we think is going to be happening, and the standard was approved back in 1997, and when did it become ANS? Do you remember, Lynne, when it became ANS? I would say like 2000, something like that, it became an ANS standard, long before there was significant use of the standard.
So we have placeholders in here that some people may not know about for future capabilities, and we are going to touch on those today, as well as what the standard will currently do, and so, hopefully, it will be enlightening and give you a little more information on what the SCRIPT Standard can do and what its potential is, and that is just as important as what it can do right now.
Three main areas. We are going to talk about what is electronic prescribing for multiple definitions, and they all are a piece of electronic prescribing, and we want to kind of set the framework for you what we are going to talk about and what we see as electronic prescribing, and what a SCRIPTS Standard addresses.
What is the actual standard? We are going to go into a little bit of detail. I am not going to go whip out the implementation guide or the standard. I see the - I've sat behind Stanley. He's got it open over there, but I am going to give you, at a little bit higher level, what the data pieces are within the SCRIPTS Standard to give you an idea what its capabilities are, and then the current status of electronic prescribing in the industry, again, our definition or our current view or our piece of the electronic prescribing puzzle.
We like to break it down into two parts. Part 1, electronic prescribing is a two-way communication between physicians and pharmacies, and that is the first thing that the standard addressed. It will do new prescriptions, refills, authorizations, change requests, et cetera. We do not look at electronic prescribing as faxing or paper scripts. Electronic prescribing means computer to computer. So it leaves the physician's office, sent electronically, received by the pharmacy's computer and taken right in. One of the things that we are talking about is efficiencies, reduction of errors, et cetera.
If you print it, you can still read it, yes, but someone then has to enter it into another computer and will have fat fingers, and we all need glasses sometimes that we don't have on or et cetera. So there are still opportunities for errors. Computer to computer really minimizes that, and, more important, the efficiency. Someone's not carrying in that piece of paper and then waiting 20 or 30 minutes to get the prescription filled. It's already at the pharmacy. It is already being filled while you are in transit to the pharmacy.
Part 2 is what we classify as the area for potential that the standard can address or is in the process of addressing, and those are the things that we have talked about also today - eligibility, formulary information, medical history - and we'll touch on those on what the standard could potentially do with clear business requirements and needs from all parties involved.
I think there was a comment that we need more input from the physician side, which is what we hear at NCPDP at lot. We hear we need more information from the physician's side because this is the - you know, SCRIPTS Standard was mostly input from the pharmacy side.
And one more plug for pharmacy: We see this as a triangle. We saw the triangle earlier. That triangle is excellent. We see the triangle as patient on the top, physician on one point and the pharmacy on the other point, and that is the healthcare triangle of the parties that have to communicate to each other to give proper healthcare to a patient. So pharmacies are very involved in electronic prescribing. They are just not the end point where a piece of paper gets dropped off.
One other thing, the SCRIPTS Standard is addressing the electronic communication. It is a messaging format. Some of the things we have talked a little bit about today are also potential workflow standards. This is a messaging standard, like your standard transaction sets. So we need to also - you know, you may say, well, how does that data get into that message? That's workflow. That's a software vendor's piece of the puzzle, how they take the information or how they take the workflow, as Jonathan was showing earlier, and they take the information, display it to the end users, so they can make decisions, but when they are ready to send it to the pharmacy, then it goes into a standard format, in a sense. So we are going to be talking about the electronic message of communicating between a physician and a pharmacy.
SCRIPT, as I mentioned, is a standard created to facilitate the electronic transfer of prescription data between pharmacies and prescribers, an important thing. This is not a batch standard. It is real time.
When a prescriber - we use the term prescriber, because it could be a physician, a nurse practitioner, a physician's assistant. When a prescriber writes a prescription they can transmit, it doesn't batch up every 10 or 15 minutes, send a bunch of messages out to the pharmacies. It goes immediately, because that patient could be just three floors upstairs going down to the clinic pharmacy. So it goes immediately to the pharmacy. So real time is very important.
Here are the current messages that the SCRIPTS Standard supports: New prescriptions from the physician to the pharmacy, prescription changes initiated by a pharmacy going back to the physician - and I'll explain a little bit more about that in a minute, but it is basically I have run across a DUR. Pharmacies have complete clinical systems. Every prescription, before it is filled - whether it is a refill or new Rx B goes through an entire DUR process in a pharmacy, drug-to-drug interactions, drug-to-allergy, drug-to-disease, dosage, et cetera, age, the entire thing. The pharmacy could come up with a DUR situation that the physician may not have been aware of, and a change Rx is one of the ways that you can communicate back to the physician if we have run across this situation. Pharmacies also catch formulary issues they could send back electronically.
Refill requests. A very, very important message. Refill requests. When people say electronic prescribing, especially when you talk to physicians the first time, they think new Rxs only. Refill requests are huge. It is an incredible time saver for both the pharmacy and the physician. Imagine - here is my perfect scenario, and it is happening today. Eleven o'clock at night, I take my last pill, whatever I am taking, and that is when I realize I'm out. I go over to my telephone. I pick up. I call my pharmacy. The IVR system, the automated voice, answers the phone. I punch in my refill request. It says, I've got your prescription, Bob. It'll be ready - and it may even indicate, Bob, you don't have any refills left. We are going to contact your doctor for you. If you want me to do that, punch in one. I say, yes, please do.
When I hang up, the pharmacy system knows there are no refills left. It knows if the doctor or the prescriber is electronically enabled, and a message is sent immediately to the physician, the prescriber, saying, can we get more refills for Bob? at 11:05 at night.
When the physician comes in in the morning - when the physician's office come in in the morning, they have a nice screen of all their refill requests. They gather the charts - instead of paper lying all over the floor from the fax machine, the little blinking light on their answering machine - Imagine Monday morning. The little blinking light on the answering machine saying they have all these messages someone has to transcribe before you can start to pull the charts, but the best part is, after you approve or disapprove the refill request or renewal, as we also frequently call it, is, now, you have to - everything back up and put them in the right order to call the 30 different pharmacies or 20 different pharmacies you have. So I have - here is Pharmacy A, B, C - these are faxes, these are telephone calls.
Electronic prescribing, if the system is set up right, you go back to that one screen, you answer all the questions and you hit transmit, and they all go. They're gone.
Out in the real world today - and we'll have a little bit more of this at the end, but I'll give you a little piece up front - we know of an eight-physician practice that went electronic prescribing and they had connectivity to over 80 percent of the pharmacies in their area. They had a nurse that spent full time talking to the pharmacies, over eight hours a day.
That nurse now has the additional - now spends three to four hours a day with patients and the doctors versus working on answering phone calls and faxes for the pharmacy. So refill is huge. Refill is very large, and that is why I want to spend a little time on that. Sometimes that is overlooked. That is a two-way communication between the physician and B the pharmacy and the physician, and one that is frequently overlooked by physicians'systems. They incorporate new prescribing. They incorporate it, but they cannot receive a refill request. They have the history on their system, but they don't have the two-way communication. That is a very important piece. It is one of the - we talked about return on investments, it is a huge return on investment for the pharmacy side to incorporate this functionality.
Prescription fill status. This is another big message. Imagine every time a prescription was filled by the pharmacy if a message was sent to the subscriber saying, Lynne picked up her medication. So the next time Lynne goes back to the doctor and she says - the example was they were increasing - I think that that Jonathan gave - they kept increasing the medication for asthma, I believe it was, because it wasn't working. Lynne tells the doctor, oh, I'm a very compliant patient. I'm doing exactly like you say, but then physician or the prescriber takes a look at the information provided by the pharmacy that indicates that Lynne is getting refills every 45 to 50 days, and it's a 30-day supply. Evidentially, she's not a very compliant patient. So instead of increasing the dosage, you need to counsel Lynne on being a compliant patient. Fill status notification is a very important one.
Prescription cancellations. If you are in the middle of a therapy and the patient comes back to the physician and they have a rash or it's not working, physician can notify the pharmacy to stop that medication. No more fills, please. Especially when dealing with elderly patients, they just - when it's empty, they go back.
There are some systems that you can sign up for. If you are on a maintenance medication, you can sign up for your pharmacy to prompt you when it's time to get your refill. Well, if that cancel notification is not sent out, it'll prompt the patient to get their refill. So cancellation is very important also.
And there are also housekeeping transactions revolving around if there's mailbox and changing passwords, and you can also request a return receipt on a message. So there are many messages within the SCRIPTS Standard besides just sending a new Rx to a pharmacy.
So let's talk a little bit about pharmacy-initiated messages. I'll just go over these quickly. A pharmacy initiates a refill request, also called a renewal authorization. They initialize a change request, which could be because of a drug utilization review. It could be formulary. We talked a little bit about prior authorization. It could also be about - I mean, it could ask for a generic. The doctor wrote brand and the patient realizes what that's going to cost them, and they could ask to go to generic. There could be other types of questions around that prescription that the pharmacy could send back to the physician electronically. Nothing is worse than getting an electronic prescription and then calling the doctor back asking a question. Let's do it electronically.
I mentioned the fill notification. Every time that prescription is filled - or more importantly, there's also what is known as a non-fill. I'll give you an example of that real quick. The physician sends an electronic prescription to the pharmacy and the pharmacy fills it, and it goes into what is known as a will-call bin for when the patient comes in. If that script isn't picked up in a certain period of time, all pharmacies have a routine where they go back and they return to stock what was in the will-call bin. When that happens, a message gets sent to the physician saying it was not filled. You wrote this prescription, the patient did not pick it up. Again, the physician knows when the patient comes in the next time with the same condition what is happening on their medication side of the situation.
And then respond to a cancelled Rx. The pharmacy telling the physician, I did cancel that prescription. I will not dispense any more. It is deactivated.
Physicians can initiate a new prescription. They respond to a refer request, respond to a change request, and they can initiate a cancel request.
I'm going to go a little bit now into the details of what is actually in the SCRIPT Standard.
Everything is broken down into data segments. So, first of all, you have your header, which basically has your sender and receiver information, routing information, where this is going to go, so when a physician has it, they ask the patient what is your pharmacy of choice? They enter that information. It is usually from a drop-down screen, XYZ pharmacy on Main Street, Washington, D.C. Boom. And then behind the scenes, the routing information is included so that it can be directed to the appropriate pharmacy. There's a physician segment, a pharmacy segment, patient information, drug information. Remember I mentioned some futures? A coordination of benefits segment, which is payer information. That is not used right now. An observation segment, which is not fully developed yet, but things like weight, labs, other things like that to show lab values could be included in this segment to be sent, but they are not being used right now. We have a tough time getting ICD9 codes?
MS. GILBERTSON: Diagnosis codes.
MR. BECKLEY: Yes, diagnosis codes. Pharmacies - diagnosis codes. So that is why that segment is not development. When we talked about it, the whole room went up in a laugh, when we - well, maybe they'll send us lab values. Yeah, yeah, right.
And then the trailer information, which says that the message is intact, tells you how many segments are there, byte count, et cetera, and that is the entire message.
So, as I said, the header segment, it contains a version number, the message type - is it a new, refill request, et cetera. There are trace numbers in there assigned by the originator and has to be echoed back by the responder, so that systems, on both sides, can track, and when a message comes back, things do not have to be serial. So when it comes back, you can match back up and process the messages appropriately.
Sending and receiving identifications. Physician. I am Physician Joe. I am sending it to Pharmacy XYZ. Things that are used for that right now are DEA, we were hoping the MPI, HCIdea, but, mostly - I have it underlined - is trading partner identifiers. In the networks there right now, the trading partners agree how they are going to identify a physician or a clinic.
MR. BLAIR: I think that you would probably need to tell our subcommittee a little bit, HCIdea, what that is, and what the role of EA codes as identifiers are as well.
MR. BECKLEY: Well, I'll let Lynne tackle that one.
MS. GILBERTSON: Oh, okay.
MR. BECKLEY: Color commentator.
MS. GILBERTSON: With Randy in the room. (Laughter).
HCIdea is an NCPDP-formed company that was formed as a result of the membership in the industry coming forward and not wanting to use what is commonly used for physician identifiers in the claims-processing world, which is the DEA number, and it is recognized that the DEA number should be used for controlled substances, but it's like a Social Security number. It's kind of a de-facto standard. So it was being used in many, many claims that were not for scheduled drugs, for example. So HCIdea is an enumeration of an HCID which cross references DEA numbers, state-issued ID's, Medicare numbers, Medicaid numbers, UPNs, just about anything you can think of that are used for physicians at this point with - right now, it is addressing prescribers, since that is the first pharmacy need at this point. It will cross reference to the NPI as well, and, as of now, I think there are over a million enumerated numbers - or prescribers, at this point.
Does that answer you?
MR. BLAIR: Yes, I think one of the other aspects is, if I recall correctly, unlike the NPI, there's multiple pharmacy sites. HCIdea is able to handle multiple healthcare facilities and multiple pharmacy sites, which NPI is not able to handle.
MS. GILBERTSON: Multiple prescriber sites. That's correct. It's much more detailed. It would be interesting to see that cross reference, since the NPI is a more bubbled-up summary level than what an actual tip of the nose prescriber on HCIdea would have.
MR. BLAIR: And the point of that is that even when NPI is available, there'll still be a need for HCID.
MS. GILBERTSON: Yes, that is correct.
MR. BECKLEY: One of the other things - it seems like in our understanding of NPI, it is more payer specific. So if you have, let's say, a hospital or emergency room where the physicians are an employee of the hospital, the NPI is more for billing purposes. So they all may use the same NPI, because it's who do we pay for the services, while that doesn't tell a pharmacy where that prescription came from, who was the doctor that wrote it. So, as Lynne said, we need tip of the nose, who is the prescriber, not where do we send the check, and our understanding is the NPI does not go to that level, and if there are - and so that is what really is needed. You need to know where can I - think about I am sending out a refill request to a physician. I need to know where that physician is and which location. If that physician practices in a hospital or in a clinic, I need to know where that prescription is written, because that is where the refill request needs to go back to. So I need to know location. So we need to know who they are and also their location, because that is how I have to route the message.
Picture using a telephone. If I am calling the doctor for a refill, I call up on the system what the prescription was. It points to the doctor record and the location that doctor came from, and that is how I know who to call. Same thing - prescribing.
I've got Simon's curiosity - (laughter).
DR. COHN: Well, I was going to ask later on - brought this up, because I had the same questions about this. So do physician providers know that they have an HCIdea or is this something that is - I mean, who and how do you get this? The reason I am, obviously, asking is is that I - I mean, for example, I have never applied for anything like this. I mean, is this something that I would be tagged with as I write prescriptions?
MS. GILBERTSON: That is correct. That is correct. There isn't an enrollment process. There are data supplier - like, for example - and I'm going to be out of league, because I am not involved in that part of the business, but Medicare, Medicaid's payers, pharmacies, anybody who has databases that have prescribers enumerated on them, they all are aggregated at one point, meaning all these files could come in and they are scrubbed multiple times to ascertain you've got one tip of the nose person. You've got the right address, and you've got the right ID's for that person. So it's all done kind of behind the scene.
And just as an FYI, this was not intended to replace NPI or anything like that, but it was a need of the industry, and the NPI was not available for all these years, and so something - the industry came forward and said do something.
DR. COHN: Just one final question on this one - at least for me, hopefully. Maybe they have their questions answered, but is this something that has uses beyond the SCRIPT Standard? Is this used in other -
MS. GILBERTSON: Yes, it is not intended for a specific standard, as much as it is intended as an enumerator. Where it specifically probably - the first use would have been in the claims-processing world. How many different ID's does a given prescriber have that a pharmacy has to know to be able to bill a claim? So that is where it came first, but, obviously, SCRIPT is one more standard where you need to know the tip of the nose.
MR. REYNOLDS: On the NPI, the industry is going to have to have NPIs down to the individual provider level anyhow, because even though it's sent in from a clinic, you are still going to want to know what the doctor actually did. So I am struggling, at a time where we are putting out the NPI, that we have another standard that is being considered. So I - may not do it right now, but my understanding of the NPI and the way it has been reviewed is not what I think I heard.
MS. GILBERTSON: And I can't quote the NPI regulations back, but I do believe there is the ability to enumerate at an organization level or at an entity level. I think those are the two, or entity and a person. So there is a bit of a subset and a super set as well.
MR. FITZMAURICE: Can a physician have more than one HCIdea ID or is it just one per physician?
MS. GILBERTSON: One per prescriber with - it would have a cross reference to all those other ID's they might have.
MR. BECKLEY: Plus multiple location codes. So no matter where you practiced, we would know it was you, but then we would also know A, B or C.
DR. COHN: And the NPI doesn't have the location codes.
MR. BECKLEY: I believe it can have two addresses. So if you were at more than two, then, you have a problem.
DR. COHN: Okay. Karen, I think you have a question.
MS. TRUDEL: No, I just want to make a clarification. The NPI is intended to enumerate the tip-of-the-nose provider, so to speak, and we very deliberately, because of the avalanche of comments we received about the inability to keep practice location information up to date, did not do that. So that is - if that is a business need, it is not one that is addressed by the NPI.
We have met with NCPDP over the years B we CMS - and I view the HCID project as having a useful life into the future as a master prescriber registry index kind of thing, so that over and above just being an identifier, it is a cross reference repository that has useful information in it that I think will continue.
MR. BECKLEY: Okay. We were talking about sending-receiver identifiers in the header segment. I didn't think we'd get hung up in a header segment, but that's - the other identifier we use for the pharmacy, to identify the pharmacy is what is known as the NCPDP provider number. It was formerly called the NABP number. Every pharmacy has one. It is unique to that pharmacy. It is dead on. You can't be a licensed pharmacy without your NCPDP number. So that very clearly identifies the location of that pharmacy and where it needs to be routed.
Let's talk a little bit about the physician segment. Again, we have already mentioned -
MR. BLAIR: Question.
MR. BECKLEY: Yes, sir.
MR. BLAIR: Will mailing facilities have an NCPDP number?
MR. BECKLEY: Mail-order pharmacies?
MR. BLAIR: Mail order.
MR. BECKLEY: Yes, they do.
MR. BLAIR: Good.
MR. BECKLEY: They do. Any -
MR. BLAIR: What about internet sites?
MR. BECKLEY: Yes, they do. You can't get a third-party claim - First of all, I know you can't get a third-party claim paid without one. That is why there are also some dispensing physicians. They also have NCPDP numbers, because that is how you get paid, and, number two, I think in many - also in many states, I believe, when your pharmacy is being inspected to receive your license, they ask you what your NCPDP number is before they'll issue your license and allow you to open your doors. So mail-order pharmacies are included in that, yes.
As we said - we have already gone over the identifiers. The segment also contains the physician's name, practice name, address, all types of communication identifiers. Basically, this is - where you have a code saying this is an email address. This is a cell-phone number. This is a pager number. This is an office number, et cetera. Important information. Authorized agent, physician's assistant and nurse, et cetera.
If the nurse is typing in the new prescription on behalf of the physician, because they put it on the chart, then the pharmacy wants to capture that information, and there is a place for that on there, and we are also in the process of working on an enhancement for also a supervisor, going back to, let's say, a hospital situation where you have someone writing under the supervision of a physician. You need to know who the supervisor is, also, for that to be retained at the pharmacy site, in case there is an audit later.
So the physician segment pretty much tells you everything, where the physician is, who all is involved, is there any supervision or is there an authorized agent acting on behalf of the physician.
On the pharmacy side, we talked about the pharmacy identifier again. Pharmacy name.
Yes, sir. Do you want me to go back a slide?
DR. HUFF: Yes, because I am going to ask Carol's question before she - is this really a prescriber segment? Does it have to be a physician?
MR. BECKLEY: You're correct. It's a prescriber segment. The label name - it is a prescriber segment, because if the state allows a physician assistant to write a prescription, then the only thing that would be on there would be the identifier for the physician assistant, if they - or nurse practitioner. You are correct. It is a prescriber segment.
Yes, sir.
DR. STEINDEL: If the physician has multiple locations, the address that appears is the address that it is ordered from?
MR. BECKLEY: Correct. Because that helps the pharmacy when - and in the pharmacy system, when you dispense, it is linked to physician record and to the specific address. So if a physician has three addresses, it is linked to the right one, because we have to know who to call. Hopefully, we don't call or fax. We have to know what location to send that electronic refill request to if it is a maintenance medication. So yes.
MS. GRAHAM: The authorized agent. Is that identified by their name or how is -
MR. BECKLEY: Right now, it is mostly name. It would be Nurse Bob or, you know, Office Manager So-and-So, whoever actually did the keystrokes, and usually the way that is captured is I believe in most of the physician systems, whoever logs on it captures their user, their log, their user name and password and what their access levels are, and so, at that point, then, if they are just responding to refill requests on behalf of the physician, it captures that. Bob responded on behalf of Physician So-and-So. Physician had the charge(?), checked them all off and handed - same thing as if you call in. You know, XYZ Pharmacist, this is Bob from Dr. Gilbertson's office. Here are your responses. Same thing.
We talked about - Jonathan, I think, mentioned some of the states. Some of the states require that information on electronic prescribing. They want to see who the authorized agent was.
Pharmacy identifiers. That was pretty straightforward.
Yes, ma'am.
DR. WARREN: You said something about supervisors -
MR. BECKLEY: Yes.
DR. WARREN: Is that bullet not on there? Is that folded into one of those items?
MR. BECKLEY: Right now, this is an enhancement to the standard that is in process.
DR. WARREN: Okay -
MR. BECKLEY: That's a business thing that's come up. People have said, hey - especially in the teaching environment -
DR. WARREN: Right.
MR. BECKLEY: - we need to know who the supervisor is -
DR. WARREN: That was my next question.
MR. BECKLEY: - and so we are adding that in there.
Pharmacy identifiers. Pharmacy name. The pharmacist's name. That is usually not when you are sending it to the pharmacy, but, sometimes, when the pharmacy has a question or they are asking a refill request, you can identify who is requesting this information. The address, and, again, the communication identifiers, in case you need to fall back to telephone communications.
In the patient segment, when a new prescription comes down or a refill request goes to the doctor, patient's name, birth date, gender, an identifier, which is really tough, sometimes a Social Security number, many times, you don't get that. Frequently, it is clinic specific, which doesn't do a lot of good if you are trying to take a look at the entire medical record. I'll get to more on that a little bit later. At the end, I have a couple of comments about identifiers.
Patient address information and communication identifiers. Much of this is needed, especially if it's a brand new patient for a pharmacy, because they have to set up a patient record, and the more information they can get, the more they can set up the patient record before the patient comes in.
There are some pharmacy systems that will actually create a patient record from what the doctor sends or the prescriber will send. It's like cut and paste. They hit add this patient - If it is an existing patient, then it's matched.
The drug segment. Here's the biggie. Okay. In a text strain(?) - we have a spot for the text strain, which is just like if you wrote it out today, drug name, strength and form. Lipitor 40 milligram tablet. Text strain.
Then, you can also send a code - an NDC, a UPC, a manufacturer's code. All those codes are acceptable and there could be more identified if there are, because you just have a qualifier after it saying this is the identifier that I am using.
There is also a spot for the form encoded. Is it a tablet, injectable, patch, cream? Go down the whole list. You should see the appendix for all the different forms.
Drug strength code. Is it milligrams, milliliters, vials?
Generic drug identifier. This is one we have talked about quite a bit already. We have mentioned the multiple drug databases. Unfortunately, if you have - let's say you're using XYZ. I won't get into - I'll just - using XYZ. They may have an identifier for a class of statins that's A. So if the physician sends an A to the pharmacy, but the pharmacy uses Drug Data Base B, statins to Drug Data Base B is a C. There is no cross reference. One of the things that are being worked on is a cross reference between the different drug databases, and we mentioned before First Data Bank, Medispan, Multim(?), Macrometics(?), I mean, I think there are about six, but they are working to how that we can send more codes, versus less texturings, and no matter what the database is on the other side, it can be translated correctly. These codes are what drive the DUR process. The GCNs, the GPIs, et cetera, those database codes are how those drug databases determine drug or drug interactions, drug to diseases, et cetera. They even have codes for allergies, and they may not be the same either.
MR. BLAIR: I had hoped that we would have gotten a little bit of this in our previous presentation.
Can you explain to us, in the models where you have a prescriber using an electronic health record, their interaction with drug-knowledge bases to be able to do all of these interactions before they send the message versus how that interaction takes place when you have a pharmacy benefit manager-centric network and when that pulls that in versus it being pulled in at the pharmacist's level at the end of the message? Could you help us to understand when it is pulled in how it is pulled in and if there is an alert or warning or reminder of a drug-to-drug or a drug-to-allergy, how does that get back to the physician, the prescriber for them to react to it?
MR. BECKLEY: Okay. We'll walk down the process, and there are some ifs in there.
If the prescriber has drug-history information and they have a database with the algorithms that will determine if there is a drug-to-drug interaction like we saw Jonathan put up earlier, at that time, the physician will see a message saying there is a potential drug interaction with the appropriate severity level. So if that information is available to the physician, it will be displayed at that time. The prescription is sent to the pharmacy.
MR. BLAIR: So the resolution of any drug-to-drug interactions or drug-to-allergy is done by the prescriber before the message is sent.
MR. BECKLEY: If they have the appropriate information.
MR. BLAIR: Okay -
MR. BECKLEY: And that is a very big if.
MR. BLAIR: Is that true of formulary information as well?
MR. BECKLEY: If formulary information is available, yes, that can be also resolved before the prescription is sent to the pharmacy.
MR. BLAIR: All that before the message is sent.
MR. BECKLEY: Correct.
MS. GILBERTSON: Something that would be of interest, as I try to drop down a little level, is there is a concern at what level you can tag drug interaction, and one of the things that I always use as an example is what if you are allergic to the binders in a particular pill. You may have to go down to an NDC level to actually know what the ingredients are in that makeup to get to the level of I am allergic to cornstarch versus flour, whatever it might be. So there's different levels of the if in the condition that Bob mentioned.
MR. BLAIR: Could you take us through the other two scenarios?
MR. BECKLEY: Sure. So, now, the prescription gets to the pharmacy. Regardless - in today's environment, regardless if it's paper or electronic, the pharmacy always does a drug-to-drug interaction. They have - their history, they have any OTCs the patient has made the pharmacy aware of. They also usually enter prescriptions they may be receiving from any other location, whether it is a community pharmacy, medications received from mail order or at the pharmacy next to their house and they're getting the one next to work. All this is used to perform the drug-to-drug interaction at the pharmacy.
If an interaction is indicated at the pharmacy, then a communication goes back to the physician, telling the physician, I have run across a situation. Do you want me to proceed? Do you want to prescribe something else? Do you want to cancel this prescription? And then the physician responds, and they proceed accordingly.
MR. BLAIR: Now, how common is it that the pharmacist will have information about allergies or recent lab tests?
MR. BECKLEY: Allergies, very common. Lab test, not, because, again, many of the pharmacies will actually - some of them do it on an occasional basis. Some of them anytime you're a new patient, they'll sit down and ask you questions or give you a form to fill out, so that they try to find out what your allergies are, so they can do the drug allergy interaction check.
But labs, they can't really ask the patient their labs, and it's not very common that the pharmacy gets lab values from the physician.
MS. GILBERTSON: And there is one more DUR checking that can happen and that is when the pharmacy actually submits -
MR. BECKLEY: Right -
MS. GILBERTSON: - a claim, through the payer or the PBM. They have drug interaction modules that they are checking as well, which they can respond back, because, for example, the payer may have knowledge of other pharmacy prescriptions that that particular pharmacy might not have knowledge of. So you get other pharmacy indicators, things like that. So it's the triumvirate again.
MR. BECKLEY: Right. But there's one piece that is missing, though. That interaction could come up three times and set off three alarms, because people aren't passing information down to the next one, so that they know, and the prime example that happens every day today is the pharmacy knows of a drug interaction, has discussed it with a physician, the physician has approved it, said, yes, that's okay. They are no longer taking that medication anymore or whatever the reason, and they send it to the payer, and they tell the payer, we know this interaction. It's okay. Guess what happens? The payer still rejects it, sends it back and says, do you know that you have a drug-to-drug interaction? And the pharmacy turns around and says, yeah, I already told you that.
We need to cut down on the noise, as it is called. So when you do pass it on, you recognize it and say, I do not have to raise the red flag on this one. They already know about it and they have gone through the approval process. So that has to happen. The physician knows about it, then you can tell the pharmacy. The pharmacy knows about it and got it approved, they need to tell the payer, so that we don't echo it back up the chain.
MR. BLAIR: There is a third scenario on this that I would like to understand, and that is where we have a pharmacy benefit manager network. How does all this work when that network is connecting the physicians and the pharmacies?
MR. BECKLEY: Well, when the - take the easy part first. When the PBM is connected to the pharmacy, which they are right now, that is - I call that the payer. The payer could be the actual insurance company or, frequently, it is a pharmacy benefit manager PBM. The PBM does the interaction check and sends the message back to the pharmacy during the payment process. If the payer or the PBM is providing the physician with information, medication history, formulary, et cetera, then the physician system would catch the DUR when they are actually writing the prescription and it would be handled there.
MR. BLAIR: Now, let's see if I understand this. If it is the PBM, which you refer to as the payer -
MR. BECKLEY: Payer/PBM, right.
MR. BLAIR: And they are providing the medication history upon - the drug-to-drug interaction occurs that is based on payment information as to what other drugs the patient has, is that correct?
MR. BECKLEY: That payer has knowledge of. In other words, really say covered drugs. If it is a cash prescription, the PBM would not be aware of it. So if it's a cash script, then, that wouldn't be included in the process. The pharmacy would know about it, but the payer wouldn't.
So in talking about Medicare D, they would have all the information except for things that aren't covered by D, which would be cash scripts, and that information would have to be gathered from somewhere else, pharmacy, because the pharmacy has the information.
MR. BLAIR: Is it inaccurate for me to observe from what you have just told me that if the PBM or the pharmacist is doing the drug-to-drug interaction and the formulary checking, rather than having it done with an electronic health record, the likelihood is that it will not have as much information for drug-to-drug interactions or drug-to-allergy or drug-to-lab or drug to other diseases as if that is done with a physician with an electronic health record? Is that an inaccurate statement?
MR. BECKLEY: I would say it is. I would say -
MR. BLAIR: Okay. Please help me understand why.
MR. BECKLEY: I would say that the pharmacy and the payer, if it is not a cash script, both have the information to perform the drug-to-drug, drug-to-allergy interactions, and the payer is not going to pay for that prescription unless it is on formulary, and so when they reject it, it comes back. The patient has a decision to make: Stick with this and pay cash or ask their physician or have their pharmacist ask the physician to prescribe what is on the formulary. So it gets caught maybe a little bit farther down the road, but it does get caught. There aren't DURs that slip through. Pharmacies catch them. Payers catch them, and the same thing goes for formulary.
DR. COHN: I think what I'm hearing is a relatively redundant system with lots of checks, and I'm not hearing so much different models. I'm just hearing how many layers of checks that there may be occurring. I mean, given that - I mean, and whereas, on one hand, one would like to make it more efficient, I guess I'm wondering, given that we have a relatively - I mean, not a very well organized healthcare system currently, there is probably some value to that. I mean, sometimes a physician might be able to catch things. Other times, a pharmacy might be able to catch things. Other times, a PBM might be able to catch things. I mean, one can imagine situations where a patient goes to multiple different physicians, which may not be affiliated, where the pharmacy might catch it because the physician doesn't know all the medications the person is on, and, similarly, they may go to different pharmacies. Am I missing something here?
MS. GILBERTSON: No, that's correct. It takes the different parties to know, because they only have particular perspectives at that point. Just like this morning, when, you know, you talk about adverse drug events, if the patient is taking four or five of their medications and neither the doctor, the pharmacists know, he'll probably show up in ER, because that is not something you are going to catch.
DR. COHN: Well, I guess one hopes for some administrative simplification, which I think Jeff was going to as he was talking about these various models, but yet one needs to do that with great caution. Probably none of this is helped by the fact that there are multiple different databases that everybody is screaming against on this one.
Jeff, is that sort of where you were going with this one?
MS. GILBERTSON: Billion claims can't - I mean, there's four billion claims going through.
MR. BLAIR: There was one other last piece that is an aspect of this - and, Simon, thanks for bringing up the point that there is value in redundancy in this way.
Given that either the PBM or the pharmacist would identify either that the drug is not eligible within the formulary or there's some other reason why a different drug should be prescribed, whether it is generic or something else, are each of the scenarios fairly much equivalent in being able to get back to the prescriber in a timely manner where the prescriber has another opportunity to either justify why they made an exception or ask for special authorization for that drug or are there problems in closing the loop for that last piece?
MR. BECKLEY: If it is done in - we talked about a true electronic form, it can be done very quickly, and there's not a problem with closing a loop, because a physician would send it down, if the pharmacy catches a DUR, they immediately send an electronic message back saying here is the situation. If it goes down to the PBM/payer and they say it is not on formulary, they message back the pharmacy, you know, it is going to be a higher copay, and, again, the pharmacy can electronically message the physician and say, do you want to do something? The patient would like to go with the generic or the patient would like to go with the preferred medication. So it can be done electronically.
When it's done via phone calls and faxes, yes, it's very inefficient and very time consuming.
Did that answer your question, Jeff?
MR. BLAIR: Thank you.
MR. BECKLEY: Steven, you had a half hand a while ago. (Laughter).
DR. STEINDEL: Yes, I have a question about - as was described, it sounds like we have data residing at multiple different sites, and there's a dis-synchronization of the data, that the data can be the same at the three sites, it can be different. The sites can be holding different parts of the data, and one thing that was pointed out, this difference sometimes is good from a patient's safety point of view, because, now, we can catch more errors.
Sometimes, from a patient's convenience point of view, it might be bad, as you pointed out with the scenario where the physician said go ahead and do it. It was passed on to the pharmacy, but the PBM hadn't gotten the message, and then it delayed the prescription. So there are scenarios where we have pros and cons there, but we have a redundancy.
The question that I have is should this be an area where the NCVHS should be looking at in terms of standardization?
One of the problems that I see, for example, is is you have there the generic drug identifier. You have Drug Data Base. You have RxNorm. You have NDF-RT. We have heard other drug identifiers out there. You know, it seems to me that there's a lot of ways we are identifying drugs today, this one area that the question comes up concerning standards.
What Lynne brought up earlier, that even if we go to the - sometimes we have to go down to the NDC level. Sometimes, we do not, and so I would like some guidance on where we should be looking in terms of recommendations for standards.
MR. BECKLEY: What I think is needed, because the drug databases are an integral part of physician, pharmacy and payer systems - We cannot replace them. We have to use those that are there, but establish a linkage between them that is a common identifier, so that if someone with, again, Drug Data Base A sends me something, and I have Drug Data Base B, I can take it, make it work within my system. So I guess I would say a cross reference that'll take me to the proper level, so that I can do drug utilization review, I can clearly understand the prescriber's intentions. You know, what drug, what the form and strength were, et cetera, and you can't say statins because the doctor may want Lipitor versus Zocor. So I need to know those type of things if we come up with global identifiers.
MR. BLAIR: Just a point of clarification. When you say the drug databases, you mean the commercial drug databases -
MR. BECKLEY: Yes, First Data Bank, Medispan, et cetera, yes.
MR. BLAIR: That mapping capability, is that a different kind of mapping capability than we were referring to back in - we, NCVHS - was referring to back in November when we indicated the role of RxNorm and the mechanisms of actions of -
Pardon?
MR. BECKLEY: I would like to direct that question - there is someone in the back row back there, Karen, with Medispan, and if Karen would come to the mike, I think she would be best to address that versus us playing a translation role.
MS. GILBERTSON: One thing you would have to be careful of is that you can't broad stroke it and say one solution will solve all. That becomes a very dangerous - as Steve mentioned that you can't just say if I have one code then it will answer all the questions I will need to ask, because different providers of service have different questions they have to have answered.
MS. ECKERT: The mapping that we had talked about in November of drug database codes to RxNorm is included here. The mechanism of action and such are things that are not currently captured in script, so it wouldn't be those identifiers. However, I believe there are some additional identifiers allowed within script that are not covered by RxNorm. So it may mean that in a future time that we need to have mappings for those also.
Additionally, this code is at a higher level that you can do base screening of inactive ingredients for a product, but the use of the NDC at the actual pharmacy level or at the payer level can get you to the significantly inactive ingredient for interaction or allergy purposes that you may not be able to get at this higher level.
Does that help?
MR. BECKLEY: Help or confuse. You were good.
MS. GILBERTSON: She did it in like - what? - fifteen, twenty words. You're good.
DR. HUFF: So I want to focus in some more on these - I mean, there are two ways - and this is classic interface theory. There are two ways to do this. You can have a cross index, in which case everybody has to know everybody else's code, or you can have a central identifier that everybody knows the mapping to, and then you send one identifier in the message and everybody then knows the mapping to their database or to the set of databases that they understand, and so - I mean, what you would like, I think, is - I would at least conjecture that you would like something like RxNorm that is a non-proprietary code that everybody knows the mapping to, and we may need to buff that up.
I don't know if it meets the need, you know, whether it is sufficient for our needs, but rather than allowing any code to - you know, if you allow any drug-knowledge-based vendor's code to be there, that implies that the sender and receiver have to be aware of those - the cross mapping for every terminology. Whereas, if you standardize the code that is sent there and people know the mapping to that code, then they don't have to know their own in the standard code. So it changes it from an N-squared to an N problem in terms of mapping.
But the other question is why - or is there - pose it as a question. Is there a reason why the drug code should be NDC or UPC or the manufacturer's code? Could the same thing be set up there? I mean, could - if it was properly administered, could that always be an NDC code? And then you would know if cross mapping to the UPC or to the manufacturer's code.
MR. BECKLEY: Yes, if - you know, if everyone would agree that we are going to send this. Now, of course, the doctor doesn't prescribe by NDC. One of the issues with NDC is it also includes pack size. Well, if we chopped off the pack size, you know, if you want Lipitor 20 milligrams, that's nine digits and you know exactly what -
DR. HUFF: Yes. So if it was a code for - finished those form instead of the NDC code or something similar.
MS. GILBERTSON: I'm just thinking that not every drug - what with the use of the HRI and things like that, too, I don't know if we could broad stroke, say, there's NDC for everything.
MR. BECKLEY: Especially, if it's a compound. Then, you know, that poses a little bit of a challenge, too. You kind of go into free text on that.
But here is what is happening: Everyone is sending a drug name, because they clearly - like on a paper - piece of paper - tells the pharmacy that's their double check. That is always there, and then if the codes are sent, that helps them through work flow, automation, time savings, but they always have that name to double check. Anything that can - I think - help with the matching process, reduce errors, improve efficiency would be a big plus, and if it is something better than the NDC, then we could move the generic drug identifier up to the drug code. Yes, that drug code is just the field that has an identifier. We could put anything in there. All we gotta do is come up with an identifier code for it to say this is this code, which, as you would say, everyone could cross map to their own databases then. That would be a great solution, and I think you said we may have to buff it up. As Karen says, the RxNorm will do some of it, but it may need to do more. If that's what you mean by buffing it up, then I think the answer would be yes.
The last thing - and this is something new we just added to the drug segment is a full unabbreviated drug name. We have run across things where that drug name, strength and form is also - called label name. You ever looked at the name of a drug on the bottle? It's 30 bytes total. It's not enough. So there are so many abbreviations that it is starting to cause problems, and because of - you know - we'll say non-proprietary generic identifiers, we have gone with about 200 bytes, so you can have a full, unabbreviated name, if the physician chooses to send that down. So that field could be eliminated totally.
Other things in the drug segment, we talk about the quantity and the qualifier, how many tablets, how many grams, et cetera, dosage instructions, which is SIG, which is text. We have space for a codified SIG. Notice the parentheses. It is not used right now because there is no standard SIG. Effective date and written date. Day's supply. Dispenses written code, which is your brand, you know, must-be brand. Number of refills allowed. All of this is part of the drug segment, and the drug segment can have multiple occurrences, and - on a new Rx, you would just have one, but if the pharmacy is going back to the physician and saying this is what you prescribed. Okay? This is what I would like to dispense. It's the generic or it's another one because of formulary issue. Okay? Those type of things can happen.
Here's - as you see - formulary alternative. You can also come back and say here is the preferred. If you dispense this, I need a prior authorization. So when a pharmacy communicates with a physician, they can give them more information, so they can make a decision. So that segment, depending on the type of message, could occur multiple times in its tag for what this particular occurrence means.
DR. HUFF: Back on your last slide, the quantity and qualifier, I mean, your examples are for usual tablets. Do you also support orders or prescriptions for IVs, so you could specify an IV right here or how have you guys approached that?
MR. BECKLEY: We haven't approached that. The IV - if it is multiple - it's like a compound in a way. If it is multiple ingredients, one thing I didn't include in here is - well, there's a little bit more, but there was a free text segment, where complex messages can occur. So if I want so much of this, so much of this, so much of this, then I could spell it out for the pharmacy or the specialty pharmacy that would do the IV. It is not codified in those areas up above.
DR. STEINDEL: In our last presentation, one of the points that was made was the variety of state laws in terms of prescribing, and one of the things that was pointed out where a lot of variety existed was dispense as written, and you have a dispense as written flag.
Now, generally speaking, e-prescribing is under another set of state laws. I know Georgia is discussing one right now. So I am kind of in the middle of hearing about it, since our legislature is in session, which is a good time to be out of the state, as John Lumpkin always pointed out to us - (laughter) - and when you just have dispense as written there, I assume that is accepted as dispense as written by every state that SCRIPT Standard is used and you don't have to worry about adjudicating that.
MR. BECKLEY: There have been a few challenges. For the most part, yes. There have been a few states where the law or the regulation - and they differ - was written must be in a physician's own handwriting, and what usually occurs is business partners go to the state board of pharmacy, talk about electronic prescribing and you cannot have in a doctor's own handwriting, you know, medically necessary or brand required, and then they changed the reg or the law for electronic prescribing to have it indicated electronically, and we have not had a problem with that. It takes a little bit of work, but it has not been a significant hindrance.
So the other nice thing about electronic prescribing, too, is you get out of what's on the top and what's on the bottom and what's on the side. In electronic prescribing, it doesn't matter. So a lot of those things go away. We have not seen - we have - changing hats for a minute. When I work on the other side, we try to do electronic prescribing in states, we have what we call our problem children. You mentioned one of them. Okay?
DR. STEINDEL: They're trying to solve it. (Laughter).
MR. BECKLEY: There are some others, but, for the most part, it is frequently we - you know, they are contacted by the partners who want to do electronic prescribing. Some of them say, fine, as long as you follow our regulations. Others say, please tell me how you are going to do it, and then you get back a letter or a telephone call saying it's fine.
Two states, Ohio and the State of Washington, actually ask you to come in and demonstrate your software, whether it is prescriber software or pharmacy software or someone in the middle acting as - the different terms are used, but as a router, a messenger services broker, whatever you want to call it. So you can tell them how it is flowing, and you get approved.
So except for the few quirks here and there, it is - for the most part, electronic prescribing is getting rid of the big book, because they can't get down to the level of where you have to print your name.
Just a couple more things in the drug segment. We talked about drug utilization review information.
Oh, I'm sorry. I forgot you, Karen -
MS. TRUDEL: You mentioned a slide or two ago - and I just didn't want to lose this point - that there was no standard for a codified SIG. Has there been any groundwork done at all on that or -
MR. BECKLEY: It is one of the bloodiest conversations there is.
The concern is - and some of it is on the actual pharmacies that they are concerned about clearly understanding the physician's intentions, and if it's - the physician types in one thing and then it is translated into a code and sent to them, they are concerned about was it done correctly. They like to see it written out what they're used to.
Then the other issue is, if you standardize it, imagine trying to convert pharmacy systems where four billion prescriptions are dispensed per year, and five-six years of history on there, translating all those SIGs now to a new SIG, that scares the living daylights out of folks, because if that prescription is translated incorrectly, the next dispensing could have catastrophic consequences.
So people are really B because SIGs in different systems work different ways. I mean, what it prints on the bottle, what's stored off is very different. One TID, I could get two or three different interpretations of what that is, especially based upon the size of the T, capital or small. Okay? One tablet? One teaspoon? One tablespoon? We actually have issues. I have seen it.
DR. COHN: Well, that's interesting, because most pharmacists I have talked to have trouble figuring out whether it is a T or not. (Laughter).
DR. FITZMAURICE: What does SIG stand for?
MS. GILBERTSON: We have been through about three different -
DR. FITZMAURICE: What does SIG stand for?
DR. COHN: Oh, it's the instructions for how you take the pill.
DR. FITZMAURICE(?): Signature.
MS. GILBERTSON: Yes, it's - no, it's SIG.
DR. FITZMAURICE: It's not the electronic signature? It's -
MS. GILBERTSON: No, no, no.
MR. BECKLEY: It's instructions.
MS. GILBERTSON: It's SIG. It's instructions. Yes. We always try to make -
DR. FITZMAURICE: Must be Latin.
MS. GILBERTSON: We say SIG.
MR. BECKLEY: It is Latin, yes.
MS. GILBERTSON: Yes, but the last time I looked it up in the dictionary, it said SIG was the definition.
MR. BECKLEY: Did I answer your question, Karen?
MS. TRUDEL: Yes, unless you're talking about HL7.
MR. BECKLEY: Going back to drug utilization review, we mentioned that in the SCRIPT Standard, we can pass back and forth drug utilization review information. So, Jeff, going back to one of your comments, if the physician identifies a DUR and says it's okay, they can pass that information down to the pharmacy, so the pharmacy doesn't call the doctor back and say, do you know there's a drug interaction? Or if the pharmacy catches it, and the physician did not, the pharmacy can send a message to the physician and say, I have identified a potential drug interaction. How would you like to proceed? The SCRIPT Standard already has that in place. Not only does it tell you the DUR reason, it can tell you the action taken, the final result, and we were talking about identify the coexisting agent contributing to the situation, but guess what. That piece of data is not used, and that goes back to my initial thing. When we identify it, we have to pass it on down the road. The standard can handle it. People aren't using it.
DR. HUFF: One more question.
MR. BECKLEY: Yes, sir.
DR. HUFF: I don't know what the proper - I've heard a lot of different names for it. When you have a recipe or a concocted drug, is there a way that you can specify codes for the ingredients that are part of that concoction, as opposed to just having a paragraph that says what to do?
MR. BECKLEY: Not in the standard right now. Is there a way? I can tell you what a pharmacy does, frequently. If you send them the text string, they will actually break it down by the ingredients, and their pharmacy system will know, by NDC, what each of the pieces are and how much of each, because they need to break it down into pieces to do the DUR check. I mean, they know it's water. They know it's this. They know it's that, et cetera, because they have to go to that level for the DUR, and they also have to go to that level, frequently, for submission of payment, but how it comes to them, frequently, is in text. Could we send compounds down using the codes? Yes, we could. It would just require, I think, a little more work on the physician's system.
DR. HUFF: How would you do that? By just multiple drug segments?
MR. BECKLEY: Yes, that's exactly -
DR. HUFF: Each with an ingredient in the drugs?
MR. BECKLEY: Um-hum. Exactly right. You just have multiple drug segments, and you identify that you have a compound coming, so you know that the multiple drug segments all make up one medication, one solution or whatever it happens to be. Yes, that is the way you would do it.
DR. HUFF: And coming back to the SIG in the other part, is the freehand SIG part - contains the frequency? There's not a separate field to say VID, TID? That's included as the free text part of the SIG.
MR. BECKLEY: That's included. One tablet, three times a day. That's part of the SIG, correct. Um-hum. That is correct. Or take as needed for pain. Take as needed for pain, PRN, as needed.
MS. GILBERTSON: Over the years, we have discussed multiple times the addition of compounds into the SCRIPT, and also - what's the other one?
MR. BECKLEY: I don't know.
MS. GILBERTSON: Compounds and -
MR. BECKLEY: IVs?
MS. GILBERTSON: No.
MR. BECKLEY: Which is a compound.
MS. GILBERTSON: I just lost it. Compounds and whatever - oh, and codifying of SIG. We have had different proposals brought forth and they usually just don't quite meet the needs of the industry, so they haven't been brought forward. It's like any standard. If there is a business need brought forward that can satisfy that business need, then it can be added to the standard. It just - either the timing wasn't right or the codification wasn't close enough or - one of the things that came - as Bob mentioned earlier, over and over and over again, when it comes to a SIG is that any codification is fine if it is agreed to by the industry participants, but that - quote - text must be present as well, and whether it is - you know, and in a workstation environment, I mean, the prescriber is not writing on the terminal screen the free text message. She is probably choosing it from a list box or a drop-down box or whatever, but they want the intent of what the prescriber wanted to see if he would have - as he would have prescribed it, not something that has been translated and translated back.
There's a couple of examples. In fact, in the e-High(?) White Paper, there's a little appendix we added dealing with the codification of SIGs, and there's one good example of mistranslation where it was supposed to be two a day or something like that and it ended up being translated to put in left ear. (Laughter). Those are the kinds of things that just can't be allowed to happen.
DR. HUFF: So I guess the thing I would point out - I mean, is that if you don't in-code at least the frequency and maybe some other parts of the SIG, then there are certain kinds of dose checking you can't do. You can't know whether you are exceeding the total daily dose of this medication or, for that matter, you couldn't sum and know whether you have exceeded the lifetime allocation of this medication, et cetera.
MR. BECKLEY: The pharmacy seems to do that, though. When they get the medication and they enter one tablet three times a day and it's 90 pills, then the system calculates a 30-day supply. In other words, when the pharmacy system gets it and they input the data, it prompts them so that they can determine duration, day's supply, how long it will last, et cetera. So there are some things that happen at the pharmacy, because -
DR. HUFF: With manual intervention, you can do -
MR. BECKLEY: Yes, sir. Yes, sir. Um-hum. Some automation. It depends. If it's one tablet, three times a day, and it's 90 pills, system calculates 30-day supply. Those type of things are fairly straightforward, but some of them - as needed, then, you know, it's - it goes from there.
One thing - I have trailer segments, which we don't need to go into. Just some validation checking, but I didn't give you examples of the coordination of benefits segment, and the observation segment, because I said they weren't being used, and I want to go back to what Ross said earlier when the question was prior authorization. I mentioned that we can do prior authorization once it gets to the pharmacy and the pharmacy goes back and says to the physician, I need a prior authorization number. Let me tell you what some of the author's intentions were, since some of us are here.
The coordination of benefits segment. The physician could send to the payer - if they know who the payer was - in the coordination of benefits segment, they say - I already have a patient segment. I have what the drug is. I don't need the pharmacy. I can identify who the physician is and there's already a field that says I need a prior authorization. So I could send to the payer a request from a physician's office for prior authorization. Now, have all the details been worked out to flush out any new data elements that may be needed? Have the business - been clearly identified? No, but can the standard do it? Yes, with minor modifications. That is just one example of what it can do. Can it do an eligibility check? There is work going on right now or will be very soon to use the SCRIPT Standard to - query for an eligibility check. The standard can do much more than it is right now.
And that leads me into what is the current status of electronic prescribing? And that is what I wanted to share with you last. I'll talk about some past problems, and I'll tell you what is happening today.
In the past, very few pharmacies were directly connected to physician practices. Electronic communications meant faxes or typed prescriptions that were handed out. Only new Rxs were being addressed. Electronic prescribing didn't fit the work flow in a physician's office. It was very, very cumbersome. We didn't see tangible benefits, and automation was being driven by a few very small software vendors that disappeared, the dot-com era.
What happened was, I'd go into a doctor's office, say, here, here's this handheld device, and you can only talk to Pharmacies A. Try it. Well, after about one or two times, realizing that that was only five percent of my prescriptions that I write that went to Pharmacy A, the handheld went in the drawer.
Today, this model has changed significantly. Today, the model - there are over 75 percent of the community pharmacies have true electronic prescribing. If the docs were there, they could receive and send electronic prescriptions. They can do it, and I have a couple of charts that actually list pharmacies for you, to give you an idea, and they all are utilizing the NCPDP SCRIPT Standard. There's no hybrids. There's no -
MR. BLAIR: Could you elaborate on this just a little bit more.
MR. BECKLEY: Sure.
MR. BLAIR: Seventy-five percent of retail pharmacies in the United States B
MR. BECKLEY: Um-hum.
MR. BLAIR: Have the electronic equipment in place to receive an electronic prescription. Is that correct? Is that what you are saying?
MR. BECKLEY: Yes, and also send refill requests.
MR. BLAIR: And send refill -
MR. BECKLEY: That's correct. Yes, they do.
MR. BLAIR: Is there a disparity or a grouping where that happens to be that certain states have basically close to 100 and some have close to zero?
MR. BECKLEY: No. The issue is when I say 75 percent is in working with all the software vendors, some of them have completed it and pushed it out to all their customers. You have some chains, like - I'll just say example of Walgreen's. They write their own software. They're done. You have other software vendors that have many customers. They may be almost done with it, and so that is the 25 percent. It's not that someone cannot do it or has chosen not to do it. It's just where are they in their software distribution or software development and distribution, and that gap is closing very quickly. If I'd have made this presentation fourth quarter last year, the number would have been 50 percent. Hopefully, by the end of this year, we will be in the 90s. So it's more of a - when I present it today, it's 75 percent. So it's not a state issue.
What happens in a state - in Steven's state - (laughter) - is the pharmacies just turn it off. The functionality is there, but it's not enabled. I mean, the software goes to everyone. It's there. It's just you don't turn it on until the law allows or there is a doctor ready to communicate with you, and that leads right into the next bullet point.
Approximately three percent of the prescribers have true electronic prescribing capabilities, and I have a little - things to back this up.
Now, we are making progress. This just came out. I mean, we got permission to put this information - please note the footnote at the bottom. This is from a survey, taking the pulse - Version 4.0 study, March 2004, Manhattan Research. I mean, first of the month. Here's the trends.
Seven percent of all physicians use an electronic prescribing system, but of that seven percent, only 41 percent are connected to the pharmacy. So that is a net of three. What that means is their definition of electronic prescribing is I put the information in and a piece of paper comes out. Okay. That's - you've taken care of part of it. Okay?
How many of them can actually send it to the pharmacy electronically? That is how you get down to three percent, but the number is changing quickly. If we'd - again - done this earlier in the year, that number would have been smaller. There are many roll-outs going on right now. I heard someone say, tell me about the pilots you have going. There are not pilots going on. There are active, full-blown programs going on in entire states, and the numbers are ramping up very quickly, but those are presentations later. Okay?
But I want to make it - there are not pilot programs out there. There are full-blown implementations. This is way beyond pilot stage, when physicians are talking to pharmacies and sending information back and forth electronically.
The rest of the information: Thirty-seven percent of the physicians are very interested or somewhat interested in using an electronic prescribing system in the next 12 months, and that includes sending it electronically to the pharmacy, not just doing something in their office.
The top three drivers: Increased accuracy, 47 percent. Reduced pharmacy calls, 45 percent. You see how close that is? That is why that refill request is so important. Many of their calls are for refills. Can I have more? Can I have more?
Commonly-used Rx list, 42 percent. That little drop-down menu that Jonathan showed. Remember he pointed that out? Another one of the major drivers. Quickly being able to prescribe, but yet accurately.
Now, I mentioned 75 percent of the pharmacies. I have put up a pharmacy list of partners that I am aware of that can do electronic prescribing. I'm not going to list them all. Some of the names you may not know because they are parent companies. When I say Ahold, I'm talking about Giant Foods here, Stop and Shop up in Boston, BuyLow(?) down in South Carolina, Bruno's in Atlanta - Birmingham. You see Albertson's Osco. The list goes on and on, and the independent pharmacy software vendors, which also include the independents. There are about 55,000 community pharmacies in the United States. It's almost a 50-50 split, and they are all participating.
Now, here is where the progress is being made. Physician technology vendors are coming on board, and this is, again, a partial list of physician technology vendors that have committed and written to the SCRIPT Standard and are communicating or are in the process of developing their software, and it is a significant list, and that is what I said in that earlier slide, progress is being made. Progress is being made. They have seen the light, so to speak.
The important thing was the pharmacy connectivity is there. Someone had to get there first. That's been one of the big issues with electronic prescribing. You talk to a doc. How many pharmacies are there? You talk to the pharmacy, how many docs are there? Pharmacies said, okay, enough of this. We'll write it. Hopefully, they will come, and they are. The physicians are coming, especially when they see the benefits of especially some of the refill requests.
As I said, pharmacies put a stake in the ground in implementing electronic prescribing in hopes the physicians would then join. This hope is coming to fruition. Millions of true electronic prescription messages will be sent in 2004.
Little bit about the barriers. As I said before - you brought it up, Steven - the state regulations are really not a barrier. Sometimes, they are a bump, but, for the most part, all of them have been resolved in a very timely manner. Depends on whose definition of timely, but sometimes it takes a few months, especially if you are dealing with legislative law instead of a regulation - legislation. You have to go through and get it changed.
Electronic signatures are not a barrier. Electronic signatures - difference between electronic and digital - because of the way the SCRIPT Standard has a unique identifier for that physician. It is attached the time it's sent. Electronic signatures are not a barrier. We haven't had any problems with any states. That's not controlled substances, mind you. That's not controlled substances. I saw you coming. (Laughter).
DR. COHN: So what happens with controlled substances?
MR. BECKLEY: Controlled substances, which are about 15 percent of the prescriptions, Schedule 2 through 5, handwritten.
DR. COHN: Interesting. Okay -
MR. BECKLEY: Handwritten. I mean, one would like to see it, but the regs that are coming down, we'll have to see, because they haven't gone out for comment yet.
DR. COHN: Okay. And that is usually a combination - I guess I have to ask later on, but it's usually a combination of state regulations plus DEA.
MR. BECKLEY: It's DEA.
DR. COHN: It's all DEA?
MR. BECKLEY: DEA, um-hum. Mostly DEA, yes, sir.
The biggest barrier or hindrance into electronic prescribing is educating the prescribers to the benefits of electronic prescribing and letting them know of the pharmacy readiness. Many of them do not know that percentage of pharmacies that are ready. They think electronic prescribing is just Rxs. They don't see the benefit or they are not aware of the significant return investment for automating refills and changes, et cetera, and when they understand that or when their office manager understands that, adoption goes very quickly and very easily.
Standards. The transmission standard, in our opinion, is not the issue for - pharmacy or physician software vendors. I think you have seen the numbers. They are adapting it. They are sending it. It's working.
Code sets, I say, not a major issue. We are doing it right now, but some of it is being done with text versus codes, but it hasn't stopped the advancement of electronic prescribing. So we can continue while we develop code sets. It doesn't stop us, but one of the major barriers is a standard identifier for patients, physicians and payers.
Now, we talked a little bit about the physicians, but medication history, beyond Medicare, how do you do that?
You have to go to databases that try to - you know, through algorithm determine, because everyone has a different identifier. For every physician practice you go to, for every pharmacy you go to, if you switch payers, your numbers probably change, and I know that came up in Chicago. Karen and I were reminiscing about a few - what was it? Ninety what? Ninety-seven something? Chicago. It was ugly. It was ugly as all get out.
And we already heard today, and a standard payer identifier. Those are three - beating someone to the question of what are the three major identifiers. Those are the three majors that would really advance and make electronic prescribing easier. The other code sets will definitely help, but they haven't stopped the progress. People have come up with workarounds for these others. Okay?
MS. GILBERTSON: One of the interesting things with the standards for payers that was mentioned earlier, will the health plan regulation help us out, and it is one of the things we are kind of waiting with bated breath, because, right now, the billions of pharmacy claims that are billed each year electronically are using what is called a bin number, an identification number that can go on the standard card, which is also one of the attachments that was available to the committee. How will that function in the new world? Will that create another cross reference that - well, this is the number that you have been using for years to identify your pharmacy benefit package for billing of claims, but, now, you have a new number that you somehow have to cross reference to as your health plan ID, and that could be an interesting challenge to get around, because it may cause more headaches with another cross mapping going on.
The other thing was the - when Bob was mentioning about the work flow, you have now the introduction of the physician office asking for prescription benefit information. I don't think anybody probably gives their doc any information about their prescription benefit today. So whether you give the standard ID card or whatever, the physician's office has to include that in their workflow as well and recognizing even if I do have a standard pharmacy ID card, that I know where the identifiers are for routing to a particular benefit package, it is still adding that into my system and being comfortable with it and asking changes every year, if your benefit program changes. Not insurmountable, but just a different aspect that the provider system is not used to doing today. So those are just some things to bear in mind as well.
MR. BECKLEY: I was going to add one other additional thing is Lynne mentioned the bin number. I believe that used to stand for banking identification number, routing. Electronic prescribing is very similar. One of the examples that we use out there is, like the ATM networks you don't care where you put your card in. Karen pointed out earlier, you don't get advertising when you go through prompts. As soon as you put your card in, it comes up with basic information. You enter it. You know it goes to your bank. You can walk up to any machine, and you are going to get your cash, and everything is handled behind the scenes.
So think of - you know - this standard here is like a banking standard. It is a standard to communicate those type of important information.
MR. BLAIR: Two questions. One is you say we still have a problem with the provider identifier. Why do we still have a problem, if you are able to use HCIdea?
MR. BECKLEY: If we get - with anything, it's getting full adoption. If everyone would adopt HCIdea, I think that would - if everyone would agree upon an identifier, and - you know - Simon asked the question. He wasn't even aware of it. If people became more aware of it and it got backing, I think you could resolve the issue, because the HCIdea would take it down to - you know - the person and the location, which is what is needed for electronic prescribing and for claims adjudication.
MR. BLAIR: Okay. The other question was on your list you didn't list the issue we previously mentioned which was the need to be able to map the ingredients and drug identifiers to a referenced drug terminology like RxNorm, but we don't know if that is adequate the way we have envisioned it so far. Was that just omitted or is that a separate issue?
MR. BECKLEY: The code sets for those things are not a major issue that prevents electronic prescribing from moving forward, because there have been - we talked about - there have been ways that's been worked around or handled. Multiple checks of DUR, as you go down the path. You get the text string. It's not prohibiting electronic prescribing from moving forward. It could definitely enhance it and make it easier, yes, but it is not what I was calling a barrier of electronic prescribing, where these others are more of a hindrance where you have people coming up with their own proprietary identifiers. A calls doc this number and B calls doc this number, and those are more of a barrier than the code sets for the drugs, but that would definitely help with safety and efficiency if we can get those, but I didn't classify them as major for implementation.
MR. BLAIR: One more piece, because in the Medicare Prescription Drug Improvement Modernization Act, it also looks for us to explore the area of eligibility checking, and we have, of course - you know, one of our HIPAA transactions with ASCX12 is an eligibility check.
MR. BECKLEY: Correct.
MR. BLAIR: How do you deal with eligibility checking in your environment?
MS. GILBERTSON: HIPAA also allowed the NCPDP format.
MR. BLAIR: Telecommunications -
MS. GILBERTSON: Yes, used for eligibility, which, you know -
MR. BLAIR: Um-hum. So it's done that way.
MS. GILBERTSON: I mean, currently, from what I understand in the medical world of eligibility checking, you get a larger disclaimer of what may or may not be available on that moment of the transaction than you do get what you are eligible for. So I think it's the maturity of - if you mention the X12 environment of the 270-271 of good information that is returned to the provider based on that 270 request, but I remember environments where you got a little bit about, yes, this is a patient. Yes, we think they're covered, but here is the disclaimer of we are not saying we are going to pay for anything at any particular point in time. So that maturity will be helpful.
From the pharmacy side, the eligibility transaction - oh, gosh, out of billions of claims that are filed each year, maybe there's 10,000 eligibility checks that are done, because if you can wrap it, once again, in a stronger transaction, which is the claim - check eligibility, check DUR, check formulary, check benefit, check -
MR. BLAIR: One piece I still don't understand. I'm a physician, then I would use the SCX12N to be able to check the eligibility with the health plan. However, if that message is now in the pharmacy location, you'd be using the NCPDP telecommunications standard to check with - with who? Would it be the same health plan? Would it be a PBM or what - is there a disconnect here with the fact that we are using two different eligibility standards, possibly, where one might wind up getting, yes, the individual is eligible, and the other one would wind up saying, I don't know who that individual is.
MS. GILBERTSON: It wouldn't so much be two different transactions as it would be the questions you are asking.
For example, you would be requesting eligibility on medical benefits versus a pharmacy benefit. So that might determine - at this point, set aside which standard. It really doesn't make any difference. It is who is communicating with who, and so you've got a prescriber, who, when they are in the prescribing mode, may need to check with the pharmacy benefit program, the PBM, and when they are checking - I don't know - some medical benefit, they would be - it could be the same entity if coverage is through both, but, very often, it is separate coverages, and how many people carry two different cards in their wallets?
MR. BECKLEY: There is the - the pharmacy doing the eligibility payment, that's very mature. That's being handled every day, you know, four-billion times a year. The physician asking for prescription eligibility is infant, if that far along. There is some work in that area. There is some work starting at NCPDP in that area, because you are talking to, in the most part, the same - you are talking to the same entity. The physician is asking the same entity, the same PBM that the pharmacy will submit the claim to. So, as Lynne was saying, it goes to the same B pretty much the same person, the same PBM or someone acting on their behalf to have it checked, and so, you know, that entity receiving it is not a 270-721 type of entity, and it is definitely not batch. It is real time, and that's why, probably, you know, if the business dictates it, it'll probably be part of the SCRIPT Standard, because that is what the PBMs will receive. That's what'll be interactive instead of batch mode. So I don't think it's a disconnect. I think it's an area of infancy.
DR. COHN: I think Karen had a comment or a question and then -
MS. TRUDEL: Yes, I would just like to kind of summarize that, because I think it is an important point. It sounds as though the current modes of communication in the industry are from the prescriber to the pharmacy and from the pharmacy to the PBM and that there are two fairly mature standards that support those lines of communication, and that the Medicare Modernization Act envisions an additional line of communication that may be directly from the prescriber to the PDP, the PDM plan, whatever you want to call them, that is not mature and the line of communication isn't even very well exercised today. Is that basically what we are saying?
MR. BECKLEY: Not well exercised? That's probably correct. There are advancements in that area, and NCPDP is working on that as business needs are brought forward.
MS. TRUDEL: That is certainly a gap area, right?
MR. BECKLEY: Yes, but in progress. In progress.
MR. HAUSNER: Hi, I'm Tony Hausner with CMS.
I was interested in your thoughts about standards related to the medication history and patient history.
MR. BECKLEY: I had a bullet that, you know, I think, an identifier, so that you can pull from multiple sources, is going to be very important, because depending upon what system you are in, whether it's a physician's or an electronic health record, if you are in a pharmacy system, if you are in a payer system, you have different identifiers everywhere.
So to do medication history, there either has to be a master index that is built and maintained all the time or we need to come up with a standard identifier, and then it becomes easier to find that information and bring it together. That is one of the major hurdles.
In electronic prescribing, it is being discussed. It is - I liked Karen's comment earlier today. It is something that is in there, but it is probably on a separate time line.
I used the example if you're from Boston, medication history is like the big dig. It is going to take a long time to - and, as we go along, we are going to hit soggy spots. That was a landfill that we have to pour concrete into to shore it up. Okay? (Laughter). I mean, the big dig. All right?
Where electronic prescribing, except for the medication history is - you know, you are just maybe expanding an existing highway or you are putting in a two-lane road to start some traffic. Huge difference. It is what we all want to get to, absolutely. It is going to just take a little longer and quite a bit more work. I think the term before, buffing up, doesn't even fit.
MS. GILBERTSON: The medication history that we do have available today would be, for example, a pharmacy or a prescriber to the PBM, using the identifiers that that PBM has for that patient. So there's some infrastructure there. It's how far outside those lines you can go, and, you know, if you have to query four different PBMs for history over the past two years, because the patient has jumped coverage different times, that adds complexity, but if you start out slow, I think there's some identifiers that can be used and some relationships that are built or being built that can start facilitating some of that and have.
MR. BECKLEY: I was going to say - one other comment. If you're talking medication history versus medical history, there is one place that you can get the medication history. All medications have to be dispensed by a pharmacy, whether it's cash, third party, it has to come out of a pharmacy, mail order, community pharmacy, et cetera - okay? - internet. Has to come out of a pharmacy. So if you have a standard identifier, a physician could get - say to the patient, what pharmacist do you go to? You could get medication history with a few queries, versus having to query - you know - the nation or trying to have this big database in the sky.
MS. BERN: Hi, I'm Terry Bern from Rx Hub, and I am responsible at Rx Hub for implementing all of the standards - PDP standards as well as X12 standards - and I did want to make one clarification on eligibility, because I am familiar with both, telecommunication and X12.
The X12 standard was designed to obtain eligibility from a doctor to a payer, and so that standard can be utilized within our model between the doctor and the PBM. We do have a lot of experience with that, and that standard is designed to give back information about the patient, what their identifier is with the payer, and we can go to multiple pairs, et cetera.
So in the absence of having a standard identifier per patient, that actually is a good model, and I wanted to make that clarification, because the X12 standard is useful for that to go to the PBMs as well as the health plans.
In addition, that model helps us implement - or that X12 standard helps us implement our model for obtaining drug history from the PBMs, because they are able to tell the doctor or the point-of-care application what the identifier is for that patient and where to get that patient history.
Now, today, we can only get it from the PBMs. In the future world, we probably need to develop a standard where we can get it from any entity, because, as Bob said, the pharmacies dispense drugs that are cash only. However, a patient could go to multiple pharmacies as well, and so there isn't one central place where you can get the information, which only iterates the need for a standard to get patient history from any entity that has it.
DR. COHN: Actually, I wanted to run back to the eligibility issue, also - I'm trying to remember exactly what I was going to ask, at this point, or comment on.
I guess, without trying to answer the question about eligibility, it occurs to me under the Medicare Modernization Act that, obviously, there are a bunch of prescription drug plans, some of which are existent or are going to become - they'll become, over the next year, year-and-a-half, as well as a group of Medicare Advantage Plans, at this point, which include both the current ones, but also regional PPOs, national PPOs and others, all of which will be in the Part D business, and I think that maybe we need to talk to them and ask them how they would best like to handle some of these eligibility issues, recognizing that right now, in many cases, PBMs act as their agents, as I understand, to handle eligibility issues, but we probably ought to ask sort of their choice of models and what would make sense to best support eligibility with them, recognizing that, at the end of the day, they may choose to have agents or they may choose not to have agents, and we ought to ask.
Karen, what are your thoughts on that?
MS. TRUDEL: Actually, I was going to add a point that this is complex enough without adding on more complexity that we don't need, and I think -
DR. COHN: Okay. Have I gone beyond -
MS. TRUDEL: - that it is important for people to realize that in the health industry as a whole identifiers may be a problem, because there are different payers. We are talking about a Medicare-only environment. Medicare does have an identifier for all of its beneficiaries, and it will have a process, whereby each of those beneficiaries who decides to participate in a plan will elect which one - one - it chooses to participate in.
So, in a sense, we are looking at a much more homogeneous closed environment than you will see if you are looking about - into how to implement this on a nationwide basis, and so I would suggest that while some of these issues are important and they probably need to be communicated to the Secretary, I don't think that is necessarily something that is beneficial to spend an awful lot of time on, in the context of MMA and the deadlines that this committee has.
DR. COHN: Sure. And I guess, just to clarify, really, what I was commenting about was is that we should probably clarify with the PDPs that they are comfortable - you know, recognize that they have a choice of the X12 transaction for eligibility or the NCPDP transaction is a recommendation one or both or what? And that was really B I was not trying to reestablish a patient identifier, because we do, thankfully, have HICK(?) numbers.
MS. CRONIN: Simon, I'd just like to add on to that. I think that when we have the opportunity to get testimony from what we think will be the PDP sponsors in a couple of years, it would be very helpful to find that out, but, also, get their specific feedback on formulary standards and how they think they might be dealing with standards around classifications of drugs, in particular, and, for example, therapeutic categories that might enable therapeutic interchange. So I think there's a lot of issues that we'll need to ask them about once they are in front of us.
MR. BECKLEY: Also like to say - you know, you're talking about - bring the pharmacies to the table. Bring some of the larger chains that write their own software and know all the things they have to do. I think they'll bring a very interesting perspective to you. Also, on the DUR, when you're talking about DUR, I think it's - Roy Busowitz is here. I think over 90 required pharmacies to perform DUR. Is that right, Roy?
MR. BUSOWITZ: That is correct.
MR. BECKLEY: And so they have been doing it for 14 years, detailed DUR, and that is when the drug databases started. So they can give you a very good perspective of feet on the street what it means and how they do it, et cetera. So bring the pharmacies in, and I know there's a lot of them that would be more than happy to testify. We'd be happy to help you with that, too.
MS. GILBERTSON: In addition to our testimony, we included a pharmacy ID card fact sheet. It's just a couple of page sheet, just to show you what the ID card on a high level summary looks like. That was referenced in the Medicare bill, and, also, there is just a - I think - a two-page document. Jeff had asked us if there was any thoughts that we could provide back to the committee of things to look forward in testimony going on this summer. I think I could probably add 10 more items to it, but one of the things was who to invite to the hearings, and things like that. So we stand ready to help.
DR. COHN: Okay. Lynne, thank you.
MR. RATHERMICK: I'm Phil Rathermick with Express Scripts.
May be a semantic issue, but I wanted to just raise the issue, because I don't think the opportunity for preemption should be understated.
The comment you made about state regulation not being a barrier I agree with in the context that, in most states today, you can do electronic prescribing.
The difficulty with having different standards and the vendors having to go state to state to get approval is an issue, and, from a pharmacy perspective, we operate pharmacies in five states that are subject to five states'boards of pharmacy, and allocation of clients and members to pharmacies isn't intuitive, necessarily. So if a script came to Express Scripts and we have to fire it off to a facility in one state or another, we have to get to sort of a lowest common denominator, and so it is important to recognize, for this committee, that to set a single standard for both authentication of end users and what constitutes an acceptable script for the pharmacist to fill without having to look at different state regulations is very important, and I just wanted to make sure that that was clear.
MR. REYNOLD: Back to Karen's comment a minute. There's a significant healthcare industry out there right now that is using automated scriptions from the pharmacies to the PBMs, using NCPDP, using the other things that are going on. So, although I understand that the committee is focused on that, I hope that the NCPDPs and the other entities that are out there keep in mind that since there is mention in HIPAA of NCPDP and a mention in other things that are going on, that the whole industry is not lost sight of, because, otherwise, then, what the government does becomes a standard, because if we are doing our job, we don't want the doctors and the pharmacies to have to go to many standards in many ways for this industry.
So I'd like to also put that on the table as a consideration, because it is the same doctor. It is the same pharmacy and it is the same PBM. So I think that is something that - I know we can't dwell on it, but I believe it is something that if we are shortsighted in doing it, then we are doing a disservice to those three entities that I think - that are already out there leading the way, so that this can be a piggyback. This is not a new discussion.
MS. CRONIN: Simon, can I just add one minor comment?
DR. COHN: Sure, Kelly, please -
MS. CRONIN: The subcommittee should probably stay in touch with what is happening with the NHII subcommittee, because there is going to be a lot of activities over the next year or two at a state level, where they are going to be, perhaps, developing local indexes, and there'll be other mechanisms for perhaps looking at a unique identifier that would be perhaps beyond an incripted SSN or whatever we are dealing with within Medicare.
MS. GILBERTSON: You want to get some PBM interest, just ask the PBMs how they are jumping through hoops to modify from use of SSN to a non-SSN when it comes to the State of California and Minnesota and wherever else. It's tough. Now, you have cross references of cross references of cross references.
MR. REYNOLDS: I would say within the next 18 months most every payer would have probably transferred from a Social Security number to some unique identifier that is outside SSN. So, as we deliberate this, that is going on full speed right now.
MS. GILBERTSON: And some of those identifiers are assigned by the health plan, some are assigned by their agents. Some are B you know, they are all over the place.
MR. REYNOLDS: Some are grabbed by the employer.
MS. GILBERTSON: Um-hum.
DR. HUFF: Just a quick question about access to the standard and how much does it cost and how do you license the use of the standard?
MS. GILBERTSON: The NCPDP standards, as an entire package, everything that we publish, is available for $650 for the entire package, and that is telecom, script, pharmacy ID - it's everything we publish, that whole package comes out.
There is also a yearly membership that is $550 a year, and with that membership, you receive the entire package of standards, as well as access to the members-only section of the site, and free attendance at any of the workgroup meetings, things like that.
One of the things that is of interest is - I happened to be at a HIPAA 3 summit not too long ago and it was - maybe a HIPAA 8, a HIPAA 8 - and the discussion of the organization of X12 or the organization of NCPDP or the organization of XYZ doesn't create a standard. It is the participation of the industry, and one of the things that we like to remind folks is that you don't have to be a member to participate in the standards development, because most of our work is done in task groups, over phone calls, and, at that point, anyone is allowed to participate. So we hope it is never seen as a barrier, because it is what the participants want, because I don't sit and dream up these standards, even though once upon a time we did. It is really what does the industry want, as we move forward, and it is important, because if it's not you, who is getting involved?
MR. BECKLEY: To use the standard, there is no fee. I mean, you were asking -
MS. GILBERTSON: That's true. Licensing.
MR. BECKLEY: - what is the licensing. There is no licensing. It is basically - if you are a member, $550 a year, you get the documents, you get the standard, the layouts, the implementation guide. If you are not a member, we charge a little bit more, so do you get the drift of what we want you to do? We want you to be a member.
MS. GILBERTSON: The doctor doesn't have to purchase the standards.
MR. BECKLEY: Right.
MS. GILBERTSON: They are not going to code to it -
MR. BECKLEY: Their software vendor does. So you take a large software vendor, they have a representative there. They program it. The physicians don't have to know about NCPDP. The same thing goes for the pharmacies. Their software vendor belongs to NCPDP, helps write the standards, and they - you know, they put it in their software, and the pharmacists just use it. So there is no per-site licensing. It's just how you get the documentation so you can code to it.
DR. COHN: Well, you know, with this, I am going to suggest we take a 15-minute break.
We thank our presenters for the great conversation. (Applause).
(2:47 p.m.)
(3:07 p.m.)
DR. COHN: Okay. The next session actually begins with an opportunity to hear federal perspectives on the e-prescribing, and I think we'll be hearing from FDA and the VA. We are obviously glad to have you both here, and, then, from there, we move into an open-mike period, and, then, from there, into subcommittee discussions of the testimony of the day.
Agenda Item: Federal Perspectives on E-Prescribing
DR. COHN: So, Randy, would you like to lead off discussions representing the FDA, please?
MR. LEVIN: Okay. Thank you.
I just want to mention that because of budget problems at the FDA, we will have no background on our slides, okay? (Laughter). You're aware of that.
I'm going to talk a little bit about what FDA is doing to support the electronic prescribing, and a lot of this work is interagency work. So it is involving a lot of work we have done with the VA, with the National Library of Medicine and with ARC and some other groups, and it focuses around something we are calling structured product labeling, which is a computer file that contains information about medication. It's what is being proposed as a standard for exchange of medical information between the FDA and the pharmaceutical companies and the manufacturers and with the NLM and with information suppliers. It is an HL7 XML standard, based on the clinical document architecture, and it is currently being balloted at HL7. It has passed the committee-level ballot and is going for membership ballot this May.
The source of information for this - the structured product labeling would be a professional labeling for prescription drugs, but also includes - will include the over-the-counter drugs, and we'll get that from Drug Facts, from over-the-counter drugs, and information from drug listing.
The contents of SPL, we would include things of how to use the medications, things like dosing recommendations, when to use the medication, indication - like indications, clinical effects, including interactions and adverse events.
Description of the medication, including the various names of the medication, ingredients, strength, appearance, dosage form and codes related to those - the names and ingredients.
How the medication is supplied, name, package type and quantity, and the distributor of the medication.
So here is a - just showing now we are going to have - break the labeling down into sections. So each section of the labeling, like indications or box warnings or dosage administration, will be divided into sections that will be tagged as a blob of text. So this is taking the current labeling information, dividing it into these sections, but - and what we have heard is that we need more data elements actually captured that could be used in decision support systems like what would be used at the VA, and a lot of this information has come, actually, from the work that we have done with the VA and others, where we would take and have data elements for specific parts of the information that is in the drug labeling. So this would include things related to the active ingredient, including codes for the active ingredient, names, and I'll go over this in more detail, but also the mechanism of actions and clinical effects, things related to the drug product and package product.
So for the active ingredients, the things we are talking about, the data elements we are talking about are a tag for the active-ingredient name - this would be the established name and this would be what we would refer to as the established name for the ingredient - the ingredient ID, which we are calling the unique ingredient identifier, UNII, for the whole substance, also, an ingredient ID for an active - if that's different than the substance. Sometimes, there is an active portion of the ingredient and we would identify that as well, as well as for the active ingredient, the activity of it. That would be a mechanism of action or physiologic effects, and the clinical effects.
For the clinical effects, some of the - what we have seen requests for are to categorize the clinical effects, such as if it is an adverse event or a drug interaction or a food interaction or some other types of interactions, and to describe that are there contributing factors to this interaction, such as if you take the medication with a meal, you are going to have a consequence of decreased absorption, so capturing the contributing factors as well as the consequences of those factors. So if you take the medication with another medication, you'll have a certain interaction, and describe those things in data elements.
Then also describe where the information is located in the labeling text, so that - so you can actually see more detail about it.
The things that we heard are important - some idea of the frequency of the clinical effect, some idea about the severity of the effect and if it is related to any special population. So these are some of the data elements that we have heard about that would be helpful if they were tagged and then provided in the labeling, in the structured product labeling. So it would be available as machine-readable information.
Then information about the actual finished dosage(?) form. This is the - could be the pill that you are taking. This would be the ingredients that are in this, the medication, the strength and dosage form, the color and shape, if it's scored, things like coating and other things that might be related to the appearance of the product.
The manufacturer, the labeled route of administration, inactive ingredients and imprint coding. That's things that are actually on the finished dosage form used for identification. So these would be things that would be related to the finished dosage form.
And for an active - inactive ingredient, we would also have a name for the - I mean, for the inactive ingredient and an identifier for inactive ingredients as well.
For the product itself, there would be - usually a product is confined to one of the finished dosage forms, but can be related to a multiple finished dosage form, but it has a trade name, an established name, which we would tag, as well as a product code, and this is a code that would be for minus the packaging information that - this is what was talked about before that there is - there would be a product code, a drug product code.
And discussion about the indications, and some of the ideas about indications would be that have some - the name of the indication, some grouping of the indication that - the type, the disease, conditions, sign or symptom. What is the severity that you are treating? What is the intent? Is it treatment prevention? Mitigation, cure, diagnosis? Is it a primary adjunctive treatment? Are there any exclusions for use, such as shouldn't be used in pediatric age groups? What are dosing and monitoring issues about the - for the indication? And things about dosing -
DR. HUFF: I know, in times past, we talked some about whether that - the name of the indication could be coded rather than text, but you are still at a level where you think you just support X names for these indications?
MR. LEVIN: I think with the structured product labeling, you can go with either. You can have coding and we can have names. So one of the - I think they were - for the last discussion - talking about that if you have text, that is one thing. If we can do it without the codes, but we can - we can work with codes as well. So, I mean, these are things that are open for discussion. These are the requests that we have seen that we're - things that we are aiming for. So that is definitely something that we could consider.
Then dosing, things like the initial dose and the usual daily dose, the do-not-exceed dose, and if there's a - you need to change your dosing for special populations.
We looked - when we were working on this with - in our - looking at the different requirements and trying to model dosing, it was very difficult, but these were some of the key features of dosing that seemed to be helpful as far as if they have that immediately available.
And then if there are some issues about monitoring, these are things that people talked about with monitoring. If you have to measure liver-function tests to note that, to say how frequent you have to do that, and, again, to reference if you need more details into the text.
So these are some of the data elements that were discussed to describe the products including the indications and dosing, and then when you package the product together, you have a package type and you have a quantity, and this is where the National Drug Code comes, and this is the level - down - all the way to the packaged product.
But there are codes before that that would be that the ingredients has codes and the drug product itself would have codes.
Now, the proposal for this is really a partnership between many different groups, and one would be the FTA, the manufacturers, repackers and relabelers of the product. Now, these are the people that would provide the information that we have just been describing. So they would collaborate with the FTA to provide the information about the products, including how they are distributed and how they are packaging it.
Then, there is a collaboration between FTA and the National Library of Medicine where we would provide the up-to-date information in this XML, the structured product labeling XML file, and the National Library of Medicine would make that available in the daily med repository.
At the same time, the National Library of Medicine would take the SPL and link it to other features that they would have, such as the RxNorm, and this is where the labeling and RxNorm get - together.
The labeling information supports the NM in their creation of the RxNorm because it provides information about new products that are available, so they can see what the up-to-date products are. It gives information about the ingredients. It gives information about the strength and dosage forms and route of administration that helps them to generate the RxNorm. So this would be supporting the RxNorm, and it would be part of their repository of information, their daily med repository of medication information.
And, then, finally, the health information suppliers, which you have heard a lot in the previous discussion, they are providing the information to the various groups, and they would be able to have access to this information through NLM, so they could use that in their systems, whatever those systems would be, decision-support systems or whatever, that they would be available for them to use.
So all the decision-support people - the information suppliers there who are established - we are hoping to have them use this as a source for information that they would use in their systems.
So the flow would be coming from the manufacturers, repackers and relabelers would have - if they have new medication or if they are marketing new medication, they are changing their packaging, they are changing their labeling, they would submit that information to the FDA, which we would then, in our systems, be able to generate the structured product labeling that we would send to the National Library of Medicine. They would make that available to the health-information suppliers and they would use electronic prescribing systems or whatever to get it down to the user. So it is this collaboration between all these different partners to have this work.
Just to show you - here are some of the - what we have been doing most recently is been working with ARC on trying to get this done with - they have been supporting us with this activity, and we are looking forward to have the SBL available for approved human prescription drugs is our Phase One, our first goal, and we are looking to start this in July of 2005. The system is up, that we would start to roll out the new medications with this SPL for - available for download.
To do that, there are certain regulations that we need to have in effect to help us do that. One is an electronic labeling rule which requires manufacturers to send in their labeling in electronic format. So we have that. That rule is finalized. It will go into effect in June of this year, and, in there, we have a transition where we would transition from what we currently get the labeling in in a PDF format to the structured product labeling, so that the manufacturers would transition over from the current format to the structured labeling format.
The other regulation is the professional labeling rule. This is the - this is a rule that was proposed to require the manufacturers to define a highlight section of the labeling, among other things, but the major push of this is to show off highlight section.
What this is is key information from the labeling that the prescribers use the most. The labeling has a lot of information. This was going and looking - talking to the different users of the labeling. This is information that we found that was key for the prescribers.
Now, we are using this into defining some of the things that we would tag, indications and clinical effects. What clinical effects do you tag? You want only to tag the important ones, the ones that you want to see, and that was brought up in earlier discussions? What level? Who decides? How do you decide what to tag? And that was part of this highlight section. It was to bring out the key information. That would be things that the FDA and the manufacturers would work together to bring forward.
So we need that highlight section that highlights area to help us move forward with tagging this important information for the labeling.
Now, right now, that was a proposed rule. We had received comments, and, now, we are moving toward finalizing this rule, but it still has to go through the procedures for finalization, but, in order for us to get where we want to be with the information that we - that was described before, we need to have a professional labeling rule to go through.
In this Phase One, we would introduce the SPL as a standard for communicating the information. The UNIs, which is unique ingredient identifiers for the active and inactive ingredients, and then medication terminology, which would include terminology for indication, anything that - those things that we can establish, then we can add to the structured product labeling. So the more terminology standards that we have, the better we'll be, and the more helpful the standard will be.
Some of the systems that we are working on to get to this point is a substance registration system, which is where we assign our unique ingredient identifiers. This is based on molecular structure or the manufacturing process. We have a set of business rules that we follow of how you actually draw the molecule, so it's - everything is drawn in a standardized way. It's not a simple process to go through and set all those standards, but we are working through that, and we have already set certain - the easy ones we have already done and we are putting those into the system as - already entering them into the system.
Things, when - there are different ways to draw the - centers and other specifics like that. We have to work on those details, but that is a smaller percentage, and then we have substances that don't have molecular structures, such as botanicals, and we have specific rules of how we define what a botanical is and assign an ingredient identifier to that.
Then the other system is the electronic labeling information processing system or ELIPS, and this is a system that will help us do a content management of the labeling information, help us review the labeling, and move that into SPL and for export to the MLN. So that is in Phase One.
Phase Two, we are looking to add the availability of the other human drugs to this, and that would include the over-the-counter drugs. We are looking to start that and to start to have those things moving through the system July of 2006. This requires us to finalize a rule for drug listing. The drug-listing rule would require the repackers and relabelers to come to the FDA for sending them the information about their new products and for assignment of codes and the National Drug Code and the drug product code.
So that's the standards that would be introduced into this section.
We have a system that we are working on, an electronic listing system that we call eLIST, which we have already gone through a pile - that was a couple of years ago, when we were just - this, and where people would go on line and register their products and work with registering their information.
We also register all facilities where drugs are manufactured and repackaged for inspection purposes. So that would be part of that Phase Two.
DR. HUFF: Is that an enhanced National Drug Code or is that -
MR. LEVIN: This would be the National Drug Code where we would take control of the National Drug Code.
DR. HUFF: You need new regulations to do that?
MR. LEVIN: That drug-listing rule. That -
DR. HUFF: Drug listing will do that.
MR. LEVIN: That would do that.
Currently, the way that the National Drug Code works is that you - companies assign their own codes and then come to us with the registration information after they - the listing information after they have assigned the code, and I sort of look at it like if the Department of Motor Vehicles gave you your license plate for your car first and then said, okay, here's a card. Fill this in with your information about your car and send it to us, and they wouldn't get many of those cards coming back. So that is the way we do it right now. The numbers are assigned first, then we ask for information to come later. We would like to reverse that, where the information comes in first and then the number comes with the information, but that would require a change in our regulations, and that would require this rule to go through.
Just to lay it all out, people who want to look at this visually, this will get pretty confusing, but if you follow with me, here is our goal is to improve - we are looking at to improve patient safety, because we think that if we improve the access to information, this will lead to improved patient safety.
Electronic prescribing, all the other benefits of having labeling in an electronic format. It goes from the SPL, from the FDA to the National Library of Medicine, the Daily Med(?), to the health information suppliers to get to the patients. So that is the partnership.
It starts with some drivers on one end that we need certain rules and regulations that - the electronic labeling rule, the professional labeling rule and the drug listing rule, that drives the source of the information. That is the manufacturers of the medication as well as the repackers and relabelers who are working for the distributors and medications. They provide the information about the product. They provide when to use the medication, how to use it, description of the medication. The repackinging relabelers provide how it is supplied and who the distributor is of the medications, and they would use standards to do this, and we would use the structured product labeling. We would use standards for indication if we could, codes, and names, as well as classifications, and we are looking to the VA National Drug File and the FRT for that kind of information using those codes and those terminology, drug interactions and adverse events, how to use the medications to have standards on how we represent dose and the things that we describe, description medications, standards - the unique ingredient identifier, the ingredient names, standard names, strength, appearance, standards for appearance in dosage form, and then how supplied - the names, the product names, the package types and the quantity, and also the distributors. Those go into these two systems, the ELIPS System and the eLIST System, where FDA approves labeling and approves the changes. They also, through a listing, do their qualify control and generate National Drug Codes and drug product codes -
So this is what we are working on for supporting the electronic prescribing, again, with various partners, again, from National Library of Medicine, one of our - partners. VA has been helping us a lot, people from NIH and NCI with terminology, working at HL7. ARC has been supporting that, and our task master, Mike Fitzmaurice. I mean, our collaborator - (laughter) - has been helping us with - so that we can have this happen.
DR. COHN: I guess I am presuming that at least some time by the end of 2006, this data will be time line, because of the way you are going to be changing how numbers are given out.
MR. LEVIN: When we get that drug-listing rule -
DR. COHN: Yes.
MR. LEVIN: B and that is what we are looking at the beginning of - in the middle of 2006 that that would be - we'll start to working with that, and then it takes time - for example, with the labeling, once the structured product labeling goes in effect and we can start working on that, it will - new drugs coming through will get the structured product labeling to have the previous drugs to convert to structured product labeling, once a year, manufacturers have to file their labels with us. So over the year, we will gather up all the labels for the rest of the prescription drugs.
DR. COHN: Okay. Well, make sure I understood, because you are talking about a couple of different things.
MR. LEVIN: Yes.
DR. COHN: To me, the fundamental issue with all of this is the timeliness of the data.
MR. LEVIN: Oh, the timeliness of the data. I'm sorry.
DR. COHN: The timeliness of the data.
MR. LEVIN: I'm sorry.
DR. COHN: And so what I was thinking I was seeing with what you were describing was is that in the middle of 2006, you are expecting final rules that because people won't get a number until they send you the information will help ensure the timeliness of information to make all of this work. Am I misunderstanding something or is that correct?
MR. LEVIN: What we - first the - that people right now, when they assign their own National Drug Code - assign at any time, so that they always have a National Drug Code, we'll make sure that they can assign their National Drug - we'll get them a National Drug Code before they market their product.
In 2006, we are looking at that the rule would be implemented, the systems would in place that we can then start to take advantage of that, that we would then be able to generate the list of National Drug Codes that we would have the - we would have control over the National Drug Codes at that time.
DR. COHN: Okay. I think you're agreeing with me.
MR. LEVIN: Yes.
DR. COHN: Okay. Thank you.
MR. BLAIR: Randy, first of all, let me applaud all of the work that you are doing with the structured label identifier and the structured labeling and with the professional labeling and the way that you're working with all of the other agencies and the drug knowledge base vendors, so that this all fits together.
MR. LEVIN: That usually means there is going to be a hard question that is going to follow that. (Laughter).
MR. BLAIR: The hard question is my understanding of the National Prescription Drug Improvement and Modernization Act - see, I haven't learned the abbreviation for it yet, you noticed -
DR. COHN: The Medicare Modernization Act -
MR. BLAIR: Is that what -
DR. COHN: - of 2003.
MR. BLAIR: Yes, okay - has indicated to us that, after NCVHS gives its recommendations on e-prescribing standards that the Secretary, at the beginning of 2006, would begin demonstration projects of e-prescribing, and is there an aspect of all of the things that you are doing where you would need either help or support in order to be ready to support those demonstration projects in 2006 where the NCVHS could identify that and support you?
MR. LEVIN: I think that some of our - the pieces that are going to be potential trouble spots for us would be the regulations, as far as moving the - having the regulations move through, because that requires, as the people from - as you know - from the work that you do in CMS and other areas - that does - requires a comment period and respond to the comments, and depends on the support we have from the regulations how that moves through, but that is one potential problem for us.
The other thing that where you can help is that the terminology, if you have terminology standards that we can then incorporate into the SBL, and the things that you'd like to see in the SBL, those types - giving us those types of requirements, showing us what you want us to incorporate, that would be very helpful that you can supply that kind of information to help us, then, address the - you know, what you need for those pilots.
MR. BLAIR: Thank you.
DR. STEINDEL: I think, Randy, you just answered one of my questions, which was the numerous places in the SBL tags that I saw places that we could use standards that have already been enumerated -
MR. LEVIN: Yes.
DR. STEINDEL: - by CHI and otherwise, and I was wondering if you were thinking about using them, and you seemed to indicate yes you are.
MR. LEVIN: Right. Yes.
DR. STEINDEL: That was my first question.
The second one that I had was I noticed in various places there were some items in the SBL, like, for instance, the one that came to mind, because this was brought up earlier, was the severity of the indication - severe, moderate, et cetera, whatever scale we are using. Is that going to be assigned by the manufacturer? Because you seemed to indicate that everything from the label is going to come from the manufacturer, except for some stuff, you know, like bookkeeping type things -
MR. LEVIN: Right. All the - the things - those are requests that we have already received for what should be in there. So we are going to be vetting that through - but it is a collaboration with the manufacturer. So the - it was a collaboration -
DR. STEINDEL: Um-hum.
MR. LEVIN: B between the manufacturer and the FDA.
DR. STEINDEL: So when the manufacturer is submitting their label for approval and they put in there that this indication is severe -
MR. LEVIN: Right.
DR. STEINDEL: - you would be passing on that as -
MR. LEVIN: Yes.
DR. STEINDEL: - yes, this is correct?
MR. LEVIN: Absolutely.
DR. STEINDEL: And you would be asking for evidence for that?
MR. LEVIN: Yes.
DR. STEINDEL: Okay.
MR. LEVIN: Yes. So that - yes.
DR. STEINDEL: I wanted to see what the process was going to be there.
And the last question actually relates to what Simon was asking about timeliness, and there is a stage when - I noticed two things with regard to the structured product labeling itself. There are places when there's obviously a totally new drug coming out, and the structured product label is totally new and it goes through the usual type of approval process, and there's a second case when the NDC code changes, like when you change from a 12-blister pack to a six-blister pack, I understand, now, you get a new NDC code for that.
MR. LEVIN: Right.
DR. STEINDEL: How is that going to be handled with respect to the structured product label? Would you be submitting a whole new label to the National Library or just that portion of the label that indicates the change?
MR. LEVIN: Well, the actual handoff of what we are going to be giving to the National Library, we are still working on the details of that. Right now, it looks like we would just give the structured product labeling the whole piece, when any part changes. Remember, even a part of the labeling, someone might add a new adverse event, and the labeling would change, too.
When someone comes in with a new package type, that will come through the listing portion of that, because, many times, it's just a repacker that is going to be supplying that, and they don't have to supply the rest of the labeling information. That will all stay the same. So the labeling is divided into these pieces. So they might just change one section, one part, and that is all that we would capture.
DR. STEINDEL: Okay. And this gets me to the second side of the question which has to do with the extent of the change of the label. There are two areas where a time delay can occur, and one is the time that it gets into you to do your review, an actual review, which is what occurs today, and the second is the actual assignment of the NDC code and release to the library, and I could see something where you were talking about it comes just through the listing service. That could be a kind of a perfunctory thing where it might come through very quickly.
MR. LEVIN: Right.
DR. STEINDEL: And so what I was concerned about, from a timeliness point of view, are you giving yourself any requirements in the regulation that you are proposing where the FDA needs to assign things within a certain time period?
MR. LEVIN: Yes, let me speak from what the comments that we have heard from the outside, because the rule hasn't even been proposed, and what we have heard is that the National Drug Code, the code needs to be known to the manufacturer in advance of their even marketing the product. So we would need to have that kind of arrangement that the code is available to them ahead of time, because they have to print the packaging and do all the other preparation. So it has to be - that is the time when we have to have that built into the system, so that people can get their National Drug Code ahead of time. Just that we need to know some information about the product at that time as well.
Does that answer your question?
DR. STEINDEL: Somewhat.
If I was repackaging -
MR. LEVIN: Yes.
DR. STEINDEL: - a product and I needed a new NDC code -
MR. LEVIN: Right.
DR. STEINDEL: - and I wanted to market the product in July -
MR. LEVIN: Right.
DR. STEINDEL: - for instance, and my experience shows that I could ramp up this type of manufacturing in two months and distribute it, would I have to come to you in July of the year before to get the NDC code or in May?
MR. LEVIN: I don't have those details, but we have heard from the outside various timing issues, and we'll - it'll be, hopefully, appropriate to that, and that would be part of the proposal, the rule and the comments and making sure that we got the numbers right, because we have gotten a lot of feedback about that.
DR. STEINDEL: And I think, Randy, that does answer my question, as long as you were passing it out for comment.
DR. COHN: Well, welcome.
DR. DE LISLE: Yes, good afternoon.
I was asked to come to give you some perspective about the VA.
The VA is - I am a practicing physician. I am also an academic, and I have an interest in medical informatics. So what I will tell you is really sort of practical issues that arise in the system where all of what you are discussing now is - or much of what you are discussing now have already been accomplished for several years, and so we are wired to the hilt and now what?
And I don't want to say that the VA is this normal healthcare system, because for a U.S. healthcare system, it really isn't. I mean, it is - when we have a captive patient population, we have economics - we have a global budget and we have economics that are aligned for waste management of resources, and so I'm not sure whether the rest of the U.S. system will ever evolve that way, but if I can give you sort of a picture how this electronic system that you are envisioning - you know, one key component is establishing standards, how does - has a chance to evolve in the future.
And I've been making this talk as I went this morning. So I have been adapting it all the time. We'll see how this current iteration - whether or not it pleases you guys. (Laughter).
So what's - we call our patient record CPRS, Computerized Patient Record System, and so I'll use this jargon, but I'll spare you of any other jargon, hopefully, for the rest of the afternoon.
The current generation started in 1997, although the infrastructure and the standardization of the informatics has been ongoing for 20-or-some-odd years at the VA. So the system was ripe for putting an electronic patient record.
It is now in place in 153 hospitals, 800 clinics in which 1,000 full-time physicians and 30,000 part-time physicians work. I think it is fair to say that for the residents and interns that come in and out of the VA that we have trained over 100,000 physicians over the years with an electronic patient record.
The prescription itself, it is used currently for - about 95 percent of VA prescriptions are prescribed electronically. Whereas, the rest of the five percent, that is basically the written prescriptions that are required for controlled substances, essentially. That's the last bastion of written, longhand prescriptions.
Most treatments - if you are looking at VA's with brick and mortar, that's nice, but, really, the VA system is principally an outpatient, ambulatory system. So, for example, our little hospital in Baltimore is only 300 beds, but we see - the VA system sees 600 (sic) outpatient visits a year, so - which is 11 times more than the University of Maryland Hospital, which has 1,000 beds. So it really is mostly an ambulatory system, believe it or not.
Seeing a very old population that has a lot of chronic disease, very much like the rest of the U.S. population will be in half a generation from now. So we are just out there as a pilot project, if you will, for this whole enterprise.
We have done 102 million prescriptions last year - and I thought that was a pretty big number, until I heard the four billion prescriptions that were prescribed by the industry electronically - and over half-a-billion prescriptions since the inception of the system. So we've kind of been there, as far as the e-prescription is concerned.
Now, as much as this talk - there's been many technical issues here with the e-prescription and the transactional aspect of the e-prescription. Here is the really practical problem of the practicing outpatient physician. He is seeing - and I am just going to lay it out to see that - I'm an intensivist. I don't do outpatient care, because I can't handle this. (Laughter).
This is a 73-year-old guy who comes in with a three-day history of cough, produces a bit of sputum. He's on 13 drugs. That's our standard veterans. They are from six different providers for seven different diagnoses. We know these drugs. We know which provider started the whole show, and we have these diagnoses on our problem list in our ICD9 codes. This we do know, but it doesn't help you at the point of service when you have 15 to 30 minutes to deal with this guy's productive cough, and there were 10,000 clinical trials last year, meaning that none of us can really aspire to catch up with all of the science out there.
So this, to me, is much, much more difficult to deal with than any critically-ill patient - okay? This is a very scary problem.
And, now, how is pharmacal therapeutics? What is that all about? Well, we figure out if a drug is needed. You have it there. Then we pick one among alternatives.
See if I can travel a bit.
We prescribe it, and then someone delivers it, and, if we are lucky, we reevaluate this pharmacal therapeutic at a later point in time to make sure it is safe and effective, and if the drug is needed, you continue it. If not, you stop. So that is the simplest expression of pharmacal therapies, and the reason I put it out there is to sort of get to a model of where the e-prescription system need to evolve.
Those are the current systems we have in place when we pick a drug. We have to sort of figure if it is on the formulary. If you are the VA, you are lucky, because there is only one formulary, but there are some kinks to that.
If it's not on the formulary, you've got to go to the non-formulary request process, which is a complex process in its own. It's got all kinds of flaws. Either way - or if it's under-formulated, it might be subject to restrictions, and there's all kinds of restrictions, and there is no nomenclature for the restrictions, and there's no algorithm that has been invented for the formulary restrictions.
So either way, if it is restricted or part of the non-permanent process, there is this justification process by which the doc sort of justifies what it is that he or she is doing, and that justification process also is not codified or specified in any way, form or fashion. There's no accountability there.
Now, if you are lucky and if you go - if the drug is not restricted, you get down to the best practices, and, as you well know, the best practices are out there. Maybe they are on the web, but they are in a 125-page format. They are really not useful for the 15 minutes I've got to deal with this patient. So this is a big - Outside of the inclusion or exclusion from the formulary, all these other restrictions here are flawed to a great degree. All these - could help us to best treat our patients are flawed.
Now, comes the time - so we basically - the drug is on formulary, we prescribe it, and that is good.
Now, the pharmacy people, that's what they do. They make sure that the right drug goes to the right patient and at the right time for the delivery system. This, comparatively, although we have been spending a lot of time making sure that the drug interaction and drug allergy interactions are correct, this is a much, much more robust part of the pharmacal therapeutic process. So, comparatively, here is not a big issue, as far as I can see it. That, here, is a situation -
MR. BLAIR: Question.
DR. DE LISLE: Oh, I got myself in trouble already. (Laughter).
MR. BLAIR: Question.
DR. DE LISLE: Yes, sir.
MR. BLAIR: In order to put your comments in context a little bit, are you using current standards, so that as you are making your observations and comments about what works and what doesn't work, we would sort of know whether you are using current standards and how well they are working or not.
DR. DE LISLE: I have done this analysis for our own healthcare system, which is probably much more advanced as far as applications of the standards than is customary. So that is my own observations.
So then we evaluate the drug, and you get into the reevaluation process, which we just talked about.
MS. GRAHAM: I just want to clarify. I mean, I think the point about - I think it's been raised earlier, when you get to say the - you know, going off formulary, there isn't a standard - and I think it has been reiterated earlier today - for how you present your justification or how you communicate that it has been approved or - for many of those things, a standard does not exist or isn't widely known about. We do use standards for order checks, for drug-drug interactions, drug-lab interactions, those kind of things that happen in our system at the point of physician order entry. Before the order is even signed off on, those feedback mechanisms are coming back to the provider.
I think when Dr. DeLisle refers to the secondary thing, it is much like it going to the retail pharmacy, where the pharmacist then gets involved with the order itself and the delivery modes and further checks on that.
DR. WARREN: Yes, but what standards -
MR. BLAIR: Yes, what standards are you using -
DR. WARREN: The name of the standards you are using -
MR. BLAIR: - so that we can put this in context.
DR. STEINDEL: What about drug interactions?
MS. GRAHAM: Drug interactions are based on commercial information. We use NDFRT. I mean, I think some of that - and that is probably - Dr. De Lisle was really asked to talk about how it works from a clinical perspective because we thought you had probably been talked to death about -
DR. STEINDEL: But, basically, what it comes down to is for things like drug-lab checking, drug-drug checking, you are using your standards.
MS. GRAHAM: Right. Correct.
DR. STEINDEL: But you have developed -
MS. GRAHAM: Correct.
DR. DE LISLE: And not only that, but for the drug-drug interaction, we are left with - we have a standardized drug nomenclature. That's nice, but then the algorithm as to whether this particular drug-drug interaction and the patient that's got 13 medications is really - the algorithms are not built. We have to build them one after the other, and that is a very local issue. So that part of it is not standardized. We would very much appreciate if - the enormous amount of work that would take to develop such an algorithm, we would very much - would like to take advantage of it.
MS. GRAHAM: And checks against things like problem list are truly based on ICD at this time. I mean, it's at that level. So if you have something that is based on something that exists on the patient's problem list or on a prior problem that has been codified, it's based on the ICD level, which we recognize is not granular enough for many purposes.
DR. STEINDEL: But we're talking about the ICD code at that point, but the actual algorithm for doing the checking is something you have developed.
MS. GRAHAM: Right.
DR. DE LISLE: So, and, again, I just wanted to put things in perspective a little bit for our system. The major failures in pharmacal therapy is to figure out whether the drug is needed in the first place, whether we picked up the most efficient drug, secondly, and whether we are evaluating a theory altogether. So those are the major failures.
The thing that can help us do this are the best practice guidelines or the science that is out there, and it really is not there at the point of service.
So what we have had to do to bring those practice guidelines into our process is really to put the practice guideline there at the point of service when there is a prescription. Doesn't get the doctor to think about a drug that he is not thinking of, if he is not thinking about prescribing anything, but if he is thinking of one drug and he goes there, we can actually grab this doc and deliver science to him.
Now, this is our electronic patient, electronic order entry window, and you have seen - most of you are more familiar with these than I am. So, but it basically gets you to name a drug with a dosage that actually exists, a route that we carry and then a schedule that makes sense, and so all of this is - and then where to pick it up. None of that is particularly exciting as far as - is particularly novel, but, as you noticed, there is - and the features, the robustness of not being able to misspell a drug or write the wrong dose is in place, so we don't even think about this anymore. The problem is there is nothing in this order entry that helps me decide whether the patient needs purowsonide(?) or not in the first place or whether his dose needs to be increased or decreased. This is a different problem.
So we would like to have beautiful software - (laughter) - that will let us do these things, you know, especially in your case, extend the deadline - you know - if I continue like this, but, basically - and our reality was something like this, which is far - it doesn't get us anywhere near to stuff we want to do in pharmacal therapeutics.
So what we have done - what the docs have started to do at places is highjack sort of unfamiliar features of our electronic patient record to go into the prescription process so as to supplement science or - to those poor docs out there that are trying to survive, and, basically, here is a - if you typed in the name of Amiodarone, this is a template that would appear before you were sent to finally order Amiodarone. Amiodarone, for those of you that are not in the medical field, is a medication for heart rhythm, and so you have a little B and the format of these templates has evolved over time, based on feedback from providers and based on what we have learned about provider's behavior in these templates.
So here is a little introduction. They want to know what they are getting into first. Here's an entry to the logic of the tool, and, finally, here is a feedback button that they can click. When they do so, they get into our PNT feedback, and I can look at this every morning to see if somebody has safety issues with the tool, issues about the science itself, issues about the logic, the English or they are simply not happy about the system in general, and we have canned answers for many of these things - there's been over 30,000 of these things that have -
So back to the tool. Most commonly, a primary care doc would click on continuation of therapy here, and then they would get an entry into a logic which was that the Amiodarone was originally prescribed for atrial fibrillation. That would be the most common cause of prescribing Amiodarone. So it's put out there first.
Now, under that rubric is - first of all, there's a - we know that the doc will need the electrocardiogram to make an appropriate decision about this patient. So there's a drill that went into the electronic patient record and retrieved the latest EKG along with its readings - interpretation. So, and, here, we have a series of questions about the EKG to see if this patient fits the profile for a continuation of therapy for Amiodarone, and the patient might not have had an EKG, at which point, we sort of get them to order an EKG before they go on. They do get to go on.
So, here, for example, we say that the EKG had normal - rhythm, and you have a date. It was done in the last year. So the doctor would click here.
Now, you notice that we have all this information there. We don't have the software to be able to make the decision for the doc, because we could push this one step further if we had these features, but, nevertheless, the doc would then enter into the - the therapy for Amiodarone is now justified.
Then we tell them to look - there's a couple of trials that came out that say that perhaps this is not the safest way to go about treating atrial fibrillation, and if they don't believe us, we deliver - if they click on this hypertext, we have the full article in the New England about those two trials, but, basically, it's - you know - but, basically, we don't tell them that this is current practice, now, that they should get off Amiodarone, put the patient on another medication that is safer, but we do give them the information, when it counts, when they are thinking about this.
Now, the problem with Amiodarone is that it is a very toxic drug. You have to do five tests regularly and check their results, know how to interpret these results, whether they need to stop Amiodarone, crank the dose up or down or whatever. It is very complicated to prescribe Amiodarone. It is very time consuming. Think about even with an electronic patient record, that you need to order pulmonary function tests, liver function tests, thyroid function, chest Xray, an opthomology exam, each of them with their different monitoring requirement over time.
So what do we do? Let's pick one that would be the thyroid function, that we tell them about what the requirements - the monitoring requirements would be, and then we would build a drill that would get the TSH out, tell them what it is.
Underneath here, if they don't know what to do with hyperthyroidism or hypothyroidism in the context of Amiodarone therapy, there are papers hidden in there to tell them what to do, because they might not know. I certainly don't remember, and then here is a logic that allows them to pursue ordering this medication. So it is very complicated to order Amiodarone.
When they are all done with these five tests and checked the old results and reordered it for future's sake, they get to this - they finally get to order Amiodarone - we have this window that we were talking about before - and here is an army of tests that is being ordered right now automatically for them.
Now, we know why they are there, and we know that they are ordering a chest Xray for the purpose of Amiodarone therapy. So we can prefill the chest Xray, because, think about it, when you are ordering a chest Xray, you gotta order - you gotta figure out where - what kind of Xray that is that's a two view and lateral, gotta give a history, and we can fill the history because we know - they can modify anything they want, and that way we could fill it to the max, and so on.
So, now, while they were clicking - they finally get to order Amiodarone. While they were clicking, we were generating a text down here, which really documents what they have just done automatically, and that text, if they are continuing Amiodarone therapy, originally prescribed for a fib. The patient now is in sinus freedom(?). I have ordered all of this. Leave me alone. (Laughter).
But that is now structured text, which we, again, go and mined for with - we don't need to have sophisticated text analysis, we are just checking whether the strings are there or not, and whether we have extra characters, because if you have extra characters - characters that are not predicted - then that provider was not satisfied with that. The matter is a safety issue with an unsatisfied provider, so we want to know about these notes where extra characters were added.
So does that work? Yes. He ordered a whole bunch more tests when this was implemented. This is pre - the difference between the sixth month time for people who did not use this software tool and people who have used these software tool, as far as improvement - baseline of ordering all of these tests. So our process is better.
Is this silly to do all this ordering or not? This is where we are at right now. Well, some of it isn't - TSH is abnormal in a third of these patients. So those are brand-new patients with hypo- or hyperthyroidism, and hyperthyroidism is contraindicated with Amiodarone.
So this is certainly not silly. Some of that might be silly without any symptoms, and we are looking into whether this is useful or not, but we can at least have a shot at performing a service to the patient.
So the evolution of the e-prescription - and that's - the whole impetus of this presentation is there. We now deployed the logic of evidence-based drug utilization. We provide context-sensitive information. We mined for the data from the EPR. We accessed supportive literature through the hypertext. We automate actions - it takes, on average, 5.4 minutes to fill the Amiodarone tool, which is an enormous amount of time. I say to my programmers, we've got 15 seconds with that doc, 30 seconds max. This is a very, very long tool, but I put it out because, you know, the alternative of doing everything manually is somewhere close to 15 to 20 minutes. So it's a good tool from that standpoint, and then it allows the feedback.
So what have we learned through the e-prescription process? The rules had to be embraceable. This is a safety tool. Other tools are - address high-risk medication. We have medication for - 14 medications. Again, this is one VA center. Other VA centers are doing it differently, and there is a lot of creativity that those kinds of tools have afforded us - have afforded to get the docs on board.
The goal really - reducing wasteful use of medication is not something to shy away from. The docs will embrace that. They know that if somebody is overusing a - somebody else isn't getting his wheelchair. So you gotta pick your choices, and, again, the economics are aligned for waste to be meaningful to these docs. They may be a very special case.
Whatever toy you have there that brings the science to the point of service, and the process by which you do it must be both practical and credible. We have heard about this earlier today, but that cannot be emphasized enough.
The credibility part of it, bringing the papers and the science - if you don't believe me, you can feedback to me and we'll talk about it. That brings a whole lot of credibility to the system.
The PNT activities were completely wrong for creating these tools, maintaining them. They were not the kind of people that were required to be in the PNT activity to take use of that. So we are not(?) building a surveillance system even for drug utilization.
Now, what is our interest in the standards? I think we have mentioned we have our own - we have developed our own drug nomenclature, which is immensely useful. It allows me at my desktop to actually have all the pills that have ever been prescribed at the VA. I can compare my center to a different center to see whether we have access utilization. It is strictly utilization data. In that sense, it is somewhat limited, but it gets you a start - some start for generating a hypothesis.
The lexicons for adverse event and drug allergies. Now, the docs are entering this - these drug allergies in free text right now. We can't use this for alert systems. So we are starting to develop a lexicon, and now the docs are bypassing the lexicon, because they don't know better. So there's all kinds of implementation issues about lexicons for adverse events and drug allergies, but that is a basic for being able to implement algorithms that will check for these events as the docs enter them.
I will talk to you a little bit about the formulary themselves and their formulary restriction rules to sort of somewhat formulize(? this. I'm not even sure what form that might take or whether it is even useful at this stage to even think about this.
The interface to the clinical guideline rules. Now, the clinical guidelines keep changing. If there was a way to have a standard that would interface with our tools that are taken straight out of the clinical guidelines, that would be nice - that is probably pie in the sky, at this stage of the game.
Now, but what I do want to emphasize is that whatever standards are put together that the interface with the data elements from the electronic patient record is absolutely critical to - for the good practice of medicine, and I think we are getting an enormous amount of interest from our providers.
Yes, their autonomy gets hampered, but, you know, our autonomy gets hampered every time we stop at a red light. The key here is if they have - is a goal that is embraceable, and good medicine as a basis, then you'll have your docs on board. It has to be implemented extremely cautiously, but with embraceable goals.
So I had some things to plug in from the pharmacy folks, so one question was will authentication standard use technology as secure as that being developed by the DEA, et cetera. Those are questions for the group that I was asked. Sort of - bit of a disconnect now, but let me put it out.
Will e-prescription standard allow for different transmission standards? So the distinction between the transmission and the transaction standards.
And then the NCPDP - I think the VA folks would love to have the prescription standard harmonize with HL7, which I believe B again, I'm not a standard guy, so I'm out of my depth here, but, you know, if you give us the data elements, we'll use them.
So here it is. This was our attempt at really using all the toys - (laughter) - intelligently, and God knows that a lot of work remains to be done there.
Any questions?
(Laughter).
SPEAKER: You might want to talk to Gates about licensing that.
DR. DE LISLE: Well, I mean -
SPEAKER: The interface.
DR. DE LISLE: The interface. Well, you know, I think people get all hung up - especially the teckies(?), get all hung up with the software itself and the features and all of this, and what is really important isn't so much a software feature, but really the rules, the scientific rules that - and the science on which the rules are based, and this looks a lot more complicated than it really is, if you've got the system geared up.
For example, one Thursday afternoon, we had a drug company that could no longer supply Filodapine(?), and they said, well, we don't have it anymore. We can't make it anymore, and that happens for a big system like VA, which now, you know, gets drug - buys its drugs with DoD at times? We are buying an enormous amount of drugs, so if there is anything wrong in the supply chain, then all of a sudden, whoops, there is no more drugs for our veterans. That's a big deal.
So we turn around and say, well, gee, you know, we have 3,200 patients on Filodapine. What are we going to do?
Well, you can have two choices. You could switch to Ladapine(?), which is the equivalent drug, and the system would take $1 million a year in costs. That's the dumb thing to do.
The intelligent thing to do, and the hard thing to do is actually to go review four sets of guidelines for hypertension, congestive heart failure, et cetera, and extract from there the key elements for - that pertains to long-acting chasm-channel(?) blocker. Deploy that on a tool like this and then send out all the providers, elicit their patient on that particular medication and get an evidence-based medication switch, which we had to do, and we could do this in 48 hours, essentially.
So this is a lot easier than - once you get the system set up and you're got the tools in place, you can really respond to these things very well, and, you know, how many patients ended up on Ladapine? Eighteen percent of those that were originally on Filodapine.
So, again, there's enormous potential for - if this is done right, at the limit, the major - I think that the major improvements will be for the application of medicine.
DR. COHN: Well, thank you.
Questions? Comments?
DR. STEINDEL: You said earlier that the VA system was a bit unusual because it is more or less self contained. Now, after you have gone through all this decision chain and you are actually prescribing the drug, it goes to your internal pharmacy for dispensing - and if you have to go to an external -
DR. DE LISLE: It goes to a mail order pharmacy, about 80-85 percent of our drugs go to mail order.
DR. STEINDEL: But what is the transmission standard that is used to the mail order pharmacy?
MS. GRAHAM: It's our internal email system -
DR. STEINDEL: Okay. That's what - really, the question I was going to get at about was what type of transmission standard do you use when you order externally, and it doesn't sound like you do much ordering externally.
MS. GRAHAM: No, but we are - yes, we have very few people that have insurance coverage, but we are developing and putting in retail pharmacy capability between our pharmacy and retail pharmacy. I think - hence some of the questions about the interface and the harmonization of standards.
DR. DE LISLE: Um-hum. And even in a system where we are supposed to supply all the drugs to the veterans, you know, they have a copay. So $7 for a bottle of aspirin, forget that. These guys get it over the counter, and so, even in a system like this, we have a devil of a time keeping a reasonable drug history for - you know - certainly herbal medications or over-the-counter medications.
DR. FITZMAURICE: As you described the VA system throughout, I got a little confused, and part of the confusion was you showed how it worked. You showed that it took longer than you wanted it to work, four or five minutes, rather than 15 seconds, but you showed that it was faster than 15 minutes, which it would otherwise take. Do the docs like it or do they just turn off an awful lot of the parts of it?
DR. DE LISLE: I mean, nobody likes to stop at a red light. So they need to be convinced that there is a good reason for that, and so the - nobody likes red lights. I would say - blanket statement, they don't like it, but they can live with it, and they do get a lot of pride when they are - you know - picking up a hypothyroid patient that they would not have normally suspected.
DR. FITZMAURICE: Now the VA has maybe one of the best patient-safety reporting systems in the United States so far. Is there any feedback or any input from that system to your system, so that you can target particular areas where you know we've got a lot of adverse drug events for these particular drugs. Let's put something in here, and this is the reason why, because we have had all these things, so you can get a sense of communicating priorities to the physicians. Is there this interchange between the patient safety - reporting and the drug-ordering system?
DR. DE LISLE: Again, I am out of my area of expertise. Certainly, the NASA - we have a reporting system that works out of NASA, and, in the interest of keeping the providers'confidentiality, and the NASA reports back to the sites from time to time. Most of the time there are things like, you know, you shouldn't put that kind of canyon(?) on somebody's nose if they can't tell you that they're - if they can't cough, for example. So there's all kinds of safety issues that are reported, and, so far, the drug - do you know what the drug-safety issues have been? I can't recall them -
MS. GRAHAM: We actually have a mechanism - it is something that we can correct with the electronic record. Then, we work with the National Center for Patient Safety to say make a new order check or make a new provision, and I just wanted - some alerts in different parts of the system can be turned off, but some can't. Some are mandatory. Some are set at the institution level and not left up to individual providers, but, as was mentioned earlier, we have had our issues, too, with overloading providers with alerts, with being very careful, cognizant that alert overload kind of gets people to the point where they are desensitized to the alert, but, on the patient safety, we try to bring that feedback back, loop into the system into the practical way.
If we don't change a system, it is sometimes is done by education to different providers.
DR. DE LISLE: I think an overall project that emerged from the sort of aggregate data through NASA has been the issues of anticoagulants in hospital, and in particular heparin errors in just putting an extra zero and just mechanical calculation errors that result in overdose or under-dose of heparin, and so what our pharmacy has done is they bought a whole bunch of pumps in which these calculation were already pre-inputted, and then we created quick order sets that would just name the dose or the protocol that you wanted the patient to be anticoagulated by, and from there - from that order, which is pretty robust, going into the - directly going into the - what is that? Lara(?) pump, some delivery system.
MS. CRONIN: I'm wondering if the VA uses NDFRT to inform their formulary standards, in particular like, say, with the Cox 2(?) example that you gave earlier, if, you know, you hadn't restricted use for people who might be at high risk for a GI bleed, would the formulary standards allow for an automatic prompting of replacement with another - and would it do that through the classifications that are in NDFRT?
MS. GRAHAM: It won't do it at this time.
DR. DE LISLE: No. I'm not aware that we can use these algorithm as deep into the - we had to generate - we had to read the literature and generate these workaround tools to get to the Cox 2 utilization.
DR. COHN: Yes. Though I think, Kelly, there is probably no reason why it couldn't be -
DR. DE LISLE: Right.
DR. COHN: - because it clearly makes the distinction.
MS. GRAHAM: Yes, exactly.
DR. COHN: And so you could choose to run things off of that.
I was actually going to comment that I think one of the things he's done a very good job is reminding us of the complexities of not just formulary management, but formulary and the provider interface, and having it be something that turns out to be a value added as opposed just to complexity, and I want to thank you.
DR. DE LISLE: I've got a whole talk strictly on management issues of actually getting to operationalize formulary restrictions, going from the PBM review of the literature and the science to the point of service without losing your providers in between. We have learned a tremendous amount about how to keep the providers in the loop and actually use them as an asset, rather than getting all aggravated.
DR. COHN: Yes. I expect that that will be one issue that will be coming back to -
DR. DE LISLE: It's a big deal.
DR. COHN: - probably again and again, as we get into this area.
Well, thank you so much. (Applause).
DR. COHN: I think our next session is really an opportunity for open microphone, if anybody wants to make a comment from before or - Actually come to the microphone. Please introduce yourself, and I guess we would ask if you could keep it brief, as opposed to longer, if possible. Thank you.
MR. RATHERMICK: Again, I'm Phil Rathermick with Express Scripts.
There has been a lot of conversation about formulary today. I wanted to make sure that people understood the difference between formulary and benefit, because it is an important distinction.
A health plan can have a single benefit and have hundreds - a single formulary have hundreds of benefits. So as you are creating a standard, it is important to allow for the provision of both, not to say that the systems behind all this could necessarily get there today, but it is important to understand that you have to allow for both.
For example, a health plan has numerous customers. A PBM has numerous customers that are health plans. So it gets exponential. A health plan may pick a formulary agent, say, a statin, that is preferred, but a better example might be like non-sedating antihistamines. Now that there is one over the counter, there may be a preferred agent on formulary, but individual payers, individual clients of the health plan may decide not to cover non-sedating antihistamines because there is an over-the-counter option available. So just to say an agent is on formulary, may not be enough information, because the person could get to the pharmacy and find out it is not covered.
Formulary, by itself - yes or no, formulary answers doesn't tell you anything about tiered benefits, so it is important for people to understand that for a physician to make an informed choice with their patient, in addition to knowing yes or no with respect to formulary, they need to know the benefit. So even if it is relative value. Is this a $5 drug or a $50 drug? One brand may be $25, because it is preferred. Another brand may be $50 because it is non-preferred, and we talk about encouraging choice, which is important, but if you don't get enough information to the physician to choose the lowest cost alternative, the patient may get a surprise at the pharmacy and end up not filling it, in which case you have clinical implications, because they are not getting the drugs they need. So I just wanted to make sure everybody understood that.
MR. CRONIN: Can I ask for a point of clarification?
MR. RATHERMICK: Sure.
DR. COHN: Well, someone's got questions for you. Kelly, you first, and then Jeff.
MS. CRONIN: Sorry.
DR. COHN: No, go ahead. Go ahead.
MS. CRONIN: So you are then advocating or recommending that the committee give serious consideration to developing formulary centers that would include representation of cost-sharing schemes or out-of-pocket costs for the various therapeutic options.
MR. RATHERMICK: I think it is important to allow flexibility in the standard again, because there's systems questions. In other words, today, we might be able to give relative copays and we may not be able to get to member-level benefit, to, say, a $5 versus a $50, but we may be able to say this is - you know - one dollar sign and this is three dollar signs.
We are - you know - we and other PBMs are trying to enhance our systems to be able to get to member level, but it is complicated.
My concern is if you create a standard that doesn't contemplate that, it is sort of like NCPDP, you've got to have a place for it, so that if the information is available, you can send the information, and then the application provider, the software vendor has to be able to know what to do with that information, and so it is just important to understand that it could come, and if it comes, you gotta have someplace to put it.
MS. CRONIN: And is complication primarily due to the type of eligibility? For example, if someone is 150 percent of the federal poverty level, then they might have a different cautionary scheme versus -
MR. RATHERMICK: Certainly, in the Medicare context, that will be true. You know, whether they are TA or not TA, there may be a different benefit, so to speak, figuring out whether this is covered or whether it is just 100 percent copay, those kinds of things. That is a little bit different question, but -
MS. CRONIN: So the complexity is beyond that.
MR. RATHERMICK: The complexity I was referring to is a systems question. In other words, can the system identify you uniquely and get to - all the way down to your individual group. In other words, you are a Blue Cross/Blue Shield member, but you work for GE or - bad example, but, you know, your employer is going to have a particular benefit plan. They make specific coverage decisions about what you can get, even if they subscribe to the Blue Cross/Blue Shield of Massachusetts formulary. So Viagra is a good example. On a lot of formularies, but individual companies make decisions as to whether that should be covered, where there's quantity limits. People have talked today a little bit about prior authorization. That is a benefit question. That is not a formulary question.
DR. COHN: Jeff, did you have a question?
MR. BLAIR: Yes.
DR. COHN: Please.
MR. BLAIR: NCVHS, in the past, has looked to be able to help patient care and patient safety and efficacy by looking at either message format standards or identifiers and standardizing those identifiers for the healthcare industry to use or look to have national standards for clinically-specific terminologies or other terminologies.
As we are going through this process on a-prescribing, I have heard a lot of complexity described. I have sort of been trying to listen for where is it that NCVHS needs to consider or recommend a national standard that will help the industry? Somehow it seems to be eluding me.
MR. RATHERMICK: Is there more? (Laughter). I don't want to interrupt you.
MR. BLAIR: Are you saying that there is a national standard relevant to the communication of benefits or formularies that needs to be put in place that has not been adopted?
MR. RATHERMICK: Well, a lot of this capability exists today. In other words, a lot of the software vendors that are providing electronic prescribing today allow for provision of formulary information, and they allow for some level of benefit information. Most of them use sort of a red, yellow, green kind of schematic, where green is, obviously, full throttle. Yellow is approved, maybe, but, generally, yellow is like the preferred brand; and red is either off formulary or the non-preferred third tier, something like that, and there's some different questions about how those are interpreted, because there is a difference between third tier and not covered, obviously.
With respect to that kind of information, I guess what I am responding to is a concern that, to the extent we create standards for provision of formulary information, and people do formularies a lot of different ways, whether we necessarily need a standard for provision of benefit information, I suppose, is a debatable question, but my concern is that we not create a standard that precludes the availability of that information, because that information is key to the decision making on the other end.
DR. COHN: Yes, Steve, and then I have a comment, please.
DR. STEINDEL: Yes, I have a question. Thinking about this several times during the presentations today, and I think your call for a formulary benefit type standard is the vehicle that I can ask the question, but the Medicare drug benefit payment point of view from the person is very complex, and we have heard a lot about the patient coming into the pharmacy and getting sticker shock, and that the patient is walking out of the pharmacy, perhaps not getting the drug, and then we have periods where the copayment for the drug that the patient is picking up from Medicare - under Medicare changes. Does our standard, whatever standard that we have to recommend in this area, have to take that into account and present that information at the time of the order, the prescription itself, which may change in the middle of the prescription?
MR. RATHERMICK: I guess what I envision as a standard is more a transaction standard. So to get to your issue, if the copay were to change midstream, it speaks to a question of real time availability of information. So I guess, in that instance, I would envision a transaction going back to the PDP or - you know, the PBM behind the PDP perhaps, and there being enough information in that system to determine whether today the copay - and I'm not particularly familiar with the scenario you are describing, but if the copay goes down because they have met a certain coinsurance or it goes up because their TA is over something like that. There should be enough information in the system to allow that, but what I envision is the standard is really a transaction standard. In other words, like NCPDP, where you have set up a mechanism for people to communicate information in a standard way, so that everybody is speaking the same language, essentially, as opposed to - someone today suggested that we create a standard for formulary, which I think is more problematic than it looks like on its face, but to the extent the transaction standards support the provision of formulary information to people, that is a good thing. If we are trying to standardize the industry so everyone's formularies look the same, that is more complicated, and I think it is going to be harder to get to.
DR. COHN: I just wanted to comment. I actually wanted to thank you for clarifying - that someone obviously has to write prescriptions. I think it's very much in patients'benefits to know what they are getting into before they leave the doctor's offices, and, certainly, I think providers and physicians generally would like to be able to order medications that they can feel confident that the patient can afford, and, obviously, I think we have talked about formulary as a piece of that. I really want to thank you for adding sort of this benefit piece to the equation, and I think - we are going to actually talk about - probably as we talk more to the standards groups and others - about that capability.
Obviously, the Medicare benefit itself is a - Steven, you commented at the extraordinarily complex benefit. People described it as something that did not occur in nature with the donut hole and all of this stuff, but, certainly, it will need to be very flexible to be able to support that, but, certainly, everyone might benefit from this sort of additional functionality. So thank you very much.
Other comments?
MS. BICKFORD: Carol Bickford(?), American Nurses Association.
I was pleased to see that Stan Huff commented that we had other prescribers besides physicians - (laughter) - but I want to take that a little bit further.
DR. HUFF: I'm educable.
MS. BICKFORD: Thank you.
I would like to take it a bit further and clarifying what the definition of e-prescribing is. Is that related only to pharmaceuticals? Is it related to durable medical equipment? Is it related to orders for ancillary services; for example, PTOT? Does e-prescribing support me as a registered nurse in my order's activities as I am establishing initiatives?
Prescribing is sort of an artificiality of our system in that we have to do prescribing to make the resources happen at the place. If we had a plan, we identified that the plan was, what we wanted done, and it automatically happened, we wouldn't have to have prescribing. So I am raising that as a question to confirm that prescribing is going to be addressed as more than just pharmaceuticals. Is that correct or are we only focusing on that?
DR. COHN: Carol, did you want an answer from us on that one?
MS. BICKFORD: Yes, please.
DR. COHN: Okay. The prime focus of the subcommittee work at this point has to do with meeting the requirements of the Medicare Modernization Act, which specifically relates to Part D, drug benefits. So it is not the larger issue of all orderables, which I think is what you are getting into, but, certainly, we'll obviously be talking about that as we go forward, but, certainly, there is a point at which - only a pharmaceutical versus ordering a lab test versus ordering PT and OT, it all begins to - they all begin to merge a little bit, but, certainly, our main requirement is really the Part D benefit.
MS. BICKFORD: Well, in light of that comment, is there the expectation that you, as the advisory body to the Secretary, will be thinking about the implications and the generalizability and the applications for the bigger picture, even though an example of that is the NCPDP presentation that we just had? Could all that structure that has been put in place be supportive of the durable medical equipment that has to be used in conjunction with some of the pharmaceuticals related to - for example, the syringes and insulin pumps that are associated with insulin therapies for your diabetic patient? You can't have the two separate. They are part of a systems piece. It becomes somewhat of a hybrid.
So I am asking if, as you are moving through this use case, that you are actually thinking of the bigger picture and the important issues that need to be attended to, so that this could, perhaps be an exemplar for future work that this type of coding structure, this type of thinking may have application to other commodities or resources.
I had a question in relation to the FDA, but, of course, he has left, so he can't answer it, and that was his discussion about it being human pharmaceuticals. Is that the sole activity that they are working on or are they going to be able to translate that into the animal products as well? Do you know, anyone?
MS. CRONIN: I am still officially employed by FDA, so I could comment on this.
As far as I know, there's no immediate plans to bring that in, but I know that the structured product label and daily med, in general, is of great interest to some of the other centers at FDA and there is sort of active consideration as to whether or not that could be expanded, but there is no immediate plans.
MS. BICKFORD: Okay. And, again, that is an example of thinking about it from the big picture and then utilizing that same technology to another application, trying to attend to the issues to make it a more useful initiative.
And, in light of the FDA's initiatives focusing on the human piece, I would want to be sure that there's consideration of hybrid products - that may be mechanical as well as biological in their coding structure and their plans to accommodate the naming and the components of it. As we are doing the evolution with the human genome sorts of things there may be a combination of inanimate mechanical plus the biologics attached to it that could be considered a drug.
So I am just trying to be thinking outside the box, being prepared for some of the new technologies that we haven't a clue what is coming down the pipeline.
DR. COHN: Carol, thank you.
MR. HUTCHINSON: Hi, my name is Kevin Hutchinson. I'm the CEO of a company called SureScripts.
First off, I want to take the time to thank the committee. I am assuming that these high-paid positions of sitting on this committee will be worth it at the end of this program. You have a large task ahead of you in this space, in the sense that - a comment that I think Harry made earlier about the impact - this is only focused on Medicare, and we realize this, but I just want to make sure the committee understands and appreciates the sensitivity to what will be decided around these standards will impact work that has been going on now in the industry for years.
The good news is there is a lot of work out there. The bad news is, you have the task of sifting through a lot of the work that is out there and coming up with what are the standards that we need to address.
There is great work that has been done by the pharmacies. There's great work that has been done by the PBMs. There's great work that has been done by the payers, and a lot of organizations, manufacturers that have gotten involved in this space, position groups and position associations taking positions on the rollout of electronic health records and the standards that they have for the exchange of information.
I would submit that there are two standards that you have to focus on. We have to figure out if they are black and white or if they are grey, but there is the technical standards of the exchange of information that we need to be able to do electronic prescribing, and then there are workflow standards, and which standards are we focused on with this particular process? Are we determining what the workflow standards should be in a physician's practice? Are we determining what the workflow standards should be in a pharmacy? Are we determining what the exchange - the technical exchange standards should be between clinical applications to safely exchange and do electronic prescribing, and that is a big task alone is just defining where do you stop in the standards work, because you could do a lot of things in this space.
The further you take the standards work, I will tell you, you will have to start holding these sessions in the MCI Center, because you will be getting a lot more interested parties that will be coming to this table the further that the standard work is begun.
The good news is that the comments that were made earlier, there is a lot of progress in this area. The pharmacies are getting connected. The PBMs are delivering formulary information electronically. Medication history work is begun. There is a lot to learn from and look at - HL7 standards, NCPDP standards - a lot of collaboration amongst competitors as well as complimentary companies, manufacturers and pharmacies and payers and PBMs that is beginning to happen in the industry. So the good news is the way this is on a move, and we are very excited about that, but I just wanted to stop and applaud you for the work that you are doing.
DR. COHN: Well, thank you. Hopefully, you'll still be applauding us in six or eight months. (Laughter).
Jeff -
MR. BLAIR: Yes. Well, thank you very much for your comments, and if you have watched our committee, we have never stretched our scope of standardization to workflow. So since you mentioned that, I sort of want to know if you know something that we don't know. (Laughter). Are there any workflow standards that are being widely adopted that have been developed and supported by an ANCI-accredited, standards-development organization where you feel we should consider it, because it should be applied nationally? Is there something we don't know?
MR. HUTCHINSON: I don't believe there is something you don't know, and I don't believe that there are ANSI-accredited workflow standards that exist -
MR. BLAIR: Okay.
MR. HUTCHINSON: - to my knowledge in this industry, but there are things in this Medicare legislation, things like no commercial messaging, and which we support 100 percent, and, actually, one of the things that SureScripts requires in all of our contracts - we are like the ATM network of prescriptions in the sense that we route them to pharmacies or mail order, whatever may be the choice of patient for pharmacy and whatever the choice of therapy should be, and we enforce those rules of choice of pharmacy, choice of therapy, but in the legislation, it talks about no commercial messaging, but it doesn't define what you mean if you talk about a standard, and this could impact a workflow standard of what you mean by commercial messaging. If it is only clinically based, if it is an evidence-based message, like a drug alert, that is okay, but if there is another type of message that pops up when a physician is in the act of writing a prescription, what determines whether that is a commercial message or an evidence-based message? And that will impact workflow. It will also impact adoption by physicians as well.
Thank you.
DR. COHN: Any other - anyone else wish to make any comments? No?
Okay. Well, now, it is time to put this altogether and figure out our next steps.
MR. BLAIR: That'll be easy. (Laughter).
DR. COHN: That'll be easy.
Jeff, you have some comments?
MR. BLAIR: Well, let me just - yes, let me make a few comments.
First of all, I want to thank all of the folks that have testified to us whether they were scheduled speakers or folks that have spoken to us in the last 15-20 minutes. I think that a lot of this - this is our first day. This is our introductory overview day, and for those of you who may not be aware of it in the audience, we have a work plan to solicit input and testimony during the summer, during the fall and during the winter and spring of next year before we come up with our final recommendations in June of 2005. So this is to get us started, and maybe the thoughts that I have at this point is maybe if - Simon, if you feel comfortable with this - if maybe the subcommittee members and the staff to the subcommittee could identify the things that they think are important lessons learned that we have learned from these particular hearings here, so we capture all these ideas. I'm not sure that we had a central individual that was capturing all these things, so I think maybe this is our opportunity to do that, and at the same time that we are capturing the lessons learned from those things, if that could include either testifiers that we need to hear from or areas of standardization that we need to consider that we haven't already identified.
DR. COHN: Sounds good to me, as well as topics that need to be handled in upcoming hearings.
Would anyone like to start?
MR. BLAIR: Let's see. By the way, I'm only capturing these things on my Dictaphone, which is a less than ideal way to do that. Is there an individual on the subcommittee or the staff that -
DR. COHN: I think Marjorie. Yes.
I'll just start from my notes here, and I'm not sure that I wrote down so much what I learned, but more what I - as I was reflecting on both our project plan and other things, maybe what we hadn't thought about and things that we needed to include, and I was both - once again, having read on the plane yesterday the project plan - thank goodness for long flights - and also reflecting on what we heard today, I was sort of struck that I do think we need to make time for some experts on patient safety to come and specifically talk to us and share their thoughts about how patient safety can be assisted and encouraged with ambulatory e-prescribing, just to make sure that we aren't missing something that is sort of obvious here as we go forward. So I thought that was sort of a - I mean, we talked about it a little bit today, but not really a full-throttle piece from quality experts.
The other piece - and, once again, this may be more of a terminology issue more than anything - had to do with the people we were going to have testify, and I see that we have PBMs, we have pharmacies, we have providers. In many ways, I think PBMs are really - you know, it is always - our agents are the payers, but I think we need to find some payers specifically that we need to be talking to to make sure that we are meeting their needs, and, obviously, at the end of the day, of course, CMS is the payer of last resort, but it is also going to be working through intermediaries, prescription drug plans, Medicare Advantage organizations, et cetera, and it might make sense for us to - once again - when you figure out when we include that. That is probably a summer activity, I would imagine, but that is a group that we need to make sure that we are getting feedback from.
I remember Stan about complexity, I mean - oh, actually Stan brought a comment early on about this issue of really what is in Part D versus Part B versus Part A, in terms of prescriptions, and I think probably we need a little bit of a briefing about where the line is there. I mean, Stan asked questions about IVs at home and home health medications and all of that, and even though I consider myself sort of knowledgeable about this area, I, for the life of me, don't know whether they are Part A, Part B or Part D services, and I think we better make sure that we are clear about what is in the world of Part D and how all of this sort of splits out.
I think it was also - I mean, Carol Bickford, when she was talking, you know, because we know that, for example, syringes for insulin are included in all of this stuff, but how much more in the world of DME and others are really included? And Karen is asking no, but I do know, for example, some of that is included in Part B. So, once again, those issues of where the lines are for the Medicare benefits. Anyway, I'll stop there.
Stan, do you have comments?
DR. HUFF: I don't know what level to tell you on - to get to. I mean, obviously, I focus on things I know. So - you know - I'm interested in what -
DR. COHN: Will you email that to us -
DR. HUFF: Sure. I'd be glad to email this, but, you know, what - my perspective is that it would be nice to get to one set of drug codes that are used in the standard, and it ties into the drug codes we hope the FDA is going to provide, or, you know, a combination of RxNorm and/or new product ID's and those sort of things, which I think are things that we would go on.
I think some of the other things I would probably characterize is there may be some situations where things that we need to do aren't already a standard part of the SCRIPT Standard and rather than talk about the individual things, I think we need to think, again, about what is the process for how the standard gets updated, so that we are not locked, you know, for a 10- or 20-year period with something that needs enhancement and additions. We need to think about enabling a process that allows enhancements to be made, and that is done in an orderly way - orderly and timely way to the standard.
Surprised to learn about controlled substances not working in the SCRIPT Standard. So I need to think about - I think we wanted to cover that. So we need to think about how that works and how maybe digital signatures, then, have to become a part of that standard or some new version of the standard.
This came out of a lunch. One of the other things that comes up as a question is while there is some redundancy in how checks are done at the provider versus the pharmacy versus the payers or PBMs, one of the things that would seem to me - well, I won't try and bias the discussion, but you could - I mean, one way to do this is have the provider send all of the information they have to the pharmacies, including problem lists and medications and other things, so that they could do more work or we could make some - in a sense - this kind of workflow related things. I mean, do we really want to do that or do we want to make some statements about the fact that we think a particular kind of checking - or maybe even say, the kind of checking we expect to be done by the prescriber versus the kind of checking that would be done by the pharmacy, so that, in fact, I don't have to send my entire medical record to a pharmacy for them to be able to do their job correctly.
So it's - you know - what is workable and what is feasible in terms of who does what kind of checking where.
I think that's a summary, but I'll be glad to send you my notes.
DR. COHN: Okay. Harry.
MR. REYNOLDS: Yes, I - first word is wow. We heard a lot today.
The way I tried to take some notes is to try to put together an overview packet of what we have to think about, and I think that - for example, some of the excerpts from each of the speakers.
Karen did an excellent job talking about what the regulation includes, the basic prescription - so those are kind of - trying to draw box around this, so when you listen and - standards, and I think some of the speakers at the end said this can get real big, and we gotta - I know, I, at least, am going to try to stay very focused on what actually we are supposed to be delivering.
The standards - she mentioned four standards that we needed. So these are kind of - these are almost like guiding principles, and that is what I tried to listen today. What are the guiding principles? What are the legislative things? What are the things that kind of draw a box around this thing? Because this is a huge industry doing a lot of things a lot of ways.
Her slide 8 that talked about what is our role, that is another key one to just continually for me to keep in mind.
Moving to Jonathan, the whole idea of speed, making this - it is going to have to be easily useable by the physicians, I think, is a key mantra, and the pharmacies and anybody else, but I mean, that is a mantra that has to go on, if we are truly going to try to be successful.
His slide 12, which was the one that talked about the communication, so that we keep in mind how everybody is talking to each other, so we don't miss - as we are trying to set up a standard, we don't miss how people are working together.
His slide 21, which was the doctor concerns, which he gave a good list of those.
He had some guiding principles that they had used on his slide 26.
He was willing to share some items on related medical history, because I think the last gentleman that spoke, this idea of workflow, depending upon how some of these items get defined, like what would be the medical history you would want, it can dramatically change the workflow process. Right now, that's going on whether in a doctor's office or pharmacy, PBMs, payer sending it to PBMs, whether it is Medicare, whoever it is. That is the kind of thing that silently changes an entire industry's workflow process, depending upon what data you have to have, where you have to have it and how timely it has to be. So that is one that - when he said the word workflow, that is exactly what I -
Refill requests appears to be an abundant area or making a big difference. Sounds like the initial script does one thing, but the refill appears to be something where we can actually really help the environment on how to do that, so focusing on getting that done, I think, would be excellent.
The whole idea of the formulary versus the benefit versus eligibility, whether or not - when we say - up until the statements earlier, when somebody said eligibility to me, I thought one thing, and when they said formulary, I thought another thing. They just morphed it together, and so we are going to have - you know, trying to sort that out as to what is an eligibility transaction and what does formulary deliver back is something I know we are going to have to keep in mind.
So, you know, just trying - in my own mind, I'm trying to put together an overview, and what we have done in other times is, if we agreed as a committee on some guiding principles or some things we want to remember - maybe even having those charts on the wall, a few of them, so that we just continually can focus back to something rather than everybody trying to keep this mass of paper and the next 25 presentations together, may be something that would be helpful, so that even if we are talking - somebody is presenting or something, we could say, so how does that relate to what we thought we had to do here? Because that is going to be the hard part.
We heard a lot of data. Trying to make it into something is going to be, I think, what is preeminent in my mind, and so that would be my recommendation, rather than making specific recommendations, that would be what I would think maybe is a way to keep us together.
That's all I have.
DR. COHN: Steve.
DR. STEINDEL: I think Harry did an excellent job of summarizing a lot of what I was thinking, and I would like to see the notes as well.
Two things that came to mind. One was the thing that we have been talking about and discussing is the medical history part - how we're going to attack that, and I think we got a good description that probably - if we look at the problem list in recent procedures, that might be a good way to encapsulate this, and so we need to have some discussions in that area.
The physician's choice thing and the speed issues, I think, is something that we need to consider very highly, but what really got me fascinated from a standards point of view, aside from all the other standards we have enumerated in various discussions in the work plan, was one thing that hadn't come up, but came up, I think, very strongly in the NCPDP discussion, and that is the issue of identifiers. That seemed to be a very - a bigger issue than I had originally thought it would be, and this is something that we have identified at CDC in the area of messaging. It is very critical to have identifiers that allow you to have some intelligence about what you are sending, where you are sending it and what is at the location, and we probably should spend some time exploring that. The main identifier was the one that was the provider identifier and I thought was incomplete from our standards point of view.
DR. WARREN: I have been sitting here and thinking about what it is I know and don't know. I probably have a longer list of what I thought I knew, but don't, or some of the assumptions that I had made of a practice I've spent all my career in, and, now, I am hearing things that I never knew about, and that - so I need to spend some time really thinking about the prescription.
But I am also caught on this medical history thing that some of the questions that came out earlier is we only want to send the relevant medical history with the prescription, and so I am immediately caught with, well, who decides what is relevant? You know, if it's an automated thing that comes out of an EHR, can we automate that, and how would that happen? So I am still kind of stuck on what medical history is.
And, then, there was another comment made when we were listening to the NCPDP about, well, we can just put some queries together and get the history of the pharmaceuticals, and I would like to explore that a little bit more, because, I mean, I can put together a whole set of queries in almost any database. Now, how long it takes me to do that and what is involved in writing those queries is a whole different issue, but I think we need to explore some of that, because that does have to do with some standards that come in there.
And, then, in watching the VA demonstration, we were looking at a lot of their interfaces, and I kept going back to the time issue, and that was a question that I had asked Karen about when she was talking about we need standards for knowledge representation, because I come from a fairly academic perspective on what knowledge representation is, and she was also including what the displays would look like, which is not something that I would see as knowledge representation, and so, now, I am struggling with is the way we display the information also part of what we are doing and looking at?
I know. I'm just trying to say, these are things I'm confused about.
DR. COHN: No, I agree -
DR. WARREN: And I don't know if they are in scope or if they are out of scope, and some of the things I would like to do that.
And then you talked about patient safety, and so do we also look at some of the quality indicators that are coming out being mandated but have to do with adverse drug events?
DR. COHN: For the ambulatory environment.
DR. WARREN: Right. And some of those are for the acute-care environment and some are for ambulatory. So do we need to be sure that these standards can help work with those or are we, again, developing standards in silos for each kind of application that we are doing? So that is where I am coming from.
DR. FITZMAURICE: This is good. It is hard to summarize, so I don't think I can. I am just going to pull some nuggets that triggered some of my thinking, to the extent that I was thinking.
For example, this morning, it was very well put together, and I think Steve and Maria are to be congratulated.
We heard what MMA requires, then we heard the functions described desired by clinicians and by pharmacies, and then we heard the functions permitted by the NCPDP SCRIPT Standard, and there is more there in all three of those than I would have thought coming in, particularly in the SCRIPT Standard. I didn't realize the amount of anticipation of the business need for information.
So my next thought was that I would like to see, at least in my mind, a mapping, a schematic representation of scenarios and functions that could be performed if standards were available, and so I am thinking of here is a function. What information is needed, and then who supplies this information?
And, again, our lunchtime discussion with Stan and Jeff and Steve, we had some discussion about, well, should it come from PBM? Should it come from the Medicare program? Should it come from the health plans? Should the patient have to carry it around? What is the cost and what is the benefit of that?
But the key to all of this is access to information to making these decisions and to making the workflow move more smoothly.
We learned of the information needed from the testimony and the information sources, and so we kind of have to think about what information needs a standard representation, and does one exist? Do many exist? And we saw that, in many cases, many exist. Does it need a reference terminology, a reference, so that everybody can point to it?
Stan informed us that that is the most efficient way to compile information and to retrieve it. At least, I think that is what Stan said.
We face this when we talk not only about drugs, but when we talk about guidelines, when we talk about decision rules and when we talk about priorities for alerts and reminders.
And, then, finally, electronic signatures remain very problematic, especially if you think digital signatures, rather than pictures of signatures or some other way to electronically represent a signature. It boils down to how do you authenticate who the person is that is sending you the information, and, then, secondly, how do you authenticate that the information is valid. If you believe the first person, then you put the trust in the person. I don't see the industry solving the digital-signature problem with a standard yet, and so maybe we'll learn from that in the coming year that something does exist that fits well within business use.
DR. COHN: Okay. Jeff.
MR. BLAIR: In a sense, I'm pulling together a lot of the things that a lot of folks have said here. I'm sort of grouping them into areas that I think we have to follow up on, and I've got eight items.
The first four of the eight were things that the law told us were areas we should look for for standardization, and the first four are ones where I have heard many people wind up saying that they think we've got gaps, and we've gotta either get more information or question whether or not standards are really needed in these areas, and, if so, what kind of standards.
One is medication history. Do we need standards for that either in terms of messages or in terms of content?
Number two is medical history. What information from the patient record should we consider required, and if we say it is required, what entity in that environment is expected to provide them and share them?
Number three. This was an area I thought we were okay on, but, now, there seems to be some questions about consistency and connection, and that is eligibility standards. Okay?
What was my fourth one? I may have to come back to the fourth one. That was one, two, three, four. Three out of the four.
Okay. The other areas that the law didn't identify that we seemed to have learned as issue was the identifier standards. NCPDP pointed out to us that they have come up with HCIdea and that that will still be needed even after the NPI is available, and I think we need to get a better understanding whether that needs either better recognition or support or whether that meets - you know, fully meets everything we need.
The other area was, as Stan said, do we need to look at little bit more closely at whether RxNorm in the portions of NDFRT and FDA's code is sufficient now to support the needs of e-prescribing or do we need to - I think you said embellish them or buff up - buff up? So that was another one.
The other new area to look at was Simon's, which was to look at patient safety.
And then Carl Bickford challenged us to take another look at our scope, the definition of e-prescribing, and make sure that we don't leave off certain things like syringes and insulin pumps and things like that, and make sure that, while we don't necessarily extend it beyond what we need to, that we don't define it so narrowly that we make some things not practical.
There was a fourth area that was in the law.
DR. COHN: Decision support, Jeff?
MR. BLAIR: Pardon?
DR. COHN: Decision support?
MR. BLAIR: Well, you know, the law didn't use the words decision support, and I tended to infer that, from both the medication history and the medical history, that it was drawing upon that for the interactions. So I kind of figure that if we understand those better, we would understand the decision-support requirements, but that, you know, we could interpret that differently, but that was the way I was looking at it.
So I have left one of the four areas of the law, and I guess I'll have to - yes, yes, on the plane back, I'll remember it, and I'll leave Maria a voice mail or -
DR. COHN: Yes. Jeff, might it have had something to do with formularies?
MR. BLAIR: Yes, thank you. That was it. Thank you. You got it, and that was the law also indicated we should examine what standards might be appropriate for formularies. We got a little bit of guidance here is that I don't think we want to standardize formularies, but do we need to examine whether formularies are communicated in a standardized manner or not.
Thank you, Simon.
DR. COHN: You're welcome. Now, you don't have to stay awake all night worrying about that one.
Comments, Steve?
DR. STEINDEL: Jonathan Teich mentioned this in his presentation, I just want to raise it, and that is are there any special considerations that we have to give to privacy and confidentiality with respect to e-prescribing above what we consider with respect to the HIPAA requirements?
One of the things that concerns me was we have heard several times - the lunchtime discussion the four of us had was a realization that there is going to be a lot of this information available to a lot of people, and is there any consideration that we need - any further consideration that we need to give in this area? And one thing Jonathan specifically mentioned was the ability to make sure that there are good protections to prevent the ability to sell any of this information, the marketing aspect.
MS. CRONIN: Steve, I'd just like to add onto that. If there is clear consensus across the subcommittee that that is something that should be happening internally within HHS, in parallel with the hearings and everything else that you are doing, then that would be helpful to know, when you are ready to tell us.
DR. COHN: You know, that is actually something we could also refer over to the Subcommittee on Privacy and Confidentiality. Well, I mean, just - I mean, we can handle it ourselves, but it is something that we could ask -
DR. STEINDEL: (Off mike).
DR. COHN: Well, that's a question.
You know, a lot of the issues around the privacy and confidentiality really get back to this issue of medical history information, which I have got to say that I have read about 12 times, and I can't, for the life of me, tell whether it has the same urgency or scope issue as the other pieces.
DR. STEINDEL: (Off mike).
DR. COHN: What?
DR. STEINDEL: (Off mike).
DR. COHN: Well, medications are already - I mean, those already go around a lot, I guess - I mean, I think I would be a little more concerned about the medical history aspects.
I'm sorry. Maria.
MS. FRIEDMAN: But you can infer medical history from the medications. You know, if somebody is getting AZT, you have a fairly good idea of what is going on with that -
MR. BLAIR: But at least my perception of what they may be asking us to do when they say medical history is identify allergies, other disease conditions and symptoms, lab tests, which one of those, and to what degree, do we need to consider that is included in the e-prescribing process, and, if so, how do we communicate it and to who.
DR. COHN: Gail, were you going to comment?
MS. GRAHAM: Well, I just - that whole discussion of all of those aspects and how you have the timing of that in isolation from the electronic health record adoption, seems to me, to be a little problematic.
DR. COHN: Well, I am actually reminded of the pyramid that we saw earlier today, recognizing that you can do a lot of e-prescribing without an electronic health record.
MS. GRAHAM: Right, but when you start broaching those things -
DR. COHN: Yes.
MS. GRAHAM: - the you get beyond that.
DR. COHN: Yes. You know, recognizing that - I mean - the intent of today, I don't think, is to answer all the questions. If we answer all the questions, we wouldn't have to hold anymore hearings. Now, don't clap right now. Don't clap yet.
But certainly - you know, one has to recognize in all of this is we recognize the issues and questions we have is that I think we have heard today there is a lot of activity and a lot of what appears to be very successful activity going out, out in the private sector with e-prescribing. I mean, above and beyond what the VA is doing or other integrated healthcare organizations which I may represent, but I think that some of these things are things that we really need to be asking people that are doing demonstration projects, other vendors and all of this stuff, about their thoughts about a variety of these issues, you know, what, if any, medical information needs to go around, you know, confidentiality issues, and I think - I mean, today, we have heard a variety of other pieces in this thing.
So, I mean, it may be great wisdom, Jeff, that - as I am remembering, I think our next set of hearings talks to some of those groups, and so maybe some of these things are things that we can get further wisdom on there, because I don't think I have heard anything so far - you know, there is obviously this issue of perfection -
MR. BLAIR: There you go.
DR. COHN: - which I -
MR. BLAIR: Don't let the perfect be the enemy -
DR. COHN: Of the good -
MR. BLAIR: Yes.
DR. COHN: - and all that, and I think that - certainly, I think what we would all like to see - I mean, on a good day, I sort of say, geez, maybe by the time we get ready to say something, maybe the whole industry will be implemented, and things could be worse than that. I'm not sure I'm quite expecting that, but it would be a - certainly, a very nice outcome to these conversations, and have them be on the right standard, so we wouldn't even have to worry about it. Maybe that is a little hopeful, but, certainly, the fact that we are beginning meeting and talking with all of them in May, these are some questions we can begin to ask.
Comments? Questions? Looked like, Kelly, you were going to make a comment? No.
SPEAKER: Sort of in line with your comment about perfect being the enemy of good, one thing, in my job what I do is I deal with all these software vendors who produce these e-prescribing applications, and one thing I think it is important to keep in mind is the standards that are created could encourage adoption, which I think is part of the purpose, or it could kill the whole thing, and so it is important to keep in mind that there is the workflow issue that Kevin raised, which is - I don't know that we want a standard for workflow, but certainly workflow has to be considered. In other words, if you create so many requirements that physicians are sitting there waiting forever for a response from these systems, they won't ever adopt.
And the other thing is the way the legislation was created, it allows for standards, but it doesn't provide money for implementation. So you have to keep in mind that as the industry exists today, this is still a commercial enterprise, and so it has to be a standard that is implementable within some reasonable business model that people - somebody will pay for, and I just think that that is kind of a good starting point to keep in mind.
DR. COHN: Thank you. Back to reality here a little bit -
Kelly, it looks like you want to make a comment now.
MS. CRONIN: Well, only to clarify for those of you who haven't combed through every page of the new law. There are e-prescribing grants that will be available to providers in 2007, if, in fact, it is funded, if appropriations allow for it, but, again, that is just the provider element, and that is not really getting at potential burden to industry.
DR. COHN: It would be nice if we could do this in a way where the business case is so obvious that there was obvious reasons to implement, which really - there's a lot more than grants, but we do appreciate the fact that grants might be available if Congress appropriates the money for 2007. I don't mean to put it that way, but - I'm reminded that that isn't always necessarily something that happens.
Other comments or thoughts on this?
You know, certainly, as I said, I don't think we have the answers at this point. I think we do need to collect everybody's notes so we can read them, of course.
MS. FRIEDMAN: Or if you could email them to me, that would be great.
DR. COHN: Yes, maybe we should email them to Maria, and put them together, because I think what we have is a number of questions to ask the next set of testifiers.
I guess, from my own view, it would be nice if there was a way, at our next hearing - and I'm not thinking of a major exploration into patient safety lasting several days, but it would seem to me if we could have an expert come and meet with us to talk some about the patient safety aspects of this earlier, rather than later, just to make sure that it doesn't change either our thinking or priorities or anything else, it might be useful for an hour -
MR. BLAIR: You know, Simon, may I suggest, there's two or three individuals who have really focused on patient safety, who are also considered industry experts on e-prescribing, because they have looked at the patient safety from the viewpoint of e-prescribing, and that may mean we could kill two birds with one stone.
DR. COHN: Well.
MS. GRAHAM: I'm sure Dr. Bayshon(?) could assist, if desired, as well.
DR. COHN: Okay.
MS. CRONIN: David Bates also comes to mind. Yes.
DR. COHN: I didn't want to name names -
MS. CRONIN: He's done extensive consulting with FDA, certainly, and in bar coding and a lot of other issues.
DR. COHN: Okay. Well, it sounds like - once again, I don't think they should take over our May hearing, but at least a session to talk about this one, I think would be useful.
Well, I mean, I'm trying to think of what other - do we have other issues related to e-prescribing today? I mean, we can all cogitate over it, and if there are other issues that come tomorrow, we can, of course, talk about it.
Now, I just wanted to briefly remind everyone that tomorrow morning starts at 8:30. So - and, obviously, our focus tomorrow is on HIPAA. We begin with a discussion with a HIPAA update, which I think, Karen, you'll be here to - oh, Maria? Oh, Maria is going to be presenting. Okay.
Then we follow up with meetings with - other testifiers on the status of the HIPAA implementation, followed by our yearly report by the DSMOs. I think after that, we'll be spending time talking specifically about some specific DSMO recommendations.
So, anyway, that is what is planned for tomorrow. I look forward to seeing you all bright and early at 8:30, and the meeting is adjourned. Thank you. (Applause).
(5:17 p.m.)