[This Transcript is Unedited]
Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, SW
Washington, DC 20201
Agenda Item: Call to Order - Welcome and Introductions - Dr. Cohn
DR. COHN: Well good morning, I want to call this meeting to order. This is the first of three days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The committee as you all know 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, and the national director for health information policy for Kaiser Permanente.
I want to welcome fellow subcommittee members, HHS staff, and others here in person. I do want to inform everyone that normally we are on the internet but I believe that currently our internet connection is down, I think well try to notify everyone when we get on the internet, for the moment the testimony and discussions will just be recorded and transcribed.
Obviously theres a lot to cover over the next three days and I think those in the audience and those around the table need to realize that the agenda has changed since yesterday and theres been some reshuffling of presenters and times. This morning we start out with a presentation on formulary issues from Steve Avey from the Foundation for Managed Care Pharmacy and well start onto that after introductions and introductory comments. That will be followed by a discussion hearing from those representing consumer perspectives. After the break we hear from the state boards of medicine, then after lunch we move to the state boards of pharmacy, payer perspectives, then talking about pharmacist perspectives and finishing with physician perspectives.
As we always do we do have an open mic that will be at the end of the day, right now its scheduled for likely somewhere starting between 4:00 and 4:15 and that will be followed by subcommittee discussion. Were hoping to adjourn no later then 5:45 today but if were lucky maybe a couple of minutes earlier, well see what we can do on that one.
Just to remind everyone in the audience and around the table sessions for Thursday and Friday start at 8:30, not 9:00, and the final adjournment on Friday is scheduled for 12:30.
Now as always I want to emphasize that this is an open session, those who are in attendance are welcome to make brief remarks if you have information pertinent to the subject being discussed. We are obviously as I mentioned also have time at the end for an open microphone session for those who want to make comments about the activities or discussion items of the day.
Obviously in all of this I want to thank Jeff Blair, our vice chair, for his leadership in moving this agenda forward. Maria Friedman isnt here right at this moment, we obviously want to thank her for tremendous efforts to put these meetings together, and its really been a remarkable effort in terms of us moving forward.
With that lets have introductions around the table and then around the room. For those on the subcommittee, and this is only in reference to those on the subcommittee, if there are, if you have any conflicts of interest related to any of the issues coming before us today would you please so publicly note during your introductions. With that, Jeff, would you like to introduce yourself?
MR. BLAIR: Im Jeff Blair, Medical Records Institute, vice chair of the subcommittee, and Im not aware of any conflicts of interest, however if discussion on the CCR comes up I will need to recuse myself. Ive been asked to clarify this, Im not participating in CCR activities however my employer has been.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the subcommittee and liaison to the full committee.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to the full committee and staff to the subcommittee.
MS. AMATOYABUL(?): Margaret Amatoyabul, independent consultant and contractor to the subcommittee.
MS. GRAHAM: Gail Graham, staff to the subcommittee, Department of Veterans Affairs.
MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC, and executive secretary to the committee.
MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina, member of the committee.
DR. WARREN: Judy Warren, University of Kansas School of Nursing, member of the subcommittee, and Im not aware of any conflicts that I have.
MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services, staff to the subcommittee.
MS. SQUIRE: Marietta Squire, CDC, NCHS, and staff to the subcommittee.
MR. MILLEK(?): Ed Millek, a company called Prescription Informatics.
MR. THINK(?): Carl Think, also with Prescription Informatics, were an e-prescribing technology company.
MR. AVEY: Steve Avey with the Foundation for Managed Care Pharmacy.
MS. SCHLAY(?): Marissa Schlay for the Academy of Managed Care Pharmacy.
MR. SHEETH(?): Im Tony Sheeth with Point of Care Partners, Im a consultant and I do a lot of work in electronic prescribing.
MS. JACKSON: Debbie Jackson, National Centers for Health Statistics, CDC, staff to the committee.
MR. SIMPCO(?): Mike Simpco, Wal-Greens Health Services.
MS. ZIGMAN-LUKE: Marilyn Zigman-Luke, Americas Health Insurance Plans.
MR. HAUSNER(?): Tony Hausner, CMS.
MS. GILBERTSON: Lynn Gilbertson, National Council for Prescription Drug Programs.
MS. TOWNSEND: Jessica Townsend from HRSA.
MR. WEINARD(?): Ron Weinard from Wal-Greens.
MS. DROWL(?): Jill Drowl from Wal-Greens.
MS. REIN: Allison Rein from the National Consumers League.
MR. BUSOWITZ(?): Roy Busowitz, National Association of Chain Drug Stores.
MR. SANICK(?): Dan Sanick from Caremark(?), a pharmacy benefit management company.
MR. BIZZARO: Tom Bizzaro, FirstDataBank.
MS. MACARTHUR: Kit MacArthur with Wellpoint.
MR. ROTHERMICH: Phil Rothermich, Express Scripts.
MS. SWANSON: Terri Swanson, CIGNA Pharmacy Management.
MS. BURN(?): Terri Burn, Rx Hub.
MS. WOOLY(?): Shelly Wooly, Rx Hub.
MS. HAMBY(?): Pat Hamby with McKesson.
MR. MARTIN: Ross Martin with Pfizer.
MR. ROBERTSON: Scott Robertson with HL7.
MS. COKLEY(?): Emily Cokley, Community Health Funding Report.
MR. MELLIKAN(?): Mark Mellikan, MediSpan.
MS. ECKERD: Karen Eckerd from MediSpan.
MR. SCOTT: Phillip Scott with the National Council for Prescription Drug Programs.
MS. STEMBER(?): Leanne Stember with the National Council for Prescription Drug Programs.
MR. SILKE(?): David Silke, Health Strategies Consultancy.
DR. COHN: Okay, well I thank everyone for joining us. I first of all should mention that the internet is now on, so I want to welcome those who are listening in on the internet. This is a meeting of the National Committee on Vital and Health Statistics, the Subcommittee on Standards and Security. I should also comment that I know many of you got in a little late last night, we want to thank you obviously for showing up and obviously thunderstorms and weather are sometimes difficult in Washington during the summer.
With that Stan would you like to introduce yourself and identify if there are any issues that you need to recuse yourself of.
DR. HUFF: I apologize for being late. Stan Huff with Intermountain Health Care and the University of Utah in Salt Lake City, and I would need to recuse myself on issues related to HL7, Im a vocabulary co-chair with HL7.
DR. COHN: And before I ask Jeff to make any introductory remarks for the day I actually also just want to publicly note that Im a member of the CPT editorial panel, therefore if the issues around CPT come up today, which I doubt but you never know, I will obviously be recusing myself from those discussions.
Jeff, do you want to make some introductory comments before we move into the testimony for the day?
MR. BLAIR: You betcha. We are here because of the directive from the Medicare Prescription Drug Improvement Modernization Act to the NCVHS to evaluate and make recommendations on e-prescribing standards. For those of you who are not aware of the fact that the work plan that we are following, right now its work plan version nine, it may go up to 21 or 30 or something, who knows, but as of know its version nine, is available on the NCVHS website and that would help you to wind up putting in perspective the thinking of the committee as we go forward to try to give our first set of e-prescribing recommendations to the Secretary in September, and then the second set in March. The main thing that will be deferred until after that first set will be electronic signatures and other issues that we cant cover between now and September.
Other then that let me just acknowledge the assistance of Margaret Amatoyabul, who is a consultant who is assisting the subcommittee in being able to capture all of the information about standards, their limitations, their gaps, the related issues, because she has done a tremendous job for us.
Simon, let me turn it back to you.
DR. COHN: Okay, well Jeff, thank you. I think with this well ask our first testifier, I think Steve Avey, come to the front and talk to us a little about your perspectives on formulary management. Thank you for joining us.
Youre going to need to get near a microphone and I believe we have a computer, you actually may want to, okay, great.
Agenda Item: Formulary Issues - Mr. Avey
MR. AVEY: If I could first very quickly introduce the organization that I represent, first of all theres the Academy of Managed Care Pharmacy which is a professional organization of about 5,000 pharmacists who work in a variety of managed care settings, be it health plan or PBMs. I am the executive director for the Foundation for Managed Care Pharmacy, which is the research and education arm for the Academy. I was asked this morning to present some testimony regarding some formulary issues so what I would like to do is first of all talk about the basics of a sound formulary management program and we had distributed to you this document, and then Id like to talk about the environment that we have lived in and are living in today in terms of formulary evaluations. Were going to introduce you to a guideline that the Academy has established for formulary evaluation of medication and the impact that that guidelines has had.
In terms of sound formulary management I think this committee is familiar with what a formulary is, it has evolved over time. In the old days a formulary was something that it was a list specifically of drugs that were covered for benefit and those drugs that were not on that list obviously were not covered. But in todays environment it isnt so much is a drug covered or is it not covered, its at what level is it covered, so we have a variety of tiers that a medication may fall into. But a sound formulary management system is vitally important for many reasons. First of all when its properly designed and implemented it really can establish drug therapy that is rational, clinically appropriate, safe, and cost effective, and each of those is vitally important to us.
It also supports not only an affordable but a sustainable benefit, and as we have dealt for the past 15 to 20 years with employers and a variety of other payers its not only critical to have a benefit design that is affordable today but that you can sustain into the future as we think about the Medicare Modernization Act and you think about sustaining that over the long term, its vitally important that we have a sound formulary management process. It balances high quality care with the cost associated with that care and in a few minutes Im going to describe how exactly were able to do that.
In order for us to have a sound formulary management system we have to have something called a P&T Committee, a Pharmacy and Therapeutics Committee, which is made up typically of physicians, pharmacists, and other health care professionals. They have some very important responsibilities if theyre going to have a sound formulary process and first of all its their responsibility to evaluate medications for inclusion on the formulary. And in some cases even to describe at what tier a medication might be covered. Communications are vitally important specifically as medications are added to a formulary or medications are taken off of a formulary, of communicating to prescribers those changes. They have to periodically assess therapeutic categories because what is true today may be different two years from now so occasionally P&T Committees will go back and reexamine a therapeutic category that previously they had done to see what influence new medications might have in that therapeutic class. And then they have to develop a strategy for medications that are not covered in terms of making those medications accessible by patients in some format.
Now the system itself should also be involved in informing physicians and pharmacists who have a difficult time as formularies change understanding what the coverage is for a specific medication in a specific program. They have to also educate plan members of what a formulary is, how it works, how medications are added to that process. And then when asked I think they also should be responsible for explaining what the rationale is for decisions that are made for inclusion on a formulary.
So let me tell you just a little about the environment that we live in and this slide shows you, on the green line what were showing you is the expenditures for pharmaceuticals, the red line is hospital expenditures, and the blue line is physician cost. And as you can see the expenditures for pharmaceuticals has been in the double digit rate for a considerable period of time and if youre a payer you would look at that and say why are my expenditures on pharmaceuticals so much higher then they are for hospital and physicians.
And theres actually a good reason for that, there really are three areas that that expenditure increase really falls into and unfortunately if you listen to the trade press they would have you believe that its all cost. But in reality the cost piece is only about a quarter of the increase, the biggest piece of it has to do with utilization and as youre well aware as we find out how medications work and what impact they have on us we have tended to add more medication to our regimens. If you just look at cholesterol for example in 1990 the acceptable cholesterol rate in the United States was 240 and today it is below 200 so you can see that millions of Americans now are taking medications to reduce cholesterol because we have found that there are positive benefits from doing that.
The area that I want to focus on today though is that one of the reasons that we have increases in pharmacy expenditures is changes in prescribing habits, that physicians are using newer medications as opposed to older ones. Clearly from employers and payers what we have heard is that they want better control over pharmacy expenditures and what we have seen in the past four or five years is a shift in payment to the recipient, to the member, who now is paying a higher co-pay for that benefit. They also want to ensure appropriate utilization, if we get a great new drug out on the market payers will want to pay for it but they want to make sure that the utilization is appropriate.
And then the payer is also demanding that they understand what the value is from these new medications, there obviously is a higher price tag associated with it and they want to understand what value theyre actually getting back. And then they also want to understand what the rationale is when formulary decisions are made.
Well the Academy about five years ago looked at the decision making environment for formularies and found that there were a number of issues there. The first one is that there was no consistent way in which managed care organizations evaluated medications, and some were doing an outstanding job and others we felt needed to improve. The information needed to do a good quality evaluation was really lacking and in just a minute Ill show you why. We also felt that there needed to be more emphasis on the value that the medication brought as opposed to just what it simple acquisition cost was.
We really see that for the past five years there has truly been a changing environment. In the old days, in the early 90s when I actually sat on some P&T Committees I can tell you that we clearly were in the top half there. Unfortunately without proper information decisions would fall to anecdote and bias, we clearly did not have complete information, and we clearly focused on drug impact only. And what were trying to do is shift things down to the bottom where we make decisions based on evidence, where we look at the total medical costs that are associated, and that we really look at total health impact. But if were to do that how do we do that?
Well, the Academy came out with a new set of guidelines that Id like to talk to you about. We looked at the decision making environment and we thought you know what, there really is a need for improvement. And when we looked at the diversity out there we felt like there had to be a more standardized approach to evaluating medications. And so we came up with a new guideline that is called AMCPs Format for Formulary Submissions, it is also known in the briefest context as the AMCP Format, or youll also hear it called the Dossier Process. And the idea behind this was to reduce this variation that I just described, we wanted to see a much more standardized approach to making formulary decisions, we wanted to make sure that we were truly focusing on value and not just specific costs.
And so what we did is develop a standardized template that could be sent to a manufacturer and say this is the information that we need in order to make a good decision. The manufacturer then develops whats called a dossier that has that information in it and submits it back to the P&T Committee.
Now the additional information primarily that were talking about is off label use, outcomes information, unpublished studies, database studies, quality of life, functional status, and then a health economics and modeling studies. All of those are pieces of information that we believe are vital to a P&T Committee as they make a decision. Well of course that information is not the kind of information that a pharmaceutical company could just provide as say a marketing brochure, and so we had to talk to the FDA and say were interested in obtaining this information and so what wed like to do is develop a process where we can request that information and that a pharmaceutical company can submit it to us. And so the FDA accepted the fact that if we were to ask for a dossier that that would come under the guidelines of an unsolicited request and the pharmaceutical company could provide that information.
The FDA was supportive of the overall concept, they liked our goals and objectives, and they were interested in what pharmas response to that was. And as we explained to them that most pharmaceutical companies were building dossiers at the corporate office level they were comfortable with that analysis.
So the objectives of the Academy and my foundation for the last three years have been first of all to refine the format document itself, the guidelines, and second of all to provide training at all levels so that people could understand how to use this new tool. And thats exactly what we have been doing. Now to understand the process, when we say dossier we mean data, we mean that this is a scientific document. We have told pharmaceutical companies we dont even care if its on glossy paper, we dont care if you provide us graphs that are in color, all we care about is the science behind it. And one of the things thats clear is just because you build a dossier does not mean that youre necessarily going to make it on formulary, its dependent upon what science that document has.
Communication is obviously vital in this and its going to require as it has the last three years new thinking. And what weve actually asked pharmaceutical companies to do is include in their clinical trials thinking about outcomes because no longer is it enough for a drug to just be safe and efficacious, now we have to understand how does that drug fit in with other therapies that currently exist and that truly is a new way of thinking and clearly patient outcomes is what were really focusing on.
So to date, three years after the guidelines were instituted, we have over 150 million Americans who have coverage from a health plan or a PBM that are using the AMCP Format process. We have had wide acceptance from the pharmaceutical companies, I think in the beginning they were somewhat reticent about this new process, it truly is a new way of thinking, its a different way of marketing clearly with evidence as the basis and clearly focusing on patient outcomes. The thing is the United States is late in the game, actually when you look around the world Great Britain, Australia, and Canada have been requiring this same kind of analysis for some period of time and were just late coming to the table.
Well I wanted to show you this because in a second youre going to see where we put the format in terms of formulary decisions. When you look at a formulary decision there are a lot of elements that are there, the elements of the format really talk about evaluation based on the factors that I discussed previously. There are a lot of other factors that a P&T Committee have to take into consideration besides that.
Well, in terms of a reality check the format does identify the evidence thats needed and thats much different evidence then what we used to use in the old days of prior to five years ago. What it doesnt do is it does not provide a precise answer, we do not give an answer there, we just tell you what information you should be requiring. It does define how the information should be provided but we do not define what the decision making process should necessarily be. It provides really great data to a P&T and we believe that its the basis for a sound decision, but it doesnt necessarily guarantee that were going to lower health care expenditures.
Final thought, when you consider managed cares responsibility to make valuable medications to patient populations at the right co-pay level and I cannot stress that enough. We have concerns about co-pay level and how high can they go and what impact does that have on compliance. When you consider a patients right to have access to the medications that have the highest chance of succeeding, and when you consider the cost consequences of some of the new therapies available, sound formulary management is absolutely critical and we believe that an evaluation process similar to what the AMCP Format offers is something that really makes a lot of sense.
So those are my prepared remarks, Id like to open it up and have you ask whatever questions you would like.
DR. COHN: Okay, questions from the subcommittee. Steve?
DR. STEINDEL: Thank you, that was a very interesting talk, it gave me some thoughts on some ideas about formulary standards which I hadnt considered before, I appreciate it. One question that I do have is how often does a formulary change decision have to be made? Is that a periodic thing or if a hot new drug comes out on the market tomorrow the formulary is going to make a decision to put it on the next day?
MR. AVEY: That would rarely be the case, normally P&T Committees have scheduled meetings and a typical P&T Committee may meet four times a year, it may meet monthly, that depends widely by the health plan and the PBM. But its all thought out in advance and you heard me say that communication is critical, if theres a new blockbuster drug coming down the pike a pharmaceutical company knows about it and actually most of the folks in managed care probably know about it well in advance. Its important that that entity have a discussion with that pharmaceutical company months in advance of the launch of that product so that they can get that scheduled on their P&T Committee process and have the best information available at the time that meeting comes up.
DR. COHN: Harry, Stan, and then Jeff.
MR. REYNOLDS: You presented the relationship between PBM and the drug manufacturers as far as the formulary information going back and forth. One of the issues that we face as you look at e-prescribing is once that formulary is decided and in place and gone through your whole process, now it has to be delivered to the care giver in some kind of a structured standard way so that one is the only way, they can understand it, its clear, it takes that entire template you had, breaks it down into actual practical capabilities for them to use. Could you give us any thoughts on how you see that as the next step because thats the step that were pretty much having to face as far as establishing our process --
MR. AVEY: Its an absolute critical step because if you can appreciate the pharmacist in the field who has met with prescriptions that a physician has not known whether it was covered or not and the patient arrives at a pharmacy counter, theyre then told that its not covered and then a phone call needs to be made back to the physician who then needs to be gotten a hold of first of all and then explained what medications are available for them to select, a very inefficient process. E-prescribing is the answer and I will be honest with you that we within managed care have been frustrated with the lack of progress that weve actually made on e-prescribing because in that modality a physician can tell at the moment of prescribing what medications are on formulary and off. It is the answer for us and weve been very slow at adoption. The ultimate response to e-prescribing where we can arrive at a prescription that gets submitted to a pharmacy thats already gone through the formulary editing process is one that will make our system far more effective and efficient then it currently is, its absolutely critical to the process.
DR. COHN: Did that answer your question?
MR. REYNOLDS: Not completely.
MR. AVEY: Okay, so one of the things, let me go back to the process situation. Today the e-prescriber community has developed formularies that a physician with a Palm can go to a specific health plan, lets say that its Blue Cross/Blue Shield of California. They can actually click onto that health plan and it will bring up by disease state or by therapeutic category what medications are on formulary. Its fairly sophisticated and so it answers the question for the physician right up front what drugs are covered and which ones are not.
MR. REYNOLDS: But I mean, obviously you have a handle on the whole industry, are there formats out there that you think really are delivering the right things to the physician versus that you think we ought to consider looking at or hear about or do to consider endorsing as we try to develop some standards because in the end were supposed, actually where it happens were supposed to try and do something about it.
MR. AVEY: I think theres some organizations that are sitting in this room right now that have products that you would certainly want to consider. Quite frankly the frustration that we have isnt that the systems arent there and that they dont work, its been adoption by the physician community to utilize that technology. And the problem is I think we havent yet convinced the physician community of the real value of that and how that can save them administratively. It has not been done in such a way that the physician community has bought into it because there clearly is a financial obligation established with that.
DR. COHN: Okay, Stan?
DR. HUFF: So just to make sure, you develop content and formulary content, how is that communicated, I mean are you using, is it a human readable format or do you actually have a data format in which you communicate the formulary information to --
MR. AVEY: The means by which managed care organizations and PBMs present that information to their members varies by the organization. Lately the best technology available is that its available on websites and so a patient could actually go to a health plan or PBMs website and determine whether the medication theyre on is covered. The beauty of that kind of system is that it can be updated very regularly and so any changes that occur can be presented to that member. Previously we literally had hard copy formularies available, they get outdated very quickly and it becomes a very frustrating situation in trying to make the best information available to members.
DR. HUFF: The scenario Im most familiar with or maybe Im conjecturing, there are really two ways at the time or ordering that formulary information could be made available. One is that I could have in some batch way transferred the formulary once a week or once a day or once a month into the pharmacy ordering software. Or at the time of order I could actually go query some other database that was external to myself on a real time transaction basis and just ask about the particular circumstance that Im in. Are you familiar, or do you have any recommendation for the committee in terms of the format that would be used to move formulary information in a batch form from some content source to the actual environment of the ordering, or a transactional format for doing that same kind of transfer of information?
MR. BLAIR: To the prescriber.
DR. HUFF: To the prescriber.
MR. AVEY: Yeah, I was going to say we need to talk about which provider youre talking about. Obviously its critical that the provider have that information at the moment that theyre actually prescribing the medication. The systems that I have seen that are available, the database is updated actually in I think most cases at least on a weekly basis if not on a daily basis and actually the database thats being queried in a variety of ways can be downloaded overnight into the physicians personal server, or it might be that theyre actually querying a database thats remote that can be updated again on nightly basis, or would be available to a physician in real time. I think the vast majority of organizations download that information onto the physicians server.
DR. HUFF: And do you have any recommendation for the committee on the format that would be used for downloading that formulary information?
MR. AVEY: No, I dont think Im the right person to ask that question, I think youll have to talk with other folks that have greater understanding of that process.
DR. COHN: Thanks. Jeff, youre next and then Marjorie --
MR. BLAIR: Before I ask my questions I want to make sure that my understanding is correct, otherwise my questions are irrelevant. You do not gather, my understanding is that you do not gather formulary information, what you gather is the information from the pharmaceutical manufacturers that enable the PBMs and the payers to decide what will be in the formularies they create. Is that a correct statement?
MR. AVEY: Its a correct statement but I need to make sure that you understand one thing, the only way that a pharmaceutical company can disseminate that information is if it is specific to the requester, so our foundation doesnt touch it, we dont actually ourselves request that information, it has to be requested by the specific organization thats evaluating the mediation. The FDA is very clear on that, they dont want these dossiers just out in the public, they want it sent directly to the individuals who are evaluating that drug.
MR. BLAIR: Right, so what you have done with AMCP is youve set up criteria so that the information that will be provided to the PBMs and the payers will be more scientific then they have been before --
MR. AVEY: That is absolutely correct.
MR. BLAIR: So that the decision that the PMBs and the payers make about what goes into their formularies should become more consistent and defensible, is that correct?
MR. AVEY: That is absolutely correct.
MR. BLAIR: Okay, now heres my question then. In the three years that you have been providing this very constructive helpful service has there been any observation or measurement that in fact the PBMs and the payers have moved towards either greater uniformity or consistency in terms of their formularies they create?
MR. AVEY: That is an outstanding question, and the answer to it is we dont know. Its very difficult for us number one to gather information on who exactly is using it. As I gave you some data, those are the organizations that actually have let us know that theyre indeed utilizing the guidelines. But heres the rub, the problem is just because somebody says theyre requesting dossiers doesnt really tell us exactly how theyre utilizing them. It doesnt tell us what rigor theyre going through in that evaluation process. We actually are in the process of doing a formal evaluation that does exactly what you just described and that is to help us understand at the end of the day have we really improved the process or did we just improve the information passing phase of it, and thats a very good question.
MR. BLAIR: One thing that I think might be helpful to the committee, or Health and Human Services, is when you get the results of that and it does show the areas where theres greater consistency in the formularies or in the structures of the formularies or in the decision making criteria that the PBMs and health plans use to create the formularies, that would be helpful information because that might then provide a foundation for some future development of standards for communicating in the formulary information to the prescribers, it would be input, it would be background base information, so that I think would be helpful. Do you have any idea when that information might be available?
MR. AVEY: I think that we could have some preliminary information available within a year. The kind of evaluation were talking about will be extended over probably the next two years but well have some preliminary information within 12 months. So were happy to share that information back with this committee, and quite frankly wed love to see a more formalized process and adoption take place.
MR. BLAIR: And I wasnt implying in my question, for those folks that are here from PBMs and health plans, I was not implying that all health plans and PBMs select the same drugs for their formularies, I think all Im looking for is if we can standardize either the communication of the formularies or the structure of the formularies to prescribers so that they can more readily understand what drugs they can prescribe and if they want to ask for preauthorizations that we could expedite in a balanced way, in a balanced way, how and when exceptions to the formularies could be process, then that would improve the e-prescribing process.
MR. AVEY: Mr. Blair, you actually have encapsulated what our concept was all along, we did not intend to dictate to anybody what their formulary decisions were, what our attempt was was to standardize at least the evaluation and to standardize the information that an organization should look at in order to make that decision. And our attempt was to make sure that we were doing the best job of evaluating the medications, the decision making process is left up to the individual organization.
DR. COHN: Steve, thank you. Marjorie and then Judy.
MS. GREENBERG: Thank you. Actually my question I think follows nicely on this discussion of standardization of the evaluation process. I noticed in the list of elements that youre recommending in this sort of evidence based review that you included outcomes broadly and specifically functional status information. And I wondered if you are recommending standards or some kind of methodology or information systems or whatever to collect that information, this is an issue that weve discussed in the national committee and is quite, and in the Quality Workgroup, etc.
MR. AVEY: There are many areas of the evaluation where were breaking new territory and actually quality of life studies are relatively new. And probably not as accepted as some of the other areas of science because theyre far more subjective. It doesnt mean that they arent important but we need to have those folks who serve on P&T Committees to understand what a good quality of life study is and what a poor one is. We have the same problem with pharmacoeconomics, thats an area that is relatively new as well and not well understood by the average pharmacist or physician, which is why weve been doing these training programs for the last three years to bring the expertise level up. Were always interested in pursuing guidelines or standards that help make any of these studies more plausible and more acceptable. I dont think were into it far enough for me to state yeah theres a standard here that will help us in that process, but clearly thats the direction that wed like to see thing go because as we train professionals to look at the information the more standardized approach there is to those studies the easier it is to evaluate.
DR. COHN: Okay, thank you. Judy?
DR. WARREN: Stan asked my question.
DR. COHN: What?
DR. WARREN: Stan asked my question.
DR. COHN: Okay, thats fine. Any other questions from the subcommittee? Well, Steve, I actually want to thank you, I think its been a very useful conversation. Obviously I think we need to be all aware just in the subcommittee that this is sort of one level above how this information gets to the physician and clearly theres a piece here that everyone needs to recognize which is that its one thing to have that dossier, its another thing to figure out how that connects in with benefits and the type of programs youre offering and obviously thats a critical issue, all PBMs and all health plans do not get the same costs and contract negotiations with pharmaceutical companies, etc., and all this does impact final decisions about whats going to be in a formulary.
MR. AVEY: Right.
DR. COHN: Anyway, thank you very much.
MR. AVEY: Thank you, I appreciate it.
DR. COHN: Okay, now our next set of testifiers is consumer perspective and I guess I would ask David Chess and Allison Rein to come up and join us if you could, in front. While you work technically on getting the presentation up on the screen I obviously want to thank both of you for joining us. As I understand David youre from Project Patient Care, thank you for joining us, and Allison Rein youre from the National Consumers League, so thank you both for joining us. And David I think youre going to start out as soon as we can find the presentation.
Agenda Item: Consumer Perspectives - Dr. Chess
DR. CHESS: First Id like to thank you for inviting me to speak before the subcommittee and let me give you a little background on myself. I am an internist, geriatrician, a devoted caregiver, have been practicing for 20 years, and founder and executive director for an organization called Project Patient Care. And it is from those seats that I want to give you a patient perspective and a physician caregiver perspective.
I have personally used e-prescribing for approximately four years so I dont know if theres anyone else out there in this audience who has but I have actual, its been between myself and my patients for some time now. And clearly I believe it is an important technology and an important innovation for improving patient care. As you already know e-prescribing has the potential to make our prescribing system safer, more efficient, and may ultimately save money. E-prescribing can markedly decrease errors inherent in physicians handwriting and pharmacy interpretation and transcription of prescriptions. It can immediately alert physicians to drug interactions, allergies, can tell us when patients have filled and refilled their prescriptions to improve compliance. E-prescribing will be an important part of our EMR, our information, our health record for the individual patient, and it will be an important tool for quality assessment and improvement.
Like most tools with great promise theres also a significant opportunity for abuse. When a physician is applying an e-prescribing tool he or she is not alone in the room with their patient, there is now a third party. This third party can potentially influence the physicians prescribing. E-prescribing is in fact, at least potentially, the most effective way for affecting physician prescribing behavior out of any tool yet far implemented.
It is an efficient avenue for government, pharmacy benefit managers, and managed care organizations to markedly influence what is being prescribed for their members. One can easily envision a physician with a patient in an exam room prescribing what he or she decides is the best remedy for that individual, putting the prescription of choice in the Palm Pilot, and a screen that pops up notifying the physician that the medication needs to be pre-approved by the managed care organization, and on the same screen some alternative medications that are preferred by the managed care organization popping.
Alternately the screen may automatically steer the physician to an approved medication limiting choices that the physician may make through this device. And alternately again the screen may just flash preauthorization required, call 1-800-preauthorization. These barriers, these levels, will significantly impact what physicians prescribe and Im sure that everyone here will understand that. Doctors will not pick up the phone on a routine type of basis to get a preauthorization.
Pharmaceuticals represent about 17 percent of the health care budget. The ability to influence how a physician prescribes has massive financial consequences for companies with a vested interest. Currently there are many ongoing efforts to influence physician prescribing behavior. What distinguishes e-prescribing is a remarkable efficiency by which this application can effect physician prescribing behavior real time. This again may be good or bad. There are surely physicians who could use the help. The concern is based on the motives that drive the development of formularies. Most medication formularies are economically driven and do not take into account individual patient needs. Our concern is that we are creating further barriers to individual patient care and in fact making it more difficult for physicians to care for patients and for patients to receive the treatment that is in their own best interest.
This is particularly important for chronic conditions and for people with multiple active conditions. As our society continues to age chronic disease and co-morbidities become the rule, not the exception. Individualized prescribing will be increasingly important. Our concerns have been reinforced by a recent study sponsored by Project Patient Care, the potential cost and burden of restrictive formularies, which looked at the impact of restricted prescribing on people 50 years and older, all with insurance, and we also queried the physicians who cared for this subset of people, all of who had a chronic disease.
What we found was that in this study of over 1,000 participants, the study was performed by Harris Interactive, we found that over 12 percent of adults 50 and older with chronic disease undergo a medication switch per year, thats approximately 8.9 million people when extrapolated. Of these people who underwent medication switches, Im not going into the details of this slide only because its not particularly relevant to this conversation, but of the people who did undergo a switch we found that 30 percent had some adverse reaction, either 13 percent the medication didnt work, or 22 percent that was an untoward side effect.
We then dug deeper and we asked what happened to these 30 percent of people. And we found that 58 percent reported that the incident, that the switch resulted in either a moderate to severe event and it was the premise that it was going to be mainly minor side effects but thats not what was reported. When we then dug deeper and looked to see what happened to the 58 percent of people who had moderate to severe interactions we found that of those 30 percent, 33 percent of them required an additional medication to treat the side effect, 18 percent required an urgent physician visit, 14 percent found themselves in the emergency room, and 11 percent reported hospitalizations. The N on this becomes insignificant and it may be off by a factor of four but even at a factor of four youre talking about hundreds of thousands of people being impacted by formularies who have chronic disease.
Now the striking thing here frankly, and I just completed a review of the literature with David Nash(?) over at Thomas Jefferson, is that the amount of study that has been given to the impact of formulary in people with chronic disease, people who are seniors, as we roll out a prescription plan for our nation, is microscopic. And thats why this is of concern to me in that --
MR. BLAIR: Could you repeat that sentence? I didnt quite hear that, what is microscopic?
DR. CHESS: The amount of study that has been done of the effect of formularies, in switching people from medication to medication in people with chronic disease has not been studied as a system change.
Our health care system is a study in contrast, we expend enormous sums of money trying to prove the efficacy of a given treatment yet we rarely study how changes in the system impact on the product, patient care. Other industries study the processes before full implementation so it fully understands its value proposition, the quality versus cost equation. An automaker knows that a small shift in the assembly line can have important consequences.
With e-prescribing we are about to markedly impact patient care. I am an advocate for this innovation, I am also worried about its abuse and how it will effect my ability to best serve my patients and ultimately our community. I ask this committee to put patient safety first, patient safety demands that we study the impact of e-prescribing on patient care outcomes, that we establish guidelines to ensure that this new technology will not be yet another barrier to care.
I ask this committee to be wary of not creating another fissure between physician and patient as a third entity enters the examining room.
DR. COHN: Thank you very much. Well have questions and discussions after weve had the other testimony. Allison?
Agenda Item: Consumer Perspectives - Ms. Rein
MS. REIN: I will apologize in advance, while the National Consumers League is highly supportive of efforts to become electronic it is usually our approach to communicate to people at a very basic level so I dont have anything for you to look at, I should have brought a picture of my dog but youll just have to bear with the blank screen.
My name is Allison Rein and Im the assistant director of food and health policy at the National Consumers League. Im here today to share with you some of the ongoing efforts underway at NCL and to provide a patient oriented perspective on electronic prescribing. Ill begin my comments with an overview of NCL and the SOS-Rx Coalition and its current activities in the electronic health domain.
The National Consumers League is a private non-profit advocacy group that uses education, research, advocacy, investigation, publications, and public/private collaboration to accomplish its mission of representing consumer interests on marketplace and workplace issues. Formed in 1899 we are the nations oldest consumer organization committed to protecting, representing, and advancing the economic, social, and health interests of consumers. For over 100 years NCL has provided government, business, and other organizations with the consumer perspective on social concerns including child labor, privacy, food safety, and health care. A natural extension of this mission is our recent initiation of the SOS-Rx Coalition.
The Coalition is a collaborative one thats dedicated to promoting outpatient medication safety initially among seniors. Convened in 2003 by NCL with support from Express Scripts as founding sponsor the purpose of the Coalition is to make the outpatient use of medications safer. To ensure that the work of the Coalition drives real change in the health care system our voice is national and our actions evidence based. The Coalition represents more then 60 organizations from a broad perspective from the health care field including patients, consumer groups, academic research institutions, government, payers, providers, pharmacists, pharmacy benefits managers, employees, or employers rather, and pharmaceutical companies.
SOS-Rx has chosen to focus on initiatives aimed at promoting consumer actions and system changes that enhance the safe outpatient use of medications. From the outset the Coalition considered how best its members could contribute to the dialogue without replicating efforts already underway. Furthermore, the Coalition did not wish to serve as, or be perceived as, a standards setting organization. Rather Coalition members expressed a strong desire to educate patients and then harness the force of an empowered consumer to advance broader health system change.
I know that this audience is acutely aware of the current limitations in our health care system, it is economically inefficiency, administratively burdensome and complicated, and too often yields unwanted clinical outcomes. We have many data points to suggest that some action must be taken to improve upon the status quo. Adverse drug events occur in five to 18 percent of ambulatory patients each year and preventable medication errors cost an estimated $2 billion a year in the U.S. And while electronic prescribing initiatives have demonstrated significant gains in patient safety, communications, and overall efficiency, only ten to 16 percent of U.S. physicians use some form of electronic prescribing.
Recognizing the need to consider the patient perspective in any solution the SOS-Rx Coalition has embarked upon four projects that either directly or indirectly empower patients to effect change. Of the four projects currently underway two warrant specific mention in this forum given their relevance to the issue of electronic prescribing and the potential it has as part of a broader health care paradigm shift to improve patient safety.
One ongoing effort of the Coalition is the development and promotion of a standard personal medication record template that could be used by patients to record and track all medication use. This would include prescription drugs, over the counter drugs, vitamins and herbal supplements taken regularly or sporadically. The guiding principle behind this effort is summarized as follows. Consumers should have a role in ensuring that a complete accurate and updated list of medications and supplements is available to all of their medical care providers so as to maximize therapeutic benefit and minimize the risk of adverse events.
The specific technologies required to make this happen are not the subject of this Coalition effort. We realize that technology ranges from paper forms to cards, electronic records, web portals, and beyond. These are merely the enablers. Our focus is on the role of the patient in making sure the specific outcome of an accurate medication list is achieved on a broad scale and in the near term.
Although the personal medication list would ideally be implemented as part of a broader personal health record the Coalition recognizes that incremental steps are needed. The fact that many patients interact with numerous prescribing physicians and receive medications from a variety of sources speaks to the urgent need to establish a hub for this information. To this end the Coalition has developed a paper based template that will be reviewed and tested on patients and eventually disseminated widely as part of an aggressive campaign.
The other relevant project thats been undertaken by the Coalition involves a two tiered effort to accelerate the adoption of e-prescribing, an initial phase of research and discussion has yielded a definition and an accompanying set of guiding principles that can be used to establish a baseline standard for e-prescribing that is patient oriented. As has been suggested in the report of the eHealth Initiative electronic prescribing is broadly defined as any system that uses a computer to assist in creating a prescription. This definition can encompass several options ranging from basic clinical decision support to a vastly preferred fully integrated electronic health record. The initiative further specified, and the Coalition supports this notion, that any definition must meet additional requirements and some of these include rapid adoption of implementable and usable computerized prescribing technologies, the ability to work in a variety of practice settings with a variety of existing IT infrastructures, encouragement of rapid development and adoption of standards to allow choice of systems and use of common services, encouragement in the creation and application of appropriate incentives and education, and preservation of the patient/physician relationship and choice in the delivery of health care.
As this project develops further the Coalition will consider additional patient focused criteria that must be met by any normative definition of electronic prescribing. An initial but not yet comprehensive list includes support of safe care, use of nationally adopted technology standards, compliance with best practices, patient access to educational and reference materials, patient access to a complete medication regimen, enhanced communications, for example renewal requests and compliance reminders, portability across all systems regardless of provider, pharmacist, or insurer, and maintenance of patient privacy and trust.
MR. BLAIR: Excuse me. For my benefit could you please reread that list slowly.
MS. REIN: Sure, sorry. Support of safe care, use of nationally adopted technology standards, compliance with best practices, patient access to educational and reference materials, patient access to a complete medication regimen, enhanced communications, such as renewal requests and compliance reminders, portability across all systems regardless of provider, pharmacist, or insurer, and maintenance of patient privacy and trust.
Given the task of this committee we ask that you also acknowledge the critical nature of workflow standards as well as technology and data standards in determining the uptake and successful use of any electronic prescribing system. If we truly want to empower consumers then we will need to create a system that is highly attuned to their needs and that does not create tension between patients and providers. For example, if patients are going to be encouraged to promote e-prescribing then we will want to ensure that some of the following needs are addressed.
First, the patient must be able to instruct their provider to transmit a prescription to any pharmacy they choose regardless of which vendor created the system. Anything less will result in more work for the physician and less satisfaction for the patient. Second, any e-prescribing capability must make it possible for the interested patient to review his or her medication list and update it before any electronic prescription transaction occurs. This ensures that patient efforts to maintain an accurate list are not undermined by implementation of the e-prescribing system. The same information should be available to the physician and in both cases should be accessible by PDA, cell phone, PC, and/or some other medium.
Third, any e-prescribing system must enable patients to self report minor and major adverse drug reactions as defined by standards. Physicians also should be able to incorporate this information into the patients medication record. And finally, and decision support rules must be able to distinguish between information submitted by patients and information submitted by a provider.
These suggestions do not represent a comprehensive list but rather highlight the need for any workable system to incorporate patient needs and preferences into its design. Many of these needs and preferences may be revealed in the second phase of the effort which involves a collaboration with eHealth Initiative. Working together the Coalition and the Initiative plan to identify patient touch points in the continuum of care that are effected by the prescribing process and chronicle the benefits that can accrue to patients through use of e-prescribing. Having gone through this exercise the group will recommend strategies for communicating these benefits to patients as part of a broad campaign. However, before embarking on a patient education campaign that sells patients on benefits of electronic prescribing the SOS-Rx Coalition believes that it is critical to take a step back and consider a broader spectrum.
That is, we need to address the current consumer demand problem that stems from the public misperception that there is no problem with the status quo. Many Americans may be generally aware that there are flaws in the current health care system, and some even have personal encounters that undermine their faith in that system. But most do not fully appreciate how frequently medication errors seriously effect patient health.
One proxy for consumer awareness is the extent to which an issue is covered in the popular print media. Those in this room likely have read numerous reports in peer review publications outlining the potential benefits of e-prescribing but how many patients have even heard the term let alone have a knowledge base to provide rudimentary definition or describe how it might actually benefit them. To demonstrate this the Coalition commissioned a content analysis of e-prescribing media coverage in consumer publications between October 1st 2003 and July 20th 2004. In total fewer then 20 stories covered the topic and most of these were business journals oriented to industry analysts and not general consumers.
Obviously much needs to be done to educate patients about this issue. In implementing its campaign the Coalition plans to develop messages that will help patients understand both the risks inherent in the current system and the potential safety benefits that could accrue with adoption of electronic prescribing. Of critical importance however is the notion that we do not want to do this in such a way that scares patients into inaction. Rather, we hope to provide support to patients by integrating use of a tool, the personal medication record. If patients feel educated and empowered with a tool that is immediately at their disposal to improve their safety then it is more likely that they will have a positive response to the campaign.
In addition it is the Coalitions hope that through adoption of this tool patients will not only have to take, have taken steps to improve their own safety, but will have compelled their providers of care to recognize at the personal patient level the benefits of e-prescribing. In taking this approach the Coalition has redirected lobbying tactics for achieving electronic prescribing. Instead of focusing efforts solely on the physician through incentives and education the focus is turned to the patient. As more and more patients learn about the flaws of the current system and the incredible benefits of e-prescribing more and more physicians will be compelled to consider such options.
Despite the promise of improved patient safety that this campaign may yield the Coalition acknowledges that several issues will need to be considered as it moves forward. To maximize the success of the campaign we will need to identify and segment approach via patient targets, conduct further research to gain a better understanding of patient perspectives, perhaps conducting an evaluation of current understanding as well as the wants and needs for an e-prescribing system. We will need to convert the e-prescribing concept and information into a language that people can actually understand. And we will want to partner with other private and public entities to broaden dissemination of the campaign messages.
Ultimately the National Consumers League and the SOS-Rx Coalition believe that through a dual process of educating patients and providing them with useful and appropriate tools it is the patients who will have the greatest influence in promoting the rapid adoption of electronic prescribing. It is with this consumer focus that we hope to drive electronic prescribing standards development.
Thank you.
DR. COHN: Well, thank you both for very interesting and hopefully useful testimony. I know the subcommittee has a number of questions, I think Jeff had already indicated to me that he wanted to lead with the questions. Are there others that have questions? Okay, Jeff youre on first.
MR. BLAIR: Thank you both, it is really helpful that we have this important perspective included among all of the testifiers that weve been receiving. Allison, you have mentioned that its important to have workflow standards --
MS. REIN: Yes.
MR. BLAIR: Youre not the only one that has suggested that to us but Im not aware of a workflow standard. Do you know of one that could be made available to us?
MS. REIN: I dont know of a particular standard, what Im suggesting by some of the points is that we need to establish them --
MR. BLAIR: Okay, so it needs to be developed.
MS. REIN: Yes.
MR. BLAIR: Okay, and I gather that NCL SOS-Rx intends to participate in that or contribute to it or support it, is that correct?
MS. REIN: Yes, I mean as I mentioned at the outset were not a standards setting organization in a technical sense but we do hope to in our collaboration hit upon all of the touch points for patients in the continuum of care and ultimately figure out where the process needs to go and then we would provide recommendations along those lines.
MR. BLAIR: Normally Im not in the mode of being a cheerleader but let me go ahead and wind up indicating that I think your initiative is extremely important and one of the things that has been absent in standards, accredited standards development organizations that create standards for information technology in health care is theres little or no representation of the consumer viewpoint. So I would like to encourage NCL SOS-Rx to make it an objective to send representatives and participate in the standards development of accredited standards development organization for health care information technology. It would be a wonderful contribution if you could make sure that the consumer view is represented.
MS. REIN: Thank you, Im sure we would be very, very happy to do that.
MR. BLAIR: And if you need any guidance on that theres a number of people on the committee and other people in this room that could help identify the different accredited standards organizations that are working in this area that could benefit by your participation.
MS. REIN: Thank you.
MR. BLAIR: Dr. Chess? I think you made a very appropriate case for concern that there might be abuse by payers in terms of the criteria that they use for establishing formularies. And I felt perfectly comfortable with the points that you made about the possibility of abuse from that sector. I think that when we hear from the payer viewpoint theyre concerned about abuse or if not abuse maybe neglect or lack of concern by health care providers in prescribing drugs that may not be in a thoughtful manner where there are appropriate lower cost regimens available or that there might be in some cases fraud. So I get the impression that your concerns are valid and their concerns are valid, so what Im going to get to is Im giving you the premise of my observation here and then Ill ask my question. Given that the concern of abuse is valid in both areas have you given some thought to the standards that might be appropriate for the display of a formulary that could at least make the motivations of both sides transparent a la how should the formulary from the PBM or payer be displayed? What is the structure, what is the content, that is shared between the two entities? Have you done any work on this or considered this or is there someone we could refer to that might help us to look at standardizing the format communication and/or display of formularies to prescribers?
DR. CHESS: Thank you for your question. There are actually two parts to the answer as I see it. Number one the concept of abuse is interesting, I dont think that the vast majority of physicians out there will consider their prescribing methods to have anything to do with abuse. They may have preferences, they may be influenced in different ways, but the vast majority of physicians that I know, and Ive put together a 70 doctor group in Connecticut so I know a lot of doctors and Ive had tons of interactions, dont work on that level. However, like managed care in the early 80s where there was massive promise for doing better for our consumers, for our patients, for ourselves, it has fallen far short of that dream and it is mainly motivated by dollars at this point. It has become another company. And so we can have our dreams and our wish list about what e-prescribing can do but I think were going to be enormously naïve to think that the dollar will not massively influence how you are taken care of by your physician. And a lot of this will be transparent to the patient because the doctor is going to be looking at this here and the patient is not going to see that there. So I think that theres an important backdrop here and its not about good guy or bad guy, its not about that at all, its about human beings, organizations, everyone wanting to survive and do the best they can for themselves.
As I see it the responsibility that we all have here is to create guidelines to help guide the system and I would be delighted to, there are many specific ideas in terms of since Ive used the technology of how to make that interface both informative and not a barrier to care, and there are ways to do it that are relatively simple. And there are Sure Scripts and others who are doing it in a very thoughtful way at this point and it may not be the way were doing it today, its what happens as the dollars get turned and the opportunities for more profits are there.
So Ill be glad to speak with whoever wants to hear me about specifics of how that can be done but thats not a problem. The biggest underlying problem frankly is that we continue to make changes in the health care system without appropriately studying its impact. Ill give you a wonderful example of this, the gatekeeper, in order for you to go see your specialist for how many years did you have to get approval from your primary care physician. Do primary care doctors ask for this anointed position? We did not, this was something that was brought on by health care companies saying that we need to control specialist utilization. 17 years after implementation, after many of us added personnel to our staff to be able to make those referrals and live within the system, all those gatekeepers have disappeared, theres hardly a health care company out here who uses it and guess what they found, it wasnt cost effective. It is not fair and it is not right and its not right for patients to implement policy without studying its impact. All these things effect the ability of patients to get care. And with chronic care it gets amplified. When a person is on multiple medications that formulary may not work and we just need to make it that it works for individuals, that there are easy ways to document exceptions.
Im not saying that we dont need guidelines, Im not saying that I personally believe that this whole piece can be a wonderful way of improving care, monitoring and feeding back to physicians in terms of standards of care, but again it needs to be framed in a way that is not driven just by the dollar and we need to do these studies up front before we implement a massive change in our system. And if were not going to do that we at least need to set up simultaneously significant studies so that three years down the line we have some data so we know what to do. Formulary itself is not a bad thing but Ill make you a bet for certain subsets of medications it is bad, but the studies have not been done.
So again, Im not for or against anything except I want the best for my patients.
MR. BLAIR: We need better information, the studies need to be done, yes --
DR. CHESS: We need to study things just like General Motors does, just like Proctor and Gamble does for their toothbrushes before they put out a new toothbrush, they know when they change the system of development what its impact is going to be. Were making a substantive change here, and I believe a very potentially wonderful change, but we need to do it with real study --
MR. BLAIR: Sensitivity to the fact that if we dont do it carefully and in a transparent manner there could be abuse by one side or the other. Is that fair?
DR. CHESS: Correct.
DR. COHN: Okay, Jeff, thank you. Judy and then Harry and then I have a couple questions and Michael.
DR. WARREN: This is for Dr. Chess. It really kind of follows up on Jeffs thing, when you were giving testimony I was really struck by the passionate way you described with e-prescribing being the third party in the room, in the exam room, and how that would effect your relationship with the patient. My understanding is is before e-prescribing you still had a third party in the room but it was a piece of paper, which was the formulary that you had to prescribe to. So now Im trying to understand the caution you want the committee to take in looking at standards.
DR. CHESS: The reality, and we did a survey of physicians, is that it is unusual for a physician to go look for a piece of paper to find out whats on that patients formulary, there are too many out there. In my community there are a dozen different HMOs each with their own formulary. We dont know them, we dont go looking for them, I prescribe what I believe is in the best interest of my patient. I may then get a phone call from the, in fact this slide here looks at how people get switched from the medication that theyre on to an alternative medication and there are three different methods. One is they have been stable on a medication and theres a call from Medco, or theyve changed health plans or the health plan has changed formulary and they come to you and say this is going to cost me $30 dollars, if I get this it will cost me $10 dollars. And so theyre already stable on something and you switch them, thats the majority, thats the ten percent bar.
The next is when I write the prescription and then the person takes it to their pharmacy and the pharmacist tells them that this is going to cost them $100 dollars, if you get this it will cost $30 dollars, and then the pharmacist calls me, or the patient calls me and a discussion ensues. And then the third way is while Im writing the prescription a conversation about economics occurs. Those are the three ways that we identified that those changes occur. But we dont sit there with a piece of paper looking, we dont focus on whats best for the pharmacy, for the pharmaceutical company or for the HMO or for the PBM, were considering the side effects and the benefits for that individual patient and I believe thats the way the majority of physicians, and the data that we have speaks to that, that is how most doctors work.
This will markedly change that, in fact there was a study, I dont remember exactly where I saw it but approximately 40 percent of prescriptions, the efficacy of switching from the PBM point of view is about 40 percent and the main driver for it is the fax machine as of today. With this device it will markedly change and they expect compliance with formulary to go up into the mid 90s, so its the efficacy of this intervention that is going, that has the potential to markedly impact patient care.
DR. WARREN: Im still not really clear what your issue is in us recommending standards because were looking at providing more information to the physician at the point that theyre writing the prescription.
DR. CHESS: The issue is not standards, the issue is what the interface is, its how its done and how and if it creates barriers for the physician to prescribe what he or she believes is in the best interest of their patient. It is not having a window that says this is the preferred and these are the different dollars involved if a person has that. Its the easy override of that because I know thats whats in the best interest of my patient. And in fact that may be a good thing because it cuts out a phone call from the pharmacist because Im writing the more expensive thing for you and this is why, so that conversation ensues.
DR. WARREN: Then what youre speaking more about is some of the workflow standards that Ms. Rein was talking about.
DR. CHESS: Right, but those are guidelines, those are going to be guidelines in terms of what a PBM or what government or what a health care company is allowed to put on that face. Are you allowed to put required to call this number? You do that you are markedly impacting patient care.
DR. WARREN: My last question is for Ms. Rein, you had talked about having the patients accessing their own medication record and being able to update that and things like that. How would you see that happening, would that be like a web based tool or have you not --
MS. REIN: I think that eventually thats the direction we would like to see and it would be part of a broader health record thats accessed. But I think were a long way of seeing the vast majority of consumers having access to those types of tools. So the way were approaching it initially is I see the trajectory for our two projects, the personal medication record and the electronic prescribing as moving in tandem. So I think initially were thinking of a paper based system for that personal medication record but eventually the electronic prescribing system should be able to incorporate in those elements for patient access and it could be through the same media that are used by the physicians as by the patients.
DR. WARREN: You kind of see that as an add-on to e-prescribing sometime in the future? That that would be part of the process of the patient participation?
MS. REIN: Its something we feel very strongly that patients need to be able to access, they need to, we need to start somewhere so were starting with paper saying they need to keep track of it. But in terms of moving forward with electronic prescribing they need to be able to access that information otherwise the decisions that are being made by the clinician may be done without full information and I think what were trying to do is mitigate the likelihood that you have adverse events and that you have fully informed patients and fully informed physicians. I have a couple of colleagues in the back of the room who might have something to add on this. Andy or Will, do you have anything to --
MS. GREENBERG: Come to the microphone please.
DR. COHN: And Andy, please introduce yourself.
DR. BARBASH(?): Im Andy Barbash, Im a neurologist, I actually work with the SOS-Rx initiative while still practicing and doing other things. A basic premise I think is to understand that the project to engage consumers in their role in the management of their medication list in many ways were that to be accelerated and become part of our standard operating culture, it would potentially have a big impact actually on things that happen within the e-prescribing world. So were envisioning that as a process in educational outreach and beginning to develop a much more standard assumption on the part of the larger fraction of consumers in this country that they have an active role and responsibility in ensuring, just like all the doctors in the room know, people walk in with a piece of paper, that that becomes more of a standard operating behavior. So realistically the way to start that is to work with the kinds of tools and technologies and methods that people have available today, for some people thats a web portal, for some others its cards, and others its paper. The important thing is developing a standard understanding of what is the nature of the information that the consumer has the greatest knowledge about and what role did they play in that process. Were that to become more of a standard part of our culture that can come well in advance of the broad adoption of electronic prescribing but it would end up actually having an impact on some elements of electronics prescribing. Is that helpful? And relatively brief for me.
DR. COHN: Thank you Dr. Barbash. Are you done Judy? Okay, Harry.
MR. REYNOLDS: Kind of controlling the care for two senior adults Im well, your testimony brings back many fears from this year where we had two drug incidents and almost lost somebody.
The issue that I see thats our job is most of the standards that have been set forward or most of the things that have been done in the health industry have been back office. We are now moving the back office in the front room together very closely in the patient care and as health care gets more complicated education is key. So if both of you can step back, which Im having to do right now from the personal situation of having seen some of these things occur so I agree with much of what you have to say, and help us take a look at e-prescribing can be a way of sharing information, it should not be a way necessarily telling people how to, consumers how to do what they do or doctors how to do what they do or payers or anyone else. So our job is to have to step back from that both personally our own environments or anything we do to try to create these standards.
So if each of you, and especially to Dr. Chess, the idea of things like the prior approval or the things that since youve done e-prescribing, Ive got 150 questions for you and Im going to ask one, but I think the key thing is since you have used e-prescribing, when you mention things like prior approval and you mention other things, what are the things that you have used in e-prescribing that are pluses, and on things like prior approval which probably going forward there will still be limitations whether on what is or isnt covered in the industry period for a while until things sort out and until more information is available and so on.
Now Ms. Rein from your standpoint you mentioned incentives and you mentioned access to education material, if you could go a little further on what youre thinking about on both of those as we do this. So, Dr. Chess?
DR. CHESS: The e-prescribing tool that I used, actually the company recently went out of business, so Ive been without my toy. But number one the first thing that had to be done to make it workable was they had to electronically download all my patient data into it and they did that. They loaded it with all the pharmacies in Connecticut that I might be using so that was already loaded on there. And it was, I mean I actually dont have a copy of it here but I have it on my Palm and its just very, very simple, you need a preauthorization to get into it so theres security there. And then it was a very rapid easy to find, all the meds were there and you just scroll down, you hit what you want, and once it had the patients information it would, if there was an allergy it would pop out allergy, it was there was a potential drug interaction, if the person was on Cumadon(?) and on something else it would pop that out for you right up front before you send it. It also had formularies in there but it had no barriers, it was all informative so at this early stage there was no push, it was just education. So I mean I loved the tool.
And then what happened is we did all of our refilling on my medical assistants computer, that was also on the same web channel, and so I downloaded all my stuff on that machine so the background stuff, information on the patient is there. When the patients meds are refilled we know its been refilled, when it hasnt been we get a report every month of who hasnt filled their medication, so we can then follow-up with a phone call and say are you okay, whats going on. Or pull the chart and say oh yeah, we DCd that medication. So as a patient quality tool its a great tool. And you have to understand, Im not here to stop progress, Im here because Im an advocate for it, I just know like every tool out there it can be abused and this is our opportunity to frame it in a way that it can be used quickly, easily, and improve office efficiency and improve care.
MR. REYNOLDS: So what did the formulary have on it that made it come across to you as helpful, not a push?
DR. CHESS: Once I chose the medication, and lets say the person was on a Blue Cross plan, it would flash that persons Blue Cross plan, it would say formulary, within formulary, or if its not it would say not in formulary and give me choices of what was formulary. So if it was a medication that it didnt really matter to me I would just pick something that was on formulary. If it did matter to me I would then talk to the patient and say listen, this is what your insurance company pays for, this is what Id like to do. So there arent any surprises when the person gets to the pharmacy. But again, it wasnt going through a lot of different screen, it wasnt advertising, it gave me the data to have an intelligent informed conversation and thats what I would like to see built in as our standards.
MR. BLAIR: Could I ask for a little more elaboration on this? Harry, could I share your question a little bit? So here was information from PBM or health plan providing a formulary to you that you felt comfortable with and what would happen for example if you wanted to prescribe something that was not in the formulary and you had to ask for a preauthorization, what mechanism did they have there?
DR. CHESS: There was no preauthorization in the system.
MR. BLAIR: There was no, was that a frustration to you?
DR. CHESS: No, it was wonderful because then I just prescribed what I wanted to prescribe. And then again it becomes an issue, the economics here is that we all can pay out of pocket any time we want, its our health and it is not, sometimes we choose to get what we believe is in our best interest and not what is the cheapest or what the PBM thinks is. So what it allows me to do is have that conversation with the patient up front that this is what they want me to prescribe, this is what I want to prescribe, this is what my concerns are, and its the persons individual health, they get to make that choice. But that machine doesnt restrict me from sending in that prescription.
PARTICIPANT: I have a quick follow-on question, when you did receive information of whether or not a drug was on or off formulary did it specify the degree of cost sharing if it were?
DR. CHESS: Yes, it usually had dollars signs, if it was three dollar signs it was a lot, if it was two it was, so that was kind of how they broke it down.
PARTICIPANT: So it wouldnt differentiate between say a $20 dollar or a $50 dollar co-pay?
DR. CHESS: It didnt give that degree of detail but I would welcome if it did, that would be fine.
DR. COHN: I think Im up next unless Harry you have a final, Im sorry, Allison.
MS. REIN: Sure, your question was about incentives and education and I think that what we plan on doing will address those. I dont have unfortunately answers because we need to do research with consumers and we need to figure out that workflow spectrum on the continuum of care where consumers are going to be interfacing with electronic prescribing. And theyre currently engaging in some kind of behavior and we want them to exchange that behavior for something that is going to benefit their health, so we need to figure out what the compelling arguments are going to be to convince them to do that and so whatever messages we come up with that communicate incentives are going to hopefully capture those elements and then we would provide the educational materials in support of that. I could envision there being a lot certainly with the personal medication record, encouraging use of that and providing them with the support materials needed to do that.
DR. COHN: Let me just ask one or two quick questions here and I just want to warn everybody we have five more minutes before we adjourn for this session so well try to keep it brief. David I was actually going to ask you, I mean we already had about five questions about this, you talked about sort of principles of formulary but if you have any further thoughts wed obviously welcome a communication, a letter from you about any other thoughts you had though I think based on what Im hearing, principally what youre describing is a level of transparency and I think if you had your rather you wouldnt have pharmacy plans constructed in a way where they required preauthorization but Im not sure Im hearing a whole lot more then that. Am I about right? Am I close to it?
DR. CHESS: Thats correct in the other piece and I know its not the purview of this committee but we have accepted formulary as a carte blanche being acceptable and we need to go back and question that premise and say that yes, we need to do the studies to know its good for this group of medicines but it may not be good for this group of medicines. Is it good for antidepressants, is it good for cholesterol medicine, is it good for high blood pressure medicines, and the answer is not the same for all of them, weve data that really raises red flags. We need a whole lot more study out there to look at that because again, this is a tool thats going to push everyone into formularies.
DR. COHN: Okay, well David I guess I live in a world where as far as I know most everybody does have a formulary of one sort or another, at least in the managed care world, and I guess the data you showed me didnt tell me that one shouldnt have formularies, its more that they should be intelligently constructed. Now let me just ask a very quick question about your research because I notice it all labeled as unpublished data. Obviously this is stuff that I mean I think is interesting, obviously I would tend to believe it more if it had been refereed and published, is this going to be coming out and will others --
DR. CHESS: We have an economic analysis of the data that Ive done with Marilyn Moon, that should be coming out, were sending it into JAMA, whether theyll accept it or not I dont know but we are working on getting that published. And then the data itself has only been delayed by my own laziness, I confess.
DR. COHN: Under those circumstances I would have a hard time faulting you just because I think we all have that problem. I guess in all of this as I look at this theres quality issues, theres economic issues, and I think that recognizing the economics is just not a health plan issue, its really a consumer issue, because its how much the consumers have to pay in terms of cost shifting and new products, its how much really comes out of their monthly dues and all of this. But I guess I was sort of seeing underneath all of this that there may be an economic argument the health plans and PBMs should consider.
DR. CHESS: Thats exactly right, what a lot of this is just taking it from this pocket and putting it in that pocket, its all silo medicine here, silo economics, and thats really the point of the work that Ive done with Marilyn, Marilyn Moon, and that will be coming out shortly.
DR. COHN: And we would certainly welcome quick publication of that so we could sort of further review it. Michael and then Steve and then hopefully well take a break.
DR. FITZMAURICE: Thank you, I enjoyed the testimony, its always good to hear from consumers and I think youve registered well your concerns for patient choice and patient safety and your advocacy for more research on health system changes on policies. But Judys question and Harrys questions got me thinking about which is better, to have a formulary that guides, restricts physician choice, or to have the drugs tagged with their out of pocket cost to the patient so the patient and the physician can reach a mutually informed choice of benefits and costs. Obviously the goal is to increase the effectiveness of the drug decision making process and improving patient outcomes while as Simon said constrained by the out of pocket cost to the patient. So the question is should the national committee advocate a standard that permits transmitting, or permits access, to the effectiveness, the side effect, and the patient cost information to this prescriber at the point of the time from the prescribers making that drug decision making choice? And then secondly, should we be looking at a standard that allows the prescriber to communicate to the pharmacy why that drug was chosen for that patient? Either one or both.
DR. CHESS: It would be wonderful to have a real data repository that had head to head comparisons of the medications that we use. Those studies are extremely rare, the only one thats come out was the recent one, Lipitor versus Provocal(?) and they will never do that again, that is just not research thats done. So if youre going to have something that is reliable and not just opinion were going to have to, we have a lot of catch up work to do. So in terms of really having a comparative efficacy chart that doesnt exist to date so thats the problem there. And again, thats why there needs to be really substantive research. As we get older and were setting up the system for all of us here, were all patients, were all on stuff and were going to be on more stuff, so Im not sure I answered your question but if it was available then I certainly would think that that should be a part of it.
MS. REIN: I would 100 percent echo that but just add that that seems like an awful lot of information to be conveyed both to a physician and a patient and the medium would have to be, it would have to be conducive to understanding at both levels and I think that would be a real challenge.
DR. COHN: Okay, Steve?
DR. STEINDEL: First I have a comment and then my question, when you mentioned there was only one study, Im aware of another study which was the diuretics study versus the other forms of hypertensive medication.
DR. CHESS: That study is different because its not, its generic versus other generics in other types of medications. What usually the question becomes is it between a Vasotec or Lycinopril(?) or Prinivil or all these in the same class and theres no head to head between them. That was comparing a separate class of medication with other classes --
DR. STEINDEL: Which actually leads me into the question that I was planning to ask because I got a little confused on your responses to several of the questions looking in a broader case. And we had a very large conference here in Washington last week that introduced the stakeholder framework for health IT over the next ten years and one of the key drivers for that system is the widespread introduction of electronic health records broadly to all providers. And also implicit is that is decision support systems that would come up and talk to the providers. And information on formulary and formulary content can be viewed as one part of a decision support system and I was confused on at times I heard that you were in favor of these types of systems and at other times I felt that you were not. And if I can summarize what Im hearing is that when they provide the proper information based on proper studies youre very supportive of them. Is that a fair assumption?
DR. CHESS: Thats 100 percent correct.
MR. BLAIR: When Steve was referring to your decision support, that is drug to drug interactions, drug to allergy, drug to lab, thats --
DR. CHESS: Its algorithms, I mean EMR is not foreign to me and this is part of my world frankly. And I have, I welcome that type of, were all human beings, we all forget things, we all need triggers and reminders and if it helps me do my job better Im all for it. At the end of the day though I need to make a decision about the care of my patient and it may mean taking risks that are not what the textbook say is the best channel but thats what I need to do and I dont need barriers to do it.
DR. STEINDEL: Thank you for that clarification.
DR. COHN: Well with this I want to thank both of you for really whats been a fascinating panel, we are despite my --
MR. ROTHERMICH: May I make a comment?
DR. COHN: Sure, if you make it brief because were going to take a break.
MR. ROTHERMICH: We have our turn tomorrow so Ill keep it brief. Phil Rothermich with Express Scripts. I wanted to just take issue with a couple of points that were made about formularies being driven by economics because theyre not. As AMCP pointed out these formularies are developed by P&T Committees which are composed of pharmacists and physicians who take their obligations very seriously. Economics are used to break the ties, when research thats out there suggests that two drugs are equivalent the lower cost alternative may be on formulary and the less efficient medication may be considered non-formulary. But this process is about providing information at the point of care, its not about changing the allegation of the physician to make the correct decision and as Dr. Chess pointed out the conversation between the patient and the physician can be about making those economic choices and about making them in an informed manner. So this shouldnt be considered a referendum on cost management tools because I think we all understand there isnt enough money in the system to give everybody everything and theres often the case where there are equivalent choices, things go generic and utilization drops dramatically because samples are no longer available and physicians needs to be reminded that what was once a wonder drug is still a good drug and a good choice to begin with when you have no information about what the patient will or wont tolerate. And so I just want to make sure that we stay clear to the mission that no one is suggesting that e-prescribing be used to make incorrect decisions, its all about making informed decisions.
DR. COHN: Thank you.
DR. CHESS: Can I comment?
DR. COHN: Sure, David, go with your final comment.
DR. CHESS: I agree with everything you said but theres, first of all there are thousands of formularies out there and one company may be doing it in a way that has more integrity then others. And again its a free market economy so thats one point, that theres tremendous variability in how these formularies are formed. Number two is that you cant show me data that says that formularies save money because the data is not out there. When you look at the whole continuum of care, the whole, that youre just not increasing hospital costs, that youre just not increasing long term care admissions, and thats the type of studies that have not been done. So you dont know whether or not formularies help our health care system contain costs. I think that they can if theyre done intelligently but I dont think we have that information.
DR. COHN: And thankfully I guess I would observe that under the MMA actually there are formulary discussions going on a separate track literally as we are probably meeting here to sort of figure out how the Part D formulary is going to be structured and what the categories are going to be. So obviously we have a piece of it but theres obviously, we are not ourselves responsible for actually the formulary, we are responsible for trying to identify ways to get that information in the most useful way possible to the clinician.
Anyway with that I want to give everybody a ten minute break, were running a little bit over but not badly. And I want to thank the people for really a wonderful session.
[Brief break.]
DR. COHN: Okay, would everyone please be seated? Okay, our next presentation is really from the Federation of State Medical Boards and I want to thank Lisa Robin for coming and joining us. I dont know if youd like to introduce, yourself further or just start your testimony, your choice but we obviously look forward to your testimony.
Agenda Item: State Boards of Medicine - Ms. Robin
MS. ROBIN: Alright, thank you. Well good morning Mr. Chairman and members of the committee, Im Lisa Robin, vice president of leadership, government relations, and policy for the Federation of State Medical Boards. The Federation is a national non-profit organization comprised of the 70 state medical licensing and disciplinary boards of the United States and territories. As such the Federation is positioned as a leader in medical regulation and an authoritative source of research, policy development, education, and information. The Federations primary mission is to improve the quality, safety, and integrity of health care by developing and promoting high standards for medical licensure and practice. We also assist state medical boards in achieving their statutory mandate to protect the public. As a collective voice for state medical boards the Federation monitors state and federal legislative initiatives, works collaboratively with federal and state regulatory agencies, and offers legislative assistance to and on behalf of our member medical boards.
Regarding the subject of interest today the internet has had a profound impact on society including the practice of medicine and pharmacy, and offers opportunities for improving the delivery of health care. The appropriate application of this technology can enhance medical care by facilitating communications with physicians and other health care providers, refilling prescriptions, obtaining laboratory results, scheduling appointments, monitoring chronic conditions, providing health care information and clarifying medicine advice. However, the practice of medicine, including prescribing and dispensing medications via the internet, has created complex regulatory challenges for state medical boards in protecting the public.
The Federation of State Medical Boards has actively been involved as a national leader on the use of telecommunications and the internet in the practice of medicine for a number of years. In 1996 the Federation published a model act to regulate the practice of medicine across state lines. In 2000 it published guidelines for internet prescribing. In 2002 it published model guidelines for the appropriate use of the internet in medical practice, one of the first national standards established for internet medical practice.
Those guidelines, which the Federation recommends be adopted by state medical boards, emphasize the key interest of the Federation with respect to internet pharmacies and the use of the internet in the practice of medicine as follows. An appropriate relationship between the patient and the physician must exist before a prescription is written and medication dispensed. Failure to have an appropriate physician/patient relationship poses serious health risk including adverse drug reactions and/or interactions, misdiagnosis or delay in diagnosis, failure to identify complicating conditions, and the misuse, abuse, and diversion of prescription drugs including controlled substances. In addition to issuing model guidelines the Federation has aggressively sought to identify internet pharmacies that are dispensing drugs on the basis of prescriptions written by health care providers whose relationship with the patient does not appear to meet minimal standards.
In 2000 the Federation established the National Clearinghouse on Internet Prescribing to collect and disseminate information on rogue internet sites, those sites that offer both prescribing and dispensing services for prescription drugs to consumers based on an online questionnaire. The Clearinghouse is unique qualified to coordinate information between regulatory and enforcement entities because of its formal relationship with all state medical boards and its well established lines of communication with state and federal regulatory agencies, including the Department of Justice, the Drug Enforcement Agency, Food and Drug Administration, and the Federal Trade Commission, as well as the National Association of Boards of Pharmacy, the National Association of Drug Diversion Investigators, and the National Association of Attorneys General.
To date the Clearinghouse has supplied information for more then 150 cases on the federal level and more then 300 cases on the state level. The Federation strongly supports state based regulation of the practice of medicine. With regard to internet prescribing state medical boards have the authority to discipline licensed physicians prescribing and dispensing medications inappropriately. 39 state medical boards have already taken actions against licensees. 26 have adopted rules and policies, and 14 states have introduced legislation to clarify this authority. In addition state medical boards are communicating among themselves regarding physicians licensed in more then one state. These cooperative efforts have been effective in closing several internet sites and causing a number of physicians to cease their affiliation with questionable operations.
The Federation has also supported the development of federal legislation to protect patients ordering prescriptions over the internet. H.R. 3880, the Internet Pharmacy Consumer Protection Act, and its companion bill S. 2464, which are currently before Congress, would provide significant protection for consumers who use the internet to obtain pharmaceuticals. H.R. 3880 addresses three issues crucial to the protection of patients ordering prescriptions over the internet.
First, patients should know with whom they are dealing, the bill requires an internet pharmacy to disclose the name and location of the pharmacy that is dispensing the drug as well as the name and licensing information of the physician providing the medical consultation on which the prescription is based. If a physician wrote a prescription on the basis of an online questionnaire without having any preexisting relationship with the patient then almost without exception a state would find that such physician had violated practice standards. Therefore disclosure will not only be beneficial to patients but will allow state medical boards to identify individuals against whom they can take a disciplinary action.
Second, state attorneys general are not able to enjoin the operations of an internet pharmacy that effects citizens in their particular state if that pharmacy is operated out of another state. Many of our member boards believe that a number of internet sites that dispense drugs in an inappropriate manner could be shut down if the attorneys general had nationwide injunctive powers as well as the ability to pursue other civil remedies, including damages, restitution, or other compensation across state lines. The bill authorizes those injunctive powers.
Third, while state boards have the authority to discipline physicians who are prescribing and dispensing drugs over the internet inappropriately the boards cannot take action against operators of internet sites that dispense drugs. While state medical boards believe that the law and regulations governing the physicians in their state are clear as to what constitutes an appropriate physician/patient relationship for purposes of writing a prescriptions some courts and prosecutors believe that certain state laws and regulations were ambiguous in this regard and thus failed to pursue certain legal actions. H.R. 3880 addresses this ambiguity with language which strikes a reasonable balance in requiring and defining an appropriate physician/patient relationship for the narrow purpose of regulating internet pharmacies while recognizing the exclusive role of state medical boards in defining that relationship under other circumstances.
In its model guidelines for the appropriate use of the internet in medical practice the Federation addresses physician use of electronic communications and the internet in the delivery of patient care. Pertinent portions of the guidelines are as follows. Treatment and consultation recommendations made in an online setting, including issuing a prescription via electronic means, will be held to the same standards of appropriate practice as those in traditional or face to face settings. Treatment including issuing a prescription based solely on an online questionnaire or consultation does not constitute an acceptable standard of care. A documented patient evaluation including history and physical evaluation adequate to establish diagnosis and identify underlying conditions must be obtained prior to providing treatment, including issuing prescriptions electronically or otherwise. Physician offices should have written policies and procedures that address privacy, health care personnel who will process electronic messages, hours of operation, types of transactions that will be permitted electronically, required patient information that should be included in the communications, archival and retrieval, and quality oversight mechanisms. Sufficient security measures must be in place and documented to assure confidentiality and integrity of patient identifiable information. All patient related electronic communications, including patient/physician email, prescriptions, lab results, evaluation, and consultations should be stored and filed in the patients medical record.
In conclusion the internet offers tremendous opportunities for improving the delivery of health care and can be convenient for patients and cost effective. However, it is the position of the Federation that use of the internet in providing medical services, including prescribing and dispensing medications, should supplement and enhance but not replace the crucial interpersonal interactions that create the very basis of the physician/patient relationship.
Thank you for the opportunity to testify today and Ill be happy to answer any questions.
DR. COHN: Lisa, thank you. Do you want to introduce the person --
MS. ROBIN: Yes, this is Eddie Allen and hes the Federations Washington representative.
DR. COHN: Okay, thank you for joining us. Jeff, I know you have a question and I think I have, okay, Jeff.
MR. BLAIR: Thank you, Lisa, I think what the Federation is doing with respect to internet pharmacies is very important and very helpful. Has the Federation looked at all at issues related to e-prescribing between prescribers and retail and commercial pharmacies?
MS. ROBIN: No, we have not, actually the scope of the Federation is limited to the physicians practice and protecting the patients in this area.
DR. COHN: Jeff I think you sort of asked the question that I was asking which is whether they had any comments related to the Medicare Modernization Act and it looks like thats not something that either has been discussed by the Federation or at this point isnt within the scope of your discussions.
MS. ROBIN: Right, we just wanted to raise our concerns that there would be adequate standards in place that would protect patient information and ensure that theres an appropriate relationship between the physician and patient.
DR. COHN: Let me just ask about that one because Im actually looking at your areas and concerns, its actually sort of a novel, its an area that I havent really thought about. Actually thats not quite true, its an area that Ive thought about in a different context but it seems to me that really probably somewhere in our document should be a comment about a need for all of this coming out of an appropriate interaction and relationship between a physician and provider, which I think is really the basis of your concern here.
MS. ROBIN: Yes, and that there be appropriate licensure, that the physician would be licensed in the jurisdiction that the patient is located.
DR. COHN: I think thats very helpful. Steve?
DR. STEINDEL: Just a quick clarification on the comment that you just made, do you mean the prescriber? Because in many cases in many states it can be somebody other then the physician.
MS. ROBIN: Correct, my comments would be limited to usually the physician because thats who state medical boards, but also in some states they have jurisdiction over other prescribers but it would be the prescriber, yeah.
DR. STEINDEL: Thank you.
DR. FITZMAURICE: I notice in your testimony that youre concerned about the physician/patient relationship and the internet pharmacies and the lack of relationship between a physician and a patient, or at least the prescriber and the patient. A lot of what you talk about though since a pharmacy could be one place, a prescriber could be another place, seems to be interstate commerce with these internet pharmacies and usually were getting into states versus federal authorities. And your response seems to be well lets give the state attorneys general national authority. Is there some point at which it crosses and you would say well maybe this is a role for some place in the federal government and Im not sure where that would be?
Secondly, you want the patient information to be put into the patients record, but some people have an idea of the electronic health record as being a website located wherever and physicians and hospitals and caregivers from all over feed information into that record even across state lines. So Im sensing a starting of the blurring of state lines and a discussion perhaps somewhere else of states responsibilities versus federal responsibilities. Has any of that been part of your thinking as well?
MS. ROBIN: Yes, as we have, and Eddie may be able to address this better then I.
MR. ALLEN: With respect to the jurisdiction of states attorney generals, our support of giving them those types of abilities really stems from the fact that the main tool to go after internet pharmacies in terms of statute now is the Food Drug and Cosmetic Act, which is a federal law but we are aware of the fact that the prosecutorial resources at the federal level may be limited particularly in certain areas. And so this would be a situation where the state attorney generals essentially would be able to supplement the activities of the local U.S. attorneys.
DR. FITZMAURICE: Let me follow-up with a second question and that is the role I see of all this is really to protect the public from this, and you talk about, youve identified rogue pharmacies and 14 physicians have been the subject of disciplinary actions, more then 150 cases and so forth. Is this information about how the rogue pharmacies are, which physicians have been disciplined, is that available to the public that were trying to protect?
MS. ROBIN: Yes, any disciplinary actions against physicians is public information. Weve worked with the Department of Justice and oftentimes that is not public information until after the cases have been closed.
DR. COHN: Other questions, comments? Im not sure that I have any questions either based on, I mean I think you had a very succinct testimony. I guess the only other piece I would ask from the subcommittees perspective is recognizing that we are obviously talking specifically about e-prescribing under Part D and this more general issue assuming obviously there is the appropriate physician/patient relationship. Obviously we would invite any written communication if you have further discussions with your state bodies just because some of them may have opinions on this that are not immediately obvious to us but as such I think well obviously take your testimony under consideration in terms of our report to the Secretary and CMS.
Is there anything else that we have at this point? I mean what this mean is likely we can actually adjourn early for lunch. Judy, I take back what I just said.
DR. WARREN: Well, no, its what you said made me think of something a little bit different. When youre talking about this relationship between the physician and the patient, and most of your testimony was about the internet pharmacies, is there any distinction between what happens in a telemedicine interaction with this and do you have any comments on that on where e-prescribing would fit within that kind of interaction?
MS. ROBIN: Well certainly and I think it does fit within the telemedicine arena and we certainly are supportive of mechanisms that would facilitate legitimate telemedicine practice. The difference between the internet pharmacies and the telemedicine is that patient records are available in a telemedicine consultation, those physicians would have access to information about the patient that he would be treating, prescribing, or providing medical services for.
DR. WARREN: So your main concern is in using the internet pharmacies that there can be prescriptions written without any access to patient information whatsoever?
MS. ROBIN: Yes --
MR. ALLEN: I mean the classic rogue pharmacy that were talking about is the one where the person has never had any contact with the pharmacy at all or with a provider regarding this particular prescription, he or she fills out an online questionnaire and on the basis of that a drug is put into the mail to that person and sent to that person, thats what we consider the kind of classic rogue pharmacy.
DR. HUFF: I dont know if this applies or not but do you have any, or have you had discussions about digital signatures or electronic signatures or any issues related to that that need to be in place for instance if somebody was prescribing inappropriately that would allow you then to uniquely identify and be able to prosecute somebody who was inappropriately prescribing? Has that been an issue of discussion?
MS. ROBIN: It was discussed among the committee that came up with these model policies and any system of unique identifiers would be helpful to the system and be helpful to medical boards or other regulators in identifying those individuals.
DR. COHN: Steve and Michael.
DR. STEINDEL: Your statement about the rogue pharmacies and your issue about them not having access to the patients medical records and just basing on a questionnaire, if we move on to what was envisioned last week here in Washington to the National Health Information Infrastructure where that information could be made accessible would your objections go away?
MS. ROBIN: The language in our policy, if the information about the patient was evaluated, available and evaluated, yes, I dont believe that our policy would make any distinction that there be a separate paper record, just so the information would be available and evaluated before treatment was given.
DR. FITZMAURICE: I guess your comments about the appropriate physician/patient relationship gives me a little pause and I guess my question would be does FSMB have a national definition of what the appropriate physician relationship might be because it seems that you have guidelines for a telemedicine relationship so thats video, you might have guidelines for a phone relationship, and then guidelines for an email relationship, at some point the relationship becomes so stretched or so not much of a relationship you say now there shouldnt be a prescription filled on the basis of this relationship. Do you have such a definition?
MS. ROBIN: We did not define the physician/ patient relationship and very states have defined it because its a fluid relationship, its basically, it is an offer and agreement for treatment between the physician and the patient. It doesnt have to be in person according to our policies, it could be a distance relationship, but there has to be some offer for treatment and acceptance for that treatment.
MR. ALLEN: But Lisas answer points up one of the problems which is that when youre in a situation involving a rogue pharmacy in the absence of there being a very hard and fast definition of what a patient relationship with a physician is prosecutors are reluctant to proceed for fear of not being able to prevail in court, which is why we signed on to a definition in this legislation that Lisa talked about for the limited purpose of pursuing people who operate these rogue internet pharmacy sites with a specific proviso in the legislation that for all other purposes the definition of what an adequate patient/physician relationship resided in the individual states.
DR. COHN: Jeff, I think you have a question?
MR. BLAIR: Yes, whenever Stan asks a question I always try to piggyback on it, its just a policy that I have. His question just brought up a thought, because he asked about e-prescribing, actually electronic signatures, and what occurred to me was youre concerned about whether or not theres either appropriate information or an authenticated prescriber involved in the process that evaluates that information. And e-signatures kind of gets to that in the sense that do you have a position, or have you examined the idea of using electronic signatures to authenticate that there is a board certified prescriber of some type that actually assumes the responsibility for reviewing the patient information, might be done electronically, where are you or what guidance or what thoughts can you share with us on those lines?
MR. ALLEN: I think a number of the individual states are looking at how to use electronic signatures and how those fit into the practice of medicine. The Federation has not provided guidance to the states on that.
DR. COHN: And I guess just maybe to paraphrase what I think Im hearing from you, I dont hear that youre having an issue identifying whos dispensing the medication or whos writing the prescription here, its really more a question that you have that its not a legitimate physician/patient relationship.
MS. ROBIN: Well, that they are a licensed physician and as far as --
MR. ALLEN: We eventually identify them but the fact is that if theyre hiding without any identifying information on a website that doesnt identify whose actually writing the prescription it takes us a whole to find out who actually, I mean it mean, its not until we get B. Smith on the package of pills that arrives in the patients home that we have any hint as to who this person is.
MS. ROBIN: We believe its critical that the patient have information as to where the physician or the other, or the prescriber is licensed, so in the event of an adverse outcome they do have a remedy, they know what state board, who has jurisdiction for that prescriber and where they may go to file a complaint.
MR. BLAIR: Let me clarify my question a little bit here. Remove the issue of whether electronic signatures is a mechanism here, what youre focused on is that the prescriber be identified, be licensed, and theres some authentication process that that prescriber is the one that reviewed the specific information for that prescription. Is that correct?
MS. ROBIN: Yes.
MR. ALLEN: Exactly right.
MR. BLAIR: Okay, then that probably becomes a set of criteria thats applicable whether it is an internet pharmacy or whether its e-prescribing.
MS. ROBIN: Yes.
MR. BLAIR: Thank you.
DR. COHN: Karen has a question?
MS. TRUDEL: I just want to clarify and I dont mean to put you on the spot but in the list of stakeholders that the Congress wanted the committee to consult was state boards of medicine. And what I think Im hearing as the bottom line here in terms of your general position on electronic prescribing is that electronic prescribing in and of itself when done as part of a physicians normal office practice does not generate any additional conduct requirements then if the prescription were being written on paper. And so I guess what Im kind of saying is it sounds like youre saying this is not a particularly critical factor from the perspective of state boards and I just want to clarify that.
MS. ROBIN: I would just make the point that e-prescribing should be held to the same standards as any other area of practice.
MS. TRUDEL: Okay, thanks.
DR. COHN: Any other questions? Okay, well I think were actually going to adjourn a couple minutes early, we will reconvene at 1:00, I want to thank our presenters for a very helpful session and well come back, give everybody a couple minutes over an hour and well see everybody back at 1:00.
[Whereupon at 11:56 a.m. the meeting was recessed, to reconvene at 1:00 p.m. the same afternoon, July 28, 2004.]
A F T E R N O O N S E S S I O N [1:10 p.m.]
DR. COHN: Were going to get started here for our afternoon session. Our first panel this afternoon is from the State Boards of Pharmacy and were happy to have, well, --
MS. ANAGNOSTIADIS: Ill help you out --
DR. COHN: Thank you, we were trying to practice and I think I would butcher it.
MS. ANAGNOSTIADIS: Eleni Anagnostiadis, Im the patient safety senior manager with NABP.
DR. COHN: Okay, thanks. And our other panelist is Carmen Catizone, 50 percent thats not too bad. I believe Eleni youre going to lead off. Oh, Carmen is going to lead off, okay, please.
Agenda Item: State Boards of Pharmacy - Mr. Catizone and Ms. Anagnostiadis
MR. CATIZONE: Thank you Mr. Chairman and thank you to the committee members for the opportunity to appear today and share some information with all of you. We represent the National Association of Boards of Pharmacy which is very similar to the Federation of State Medical Boards and our members are the jurisdictions that regulate the practice of pharmacy, the pharmacist and pharmacies throughout the United States. Our membership also includes New Zealand, Australia, South Africa, and eight provinces in Canada, so we have an international perspective as well.
Weve been involved in electronic transmission of prescriptions since 1996, weve convened various task forces, participated in various conferences, and in fact contacted CMS in 2001 after a task force convened and presented some information to CMS in regard to electronic transmission and the efforts of the State Boards of Pharmacy. At that time CMS responded back to us in February of 2003 and indicated that they were sensitive to the issues of the state boards and were anxious to work with us.
The primary document that we use in communicating or working with electronic transmission is a model state pharmacy practice act and regulations, which is a roadmap or guideline for the states. And early on the activities on the model act and what the states focuses on facsimile transmissions, although electronic transmission was a new concept the computer to computer processes and programs werent actually in effect and it was primarily facsimile transmissions of prescriptions, and even at that time it was limited to transmission of prescriptions.
Weve defined key terms that are relevant to electronic transmission, digital signature, electronic signature, and if computer systems which the states utilize have to have security systems for access and authenticating the prescriber, authenticating the pharmacist, and authenticating the patient information. So state regulations are very much involved in this area and have been very interested in whats happening federally and the new standards that may be developed.
Id like to turn it over to Eleni now who will talk with you about a recent survey she conducted of the States Boards of Pharmacy.
MS. ANAGNOSTIADIS: Regulatory activity regarding the electronic transmission has significantly increased in the past year closely associated with anticipated changes in the Medicare requirements and the expected initiative of the federal government to encourage that adaptation. In order to determine the extent of this activity and the similarity or variations among the states NABP recently conducted a survey of the State Boards of Pharmacy to determine which states actually allow for electronic transmission of prescriptions and to determine and identify challenges and/or barriers the states face in either developing regulations and/or implementing electronic transmission of prescriptions in their state.
We did learn that nearly every state does allow for electronic transmission of prescriptions in some form, as Carmen alluded to this also includes facsimile prescriptions.
A couple of the major challenges and barriers that came out of the survey results had to do with security and technology and Ill just list a couple, theyre bulleted in your handout, these are some of the things that the states responded to specifically. The lack of uniformity of security and safeguards used by companies. The actual security of the prescriptions verifying the authenticity. Electronic signatures versus digital signatures. Intervention by a third party, that is a software company perhaps having access to patient specific information. Forgery. And incorporating biometrics to assure irrefutability.
In the technology area the things that they mentioned had to do with the ever changing technology and sometimes the regulations, they cant change the regulations as frequently as the evolving technology so that was one of the barriers that they faced. One of the states also mentioned that the government process required to approve new regulations can be timely and sometimes it is an impediment in getting something like this passed.
In discussions that I had with Maria from CMS, who by the way did a phenomenal job in setting this up and we appreciate her efforts here, I asked her what might be of benefit to this committee and she asked if we could maybe do a side by side comparison of the various state regulations that had to do with electronic transmission of prescriptions. It was very difficult to do because its like comparing apples and oranges but I did attempt and in the back of the handout, and Im going to highlight some of these points here, but there is a comparison chart at the back of the handout and Im just going to preface it by saying it is not all inclusive nor is it comprehensive, its just to give you an idea of the different regulations that might, that you might find in the different states.
First Im going to point out some of the similarities among the regulations in the various states. Electronic signature and/or other secure method of validation is very high on the priority list of many of the states and they include them in their regulations. Nearly half of the states require some form of electronic signature and/or other secure method of validation. A few states, I believe its two or three, require digital signatures, however I will tell you Ive been in contact with one of those states who have said that theyre trying now to change the regulations to allow for electronic signatures, so theyre moving backwards and saying I think this is a cost of the technology thats available, they actually are going to address it in their next legislative session to alter that language to include electronic signatures. And roughly one third of the states do not specifically address this issue of electronic transmission or signature.
Im going to leave a copy of this with you, Carmen alluded to it earlier, this is actually the roadmap and model rules and regulations that the National Association of Boards of Pharmacy puts together that has to do with the practice act and regulations. This actually, we do define electronic signature and digital signatures in here and our recommendation to the state boards is to if a prescription is transmitted electronically that either an electronic or a digital signature accompany the prescription from the prescriber to the pharmacy. I will mention one thing, the Drug Enforcement Agency is the agency that is responsible for controlled substances and the allowance of prescriptions to be transposed electronically, however they have not come out yet with their regulations regarding what type of signature will be necessary in order to transmit controlled substances. So I would urge the committee to maybe have a conversation or dialogue with the Drug Enforcement Administration to see where they stand.
Some of the other similarities regarding what must be included on the electronic order, for example the transmitters phone number must be there for verbal confirmation, the time and date of the transmission, the identity of the pharmacy intended to receive the transmission, and also the authorizing agent. We must be able to track back who the authorizing agent is who allowed that prescription to go through.
And finally another commonality is the pharmacists ability to exercise professional judgment regarding authenticity and validity of the prescription. And those three commonalities are incorporated in the model rules and I do have, appendix A actually has some of that information there for you as well.
Im going to switch gears real quick and just talk about five core principles that we at NABP would like to see incorporated into a standard, or core elements. These principles were designed to assure that electronic transmission standards safeguard patient health, safety, and welfare. The objectives in the Medicare law are very similar to the objectives that we have, one, improving patient care and two, improving the quality of the care that the patient receives.
The first element is ensuring against unauthorized access, its really important that the integrity of the prescription not be compromised in electronic transmission of a prescription. The prescription shall be transmitted directly to a pharmacist in a licensed pharmacy of the patients choice with no intervening person having access to the prescription drug order. Any altering by an intermediary would adversely effect patient safety and is in direct conflict with state laws that were established to ensure the integrity of the prescribing process.
The second core element is the authenticity and security of prescriptions which I alluded to earlier, its important that either an electronic or digital signature or some method of validation to authenticate that prescription be part of the national standard. Privacy and patient confidentiality, everybody that was at the meeting last week I know understands that this is an issue, its greater then just electronic prescribing and its going to be even more important as we move towards the electronic health record. But the national standard should require that all entities that have access to any of the patient specific information comply with the HIPAA regulations.
Patient choice, the patient shall have the freedom of choice regarding the pharmacy at which their prescriptions are filled regardless of whether or not the technological capabilities are there. And finally the prescriber/pharmacist collaboration must remain intact. Its very important that the communication between the prescriber and the pharmacist is not hindered at all with the adoption of electronic prescribing. We see it as an opportunity to increase the communication between the prescriber and the pharmacy but its just important that the pharmacy have the opportunity to contact the doctor for questions about drug interactions or perhaps there may be allergies noted on the pharmacy prescription, the software system in the pharmacy, or there might be over the counter medications that the patient takes the doctor might not be aware of. So maintaining that interaction between the prescriber and the pharmacist is also key.
Now Im going to turn it back over to Carmen.
MR. CATIZONE: And to summarize and close I think what we tried to illustrate in our verbal presentation today which is presented more in depth in our written testimony was that the State Boards of Pharmacy have been involved in this issue since 1996 beginning with the use of facsimile transmissions and our perspective has been the public health and safety, so weve looked at issues like access to that prescription order, who should have access, who shouldnt, and the standards for the prescription format, standards for the quality of care that the provider should be delivering to their patients, as well as defining any entity thats involved in accessing those records and making decisions about that patients medication as being involved in the practice of pharmacy and therefore being required to be licensed as a pharmacy or as a pharmacy benefit manager, or as an entity thats practicing pharmacy in those states.
Weve not been as much involved in the technical standard portion of electronic transmission, weve deferred to the other standards setting organizations but weve worked very closely with them to make sure those standards are recognized by state regulation in some degree, and also that those standards dont conflict with state regulation or state security requirements for processing systems.
And finally were concerned about preemption, we understand the need for preemption of state pharmacy acts and regulations to avoid a disparity among the states and to provide some uniformity and to ease the interstate transmission and conduct of business, but at the same time we think there are some very good safeguards in the state laws that should not be preempted by any federal standards or any federal legislation. Weve been involved in the internet like the Federation, we have an accreditation program for internet pharmacies, we look at the transmission of data and prescriptions, and we also have a service where we notify states of pharmacies and pharmacists that have been disciplined, as well as collect consumer complaints in regard to internet transactions, internet adverse reactions.
And again in closing we would be glad to work very closely with the committee and provide you with any additional information or answer any questions you may have as you move through your process. Thank you.
DR. COHN: Thank you both very much, Im sure that we have a number of questions from the subcommittee. I guess I want to lead off with one or two here and one of them just to get some additional clarification from not your last sentence but probably two or three sentences back where you made a comment that sounded very good at a high level but I dont know exactly what it means about that there are certain things in the state regs that ought not to be preempted, and maybe you can explain that a little further especially in light I think of Elenis sort of comment that she believed that she reviewed the various state regs, that they were described as apples and oranges. So either give us some examples or give us some --
MR. CATIZONE: The principles which Eleni touched upon are the areas that we think shouldnt be preempted, the access to the medication record, the security, the confidentiality --
MR. BLAIR: Could you go a little slower and when you say these items could you, like access, access by who, please explain it fully, each of these.
MR. CATIZONE: The position which NABP has taken and which many of the state boards have taken in regard to access is that when that medication order or that prescription is transmitted from the prescriber to the pharmacy there should not be an intervening third party that would alter that medication or alter that prescription. If there is access to that medication to determine whether or not the patient is eligible for that health plan or whether or not that actually is the person within that plan or within a certain formulary, thats a lot different then changing the medication to some other product, thats the access that were talking about.
In terms of security some states do not even allow passwords to be used for computer systems for processing prescriptions because theyre concerned that the passwords dont provide the level of security that they feel necessary for some of those systems. Thats probably the extreme and not the position that NABP would take but certainly we would ask that you look at certain security provisions for accessing systems that are being used by prescribers and pharmacies for sending and receiving prescriptions.
And then the HIPAA privacy requirements and confidentiality laws, weve worked with the states to make sure that the state laws complement HIPAA and provide the extra assurances that may be needed that werent part of the federal act. So those are just some of the areas that we would have concern with.
DR. COHN: I think Jeff has a question and then Steve.
MR. BLAIR: Eleni, I believe you had the observation that theres some of the states that have backed off of digital signatures and are now finding electronic signatures acceptable. And are you able to give us a little bit more of a description as to how you or they define digital signatures versus electronic signatures?
MS. ANAGNOSTIADIS: Ill be happy to share what our definition is of digital and electronic signature. I dont know that theyre utilizing the same definition that we are but --
MR. CATIZONE: And as Eleni is looking that up, the problem that were facing at the state level with these definitions is were awaiting the federal definitions to make sure theres not a conflict. So weve looked at the FDAs definition of electronic signature which they accept as part of the drug approval process in those applications and were awaiting with the DEA is going to say in terms of their digital signatures. So the states have been on hold saying how do we define this, not knowing what the federal definitions may be and as Eleni reads our definitions theyve served as just a starting point for the states, maybe a holding pattern, to reserve a place in their definition sections for what may be forthcoming we hope soon from the federal government.
MS. ANAGNOSTIADIS: And before I share those definitions with you I am happy to supply the subcommittee with the results of the survey and one thing that I didnt mention just because of the time limitation was that a lot of the states did talk about the Drug Enforcement Agency and the importance of them getting out what their regulations are going to be for controlled substances. Because again, they dont want to go in and put electronic, change the regulations and the DEA say you need a digital signature, so there are some states that are on hold.
For Mr. Blair, electronic signature is an electronic sound, symbol, or process attached to or logically associated with a record, an executed or adopted by a person with the intent to sign the record. A digital signature on the other hand means an electronic signature based upon cryptographic methods of originator authentication and computed by using a set of rules and a set of parameters so that the identity of the signer and the integrity of the data can be verified.
MR. BLAIR: So in both cases, I may be reading something in here, maybe your thought on this, is it your opinion that in both cases whether its an electronic signature which from your definition, thats consistent with my perceptions of what they are too in that electronic signatures are broader and a digital signature is an electronic signature but not all electronic signatures are digital, thats one piece. But the other piece is it sounds to me as if they require, or they enable the identification of the individual signing it, authentication and non-repudiation. Are those the three elements that seem to be retained no matter whether they call it digital or electronic?
MS. ANAGNOSTIADIS: Yes, that is my understanding.
DR. COHN: Steve?
DR. STEINDEL: Yes, thank you, I have two unrelated questions, originally it was just to one of you but you both picked up on this. When you said that an electronic prescription should, the way it flows, the original words were used was it should not be touched by another person in the process. And then Carmen the way I interpreted some of your expansion of it, it might be we could have intervening computer systems involved with it, which arent persons, that could potentially change it and what really I was, the question I was getting to was are you really looking for some type of non-repudiation on an electronic signature and it really doesnt matter when intervening bodies come in the way. Because the person thing I would see fine because I can see the flow of electronic prescriptions going through various computer systems, so I was originally just going to ask a clarifying question on that but when you made the statement about potential changes, etc., which really could occur by a computer system. Is what youre looking for is non-repudiation?
MR. CATIZONE: Exactly, and in our model act we define person as any entity, including both an individual, a corporation or pharmacy, so that term is much broader and in the sense of touching were saying one doesnt manipulate that prescription to be involved in the practice of pharmacy and secondly repudiation must occur.
DR. STEINDEL: Thank you for the clarification. My second question concerns this very nice list youve put together about state standards in this area. I notice a lot of them have some type of requirement for written retention, do you have any comments on that?
MS. ANAGNOSTIADIS: I think a lot of these, I cant tell you how recently these regulations were updated, I think a lot of these regulations were put into place years back before we had the every evolving technology and moving towards that, thats a concern or a light bulb that went off in my head as well if you have, for example, one state, and I apologize, I think I skipped over some of the variances, one state requires a pharmacist to verify and manually initial every electronic prescription. Well we know that if everything goes electronic at some point in time theyre going to have to change the regulation, its going to be almost impossible for the pharmacist to initial each and every one of those.
MR. CATIZONE: Many of those regulations were written as Eleni said when fax paper still came on rolls and it would disappear over time, so they havent been updated by the states.
DR. STEINDEL: I was confused, I live in Georgia and I was confused whether a prescription could actually flow electronically because it seemed to require a written prescription as well.
MR. CATIZONE: Were talking George, were talking a lot different, Georgia even licenses PBMs so thats a whole different state.
DR. COHN: Okay, Michael?
DR. FITZMAURICE: Earlier this morning we heard from the Federation of State Medical Boards what a physician has to do to get disciplined for internet prescribing, essentially not have patient information or have only a questionnaire without ever seeing the patient. What does a pharmacy have to do to get disciplined for internet dispensing?
MR. CATIZONE: The basis for taking action against the pharmacies and pharmacists has been that theres not been a valid prescription as the basis for the dispensing of that medication to the patient, or that theyve engaged in the trafficking of diverted products by dispensing medications to patients without any prescriptions whatsoever, or that theyve dispensed unapproved products, particularly those that have been imported from Canada. And like the Federation the states are following that but the lynchpin is how you define what is a valid prescription which goes back to the Federation of the Medical Boards as to whether or not that involves a person to person interaction between the prescriber and the patient, or whether a medical questionnaire or cyberspace consultation will suffice. Our members in the state medical boards have said online questionnaires and cyberspace consultations do not constitute an acceptable standard of medical practice and our state boards have used that as a basis for taking action against pharmacists.
DR. COHN: Other questions from the subcommittee? Karen?
MS. TRUDEL: Im mindful of your statement of apples and oranges but Im also harking back to your statement about Georgia, are there any state laws where there are significant enough restrictions that we would be hard put to be able to implement e-prescribing in those states or that the restrictions would be so significant that it would be very difficult to get adequate uptake of electronic prescribing? And if the answer to that is yes then what would you propose would be a course of action in those states?
MS. ANAGNOSTIADIS: Without going back and actually looking at each state individually Id say there might be two or three states that would have difficulty in implementing electronic prescribing. I dont think its not something that we can overcome, were more then happy to talk with the individual state boards of pharmacy and a lot of times it doesnt reside with the board of pharmacy because they may agree with it but trying to get it passed within their legislatures, so its sometimes bigger then the board of pharmacy piece. But I dont think that any of these issues, challenges, or barriers are things that we cant work with the boards to help them overcome and if we say that this is something thats going to be done at a federal level, if you want to participate in providing these services for Medicare patients, then youre going to have to adapt to some of these changes.
DR. COHN: Margaret?
MS. AMATOYABUL: Can you address the variability of content in the sig by state? How variable it is?
MR. CATIZONE: Im sorry I didnt hear that.
MS. AMATOYABUL: Can you address the variability in the content of the sig?
DR. COHN: And you mean in the prescription right?
MR. CATIZONE: You mean what is required on the prescription? Again I would say the bulk of what is required is fairly uniform across the states and it mirrors the federal requirements. But as you move beyond the core requirements youre going to find variations that may require expiration dates in some states, that may require the pharmacists full name in some states, different ways to present the product, whether its the generic version or whether its the brand name product with the following substitutions. So those are probably a lot more numerous then we would like them to be and could be problematic if theres a standard format for e-prescribing that doesnt meet some of those state requirements.
DR. COHN: Any follow-up, Margaret?
MS. AMATOYABUL: Does your model include that or did the survey include that, the extent of variability?
MS. ANAGNOSTIADIS: No.
MS. AMATOYABUL: So we couldnt do anything, I mean we cant get at that information.
MR. CATIZONE: Sure you can, weve done surveys, we also have within our offices that we make available as a program that has all of the state laws and regulations on a computer program that you can access and weve run surveys on what the prescription formats are in the various states, wed be glad to run that and turn that over to the subcommittee for additional information.
DR. COHN: That would actually be very useful and probably sooner rather then later.
DR. HUFF: And just to clarify, I mean shes specifically talking about the signature line where you say two tabs four times a day, the directions to the patient line --
DR. COHN: Actually I think that she was referring to the entire, well, thats both, thats why I was asking her for correction because I didnt think it was the sig line, I thought it was the overall content that needs to be in the sig, well, in the prescription.
MR. CATIZONE: In our written testimony Eleni has outlined what the basic requirements are that weve advocated in our model act but if youre talking about the signature youre crossing over into a whole other area and its outside the scope because of the drug product selection laws and the medically necessary, those sometimes are outside the scope.
DR. COHN: I think the sig as were describe it is like QID, take twice after meals, whatever, but I think that what were really talking about is the overall data content that is required from state to state for a legitimate prescription. Margaret, do I have that right? Stan, are you okay with that?
DR. HUFF: Yeah, I would like the sig data but it sounds like its hard to get.
DR. COHN: Well, maybe thats part of it, is that if there is, but Im not sure anybody requires any particular content on sig level, I mean how they write it is all free text isnt it?
DR. CATIZONE: Well its based upon medical and pharmacy practice standards and what the accepted terminologies may or may not be, we now see that the Joint Commission, JCAHO, is saying that theyre trying to eliminate the abbreviations and the use of some of those Latin or other terminologies. So as that standard takes effect in the hospitals it will probably be developed or adopted by the states and those variations, those abbreviations will be eliminated and incorporated in the state regs also.
DR. COHN: Okay. Jeff, question?
MR. BLAIR: Karen Trudel asked a question about whether theres anything that youre aware of varying by state in terms that would limit e-prescribing. I sort of want to pin that down a little bit more, specifically do different states have regulations that effect either what can be done, what can be included in the formulary or anything about formulary information, preauthorization, or drug utilization review, those three things, are there issues in those three areas that have to be considered if theres federal adoption of standards for e-prescribing?
MR. CATIZONE: As Elena mentioned earlier electronic transmission of prescribing is probably allowed to some extent in all states. There are probably existing laws and regulations in the states now that are going to slow that process down or make it more burdensome in one state compared to another state. Ohio is an example of a state that I think is very highly regulated and has some very specific requirements for authentication, signatures, passwords, those areas that may impact electronic prescribing. If the federal preemption is broad and ignores some of the state requirements or the state laws that are in effect youll probably see a backlash from the states to try and gain some of that ground. But if a preemption looks at what are the good components of state laws, retains that but tries to help, tries to work with the state to eliminate those burdens, the more restrictive requirements, I think that approach will be much better. Theres nothing that we can think of that effects formulary or requires formulary decisions or prior authorization in the pharmacy practice act, they may be part of the Medicaid program requirements or some of the drug product selection laws within the states that are outside of the boards of pharmacy authority. The drug utilization review would fall within the state boards of pharmacy and states do have regulations that address that issue and what should be done and some of the record keeping that may be necessary for that activity.
DR. COHN: Other questions? Comments? I actually have one question, I just want to explore this just a little further, I think the full committee or one of its associate committees may very well have a hearing looking at privacy issues at some point in the future but having said that you did obviously bring up the issue of privacy. And it looks to me like you have principles that are certainly very appropriate privacy principles in terms of alignment with HIPAA, coverage by HIPAA in terms of this entire process. Are there any other concerns you have in relationship to privacy and e-prescribing that we should be aware of or take into account?
MR. CATIZONE: I think the other concerns or the other issues of privacy and confidentiality are already addressed in the state practice acts and would pertain to any medical record or patient record, whether it was transmitted electronically or via paper or via telephone, so those requirements are already in the state laws and acts, its just a matter of making sure that we complement what e-prescribing would ask for or what safeguards they would put in place rather then conflict with existing state laws.
DR. COHN: Okay, so I think this, make sure I understand you, I think what youre saying is is that youre at this point not concerned about privacy as it is right now, you just want to make sure that anything that goes forward doesnt inadvertently decrease the privacy safeguards currently intact.
MR. CATIZONE: Right, or decrease them to a point where the states wouldnt be comfortable with that lessoning of restrictions.
DR. COHN: Okay, great, thank you. Other questions from the subcommittee? Well, I actually want to thank you, both the amount of information and Im sorry I didnt have a chance to review your appendix in advance to look at the state variability but I suspect that we will have some additional questions for you as we begin to look through that and analyze it and certainly any additional information that you can provide us about any of this over the next several weeks would be certainly well appreciated, especially the relationship to the differences in content requirements from state to state on these prescriptions would also be very helpful as we sort of move forward to our first set of recommendations. Obviously I want to thank you both very much for really a wonderful bit of information.
MS. ANAGNOSTIADIS: I just have one parting comment, I had the privilege of attending the meetings last week which most of you were a part of and I just want to comment the committee for their enthusiasm and dedication to this cause. When I heard Secretary Thompson get up there the first day and said his expectations of a recommendation from this committee is the end of this year instead of next June I know how hard each and every one of you are working and we are more then happy to support you in any way that we can. Like I said Ill leave a copy of the model rules, forthcoming will be our survey results, and we will be happy to do that search for you regarding the prescription drug order. So if we can be of further assistance dont hesitate to ask.
DR. COHN: Thank you so much. Now our next panel is the payer perspective and we can ask Joseph and Charles Kennedy, Charles I can say his last name, Joseph maybe you can help me --
DR. RADUAZZO: It would be my pleasure, first of all its spelled incorrectly, R a d u a z z o, Raduazzo --
DR. COHN: Well, Im actually delighted that I didnt try to pronounce your name since I would have butchered it by definition under the circumstances.
DR. RADUAZZO: You most certainly would not have been the first nor the last.
I would like to thank the committee for allowing me to come and speak to you today, electronic prescribing is something that we feel very strongly about, as Tufts Health Plan and I do personally --
DR. COHN: You need to get closer to the microphone.
DR. RADUAZZO: Electronic prescribing is something that we feel is very much needed, this comes at a level of a health plan, as a provider, and also as the son of a pharmacist. And also when I came in this morning, or this afternoon and looked at the name on the outside of the building I had to chuckle because I dont know if all of you are aware but Hubert Humphreys chosen profession was pharmacy, he only later went into politics and had some success there as I recall.
What wed like to talk about today are the standards but I think more specifically in my case Id like to tell you about our experience at Tufts Health Plan with a pilot we did up in Massachusetts. This little background here, Americas Health Insurance Plans is a national trade organization for health insurance companies, there are 1300 member companies and those companies insure approximately 200 million Americans. Tufts Health Plan is an AHIP member, we are a health maintenance organization, we also offer a wide array of products to individuals through employer groups.
We undertook a pilot for electronic prescribing along with PocketScript, which is a company that has since been purchased by the Zicks(?) Corporation, and AdvancePCS which has since merged with CareMark(?), we however have kept our name over that time. The purpose of the pilot was to demonstrate that electronic prescribing technology could improve both the safety and efficiency of our process of prescribing.
I dont think Id have to try to hard to convince all of you that electronic prescribing is a necessary thing, a couple of things that you may need to know because as we move forward with standards and try to implement electronic prescribing we want to make sure that were accomplishing what needs to be done. First of all physicians need a great deal of help keeping track of all the medications on the market. Its been estimated theres 17,000 brand and generic medications on the market. There are approximately 1500 medications or new indications for existing medications that have been released in the past three years. The average physician deals with 16 insurance plans, thats at least 16 different formularies and multiple benefit designs for each plan. This is something that we cant realistically expect physicians to keep track of, theyre going to need some help. And rather then send them something in the mail or have them find out after theyve made a prescribing decision that it is not a formulary drug or theres a prior authorization, we feel its necessary to give that information at the exact time that the prescription is being written and thats what makes e-prescribing a very effective tool.
Now putting that aside there are a few other issues that the Institute of Medicine has raised, such as the 7,000 deaths a year from medication errors. Ocean Leap was recently quoted as saying that that is significant under estimation of the number of deaths from medication errors. An interesting statistics, you are ten times more likely to be admitted to an emergency room due to a medication issue then a car accident, so it puts some perspective on the issue that we have. And the American Society of Health Plan Pharmacists actually did a telephone survey and found that 61 percent of patients were concerned that they might get the wrong medication so we have a significant credibility issue with the system as it stands.
Now our pilot included 200 providers, we provided to them electronic prescribing software and hardware, the original pilot was set up with individual hand held computers that were connected through a wireless network within the office, much the way your wireless phone works at home, to a server that was in the office and was updated each night through the internet. That included information on formulary choices on prior authorization needs, on preferred drugs, also had some medication drug reference involved, and finally patient history. Now this is an important piece because the patient history allows physicians to see what other physicians have prescribed, unfortunately despite the technology thats available most physicians offices are working on 19th century technology and do not communicate very well, thus a specialist could write a prescription that the primary care physician would be unaware of. This is not a good situation.
The ability to get prescribed or adjudicated patient history allows a physician at the time of prescribing to review those drugs that the patient is actually taking and avoid potential drug/drug interactions. Using this technology physicians were allowed to send an electronic fax directly to the pharmacy, an electronic fax because at that time the rules from the Board of Pharmacy in Massachusetts did not allow for electronic signature, so thats I think apropos to the discussion you just had. That has since been changed due to the Mass Medical Society and several health plans working with the Board of Pharmacy, weve been able to now legalize electronic signature within the state of Massachusetts and that has made the process much easier.
Now when we look at the functionality, Id like to run through that briefly because it mirrors what has been suggested in the Medicare Modernization Act, patient eligibility, benefit design including prior authorization requirements, formulary information, medication history, drug/drug interactions were added at a later stage in the pilot, and allergy screenings are scheduled to be added at this time I think within the next month, physician alerts about drugs that have been discontinued, formulary changes, etc., has also been added. And also reporting functionality, this allows a physician to see whether or not members fill in a prescription as intended.
And when we move to the next slide youll see that we were able to by the use of this technology reduce prescription rejections because physicians and patients knew what the formulary was at the time the prescribing was taking place. We improved patient safety, as a matter of fact we decreased the number of errors that occurred because they were caught before the prescription was written due to drug/drug interaction or patient history information. We also were able to identify issues of non-compliance and youll three see examples up here, one of a diabetic patient that was not filling insulin, and not being up front with the physician about that. Another patient that was taking an incorrect dosage of a medication, doubling up on a pill that was potentially dangerous. And a third was identification of a patient that was in fact abusing a narcotic medication and not being truthful with the physician about filling this.
But additionally we noticed that there was a savings of at least one hour per physician per day in the office. This savings came mostly from the time involved with refilling prescriptions, which now is at the click of a button as opposed to calling the pharmacy with each individual prescription.
We also were able to poll pharmacists involved with this and found that it saved them about an hour a day of phone calls, and thats important when you consider that there are 150,000 phone calls a year to clarify prescriptions at this point. I cannot begin to estimate the number of phone calls involved with refills on prescriptions, I know that the 150,000 that was estimated probably is about twice as much as my office experienced a year for refills.
What about lessons learned? Well, we did find that we needed to keep it simple for physicians. Actually, let me skip ahead one slide and talk about that and then Ill move back to this first slide. Implementing an e-prescribing technology in an office is a bit labor intensive, theres training that needs to go on, it needs to be integrated with a practice management system that exists, so there is some up front work to be done. There are also workflow changes that must take place and that takes time. Physicians have traditionally been reluctant to change, or resistant to change, and I think its important to understand why that is. Most physicians are very busy, their offices are working to capacity, they do not have time to change what theyre doing unless its going to save them time.
Please no one quote this in the media but a very wise managed care executive in Massachusetts once said that free is not cheap enough for physicians, and he was not trying to suggest that physicians are cheap, he was trying to underscore the fact that time is at least as important to a physician as money. And that we need to make sure that these solutions are easy to use, easy to understand, and we need to be able to address their concerns about moving things into the workflow.
There are also security concerns for physician funding, the implementation of the HIPAA legislation, physicians are very concerned about what information they send or receive and how it happens. It is very important as you put together standards that the standards are compliant with the HIPAA legislation which I believe is in the Medicare Modernization Act, but also that it is very clear to physicians that this is the case, they are using an appropriate e-prescribing solution that they do not need to worry that they could potentially violate HIPAA.
State laws or regulations, I can tell you that in Massachusetts there are two issues, one was the electronic signature which has been resolved, another is the privacy act which does not allow physicians to see without the expressed approval of a patient, and this is a separate approval from the HIPAA approval thats required, to see any drug history on substance abuse, mental health, or HIV. Now that has caused us to limit what physicians can see in the patient history when they use our e-prescribing devices and I will tell you that their response has been quite negative to this. They feel it compromises their ability to safely prescribe and I would agree, many of those drugs have significant drug/drug interactions.
And as far as expense physicians as far as we can tell are not willing to foot the bill for implementing electronic prescribing, most physician offices do not have an IT budget, they are small business for the most part and do not have the money to invest in electronic prescribing. As a matter of fact our focus groups have told us that they feel they should be reimbursed to use an electronic prescribing device. Now I dont know whether the government has any plans to do that, I can tell you that at the present time health plans are considering it but weve made no move in that direction.
Let me move back for one minute, other potential barriers to adoption. Its our opinion that you should stick as close as possible to the standards that were put out in the MMA. The reason is that some of the other suggested standards such as laboratory data and drug interaction screening will require a merging of databases that currently do not merge, theres no opportunity at this point except in a practice that has a very sophisticated electronic medical record and has a very close relationship with either the lab that they use or the hospital which they work to integrate that level of data.
Given the fact that its difficult to get physicians to warm up to this technology because it represents a change I think the simpler the standards are the better. Wed like to make sure that the standards are straightforward enough that they could be applied evenly throughout the country. I would also like to suggest that the ability to change the standards be a streamlined process.
Technology is developing at such a pace right now very similar to say cell phones or any other electronic equipment, we are about to see RxHub come up online, SureScripts is up online, at this point in time if it takes a year to amend the standard as it does for the HIPAA legislation were going to have a problem keeping up with technologies that move slower. So I would implore you to find a way to create a very streamlined process so that we can keep pace with the changes that are coming.
As far as Americas Health Insurance Plans recommendations, and I will tell you that these are certainly in line with the feeling of payers, formulary benefit information should be available at the point of care, I think thats a given. I mentioned the streamlined process so that the standards can grow as the technology expands. I strongly suggest, and we strongly suggest, that a pilot be undertaken with these standards. We learned a tremendous amount from the pilot that we did working with only 200 physicians and I think as you approach mandating electronic prescribing it would be very helpful to do a pilot and Im sure that there would be ample opportunity to perform such a pilot.
The standards as we mentioned earlier should definitely be in compliance with HIPAA and not create additional administrative burden, and I believe thats specifically listed in the MMA, that there shouldnt be any specific or increased administrative burden on pharmacists or physicians. I think by allowing the standards to be in compliance with HIPAA and consistent with HIPAA then physicians who have just spent a great deal of time and effort in complying with HIPAA will find it much easier to use.
And also I think its important to understand what eHealth Initiatives are out there, I know that youve had representatives from the Mass Medical Society speak to you earlier, I believe Tom Sullivan came down, and he must have informed you about the interoperable medical record which is what theyre moving toward, the ability to take a medical record with you as a thumb drive or a smart card so that the patient is carrying his or her own record. Its important that as the standards evolve they allow that to happen, they also are consistent with electronic medical records which are being instituted in many of the large physician practices across the country, in particularly in academic medical centers.
That ends my part of the discussion, Ill be very happy to entertain any questions you may have.
DR. COHN: Okay, well have a conversation after both of you have presented.
Agenda Item: Payer Perspective - Dr. Kennedy
DR. KENNEDY: Good afternoon everyone and thanks for the opportunity to share with you what Wellpoint Health Networks has done in the area of e-prescribing. To give you a little introduction on Wellpoint, we are a health plan, we own multiple Blues plans, Blue Cross of California, Georgia, Missouri, Wisconsin. We also have another health plan called Unicare. We have a PBM with over 40 million members associated with it. And we have quite a bit of experience with the internet, we have multiple internet initiatives underway, we also reward our physicians for quality, in fact weve paid out over $50 million dollars for pay for performance quality awards to physicians who meet our quality standards.
Id like to spend some time with you today talking about our technology effort around a program we call our Physician Quality and Technology Program, which is our name for our e-prescribing program. We have a couple of other initiatives underway Id like to touch on, weve bought an outcomes research company and with that company we are launching a variety of studies to look at the effectiveness of clinical care within our network and Ill describe one of those initiatives to you and describe how it relates back to e-prescribing.
Theres three key messages I would like to leave with you however. One is that we feel that health plans should play a central role in the deployment of e-prescribing and electronic health records and I think through this presentation some of that rationale will become clear. Secondly, that the barriers to electronic health records and e-prescribing from our perspective are as much business model and business oriented as they are technical or standards based. And thirdly, that meaningful progress in deploying e-prescribing and electronic health record solutions will require a respect for and a focus on the payment methodologies that are currently in place and may develop over time, as well as a focus on recent advances in biotech and clinical research, as well as the leverage and use of the data that you capture through this new infrastructure and how we can actually use that data to either feed information back to physicians or come up with other business process or business structures that actually allow you to get the value out of the e-prescribing investment.
Our strategy in e-commerce as a health plan has generally revolved around administrative transactions and so on the left you see I think what is quite common for most health plans to have, which is basic functionality over their internet for their physicians to use. You could think of this almost as a front office function. We have now moved into a financial function, or perhaps a back office function, where we are beginning to allow our physicians to process claims over the internet via a web based link rather then traditional EDI mechanisms.
We then plan on getting involved with what I would call clinical administrative functions, these are things that a health plan does, they arent pure clinical e-commerce per se but they are administrative transactions that are more clinically oriented, things like ER notifications, if a patient that belongs to a particular physician goes to the emergency room that generates a claim that comes to us. We can deliver that message back to that physician so he is aware of it so those types of clinical administrative functions.
And then finally we plan to get into clinical support, i.e., actual e-prescribing services, actual outcomes research services, that help us, that allow us to help our physicians in our network deliver the highest quality care that they can to our members.
With an eye towards executing this strategy we have launched a rather significant program for us. We call it the Physician Quality and Technology Program and its intent was to in a very strong and meaningful way say to the physician community that we believe e-prescribing is important and were willing to put significant financial resources behind it. We launched a program that gave physicians two choices, they could either choose a handheld e-prescribing unit with software loaded on it for e-prescribing capabilities, it had a wireless hub and it had a subscription to an e-prescribing service for a one year time period. With this infrastructure physicians were able to get decision support at the point of care when they were making their prescribing decisions and all prescriptions were faxed to the pharmacy of choice. We believe that this was the package that we hoped that most physicians would get behind because this offered real opportunity to improve both the quality of care and reduce the costs.
However, we were well aware that if you look at the level of infrastructure in the clinical environment that many of these physicians would not be ready for such a package. And so we also deployed an alternative package, we called id the paperwork reduction package. And the idea here was to give physicians the option of getting a rather beefy desktop computer that they could use and access our websites, and really if they didnt already have high speed internet access, werent already sophisticated when it came to the internet, this was at least a first step in getting them more involved with the internet.
Our hope was that the majority of physicians would choose the prescription improvement package and that the minority would choose the paperwork reduction package. In fact it was just the opposite, almost 80 percent, greater then 80 percent of the physicians who were offered this package chose the desktop computer, about 15 percent or so actually chose the e-prescribing option and that was quite disappointing to us. Ill talk a little bit more about that later.
As we looked this was a very significant investment for the company and we had to come up with a variety of rationales to make an investment of this magnitude. And when we looked at the various vendors that were in the space, when we looked at the level of technical sophistication of PDAs, we believe that the technical infrastructure was not deployed but existed to be able to do this. When we looked at for instance the Tufts experience, deploying something like this for 200, 300 physicians is one thing, trying to roll it out to 19,000 physicians over five states is quite another. And so we were looking at it from the perspective of yes we believe that the technical and business and clinical case is there, that it adds value, but then when you think about how to scale this up so that a large health plan could actually take advantage of it, what are the types of steps you would need to take to be able to make that happen and thats where we focused a lot of our activity.
One of the things we did feel we were on fairly solid ground was that there were sufficient pilot successes to justify the $42 million dollar investment and I wont go through all of these but I will mention the CAQH study that indicated the 100 physicians that they studied for one year, about one out of 73 prescriptions were cancelled or changed due to either warnings of a drug/drug interaction or an allergic reaction. And when we saw that statistic and looked at the tens of millions of prescriptions that are written every year within our PBM and our health plan we saw a significant, we saw a significant foundation to make this investment.
There were a variety of places we could enter into the e-prescribing space, we could do something relatively simple like an electronic drug reference similar to what Hippocrates offered, no connectivity but simply had drug reference information on a handheld PDA. We chose to do something more complicated and yet have the potential for greater return then that and that was what Im identifying at step four, which is a solution that offered wireless connectivity via the internet to an ASP vendor, that ASP vendor is then hooked up to our PBM and also has an interface to the practice management system within the physicians practice. What this offers is sufficient functionality so that we think over time as we look for the results we should be able to see meaningful improvement.
So the points that Joseph made about being able to track a patients medication history, we are able to do that with our solution. We are able to get demographic data out of our claim systems as well as to the degree it exists from the practice management system.
This did add a certain level of complexity however, this wasnt something that we could just contract with Dell and have them deliver thousands of PCs to physicians across this nation. What this required was an engineer to actually go out to the physician site and work with them to look at what version of their practice management system they were running and whether they actually had an interface that was already built that they could then use to interface to these practice management systems.
What we found was that we required that all of our vendors be HL7 compliant, unfortunately what we found was that most of the practice management systems out there were not. Even if the current version is many of the physicians were running on older versions that were not HL7 compliant. What weve generally done to get around that is a batch download process where we get information on a periodic basis and we are requiring our vendors to write a fair number of custom interfaces so that we can support the volume of the physician delivery system that we would like. But this is definitely a problem, this has definitely slowed us down and definitely speaks to the need for standards.
Our approach around seeding the market, as we looked at our primary value proposition, which is helping our members have financial security when it comes to their health care needs, we are certainly well aware of the ongoing increase in medical cost trend. And we felt that a bold and alternative approach to trying to control those costs other then what a health plan traditionally does was required and it was that rationale that drove this rather significant investment. The primary problem we chose to address was the lack of infrastructure so our focus was get the infrastructure out in the delivery system so that we at least have a basis to do other things from.
We also anticipated several market impacts, one of them would be that competitive parody would force other health plans on board or launch similar efforts and in fact we are already cooperating with several of our competitors to get additional physicians and additional health plan data on board with our initial initiative. The other thing we found was that when you try to do something at this scale you need vendors who can actually delivery and the vast majority of the vendors we found in this space, we put them through a variety of tests. One was a financial wherewithal test, another was a level of technical sophistication, and what we found was that there was a very small number of vendors who could meet those two requirements. And even those vendors who could meet those requirements were accustomed to deploying tens to hundreds of physicians at a time, not the thousands of physicians that we were looking to deploy. And so by making an investment of this size we were hoping to have some additional market impacts around attracting additional capital to the marketplace as well as making a statement that we think that this is a market thats going to grow and worthy of further investment.
We also used Microsoft as our technology partner so that they could provide a level of sophistication and support. One of the concerns that we heard from physicians all the time was I get involved with one of these little companies and then they go belly up and Im stuck without a solution. And so by having Microsoft there to validate the technology as well as having our own business people go through the companys financials we felt we could reduce the concern that physicians would have about making a commitment to e-prescribing.
Let me just say that the opportunity to impact the vast majority of our member visits, I mean were a rather large health plan, but what we found was that because the use of our network is relatively concentrated with an investment of this magnitude we can actually impact about 19,000 physicians within our network. And when you look at the number of office visits that that represented, that represented almost 75 percent of the office visits that our members had. So 19,000, although a large number, is not an unwieldy number and is a target we feel can shoot for to getting our physician community fully engaged with e-prescribing.
This project was launched without any specific ROI per se and what I mean by that was it was a strategic investment because we did feel that something bold and something different on a large scale needed to be done. That doesnt mean were not tracking measures of success, however, and there are some very concrete and low level measures of success that we think we will be able to measure and show value. One of them is formulary compliance and another is generic utilization. We know from our data very well that a one percent increase in generic utilization equals about a half percent decrease in total drug utilization costs. So we feel there will be some very clear financial measures that well be able to track that will show the appropriate ROI on this investment.
We will also track measures around quality of care and we will be looking at some of the standard utilization metrics, admissions to the ER due to adverse drug events, or hospitalizations, as we roll out this solution to our physician community.
I would like to mention one other thing were doing which is weve acquired a company called Health Core which is an outcomes research entity. And I mention this in association with e-prescribe because we look at e-prescribing not as an ends to itself but as a foundation upon which we can build additional value for our members. One of the things were making a very significant push towards is outcomes research, and let me give you a very concrete real world example of why we think this has value. If you have a deep unistrombosis(?) and a blood clot in your leg and you look at the clinical trial literature, what it will say is that the appropriate therapy which is heparin and cumadon blood thinning , if you can keep the bleeding time in the appropriate range the clot dissolves and you have 100 percent recovery.
If you look at the clinical trial literature it will say that about 80 percent of the time physicians are able to keep the bleeding time in the appropriate range. And that about 15 percent of the time its too low, and five percent its too high. Well, we delve into our data, this is real world data that gives us information on how the physicians and patients within our network, whats the level and quality of care that theyre getting, and what we found was that only 38 percent of the time were physicians able to keep the bleeding time in the appropriate range. 15 percent of the time it was too low, and worst of all 47 percent it was too high. And the question we asked ourselves is are the outcomes equal, and the answer is no, we know that when it comes to bleeds from having your blood too thin the odds increase by ten percent for every ten percent of the time the bleeding time is too high, and for strokes because you didnt get rid of a clot, in this case in an HO fibrillation example, the odds increase by four percent for every ten percent of the time the bleeding time is too low. And theres clear cost implications to this, retreatment doubles the cost and complications increase the cost times three.
So by using our e-prescribing infrastructure that we are deploying and a variety of other efforts we have underway including capturing lab data from our lab vendors, linking that to the administrative claim data that we already have, what we are beginning to build is a comprehensive view of the clinical practices within our network. And what we would like to do is be able to feed that information back to physicians so that we can help them deliver the highest quality care that they possibly can.
Ill wrap up with just a couple of lessons learned. The biggest question we got from the physician community when we approached them was how big a commitment is this if I implement e-prescribing, and they were very concerned about disruptions to their office workflow, to having to close down their practice for this, there was a wide variety of business relationships, be they IPAs, medical groups, how could e-prescribing be integrated when we were perhaps only giving four physicians out of a group of ten the e-prescribing capability, how would that impact my office workflow. And we spent a fair amount of time delivering good answers to that. We also pushed our vendors very hard to make sure that the vast majority of these deployments could be done remotely without a lot of onsite handholding.
There was a lot of concern about the quality of the information within the system. How could I ever be sure that this information is correct? You say you have information on what drugs my patient is taking regardless of which physician prescribed it, how can I be sure of that? So there was a lot of concerns about the quality of the health care history as well as you say youre going to give me alerts and advice about drug/drug interactions, how can I be sure that the alerts that youre giving me are quality alerts and are actually clinically valid? So those were the types of questions we received from, those were the top questions we received from the physician community.
And finally as a summary we looked at the literature out there that said physicians are very interested in e-prescribing and that they are very focused on it, that was not our experience. Our experience was that e-prescribing was not high on most physicians radar screens and that theres a significant gulf between what the literature says physicians want and what our actual experience was. That wasnt a total surprise to us but the magnitude of the gulf was a bit of a surprise.
Secondly, as we knew, there are a variety of screens between people who are trying to influence what a physician does and the physician himself, and one of the biggest ones is the office manager. And the problem we faced there is despite our best efforts to communicate the value of e-prescribing to the office manager they did not understand nor value that. And so if you dont reach the physician and get their buy off you wont have as successful a deployment as you otherwise might.
To steal Joes words, free is not cheap enough, and that is certainly the case. A major hurdle was the number of physicians who were concerned about the ongoing price after one year. Our statement to them simply was you know e-prescribing is coming, this is a risk free, free way to get involved with e-prescribing and again, even that was not enough for many physicians.
And finally there was significant concerns with a health plan delivering clinical IT solutions and the thought was are we putting cookies inside these computers that somehow enable us to understand additional information about how the physicians are practicing and will we somehow use this information to extract additional financial concessions from them. That was actually a significant concern for many physicians and several medical societies and so there is a very big perception issue that we still have to deal with to this day.
Deployment of a mobile solution is complicated and time consuming, you really are going into something that is already a high performance environment where patients are being seen very rapidly. When you introduce this technology youre interrupting the fundamental DNA of a practice, patient visits and patient revenue, and that is something that physicians are very sensitive about as they should be.
I made the point about all vendors not being ready for this large scale implementation, and finally PDAs did not seem to be sufficiently robust for physician interest and objectives. We heard quite a bit that theyd rather have a tablet PC then a PDA, we heard quite a bit that they were concerned about only being able to prescribe within their particular practice environment as we set up the wireless environment there. What they really wanted was geographic independence, wherever I am, cell phone, 802.11 environment, wherever I am I want to be able to prescribe and our solution didnt quite enable that.
So with that I wont go through any recommendations around standards, let me just stop there by saying Wellpoint has taken a very significant and very large first step into e-prescribing, weve learned a lot and we look forward to taking these learnings and applying them more broadly within our provider delivery system.
Thank you.
DR. COHN: Well, thank you both for some very good testimony. I actually want to start out with a couple of questions and Im sure other on the subcommittee have questions also. Charles I was actually intrigued because this is actually the first, I mean Ive received literature about the Wellpoint implementation, actually I wanted to make sure that I truly understood all the nuances of sort of what you were doing. I guess first of all make sure that your comment about the fact that this has been obviously promoted primarily as an e-prescribing promotion or initiative whereas youve described that 80 percent of the providers actually went for regular PCs, and just to make sure the PCs did not have the capability on them to support e-prescribing.
DR. KENNEDY: Thats correct although we are revisiting that decision, but the initial thought was if you arent on the internet today well give you a basic PC and internet access and you can begin to get accustomed to the internet. If you are already on the internet relatively technology savvy heres a way to begin using technology in your clinical practice and that was the e-prescribing solution.
DR. COHN: Okay, then let me ask a follow-up question on this one which was you had actually brought up something that I realized that we maybe not have looked at quite as hard as we should, weve obviously in the world of e-prescribing have talked a lot about integration, interoperability with the NHII, basically the clinical NHII. But I was actually struck in your conversation about the trouble you seem to be having with pieces of integration with the administrative world, sort of the world of X-12 and practice office management systems, whereas I guess I understand that what youre trying to do is to create connectivity around the demographic data primarily and get that information in and you sounded like you were unable to do that.
DR. KENNEDY: Well what we wanted to do was we knew that the top, I dont know the exact statistics but theres a relatively small number of practice management systems that have the predominance of the market and those tend to be the larger group practices that have the more sophisticated solutions. But as we looked at the 19,000 physicians in our network the majority of them were actually practicing in environments of about five or less. And in those environments you find all kinds of things, all kinds of practice management systems that havent been updated in years, that no one really thought how do you pull data out of these systems, and so we did run into significant difficulties with very, very old systems that just werent designed for these kinds of interfaces. Were working through those but the point around standards and interoperability is an absolute key one.
DR. COHN: Just to finish off this piece because Im really obviously, obviously we want to have clinical interoperability but we also need to have administrative clinical interoperability --
DR. KENNEDY: Absolutely.
DR. COHN: And is your perspective at this point based on the work youve done that with a current or relatively current practice office management system that you would not have this problem?
DR. KENNEDY: With a relatively current system were okay, and again, all of our vendors had interfaces that could support a HL7 interface, that were HL7 compliance, so if the practice management system was HL7 compliant we were fine.
DR. COHN: Thats what I meant, is you seem to be indicating issues with the practice office management information systems.
DR. KENNEDY: I would say about, I dont know the statistics offhand but my guess would be just based off the volume of noise we had around this issue that its somewhere between a third and a half of the systems could not interface easily with the e-prescribing solution.
DR. COHN: Okay, I guess the final question, I know Jeff has questions and others, but you obviously are, I mean one can take your results many different ways and 20 percent is obviously disappointing. On the other hand as I was reflecting if I were being given the choice of a PDA or versus a real computer, I hate to use those terms, Ill probably get email about that, I might choose to get something thats big and can sit on my desktop or sit on my desk. How much do you think that that sort of choice impacted sort of what happened here?
DR. KENNEDY: Oh, quite a bit, I mean if you looked at some of our marketing materials, I mean if you just put up a PC versus a little handheld PDA there is kind of a value issue there. But we went to fairly extremely lengths to talk about the value of the underlying software, the functionality that you got, and how that could improve the quality of your practice. And we did let them know that the packages were equal in value in terms of commercial value, so in fact the PDA solution actually ended up costing more. I really think a lot of it was deployment challenges, reaching the physician rather then the office manager, despite our best efforts we were effectively screened by many of the office managers, and I think that in retrospect it probably would have been better to come up with a pure e-prescribing solution but we knew that many of the physicians werent ready for it. So we wanted to bring along all of our network so we felt we needed at least to offer some base level of solution.
DR. COHN: Okay, thank you, Ive obviously taken much of the time here. Jeff, you have questions, Steve, and Harry.
MR. BLAIR: Are you able to tell us which of the HL7 standards you were looking at?
DR. KENNEDY: Not off the cuff but I could provide you that information.
MR. BLAIR: Or which in terms of the functions, I mean you said it was to practice management systems --
DR. KENNEDY: Some of them had lab data in it, some of them had patient demographic data, some of them had ICD and PCT data, and so if we had either an ANSI standard or an HL7 standard to be able to work with we could then talk to that practice management system.
MR. BLAIR: Okay, you didnt mention NCPDP as a standard at all, so that was not involved.
DR. KENNEDY: Thats correct.
MR. BLAIR: Okay, thank you. And I had a question of our other testifiers, forgive me for forgetting your name, I apologize. You had one statement that RxHub was beginning deployment, I dont remember your exact words but something to that effect, could you elaborate on that a little bit?
DR. RADUAZZO: Well, as many of you know RxHub is essentially an enormous junction box through which health plans, pharmacies, physicians can all communicate, and PBMs as well. It offers significant promise when it comes to easy transmission of electronic data in a safe secure environment. To date I know that they have tested and I believe theyve made it through the eligibility portion of the system but I would have to defer to Jim Bradley, who is the CEO of RxHub, to tell you exactly where they are. But as that approaches functionality it will completely change the situation that we have. The pilot that we did, and I would dare say that the pilot that Wellpoint did was relying upon the ability to directly connect with a PBM, not through an external junction box but actual direct connection. Thats what happened with us and currently we have the ability to do that with our health plan and with Blue Cross/Blue Shield of Massachusetts through the e-prescribing functionality that we have deployed. But none of the other health plans in the area or national health plans or Medicaid in the state of Massachusetts can send information in that way because theres no single conduit to do that. So once RxHub is functioning to that level we will have the ability to allow that level of functionality, interactive formulary information and eligibility information, on virtually any patient that comes in to see a physician.
DR. KENNEDY: And Joe is absolutely right, we have a custom direct interface with Zicks and Allscripts but weve required in our contract that they link to RxHub so that as additional PBMs come on board that functionality will be available to the physicians.
MR. BLAIR: Okay, so from what youre telling me the work at Tufts and with RxHub, it was a pilot, it wasnt an actual working implementation.
DR. RADUAZZO: No, the pilot that Tufts Health Plan undertook involved direct connection between the Zicks Corporation, which at that time was called PocketScripts and Advanced PCS.
MR. BLAIR: And how long ago did that pilot complete?
DR. RADUAZZO: That was two years ago that that was completed.
MR. BLAIR: Two years ago and its not been implemented since?
DR. RADUAZZO: RxHub is not at this point transmitting that form of information, no.
DR. COHN: I think somebody wants to make a comment on this one, can you introduce yourself?
MS. BURN: Im Terri Burn with Rx-Hub, Im not usually this quiet. Actually we did do a pilot with Zicks Corporation, and I know Tufts is part of that, a couple of years ago but we are in production with Zicks Corporation and multiple other vendors as well as three PBMs, a hospital, etc., so Im confused by your statements about that youre not working, or RxHub is not up and running, we are up and running and we are providing that data to Zicks Corporation from Advanced PCS, or CareMark, sorry.
DR. KENNEDY: I think the question is in any specific geographic market you may have varying levels of penetration and participation by PBMs but you do have some of the large ones on board dont you?
MS. BURNS: We have ExpressScripts, Medco Health, and the Advance portion of CareMark, and it is a significant portion but youre right, we arent connected to Wellpoint, however were open to connecting to any payer whod like to work with RxHub and we have been using these standards for three years, so just a clarification.
DR. COHN: Jeff, any additional questions or can we go on? Steve.
DR. STEINDEL: Yes, Dr. Kennedy I probably have about a thousand questions and a thousand comments about your presentation, mostly with respect to what happened last week when the strategic plan was presented, a lot of it has to do with incentives, etc., and what youre doing. But getting down to the specifics of what were focusing on today in the e-prescribing area, one thing I was impressed by was there seemed to be a presumption that every office you went into had a practice management system and you were linking into that. Do you have any idea of how many offices you went into had electronic health records?
DR. KENNEDY: This is a guess but about less then five percent.
DR. STEINDEL: Less then five percent, so its in line with what were hearing nationally, thats what I suspected. The other sense that I got from probably a very early slide where you showed the various stages of connectivity that Wellpoint is going through, it seemed to be that a lot of those solutions were proprietary solutions and that is the case, I can see by your nodding your head and I wanted to confirm that.
DR. KENNEDY: Yes they are.
DR. STEINDEL: Okay, if a set of e-prescribing standards came out would you still maintain those proprietary connections and provide access to the standards or would you go to the standard base solutions?
DR. KENNEDY: We would encourage our vendors to go to the standards.
DR. STEINDEL: Okay, thank you.
DR. COHN: Harry?
MR. REYNOLDS: I have three questions that each of you could answer if you would please. The first was the mention that standards should only be focused on MMA, so thats the charge of the committee but any time you look at standards you wonder why that was specifically the recommendation when you have two private sector groups sitting in front of you.
DR. RADUAZZO: I would say that the reason that we are suggesting you stick with what is in the original MMA document is that that is a reasonable expectation of what can be delivered at this point in time by most vendors. Going beyond that may require connectivity in areas where its currently not available, so in an attempt to keep it as simple as possible for physicians, because I believe as Charles pointed out there are many, many issues well beyond the standards that deal with workflow, that deal with getting used to technology, etc., that we will have to deal with in getting the physician community on board with this. Keeping the standards relatively simple will be useful in moving things along.
DR. KENNEDY: I think what we have tried to do as we have deployed this program was to insulate ourselves from many of these issues by putting the requirement on the vendors we work with to be consistent with nationally adopted standards, so our approach is more, were to some degree standards agnostic but pick a standard.
MR. REYNOLDS: Incentives for adoption, what do each of you see.
DR. KENNEDY: Well theres no commitment nor formal plan in place at this time at Wellpoint but the things that are being discussed are in a time of medicine that is as complicated as where we find ourselves today, can we really be paying quality bonuses at the level were paying them without e-prescribing and electronic health records, so that argument is being made internally, how that gets implemented, if it gets implemented how it gets implemented in a timeframe is all unknown at this point but that is certainly on our radar screen.
The other thing we were very interested in was when Dr. Brailer made his presentation it wasnt specific to e-prescribing and electronic health records, he talked about clinical research and outcomes research. We see the opportunity to enable select physicians in our network the opportunity to participate in outcomes research and clinical research in a much more administratively simple way then what has occurred to date as a potential financial opportunity for them. So we see the potential to diversity their revenue stream and we will take a close look as to how we can play a constructive role. So I think theres some pay for performance opportunities, theres some research opportunities, and finally we will, weve made a public commitment to help physicians with the financial risk and the technical risk in doing this and I think youll see us continue to do that.
DR. RADUAZZO: Our approach will likely take a pay for performance type of view. Currently were involved with a product called Bridges to Excellence that some of you may be aware of, Bridges to Excellence rewards implementation of processes into a physician office that are known to improve quality of care. We would view e-prescribing as one of those processes and as we move forward with products that do pay for performance, creating a differential in payment for physicians, e-prescribing will certainly be prominent as one of the metrics.
In addition you may have read about tiered network products that are out there, these are found throughout the country, many of them are tiered based on economics, we have introduced a product that is tiered based on a mixture of quality and efficiency and certainly e-prescribing will be one of the physician, outpatient physician metrics to determine quality. Our feeling is that by creating a financial business case it makes better sense, simply paying a dollar or two may not really do it, tiering a network makes a big difference. And we would also like to be able to pay physicians differently if they not only implement a process that demonstrates that theyre using the process and thats where our rationale is right now.
MR. REYNOLDS: And the last Simon is more I guess a comment, both of you mentioned Microsoft, Microsoft was mentioned earlier today, and as you think of the Sasser(?) virus and the other things that went rapidly through the country Microsoft seems to be a target so as we think about these and then you start communicating and then it starts getting into practice management systems, one of the things we keep hearing is protection of systems and security and other things.
DR. RADUAZZO: Actually the product that were using can be used with multiple systems, Palm, pocket PC, obviously Microsoft products and Blackberry. Weve tried to be operating system agnostic because its important to be able to connect to many different platforms, use what the physicians are comfortable using, thats another big implementation issue when you have to take a new device with a new operating system and introduce that along with e-prescribing software.
MR. REYNOLDS: Part of my point was were trying to be somewhat unsophisticated to reach everyone but that also brings in some risks that can proliferate through everybodys environment much faster so well need to consider that as we go on.
DR. COHN: We probably ought to ask Charles that question also since he was the one who obviously explicitly mentioned Microsoft as a partner. Concerns, comments?
DR. KENNEDY: I guess when I look at the level of concerns we have in trying to do this at scale security was certainly at the top of the list but part of the rationale around choosing Microsoft is they have the resources to bear to bring security patches and solutions to the equation as fast as possible, and it just so happened that we had a particularly strong relationship with them. It certainly wasnt anything magical to Microsoft per se its just theyve been a good technical partner of ours. Are we concerned about security? Absolutely and we have within our functional specs a lot of requirements that the user ID and password but we wanted to make sure that none of the data was stored on the little handheld device so if someone stole the handheld device they could get access to PHI so we made sure all the data was stored centrally. We went through a variety of steps to try and be as careful as we could be about security but there was no specific magic to Microsoft and we hope to get to platform independence, just at the time we were deploying it they stepped to the table in a big way.
DR. COHN: Michael, maybe the last question and then well take a break.
DR. FITZMAURICE: As you were talking maybe you answered the question but Im not sure, for Wellpoint what is the business model for e-prescribing? For example there are revenue streams, does the physician pay, does the pharmacy pay, the health plan pay, is it per transaction, is it subscription based and to whom? And then do national standards improve the business case for Wellpoint?
DR. KENNEDY: Those are good question. The business model is a subscriber based business mode, so we paid for all of the infrastructure to go out there and seed the market, we also paid for a one year subscription to the ASP vendor who was providing the service, but then after that the physician is required to pay for the service on an ongoing basis. Weve pushed very hard with our vendors to get a significant discount because we brought them all of this business so it will be a preferential fee but the physician will still ultimately pay.
Currently there is no role for the pharmacy to play because all of the prescriptions are being e-faxed or faxed to the pharmacy and so I know theres been a lot of discussion about who should pay around that link and we really tried to bypass all of that because we didnt really see, I mean there is significant value in having the pharmacy connected but on the list of value adding functions we felt that was toward the bottom and not toward the top so we were okay with eliminating that piece of the peer end to end electronic connectivity.
For Wellpoint theres several important value adds, I think one is we have a commitment to make sure that our members get the best quality that they possibly can get and we believe this is a vehicle to do that. That helps us both with our primary mission but it also helps us commercially because now Im seeing with all this activity when a request for proposals come from the consultants theyre now asking what are you doing in the area of e-prescribing and certainly we can describe a leadership position there. So theres certainly a commercial value proposition to us. Theres also a relationship value proposition to the physician community, certainly the relationship between health plans and physicians has had its challenges over the year but this is an area where we feel we can collaborate and truly bring some value that a typical physician in a small practice probably couldnt get it. So it has a lot of value propositions.
DR. FITZMAURICE: And do national standards improve the business case for you?
DR. KENNEDY: National standards improve the business case primarily around reducing time to deploying, improving ease of deployment, as well as probably enabling more vendors to come into the space and not get locked into proprietary solutions. We would certainly like to avoid that and national standards would certainly help.
DR. COHN: Okay, I want to thank our presenters, its been a very useful conversation and Im sure well be talking more as we move forward on this. Im going to suggest we take a break for 15 minutes and well come back at 3:00.
[Brief break.]
DR. COHN: Okay, lets get seated and well start with our last session. Were obviously running a couple of minutes early which is all to the good. This section is really on a pharmacist perspective and we want to thank Kevin Marvin and Sandi Mitchell for joining us. Kevin youre with the American Society of Health System Pharmacists --
MR. MARVIN: Yes, Im a member of ASHP and representing them.
DR. COHN: Okay, and Sandi, youre from Johns Hopkins, so I want to thank you both very much for joining us. Kevin are you going to be starting out?
MR. MARVIN: Yes, in fact I will give the presentation and Sandi here is to help support with examples and so forth as questions come up.
Agenda Item: Pharmacist Perspective - Mr. Marvin and Ms. Mitchell
MR. MARVIN: Well, thank you committee for inviting me and giving me the opportunity to present the pharmacist perspective here. I also thank ASHP for supporting this opportunity as well.
Im a pharmacist and Im currently employed as a senior project manager of information systems at Fletcher Allen Health Care in Burlington, Vermont. Fletcher Allen is a health system in alliance with Vermont College of Medicine and is the only academic medical center in Vermont. We cover both Vermont and northeastern New York, we have 500 licensed beds in the hospital, 23 sites and 50 outreach clinics with a medical staff of more then 600 physicians.
Im also the chairperson of the American Society of Health System Pharmacists, which is ASHPs pharmacy practice section advisory group on physician order entry and informatics. ASHP is a 30,000 member national professional association that represents pharmacist practice in hospital, health maintenance organizations, long term care facilities, home care agencies, and other components of health care systems. The mission of ASHP is to advance and support the professional practice of pharmacists in hospitals and health systems, and serve as their collective voice on issues related to medication use and public health.
The American Society of Health System Pharmacists has a long history of advocating Congress and federal agencies about the importance of safe and efficient medication use process. Im please to provide you with ASHPs views on developing e-prescribing standards.
Studies have shown that approximately two percent of all new prescriptions contain one or more problems requiring pharmacist intervention prior to dispensing. Approximately 0.5 percent of all new prescriptions contain an error with the potential for harm if it reaches the patient. Based on these numbers and prescription volumes it equates to approximately 9.8 million prescription errors with potential to cause patient harm entered community pharmacies in the year 2003. And not including hospital errors, $177 billion dollars is spent annually on outpatient medication related problems in the United States. Medication orders in hospitals have even a greater rate as studies have shown.
Pharmacists serve a unique role in patient care as being responsible for the medication use and drug distribution systems. This responsibility includes complying with the requirements of the FDA, the DEA, state boards of pharmacy, Joint Commission of Accreditation of Health Care Organization, or JCAHO, pharmacy benefit plans as well as state practice standards. In addition to dispensing and distribution responsibilities a large component of pharmacists responsibility is in the transcription, verification, translation and communication of medication information between the components of the medication use process. ASHP supports efforts to standardize the information pathways in the medication use process that are developed in an open forum with the involvement of all stakeholders, which youre doing a great job here in accomplishing that, to not hinder the ability to safely and efficiently meet the patients medication therapy needs, and are developed in an iterative process with appropriate measures to support continuous process improvements and improvements to the standards. Also we believe that the standards should be developed in consideration of the need to evolve existing systems to meet the standards.
So in identifying potential standards theres been discussion of identifiers, and theres a need to support universal identifiers of patients as well as prescribers as multiple people have mentioned here. The need for universal patient identifiers is especially apparent when maintaining allergy histories and immunization histories which carry throughout the life of the patient and you certainly do not want to lose. Standard methods are also needed to positively verify prescribers identifiers in order to meet the DEA and state board of pharmacy requirements which was mentioned earlier today.
In order to support the efficient use of dosing and allergy checking it is necessary to include other patient information and to try to standardize the communication of that information, which includes birth date, patient height and weight, and certain laboratory results. Minimally allergy coding should be standardized and stored with the medication profile for retrieval in order to reduce the potential for missed allergy errors.
Messaging standards of HL7 and NCPDP script have simplified the transmission of medication order and prescription information between components of the medication use process. AHSP supports the continued expansion of these standards to meet the e-prescribing and medication use process needs. It is important that the field level details of these standards match in order to maximize the interconnectivity of these standards, as well as the cross functionality between the systems that use these standards.
So with regards to coding standards drug names are very important. AHSP supports the standardization on use of the generic medication name. We support the continued development of the Rx-Norm standards which focus on generic naming structure. Current drug databases store multiple drug names and this does cause a fair amount of difficulty for pharmacy. In testimony Ive provided some examples, artificial tears are oftentimes described many different ways within drug databases. Some drugs have modifiers on them that makes significant differences from one drug to the next, even drugs within the same name, Buproprion XL and SR are some examples there. And the combination products of multiple ingredients create some difficulties as well when theyre oftentimes ordered and used in multiple trade names.
Besides drug names there are other elements that should also be standardized, and that includes dosage forms, and the dosage form is very important to supporting the clinical checking to make sure that youre not comparing apples and oranges, even though the drug component is the same the dosage may, or the form of the dosage may have significant differences in terms of dose level checking and accurate dose level checking. The unit of measure is also important, there are standards are needed which allow automated conversion of these units of measure for dose checking, one example is Digoxin which oftentimes is ordered as 125 micrograms, or 0.125 milligrams, and many systems do not have the ability to convert those and we need to have standards around that. The other standard is of course units is sometimes difficult to convert, dealing in units, not units but international units and other somewhat non-standard methods of measuring some medications.
Modifiers are also extremely important and many times these modifiers are used by pharmacy to identify which generic or trade product to fill a prescription with. And the modifiers can include such things as whether the item contains latex, the flavor of a liquid preparation, whether preservatives are in the item and what type of dyes are in the items. Oftentimes these are not supported in a standardized fashion to support the automated checking of allergies and to support pharmacy in selecting of the correct items.
The instructions or sigs are also a strong potential for standardization. The components of the sig include the frequency, the route, the site of administration, the indication for the medication, certain modifiers with the medication which oftentimes now are handled via slap on labels on prescription vials and are missed by patients, those are such modifiers take with food or milk or take without food or milk, as well as certain things like conditional frequencies, which create a lot of complexity when you need to administer something one hour before a procedure or after a procedure, and when you get to more complex therapies rates of infusion.
The historic Latin standard for sig coding has been identified as unsafe in many cases. Some codes are no longer allowed but standard alternatives have not been universally accepted. Some examples are such as QD dosing, QOD for every other day, and left and right eye and ear such as OSOD. Theres currently a great need and opportunity to standardize a new sig coding structure.
Order routes of administration need to be standardize to support the rule based clinical checking to reduce false positive warnings for drugs that have multiple routes of administration. An example there is Gentamicin which is given both topically as well as orally and you do not want to have interaction warnings for the topical item if it isnt administered orally.
When the above sig information I mentioned is not coded in a standard fashion it is very difficult to accomplish such items as automated dose checking as I mentioned, the medication administration reminders and verification to support patient therapies, and the automated translation of patient instructions to more understandable format. And I think this is an important issue, patients oftentimes have a hard time understanding medical terms and its often stated that medication terminology for patients should be at a fifth or a sixth grade reading level and we need to make it take advantage of what tools we have to support that need. Also this information if not coded in a standard fashion makes it difficult to do historical reporting and DUR against dosing and dosing instructions.
At the same time its important to recognize that free text items reduce the potential to automate downstream components of medication use process as I mentioned so therefore coding supports that. And then those components include the administration, the monitoring, the retrospective reporting, and clinical checking. Free text is still needed though, you dont want to close the gate to be able to support special instructions that many drugs require free text for.
E-prescribing standards need to be structured to support medication process workflow and handoffs. Communication between physicians, nurses, and pharmacists need to be supported. Significant telephone time is spent by pharmacists handling refill and third party issues, third party payer issues. Technologies are in place to allow patients to electronically request prescriptions refills from their pharmacy but no standard processes are available to support the request of pharmacies to the prescribers for that refill request. As a result theres significant effort and telephone work occurring between pharmacies and the prescribers and theres significant opportunity to enhance those workflows.
We also cant forget the medication administration component of the ambulatory medication process. In the hospital environment there have been a lot of studies that have showed that significant errors occur in this medication administration process and this is the case when trained professionals are doing it. Yet in the ambulatory environment patients are administering medications themselves and you can imagine the type of errors and Im sure youre well aware of the types of errors that can occur. Standardization of the coding of medication information and instructions will allow for a good translation of these instructions into the language that is better understood by the patient. Consistent labeling and language will support better understanding of patient medication use. Confusing terminologies, such as indications and dosing, can be translated in a standard fashion into a language the patient understands and then the patient can also be then involved in the validation of the prescription thats in front of them because theyll better understand the indication.
E-prescribing standards should also support the ability of a physician to order additional consultive or educational services for the patient at the time of prescription entry. Busy physician oftentimes dont have time to provide that level of education to patients and it would be very helpful to provide a mechanism of them communicating that need to the pharmacy. These cognitive services provided by pharmacy provide significant support for the patients better understanding of their medication therapies and increase compliance as a result. Many states and benefit providers will reimburse pharmacies for these services.
E-prescribing provides opportunities to automate the monitoring of the medication administration side of ambulatory medication use process. As has been mentioned you can monitor refill activity, monitor whether new written prescriptions are filled, and provide prescription fill and refill information to prescribers so theyre well aware of how the patients are using their medications.
The conversion of a prescription in e-prescribing to a pharmacy product is a complex process. It is common in the current hospital world for a computerized prescription order entry system, or prescriber order entry system, to be implemented that results in an electronic order being printed to paper in pharmacy and transcribed back into the pharmacy computer system for dispensing. And as we just heard thats oftentimes also done in the ambulatory environment. Hospitals with proprietary integrated physician order entry and pharmacy systems are the only ones that have implemented CPOE systems without some type of manual process of converting the physician order to a pharmacy product.
This cannot occur with ambulatory e-prescribing in an open ambulatory environment where product selection is determined by a combination of the patients pharmacy insurance benefit, the patients choice, and the inventory of the pharmacy filling the prescription. A typical inpatient pharmacy carries approximately 2500 to 3,000 products in stock, the total number of NDC products available has been mentioned by other prescribers to be approximately 80,000, and this number is significantly greater if you include the OTC items.
Some examples of complexity of this matching process are shown here with Warfarin, if an order is prescribed for 12 and a half milligrams of warfren a decision needs to be made based on the products available how to fill that and what Ive shown here are four different examples of how that could be filled by combining a ten milligram and a two and a half milligram tablet, or using other combinations of five, ten and two and a half milligram tablets to meet the need. And this can be complex, in some cases it results in two prescriptions and two co-pays for the patients, in one example here it results in one co-pay for the patient but the requirement for the patient, actually two examples show that, but the requirement to the patient either to split tablets or to take five tablets to meet their dose.
If e-prescribing standards dont consider the translation of medication entity to product detail we will still have an error prone transcription process. We need to develop standards that avoid this unacceptable solution.
Standards need to support the integrity of the original written prescription, the systems sure assure that pharmacists are not modifying the intent of the prescription and are selecting the appropriate product to match the medication entity prescribed. Therefore the data elements carried in the original e-prescription should carry forward the final prescription fill. Additional data elements will be coded, or need to be coded, based on the product selected and these should be the same data elements that the pharmacist uses in selecting the product to meet the original prescription.
This coding is necessary to support rule based clinical checks that work the same for physicians and pharmacists. It also supports rule based product selection which may be possible if we standardize these data elements. It may support better physician, pharmacist, and patient communication because they will all be talking the same language looking at the same data elements and the same descriptions. It will also reduce transcription and translation errors by allowing the patient to be part of the verification chain by seeing the prescription as it was originally written by the physician and not just a translation of the prescription that the physician wrote. Standards need to provide a hierarchical framework for medication coding from the drug entity level down to the product level, which would be the NDC. It is likely that manual transcription will continue until this hierarchical structure is developed.
As prescription information moves through the medication use process it should be added but not modified or deleted as can be implied by what I said earlier. Its supported best via hierarchical data structures. Standards are needed to clearly define the source and owners of each of these data elements in an order or prescription. This is necessary to control the data integrity of that prescription. In some cases the ownership of that information can be shared between the physician and the pharmacist but the rules need to be clearly defined on how that information is shared.
One example of that would be the selection of the flavor of a liquid ingredient for a pediatric preparation, in many cases the physician will be very involved in making that selection, in other cases its left up to the pharmacy. And there may be other cases such as tablet selection, select the combination of tablets based on the ability of the patient to swallow certain size tablets or the quantity of tablets, or even the patients ability to break a tablet.
Standardized methods are needed to support enhanced communication processes. The systems need to support the communication of decision rationale downstream into the medication use process. For example, when a physician overrides a clinical warning the reason for that override and the knowledge of that warning having occurred needs to pass on to the pharmacist so the pharmacist doesnt call the physician back and bother them with the same warning.
Some expansion of the messaging standard will be needed to better support the handoff of prescription from the physician office to the pharmacy. In addition to the prescription information the passing of medication or medical benefit plan information to the pharmacy will support faster processing of the prescription by the pharmacy. In addition to this the patients HIPAA release for the pharmacy would be best if received prior to during this handoff. Without proper patient approvals pharmacy will not be able to access the patients global medication history and fill the prescription until the patient arrives at the pharmacy. This will create unneeded delays for the patients.
In addition the e-prescription system should support upstream communication in the medication use process. Such upstream communication would include the request for refill authorization as I mentioned, or pharmacist interventions to clarify dosing, routes of administration, and other information on that prescription. This is all to avoid the interruptions and the use of the telephone to accomplish this need.
E-prescribing standards also need to support patient empowerment, patients need to be able to select the pharmacy, payment method, and influence proper selection or product selection within the prescribers intent. Patients also need the ability to review the consolidated medication history information as was mentioned earlier today. Standards need to support this as well as provide a mechanism for the patient to verify that the medication received matches the medication ordered.
The development of e-prescribing standards is a continuous improvement process that will occur through iterations of design change and measurement. Methodologies are needed to assess the safety and efficiency of the system and to provide the evidence to support continuous improvement of the processes and the standards. Such measurement standards should include such items as time stamps to be able to measure delays within the process and also needs to support methods to document and measure interventions that occur throughout the medication process. And these interventions may occur by pharmacists or may even occur by patients as was mentioned, it would be nice for patients to document adverse drug reactions. Methodologies are needed to monitor the measures and as appropriate to adjust systems processes and standards to improve them.
Last week the Joint Commission announced their 2005 patient safety goals and one of their patient safety goals is very relevant to e-prescribing, and that is the goal to accurately and completely reconcile medications across the continuum of care. According to this goal they want the development of this type of process and documentation to occur in 2005 with full implementation by January of 2006. This will include a complete list of patients medications, also communicated to the next provider of service when it refers or transfers a patient to another setting. So it covers the verification of prescriptions at the time a patient presents as well as passing that information forward to the next provider of service.
This direction from JCAHO will significant increase the interest in the e-prescribing effort within health systems. It will also include the need to support profile lists of OTC medications, dietary supplements, drug samples, take home medications, and possibly medications administered within the clinics and the hospitals. It is important to recognize that the e-prescribing standards, though starting as the electronic prescribing will evolve to include all medications. Since these medications will eventually be all included in the same medication profile they should ultimately share the same standard.
JCAHO and the state boards of pharmacy require that pharmacists review medication orders prior to the medication being dispensed to the patient except in the case of emergencies. In order to support this order verification pharmacists need complete access to a patients medication profile, allergy information, problems or diagnosis lists, height and weight information, and other applicable laboratory results and other clinical data. This requirement for pharmacist verification recognizes that the electronic rule based clinical checks are not complete and dont support other pharmacist functions. These other functions include the direct monitoring of patients, the education of patients, the local and regional practice differences that the pharmacists have to deal with, and the identification of programming or system set up errors.
In conclusion I would like to emphasize that the development of e-prescribing standards will be an ongoing effort with iterations and improvement. Pharmacists are important members of the health care team to assure that the components of medication use process meet the requirements of the legal, regulatory compliance, payers and most importantly the patient because the patient does deserve it.
Again, I thank the committee for providing this opportunity to present the health system pharmacist perspective with regards to development of these e-prescribing standards and ASHP remains available to provide input as these recommendations are developed.
Thank you.
DR. COHN: Okay, well we have time for a couple of questions. Jeff, I think you wanted to start?
MR. BLAIR: Kevin, your testimony was outstanding, it was very, very helpful for you to delineate the areas where standardization is needed and appropriate. Now you are I believe familiar with both the HL7 and the NCPDP script standards is that correct?
MR. MARVIN: Not to great detail but to a higher level I am.
MR. BLAIR: Which ones have you worked with?
MR. MARVIN: Mostly with HL7, HL7 is primarily used within health system environments and inpatient environments.
MR. BLAIR: Now many of the areas of standardization that you articulated here I thought that the pharmacy TC of HL7 had addressed at least to some degree.
MR. MARVIN: They have developed and identified the named fields and identified field links but data element content standardization has not been done in many of the components of the HL7 standards.
MS. MITCHELL: Additionally the HL7 standard has for example in dose routes or dose forms a list which does not suffice for clinical practice within a hospital, its a shorter list, not a clear definition as youll need to see on a practicing for nursing, so that it has not, weve found that we have to expand the list and then pass this additional expanded list system to system.
MS. BLAIR: I would find it very helpful to get a clarification of which of these areas are included with NCPDP script and which are included within the HL7 pharmacy orders and which ones are standards gaps, are not addressed by either. And I dont know, if there anyone, Stan, do you, or even Ross is working on the harmonization --
DR. HUFF: There are people here who met yesterday looking at standardizing crosswalk between NCPDP and HL7.
MR. BLAIR: Are they able to sort of map that to the things that Kevin articulated to us?
DR. COHN: Jeff, I think somebody wants to comment. Would you please introduce yourself?
MR. ROBERTSON: My name is Scott Robertson, Im one of the co-chairs of the medication information sig at HL7, actually yesterday we had a meeting between HL7 and NCPDP specifically looking at mapping function and content specifically in the area of the e-prescribing standard. There will be a more complete report in your next session but we, it was a very productive meeting yesterday and we think we can address a good crosswalk between the two to support at least the first phase of the implementations that will be needed. There are issues with specific content and vocabularies, those are issues that we have to deal with but we havent run into anything that appears insurmountable at this time, its a matter of we actually have to sit down and get the work done and weve started that process.
MR. BLAIR: One last thing, Scott, thank you so much for being here, Kevin indicated all the areas of standardization from the perspective of a pharmacist. And many of the members of HL7 in particular and who may be prescribers might have a slightly different view. It would be really helpful if when you pull together the testimony for us for August whether theres some of those areas where for one reason or another the prescriber view may not coincide with the pharmacist view and if theres an accommodation or explanation of that. Is that something that you think you can add?
MR. ROBERTSON: Yes, I neglected to mention that I am a pharmacist --
MR. BLAIR: But you do have other folks on your team that are also doctors.
MR. ROBERTSON: There are physicians, systems vendors, people representing other international organizations, so we believe that between HL7 and NCPDP we can provide a very broad range of views, bring a broad range of views to the discussion and the ultimate harmonization of these two standards.
MR. MARVIN: I would suggest you also make sure you look at the workflows, especially what I pointed out in terms of the product selection, the conversion of that physician order, what does pharmacy need in terms of data elements to support the product selection. There are efforts to map products back to the higher level order entry entity but there needs to be some discussion around what is needed to support the product selection.
MR. ROBERTSON: There is a considerable effort going on in the HL7 medication information and vocabulary committees to address issues relating to drug nomenclature and this includes input with Rx-Norm standards, NLMs work and work from a number of other terminology systems that, from England and the Netherlands and a couple other countries, so weve got, again, weve got a broad basis of people working on it, bringing a number of different perspectives, whether thats practice based or the more information based, or regulatory based, the FDA is involved in these discussions also.
MR. BLAIR: One of the other things since Stan typically has to recuse himself from things on HL7, however he can answer questions. So Stan, do you have anything else that could help the subcommittee understand?
DR. HUFF: Well, I thought again, I would second what you said that Kevin did a very nice job and brought out some of the important issues in translation of a prescription into the set of tablets or things that a patient should take and those are issues that in fact HL7 has addressed, I think we need to review and make sure theyre sufficient but there are places to represent essentially what was written and what was dispensed or what was in a sense what was filled, which is really that sort of translation from what was written to a set of pills that somebody can take. And so I mean those are issues that are at the heart of a lot of these standards, not just HL7 but NCPDP and Scott and these other guys are a lot smarter about it then I am.
MR. BLAIR: My last part of this series of questions would be since I think Lynn Gilbertson is here too, one of the areas that Kevin pointed out is that many of the messages, especially NCPDP script are in text format and I know that the ideal is that everything be codified so it can be measured and specific and everything like that, on the other hand theres an area of pragmatism and ease of use and Lynn, do you have any thoughts or comments to just put that in perspective before we go on?
MS. GILBERTSON: This is Lynn Gilbertson, NCPDP. Thats a loaded question, Jeff --
MR. BLAIR: Oh, Im sorry, I didnt mean to make a loaded one, I just wanted to give you an opportunity to add your thoughts and perspectives on it.
MS. GILBERTSON: Well, its one of the things we were discussing during lunch, codifying the sig is, I think we can all agree its a wonderful thing to accomplish and it would be good for health care in general and all the typical good things that can come from that but you also have to weight the prescriber and the pharmacist needing just what did the prescriber intend. And its the one offs and the two offs that care, can I codify it, can I use it for research, can I use it for outcomes, and so the direct users who would have to implement the modifications would not necessarily see the immediate benefit. So I think in some, we just have to bear in mind reasonableness as we go through this, we can codify everything but if anything of the intent on any of these data elements is somehow modified we are in serious trouble and we will make sure that kind of thing doesnt happen. I mean there have been enough exercises of codifying sigs that if you dont do it quite right you end up with something in the left ear instead of the left eye and things like that. And as in the NCPDP environment when it comes to the telecom standard for billing of claims we have standard billing units and standard ways of expressing items so were going to bring that to the table and with for example with HL7s experience and with the industry experience hopefully well come up with something that does not hurt the users of these systems by making it so techie that its really cool but the immediate users dont see any of the benefits, its the one offs and two offs that really like it. I didnt answer your question but its a perspective.
MR. BLAIR: No, thank you.
DR. FITZMAURICE: I wonder if I could ask a question of Lynn, about her response, it seems to me that its a pretty important patient safety concern if it goes in my left eye versus my left ear and in looking through the importance of the sig the automated dose checking, somebody has to enter that into a computer if its not already entered in a computer. If the physician at the time of prescribing is able to enter that information into the computer virtually once and for all and it doesnt get changed that would seem to me to enable the automated dose checking and alleviate some of the left eye left ear problems. And so it seemed to be more important to do the sig then not. Am I off base here?
MS. GILBERTSON: I turn to the crowd, some of the pharmacists who are deeply involved in this are Scott, you can answer that a whole lot better then I can.
MR. ROBERTSON: The automated dose checking in a majority of cases comes down to things like maximum daily doses and dose versus weight, dose versus body surface area, and those tend to be able to be done without complete codifying of the sig because you can indicate what the daily dose is and then based on other parameters do the appropriate calculations. Yes, making sure that something thats made for the left eye goes in the left eye rather then the left ear might be important but there are times that products that are made for ocular use are used in your ear. Hopefully not the other way around but there are times when the, and something that weve had to deal with in HL7 terminology, there are times when the dosage form implies a route of administration but thats not the route of administration thats being used.
DR. COHN: I guess Michael the answer to this one is that it would be helpful if the prescriber was very good at making sure that the medication went to the right place.
DR. HUFF: Yeah, well just a comment, this is a comment from IHC and our experience, we have both inpatient and outpatient prescribing systems and its as Scott described, I mean the ideal workflow is one where the clinician is in fact choosing from a structured set of codes what they want to say in the sig so theres not this idea that they write it in freehand and then a pharmacist or somebody else transcribes it and tries to figure out what they meant, and part of that is actually just for speed because its much faster to pick from a common set of things then it is for them to freehand type in what would normally be in the sig. At the same time I agree with Lynn, the common things are common, you can handle huge volumes with things where you can say you really need to take this three times a day. There are other situations that are very specific and you want to always allow the opportunity for the clinician to say in free text exactly what they meant and that goes along with the testimony that weve heard on a couple of occasions here as well.
DR. FITZMAURICE: So Stan are you saying its more important to have this standardization at the level for the physician doing the prescribing rather then having it at the point of the pharmacy?
DR. HUFF: Well, you want to allow both. Ideally you want to capture it directly from the clinician so its unambiguous what they intended.
DR. COHN: Okay, hopefully were done with this piece. Do you have a comment that you wanted to make?
MR. SIMPCO(?): Hi, Im Mike Simpco from Wal-Greens and also a pharmacist, and you made a great point that the intended directions a physician may give may not necessarily match the product being dispensed and the standardization of sig codes could present a great danger when youre trying to look for a solution to actually promote patient safety, could actually result in a more dangerous situation because of the interpretation of those sig codes. Right now in the NCPDP format the sigs do come as free form text and surely something could be done at the physicians office in a standardization sig and then a translation of that in some manner. But then again in this whole HL7/NCPDP combined workgroup thats exactly what will need to be addressed.
DR. COHN: Okay, I think weve talked about this one, thank you. Steve, do you have another topic?
DR. STEINDEL: Yes, well I have a comment on this topic, a very quick one, and then I have a couple of questions for Kevin and thank you for your very nice presentation. The comment that I have to make on this discussion that we just had, this very useful discussion about the mapping of NCPDP script to HL7 and the development of sig codes, etc., I just would like to point out that last week we got a very clear message and that clear message was doing this work tomorrow is too late, doing it today, were going to have to live with that, its not really adequate. So were moving in a very fast world so I think my message to the people who were just commenting, weve been discussing this for a long time, we have to find the paths that we can start moving down, and thats my comment. My questions Kevin, this is mostly in the workflow area, weve had numerous comments on standards for workflow and weve have numerous discussions internally about what does that mean. And the way you actually put it was standards to support workflow, not necessarily workflow standards, is that really what we should be looking at? At various points in the workflow where there should be some standardization we should make sure we have recommendations that standards, we either note that standards exist or we note that standards are needed.
MR. MARVIN: Well, I look at it as a conundrum with technology, you either try to implement technology to support your way of doing things or you adjust your way of doing things to best use the technology and I think theres some balances that need to be played with workflow and there are some cases where it does make sense that we need to change our potential way of practicing to be more efficient now that we have a new technology, there are other cases, we certainly dont want the technology to drive us in a direction we dont want to go. So I think its a balance, I think you have to approach it both ways.
DR. STEINDEL: Thank you, and this is probably my naiveté and Karen walked out of the room as probably the expert, but what is the patients HIPAA release for pharmacy?
MR. MARVIN: Its the same release that the patient signs when they come into any clinic, the first time they present at the pharmacy they need to sign a release of their information so the pharmacy can then communicate with a third party and adjudicate the claim. So theres a signature process going on with regards to that.
DR. COHN: I think thats an over statement, I think that the health care provider or entity has the option and obviously a responsibility to try to inform the person of privacy and they can I think elect to have them sign, but I think what youre describing is I think an earlier version of the privacy rule and the specifics and I think things have been levelized a little bit --
DR. STEINDEL: I think things have been changed, I dont think --
MR. MARVIN: Good, certainly the pharmacy Im aware of is still following that practice.
DR. STEINDEL: We are aware that there are people who are reading between the lines.
DR. COHN: Harry I think last question and then well move to our next discussion.
MR. REYNOLDS: I also would echo that this is well put together and just about the time I thought I was getting it together you loosened some of my thoughts up. I wrote wow on one of them actually and thats your example. Support communication of warning override rationale by the physician to avoid follow-up communication by the pharmacist. That statement adds a significant degree of complication to the systems that have to be in place, to the doctors time, to everything else that goes on. So back I guess to where Steve was, so supporting workflow versus dramatically changing the way people work now from a standpoint, especially at the point of care, is a challenge and you have, you kind of put the gauntlet down on that challenge with actually using this example --
MR. MARVIN: Because if you dont go through that effort youre going to get the call, or oftentimes you hopefully will get the call if the pharmacist is doing their job of following up on potential problems.
DR. COHN: I guess we cant throw away our phone tomorrow in all circumstances. Any last questions or comments? Kevin I really want to thank you for some very interesting testimony and thank you for having written it so comprehensively, and Sandi thank you for joining --
MR. MARVIN: Thank you for having us.
DR. COHN: Okay, with that, our next presenter is Clem McDonald, obviously thank you for joining us, its very odd having you on that side rather then with us, I think as everyone in the audience knows Clem was a member of the subcommittee for many, many years and obviously its great to see you back.
DR. MCDONALD: Well, Im not up yet by the schedule, you must be ahead of time.
DR. STEINDEL: No, youre 11 seconds late.
Agenda Item: Physician Perspective - Dr. McDonald
DR. MCDONALD: Well, this is fun to be back in this room, I think I went off in January and you wouldnt think that youd miss it after seven and a half years of all these meetings so I appreciate your giving me this chance and Im going to try to present some of the issues from the point of the view of the practitioners for e-prescribing and with the goal of defining things that could make it better and more attractive. And I may get into some of the pharmacy parts a little bit because I think theres some things arent as good for them as they could be either, and Im going to tend to read this but since most of you dont have it I guess that wont be so painful but I wont be as detailed as I am here.
So I mean bottom line I think, I personally have few doubts and from what I can even understand that a community pharmacy and pharmacy benefit managers could benefit a lot from e-prescribing as weve heard figures that it costs $25 dollars on average to handle that call back to physicians, to solve some problem with the prescription. But I certainly hope that the threshold wouldnt drop so that we get calls on every darn interaction of the 5,000, every interaction, everything, to your point.
And theres good things, patients would certainly prefer to have the prescription filling process go smoothly and to have the prescription filled and waiting for them when they reach the pharmacy and any system that would help physicians quickly traverse the jungle of different formularies that constrain prescribing from the various payers would be, I think would be nirvana to them. Methods for approving refills that use less telephone time would also be welcome, for many physicians the ability to see what medication the patient was taking based on what they really had filled would also be kind of like a new kind of heaven and so that these all are at least in principal are possible with these systems. So in principal all these and more could be delivered by e-prescribing systems and Ive got two references that kind of describe in detail what all, theres just plenty of evidence about that.
But the uptake as I understand it by physicians offices have been slow, I dont have really detailed figures but I think its quite small, I hardly know anyone whos actually using it. And some explain this lack of uptake on some intrinsic perversity of physicians as though theyre sort of a flawed human subspecies in that theyre the ones who wont use technology because theyre sort of basically something is wrong with them. But the real reason may have to do with the barriers to capturing the alluring benefits of e-prescribing, we like to point out some of these issues with the hopes NCVHS could suggest incentives and policies that would make these go away.
And first I want to emphasize that what you have to do to do a good e-prescription is youve got to identify up to six things, somehow its got to get transmitted, six entities, and I want to go over some of the issues with each of these entities. So the patient, so most e-prescribing systems, I reviewed a couple of them, use the patients name as the primary identifier, and that actually is how a lot of the office practices work and they type in the name or part of the name and they resolve ambiguities if theres multiple patients with the same name. Some of them actually require to click on things just to see the external information to help you resolve it which is not so good. But the name is not a great identifier because of misspellings and name variants, Bill and William is just some, and in large practice settings you can have hundreds of people with the same name, John Smith, I think we have 400 of them in our Wishard hospital. So a chart number, a combined identifier, would be better to have available in these systems.
But further the pharmacy systems need to have a lot of data about the patient so they can match up with the system the person as they know it in their pharmacy system so you really have to send a lot of information along which really means that stand along e-prescribing systems dont work very well, youve got to be interfaced to your office management system to pull out all those other pieces of data because writing a prescription by having you type in an insurance number and all this other stuff would be too painful.
Now furthermore because of the numbering issues and identifying issues pharmacies I think generally have to kind of double check things themselves to see theyve linked it up right so it takes just a little nudge off of the benefits and the efficiencies they could otherwise get if it just flowed in computer to computer. And so the bottom line of all this is that I think weve got to, I mean in the long haul focus on a patient identify in some fashion and I know weve been over that a long way but swipe cards that would pass all this stuff and you could swipe it on your e-prescribing system. The use of a universal person identifier that we talked about or some mechanism that would permit automatic solid and easy linking between this prescription, in the practice and the prescription person in the pharmacy system and this influences the other steps, like trying to get a medication profile from the collective of all the pharmacy prescriptions that are written and stored.
The prescriber, this is the physician or nurse practitioner writing the prescription, the system also has to have them identified, thats the one element thats kind of iced even though it isnt quite done yet, I mean were waiting for the NDC but there are things that work, the DEA number, even though it might be somebody illegal in terms of what the FDA says you can do with it and a universal, doctors license numbers, theres file out there and thats just a one time load and that sort of all works.
The medication, now here the reader should beware, the reader, the medications can be identified at different levels of granularity. The FDAs National Drug Code, NDC, is the finest grain level and one NDC record specifies a medication, a manufacturer implying a brand name often, the dose, the formulation, and sometimes more. As it happens the NDC number is the lingua franca for most pharmacy systems because its printed on all the medication packages so you can get that in hand automatically. But its not without problems and I wont belabor some of the problems of the NDC number.
But physicians would find an e-prescribing system that would require them to identify the medication at the NDC level to be very painful, there are just too many of them, I think theres 120,000 different codes and so if you type, I tried this on the FDA website, you type in PRO, which is the worst string for finding drugs in any of the systems I tried it on, a lot of drugs get the word pro into them somehow, or the brand name. So you come up with 1,008 different records when you type in PRO. And you type in ceph, which you think is a little bit more limited, you still get 208. So that doesnt work but most systems provide something in between the provider and the NDC code that help solve it and they do it at two levels, one of them actually has the generic drug and dose which really looses it down a lot, another one has the generic drug and route and the other one adds the dose to that which gives you a few more but its probably still workable.
Now the message to the pharmacy must contain the NDC code, thats by the script standards requires that, and it may contain a more general identifier supplied by one of the drug knowledge base vendors. Now the problem is the prescribing may be writing, I dont care much about what dose or pill size it is, and then the pharmacy may not have all that, the exact brand names the NDC said and that doesnt matter because they said you can, and so they got to match up these two more generic codes but they dont all use the same. So theres a bit of a problem there that youve got four or five probably two big ones, what I call generic codes but theyre really hierarchical codes and GPIN, theres some names for these things from the knowledge base manufacturers. But that creates another a little bit of a problem and requires, also adds to a little bit of pharmacy work of figuring out, looking at it by hand instead of doing it automatically.
Now the medication instruction, I guess this isnt really a problem except that in this current standard its only sent as text even though the pharmacy system may be putting in TID or some coded structure saying what it is. And I think they get 140 characters for the sig which actually in some cases might be a bit short. So the pharmacies then have to recode that sort of when they put it in, again, a little loss of efficiency that might be dealt with.
The fifth thing is the insurance company and plan and the only reason this becomes important is because for my IC patients and my practice its nightmarish dealing with these formulary constraints, its absolutely impossible. We get every week or month we get another little booklet from some pharmacy company, theyre all done differently and you cant easily get them electronically, so that would actually be a big motivator for me to be on an e-prescribing system. But to know what the formulary is you have to know the insurance company and the plan have to both be gotten into and be sent the other place. So this is one more step and that actually is not a big deal when youre connected to the office management system but its just something you have to remember, it has to be part of the flow.
And then delivering this information doesnt necessarily get you to what wed really like is to have any patient you typed in something on, you know what prescriptions you really could write and you could know something about the co-pays if there are differences that might really bankrupt your patient.
The sixth thing is the destination pharmacy and this is a subtle thing and it isnt, I dont know that its a problem everywhere but in many states an electronic prescription has to be delivered to a specific pharmacy, at least it did used to be, someone knows its all been changed and weve got the laws all fixed then tell me afterwards or tell me in the middle of this. But this is one more step and it doesnt necessarily work in the workflow, I mean youre writing a prescription after you see the patient, now you go back and find out what pharmacy are you going to be nearby today, or the patient may not know, theyre going to pick up their kid and they get a call to do something else, so its a bit of a snaggle. And I think it would be important to use restrictions on these matters such that you could send that prescription to the pharmacy central, like the main chain, and you go to any of that chain which is likely where you have to go to anyway because the insurance constrain, or maybe better yet some kind of a clearinghouse where when the patient got to any pharmacy they could pull the stuff down and they could get it filled.
Now the big benefit for the physicians, theres two big benefits I think to the physicians. The first as I alluded above is getting that insurance company formulary stuff built into the prescribing process so you dont go through all this horrendous stuff, I can tell you stories, Medicaid, you have to call this number now, the patient comes back two days they havent gotten their acid suppressing medicine and so theyre stomach is all burning up and then they say youve got to call Medicaid to get prior approval, you call the number and they go oh were not the number anymore its a different place, then you call that number and they go oh well, they tell you something else. Then you go to the pharmacy, its just like you cant get from here to there with some of this, its designed that way maybe, of course the patient saves a lot of money on those prescriptions that we cant get filled.
So I think it would really be a huge benefit so what youd like to have is youre typing in there and it just gives you the drugs that are on the formulary, you could maybe click on a button and see everything but youd like to have it so youre not going down a wrong path picking a drug and say no, this is not a drug your patient can get. Now you might argue they could still get it but practically speaking people cant afford to go off their plan for drugs that arent them at all.
So what we would like to have it all connected together so these capabilities are available in some e-prescribing systems but I havent tried these programs to know whether theres a long delay, where it goes out to search for something and finds something seamlessly, it would have to be seamlessly. And I also understand this is incomplete and Im sure there are people in the room know this better, that much of this comes from one big consortia of three pharmacy benefits managers who then have the plans for all those managers, and there may be other sources as well. But none of them have all of them, and none of them have even, they probably have maybe over half or maybe 60 percent but I think theres still a lot of them youre not going to get. Medicaid is generally not part of this, Medicaid of Florida has put a thing where their physicians can write prescriptions for Medicaid patients only but now no one else is on that system and they get the reminders.
So prescribers really need access to the formulary constraints from all the payers through one seamless mechanism and NCVHS needs to find a way to encourage collaborations of the payers through some kind of mechanism, I dont care what it is, build on whats out there and so that this can happen.
Now the second big pay off is the medication profile based on all the prescriptions filled for a given patient. Now if you do an e-prescribing system you do accumulate the drugs that youve written or your office has written but it doesnt give you as much as youd get if you knew what they really got and youd also know what they had in the ER, youd know what they had from the office down the street. I think this would be a Godsend for patient safety because providers could finally really know what the patients are really taking. We dont know now, they bring in the bags and you go through the bottles and all that and you still dont know, or its a pink pill and a red pill and Dr. Jones gave me a white pill, so it would be way more benefit and all the reminders on earth if I could just see out of my windshield when Im driving to know what theyre taking.
And we could intervene on both the redundant prescription and patient non-compliance because this could also tell us what theyre refilling and theres ways, theres formulas and stuff and pharmacy systems can do this and say this patient is not taking enough of this as prescribed or something. So one day youd like to have on the e-prescribing, now the first time they use the prescribing system they dont have to go in and type in all the drug, the just pull it down from the central source so its sort of what, its the infrastructure thing that we really need to kind of innovate and get all the stuff stimulated.
So at least one consortium, I guess its RxHub has the beginning of the capability to do this and I dont know how well formed they are, but they actually have the ability to send prescriptions down to you from those pharmacy managers they work with. So an e-prescribing system should provide a medication profile from the pharmacies that provides information about all the pharmacy sources in a single unified view, physicians shouldnt have to log into different systems to get this view and when needed the system could also provide a list of every individual prescription but what you really want is a profile which is a more sophisticated computed thing. So this lean and more useful version which only the most recently prescribed and not discontinued prescriptions for each distinct generic drug boil down, theres a boiling down here that I could spend a long time on you need to do, so you really need to have a common one of these generic codes to make this boil down right.
So you also have to be able to know who the patient is from these different systems and thats not trivial, I mean you really need to know, if youve got five pharmacy systems whos the same person or the same pharmacy system. Pharmacy benefit managers probably have more information that could help with this more then the individual pharmacies.
It would also mean that youd really like to have the physicians when they do e-prescribing be able to explicitly D/C a drug because now the inference is theyre on it if it hasnt expired and as a result in some of the pharmacies I worked with weve got three active prescriptions for the same drug because you rewrote it with more refills and they werent really out yet and they dont necessarily take them off although computationally you probably could. So youd really like to say hes not on this one explicitly just as an order, thats what you do on inpatient but it isnt generally the practice in outpatient, Im not sure theres even a mechanism to do it. I would be there is for the script system.
So now e-prescribing systems can provide other benefits to the practices including more refilled streamlines but I have to confess the recent way theyre doing faxes aint bad, theyve got these pre-printed forms and its all bolded and you hit this and hit that so its not as competitive as the old faxing, people can live with the new fax one. And the safety advantages for the e-prescribing should be equalable by the pharmacy prescribing, that is the same computer program can be checking things in the pharmacy side. So I dont think that thats the main reason to do it but I think there could be huge advantages on those two other things. Physicians would love it and they would go for it in an instant if you could get through some of these barriers. They may love it in addition because I write prescriptions in our own pharmacy system daily, and I write all my prescriptions that way and it is a good deal for us, for me, I like it, everyone doesnt like it. So I dont know that you need to have this other stuff but I think if you had this other stuff it would really make it downhill.
Those are my thoughts.
DR. COHN: Thank you.
DR. MCDONALD: Can I go now?
DR. COHN: I think we have people who want to badger you in the audience or the full committee first. Anybody have a question? Steve.
DR. STEINDEL: Clem as usual very good, thank you, we miss you. I have a couple of questions concerning medication, you said that it would be a simple world if drugs were identified by a generic name and route, have you thought about the RxNorm?
DR. MCDONALD: Well, I didnt want to pick particulars but it gets complicated and this is a longer discussion. Basically you dont want to go at the level of detail of the NDC, it would be nice if there was a common thing across the pharmacies to accomplish these other things and RxNorm I think would supply all that. Rx-Norm, I would wish for one more thing but its hard to ask for it because what I would wish for, you could ask for dyjockson oral pills but still be able to ask, but you cant do that for topicals and liquids, and when you look, its more symmetric to say you always have to say a pill size or a concentration, thats what RxNorm now is doing so theres nothing bad about RxNorm but if you could take it a step down where I didnt have to put the pill size as I prescribe because I can say I just want them to get 500 milligrams, I dont really care which pill size, whether its two 250s or one 500, and maybe fewer things in the choice, people could argue about that. But I think the key thing is to have something thats like RxNorm, the things that are in some of these knowledge bases are quite good, I know some of them well and theyre hierarchical and Im a fan of them, its just that somehow they either got to map, they got to get together, weve got to get something where theres a one way to do this, theres one way to get across these things and its not crucial that it be RxNorm versus one of the hierarchical codes in one of the knowledge bases, its just crucial that they dont create walls between the people who chose one version and another version and RxNorm might be a good lingua franca. I like RxNorm.
DR. STEINDEL: My next question actually in one sense doesnt pertain to what were looking at under Part D of MMA but just a general question, when you talked about a medication list and you specified all prescription drugs on a patient which is what theyre asking for under MMA and I think weve seen that, but as a physician would you like to also see a list that contains the other types of medications they might be on like over the counters or herbals and other stuff like that?
DR. MCDONALD: You may be getting me in trouble here. Firstly its all a good idea to walk before you run so I wouldnt want to say give me everything if Im not going to get something, the first thing is get the prescription medications. The other ones that have the most problems, the most challenges, theyre the ones that youre managing typically, are they getting their insulin, are they getting their blood pressure medications, and if they take an extra days block when theyre drinking one night I mean I dont care as much. But it wouldnt hurt, I think it will be a lot harder to get to that, it will require more data input and I wouldnt want to make that an obstacle. And the herbals are even tougher in a bunch of different ways, I think we get snaggled in privacy and all kinds of other stuff if people when they go to a regular store have to somehow record it and if someone in the office has to take time to gather this history thats going to be another snaggle and a cost and a barrier. But if you gave me the prescriptions Id be smiling all day long.
DR. STEINDEL: Weve heard that several times.
DR. COHN: Jeff?
MR. BLAIR: Clem, could you give us some guidance on preauthorization? What weve been hearing is a little bit of tension between the PBMs versus the prescriber as to what is the threshold of difficulty, maybe you could even help us zero in on what would be appropriate, in other words if a prescriber winds up wanting to prescribe something thats not on the formulary and they need preauthorization typically the prescriber wants it to be very easy for them to go ahead and go forward, on the other hand the PBM doesnt want to necessarily totally block it or make it impossible but they want to make it a little bit difficult because theyre trying to do a little bit of guidance where there might not be what they perceive to be as of use. Do you see a threshold here between those two views that may be helpful to us?
DR. MCDONALD: Yes, well I have some thoughts on it. I just want to make one other comment which I dont have in my written testimony and that is in the law it does not assert that providers need, prescribers need to enter the prescriptions and I hope we dont slip over into the world where they must because I think that could be, it could shut down offices. Right now you do an awful lot with nurses and your office staff and I should point out the pharmacies usually have, I dont know how usual, usually have pharmacy techs enter it, that entry class is real. In some environment it works and you enter it yourself. But getting back to your question, the needing of preauthorization is tantamount to not doing it, you just cant, you might as well not have it on the formulary, its horrible, preauthorization is death. What youre really faced with in most of the insurance companies is just payment differentials, they have to full or they have to pay different co-pays, and thats a little, you can manage that. The patient really wants, Medicaid has absolute and thats the one you cannot get from here to there half the time, you just cant do it. So I think weve got to really worry about so-called preauthorization, its just so much, however you do it its a delay, theres mix-ups, not knowing which is what, they get to the pharmacy they cant get it, you call back, now the office is closed, then you have to get the right paperwork to figure out who to send to what. So I think the preauthorization is really awful, I mean there are cases where they just dont allow it, its got to be prescribed by a specialist and so be it --
MR. BLAIR: Im wondering if what youre saying is consistent with what we heard from Dr. Chess and my understanding of what he was saying was if you provide me in the formulary the cost of what it would cost for a medication choice thats on the formulary and the cost of a medication thats not on the formulary and I share that with the patient to see if they could pay the difference, that that would be the information that youd want and not have to go through, not have to deal with preauthorization. Is that correct?
DR. MCDONALD: Thats correct, but its more then that, even when theres no preauthorizations you want to do that because theres penalty to the patient by making a choice that you didnt know about, the $10 dollar co-pay versus the $30 dollar co-pay. Theres clearly inducement being imposed and I dont know that its wrong because the cost of drugs is so high, and it keeps changing. Medicaid I think today if I write generic Emprisol(?) I can get a PPI to the patient, if I write anything else I cant. So thats what Im going to do, you can maybe dance and scream and somehow you might be able to get through with a call to get them to let you put emprisol or something else on it but Im just going to do the easy way, I dont think anyone, we dont know that theres any difference, that its going to make any difference to the patient. So having the information about whats on the formulary and what are the co-pays for the patient is very, very helpful, actually wouldnt hurt to see what the prices are because for some patients you might even negotiate some different kinds of approaches to things if its very, very expensive.
DR. COHN: Jeff, can I ask a question, follow-up? Obviously were talking a lot about the formulary and its actually been an issue that weve all been talking about, its sort of this issue of presentation of the information and obviously at one extreme is this issue of preauthorization. But even before that is all this issue about financial data, co-pays and all of this. Now I wasnt sure whether your system has any of that information in it --
DR. MCDONALD: This is what is particularly frustrating, have a tool and we load it by hand, well, we have our own pharmacy which is a county hospital which tends to be the pharmacy of choice in the community, people that dont have enough money to pay their health care. But we have, theres two other big ones, we actually load it in by hand once and its beautiful, reading everything and figures out it goes here, but we couldnt keep up with it, theres actually ten of them that we get that are significant numbers and we cant get any of it electronically, let alone being a standard way, it just comes as books, so we dont have the capability operationally practically, except in our own pharmacy, in our pharmacy at our hospital its pretty severe. And they make deals, they get deals and those are the drugs that you choose selectively, its not on the formulary. And I think thats what the pharmacy benefit managers do too, they make a deal so they get a better price and thats the one of the three of these drugs which are undistinguishable from clinical trials so I dont feel thats horrible, its just that I cant keep track of it so Im writing Benazepril and also Ceniprol(?) and then the poor patient is put through all these hoops.
DR. COHN: So just to make sure I understand, its sounding to me like what youre saying is if there was some easy standard fashion to get that information from sort of the minds of the health plans and PBMs and whatever and easily be able to upload it relatively frequently into your systems, that makes for a good day.
DR. MCDONALD: Right, I wouldnt mind if it goes out to a website and checks it on the fly because it changes a lot. Its the challenges, and I should point out there is a consortium of PBMs that does have that available, and it is I think, just as inference, many of the e-prescribing systems say they have it and I think thats where they get it but there may be other source, someone else may have compiled it, but thats probably 10,000 formularies, or 5,000, its a lot of formularies but it aint all of them, I know Anthem in our state isnt part of it and thats a big payer and Medicaid isnt part of it. Medicaid also has it on their computer and were not allowed to get to it, so what we do get from Medicaid is very quickly a note saying oh do your realize this patient has gotten three narcotic drugs in the last two days, but we arent yet, hopefully that will change where you could poke in and there would be some standardization to it so either a system of taking it in or you get something, what youd like to do is get the drugs, youd like to get your drug menus of what youre going to write be constrained and not have to choose it and say wrong answer, try another one, wrong answer, keep opening the door and which ones the tiger going to come out, just see these are the ones, or you see it on the screen, but I wouldnt mind having it all squish down, these are the ones you got and then you can click on some, say these are the ones that might be a problem.
DR. COHN: So let me just make sure I understand because you mentioned earlier about the web, would having this up on a web, one for Medicaid, one for whatever --
DR. MCDONALD: If an application could address it, if an application could probe it, not if you had --
DR. COHN: So you dont want yourself to go to a website --
DR. MCDONALD: A server somewhere --
DR. COHN: I just wanted to be sure about that one because it seemed to me a little overwhelming also. Harry?
MR. REYNOLDS: Weve heard a lot about prior approval, Ive heard that actual prior approval in drug situations is less then two percent, what would you put it at? Not knowing whats on the formulary --
DR. MCDONALD: Outside of Medicaid its pretty rare in my environment.
MR. REYNOLDS: I just wanted to bring it, were spending a lot of time on it and I think it is under the general practice a little more outlier as a real prior approval, not situations where somebody doesnt know what is or isnt on the formulary, thats a different question.
DR. MCDONALD: I mean its not that you cant get it, its the cost changes is what happens.
DR. COHN: So knowing the benefits of the co-pays and all that is probably the more importance piece.
MR. REYNOLDS: Because thats a subject where youre kind of going outside the process and theres something going on and it probably may never get away from some kind of an interaction back and forth at least from a standpoint of a covered drug, whether its --
DR. MCDONALD: The pressures are enormous and the reason why Medicaid is going to these steps is because theyll have to sell Indiana to some other country to pay for the cost I think, I mean they really are blossoming, I dont know how you get money when youre a state and you cant get any more taxes out of people, maybe wed have, well, anyway, sell names of things. But I understand it but they end up with these vectious(?) things arent really right and the rules arent really right and the rules are flipping and changing all the time and you cant keep track of it. I dont know the answer on the drug side but I personally am a fan of old cheap drugs because youre never surprised by the old cheap drug and the new great drug is the one that two years later ooh boy, it kills the liver and things like that. So you know all its good parts and bad parts.
DR. COHN: Well said. Was there somebody who was, a question or a comment? Just introduce yourself --
MR. SHEATH(?): My name is Tony Sheath, I am the managing partner at Point of Care Partner, its a consulting concern, 80 percent of our business is in electronic prescribing. We also produce a newsletter called e-Prescribing Perspective, it goes to about 400 stakeholders in e-prescribing. My clients include pharmaceutical manufacturers, insurance companies, PBMs, and a number of the different technology companies. I just wanted to give that sort of as a background to let you know sort of where Im coming from. Ive been in electronic prescribing for ten years, the first five years, in the mid-1990s I was the product manager for an electronic prescribing solution that no longer exists and five years prior to starting my firm I worked for Medco Health Solutions whos represented here today.
What I wanted to do was shed light on one of the things youve discussed today which is formulary aggregators and as Dr. McDonald had mentioned RxHub is indeed one of the formulary aggregators. In my experience there are five companies that aggregate formularies, four of which provide them today to technology companies, to electronic prescribing solutions or to electronic medical record companies. Those are RxHub, who has been mentioned today, CAQH, who testified to you guys last --
MR. BLAIR: Could you start that list again please?
MR. SHEATH: Sure, RxHub, who youve discussed today, CAQH, who testified at your last hearing, Medi Media, the infoscan formulary and by the way theyre here today, and the fourth would be Proximet(?) who also testified to you today as a switch, as a continuity company. Proximet also provides some formulary and Dr. Jack Gynan(?) mentioned that last time. The fifth company is Epocrates(?), Epocrates is a reference company who has been mentioned today, they do more sort of reference information relative to drugs but they also have a formulary reference that they have in their hand held. To my knowledge Epocrates does not today provide the formulary aggregation to any sort of a solution to electronic medical record or e-prescribing company, however they are integrated with at least one of the e-prescribing companies, that being Doctor First, that however is back, not formulary, its back to the referential solution.
I just wanted to sort of, because theres been a lot of questions about that and I just wanted to sort of level set on that particular point.
DR. MCDONALD: Does anyone have them all? Because I didnt know if I was right on that.
MR. SHEATH: Well, I would say that Medi Media is pretty close to having them all, RxHub as you represented today has the three largest PBMs which represent I think 140 million lives between the three PBMs. And I dont know Brian, if you want to say anything, Brian from Medi Media is here as well.
DR. COHN: And I think we have written testimony from you also.
MR. DANBERGER(?): Yes, you do. Brian Danberger(?) with Medi Media, Im president of Medi Media Information Technology, its a division to develop the formulary database. Id like to thank you, its an excellent point, several points that you made in your presentation on the implementation and the importance of the formulary. Weve been working for five years or more with the electronic partners, six years now, and prior to that in publishing formulary information, in compendiums of formulary information, we have 3400 of them so we may not be to the entire universe that folks are looking for but there are 3400 organizations or benefits, three tier, two tier, multiples in there for each plan, and 47 Medicaids for the states that have PDLs.
Getting the formulary in and correct was actually the easy part, we didnt know it when we started because it was plenty hard to get the methods down to integrate these disparate preferred drug lists, formulary books, and we accept information in a paper form, fax, email, post it note, napkin, any format that we can collect it to keep it as up to date as possible. But what became the most difficult part as we started to roll out in the industry and license, and we license to about 20 different vendors today, is identifying which patient goes with which formulary, how do you create that connectivity there because there is no identifier and you could be with a large health plan for your member benefit and theyre in your office and you say oh youre with Plan X but not their pharmacy benefit comes from some other card or other system and being able to identify that. Its been a most difficult challenge for the physicians offices that weve worked with to implement this and were estimating theres probably over 20,000 physicians using our data in their software platform with various levels of update.
DR. MCDONALD: So the insurance company link is still tough.
MR. DANBERGER: Yes, absolutely. And it is a small number and every quarter when we get our reported figures in from the vendors that are using our file were looking at whats the increase, how do we smooth it out, what knowledge can we get, and when we put up a new practice well get the listing in from those billing system that the physician uses and then we try and make sense of that against the formularies that are out there and it isnt a one to one correspondence, its a many to one or many to many in some cases to identify those. So thats been the biggest challenge, identifying is it a two tier co-pay, is it a three tier, is it just a flat open formulary, whatever.
DR. COHN: As I remember in your testimony you had been sort of proposing some sort of a standard for benefits description on the card as at least some sort of a solution to this issue.
MR. DANBERGER: Yes, there needs to be some way to identify that, Ill go back and use my personal health experience with my wife when she takes the kids to the doctor and she says how come its always the $40 dollar co-pay when I go in and she has no idea how to figure out how to move that back but she does know that theres a $40 dollar co-pay and she knows that theres one less then that, so she can tell the physician that theres a three tier co-pay in place but she doesnt know which medications are which or how to figure that out or how to explain it to him and hes clueless when hes trying to write the antibiotic for my kids. So some way to identify that is a vital piece of this whole puzzle as were moving forward.
DR. COHN: So thats described as the missing link to really being able to leverage the formulary.
MR. DANBERGER: And because weve had six years of practice of integrating formulary databases, actually we started in 1996, so that piece you can get down, we linked all the major drug files, so you end up with a crosswalk between them and yes they dont all exact, theyre not totally swappable, but those are things that you can overcome with dedicated people from HL7 and NCPDP and figuring those things out. And were moving, that car is moving down the road, but the one to identify which patient gets connected to which formulary doesnt exist yet.
DR. COHN: Well, thank you.
MR. SHEATH: This is Tony Sheath again. Id like to add one additional piece of information, I mentioned that RxHub and CAQH were two of the I guess four that provided formulary information. RxHub and CAQH are now working together so theyve sort of joined their formulary information together and are providing that to different solution partners.
Were not to open mic but I wondered if I could sort of piggyback on something that Brian said that I think is absolutely critical --
DR. COHN: Sure, I dont think Dr. McDonald minds --
DR. MCDONALD: I actually wasnt sure about some things so its great to have some clarity.
MR. SHEATH: I want to sort of underscore something that Dr. McDonald said earlier and also you actually asked some follow-up questions of Dr. Kennedy and this came up, I read all the testimony from the last time, I wasnt able to attend but I read, and some of the different vendors brought up the challenge that they have of getting practice management information into the clinical solution. I think thats a real critical challenge, whether its a stand alone e-prescribing solution like some of them that talked to you last week, Doctor First and Zicks Corporation, and Allscrips would be examples, or whether its an electronic medical record solution, they all still have the challenge of getting patient demographic data from the practice management system into their solution. I was responsible for a pilot once in I guess it was right around 1999 I think it was in Kokomo, Indiana, it was a 14 doctor physician group and we implemented an electronic medical record solution. We interfaced with a practice management system that didnt use HL7 so it was the sort of proprietary solution that Dr. Kennedy was talking about this morning, it took them three months, it took our technicians three months to build that interface. So its clearly, Id like to underscore something that Dr. Kennedy mentioned this morning, that the practice management, lets call it the administrative world of physicians offices, is still exceptionally fragmented, they do utilize standards, the standards that they tend to utilize are HL7 and Im sure Dr. Huff and there are other people that can go into more depth on HL7 then I can, but there are also many sort of homegrown, its kind of a cottage industry, there are still many homegrown solutions among practice management solutions that dont use standards at all. And so its a real challenge for those software developers that operate in the clinical world to get information out of the practice management system, be it patient demographic information or be it formulary information, its just a real challenge and I know that its been discussed but I feel its important to underscore that challenge.
DR. HUFF: Id just comment, just in Utah, I mean were trying to create interfaces to these practice management systems and its just as you described, I mean when we went into it we were thinking oh, if we did maybe interfaces to the top five practice systems we would capture 80 percent of the things and no, it turned out there was no vendor that had more then 10 percent market share and that you had, to cover 80 percent was like 50 vendors because there are just this huge number of sort of mom and pop software vendors that have developed these office systems and its terribly splintered, youd love to have some dominant, Quicken or something that took over the office practice. And those small shops, they dont know about HL7, they dont know X-12, they say what --
MR. SHEATH: And many of the particularly the stand alone solutions, they actually have to go to the step of asking their office staff to input patient demographic information. Actually what many of them do is they get a download out of the practice management system, its often one time, its pretty expensive to do a real time interface between the solutions. So if its a one time sort of download then office staff needs to manually input that information every time a new patient comes in. Well, I had some experience on Staten Island with a particular project and the one doctor I worked with estimated that he saw as many as five new patients a week, Im sorry, a day. And so what it became was a burden to the office staff to input this information. So its a real challenge that the I think the committee really needs to sort of think about, is this sort of interface between the clinical solutions and the practice management solutions, and one more point Id like to make is that office staff often, because the practice management solutions are used for billing mostly but many other things, scheduling and other things, I dont want to down play what their value is, but particularly for billing the demographics in the practice management system is the source of truth . So in other words they work very hard to make sure that information is accurate, theyre not going to want any sort of variance on that side so the critical sort of link is getting information out of the practice management system and into the clinical system, thats the critical flow.
DR. MCDONALD: Just to get back, I dont know that weve tackled the national number and all that, but maybe just a swipe card that had something on it that everybody could understand, where you could make it faster to have to load it into another system, or just some, we cant ignore that problem or the set of fields youre going to send, or maybe you have some alternative ones --
DR. COHN: Well certainly one has to be thankful that weve already done HIPAA now, at least there ought to be in the practice office management system some standardization there even though currently a lot of people do have older systems and we know that. Jeff, you had a question.
MR. BLAIR: Yes. In addition to the impediment of having a fragmented practice management system marketplace with a lack of standards, Im hoping youre going to answer no to this question, has the HIPAA privacy regs been an additional impediment for you to be able to get patient demographic information into the e-prescribing systems?
MR. SHEATH: First Ill admit that Im not the best person to answer that, my understanding, I have four technology company clients and my understanding is that its not been a barrier.
MR. BLAIR: Good.
MR. REYNOLDS: Jeff, this is Harry, it shouldnt be unless somebody didnt know how to use it.
MR. BLAIR: Yes, I agree, I was just, I felt we need to know if it was.
DR. COHN: I think Lynn Gilbertson wanted to make one comment here. By the way I want to thank everyone here for putting together ad hoc real time expert panels, this is very useful.
MS. GILBERTSON: Lynn Gilbertson, NCPDP. Just one more thought about the pre or prior authorization process. If in the Medicare Part D environment that percentage of how many prescriptions may require an authorization is above what current practice is it needs to be part of the consideration for the success of the program.
DR. MCDONALD: What number?
MS. GILBERTSON: Somebody cited --
DR. MCDONALD: What number --
MS. GILBERTSON: Or actually you did, no, I dont know, Im just wondering if part of the Medicare Part D process will require more drugs to have prior authorization, we may be in a bit of trouble if we dont address it ahead of time.
MR. REYNOLDS: In other words if most of us are experiencing two percent and they go to 15 --
MS. GILBERTSON: It is an issue, its not something thats a tiny problem.
DR. MCDONALD: Id just like to clarify that Medicaid is not that low and they account for a reasonable percentage of all the prescriptions, I dont know what it is, but of the private, of the commercial insurance Id say its pretty low.
DR. COHN: Okay, thank you. Other questions or comments? This was very good.
MR. BLAIR: Clem since I cant see and since youve answered all these questions and Im really impressed with your breadth of knowledge and experience --
DR. MCDONALD: Well, I can fool you Jeff but I cant fool everybody.
DR. COHN: Well, actually feel free to stay and listen, were really actually at this point going to move into sort of open microphone and see what other comments or ideas that other people have, please.
MR. ROTHERMICH: Phil Rothermich with Express Scripts, I just wanted to underscore something Harry said about prior auth. Were talking about managing exceptions with prior auth, I mean almost universally plans and PBMs know that prior auth is disruptive so they use it when theres a clinical reason to cover something in a very limited circumstance for a very expensive drug. So you have to be careful if you want to take down the barriers to understand that the decisions may be, you think about unintended consequences, decisions by a lot of health plans may be to just not cover it because what theyre managing is is expense and thats why theres a lot of prior auth in Medicaid because there are certain people who need very expensive drugs but if the plan covered it universally theyd run out of money.
So with all the conversation about Im concerned that people are thinking weve got to solve this problem and so take down the barriers and make it harder for people to use prior auth as a benefit tool, but the consequence may just be that people choose not to cover things and thats I dont think what people are hoping to get to. So it is an exception, its usually a rare exception, there are other tools people use like step therapy and things that are more common but in all cases that are benefit decisions used to manage overall costs and those things you cant change. So in order to understand that a person is actually in the rare sort of exception circumstance theres going to always need to be a dialogue. So telling people PA is required is one thing, but if you go and try and solve the problem and make it all electronic you may end up with consequences you dont intend to get to.
DR. COHN: And just to remind everyone, this subcommittee nor the full committee is authorized to remove preauthorization or step therapy. I think our biggest concern is that whatever needs to occur can occur within workflow and not become too disruptive to care, I think these are really the conversations. Other open mic questions, comments? Whichever one of you wants to go first.
MR. HAUSNER: Im Tony Hausner with CMS, given that prior authorization came up, we certainly, we just published as probably all of you know the proposed rules on prescriptions drugs and we welcome comments on either side of the fence as far as prior authorization, I dont think we state anything in the proposed rules but theres a lot of areas that we dont state anything because were interested in public comment on these issues.
DR. SULLIVAN: Im Tom Sullivan, Im a solo practice physician from Massachusetts and Ive been involved sort of peripherally from a physicians perspective in this area for ten or 15 years. I agree with most of what Dr. McDonald said, but I also heard some other comments that there were only four formulary aggregators, or five or whatever, I want to point out that I just finished a term as the president of the Massachusetts Medical Society and about ten years ago we started a project to aggregate formularies and about seven years ago we produced our first paper guide. Things have changed a lot in the last seven to ten years about how easy it is or difficult to aggregate formularies.
At first the health plans just didnt want to sit down at the same table with one another ten years ago, for no reason whatsoever, and then I think they also didnt trust the medical society being the mediator because we have so many differences in other areas. But gradually over a couple years they agreed that this might be a benefit of physicians making it easier to figure out which patient was on which formulary. And then the tiering process came in, and thats t i e r, it was a lot of t e a r s on the physician side. And now that weve moved to an electronic format all of a sudden the health plans are acting the same way that they were ten years ago, in part they dont want to sit down and put something that weve been doing on paper for ten years, almost ten years. They see somehow the electronic, putting this information into an electronic format is something very different and Im not sure I can get to the bottom of it other then say they tend to be naturally competitive, theres nothing wrong with that but again the formulary is a lot more complex.
Weve proposed having web services that the medical society would host and make free to the public and to every physician. But again, I think part of the difficulty is the complexity that has surrounded the health plans going electronic with their formularies and the arrangements with the PBMs have made this much more problematic, I think the PBMs have done a good job, Ive been on a health plan formulary committee trying to pick the right drug for 15 years so I think the PBMs have helped with that but theres also a lot of complexity that has been involved with whose format and is there an opportunity for the health plan to make some extra money by having their formulary in an electronic format thats easily searchable, whatever, it just seems that this spirit started many years ago, we succeeded when it was on paper and now its become more difficult because theres a business that has built up around it.
So I also agree that preauthorization for us is really only a huge problem with our state Medicaid and I think there are many people in Massachusetts who would like to sell our state to another country, we get to talk about that. Thank you very much.
One final thing, Im actually going to be here tomorrow to talk about the continuity of care record and that might help us with developing a standard interface between these practice management systems and stand alone e-prescribing, Ive been using stand alone e-prescribing, two different systems for well over a year so Im pretty familiar with them and once again I think this continuity of care record standard could help us, I agree with the prior speaker that getting the practice management system information into the e-prescribing or whatever other clinical module youre talking about and a more fully functional electronic medical record could be at least a temporary solution.
DR. COHN: Tom, thank you, any questions for Tom? You need to come to the microphone, introduce yourself. Tom thank you, well see you tomorrow morning.
MS. HOWARD: Good afternoon everyone, my name is Cynthia Howard, I work at CMS with Maria Friedman. Im a new kid on the block but I just wanted to make a comment, Ive been hearing a lot about medication reliability and I was a care giver for my mother for years and I made a database with her name, address, phone number, Social Security number, her doctors, allergic medication, all her medications on the list as well as any other pertinent information, next of kin, her doctors loved it, even had copies of her medical cards so that she went to her doctors so much that I couldnt keep up with it. So even one of my doctors even wanted me to make a blank database for his patients so that they could start doing that because its so much involved, people bringing in bags of medicine that its too difficult. And then I was able to detect if she went to an emergency room oh no, she had this before, this doctor has done this, or this doctor has not done this, so it really helped as far as the doctors. I even invested in a fax machine because I had to go back home, refax the new sheet, because the emergency room doctors could not tell all the medications that she took. So I was really organized in that although they didnt want to see her but they loved to see me because I was so organized in that respect. Thank you.
DR. COHN: Thank you. Dr. McDonald.
DR. MCDONALD: I just wanted to ask about the new regs, is that related to the Medicare benefits, prescribing benefits? And as you can maybe reveal, its probably big, they always are, is there anything in there about actually accomplishing the prescriptions, we could get a view, physicians could see all the prescriptions a patient is on if theyre on Medicare?
MR. HAUSNER: The only place where I see that offhand is medication therapy management services that the prescription drug plans and, well particularly the prescription drug plans, I think also Medicare Advantage Plans are supposed to offer those services and the pharmacist then is supposed to do these kind of brown bag consults and then work with the physician on that. So thats one service were --
DR. MCDONALD: Electronically is all, I mean I just, you have the power --
MR. HAUSNER: That has been programmed in there electronically, presumably the prescription drug plans would have the capability of doing that but thats not required in there --
DR. MCDONALD: Are they going to report back to Medicare as the hospitals do or Part B, are you going to get detail back centrally about prescriptions?
MR. HAUSNER: We will get all, from NCPDP we will get all the claims that are filled by the prescription drug plans so we are getting that or at least an extract of that, I guess were going to get the whole thing and then for our risk adjustment were extracting certain data and I think QIOs will have the whole data file from NCPDP available to them.
DR. COHN: Good, maybe another source of data, or at least of the drugs. Other comments, questions?
MR. ZORRO: Tom Zorro with FirstDataBank. Just a couple things of clarification, Dr. McDonald stated that NCPDP script standard requires NDCs, it allows NDC but it doesnt require NDC, so you can use a lot of different types of drug concept identifiers within script. And the comment from CMS about NCPDP providing any type of information about drug utilization, thats not something they would provide, so the source of that information would have to be the PBMs, it certainly wouldnt be NCPDP.
DR. COHN: I think Karen can clarify that.
MS. TRUDEL: Yeah, I think what Tony was saying was that the NCPDP telecommunications format would contain the claim information that would go to the PDP and then to Medicare for risk adjustment.
MR. ZORRO: And thats certainly true.
MS. TRUDEL: The format not the organization.
MR. ZORRO: I also wanted to make a comment about the practice management systems that exist in physicians offices now, and I think its like pharmacy was many years ago for those of us who knew that pharmacy practice management systems were built kind of the same way, there was a lot of very small vendors, some of them were mom and pop shops, they may only have two or three installations. And what happened in pharmacy as things became consolidated and we started to get standards of some sort organizations and businesses came to the forefront and said theres a way to make money here in doing conversions from these mom and pop systems to a more standardized management system. And I think that the business of the United States is business and I think thats what well see happen here so I think that some of these things that are certainly going to be impediments to the immediate acceptance of certain standards for practice management systems I think will eventually be able to be met and taken care of.
PARTICIPANT: Just a quick follow-up on that, as anecdotally you would be incredibly surprised how many calls we get a week for someone whos writing, came up with the great idea of writing electronic prescribing software and just is inventing a new idea in their mind not having searched the universe yet, doesnt have a drug database in their system, is looking for formulary information, heard about us, tracked us down, whatever, and theyre installing their first doctor physician practice as a beta next week. I mean its just incredible the number of companies that are starting up but in some ways even in e-prescribing where weve seen a number of companies go out of business we also see continuing fragmentation as more companies say we can do that, how hard could it be.
DR. COHN: I think theres a role for standards in the United States.
MR. SHEATH: Im sorry Tom, I have to beg to disagree. My experience is that these practice management systems, its a very fragmented market, its been that way for a while, there was some consolidation in the mid-1990s where some of these companies started to buy up other companies. The conversion over to one solution has been very slow, its exceptionally complicated. Doctors offices and Dr. McDonald may be, there are others that might be able to comment on this but doctors offices tend to not like to change their billing systems, their practice management systems. They do it but its a major decision for them, its not quite the same, the physician office world relative to practice management is not quite the same as the pharmacy world was and I would strongly disagree.
I dont know, Im sorry I wasnt at this last meeting, I dont know if this is the place for suggestions but it seems to me that if at least all of the practice management systems were on the same version of HL7, I dont know that we need to create new standards but if there was some way that we could get all the solution providers to be in the same standard that exists I think that would go a long way, thered still have to be an interface between the clinical system or the e-prescribing system and the practice management system but at least it would be less complicated if everyone was on the same version of HL7.
DR. COHN: Dr. McDonald you probably would agree with that comment --
DR. MCDONALD: Well its not so much HL7 although I work a lot with HL7, its just that we have this idea were going to really get standards by making two more new ones so now we got five instead of, I mean its the wrong, weve got to be really conscious how hard this stuff is and in terms of office practices, I think the offices think of that as like youre going to change a ventilator on me, youre going to leave me off it for an hour, I mean it is really, really tough and theres so many stories about guys almost going out of business with switches, even in hospitals, I mean I can tell some of those when they switch billing systems, its just very scary.
DR. COHN: Other questions or comments? Comments from the subcommittee? I know its been a long day, are there things that you would like to comment or reflect on at this point? Obviously we have tomorrow and well spend all of Friday morning I believe with, we dont have any testifiers on Friday morning, so we have all of Friday morning to also collect our thoughts and think about next steps but if anybody has anything to say, Steve?
DR. STEINDEL: Yeah, I would like to vote with selling Indiana. And Simon, I actually do have a little bit more serious, I have some comments to make probably on Friday but one comment for today that became very clear, I think it came very clear in the Wellpoint discussion and that was also a little bit in Clems discussion, and I think one thing we need to be clear about when we put this together is the use of the internet, that it can be used for e-prescribing. We had problems in the HIPAA world with the use of the internet for this area and I would perhaps just like a quick comment from Lynn Gilbertson, does NCPDP script preclude the use of internet? I think no.
MS. GILBERTSON: [Comment off microphone.]
DR. STEINDEL: And I just want to make sure that were crystal clear in the letter.
DR. MCDONALD: Sorry to be, I was always this way, I havent stopped I guess, but the issue when we say standards, we use it very broadly, what the real issue is is we have, its like when you put the gasoline hose into the car, we have four or five coupling points and those coupling points the issue really is the identifiers, thats where were getting mostly stuck and I hadnt even realized that there was even at the plan level, I just kind of assumed that by golly they must have fixed that by now. But its these little points of contact that are very special, now the messages work and all that but it doesnt help if you dont have the same code in the spot or the same identifier type or a way to get from one to another, they dont have to be the same but weve got to solve that.
DR. STEINDEL: Just picking up on, I was going to defer this a little bit to Friday but one thing that Clem did say that I dont think was clear to me beforehand, and we have had it mentioned to us multiple times about the need to have an e-prescribing standard that goes to the pharmacy, the specific pharmacy, but you made it clear that that actually imposes some type of workflow issues that we do need to consider.
DR. MCDONALD: And you want to be able, if you want to get this medication profile youd like to be able to get them all as one.
MR. REYNOLDS: One concern, the patient identifier, at a time where it wasnt picked up as part of HIPAA, when it was sitting there to be plucked out of the air if it was chosen to be, and second at a time when most of the health care industry whether its hospitals, payers or others are running away from Social Security number as fast as they can, spending millions of dollars de-identifying individuals, I struggle with that, I will continue to struggle as we talk about standards as to how we overcome or even consider making that part of a standard recommending going forward in the midst of the fact that it was there for their choosing for exactly the same kind of reasons. And second, the industry, everybodys trying to de-identify and now this, it continues to come up, Im not negating any testimony, Im talking about the reality of what seems to be the lay of the land so as we consider this, this one is one I just continue to struggle with.
DR. COHN: Well, Harry, let me give you a couple of good answers here, one which is a good answer, another which is a conundrum and I know Karen raised her finger. The good news is in the world of Part D Medicare members have HIC numbers and so they actually have an identifier that is used by their insurance company, otherwise known as CMS, to uniquely identify the member. And so for Part D maybe we have a little bit of a bye on that one.
Now on the other hand, on Friday at the NHII Workgroup meeting we were lateralled by a request that we investigate the issue not of unique identifiers but how do you uniquely identify patients in the health care system, and not with the idea that there would be a unique identifier but recognizing that theres probably pointers and a number of other approaches that might help as all of this begins to come together in the world of the NHII and others that we should be looking at and maybe these are master patient index approaches or whatever.
So the good news is that for Medicare we have a bye, the bad news is that as a subcommittee we dont have a bye --
MR. REYNOLDS: You know against the testimony for Medicare, against the testimony and against what happens in reality, we dont have a bye, because if I am 64 and a half and then I got to Medicare when Im 65 I was identified as one thing at 64 and a half, I go to Medicare Im identified as something else, Im talking about the philosophy of the one patient, all their medications and how do I identify. Now any new prescription taken in Medicare at that point is added, I might be taking ten, one or two might be new, you know me as two situations, you dont know me as ten which is what the overall thought of this thing is. So Im not, yes, Medicare will work and Im not challenging that but Im talking about the philosophy of what were trying to set a standard for, which is the full view of the person, and when they switch coverages thats where its always been a problem, when you switch coverages youre a new person, have a nice day, here we go again.
DR. COHN: Harry, Im saying that were going to be in one way or another --
MR. REYNOLDS: I was being argumentative, Im trying, this is a conundrum on how --
DR. COHN: Weve got Steve and Gail.
DR. STEINDEL: Just commenting Harry back, I think what Simon is really somewhat, I hope what Simon is referring to, I think we have a bye with respect to the pilots.
MR. REYNOLDS: I agree with that.
DR. STEINDEL: I dont think we have a bye with respect to the system.
MS. GRAHAM: I just had, we just finished our workgroup under Connecting for Health about identifying patients and our report is actually due out next week --
DR. COHN: Its already been released.
MS. GRAHAM: And its more to the use of multiple traits to identify individuals.
DR. COHN: Actually Gail it was released last week --
MS. GRAHAM: The framework was released but the our individual report --
DR. COHN: Well, I was obviously being cute but obviously this is an issue were going to have to be talking about more, its been requested that we look at it. I dont think its needed for our September letter thankfully but its not too far off in the distance and it will probably be something we handle over the next several months of hearings.
MR. REYNOLDS: The fact that youve taken it out of the September letter is more then appropriate for my question.
DR. FITZMAURICE: I just want to recall that it was about four years ago that Congress told us not to do any work on final implementation of a national provider without their explicit okay and they keep putting down in our appropriations bills every year, and what we heard at the conference well you may not need a unique patient identifier, you just put what you know about the patient into a hopper and that machine goes out and links everything that looks like what you put in the hopper. I mean in that hopper most everybody will keep the Social Security numbers, date of birth and zip codes and all of this so youve got a lot of information in there and it seems to me that the protection that not having a unique identifier gives linking data is not so great, they can link it anyway. And so you may want to look at the efficiencies of having a unique identifier, Medicare has one.
DR. COHN: Other comments?
DR. STEINDEL: Theres a comment and what well see in the, Gail probably can address this much better but well see in the Connecting for Health report, there really arent that many efficiencies gained by having a unique identifier.
DR. COHN: I suggest we hold this particular conversation for a time where we actually have some expert testimony as well as the benefit of the final roadmap. Are there any other comments before we adjourn? Okay, well I want to thank everyone for really whats been a great day, I want to thank our audience for providing expertise to the subcommittee, we will adjourn and reconvene tomorrow morning at 8:30. Thank you.
[Whereupon the meeting was recessed at 5:20 p.m. to reconvene the following day, Thursday, July 29, 2004, at 8:30 a.m.]