[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: If you will be seated we are going to get started. Good morning, I want to call this meeting to order. This is the second day of 3 days of hearings of the Subcommittee on Standards and Security of National Committee on Vital and Health Statistics.
The Committee is the main public advisory body to the US 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 on the second day, our staff and thank them for their help putting these sessions together and obviously others here in person.
I, also, want to welcome those listening on the Internet and I want to remind those testifying as well as on the Subcommittee to speak clearly and into the microphone since these don't work very well unless you are very close to them, and I know many of you have experienced that over the last day and one-half.
This morning we continue our work regarding e-prescribing standards. We are starting with a presentation and discussions on the continuity of care record being developed by ASTM and others. We follow that with a discussion with the PBMs on their perspective on e-prescribing standards. After lunch we have conversations with, oh, I am sorry before lunch we also have the Pharmaceutical Manufacturers' Perspective.
After lunch we meet with the pharmacies and their perspective and then we go from there into an open microphone and subcommittee discussion period towards the end of the day.
I want to emphasize that this is an open session. Those in attendance are welcome to make brief remarks, if you have information pertinent to the subject being discussed. We will also have time for brief comments by those in attendance during the open microphone period.
For those on the Internet we welcome e-mails and letters and comments on issues coming before the Subcommittee.
With that let us have introductions around the table and then around the room. For those on the National Committee I would ask if you have any conflicts of interest related to any issues coming before us today would you please so publicly state during your introduction.
Jeff?
MR. BLAIR: Hi, I am Jeff Blair, Medical Records Institute. I am Vice Chair of the Subcommittee on Standards and Security and I am a member of AMIA, ACMI, HL7 and ASTM. Today we have testimony on the CCR from ASTM and so it is appropriate for me to explain what relationship I do and don't have there. So, although I have been a member of ASTM I don't think I have actually attended an ASTM meeting for to the best of my knowledge about 3 years. So, I am not really actively participating in it.
However, my employer, Peter Wegerman is currently Chair of ASTM and while he is not one of the two co-chairs of the CCR group it is something of interest to him and if it is of interest to him it is of interest to me. So, I feel like it is appropriate that I recuse myself with relationships to discussions and votes on the CCR.
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 Health Care Research and Quality, staff to the Subcommittee and liaison to the full Committee.
DR. MEDIA: Margaret Media. I am an independent consultant and contractor to the Subcommittee.
DR. ZARCUBUNE: I am Alan Zarcubune. I am a pediatrician at Georgetown University School of Medicine, member of the American Academy of Pediatrics who is one of the sponsors of the continuity of care record and also on the steering committee that is working on that, a member of NCPDP and also working with Sure Scripts on developing combined applications for the CCR and electronic prescribing.
DR. SULLIVAN: I am Tom Sullivan. I am a solo practitioner north of Boston. I am a member of ASTM, HL7. I am the co-chair of E31.28, the committee that oversees the CCR. I actually brought the continuity of care record with the Massachusetts Medical Society to ASTM and a few weeks ago I became a part-time consultant for one of the e-prescribing vendors, Dr. First, a product that I have been using for about 9 months.
DR. BRAITHWAITE: Good morning. I am Bill Braithwaite. I am an independent consultant in Washington, DC. I am also on the steering committee of the CCR. I am the Treasurer of HL7 and I sit on a bunch of other standards related bodies.
DR. GRAHAM: Gail Graham, staff to the Subcommittee from the Department of Veterans Affairs.
MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services, staff to the Subcommittee.
MR. REYNOLDS: Harry Reynolds, Blue Cross Blue Shield of North Carolina, a member of the Committee.
DR. WARREN: Judith Warren, University of Kansas School of Nursing, member of the Committee and I may possibly have a conflict as I am co-chair of the patient care TC at HL7 just because we deal with some of the same content that is coming from CCR today.
DR. HUFF: Stan Huff with Intermountain Health Care and the University of Utah in Salt Lake City, member of the Subcommittee. I also have potential conflict with HL7 inasmuch as I am a co-chair of the vocabulary technical committee and a former chair of HL7.
MS. FRIEDMAN: Maria Friedman, CMS, lead staff to the Subcommittee.
PARTICIPANT: Beginning the conversation I do want to comment about everyone's recusing themselves. I guess based on what I am hearing I am really hearing notices of potential conflict. I am not actually hearing reasons for recusal at this point especially based on I don't think we are going to be voting. I think we can relate it to the chronic care record, so just a clarification there.
DR. MALIK: My name is Ed Malik. I work with Prescription Informatics.
DR. FINK: I am Carl Fink, also, with Prescription Informatics. We are an e-prescribing technology company.
MS. ANAGNOSTIADIS: Eleni Anagnostiadis with the National Association of Boards of Pharmacy.
DR. GREGORY: Mark Gregory, Cardrug(?) Pharmacies from North Carolina.
MR. KILGO: David Kilgo with WalMart Stores, Incorporated, Arkansas.
DR. BIZARO: Tom Bizaro, First Databank.
DR. RAMPI: Bill Rampi, WalMart Stores, Inc.
DR. BUSOWITZ: Ray Busowitz, National Association of Chain Drug Stores.
DR. ZIGMANUCH: Marilyn Zigmanuch, America's Health Insurance Plans.
DR. WILLIAMSON: Michele Williamson, National Center for Health Statistics, CDC.
DR. HOUSNER: Tony Housner, CMS.
DR. GILBERTSON: William Gilbertson, National Council for Prescription Drug Programs.
DR. LOMAN: Mike Loman, Health Resources and Services Administration in HHS.
DR. MARTIN: Ross Martin with Pfizer.
DR. LAPCOP: Steve Lapcop with Pfizer.
DR. BECKLEY: Bob Beckley with Sure Scripts.
DR. JACKSON: Betty Jackson, National Center for Health Statistics, CDC, staff to the Committee.
DR. WHITEFORD: Donna Whiteford, Medco Health.
DR. RYAN: Mary Ryan, Medco Health.
DR. RAH: Phil Rah,the Mick(?) Express Groups.
DR. SWANSON: Terry Swanson, Cigna Pharmacy Management.
DR. WOOLEY: Shelly Wooley, Rx Hub.
DR. CANFIELD: Ann Canfield on behalf of the Rx Benefits Coalition.
DR. JAFFE: Charles Jaffe, AstraZeneca
DR. JOHNSON: Greg Johnson, PCMA.
MS. ZAMICKEY: Alicia Zamickey, Alston and Berg law firm.
DR. SHEATHE: Tony Sheathe, Point of Care Partners.
DR. SIMKO: Mike Simko, Walgreens.
DR. WEINERT: Ryan Weinert from Walgreens.
DR. DRAW: Jill Draw from Walgreens.
DR. ROBERTSON: Scott Robertson, Kaiser Permanente and co-chair of Medication Information at HL7.
DR. MILIKIN: Mark Milikin, Medispan(?).
DR. ECKERT: Karen Eckert with Medispan.
DR. GILBERG: Anders Gilberg with the American Medical Association.
MR. BROWN: Jeff Brown, Mayer, Brown and Roehm law firm.
DR. BANBERGER: Brian Banberger, Medimedia.
DR. SANA: Dan Sana, Caremark(?) and co-chair of NCPT's work of 12, security, privacy, confidentiality.
DR. WEINBERGER: Michael Weinberger, Johnson & Johnson Health Care Systems.
DR. OVITE: Alice Ovite, Johnson & Johnson Health Care Systems.
DR. COHN: Thank you, everyone. I just have a comment or two before we start the session and I ask Jeff to make any introductory comments.
First of all I want to apologize to everybody. As you all know I am from California and it is a little before 6 a.m., at this point. I usually get a little brighter after 6 a.m. So, you will notice me getting me more articulate as the morning progresses.
Having said that, I do want to just take a moment and acknowledge a letter we have received from Senator Grassley. I am not going to take the time of the Subcommittee at this point to read it but I would just observe that it clarifies for the Subcommittee some of the legislative language and intent of the e-prescribing section of the Medicare Modernization Act as well as Senator Grassley is requesting an update on our work and progress towards developing our recommendations and we will obviously be composing a response to him next week and offering to be of any assistance we can in terms of updating him on our progress which as you know is relatively rapid at this point in the speed towards moving towards at least our first set of recommendations. So, this was just to let you all know.
Jeff, do you have any introductory comments for today?
MR. BLAIR: Just a few. Just for those on the Internet and other folks that are not thoroughly familiar with this process let me just give a brief summary.
The work that we began at the beginning of this year and that we will be working on into next year is in response to the Medicare Prescription Drug Improvement and Modernization Act where it indicated that the NCVHS was called upon to evaluate, select and recommend e-prescribing standards. The law wound up giving us a lot of very good helpful directions.
In some cases we have had to supplement that. We pulled together the way we are proceeding in a work plan which is posted on the NCVHS web site and its version nine is the most current version that is there and that will be helpful to answer a lot of questions that folks may have about what are the topics we are focusing on during different sets of hearings and what are our target deadlines for our first set of recommendations and our second set of recommendations and with that I think, Simon, let us go ahead and begin.
Agenda Item: ASTM Overview of Continuity of Care Record Initiative
DR. COHN: I want to thank our first panel for joining us and, Bill are you taking the lead since you are in front of the computer and the PowerPoint?
DR. BRAITHWAITE: Yes, I will be. As I said my name is Bill Braithwaite and the two people with me, Tom Sullivan and Alan Zuckerman, the three of us are on the CCR steering committee and have been for quite a while and have sort of monitored the CCR as it has gone through becoming an ASTM standard.
We have all introduced ourselves with our basic qualifications. Dr. David Kibbe was supposed to be with us today but unfortunately due to a health care issue that I can't talk about because of HIPAA privacy rules couldn't make it out of North Carolina but he is a family physician who directs the Center for Information Technology of the AAFP, the American Academy for Family Physicians and he sends his regrets along with a reminder that his organization, too, is very supportive of the CCR effort.
We three are here to make four basic points to you and I will go through them and then all three of us will be available for discussion.
Our first point is that we believe that for e-prescribing systems to fully succeed in clinical practice and achieve a potential for positive impact on patient safety they must be integrated into the clinical work flow and take advantage of the medical history information available from electronic health systems in that clinical environment.
No. 2, we believe that generally agreed upon non-proprietary, low-cost standards must be adopted for the exchange of information between e-prescribing systems and electronic health record systems. Whether these systems are implemented simultaneously or separately it is important that these standards are adopted.
No. 3, the data elements in the ASTM CCR standard should be looked to for this purpose because they have been generated through a consensus process by a very wide range of practicing clinicians. The purpose is completely compatible with e-prescribing and any concerns that you have, that ASTM CCR standard lacks acceptance in the world should be put to rest by considering the sources of the standard which is practicing prescribing clinicians, the support for the standard from many vendors and clinical associations, a list of which is at the end of the printout of my testimony that you have, the fact that the SDO, the Standards Developing Organization HL7 and the CCR steering group are working together to harmonize their standards under a written agreement and the fact that an implementation of the standard has already been successfully demonstrated by select vendors at the HL7 booth at the HIMS(?) conference last February and by over 30 vendors at the TEPA(?) conference last May.
It is clear to the clinicians working on the CCR standard that an e-prescribing system working along in the clinical environment only solves part of the problem and for a short period of time.
To do the job well an e-prescribing system must know a great deal more about the patient than what other drugs have been prescribed for them, the demographics, the problem list, allergies, side effects, lab results and other elements of the basic medical record of the patient. It could be fed into the best e-prescribing protocols, compromise what are the data elements of a summary medical record if you will.
Clinicians as you have probably guessed won't enter this data twice and since they are going to enter it into an electronic patient record if they have one you need some way to get it out.
The only real choices then are to integrate the e-prescribing functions into every electronic health record system or build e-prescribing systems and EO charge systems using interoperable standards so that whichever is implemented second can interface and get data back and forth from the first without disrupting the clinical data flow and work flow.
We have ample precedent for making this point. You only have to remember the joy of having terminals in the clinic where you can immediately get results from the clinical laboratory and see that turning into frustration when the new health information technology being implemented in the clinic couldn't get that data and you ended up with two or three or four terminals on every desk. We have got to avoid that this time around.
The primary purpose for which the CCR standard was developed and is receiving great interest is to form an electronic summary of personal health information that clinicians can send when a patient is referred and that patients can carry with them to promote continuity, quality and safety of care.
Since one of the most common activities of a clinician who receives a patient in transfer is to review their medications and potentially prescribe new medications for that person it should be clear that clinicians in active practice who reached consensus on the data elements that comprise the CCR did so with this, the prescribing function clearly in mind as well as others of course.
The CCR has very strong support from practicing clinicians and other health care providers as indicated by the wide range of organizations who have agreed to support it.
The vendor community is also very supportive and have implemented the CCR standard in demonstrations and there is a list of vendors at the end of the testimony as well.
Although it is generally more granular than the others, the CCR standard has been mapped to Sure Scripts Proxymed(?) NCPDP(?) and Rx Hub formats and has been shown to contain all of the data elements needed to prescribe using those mechanisms.
At the end of the testimony you will see a diagram of the work flow that we use to model the prescribing effort from which we derived this mapping.
The CCR is a low-cost, non-proprietary standard already adopted by an ANSI accredited standard developing organization, that is ASTM.
The list of sponsors you have. So, I won't bore you by reading them al except to point out that they represent 400,000 clinical practitioners, 13,000 IT professionals and over 12,000 institutions in the long term care community that provide care and/or patient advocates, data sources, corporations, provider institutions, lots of folks who have signed onto this basic idea.
I think part of the excitement about the CCR standard itself is not particularly about e-prescribing but about the fact that clinicians have a way of getting into the standard-setting process at a level that they can't deal with. They can't come to HL7 and get EPA involved. They don't have the time to take the 2 years it takes to get into the technology that deeply but when they can say that this is what I need for my clinical practice then they are really excited about it and they can participate and that is what they have done.
Now, the CCR standard itself is technology neutral and vendor neutral. It is based on XML which means that a CCR description of the summary medical record can be expressed on paper in an HL7 standard message. You can view it in a standard browser. It has got lots of flexibility and since most vendors are already using XML tools now because it is seen as the thing as they move into using web services and others things, it makes it easier for them to adapt to the use of the standard to get data and get it out of their EHR systems and presumably the e-prescribing systems as well.
I just put up the diagram that we use to show the eight sections of the CCR to point out that it is not only information that identifies the document and where it is coming from and where it is going to but the details of the patient's health status which includes family history, adverse reactions, medications, immunizations, etc., lab results, the things you need to do appropriate e-prescribing.
So, now that those data elements have been selected by practicing clinicians it is the job of vendors and message standard organizations to define a standard way to move those data elements from one system to another. To that end the board of HL7 which I represent as treasurer of the board and the steering committee of the ASTM E31 CCR project which we all three represent have agreed to harmonize the CCR standard data elements with the HL7 reference information models and vocabulary models and the message standard so that data elements can be exchanged using the CCR data element missed but using HL7 standard messages.
We are working actively on this harmonization and expect to demonstrate standard interoperability at a major health informatics meeting or two sometime in the next 6 months.
Our four recommendations to summarize, the NCVHS should ensure that any standards for e-prescribing allow integration of existing and future EHR systems as sources of needed medical history, ensure that data standards for such interoperability are ANSI accredited, consensus-based standards, look first to the CCR data element standards to meet this need because of the consistency of the purpose under which they were created and expect that the CCR and HL7 organizations will issue harmonized versions of these standards in time to serve this purpose.
Thank you.
DR. COHN: We are open for questions. Questions from the Subcommittee.
Steve and then Michael.
DR. STEINDEL: Bill, thank you. I think you someplace in your talk covered virtually every one of the real detailed questions I might have.
I have a question for you, Tom. Massachusetts was the group that introduced the CCR and I remember the, I have forgotten after what meeting the exciting session I went to when you first asked people to join in the effort. How widely used is it in Massachusetts and is it used electronically?
DR. SULLIVAN: The answer is it is not widely used at all, and it is not used electronically in the ASTM version but to answer that I should say that it originated from a Department of Public Health mandated form, APER(?) form that has been around for 30 years and so to the extent, if you ask the question you know is there a standard format that is being used to exchange information and this is the particular setting when you go from an inpatient to an outpatient setting or between any two institutions. There is a form that was called the patient care referral form and there is a big medication list on that, for somebody who is a cardiologist I have to slavishly, obsequiously fill out and necessity is the mother of invention and laziness is in there, too. I felt that this form that is being used everywhere in Massachusetts for that setting could be helped quite a bit by making it electronic and also changing it so that it would be between any two settings.
So, I work within the Partners Health System in Boston and Brigham and Women's for instance has developed their own electronic version of this Massachusetts form but it is not quite the same as this.
I think the point is there are lots of people who are using these kinds of things electronically now including in Massachusetts my own hospital developed its own version which even though we are part of Partners is different than the one at Brigham and Women's.
So, I would like to standardize this and that was the effort that made me bring it to ASTM and a lot of people don't understand that this originated from a Department of Public Health. Some of the resistance to this has been DPH people who say, "Well, this is not conforming," but it actually originated in a state department. I would like to point out, too, that the oldest department of public health in the United States is Massachusetts and it was the Massachusetts Medical Society that helped created it.
DR. STEINDEL: Thank you, Tom for clarifying that. I think it was very informative on its use.
Bill, there is one question that I did have not pertaining to technical details but actually in terms of implementation, etc.
You pointed out that the CCR would be very useful in the area of an electronic health record as the way to transfer data from the electronic health record to an e-prescribing system. If we are looking at an e-prescribing system going in first how do you envision that scenario and how do you envision the CCR type data getting into the e-prescribing system?
DR. BRAITHWAITE: If the e-prescribing system is broken first then of course there is no EHR system to feed it the clinical data. It still needs that clinical data. You can't just do e-prescribing with only a list of drugs. You need a lot more information. Presumably secondarily if you go to install and electronic health record system you could feed the information necessary to sort of bring the EHR system up to speed out of the e-prescribing system or vice versa depending on whichever one is implemented first.
In addition because the CCR standard is XML and we have already demonstrated people walking around with their medical records in their pockets on a USD fund drive it could be built to accept that kind of input. So, if a patient had their medical record, a summary on a CCR fund drive and they came into another physician who did not have NEHR they could still because the e-prescribing system had a USB port, could accept their CCR as a sort of leg up on getting the information necessary to do good e-prescribing for that patient.
DR. STEINDEL: So, if I could summarize very quickly the CCR can be used in either scenario first without any real loss of implementation time or productivity.
DR. BRAITHWAITE: As long as they are using interoperable standards.
DR. STEINDEL: The magic words.
Thank you.
DR. COHN: Michael and then I have a question and Judy has a question after that.
DR. FITZMAURICE: In this era of political campaigns the standard seems to have a good grassroots origin, public health departments, comes from the providers, from medical associations around the country.
As you know the department has purchased the rights to SNOMED for 5 years for $32 million and we are anxious to get value out of that investment.
One of the comments that I have heard about the CCR is that there is no vocabulary behind it. There is just a list of data elements. Yet, these are common data elements and it seems to me that they could be mapped to just about anything especially SNOMED, UMLS. Is that true and are there any plans in the works to harmonize not just with HL7 but also with UMLS and the SNOMED vocabulary?
DR.BRAITHWAITE: I think, Mike you are right that at some point we have to come down on the side of particular standardized clinical vocabularies in order to implement great e-prescribing systems and other systems that do clinical data support, clinical decision support. You need computable standardized vocabularies to make that work.
Now, HL7 has message standards that allow you to put SNOMED in it but don't insist that you put SNOMED in it. It allows you also to put in ICD9 CM or any other encoded mechanism you have, you want of diagnoses and the CCR is exactly the same, that is you can write the diagnosis in English and you can still build a CCR with that. You can encode it in SNOMED and the CCR will carry that encoded message or you can encode it in ICD-9. So the CCR itself says that you need the diagnosis and here is the way you will express that or ways that you can express that diagnosis but it has not come down and said that it must be expressed only in SNOMED at this point.
DR. ZUCKERMAN: I think one of the things that I would like to add is one of the reasons the CCR is not in widespread use yet is that we are in the process of finalizing the implementation guides and we will go out to ballot on September 1. So, it will be in October that the implementation will go, and among the important areas being considered are the links to vocabularies including SNOMED, LOINK(?), Rx Norm and others that are being considered. The CCR has been structured to be extremely flexible in terms of accommodating multiple coding systems but the implementation guide recommendations will definitely look at this and it is important to note the big difference between the CCR and an EHR system is the CCR is a comprehensive patient summary and the problem list within the CCR, the medication lists within the CCR are meant to inclusive and one of the key values of SNOMED is the ability to code problem types that might be missed in a pure diagnosis coding scheme such as ICD-9 or ICD-10. Similarly the medication list is intended to be comprehensive and include both over-the-counter and other medications, but without the coding it is hard to standardize the usefulness to other physicians.
DR. FITZMAURICE: Dr. Zuckerman, you mentioned that it was going out to ballot in September.We have heard an awful lot about how sometimes ANSI accredited consensus-based standards can take a long time. How long has it taken CCR to go through the standards process?
DR. SULLIVAN: Once the ballot goes out it is 30 days. At least when we put out the first ballot for the standard it was 30 days and come in with the vote and then you have to address all the negatives, but it has been probably 2 years since I initially brought this to ASTM.
DR. ZUCKERMAN: This ia ballot on the implementation guide that clarifies the details of the concepts. We were balloted back in April.
DR. FITZMAURICE: So, the balloting on the standard that is the content of the elements has already taken place.
DR. ZUCKERMAN: Yes, and this implementation guide simply spells out the details and reflects the experience of the vendor trials that have taken place and among the things coming back are the need to improve guidelines for coding, guidelines for security and guidelines for dealing with data that is not completely available at the time, so that some data will be fully tagged and coded. Some data will be entered as strings if that is the greatest level of detail.
DR. FITZMAURICE: So, from the start when you started working with ASTM until you got a ballot that is standard was about 2 years?
DR. SULLIVAN: I would say 2, 2-1/2 years. It is a concept though that had started as a journey a long time ago, longer than that.
Let me point out, too Bill mentioned you can't do e-prescribing without clinical information and I have been doing it for about a year and one-half with no support, no EHR but I would agree that it is not good. I would much rather have a CCR and a full electronic health record.
One of the benefits of the more current e-prescribing systems are these connectivities, both to the Rx Hub-like and Sure Scripts-like, you know one to the pharmacy and one to the PBMs and most of the really fully functional electronic health records that have been around for a while including the ones that have been hand built so painstakingly by my own institutions can't do that. They don't have that kind of connectivity. They don't have the ability to easily search a formulary to find out which the right drugs is and I think you all heard Clem McDonald and others yesterday talk about what a desirable feature that is but I believe that with the e-prescribing stand alones sort of married to CCRs and the ability to get practice management system information into the e-prescribing system using a CCR and connected to the electronic health record that this will be a real boon.
So, I see it as a journey and as far as the codes go again we are in a period of evolution. I believe that we won't see the full potential of clinical decision support unless we have -- we have got plenty of structure in the CCR but we are going to be favoring the use of coded instruction, controlled vocabularies. I guess that is the best way to put it.
DR. COHN: I guess I have a couple of questions and comments. First of all I guess I am hoping that since the PowerPoint has actual information that isn't in the testimony I guess I am hoping that we will have access to that --
DR. BRAITHWAITE: We will make that available.
DR. COHN: -- to reference our recommendations. Now, I guess I am sort of listening and Teri and I, I guess are the only ones who aren't either conflicted, have an employer that is relating to it so we can ask and Judy is going to ask questions, too. So, we are okay but I guess as I am thinking I am sort of reminded by the statement about standards is it is wonderful how many, you know about the plural standards here and I am looking at the last bullet which is obviously this harmonization of CCR and HL7 which obviously is not there now. Now, I guess as I am listening to you and I saw at the slide talking about the functionality of CCR it went by pretty quickly but at least as I saw it it looked like a summary medical record and obviously many of us have lived with summary medical records for decades if not longer.
I know Bill did one, I don't even want to tell how many years ago in one of his earlier lives and obviously all of us have lived with them, have developed them or whatever and this is sort of the style of it. So, I would almost describe this as almost EHI e-prescribing paradigm of did you have e-prescribing as a module. Then you sort of transition to a complete electronic health record, and this is somewhere in the middle. This is somewhere along the journey, including I wanted to make sure that it is directionally correct along the journey.
So, I guess the question I have is is the critical piece here an expedited attempt to harmonize CCR with HL7 given that HL7 seems to be positing itself as the place that is trying to fully specify that sort of end piece making sure that this middle interoperable piece that you are describing really is harmonized with both edges. Is that really the critical piece here that we need to make sure happens expeditiously?
DR. BRAITHWAITE: I think Tom and I both agree that harmonizing with HL7 is critical and we are putting significant effort into that over the next 6 months.
DR. SULLIVAN: I would definitely agree with that. However, I would also say to you that there are a number of vendors out there who don't have an investment in HL7 and want to get something out there that will be functional and we are not trying to control the market in this nor control vendors. We are offering a standard that we think will not reach its full potential until it is harmonized with HL7, but we can't control, I mean you know, some vendors have taken this already in spite of the fact, even though it is a standard but they haven't seen the final implementation guide. They have already taken it and are doing some things with it to enhance its function.
DR. BRAITHWAITE: With the understanding that they will have to change their systems to comply with the final standard when the implementation guide is complete, but they are so anxious for it they have already started work.
DR. COHN: Let me ask maybe a slightly more direct question then which is obviously many of us were at meetings and summits last week and obviously one of the discussion items there was dead ends and assuring that we don't do things that lead to dead ends and obviously one conversation is let us make sure that whatever we do with e-prescribing doesn't become a dead end. I similarly I guess would ask based on, Tom, your comment what assurances do we have at this moment that if a vendor went out and implemented their vision of a CCR that it wouldn't also be a dead end?
DR. SULLIVAN: I would say to the extent that the vendor wants to increase their market share, I believe that one of the features that will sell systems will be the ability to exchange seamlessly. If they produce their own version of the CCR and it is not easy to exchange that clinical information with any other organization or vendor then I hope that that will lead to a dead end for that vendor, frankly, but I see you know this is more of a philosophical argument about the use of standards. What is the benefit of a standard and to me harmonizing it with HL7 which is a standards development organization that has put a lot of time and energy into the messaging and now clinical document architecture, it makes no sense for me to ignore that or to promote that vendors do something other than that, but you know, again we are not a sort of a socialist --
DR. COHN: No, and I guess the point that I was making was I just have seen enough harmonization efforts to know that sometimes when things harmonize they change because as you try to connect them you discover that you actually need to change one or both sides to harmonize and so --
DR. SULLIVAN: That is what harmonization is all about.
DR. COHN: Yes, and so what I was concerned about is that I mean I think you guys have a very good idea and I think the idea of providing direction to what are essential parts of an electronic health record as an interim step, I mean it is super. It is just my concern that if a vendor got on the bandwagon tomorrow this bullet here about this thing coming in time, quote, unquote, I would be concerned that a vendor would go off and do this and you discover 6 months or a year or 2 years down the line as you are attempting to harmonize that there really need to be substantial changes to the standard or further specification to really make it interoperable with these other pieces, that there may be some problems and that was really my concern.
DR.SULLIVAN: Yes, there is one other message from last week regarding consumer-centered care and another key focus of the CCR is as a means of transferring data to patients with their personal health records. We view the CCR not only as a conduit for medication data of an EHR but also a conduit to transfer electronic prescribing data to patients and I think that is very much not likely to become a dead end, but the harmonization is moving forward and I don't see any substantial change. It largely amounts to reordering sections, changing names of individual tags. It does not seem to involve a lot of substantive change.
DR. ZUCKERMAN; Another point on that, even the vendors themselves in their own products can't talk one another. I have some personal experience. My hospital used to be an SMS system. Now, it is SEMONS(?) and for 15 years I have been going to the user group meetings and we all have the same system but we can't talk to one another.
Recently I was approached by the CEO of probably the most successful ambulatory medical record vendor in the country and she said to me that she likes the CCR because again her own customers because she gives them the source code and we all have this irresistible temptation to customize you know for our own local uses. I am sure you know very well, better than I the history of Kaiser and their exploration into this area. Well, she said to me, "I think this is a good idea because it will allow us, my own customers to talk to one another, and the idea is to aggregate clinical data to allow bench marking. You can't do that so easily without a fairly rigid uniform standard.
DR. COHN: Judy and then Harry?
DR. WARREN: Mine is a comment and I guess I want to put on my hat as co-chair of patient care at HL7. Look at the August ballot. We have a message for you called care provision that will message everything in the CCR and so harmonization probably is going to be very easy and I don't know if you knew that, Bill, I mean out on the ballot or not but it is there. So, anybody here that is an HL7 member sign up for the ballot pool. It is at a committee level. We have worked on this. You asked about timely, probably about 2 years. We started out trying to write a message for referrals and realized it was far bigger than that and so again I encourage especially you since you started the CCR to take a look at that and sign up.
DR. SULLIVAN: Which version of HL7?
DR. WARREN: Version 3.
DR. SULLIVAN: Do they have XML in it?
DR. WARREN: Absolutely. Look at the ballot and it will all be there in explicit detail.
MR. REYNOLDS: I have a question and then I have not a challenge but a concern. The question is being new to the Committee obviously I am not as up to date on CCR as maybe others. Are you talking about a standard format of being able to take information from whatever EHRs are out there and transport it to wherever else whether it is, as you talked, whether it is to a personal health record, whether it is to a PBM, whether it is for research, whatever it is for. So, you are really looking at a standard conduit; is that correct?
DR. BRAITHWAITE: That is what we are looking at. At the moment the standard, the CCR that is a balloted standard is simply a defined list of data elements that clinicians believe are the critical ones to move from one clinical environment to another, and with the coming work with HL7 and with the implementation guide for the CCR then you will be able to see a format that gets added to that that specifies how those messages should be constructed to move that information from one to the other.
MR. REYNOLDS: Okay, I thought that was what I was hearing. If you read some of your testimony about doctors not entering the data twice, if you sat through any of our discussion yesterday about the practice management systems, you look at our charge which is not for the electronic health record to recommend things to the Secretary and others soon to make e-prescribing a reality you have drawn a pretty strong line in the sand with some of your comments today, all of you as to it is not going to work without this; it is not going to work without that. So, step back from your testimony if you would and help us think about how we should think based on the parameters that have been handed to us and your positions with what you are doing.
DR. SULLIVAN: In answer to that I said that it is already working for me but it is painful and it is expensive and I think what we are trying to do is we are not saying it is not going to work.
MR. BLAIR: When you said, "It is already working for me, but it is painful, and expensive" --
DR. SULLIVAN: Well, e-prescribing. You know you are talking about recommending e-prescribing standards. Again, I think there are thousands and thousands of physicians who are doing electronic prescribing but when you say, "Electronic prescribing," you are talking about a huge complex area as I mentioned. You know the standard EHRs that are out there today, they will generally all say, "We do e-prescribing," but they don't have any connectivity. They don't connect to -- or they connect with a fax to the pharmacy and Clem McDonald said yesterday he loves that fax, but I have done it both ways. I have used a couple of different vendors and the difference between what Sure Scripts brings to it or any other organization that develops an electronic, true electronic message to the pharmacy as opposed to a fax where somebody has to copy it down again is a big difference. It is an area for mistakes. It is an issue of patient safety.
So, I think it works today but not well and it has much greater potential for streamlining efficiency, safety and quality if we do adopt standards that allow for this information to move more seamlessly and not burden the physician or the physician's office staff to have to fill out these forms in duplicate or triplicate.
DR. BRAITHWAITE: Harry, I think the point of our testimony was that e-prescribing systems that are implemented first obviously will work but that they are likely not to work or not to be received well by the clinicians, the minute the clinician has access to or need for an electronic health record system where the same information is going to have to be entered once again if there is no mechanism for exchanging information between the two. So, we are not saying, "Don't do e-prescribing until EHR systems are ready." We are saying, "Do e-prescribing first if you must but make sure that there is a mechanism to get the information in and out of an e-prescribing system that is compatible with EHR systems to come.
DR. SULLIVAN: Let me add another element to that, too. Depending on what kind of a physician, what specialty you are in you have a very different opinion about e-prescribing or whatever. If you are a thoracic surgeon as opposed to an endocrinologist taking care of a bunch of elderly diabetics there is a huge difference in the number of prescriptions that you write. So, this is not for everyone right now, but if you are a high volume prescriber you will be looking much more closely. You will be scrutinizing this. If you are a very low volume prescriber you are going to want all the bells and whistles that really make it easy to transfer this information because you don't want your staff to do anything extra at all.
MR. REYNOLDS: That is helpful because obviously those are the things that we are considering as we look at this and I just wanted to make sure that you didn't have something different other than what we are already trying to take into consideration as we look at it. So, thank you. I appreciate that.
DR. COHN: Okay, I think Judy and then we will wrap up.
DR. WARREN: I just wanted to clarify, did you say the high-volume prescribers would be looking more for e-prescribing than low volume?
DR. SULLIVAN: The ROI as they say for a high-volume prescriber is much easier to demonstrate early on without all this standardization.
DR. WARREN: And the reason for that would be the refills and --
DR. SULLIVAN; Refills are a huge part of it. I can tell you my office staff, my single office staffer, her life has changed. It is so much easier now. We turn on the computer and the refill request is already there electronically and this is just beginning to roll out in Massachusetts over the last few months.
DR. ZUCKERMAN; There is another dimension that comes in the primary care setting. One of the reasons why we would have had a family physician, pediatrician, internist here in most primary care settings a very large percentage of prescriptions that have been written for patients are not written by the physician they are seeing at that time. They are written in hospitals, written in emergency rooms. They are written by specialists to whom a patient been referred or by a previous physician. What the CCR enables you to do is to bring together accurate data from these other physicians and then begin to write new prescriptions from that same information. I am sure you will also hear from many of the PBMs and other groups that you can get a patient's prescribing history directly from the pharmacy or from insurance companies but there is a difference between edited clinical data that is relevant at the current point in time and comprehensive history. What the CCR attempts to capture is the ability of physicians to edit what is relevant for the next provider who sees the patient and there is ample room for multiple comments by different physicians on a particular prescription..
DR. COHN: Steve, I think you have a final comment?
DR. STEINDEL: I have a quick question. What intrigues me about this conversation is one of the reasons w are looking at introducing e-prescribing is for patient safety protection and are the errors that occur in, are there any studies done on where the errors in medication occur? Do they occur with the high-volume prescriber or the one that is the incidental prescriber and we have heard a lot in areas of surgery and everything, go to the one who does the most? Is this analogous? Is there any evidence?
DR. SULLIVAN: I have never seen any studies that say that high volume versus low volume, and I have been looking at this for a while although I don't know the academic literature on it but I would just say that it depends. You know, it depends if you are doing it in handwriting it doesn't matter whether you are high volume or low volume. There is a potential for error and that is still the way most prescriptions are written. I am not aware of any high versus low volume.
DR. STEINDEL: What I am concerned about is not necessarily the transcription errors or something like that . What I am concerned about is the wrong medication being given because of the patient's history or the medications that they are on that the low-volume prescriber may not take the time to really ascertain where they are dealing with a patient that doesn't have or doesn't know the information which we heard time and time again, and in those places is where we really want to have e-prescribing.
DR. SULLIVAN: I would agree with that. I would tend to say what Alan said that the people doing primary care it is more their obligation to know what all the other medicines are. I am not saying that surgeons or others who are not doing primary care eliminate or forget that but I am just saying that I think that is the traditional professional obligation.
DR. BRAITHWAITE: Steve, I would add that the high-volume prescribers are typically high-volume prescribers because they are prescribing many drugs for the same person, typically an elderly person with lots of problems and in fact that is where the human mind of the physician can't wrap around all of the possible interactions and relationships with the history of that patient.
So, I think although I don't remember any particular cut on this from the literature I would expect that the high-volume prescribers would make more mistakes and that this would from a patient safety perspective be more valuable to the high-volume prescribers.
DR. STEINDEL: I have to make the comment from the public health point of view that the denominator is also very important.
DR. BRAITHWAITE: What does that mean?:
DR. STEINDEL: That means that the high-volume prescriber sees a lot of patients and they do make errors which they probably do. The actual percent of errors may be lower than in the low-volume prescriber.
DR. COHN: I find your questions interesting. I suspect that from all of our perspectives we would like to see all prescriptions written with the benefit of e-prescribing as well as alerts and decision support so that all patients have protection, be it from a low prescriber to a high prescriber to a patient that is on one medication to a patient that is on multiple medications.
I want to thank you very much. Bill, it is great to see you back again. It was an interesting different role here and everyone here knows that Bill spent many years as being part of HHS and also a support for this Subcommittee.
Anyway thank you all very much.
Now, we are going to move on to a panel with the PBMs. So, if we could have you come up to the front? I want to thank you for joining us and I also want to thank you, I was looking with some concern at a 31-page or 35-page testimony and I realized it was actually a joint presentation by all of you. So, thank you. That obviously makes me feel a lot better. Actually we have Phil Rothermich from Express Scripts and thank you for joining us, Mary Ryan from Medco and Teri Swanson from Cigna and --
MR. ROTHERMICH: Teri Byrne is joining us with Rx Hub.
DR. COHN: Okay, and are you leading off?
MR. ROTHERMICH: We will get started, yes.
DR. ROTHERMICH: I did want to point out that we are doing a joint presentation today and we worked collaboratively amongst ourselves as well as among a number of other PBMs and industry groups to create this presentation.
It points out the fact that there is a long history of collaboration with respect to this sort of thing and prescribing in particular if you look back on NCPDP starting long ago to solve a problem with paper claims and about 3-1/2 years ago a few of the PBMs came together recognizing a need to work together on e-prescribing to solve what we had already determined at that point to be some issues with a need for standardizing both transactions and the way we do things and the way we connect to point of care vendors.
So, aside from collaborating on the presentation we have a cross-functional group here today to bring a wide variety of experiences. Mary is a pharmacist. I have a legal background and Teri has a lot of IT experience. She is a CIO and has a lot of experience in electronic prescribing in her past.
We have got a couple of objectives here today. We have broken down the prescribing process based on our experience into its component parts and tried to attach to each component the standards that are out there, both those that have been developed in collaboration with Rx Hub over the past 2 years as well as those that have been developed by other organizations that can be leveraged in this process.
So, I am going to give a brief introduction and then Teri will walk through each of those components and talk to us about how those standards can be leveraged in this process and then Mary will talk to a number of additional sort of miscellaneous issues that we need to get through.
A key point here is that most of the standards that are being leveraged today are industry accepted standards. People are doing this stuff today. We are doing patient ID without having to have an ID assigned to a patient. We are doing eligibility transactions. We are doing drug history transactions. We are providing formulary information at the point of care.
So, this stuff can be done. It is being done and I think the point here is let us not recreate the wheel. Let us make use of what is out there.
To start with we wanted to just lay the groundwork with some definitions just so that we are all sort of speaking the same language here today.
We talk about MPI or the master patient index. That is really just a central database of demographic information. It isn't health care information. It is simply a mechanism to aggregate demographic information in order to ID uniquely a patient in a very efficient manner.
Eligibility simply is just whether a patient has a benefit with a payer or a PBM. We have had a lot of conversation over the past couple of months here about the distinction between formulary and benefit.
Formulary generally speaking at a planned level is one or two or three lists of drugs that physicians can choose from but it is actually benefit information that can make some of the key decisions.
You can have two tier or three tier formularies. There are also a number of benefit rules that apply that can sort of change the landscape. So, it is possible to have a drug that is on formulary but isn't covered. So, you can have 100 percent co-pay and things like that.
There has been some conversation in this process as well as about medication history. When we speak to medication history what we provide today is claim history. So, a person who has a benefit, all of the claims for drugs that that person gets billed at the pharmacy come to the payer of the claim, either the PBM or the payer if they do it directly.
It is not perfect. I think everyone recognizes that there is not a system today that provides perfect drug history. Pharmacies have some drug history. The physician has some drug history but people move around. They move physicians. They move pharmacies. So, the drug history that comes from the payer or the PBM is probably as good as it gets today. I think the last of the speakers recognized there is an obligation still on the physician's part to go through that list with the patient and make sure that first of all just because they filled a prescription they are actually taking it, and find out whether there are other things that they are taking as well such as things they may have paid cash for or things they have bought over the counter. There are lots of drugs like Claritin and Prilosec that are going OTC. There are more and more opportunities for people to just be buying things that could have some relative impact to the physician's care.
We talk about point of care vendors or technology vendors. These are just the software companies that provide the electronic prescribing solutions and we refer to routers. Routers in our vernacular are Rx Hub. It is Sure Script. It is anybody who serves as a central hub so to speak for carrying transactions from point A to point B and switching them to get to the right place.
I am going to give a quick overview of our recommendations and then after our presentation will come back to this list and speak to them again.
We have talked I think repeatedly in this group about harvesting low-hanging fruit and the key take away today from our perspective is Rx Hub has developed a great deal of standards that could be used in this process. They were developed through an industry collaborative process which we will talk a little bit about that involved pharmacies. It involved point of care players. It involved PBMs and other payers and so it isn't a black box. It is something that was done publicly and it is designed from the beginning to leverage work that had been done previously. So, they used NCPDP standards where they could. They used HL7 or they referred to it. They used X12, a number of these things.
We think it is important to enable the free flow of information. So, we believe that the key opportunity here is to give information to physicians to make informed choices. No one is suggesting to take away choice from the physician. It is simply a matter of if they are going to make the best both clinical and economic choice for a patient they need full information.
We think it is important for the standards to enable adoption and so in the process of creating these standards it is important to think about work flow and to think about the time it takes to do transactions and so the standards that are adopted need to take into account speed and the way that these transactions can most effectively and efficiently be delivered.
It is important that the transmission standards for a formulary be standardized without trying to standardize the formulary process or standardize how the industry makes decisions about what formularies look like and we have done that today. Medco and Advance PCS or Caremark(?) and Express Scripts all provide formulary information through Rx Hub. None of us have changed the way we do our businesses and we are fairly confident that we do them differently but one of the benefits that Rx Hub provided is that we could do that without having to share competitive information.
Again, we support standards from multiple standards development organizations. We support translation between those standards. We think it is important for this Committee to adopt as many standards as possible given that some of the standard development agencies or organizations take significant or in this scheme of things what could be significant amounts of time to get through the way they have to do their process.
So,to the extent we can leverage NCPDP, if NCPDP doesn't go quite far enough but we know where it needs to go this Committee could adopt what it needs and then work with NCPDP going forward to fine tune or create future standards that could be useful in this process.
We think it is important for standards to recognize all types of pharmacies whether it be retail, mail, hospital or other. There has been some conversation about translation between NCPDP and HL7. We think that is important.
We support a multi-payer solution. So, we just need to make clear that while we believe the standards that Rx Hub has created are the answer to many of these issues we are not suggesting that Rx Hub be mandated, that people have to use Rx Hub. In other words Rx Hub is one mechanism. We have connected through Rx Hub to a number of technology vendors and will speak specifically to how many that is. Those vendors are free to connect to other people but they don't want to have to do it in another way as well. So leveraging those standards people can connect in a number of different ways whether it be through Rx Hub or through some other mechanism, and we think it is important to adopt a solution that recognizes that what goes for Medicare is really going to go for the entire system because it isn't feasible for people to use two different systems.
So, it would be shortsighted to look at this process as simply Medicare without recognizing that whatever we do here is going to create the standards for electronic prescribing and so we really need to recognize that to the extent that the commercial market needs something different or there are some other considerations we need to take those into account.
This slide obviously can't be read but the point of what we are doing and there is a big copy of this I think as well but really what we are trying to lay out here is that the process is broken down into what happens before the prescribing process, before the physician is actually standing in front of the patient and we call that sort of a pre-load process. So, there is a number of things that can be done in advance in order to speed up the ability to get the information to the physician when they are standing in front of the patient because there is a recognition that even a 5-second delay while the physician is standing there with the device in his hand could be fatal to adoption and so Teri will walk through each of these processes in depth but the point we are trying to make here is there are really four steps to prescribing. There are these pre-loads. There is the actual prescribing process when the physician is standing in front of the patient. There is fulfillment which is getting the script to the pharmacy and getting it filled and then there is the claim processing piece which is getting paid.
The next step really just sort of details those but that is really the overview of what we did and Teri will just jump in to this first pre-load process.
MS. SWANSON: All right, I am Terri Swanson from Cigna Pharmacy Management and as Phil mentioned the pre-loads are designed to do a couple of things. They are designed to get information to the right place prior to it needing to be accessed by the physician to enable a fast and efficient decision support model.
The second thing that the pre-loads are designed to do is put information into the router or routers to ensure that the real time transactions can be routed appropriately as part of that prescribing process. So, there are really kind of two flavors.
The first pre-load that I want to talk about is taking membership data that resides with the payer of PBM and getting it loaded at the router. Basic demographic data is extracted from the PBM. That data includes the first name, last name, date of birth, gender and zip code so that the patient can be identified in the future.
This information also includes a payer-unique ID. So, when I go back to Express Scripts or any other payer and say,"Here is the person," I have also got that payer's identifier for how to quickly locate that patient in their system.
The information is loaded at the router and resides there. Please keep in mind that this master patient index or MPI is now a multi-payer data source. So, the router is able to distinguish which members came from which payers for purposes of routing transactions back to those payers during the prescribing process and you will see that in some of the real time transactions and flows that we cover later.
The next pre-load involves getting formulary and benefit information again from its source at the payer or PBM out to the point of care application. The formulary data as Phil noted is at the plan level. There may be several formularies coming from each payer. The benefit information is more granular. It tends to be at the group level. This is a key point in terms of getting the most accurate decision support information to the point of care. It is important that the physician be able to connect that patient to the right formulary and the right benefit.
You are going to see that process happening a couple of slides from now with the eligibility transaction but I do want to point that out. These two pre-loads really set up getting the correct linkage to very detailed benefit design at the member level and as was noted yesterday that linkage has been something of a challenge in the industry. This process is able to do that.
Other final note on this section, the formulary and group benefit data when it is loaded at the point of care application is generally combined at that point with other drug reference data. It may be from first databank or Many Span(?) or other reference sources but the point of care applications tend to take that information and combine it again for fast access by the physician during the prescribing process.
The next set of pre-loads that I want to talk about are really covering sharing information about prescribers with pharmacies and about pharmacies with prescribers for the purpose of routing the actual electronic prescribing transactions.
So, from the pharmacy side information about the pharmacies is extracted. This includes the pharmacy name, address, phone numbers and the NCPDP provider number which we use as the standard for identifying pharmacies.
MR. BLAIR: I just wanted to make clear that everybody was aware of that. NCPDP refers to the provider number. That provider number identifies pharmacies not physicians or health care prescribers.
MS. SWANSON: Yes, that is exactly right. So, we use that number to identify, uniquely identify a pharmacy. The one thing that we would point out on that note is that there are some pharmacies, specifically hospital pharmacies who don't all have NCPDP provider numbers today.
So, we would recommend having hospitals be included in that process in the future to provide for a single identifier for any type of pharmacy regardless of location.
Okay, so just moving on the prescriber side then the point of care application extracts the prescriber location and identification information on their side.
This information again includes the name, the clinic address and phone numbers and some type of prescriber identifier either DEA, state license number or something. They also provide a unique prescriber identifier for that prescriber using that application and this unique identifier is used today in the absence of an national prescriber identifier.
So, that is something again that we will point out in the summary that we do feel that a national prescriber identifier for physicians and other prescribers is necessary. We do have a way of working around that at this time by using a combination of other information.
All of this information is provided to the router where it is combined. So, essentially you are going to create a large routing file of information about how pharmacies can send transactions to physicians and how physicians can send transactions to pharmacies or rather the software applications that they use.
That information is provided back to the pharmacies and the prescribing applications. This is done using an NCPDP based message format. So, this is one of the transactions that Rx Hub has developed that we are recommending be looked at.
The next set of pre-loads is really now happening closer to the time of prescribing. This is involved with getting eligibility and member history in formation from the payer or PBM out to the point of care.
So, starting with the point of care application, the point of care application typically extracts patient demographic data and formats that into an eligibility request that is sent to the router.
This is the linkage that was discussed at some length yesterday with the practice management system. So, ideally the point of care application is able to access the physician schedule and create eligibility request based on who is coming into the office for example that day.
The eligibility request requires basic demographic information that will be used at the router to match the patient to the payers who cover that patient in the MPI. This is done using a standard X12 270 request. When the router matches the patient it determines which payers are able to respond to that eligibility request, in other words where do I have coverage and routes that eligibility request on to the appropriate PBM or payer for response.
This could be more than one PBM or payer. So, multiple coverage situations are possible and are handled through this process. The information that the payer returns on the eligibility response is very critical to the linkage of that member to the correct benefits and formulary. So, when you consider the data elements returned it is both the payer and that payer's unique ID for the patient links to the correct formulary and benefit information that are now resident on the point of care application as well as other information such as cardholder ID and name, the relationship of the patient to the cardholder and the payer bin and the payer bin is used to submit claims. You will see that at the very end of the process.
It is significant at this time because the point of care application is how able to pass that along to the pharmacy and the pharmacy can pass it along to the PBM ensuring that the actual payment adjudication occurs against the same set of benefits that the physician used to make their prescribing decision.
Once the point of care application has received all of this information on the eligibility request they can then request the patient's medication history from the payers and PBMs.
As Phil pointed out that is a claims process type of history. This is done using an NCPDP based message or an HL7 message. So, we have instances of systems that are more comfortable using NCPDP standards, some that already support HL7 standards and we feel that it is important to support both of those for receiving medication history. That request goes to the router who sends it on to the appropriate payer or PBM, retrieves the responses and sends them back to the point of care.
The next process that we want to get into is the actual prescribing process and by this time all of the relevant member information has been loaded at the point of care; their benefits, their formularies are there. The eligibility information has been retrieved as well as the links to the appropriate benefits and formulary, etc. So, all of the information is local and can be accessed in a decision-support model that is very responsive and high performance for the physician.
We are going to describe this process. There is a lot more to it than this that I think the point of care technologists and physicians can speak to but just at a high level generally the application is going to allow the physician to search for that drug by name or therapy class. That search should be referencing third party drug data as well as the formulary and benefit data that has been loaded at the point of care. Generally a DUR check is performed at this time pulling in the medication history that has been retrieved earlier as well as any other medical history that has been integrated into this process and in terms of the previous discussion on CCR this is where I think this process is very complementary. So if the electronic health record is available and has a good set of information to include in the DUR the most expansive and clinically appropriate set of information should be used there. So, that is really up to the point of care application.
The physician will select a drug and at that time determine what pharmacy the patient chooses to go to. At that time the application can reference that routing information to address the script transaction to the appropriate pharmacy and this would be the standard NCPDP script transaction that is already being used in this process.
We, also, included a sample or a representative application. This is not a real point of care application. It is simply a representation to illustrate what some of that information may look like when the physician is accessing it, some of the drug and benefit information combined with third party sources.
I want to spend a few minutes on payer pre-adjudication. There has been some discussion I think at other sessions about whether this pre-load model or a real-time pre-adjudication type of model is more preferable and our experience really indicates that pre-adjudication is not recommended today. It generally doesn't fit into the work flow primarily because it can be slower than the physician wants to deal with and it may need to be performed multiple times.
So, if the physician were considering different alternative therapies they would need to submit multiple therapies and wait for the response to understand the results.
The other thing that is significant about pre-adjudication is that the adjudication of a claim requires very specific and granular information. Some of that information is not known by the physician or it is not maybe the optimal place to decide that.
I think we saw some examples yesterday with some of the speakers on, you know, depending on the formulation or the type of pills that the pharmacy has in stock a prescription could be filled multiple ways.
So, to actually adjudicate a claim you need the very specific NDC of the drug being dispensed and the physician may not know nor care what exactly that is going to be.
In addition the payer really cannot guarantee the patient payment until the drug is dispensed and a claim is processed, primarily because that amount is based on a number of criteria some of which cannot be finalized until that claim is processed.
The price of the drug, authorization status, indemnity limits, quantity limits, there are a number of other payer specific things that just may not be known until the point of dispensing, deductible, out of pocket and so forth.
So, it is challenging to get to the exact patient payment amount prior to the patient being at the pharmacy and we really recommend providing the best information that we can up front about those amounts through the formulary and benefit loads and allowing that adjudication to determine the actual pennies so to speak.
DR. COHN: I guess I am just a little confused because clearly adjudication is different than pre-authorization and you obviously have formulary information here. I guess I just, very briefly just as clarification by pre-adjudication do you also mean that there is no indication that for example the patient has gone to their limits of their drug benefit for the year? So, nobody knows that until they go to the pharmacy.
MS. SWANSON: Right. One of the alternative models that has been suggested is you know, gee, you PBMs adjudicate millions of claims per day in real time. They come from the pharmacy. Why don't we just do that? Why don't we do that at the physician's office first and get to the right amount and the reason for that is that you do need the NDC being dispensed and you do need some of this other indemnity information which actually may change between when the physician issues the prescription and when the patient goes to the pharmacy to retrieve it. So, the actual financial adjudication is more optimal when done at the pharmacy for payment purposes.
Okay, the next flow is really talking about the actual prescription fulfillment process. When the NCPDP script standard transaction comes into the pharmacy there is an opportunity to pass additional data elements on the script transaction from the part that were pre-loaded earlier in the process.
I mentioned the payer bin as one example but also the cardholder ID, name, group, much of the information that today a pharmacist has to determine based on the member's ID card when they get to the pharmacy can be passed in advance on that script transaction enabling a much more efficient process at the pharmacy.
The other thing I want to point out here is when the pharmacy fills the prescription the pharmacy generally does also perform a drug utilization review check. We want to point out that we don't view the different DUR processes at different points in time as redundant or unnecessary. The physician with the tools they have in their office can perform a DUR check given one set of perspectives and information at the time the pharmacy is filling the prescription they may have a slightly differently different data set and perspective that they are taking into account and you will see in the next flow that the PBM actually also performs some DUR checking when the claim is processed again with a slightly different data set as input and a different perspective.
So, we think these are all very useful checks and balances as part of the process. They are in place today and you can benefit by using electronic prescribing and fields available in the script transaction, in the NCPDP telecommunications transaction to share the results of those DUR checks better along the path so the physician can share what they have done with the pharmacy, and the pharmacy can share what they have done with the PBM and perhaps get to a more efficient and complete DUR process.
Last but not least the claims processing piece of this. Again, this is all in place today. The NCPDP telecommunications standard is used by the pharmacy to submit a claim to the PBM. That contains a number of different pieces of information, some of which is specific to the pharmacy such as the NDC of the drug being dispensed and other things that have been passed along from the physician's office to the pharmacy on the script transaction such as the payer bin.
The claim process again is much more complex than this but at a high level the PBM will validate the pharmacy against the NCPDP pharmacy directory, validate the prescriber against their prescriber files, verify the patient's drug coverage against the plan's formulary, the group level benefit information, other financial considerations such as indemnity limits and so forth.
They will also be checking the patient's medication history for conflicts and performing DUR checking as we discussed.
So, the claims process really continues uninterrupted hopefully much more efficiently because now we won't have to reject claims because they are more in line with the benefit design and that is known at the point of decision making by the physician.
I want to spend one brief moment on the renewal process. Again, this is a process that is much more detailed but a couple of key points that we want to make are first of all the pharmacy initiates this process asking the physician to approve a renewal.
The pharmacy can use the information that has been shared by the router to determine how to send that renewal request electronically to a physician. Generally that renewal request is then sent through the router who knows the physical routing characteristics and which point of care application to send that to on behalf of the physician and then at the point of care the process really cycles back into the overall prescribing process.
So, the physician is essentially generating a new prescription using that point of care tool when they are approving that renewal.
In this process we use the NCPDP script transaction. It handles a variety of different information types that need to flow through the request.
Now, we are back to the large unreadable process slide which hopefully people understand a little bit better but just to summarize I think this process is in practice today. It is a combination of pre-loads resulting in locally stored information that gives the physician a high performance kind of prescribing application to use and it also leverages real time transactions where that is advantageous to communicate the prescription.
With that I want to turn it over to Mary and she is going to take us through some of the advantages of this process and summarize.
MS. RYAN: Thanks, Terri. I am Mary Ryan with Medco Health Solutions. So, as a result of these processes we do have some prescribing process improvements which we have heard from others related to this topic but specifically patient safety improvements because we are able to provide enough information to the prescriber to make better decisions including decisions about what drugs will interact with other drugs that the patient is taking and increasing the quality of care for the patient because again enough information has been provided to the prescriber to make that, to help them make better decisions about what is right I guess for the patient and reducing medication errors, freeing up some time for the pharmacist to spend extra time consulting with the patient and ultimately resulting in the most cost effective prescription.
Because the pharmacist does have a professional and I think obligation and desire to deal with patients on drug interactions and other profile reviews they will continue to do drug utilization review with those prescriptions.
However, because the physician is able to transmit information to the pharmacist along with the prescription in this really e-prescribing model the pharmacist is able to use this additional information to make decisions about the prescription and then to spend more time with the patients in talking about their therapy.
We don't believe that anything we have discussed today presents any kind of an undue burden on prescribers because of the fact that this is a pre-load application. It is not one of those, I think Dr. McDonald mentioned yesterday, I hit the button, I get a rejection; I hit it again with another one and get another rejection. It doesn't do that. It gives the physician the total picture so that he can choose the right things at one time and he doesn't have to keep retrying drugs and waiting for responses.
So, recapping our recommendations you have seen this slide before which is to adopt and utilize the Rx Hub standards that we talked about today, this will enable a free flow of information to physicians.
DR. COHN: I am sorry and I apologize for not asking earlier on because I have heard it about seven times now about the Rx standard recommendations. Could you just go very quickly across because I don't remember exactly who owns or invests in Rx Hub? Of the PBMs in front of us can you very quickly identify which ones are owners or investors in Rx Hub?
MR. ROTHERMICH: It was launched in February 2001 by Advance PCS at the time which is now part of Caremart(?) Medico Health and Express Scripts.
DR. COHN: So, Cigma is the only one here who is not part of that. Okay, I just wanted to make sure that we understood the interest there. Thank you.
MS. RYAN: And I will get into who is using them in another moment here. The standards that the NCVHS adopts should enable the free flow of information and should also entice people to adopt ERX processes. They should not set up barriers to the process and that is why we think that if we look at some of the standards that are in place today and use those we will have a better chance of getting success in adopting those.
So, using the standards that were developed by the standards development organizations, NCPDP HL7 and X12 and also those that we have talked about here for Rx Hub will provide you with a basis for creating standards that everybody can use and that fit multiple purposes.
Again, we want to reiterate that it needs the support of multi-payer solution and we are not advocating that Rx Hub be the only solution just that we use the standards associated with Rx Hub.
Here are the actual transaction standard recommendations that we are talking about for eligibility. We are talking about that master patient index we described plus the X12 270 271 standards and the batch load of patient demographic information that goes along with the MPI.
MR. BLAIR: And that is eligibility to and from the prescriber you are talking about now?
MR. RYAN: Correct, yes. Benefit information again to the prescriber would be a batch load that has been created through the Rx Hub. Patient medication information or history is based on NCPDP messaging that the Rx Hub used to create information for the doctors and also from HL7's medication history messages.
Using participating providers, again we will be talking in terms of provider messaging that NCPDP has developed.
New prescriptions and renewals and changes would be using the NCPDP script and the HL7 prescription messages.
One of the discussions, I have got kind of a miscellaneous set of topics. So, they don't flow well. Excuse me for that. One of the discussions that we have had from a variety of folks here has been about pre-certification or prior authorization and we are not recommending prior authorization as part of the real-time transaction for electronic prescribing.
First of all the transaction isn't well supported right now. There is an X12 278 request for review and response that is not applicable right now in retail pharmacy and MCPDP is developing some standards related to prior authorization but the actual process of prior authorization is very complicated and it requires an intervention and a discussion with the doctor.
In preparation for this discussion I looked up some of the ones that we do for pre-certification or prior authorization and they are extremely complicated. I looked up one for the growth hormone for example. It has got six or eight different applications for use and each of those different uses requires a different series of questions that you ask the doctor as far as what testing has taken place, how has the patient reacted to it, etc. So, it is really not something that can happen on a real-time basis.
However, we do recommend that there be standards associated with the transmission of the requests and of authorization codes. So, in other words once an authorization has been given then the authorization code can become part of that electronic prescription passed along to the pharmacy so the pharmacy doesn't have to go through that process again and that code translates along and transmits along with the claim to the payer.
MR. BLAIR: And that is part of the script.
MS. RYAN: Yes, and the transmission of the authorization code is already part of the script standard. So, there is a place for it on NCPDP script. So, it can just carry along to the claims processor.
We talked a little bit about Rx Hub standards and how they were developed. They were developed as the result of gaps in other standards that existed and they were developed in a consensus process. So, there were work groups that were formed and public work group sessions were held in Chicago and Washington, DC and we did seek consensus from technology vendors, pharmacists and other players in the industry.
So, we did start with existing standards and then expanded upon them to make the application broader and to include that front end part of the process of providing information to the prescriber about a patient's medical history and about eligibility.
Today we have 12 partners who use the standards in production. There are 10 more partners who have been certified who are waiting to go into production and there are eight additional partners that are in the certification process and we know that others are using the Rx Hub transactions as a basis for their development. They are available on the Rx Hub web site and the web side has always included the information for comment and for discussion and so they can be seen there at that web site.
As far as what national identifiers or standard identifiers and code sets that should be used we are recommending the following. First of all we don't believe that a national payer or patient identifier is really required for using demographic information and information related to things that we gather for example the master patient index. You can find the right patient as you need to and additionally what a national payer identifier would lack would be the payer information. So, you would still be missing that part. So, there would be a piece gone in any case. Additionally everybody uses a different system these days and if we had a national patient identifier everybody would be required to convert their systems to use that new identifier which we think would be rather difficult and then there is the somewhat hard to overcome privacy concern that folks have expressed about that issue.
As far as prescriber identifiers right now there really isn't a good solution for prescriber identifier. There are things that are used and are working like the DEA, the state license number, HD idea and a few others but I think what we need to do is just pick one and develop it further and use it. We don't have a particular recommendation about which one is picked but it has to cover everybody and that is the issue.
Pharmacy identifier, the NCPDP provider ID is the right number. As far as drug codes we have heard from all the prescribers that the NDC level is just too granular and so we are recommending Rx Norm as well as some of the other broader identifiers and those would need to be incorporated onto the drug databases.
CIG(?) or patient instructions as I am talking about now when I say, "CIG," I am talking about the actual how do I take the medication directions. We do support industry collaborative efforts to standardize the CIG. We think that there certainly needs to be a free form text for those that cannot be standardized but there is a significant portion that we think can be standardized.
There have been lots of efforts in this and they haven't been very successful but we think that we need to resurrect this and I will tell you that from our mail order pharmacy perspective we have standardized a significant number of the CIGs and they probably cover 80 percent of the prescriptions we dispense. So, it can be done and it can provide a good tool for prescribers in picking the right directions for use.
Now, I would like to spend a little bit of time talking about preemption. The MMA preemption, I just want to preface this by saying that I am not an attorney and some of these arguments are somewhat complex legally. So, I am going to just gloss over them and then we do have an attorney here who can answer questions about it if you would like to ask more specific questions.
The preemption in the MMA is very broad, we believe and really overcomes some of the problems associated with the individual state rules and regulations related to electronic prescribing but it needs to be extended to pass the Part D part of Medicare because once we adopt a standard it is going to be the standard that everybody will use for e-prescribing. So, we are making a case here for a preemption that goes beyond just the Medicare Part D.
The current state rules and regulations are either you heard a little bit about this yesterday from our NABP representatives; they either prohibit in some cases or place severe restrictions on our electronic prescribing. Sometimes they don't address anything at all and sometimes the states have their own standards for electronic prescribing but in any case all prescription formats are different in states, in every state just the way for example that a physician prevents or allows substitution varies from state to state. So, no matter whether you have a really good state adopted and adapted to electronic prescribing or you have a state that is really trying to prohibit it you really still always have those differentiations and distinctions in different state forms and so we really need to kind of overcome those. Some of the things that states have done to prohibit or to provide barriers against the adoption of electronic prescribing have been discussed but specifically they include, most of them include things like not using intermediaries to transmit information, having some restrictions on the prescription content itself that really only fits paper formats and also varying restrictions on privacy and how you can use the information with patients.
The benefits of federal preemption would be to overcome these various state limitations. So those states that have never addressed electronic prescribing usually have done that because they are just comfortable with the paper records and the paper prescription descriptions and rules really don't fir e-prescribing very well, and so we really need to get beyond that and to get an exemption or a preemption from those rules associated with paper prescriptions and those states that have done any kind of standard setting on e-prescribing have not done so in a uniform way. So, it would really be helpful to overcome the various state specificity related to e-prescribing.
After all we believe that MMA's goal is a nationwide solution. Electronic prescriptions do span state borders and pharmacists, physicians and other stakeholders do expect a uniform system on a nationwide basis. I think that once we have this in place it will have to apply to everybody.
Some of the areas for federal preemption are discussed here but basically what we are saying is that besides using preemptions for the Part D drugs preemption could in essence allow any electronic system that meets the minimum standards to be in this without going through individual state board approvals and also could be used to overcome restrictions related to patient consent and to the use of intermediaries in electronic prescribing, at the same time recognizing that we may need some specific patient consent issues on specific drugs. AIDS-related therapy is the one that comes to mind, but I think it is important to recognize that prescriptions do cross state lines. I just think in terms of the place I live, New Jersey and people who live in New Jersey or in New York or Connecticut tend to cross state lines a lot for their health care and so we can't just think in terms of what a particular state needs or wants with regard to electronic prescribing.
We really need do need to think of this from a federal level because prescriptions do cross state lines.
MR. ROTHERMICH: I apologize. I am a lawyer. So, I can't help myself. I just wanted to point out there was some conversation yesterday about can we name the sort of difficult states and I think the important point is that they are all different. So, you have got software vendors who are having to develop applications, specific state by state. So, the form that they send to the pharmacy might say in one state, "Dispense as written," where another state it has to say, "Where necessary," and in another state is has to say, "Substitution permissible," or something.
So, the point is for them to develop all these different standards and for them to devote the resources to keep up with all these standards is duplicative and it is inefficient.
The language of the statute specifically says that anything that is contrary to the standards or restricts the ability to carry out the MMA's electronic prescribing program can be preempted and the point is if you want physicians to adopt this there has to be a uniform program . So, you can't expect both the software vendors to develop one application to Medicare standards and a separate application to 50 state standards and the application will by definition look different to the physician because of what has to appear on the screen and so I think there is an easy argument for saying that whatever this group develops as the standard needs to be the standard for electronic prescribing generally or it just won't work.
MS. RYAN: Thanks. So, let us turn now to prescription authentication. We had some discussion of this yesterday in talking about Internet prescriptions and how you confirm whether this is or isn't a good prescription. This has been quite a topic of discussion at state board level and elsewhere. The pharmacist does have an obligation to make sure that the prescription is a legitimate prescription before filling it and many states do require a pharmacist to authenticate prescriptions. I think this concept has been somewhat derailed in the e-prescribing because the concentration has been what constitutes a valid signature as opposed to how do you verify that this is a valid prescription and there are lots of ways you can validate a prescription through the audit trails and security controls associated with e-prescribing that are in fact much more powerful than any paper prescription you would ever have. All of us who are pharmacists are involved in times when prescription pads have been stolen and you have to call each other and tell each other to look for prescriptions from a particular doctor because the pad has been stolen.
You can put controls around electronic prescribing that you would never be able to put around paper. I think you are talking in terms of people who just have a particular comfort level with paper prescriptions because they are used to seeing them and pharmacists are really pretty good at figuring out it is a good prescription or a bad prescription because of their experience but you can put electronic controls around electronic prescriptions to really validate the authenticity of that prescription and go beyond the signature. So, basically what we are saying here is that we think that we should have a system that has authentication through the use of audit trails and security controls and that the signature and what it constitutes is a little less important. Whether it is a PKI type of signature or it is an electronic signature it is not quite as important as just authenticating the source of the prescription through audit trails and through security controls.
So, we ask you to remain technology neutral as far as describing exactly what the signature should look like but rather think in terms of the security of the system.
MR. ROTHERMICH: I want to add one piece to that, too. This is another area that is very, very important for preemption. We have pharmacies in five states, and we technically today have the capability to take true electronic prescriptions into our fill system directly which is one of the promises that electronic prescribing provides. We don't have to have a human taking a piece of paper and re-entering it in the system which aside from efficiency concerns adds another opportunity for error. The problem we have had is we want to implement a uniform system across our company and we are trying to find a common denominator for five state sets of laws that the pharmacists have an obligation, a professional obligation to abide by.
So, they have got professional practice that they are used to in each place where the practice as to how to authenticate the source of a prescription and the different state laws speak to it in different ways where in some cases it isn't exactly clear if they get a prescription electronically what their professional obligation is, and so by coming up with a single standard that says that a script that comes in through a system that meets these requirements is deemed authentic, 50 states, it solves a huge problem from the pharmacy perspective and makes electronic prescribing more real.
MS. RYAN: And that wraps up our presentation. We would be happy to take any questions from you.
DR. COHN: Thank you. I think it has been a fascinating presentation. I was questioning at the beginning whether we would make it through all these slides but I thank you all for having moved through it.
I know Jeff has questions. It seems like we will have a lot of questions. I actually had one question before we started out and it was just this issue of since we are talking about Rx Hub standards, at least these are the things you are coming forward with and obviously I would observe that the only person at the table who isn't an investor in Rx is I think Terri, you, from Cigna and I this will be something obviously we will ask others as we move along but can you describe your interest, feeling about that since you are obviously not an investor in the company which you are promoting standards for?
MS. SWANSON: Sure. I think the value in these standards is they do meet needs of payers or they fill some gaps. So, there wasn't a way to get formularies uniformly out to the point of care or that benefit information out there let alone a way to actually link the patient to the right benefit and formulary information and the Rx Hub standards enable that to happen in a multi-payer, kind of a payer neutral way. So, each of us as payers whether we are an investor or not an investor can still supply our information. As Phil said nobody has changed the way they develop their formularies but they can all be supplied in a uniform way. It minimizes our costs and really allows us to interact with a wide variety of point of care applications that the physician can choose from.
You know, the physician needs to make the decision about what kind of software is going to best meet that office's needs. So, this set of standards lets lots of different types of solutions use and benefit from the information that we as payers want the physician to take into consideration at the point of prescribing and it really enables the physician to kind of drive that process.
MR. ROTHERMICH: I would like to add to that just to make clear. When we began Rx Hub the three founders didn't want to spend huge amounts of money changing our systems either.
So, we had the same interests as any other payer would have in finding a solution that solves the problem without us each having to re-engineering things that had taken years and many millions of dollars to develop.
So, for others to use those standards and the fact that most of the point-of-care providers are using those standards it is just a workable solution. There isn't anything special about it that makes it easier for us as investors than it would for the next guy.
MS. SWANSON: Just one other thing to add on that point is you know we really in this electron prescribing process we want to keep aware of what makes things work for the physician and the multi-payer solution is really what a physician wants. They want to use one tool to do all of their prescribing for all of their patients regardless who manages their benefits and so for us we are happy to use these standards to help the physician adopt.
DR. COHN: Thank you. Jeff?
MR. BLAIR: First of all, I want to disclose that the representatives of this panel, Phil and Mary and Terri and a number of other folks from the PBM payer community contacted me prior to the session knowing that I am blind, knowing that that outstanding set of graphics was something that I was not going to be able to see in this meeting and I guess it was what, last Wednesday over dinner took the time to help me through and understand that and I want to thank them and I want to publicly disclose that that meeting took place and it was a very helpful meeting so that I could understand this information in advance.
Several questions that I have. You have been referring to the Rx Hub standards and these have been developed and you have basically been able to get the payers to, and the PBMs to agree and I think the benefits to these messages and the content in these messages is clear and it really has enabled e-prescribing to move forward, and I am personally very glad and happy that that has taken place.
My understanding of our role here on this Committee is when we identify what should be national standards for e-prescribing we have to keep in mind the nation as a whole and all of the guidelines that were in the MMA and we have had a tradition of favoring standards that are accredited by the American National Standards Institute because they are open meetings, because they are consensus based and my understanding in testimony that you have given before and I just wanted to verify is again, is there any problem that you foresee in taking the Rx Hub standards to an ANSI accredited standard development organization where there could be open consensus-based meetings and go through the process of having them become ANSI accredited standards?
MR. ROTHERMICH: I don't believe so. Teri, you might be best to speak to that.
MS BYRNE: Not at all, Jeff. We haven't done that yet really because we have been proving our standards. We have been doing a lot of pilots. We have now got them in production.
We believe that they should be part of the SDOs because they have the best processes for getting changes made to the standards in a consensus way.
One of the recommendations we have though is to adopt the standards as is and then take them, you know, have an organization own them, then take them through the change processes where changes are needed only because we do have so many partners using the standards as they are today and we believe that if we try to take them through an organization prior to them getting adopted they will change or they will be changed just because that is the nature of the organization and the way it works and everybody who is using them will probably have to change as well.
MR. BLAIR: The process you are doing is pragmatic and it has value and obviously you are moving faster. There is always a trade-off because the standards development process is slow and that would slow things down. On the other hand, if you essentially have the agreement of all the payers in the PBMs but if the prescribers and the pharmacists have less influence in your process in a sense you may be coming to things with a fait accompli. So, let me offer this as two positives. No. 1, it is great what you have done and No. 2, I think that it would be helpful if you try to have it go through the ANSI accreditation process with an ANSI-accredited STO as soon as you are able to do so, so that we know that all of the constituencies have an equal chance to be represented in the process.
The last question that I had was with respect to pre-authorization and, Mary, I think it was you who explained to us the complexity of pre-authorization. I have been struggling as we have heard from different testifiers where the proper balance is here with respect to pre-authorization and if there is not the ability for a prescriber to electronically request a pre-authorization and receive electronically a response to that it appears to me as if it makes it extremely difficult for a prescriber to challenge the formulary for a particular patient. That is a concern. It is a patient safety concern and I am saying that not in isolation. I also know that we don't want to make it so easy for a prescriber that they could override the system anytime they want.
So, there is a balance there but if the messages haven't been created between the prescriber and the payer to go through a process of requesting pre-authorization and getting a response, it tilts the situation severely against the ability of a prescriber to represent that patient's interests.
Would you tell me if my perception is incorrect or unbalanced in some way?
MS. RYAN: Sure, but I am going to defer to Phil because he just whispered to me that he wanted to speak.
MR. ROTHERMICH: i just wanted to make a point. You mentioned formulary exception which I just want to be clear is different than prior authorization as we call it. Prior authorization is a very specific benefit rule and as I mentioned yesterday it relates generally to very specific high-cost drugs that should only be used or are really approved for payment only in very limited circumstances and there is an example in our presentation that Mary can speak to better than I do that gives some sense of why that is so complex.
What the prescriber is looking for is you know, I tried that one and it didn't work. I want to try another one. That is a different conversation.
Again, it is a difficult transaction to make electronic because as soon as you make it electronic you have got sort of the tools you have to drive compliance. In other words most of the time today if you pick a non-formulary agent or more typically what would be a third tier agent the only real consequence is it costs a little more and that is by design.
So, if the patient and the physician decide that generic didn't work and that brand agent that is preferred on formulary didn't work or was not tolerated and they want to keep going up the spectrum they are free to do that. If they wanted to try to call and get a different payment arrangement for that that may or may not fly but prior off as we speak of it is a different process and I think it maybe helpful to talk through that growth hormone a little bit.
MS. RYAN: Right. First of all I should also say that the pre-load information that comes to the prescriber has these drugs specifically tagged as requiring prior authorization so that they know up front that there will be a process involved in these particular drugs and the requests can come electronically. What can't really happen is that whole discussion about how to qualify the drug.
In the notes example that we sent for prior authorization I used an example of one of the growth hormones and it is an 11-step process to determine whether or not this drug should be approved or not under the benefit plan.
So, for example, it asks the question of whether or not the patient is greater than 10 years of age. If yes, proceed to step 1A. If no, proceed to step 2, etc., and it goes through the whole list of how you determine whether this drug should be covered for this patient. It talks about questions about the patient's height, whether or not you have had any trials of the product, whether when the product was tried the patient grew a particular amount, and so it becomes much more complicated than a simple yes or no and they are I think appropriate questions for the medications usd.So, it can be very complex and it is not something at this point that is available on a real-time basis because as you get different answers to the different questions you proceed to another step and ask another set of questions.
So, it is not that we don't think that there should be electronic indicators and things available to the prescriber. It is just that once you get into the whole conversation about the drug specifically that doesn't really lend itself well to an electronic real time exchange of data.
MR. ROTHERMICH: Let me add one more thing. The slides that we submitted are slightly different than the slides in front of you which maybe to you doesn't make any difference but one of the points we wanted to clarify last night was we would support where it is feasible working toward an electronic request and response but in most instances with prior off we think it is not reasonable. So, it isn't as if we are just opposed to the idea. We just think it won't work in most cases.
MR. BLAIR: Okay, and my last question is your recommendation with respect to the prescriber identifier and I believe and correct me; you could go to the exact wording but I believe you said you weren't recommending a prescriber identifier and you said DEA, HCIdea, NPI which isn't available yet or others, you know none of them is perfect. I would like a little clarification. My understanding of HCIdea is that it can encompass the DEA code, that it can identify different facilities and it is available now whereas the NPI won't be available for some time into the future.
Could you help me understand why it is that you chose not to recommend HCIdea?
MS. RYAN: HCIdea is not a number that the prescriber has that they would, for example, put on a prescription to transmit to a pharmacy or right on a prescription so that pharmacies can put it into their system.
I think if we could overcome some of those examples where it is a readily available number to the prescriber as part of the prescribing process that it probably would be a better number and would work fine.
Right now it is more of a, i would call it a translator type of system where you put in a particular number or another and then it houses or translates into sort of a separate database of information, but it is really not in use from a prescription perspective whereas for example the state ID number or license number or the DEA is in use from a prescription perspective.
So, I think it could be used. I just think we need to do some other things with it to make it usable. Likewise, I think the NPI could be used in the same way as long as it extends beyond the current NPRM which indicates that it is going to be used only for Medicare or Medicaid types of prescribers and that is just not enough. You have to extend it beyond to others and we need to have it fully used out there. At least that was my understanding of the NPRN, that it was looking more for those folks who are participating in Medicaid and Medicare.
DR. COHN: Just to clarify that and I am sure Karen can probably also speak to it but the NPI is really intended for all providers but it doesn't have the location issue. So, nothing is perfect.
MS. BYRNE: From a router perspective I would like to address your question, Jeff because I have done some research on HCIdea. So, I am representing my personal beliefs in having done some research.
I think HCIdea is really close to being able to be the answer because they have developed a model where they can include all of the other identifiers which from a router perspective is wonderful because we could purchase the HCIdea file and distribute information and match information. So, if one vendor sent us DEA numbers we could match to the HCIdea number, send that out to the pharmacy. So, I think it is very close in, you know, just having done some research on it I think if we implemented or adopted HCIdea I don't know if it is perfect but I believe it is very close and every partner would not have to adopt it because they have considered backward compatibility to some of the other identifiers.
MR. BLAIR: Is this Mary, right now?
MS. BYRNE: This is Teri Byrne from Rx Hub.
MR. BLAIR: I would appreciate it if you would just send an e-mail with what you think the things need to be done in order for HCIdea to become appropriate as a prescriber identifier. You say that it is close but there are a few things that need to be done. If you wouldn't mind and if you could send that to Maria, she will distribute it to the rest of us and I would ask since we are on such a short time line if you have a chance to do that maybe before Monday?
MS. BYRNE: I can certainly do that, Jeff, but again we haven't utilized it or implemented it. So, I can't speak exactly to what is there and I would defer to anybody else who has implemented it but I certainly can give you my opinions on what I have done as part of my research on it.
MR. BLAIR: Thank you.
MS. SWANSON: This is Terri Swanson. Just one very minor clarification, we do want to see a national prescriber identifier whether it is HCIdea or some other solution that this group recommends. We have a process that is working today that has sort of worked around that. So, you know, we have worked around it and do have a process for routing that works but this would definitely be a better solution.
DR. COHN: Jeff, I would like to let others ask questions. Are you done?
MR. BLAIR: Oh, yes.
DR. COHN: Okay, good. I think Stan and then Harry.
DR. HUFF: First, again, just thank you for all the careful thought and instruction that has gone into this very nice, lucid presentation. If there any cost associated now with using the Rx Hub standards?
MS. BYRNE: Do you mean do they have to be purchased? Our standards are free to anybody who is connecting to us as well as people who aren't connecting, we distribute them ahead of time so that they can develop to them before they are even connected with us.
DR. HUFF: And is there a stated policy to that effect or has that just been your practice to this point?
MS. BYRNE: It has been our practice. What we have is we have our standards and then we have our implementation guide which is a very detailed implementation with Rx Hub and we do request that a participant have an NDA with Rx Hub prior to distributing our implementation guide out to those participants. Otherwise it is pretty open.
MR. ROTHERMICH: I believe and Shelly maybe you could confirm this but I believe when Rx Hub was here and testified they agreed publicly to make those standards available for use.
MS. WOOLEY: Absolutely.
MR. BLAIR: As a mater of fact I recall that it was their intent to go to NCPDP and make it an ANSI accredited standard.
DR. HUFF: The second question, I notice one of the things, you know, a requirement that has been brought up before is the need to identify the prescriber at a location and I can understand that clearly.
What I have never understood is why people wanted to combine that into a single number. I mean why don't we have a unique identifier for the person and a location and always send the person identifier and the location identifier and then I would always know where this message came from, where I should route it to? Am I missing something in that.
MR. ROTHERMICH: You are talking about like a suffix or a location or something?
DR. HUFF: Not a suffix just a separate data field and the message, I mean a separate ID for the location and a separate ID for the patient or is there some part of combining them in a single number that has particular value to your process?
MR. ROTHERMICH: Maybe you have an opinion. My sense would be only that since most systems today are built around DEA that it would be nice to come up with something that we don't have to rejigger the whole system and I don't know if doing separate deals creates that problem or not.
MS. RYAN: I believe there is only one field for a prescriber ID on the NCPDP transaction standard and so you would have to add another field related to their location.
MS. SWANSON: The other thing I guess that I would want to just to clarify your question are you talking about the physical location of the prescribing office or the virtual location that I want to send say a prescription change request because one thing is it is relevant or it just historically has been relevant of where are they physically on the planet; you know, which office are they in; which hospital are they in but from a routing perspective you also have to understand where to actually send that electronic transaction and should it be going to this Palm Pilot today or that practice management system? So, there is a couple of different types of location that need to be accommodated to be able to route the information.
DR. HUFF: I was referring to whatever location you are referring to in your requirement. So, I mean whatever your requirement is for a location there that is the location that I am asking why couldn't it be coordinated with the provider number or being somehow combined into a single --
MS. SWANSON: I don't think we are saying that it has to be included or you know encapsulated inside the number.
DR. HUFF: I mean DEA numbers are not location specific. It is just the unique identifier or the provider.
MS. BYRNE: I think that we have allowed for location because some technology vendors want the doctor to be able, want to be able to send things to a doctor at different locations and they want to be able to specify that but you still want to be able to identify that that is the same doctor no matter where he is practicing.
So, it just could be the master key is one key for the doctor and then it has subkeys for locations that he can practice at.
DR. HUFF: Is that part of it? Is it that you are trying to in some way know ahead of time where that physician is allowed, what locations the physician is allowed to have?
MS. BYRNE: I think typically I mean when we went through the process of developing the standard for distributing this information what we heard was from a pharmacy perspective they typically would route things or submit renewals based on a phone number and so they need to know the clinic that the physician was practicing at. So, they made sure that renewal requests went to the right place.
Now, some technology vendors have solved that problem by giving the physician an Internet access and he can access it from any location. So, some of the vendors that we work with only submit one location for each physician but some vendors wanted the capability to distribute the renewal request to the appropriate clinic as well and so that is the reason. They want to make sure that wherever the physician wants those renewal requests to go that they get there.
DR. HUFF: Another recommendation in terms of cogent identifiers was the use of SNOMED What part of SNOMED were you positing would be used as part of the standards in particular? I mean we know lots of uses it would have in other areas of the medical record. Which things were you positing it would be used for here?
MS. BYRNE: I think we can probably all say that we haven't done a lot of research on SNOMED, okay? So, I will qualify it with that but knowing that on the prescription it is helpful to understand disease state or why the drug was prescribed it is helpful, you have heard a lot of that it would be helpful to have that information in not only the script but in the telecommunication, in the claim and in the database as well as the prescription history going back to the physician. So, that is kind of where, you know we haven't done a lot of research but we have heard consistently that it is appropriate for those uses.
DR. HUFF: You weren't proposing that SNOMED be used for the drug identifier part of --
MS. BYRNE: No. The only thing that I think we are recommending that all of these, the SNOMED and the FRT, etc., all be linked to the drug databases so that the current drug sources, the technology vendors and the PDMs and the hospitals have can all be linked back to those sources.
DR. HUFF: The final question, in your work flow the formulary information has always been a pre-load again and as you have described so that you can provide performance for the prescriber and that has always been my experience as well in our systems.
Do you think technology has evolved to a point where that could be a real-time transaction to some Internet-based knowledge base if you will of formulary information or do you think for the near term we really want to stick with strictly a pre-load?
MR. ROTHERMICH: We should just clarify, I mean real-time transactions are available today. So, it can be done just not very efficiently.
DR. HUFF: They are available. Are people using them that way?
MR. ROTHERMICH: Talking about a real-time transaction, there is a real-time request and response from the physician's office. In other words not everybody is on the schedule.So, if somebody shows up the physician's office can still get the right information in real time and I think those transactions are averaging less than 5 seconds, but the actual formulary files you know we make resident with the point of care vendor so that then when they get an eligibility transaction back and Terri can probably correct me but it is sort of table based for lack of a better way of describing it. They know which formulary to link this patient to even when they do a real-time transaction. What you don't want to do is trying to do downloads of formulary files in real time because there is no really no reason to. I mean they change but they don't change every day. So, if you get all that information to the point of care vendors that are using them then they pull them from their system very quickly and all they need to know is which formulary do I attach you to if you show up at the doctor's office.
MS. BYRNE: I do want to let you know though that we did develop a real-time formulary request response as part of our standard set early on when we published our standards and most of what we get when we offer these to the technology vendors is why would I do that? My doctor doesn't want to wait 3 to 7 seconds for an answer and he will throw the PDA against the wall. So, we had that available. We actually had one technology vendor piloting it with one EM and it really hasn't taken.
We have also offered as part of a product set and done some research; we do a lot of research in what products do our technology vendors need and what new transaction sets do they want us to develop and we have offered and Internet-based request response, so, coming just to Rx Hub not having to go all the way out to the PBMs and they still say, "You know that is okay but what you offer today, distributed formularies fits into my model and that is really what I need."
I did want to offer one more thing on the prior off because that is one other thing that we have done a lot of research on and we consistently hear back from our technology vendors that it is not something they are looking for right now. It doesn't fit into the work flow and they don't believe that, you know they think maybe the back office staff is going to be doing the prior off request if that is what happens and so you know for 2-1/2 years I have been asking the tech vendors do they want that and they consistently tell us no.
DR. HUFF: The other thing you mentioned is when you were talking about the HCID IDEA that you purchased that database. Is that a product?
MS. BYRNE: Lynn can probably speak better to that. I think they have multiple options for getting that information . You can either provide information and then get it for free or you can purchase the information a lot like the NCPD provider file. I assume I answered that correct since Lynn is still sitting there.
MR. REYNOLDS: With respect to your tight schedule Mr Chairman I would be happy to hold these and I could ask them at open microphone or subcommittee discussion later because most of this group tends to be here all the time. If that would be better for your schedule, but I would like to push on their model.
DR. COHN: Since you have them there, why don't we do it. I think everyone just has to realize that we are going into the break but I mean you have a right to ask questions as does Mike and then we will complete after that.
MR. REYNOLDS: Your model, an excellent job and I appreciate that you took it all the way to the standards. So, that is good. You know IDEA and standards, I think that is good. Your model seems to me to dump an awful lot onto the POC in the doctor's office, that system and our discussion yesterday about the fact that whether or not those vendors step up, whether or not they actually change, we have already experienced it through the rest of HIPAA. That that was a significant gap in what we are doing concerns me quite a bit. Also the fact that a lot of this pre-load is going on back to playing off a little bit of Stan's question, the idea that there would be a single point of failure with all that pre-loaded information for everybody that is going to, might get a prescription in the United States, all out there sitting waiting at any time in any day is a significant undertaking and a significant point of failure for concern and I may have misunderstood what you were saying but that is what it appears to be.
Also, the fact that when we look at the cost of all these things that having that out there and what do you foresee as who would deal with the transaction fees, who would deal, where would that get taken care of because obviously somebody has to contract with that database in the sky to be there and then obviously whether it is be the physician or someone has to pay for the fact that these point-of-care vendors have to make all these changes. So, I am asking because it pretty much spans your entire mono and then one specific question I think you could answer quickly, the idea of when you were talking about guarantying payment and so on you were not saying I don't believe that when that formulary comes down it will have the co-pays on it even though it could be filled differently in a pharmacy. Is that correct or not?
MR. ROTHERMICH: We are generally supporting relative costs, so, tiering kinds of information. When you start to talk about co-pay you really are talking about pre-adjudication because you have to know a lot of things to get to co-pay.
MR. REYNOLDS: Okay, so different than our other discussions up until now we were assuming things like the co-pay amount would appear because most people --
PARTICIPANT: The amount or the percentage?
MR. REYNOLDS: It could be either.
MR. ROTHERMICH: If you look at the sample application page in the presentation I mean it will show you know, 1 dollar sign, 2 dollar signs, 3 dollar signs. From a physician's perspective that is really all they need to know. This is the cheapest one. This is the medium one.
MR. REYNOLDS: Physicians would much prefer to see dollar amount.
MR. ROTHERMICH: I agree with you, but whether it is the 1 dollar sign means 10 dollars or 7 dollars or 15 dollars in the grand scheme of things won't change anything but to get to specifically 7 dollars or to 10 dollars or 15 dollars you need to know so much information that the physician even though they might prefer that I think in most cases wouldn't be willing to wait for it and even if they were willing to wait for it often they won't have the information to get there. In other words, we don't know if they are going to Walgreen or they are going to K Mart or they are going to Target or they are going to mail.
We don't know whether they are going to get brand Prozac or generic fluoxetine when they actually fill the script.
DR. HUFF: I think there is good, and I would have to go back and look that physicians routinely ignore the 1 dollar sign, 2 dollar sign, 3 dollar sign because they don't know how much money that means and that real dollar amounts associated with ordered items tremendously influence physicians' behavior at the time of ordering and so you are right there is some uncertainty based on where the prescription is filled how much that dollar amount is going to be used but I think people understand that but they don't think $7 is going to turn into $28.
MR. ROTHERMICH: Let me be clear. We are not opposed to $10 or $20 and to the extent we can get there some are there today. Some aren't. If we can get there at a benefit level in other words we know this person is in a three-tier group with a 7, 20, 30 dollar co-pay, we don't have any problem providing that to the extent our systems can get there recognizing that that is not a guarantee, that this person is going to show up at the pharmacy and this is going to be a $7 drug and people have to understand that when that happens they may get a phone call. "You told me it was going to be $7 and it turned out to be $50 because I have a deductible." You know, so, there are issues on both sides of that.
MS. SWANSON: I would want to point out that it is very, I agree with Phil, I think and with your point. Physicians would value this information as would patients and we would like to be able to provide as close a proximity to that as we can, but it is very highly dependent on the benefit design. We are talking a lot about co-pays, you know, a flat $10 or $7 co-pay but many,many, many benefit designs are co-insurance. You know it is 20 percent or 30 percent of the drug cost. Many of the new plan designs, the consumer driven plan designs have a high deductible. So, if there is a $1000 deductible you may very well be paying full price for that prescription.
So, you know there is in looking at how to provide this information across the board in a good way for every patient who comes into the physician's office it is challenging. So, I think we would be supportive of getting as close to real costs as we can but there are some real challenges and limitations in the system today.
MR. ROTHERMICH: This is an area where our concern is that the standard not require it but enable it and then to the extent that it is possible to get close you know, we will try to get close.
MS. BYRNE: May I make one clarification because the standard does allow, the standard that we have developed does allow for the payer to send dollar amounts; so, let us say a brand they have a tiered co-payment brand is $5 and a generic is $2, we have that ability and we also have the ability to send co-insurance numbers, so, 10 percent versus 15 percent as well as the ability to send the dollar signs. It really depends on the information that the vendor is comfortable displaying and that the PBM is comfortable sharing.
DR. HUFF: Then I am agreeing with you as long as there is the capability there and as people's capability improves they have the ability to send it then I am great. MS. BYRNE: The other thing, we are in the process of running a pilot. So, we will have better numbers about the doctor's utilization of that information within the next few months.
DR. COHN: I was actually going to remind everybody what the Part D benefit looks like because all that you are describing suddenly becomes very irrelevant when you are talking about a model that is an eighty twenty for lower cost and then you hit a dollar figure and suddenly the patient pays 100 percent up until another level. So, as we heard you want to do it in pre-adjudication. So, we can't really tell when that person hits the benefit fund that in some way 100 percent is on them. So, I just want to remind you that there are all these benefit designs but the Medicare benefit is going to be a big piece of this and we can't solve it today but I think we do need to be aware that we need to think about this.
MR. ROTHERMICH: Can I go back to Harry's first question?
DR. COHN: Sure.
MR. ROTHERMICH: Two things I wanted to just clarify, You mentioned this massive download of information to the point of care players which I don't think is quite right. I mean we talk about a big database which is the MPI that they hit against but the pre-load of actually patient-specific information in the physician's office is based on a schedule. Most of these applications tie to the scheduling applications. So, they can night before send 30 or 50 transactions out and have that information available. So, it isn't as if every point of vendor is downloading everything to every physician on the chance that you might show up in their office.
MR. REYNOLDS: I understand that part of it. My comment there was for Rx Hub database but still the provider system has to have the ability, their scheduling system interfacing with this and pulling down the specific information on the specific patients and holding it there for access by that physician. The further part of that question is if that, using your screen if that doctor wants to select another drug they do have to go back to the other databases. Is that not correct?
MR. ROTHERMICH: No, typically the applications are built is they build those connections. So, they use the multim(?) or first databank drug databases to make those connections. So, if they want to select a statin they will get a list of the statins and the formulary status of each one and they are tied together or they search by drug and they search for Pravachol and it shows non-formulary they will be able in most of the applications to push an options button and get other similar drugs and their formulary status.
So, you know you worry about the point of care vendors but this is a software application that we are talking about. So, by definition they have got to have the capabilities and frankly they have had those capabilities for many, many years.
MR. REYNOLDS: Let me disagree with that. I will use a specific North Carolina example that I used when we were doing HIPAA in a WEDI(?) presentation. We listed 30 pages of practice management systems. I made the 120 people in the room put their hands up when they recognized one. I got to page 4 before the first hand of all the people that are in the industry showing up here and everything. There is a significant population of the world out there and we are talking about individual doctors prescribing individual prescriptions. We are not talking about the big players in this room that have the money and time and effort to send people here. My concern as we look at benefit when we look at Medicare, and wherever it goes from there is the idea that the on-the-ground doctor who has ABC accounts receivable doing his practice management system is not creating these transactions. So, I just as we look at this model it is of significant concern. The specific concern that we consider this model may have an issue and anything you could bring to the table to help deal with that issue would be appreciated. That is my point.
MR. ROTHERMICH: I was referring really to the point-of-care provider not the practicing vendors but I agree with you on the practice management side. That is highly disjointed and that is an issue. One of the things I think someone spoke about yesterday and I know we spoke about a couple of meetings ago was the potential for standardizing at least some portion of the practice management component so that when a point-of-care vendor needs to pull demographics out of the system there is one way of doing that and so if you push the practice management systems to created databases of demographic information for this whole purpose of supporting point-of-care prescribing applications and they all did it the same way then all the point-of-care vendors could, because that is all they need is the demographics. They need to know who the patients are in this practice.
MR. REYNOLDS: You are considering the point-of-care vendor to be different than the practice management system in that office.
MR. ROTHERMICH: Yes, in our vernacular the point-of-care vendors --
MR. REYNOLDS: So, also, we are adding another vendor to the doctor's office.
MR. ROTHERMICH: Yes.
MS. SWANSON: The vendor landscape I think is going to continue to evolve. So, there are those back office systems you know as you said that most physicians have. Many of them are selecting different systems to use at the point of care because it is a very different more clinically based set of work flows and some companies deliver all ends of that spectrum.
So, I think it is --
MR. ROTHERMICH: It is important to point out the practice management vendors generally have been slow to get into point-of-care prescribing. I think as this process goes on and all the other conversation in Washington the interest level with them is growing rapidly. So, there will cone a time when most of them offer a fully integrated solution. It doesn't necessarily mean that if you have this practice management vendor you necessarily want their prescribing application because you may have another one you like better.
So, the point of them being able to talk to each other is still relevant and some will build and some will partner and some will buy but I think as time goes on the systems will more likely be interoperable but in the meantime enabling that demographic download to be simpler would go a long way to solving a lot of the problems in electronic prescribing.
DR. COHN: Michael, I am hoping you have a very brief question.
DR. FITZMAURICE: I have a brief set of questions but most all of them have been answered. I was going to ask about the RX Hub standards in the NCP or ANSI standards process and the answer was you were going to do that and I agree with Jeff that it does allow others to have a strong voice where they might not have a voice at all in the process.
I was going to ask a question about pre-authorization but it really was pre-adjudication and I think the answer to your question as to why we don't have pre-adjudication in the prescriber's office is that there is no market demand. They aren't saying that they really want it and therefore there is no cost recovery possible if you go through that process.
Much as I think I would like to see the system have it, if the users don't want it, if they aren't willing to pay for it our market system says that you wait for it.
So, what questions do I really have? You say that the national patient ID isn't needed but you collect additional information about a patient that could be even more invasive than a patient's ID. An MPI as I understand it assigns a unique patient ID that is unique within the enterprise but it is not unique across enterprises where a national ID might be.
So, I am asking not shouldn't we have a national ID. That will be decided politically and with due process but would the master patient index work across prescribers and pharmacies. Maybe you don't need all these IDs if your master patient index will assign identifiers to your enterprise to these entities. Is that a reasonable solution?
MS. BYRNE: I think that if we had a national patient identifier we would certainly incorporate it in the MPI because it would be easier than for, if everybody was using that great but even if they weren't we could incorporate it in as well as the local IDs for the payers that we are working with.
DR. FITZMAURICE; But i am talking about the payer ID itself or the prescriber ID that can use the same algorithm to work within your enterprise to assign unique numbers to the prescribers and the pharmacies. So, you don't need a national identifier for those.
MS. SWANSON: Right, you are suggesting an MPI for physicians or an MPI for pharmacies.
DR FITZMAURICE: Or is that much more effort than it would be worth?
MS. SWANSON: The NCPDP ID number is out there and being used and it is not a big problem I would say.
MS. BYRNE: For prescribers we have kind of already, it is not really an, it is not an MPI because we don't need to do a search because we are basically a router for prescribers whereas for patients it is difficult for the prescriber to understand where the patient is covered. So, we find the insurer or the prescribing application so they don't have to get a card and enter any information, etc.
MR. ROTHERMICH: i just want to add on the patient identifier it isn't so much that we wouldn't think it would work as much as we think it adds cost to the system because it is not necessary and you have got all these different payers using different ways of doing their claim system and so if everybody had to rework their system to go to a national patient ID you have added cost to the system rather than taking it out and we are saying with an MPI technology you don't really need to do that.
DR. FITZMAURICE: Okay, last question, without the pre-adjudication information how does the consumer, if I have a prescription in my hand, how can I obtain lowest out-of-pocket cost for that drug? Do I go to each pharmacy in my neighborhood and have them run it through and then send me back what my co-pay would be and I choose the one with the lowest co-pay at that particular time; is that the best thing for a consumer to do to find the lowest out-of-pocket cost for a drug?
MR.ROTHERMICH: It could be. Most pharmacy networks are pretty all encompassing. I mean you know most payers are demanding networks of 40 and 50 thousand stores and so the chance of a store not being in your network is unusual. So, you know, for you to find out what Walgreen's price is and K Mart's price is and everybody else's price that is really the only way I know is to go around and do that and I suspect people don't shop that way.
MS. SWANSON: The other comment I guess I would make to that is I don't know if we are saying that is the best way to go find out. I think most of the payers are providing consumers tools on their web sites to let them understand the formulary and understand the costs and very specific to their benefit plan. So, I think it varies by payer but you know in general we are trying to provide consumers tools so that they can kind of make that comparison on their own and understand the cost implications.
DR. FITZMAURICE: But I have got to know my deductibles, my co-insurance, my upper limits and if they have already got it the only way to get access to it would be to go to the pharmacy and say,"Could you run this for me?"
MS. SWANSON: The member may have access to more member specific information through that web site though. There may be multiple mechanisms for doing it.
DR. COHN: I want to thank you all for a fascinating and very useful testimony.
I want to make one comment and then we, actually two comments. One is that we are 20 minutes late. So, that means that lunch goes 20 minutes later probably. So, I just want to warn everybody about that during our 15-minute break.
The other piece is just sort of an interesting observation that no one around the table talked about I think the fact that you are really the first group who has really put preemption in a very big way on the table for the Subcommittee to consider and where that fits in with all of our standards recommendations and that is a piece that we will have to consider probably not something discussed so far, and we heard a little bit about it but basically this was like a major assault into that area which we are going to have to I think keep in mind as we think about whatever recommendations we are going forward with.
Now, it is eleven-twenty-one at least according to my watch. We will get back at eleven-thirty-five.
(Brief recess.)
DR. COHN: Our next session is the Pharmaceutical Manufacturers' Perspective and we are obviously delighted to have a number of you in attendance and participation as well as we want to thank you for some of your handouts which hopefully you will help go through them with us so that we understand them a little better.
As I understand it we actually have testifying Michael Weinberger from Johnson & Johnson and Charles Jaffee from AstraZeneca and Peter Brandt from Pfizer and I think you have some associates with you as I understand. Anyway, Michael are you leading?
MR. WEINBERGER: Peter, I think.
Agenda Item: Pharmaceutical Manufacturers' Perspective
DR. COHN: Peter, would you like to introduce your people with you?
MR. BRANDT: Absolutely. We have the pleasure of having Ross Martin here with us and Dr. Eng Ho.
Good morning. My name is Peter Brandt. I am a senior vice president of Pfizer Global Pharmaceuticals and Chairman of the Board of Amacorps(?) a joint venture company between Pfizer, IBM and Microsoft that develops and provides integrated clinical and practice management solutions to small and medium-size physician groups.
Thank you for the opportunity to testify before the Subcommittee and for including all stakeholders in these important discussions.
While I do not have a technical background per se I have provide leadership for many of Pfizer's technology-based initiatives and will be providing testimony based largely on that experience this morning.
Pfizer is the world's largest private research organization and pharmaceutical manufacturer. Our mission is to advance the quality and safety of health care through the research and development of innovative new medicines and health management services.
To this end we are strong supporter of electronic medicine and enhanced connectivity through the creation of a national health care information infrastructure.
An interoperable e-health infrastructure will greatly assist us in the search for new cures. It also will improve patient care by making clinical information more readily accessible to providers.
Equally important it will also allow us to assess and more accurately address issues of disparities in access to care and patient compliance with a prescribed therapy and will enhance the overall benefit of the medicines that we offer.
The Medicare Modernization Act charges this Subcommittee with making recommendations to the Secretary of Health and Human Services on standards for electronic prescribing.
The impact of your work will reach far beyond this discrete issue however. As Senator Bill Frist said in last week's NHII Conference here in Washington, DC as the MMA goes so goes the rest of the nation.
In other words as e-prescribing standards for Medicare are put into place all future efforts will have to be compatible with both the policies and technologies that result from your work.
You are in fact, laying the foundation for America's health care IT infrastructure. Many of you have already testified including physicians, technology vendors and standards organizations have echoed this sentiment.
E-prescribing systems that are well implemented promise many benefits. If however, e-prescribing is implemented inappropriately it could have profound adverse consequences.
Given that we are dealing with the health and lives of patients we should seek the foresight to head off these potential deleterious impacts before they occur. To this end I think it is useful in framing this important discussion to distinguish between the technology standards that will make an electronic prescribing program possible and the policy standards that will establish the ground rules for its use.
Both sets of standards are essential components of a functional and sustainable e-prescribing infrastructure. The Subcommittee has already heard a great deal of testimony on technical standards but significantly less on equally critical policy standards.
The written testimony we have already submitted focuses mainly on technical issues and in my remarks today I want therefore to give attention to policy standards for electronic prescribing under Medicare.
We understand that any conversation on policy standards can be clouded by the specific short-term needs and interests of the moment. A sustainable policy platform, however, must rise above the short-term concerns if it is to stand the test of time.
This is one of the reasons we funded the Rand e-prescribing quality standards study presented to this Subcommittee by Dr. Bell in May to better inform the discussion on policy standards so that they would focus on clinical outcomes and patient safety emphasized in the study's findings. The knowledge gleaned from the Rand study and other research has helped Pfizer develop a series of four principles on e-health.
These principles are consistent with most of the testimony you have already heard. We use these core principles as something of a litmus test to evaluate any proposal on the subject including our own business strategies to make sure they align with our mission of improving the quality and efficiency of health care for patients in the US and around the world. At the heart of these four principles are three basic tenets. Put the patient first. Support the clinical judgment of professionals without controlling them and ensure the integrity of the information used in clinical decision making.
Putting the patient first in electronic prescribing means that standards should be created to ensure patient access to appropriate care under the guidance of a skilled professional who is free to interpret and apply clinical evidence to an individual patient's situation. Appropriately designed e-prescribing tools can strengthen the vital relationship between a patient and a doctor by reducing the time required for administrative work and information management. Properly integrated the information available to them will be far richer than it is today.
Alternatively information technology can compromise even irreparably harm the quality of the physician-patient relationship.
The greatest threat is that third parties may use e-prescribing to infiltrate and inappropriately influence the clinical decision-making process at the critical point of care. These intrusions driven by financial interests represent inappropriate influence and rarely have the patient's best interests at heart.
Indeed the drafters of the Medicare law recognized this risk. I quote, the conferees intend for electronic prescribing to serve as a vehicle to reduce medical errors and improve efficiencies in the health care system but not for it to be used as a marketing platform or other mechanism to unduly influence the clinical decisions of physicians. This language applies to pharmaceutical manufacturers, pharmacy benefit managers, retail pharmacies, technology companies and payers.
We believe this intent should be honored by this Committee and by CMS as they develop standards for this program.
Therefore we believe that these tools must be designed with our second core principle in mind that is to provide decision support rather than decision control.
What we mean is that the movement toward electronic prescribing should be about supporting the patient-physician relationship and shared decision making rather than exercising control over their relationship and decisions.
In May the Subcommittee heard testimony that suggested there was no longer any reason to be concerned about external stakeholders interfering with the decisions of prescribers, that this was a relic of the excesses of the dot com era.
I can assure you that this relic is alive and kicking. Within the last year companies offering financial incentives to help influence the physician prescriber have approached both Pfizer and Amacorps.
In other words these companies were proposing an electronic method to help step into the middle of the patient-physician prescribing moment. Our refusal to follow through on their offer stems from our fundamental belief that no third party entity should unduly influence decision making at the point of prescribing.
In fact, no third party could possibly understand or account for all the factors and inform the decision at that particular moment for that particular patient.
For example, a doctor may be trying to prescribe an extended release form of a drug for a patient with a cognitive disorder to simplify treatment and therefore improve compliance. A message could pop up saying that four times a day dosing is preferred. Do you want to change? The doctor's response is no. Are you sure? The doctor's response is yes. The q.i.d. dose form is 15 percent cheaper, etc., on and on thereby frustrating the physician by adding unnecessary steps to complete the prescription or it could be as subtle as changing the order of the medication list so that the drug preferred by the third party remains at the top of the list or on the first screen, not because it has a clinical advantage over other drugs in the class or even because it costs less but rather because its maker provides the biggest manufacturer rebate. We have seen a number of instances of this type of profit-based interface bias and believe it has no place in medicine.
At Pfizer we believe strongly in informing consumers and physicians about the benefits of our medications. We actively provide medical education about our products consistent with their FDA-approved use but we do not believe that Pfizer or anyone else should be influencing or coercing the doctor as the pen hits the prescription pad or as the stylus clicks the screen. That simply does not put the patient first.
We, therefore ask the Committee to recommend standards for ensuring that a zone of autonomy surrounds the physician-patient relationship and protects that relationship from commercial messaging defined as any influence from any third party be it a payer, EBM, pharmacy, technology company or manufacturer and that this zone of autonomy be protected by carefully crafted policy standards and related technical standards to ensure that this protection is not eroded over time.
In making this request it is important that I differentiate between the passive neutral presentation of the formulary and other types of commercial messaging. Accurate formulary information helps inform a prescribing decision. The formulary should not, however, be used as a tool for decision control but rather as a form of decision support.
Another equally important policy standard is the assurance of the integrity of clinical information used in decision making. Electronic prescribing can connect physicians to contextually sensitive information about drug therapies and about their patients to allow them to make an informed clinical decision.
We believe that third party information which may be relevant to the decision-making process should be made available. However, there currently is no mechanism to ensure that the information presented to aid decision making is factually correct, reasonably applicable, properly sourced or subject to consistent and rigorous standards of accountability or balance.
Indeed the Congress recognized the need for accurate balanced formulary information when the conferees expressed their intention that physicians have ready access to and I quote neutral and unbiased information presented on the full range of covered outpatient drugs available.
An appropriately designed e-prescribing tool can present the source of information but it will take a policy standard, again, hopefully reflected in some way within the technical standard to enforce the use of this capability. Hence consistent with our third core principle of maintaining information integrity we asked that a policy standard be created to assure that the information presented within the e-prescribing environment is properly sourced and that the parties who put forth information are subject to the same rigorous standards of accountability and balance as required by the FDA for pharmaceutical manufacturers.
I would also like to make another important point about putting the patient first and how the rights and needs of the individual patient seeking care should drive the design of standards for e-health. Within the electronic prescribing environment there are tremendous opportunities to provide individualized medicine that delivers a patient's medical history and medication history to the point of care but that same tool can also be used to create a barrier to appropriate care. How so? If the e-prescribing tool does not account for a patient's individual clinical needs, life circumstances and personal values, if it simply enforces the application of a population mean or generalities about populations it removes from the physician's clinical decisions the very factors that allow patients to receive care appropriate to their unique needs.
It reduces the physician to dispensing one-size-fits-all solutions. Let us take the area of differentiating features as an example, where something that seems relatively straightforward may in actuality create significant problems if it is not designed to account for the uniqueness of individual patients. An e-prescribing tool needs to contain more information about each medication than its chemical composition, dose and the forms in which it is available.
Physicians also need to be able to know things like the availability of compliance packaging, labeling, the absence of gluten or animal products and so forth. Our experience in providing information to patients and clinicians about our products and the science behind them tells us that these issues are anything but minor.
In fact, no single feature is insignificant when you are talking about individuals. Why? Well, let us consider the simple matter of gluten content. As many as 1 in 300 people cannot tolerate having gluten in their diets. A similar concern can arise around medicines containing ingredients derived from animals or humans because of a patient's personal or religious convictions. When such an issue is discovered after the patient gets home with his or her prescription it can result in the most expensive kind of health care there is, the treatment that is paid for but not used.
Importantly, adding differentiating features to the e-prescribing process will allow prescribers and patients to clearly articulate their needs at the point of care and find appropriate products that will fill their needs.
Currently there are no standards in place for cataloguing and communicating these differentiating features. As we explain in more detail in our written testimony one solution may be to adapt to the FDA's structure product labeling initiative for this purpose as the source of the content for these features and the modifying relevant portions of NCPDP script and HL7 to transmit this information.
We, therefore ask the Subcommittee to put patients first by recommending the development of these standards for accommodating the differentiating features of medicines.
The crafters of the MMA legislation took care to insist that the electronic prescribing program posed no undue burden on prescribers but the current transaction standards do little to address some of the areas where physicians feel the greatest administrative burden. One such area is prior authorization. The very automation and efficiency principles driving the adoption of e-prescribing are not being applied with equal vigor to the prior authorization process. As a result the PA process becomes more a means to control clinical behavior, clinician behavior rather than an opportunity to optimize patient care as physicians must leave the electronic prescribing process and resort to a paper or phone-based process specifically designed to be an inconvenience.
Applying the core principles of put the patient first and support but don't control clinical judgment to this issue tell us that the best way to manage prior authorization is to make it a seamless part of the prescribing process. Take reflux in children. While the tablet form of many of these drugs is available over the counter the syrup solutions are not. As a result pediatricians are forced to have to go through the onerous process of prior authorization which usually involves repeated calls simply to prescribe a formulation of a prescription that is not available over the counter for their particular patient population.
The formulary should be structured and standardized in such a way that e-prescribing and EHR vendors can present information consistently and without bias, use intelligent tools to notify the clinician when the prior authorization requirements have been met, send the authorization request to the payer and have the prior authorization code accompany the electronic prescription on its way to the pharmacy.
This is precisely the type of efficiency gain that the electronic prescribing program was intended to capture. Efficiency, not inconvenience should drive the development of electronic prescribing. We ask that the Subcommittee recommend the development of technical and policy standards in support of a structured formulary and automated prior authorization processes.
As I said at the onset on this testimony we are pleased to have the opportunity to present our views to the Subcommittee. We believe that the goals of electronic prescribing are well-aligned with Pfizer's mission to advance human health through the research and development of medicines that allow people to add years to life and life to years but we also believe that in order for the full promise of electronic prescribing to be realized it must be implemented in a manner that stays true to the three core principles I discussed already. Put the patient first. Provide decision support, not decision control. Ensure information integrity and balance.
We sincerely appreciate the hard work that has been invested in this effort and we recognize the magnitude of the scope. Pfizer remains committed to the pursuit of health improvement through the application of innovative solutions in both medicine and technology and will work in partnership with you and all stakeholders toward that end.
Thank you.
DR. COHN: Thank you very much.
Michael, it looks like you are on next.
MR. WEINBERGER: Okay, thank you. First, thank you for inviting us here today to give you our point of view on electronic prescribing. I am here representing Johnson & Johnson Health Care Systems Managed Markets Group.
I thought I would start out by giving you a little bit of background on our experience. We have actually been interested in electronic prescribing for quite some time and it was already several years back that we became involved with some of the point of care hand-held device vendors, those early players and helped to distribute some of those types of devices to physicians.
Unfortunately most of the people that were involved with at that time are no longer in business. We experience limited success for two reasons, in part because of truly technology reasons, the technology not quite ready for prime time and then also I think supply problems that those vendors had in actually getting the devices out to physicians but there was really a more important problem that we faced and that was the limited utility of those devices. I am sure you could write a prescription on those devices and you could print it out and that certainly helped with problems of illegible handwriting but the reality is then that the patient left the office with a paper script and everything went back to status quo and so a lot of the efficiencies that could potentially be realized weren't at that point being realized, no efficiency gains through limiting faxes and phone calls in the physician's office and those kinds of things.
Fortunately we reached a point where true electronic prescribing does not seem to be possible and I know you have heard on previous days from companies that are actually providing electronic prescribing solutions that can do through electronic prescribing where the physician has access at the point of prescription to formulary and other clinical information and that when the physician finishes recording the prescription in the device or on the computer that it is then transmitted electronically to the pharmacy.
So, Johnson & Johnson Health Care Systems is a very strong supporter of electronic prescribing. Among the benefits that we see are fewer medication errors, better process and cost efficiency and ultimately better patient therapeutic compliance as both physicians and pharmacists can be aware of patient behavior whether or not prescriptions that have been requested are being filled and whether or not they are being refilled in time lines that both the physician and the pharmacist would expect.
I, also, want to point out that we recognize that electronic prescribing and this has been in the news a lot lately, electronic prescribing is a first step towards a major overhaul of health care technology in this country such as the adoption of electronic medical records. We at Johnson & Johnson have actually been involved with groups like the E-Health Initiative and the Markel(?) Foundation has tried to make some progress on those fronts.
So, we think all of this is extremely important. We do have some concerns and actually most of my comments I would like to use the time to actually share with you a couple of those concerns.
These concerns revolve around the potential that there could be some stakeholders who would use electronic prescribing technology in inappropriate ways to unduly influence or steer physician decision making and I want to underline that I am talking about undue influence. There is appropriate influence but I am going to talk about undue influence.
Fortunately as we read the statute of the Medicare law we see that Congress addressed some of these concerns in the actual statutory language. Our expectation and our read of that language was that this group here would be addressing some of these issues.
I am going to focus on two major areas of concern. The first is related to neutral presentation and the second is related to commercial messaging. As far as neutral presentation goes the MMA requires that physicians have access to neutral and unbiased information on the whole range of covered outpatient drugs. With regard to commercial the MMA limits such messaging to information that is related to the appropriate prescribing of drugs.
Now, our concern here is that both the mode of presentation and messaging that can take place could be used by electronic prescribing vendors to have an influence on the physician to try to bring prescriptions into compliance with probably preferred formulary options. Why would they do this? Again, our concern here is that electronic prescribing vendors will be offered payments to take scripts that are out of compliance and bring them into compliance.
Let us dig into neutral presentation a little bit. It is our belief that physician choice should not be skewed in favor of preferred drugs if those drugs are not in the best clinical interests of the patient and I should say for that matter the best financial interests of the patient because something that is financially appropriate but not clinically appropriate is probably not good for the patient at all.
We have a concern here about the potential for selective and incomplete presentation of drugs. So, for example, let us say the physician indicates that he or she is about to prescribe an SSRI and that the electronic prescribing system then pulls up a list of the preferred SSRIs. The physician says, "No, that is not what I am looking for," has to click again to pull up a list of other options that are in fact on the formulary but are not preferred and that if then those are not acceptable that he or she would then click yet again and bring up a list of drugs that are in fact off formulary.
We believe that physicians should not have -- we believe that would be cumbersome that physicians should not have to navigate multiple screens to see all drug choices and that in fact structuring a system in that way would be a method of trying to more often than not ensure that the physician never makes it past the first screen and that the physician will choose only from among the preferred selections and when I say, "Preferred," again and I think you all know this but I am talking about drugs that are most likely more rebate friendly to a PBM or a plan.
So, proposed remedies here, we believe that electronic prescribing solutions should be presenting drugs in a single consolidated neutral list.
We also believe that electronic prescribing solutions at the time when such list is presented should also be providing the prescriber with all other relevant prescribing information, both clinical and financial and by the way when I say a single consolidated neutral list I am not suggesting that showing dollar signs or even the actual cost of the drug next to the name of the drug is a problem. We would simply like to see that all the prescribing options are displayed in a convenient way for the physician.
Next slide, please?
Messaging. Two types of messaging that I want to talk about. The first is what we all interruptive commercial messaging. These would be pop-up windows that appear after the physician has already made a prescribing decision. We believe that most likely such pop-up windows are again based on financial considerations only and again bear in mind our point of view that the physician should have been made aware of al financial and clinical actors before having made the decision in the first place.
So, we believe that such pop-up windows are not adding clinical value and they are certainly not neutral and unbiased. The other type of messaging that I would like to address is what we would call preemptive commercial messaging. Preemptive commercial messaging would be messages that appear before the physician has made a decision. Now, if we are talking about an advertisement from a manufacturer for example that appears when the physician turns on the hand held or that appears when the physician opts to go into a specific channel that he or she would expect would contain marketing material then that is absolutely not a problem.
Our concern would be when the physician has already indicated an intent to prescribe in a certain category and at that point starts getting bombarded with advertisements or other messages regarding trying to influence the decision before any kind of clinical information has been taken into account and we believe that type of messaging is inappropriate.
So, to wrap up this group and a lot of it has gone over my head, to be honest with you but this group I know has been hearing a lot about the technical standards to ensure that prescriptions can get from point A to point B, to ensure that formulary information can get from point A to point B and what I really have been talking about here are functional standards and it has a lot more to do with how software actually operates, what the physician experience is in using that software and we recognize that such issues are much softer. We are talking about a much softer set of standards here than technical standards but it is our belief in our reading of the statute that Congress did intend that NCVHS would be addressing these issues and therefore we would like to make the following recommendation and it is by no means the only way that you could choose to address these kinds of issues but it is just a potential suggestion and that is that you might consider adopting compliance guidelines for vendors and for networks and I would make reference to certification standards that Kevin Hutchinson of Sure Scripts referred to when he testified. These are I think certification standards that Sure Scripts uses before they permit vendors to come into their network.
Such certification standards shouldn't be onerous and it is our belief that they should not interfere with the competition between different electronic prescribing vendors. Rather we are talking about a basic set of certification standards the intent of which would be simply to ensure that we maintain a level playing field for all parties.
That concludes my comments and then at the appropriate time I would be happy to entertain questions.
DR. COHN: Michael, thank you very much.
Charles?
DR. JAFFEE: I am not sure if I have the opportunity to add audiovisual assistant to my resume when I get back but apparently my slides aren't on the laptop. I will either make them available afterwards or show you my Windows skills now. I can make them available afterwards. I will go ahead and comment on the information instead.
DR. COHN: Do you want to take a second?
DR. JAFFEE: I am fine.
DR. COHN: Are you sure? We are happy to give you the minute to put it up there.
MR. REYNOLDS: In the testimony about level playing field, neutral presentation you are going to put six drugs on a screen what is neutral to you? Is it alphabetical? I am serious. It is a good philosophy but give me a reality shot.
MR. WEINBERGER: Our overriding concern is that all prescribing options appear on a single screen. Now, I have had numerous demonstrations from electronic prescribing vendors. Some have done it and by the way I want to say actually that many of the electronic prescribing vendors out there today I think are acting in a very, what we would consider inappropriate way in making the prescribing options readily available. I have seen them done alphabetically. I have seen them done in order of cost. I also think that, or with number of dollar signs or whether it is a red light or a green light or a yellow light --
MR. REYNOLDS: Cost isn't neutral, is it?
MR. WEINBERGER: Okay, maybe I will just clarify when we say neutral presentation what we intend as neutral means that the physician has access to all of the information at the time when he or she is making a decision and that it is not particularly cumbersome to try to access that list of prescribing options.
MS. LEE: I think that it is also important to realize that when you allow the physician to use a tool for decision support you allow them to choose what their favorites might be. So, while you may have a full formulary available to you a physician can customize if a tool is flexible enough to customize which medications they use more frequently or the ones that they are most comfortable with, but it is their choice and that is part of being a neutral presentation.
DR. COHN: Chuck, it looks like you are ready.
DR. JAFFEE: Good afternoon then and on behalf of AstraZeneca thanks for the opportunity of testifying before this Subcommittee of the NCVHS.
I am Chuck Jaffee and I am the Director of Medical Informatics at AstraZeneca but also as a practicing physician for 30 years I have written tens of thousands of prescriptions almost all of them on paper an as a medical information scientist I have served on the boards of standards organizations and I have helped author some of the standards that we use today.
At AstraZeneca we have been a champion of electronic health care and the value it brings to physicians and to patients alike. We are supporters of the NHII and I chair the special interest group of the pharmaceutical industry stakeholders.
Moreover at AstraZeneca we are committed to the principles of an interoperable health record and the benefits that such a system will bring to the very communities that we serve.
Many other individuals at AstraZeneca have contributed their energies and time to the development of electronic prescribing and have helped populate several of the early initiatives in deploying mobile technologies. The Medicare Modernization Act, however, has given this Committee a unique responsibility of recommending the technical and the policy standards that will serve as the framework for electronic prescribing but even more so it is an opportunity for this process as it stands to serve as a model for the development of standards that are really fundamental to the success of the NHII.
My colleagues at Pfizer and Johnson & Johnson have provided their testimony on these issues as well. We agree that the issues of policy should transcend the parochial demands and short-term needs of specific parties. These include but are not limited to decision support and medication messaging standards.
The deployment of electronic prescribing technology will have a broad impact on our patients. First and foremost electronic prescribing will significantly enhance the safety of the drug prescribing process in its entirety.
For many physicians this will be attributable to reduction in both systematic and cognitive errors. However, the role of decision support cannot be underestimated.
At the same time we have an opportunity to use these technologies to enhance both patient education and the adherence practices by broadly defining and deploying these functions that support other systems.
For many health care providers the utilization of e-prescribing technology may hasten and facilitate the adoption of more complete electronic health care systems.
As my colleagues have already mentioned there is a significant risk that the very technology we propose and the standards we adopt hinder the uptake of electronic prescribing. Certainly we can institute requirements that are too costly or demand too much process re-engineering for reasonable physician compliance.
For the patient privacy issues are paramount but developers and vendors must be able to deliver these systems despite the highly regulated environment. Of course, those parties with a vested interest in decision support and the process it represents must not hamper the physician's ability to make choices that allow the appropriate use of medications.
My colleagues and others have already described the expected benefits of e-prescribing. Certainly improved clinical outcomes and the reduction of prescribing errors are expected.
At the same time, however, patients may benefit in more tangible ways if prescribing can be linked to both education and adherence opportunities.
For physicians this may be the first step in the integration of technology into the process of patient care. The Committee has already heard from many leading authorities who support the value of electronic prescribing. In particular the report of the Rand Expert Advisory Panel which was authored by Dr. Bell and his colleagues provides many of the specifics and the details for the technical capabilities that are potentially defined by these standards.
The NHII framework reported last week describes a more ambitious prospect of a unified interoperable health records system, one benefit of which would be to link prescribing functions to specific elements of the patient's history and clinical findings. This perhaps is the first step to truly personalized medicine. Yet today there is very little objective data to justify the inclusion of any one of the many standards requirements for another.
In contrast the policy imperatives recommended by this Committee could substantially alter the practice of choosing therapies. Unfortunately, in the short term e-prescribing will exist as a stand-alone system. In the future however, these policies including safe harbor provisions must be given serious consideration if the implementation of e-prescribing systems is to be truly successful.
Safe harbor is a requirement that must be solved. In addition these policy decisions must serve the larger objective of integrating electronic prescribing into the whole of electronic health. Certainly there is a real danger of this technology becoming a point solution that addresses only the cost of therapy rather than the value of care. In defining these requirements this forum has the opportunity of becoming a model of standards development for other technologies within the health care continuum.
There are at least two important issues that we should consider here. For one we should remain acutely aware of the balance between patient privacy and the requirements for access to data both for public health use and for research needs.
Similarly my colleagues on this panel have tried to describe the opportunity to build decision support models that are free of competing commercial interests.
Within the industry the legislative prerogative to provide safe harbor is seen as an essential to the Committee's recommendations. Not only will these safe harbor policies promote the funding of the essential technologies but they will also encourage innovation that benefits the providers and the community of patients and their families. By encouraging development the provision of safe harbors is likely to advance the primary agenda of the NHII framework to interconnect local health initiatives within a network of interoperable systems.
Of course we run several significant risks if these imperatives are not met. Over the past decades care givers like myself have waited sometimes impatiently to reap the rewards of technology adoption. Most of them have been disappointed. This time our commitment to successful implementation of these programs reaches well beyond the vendor community. Patients are waiting, too. We cannot be derailed by the unbalanced commercial interests that might render the process unworkable for physicians and patients alike.
We cannot create hurdles to adoption that impede the greater gains to be made by a fully interoperable electronic health record network. We cannot permit the deficiencies of safe harbor provisions to preclude adequate development and funding.
The benefits of these policy mandates are clear. They will foster more rapid physician adoption, more defined patient benefit and more cooperative development of supporting standards.
In the course of these changes and change is difficult care givers will be able to recognize the value of electronic prescribing that had only been afforded to payers in previous generations of technology. Patients will be the ultimate beneficiaries when barriers to adoption are dismantled.
In closing my colleagues have clearly articulated some of the policy choices that the Committee has asked us to address. We are committed to the goals that electronic prescribing can achieve. For myself we are encouraged that we have a voice in this process.
In the future we would like the opportunity to participate in the development of decision support technology and the content that recognizes the total cost of care not simply the cost of any single therapy.
As our role becomes better defined we will surely contribute to the future steps leading to the full integration of electronic prescribing into electronic health are.
At AstraZeneca we are committed to those innovative technologies that lead to improvement in care and foster better lives for our patients. We appreciate the opportunity that the Subcommittee has given us to share our views.
This process of cooperation has truly inspired all of us. When the needs of the patient are placed first the standards for the implementation of e-prescribing are best defined.
DR. COHN: Chuck, thank you very much. Questions from the Subcommittee?
Steve, you are back?
DR. STEINDEL: Yes, I am back, fortunately or unfortunately. I have two questions. One is to Michael and Peter and the other is to Peter. The first question concerns and Harry brought this up in his question, the ordering of the formulary lists that are presented in e-prescribing systems and as he said, what is an unbiased order, you know, alphabetical, price and we can name different other ideas that come to mind. Yesterday we heard about the pharmacy and therapeutic committees that actually decide what appears on the formularies. Would it be considered appropriate perhaps just charging them with choosing the order that these should appear as well as what appears; is that a way to approach this? At least the are deciding the bias. I am not saying that it is unbiased.
MR. WEINBERGER: I think it depends in part n the composition of the P&T committee and I know that is the subject of the regulation that just came out as well. There obviously could be a bias that is unanswerable in nature but presumably, well, what I have seen done from vendors that have demonstrated their systems to us has largely been I think alphabetical in nature and I think that that is as good a way as any to do it. I am not sure how you come up with a fair system of display but to answer your question I think it does depend on the composition of the P&T committee.
DR. JAFFEE: May I answer that please? I have chaired a formulary committee and I believe that as wise as a collective body can be in echoing Peter's thoughts the ultimate decision rests in the hands of the physician at the point of care and it is this process that is most relevant to this decision.
DR. STEINDEL: We were talking about the initial display of the list, and I totally agree with you and of course I agree with the comment that was made that a well-designed system will probably allow the customization of the list to the physician's choices but we are talking about the point that was made was the initial display of the list and that was what I was addressing.
MR. MARTIN: This is Ross. I think the very first display of that list, having it alphabetical is as neutral as it can be because it is just the name of the drug. That is one way you could do it but it is the same thing as saying would you want to impose on somebody's computer screen how they sort their folders. No, you would want to do that according to how you like to look at the information and at times you are going to want to look at it by the date you last modified it. At times you are going to want to look at it by the title and all these tools provide that kind of sorting and it should be up to the doctor to figure out what works best in the flow of their office.
DR. STEINDEL: So, can I interpret what you were recommending with formulary displays is that something like an alphabetical display the first time they come to the screen would be suitable but the next time they come to the screen should be their choice?
MR. MARTIN: And that first time could be the very first time they use the tool.
DR. STEINDEL: That is exactly what I mean.
MR. MARTIN: That is as good a way as any.
DR. STEINDEL: Thank you for that clarification.
MR. BRANDT: And I think one of the things that we have found important is to work with the vendors to make sure that that tool in and of itself makes the sorting by the physician and/or his or her staff easy.
DR. STEINDEL: My next question is actually specific to you, Peter. You were talking about in one part in your testimony about holding some of the information that is displayed by e-prescribing standards up to the same standards that are held for regulation by FDA for marketing of drugs. Could you describe that in a greater fashion? Do you mean if we are using drugs for off-label use before they can be put into an e-prescribing system they have to go through the same rigors as FDA or what exactly do you mean by that?
MR. BRANDT: What I was referring to there wasn't so much off-label use. If you like we can address that separately. This was when you are displaying clinical information and using that as a barometer by which you want to then either rank or rate drugs or overall therapies that the clinical rigors and rules and regulations that a pharmaceutical company goes through by way of what is clinical data, what is acceptable, getting FDA approval on it and then how you can present that data, also, needs to be approved in our case by the FDA. Other parties don't fall under that same rigor. So, they can have relatively simple studies of a relatively small not statistically significant database of a few patients looking at random data and draw a conclusion, clinical conclusion that could then be input into an e-prescribing tool as justification for ordering or lack of importance of a given therapy and what we are putting on the table is that when you are looking at the kind of clinical evidence that goes behind making that kind of decision that must be sourced and it must follow the same rigor of a clinical study or a clinical marketing program that is put forth by a pharmaceutical company.
DR. STEINDEL: It must be put through the same rigor before it can be displayed or should the rigor be displayed and let the clinician make a decision as to the value of using it?
MR. BRANDT: Preferably I would say that we would love it where it was before it was displayed but if it is as it is displayed certainly all the exact source and what is behind it must go with it.
DR. STEINDEL: Thank you.
DR. COHN: Stan, you are next.
DR. HUFF: Yes. So, this is again for you, Peter. You recommend a couple of things relative to policy standards that there be policies ensuring the zone of autonomy and then the second one was again related to the information presented that is properly sourced, etc., and my question is sort of who and how those things would be enforced. Who should make those policies and how would that process, what process would you recommend for making those policies and then how would they be enforced because some of these I think at least they are essentially describing the content that would allow it to flow. It wouldn't really change the format of the standard or the technology standard. So, it is almost like now we have to have some sort of censor or policeman or somebody who is looking at content trying to decide whether these, I am having a hard time; I am struggling a little. I like the principles but I am struggling with the implementation and how this would work.
MR. BRANDT: To answer at least part of your question we were quite hopeful that this Committee would be the ones that would determine those policies and I appreciate the burden that therefore we are requesting be placed on your shoulders. I guess the way that we have thought about this, because your point is a very, very good one, it is almost impossible to imagine an effective system whereby you are trying to police against everything that could happen as opposed to trying to come at it from a different angle which says that here is what should go through that pathway to a clinician at the time that he is gathering all the information to make the most informed decision at the point of care and I think it doesn't get, it is complicated but it doesn't get a heckuva lot more complicated than eliminating a lot of the third-party primarily financially driven type of messaging that comes in at that point in time, so that there isn't any undue influence on the prescriber when he is looking at the right clinical information, the right value information which indeed includes cost. So, it is not at all the position of saying that cost should not be included in that information. It should. Ultimately we agree and I know this is getting a little far from your question. Ultimately we are all working toward that world where you can track the value of given therapies including patient interventions and self-management, etc., and bring that back into that decision at the point of care as well and our hope is that we don't make technologically based standards now that preclude that kind of information occurring and being able to be captured later.
So, I will turn to my colleagues if you have more specifics to add to it but your point is an extremely good one. I don't dismiss by any means the difficulty in protecting or grading and then protecting that autonomy, that zone of autonomy between the patient and physician. We are reacting very strongly to something that our colleagues have mentioned as well. In the last couple of years in particular there has just been a bombardment on that space between a physician and a patient and at least our experience it is all financially driven as opposed to health driven and so we are much more in the camp at this point of keeping all of it out and find the two, three, four things that are acceptable and allow them in as opposed to trying to define the way in which you police this on an ongoing basis.
MR. MARTIN: Just to build on that one simple policy standard for example and I agree that these are not technical standards, we tried to differentiate that, would be to say that any vendor that is providing e-prescribing tools for Medicare in this instance cannot have a financial benefit; they can't make money based on a clinical decision that the doctor makes, that if it goes this way they make a dollar; this way they don't make a dollar; they make 50 cents.
That is what would prohibit a lot of this stuff from happening because they wouldn't have any incentive to build a tool that would inappropriately persuade a doctor one way or another based on the way they build the tool.
So, I think that is a reasonable certification requirement that we would pose just as one example.
DR. COHN: I guess I would frame this a slightly different way. I think, Ross, maybe you are describing something that may be a little too draconian in terms of a principle but the issue gets to be that they are all principles. Obviously they are all already parts in the MMA that talk about commercial information and precluding a lot of commercial information coming through. I sort of see it as like a HIPAA issue which is it is part of regs. It is a complete driven process and if users are beginning to feel that there is too much commercial information coming down then it is something that CMS has to investigate. Am I off on this frame? I mean it is not really a standards issue. It is more of a policy.
MR. MARTIN: Why does it belong there at all? Why wait for it to become such a burden that we have to then back it out and figure out how to remove those kind of things from the system? I think there were a couple of points. One, how do you define that commercial message which is not very clearly defined in the current legislation? I admit I haven't read the multi-page report that just came out a couple of days ago, but assuming that that doesn't address it specifically what is a commercial message? Who can provide a commercial message?
Obviously I think the manufacturer is targeted as somebody who would provide a commercial message, but we think it is also those other entities, payer, PBM, pharmacy, anybody with a financial stake in that decision.
DR. COHN: Obviously the Subcommittee hasn't decided where it sits on all this stuff having been through recently hearings with the Privacy Subcommittee, having to do with marketing and obviously the issues, trying to differentiate marketing from health improvement, health promotion activities, sometimes is a tough area and I think all of us want to make sure that e-prescribing promotes health but we also don't want to do marketing which is I think what you were all pointing to and so the question that always gets to me is that the line there is not a sharp line and I think we saw that with the privacy regulations also and I am just reflecting on that.
MR. WEINBERGER: I would agree that it is not a sharp line. I will give you an example, just one real-world example where I think we are clearly on the wrong side of the line. We have had vendors come in and offer us for a fee that our products could be pre-populated on the physician favorites list. So, we have decided to advance which drugs the physician will have on his or her favorites list and I think that is a great example of inappropriate messaging.
DR. COHN: Other comments? It looks like Harry has a comment. Did you have anything else?
MR. REYNOLDS: No.
DR. COHN: Okay, Steve had yet another comment on this one.
DR. STEINDEL: Yes, I just wanted to point out and this gets to one of your slides, Charles when thinking about this type of thing that a safe harbor is not a safe harbor because that is another area that we might not think of where, quote, unquote, commercial messages might come in and people that are financing these systems we normally think about safe harbors.
DR. JAFFEE: I think in the environment as it now stands safe harbor is afforded certain entities and not others and that makes the decision process so biased. That is what we are trying to prevent.
MR. REYNOLDS: Do you consider the pharmacy a point of care? As you look at this continuum and you think about neutrality and I was in the same hearings Simon was on privacy, where if the doctor has the opportunity to deal with the medications and as we heard in our earlier testimony this morning one of the reasons that you can't give the price back or the co-pay or what it is going to be is that it may change in the pharmacy and if look at e-prescribing being including the actual care giver, the pharmacy, whatever network it goes through, whatever PBM is involved that appears to me to be a second point of are you asking for a neutrality, and when you say, "Neutrality, does neutrality go through our whole e-prescribing process or is it just at the doctor's office? That is what I guess I am trying to understand because when you try to put standards and you try to put policies and you try to put other things in place you have got to understand the continuum and there is a big continuum here and we saw that that continuum is dealt with differently as we heard in our privacy discussions.
DR. JAFFEE: I think the pharmacist is part of the continuum of health care and is part of the provider of health care and in some states pharmacists have a mandate to deliver patient education and so forth. I don't think they can be excluded either from the process as a care giver nor from the policies that mandate neutrality or the principles of e-prescribing. So, for me they must be included in this equation.
MR. BRANDT: I would agree that they must be included. I guess we believe strongly though the point of care is the point, that zone of autonomy we are trying to protect between the physician and the patient and I don't have the benefit of what was discussed this morning in terms of getting relevant cost information into the physician at that point of making that decision on the prescribing but to me that still is the most important point where you want as much value information, clinical information, cost information coming together in a uniform fashion for the physician to make the best of all decisions in consult with the patient. I agree completely that the pharmacists should not be excluded. They are a critical component in the continuum of care but to me the point at which a physician is making the prescribing decision is the paramount one and then as you are at the pharmacy level and you are looking more at the cost components I would love to find in this age of technology a way in which you can get more of the value equation back into the physician's hands at that point in prescribing.
MR. REYNOLDS: From the standpoint of a safe harbor what are you actually asking for from the safe harbor?
DR. JAFFEE: I don't want to try to address the specifics but I think in principle some of the legislative provisions prevent participation in financing of infrastructure technology, resource, content and so forth. This safe harbor has been extended to other entities in the health care process and the pharmaceutical industry just thinks that it is essential that we be allowed to contribute as well. Right now we are by statute excluded from that process.
I think David Braylor made it very clear when he asked the group of pharmaceutical stakeholders specifically what they could contribute and what was needed to make that contribution possible.
DR. COHN: Exactly. Jeff?
MR. BLAIR: First of all I would like to compliment the panelists for setting for policies that are patient focused, that are encouraging integrity, that are encouraging level playing field. I certainly appreciate that and there are many pieces to this that I don't quite understand. So, one of them which would be a potential vehicle for undermining these policies is rebates. Could you please help me understand and maybe other members of our Subcommittee do rebates go to the PBMs that are developing their formularies; do they go to prescribers; do they go to both and are you indicating that you don't want them reflected in what is displayed in any prescribing system or that you don't want them to exist at all or help me understand this area?
MR. WEINBERGER: I know we have got plenty of folks in the room that actually manage drug benefits and probably have a point of view on it as well, but I will share with you my point of view.
Rebates are paid by manufacturers to entities that manage drug benefits such as PBM in order to gain preferred placement on a plan's formulary.
Now, those rebates may be partially passed through to the entity that has hired the PBM to manage the benefit but that is not done in its entirety. That is not always the case and that is certainly the subject of lots of discussion in every major newspaper across the country and I won't comment any further on that aspect of it.
I don't know, is that helpful?
MR. BLAIR: Partially. Do rebates go to the prescriber?
MR. WEINBERGER: Rebates do not go to the prescriber to my knowledge.
DR. COHN: Any other panelists who can help clarify this?
Okay, Michael?
DR. FITZMAURICE: What a great question. In talking about the information being available to the physician and the patient do you have any position on having the physician send to the pharmacy the reason for ordering the drug for say drug utilization review purposes?
DR. JAFFEE; I would be in favor of that. I grew up in a model of problem-based record keeping which required the diagnosis or problem to precede the prescription whether it was an order for medication or an intervention or a diagnostic test. So the intervention was always preceded by the reason for the intervention.
So, I am in support of that and I think from a population standpoint certainly from the point of view of the AHRQ it will make modeling a new era.
MR. BRANDT: If I can add to that I think you raised a great point. I mean ultimately to get to be able to understand what treatment regimens are being used for what purposes and then ultimately being able to track the outcomes of those different treatment regimens, it is only at that point are we then able to adjust those treatment regimens and it is only at that point when we have that data are we able to then take that back into our research houses and to be able to say that it is not having the effect we thought here; we shouldn't do that; we should do X or Y or Z or it is having a benefit that we did not anticipate. Let us go down that research path as well.
I think this does though fall a little bit into one of the things we mentioned earlier in terms of make sure that there are standards that indeed support decision as opposed to control decision. In some cases if it is literally just inserting a diagnostic code and having that as a gate that if that is not for an approved indication or approved use or what we want to see on the formulary and therefore the answer is no, without having the flexibility of a physician utilizing their knowledge of that patient in those individual circumstances to be able to electronically move forward with what they deem to be the appropriate therapy, then all we have done is create a blockade where we are never going to get to that data that I referred to that is kind of the holy grail at the end.
DR. FITZMAURICE: I think I agree with what you are saying but my question is do you agree with giving information to the pharmacist so the pharmacist can serve as a check on gee, are you sure this is the right drug, doctor, for this condition, and the doctor can then come back and say, "Yes, it is," or "No, it isn't."
MS. LEE: Why introduce an extra step in the process that challenges the physician in a way where the physician cannot go forward in terms of proceeding with the care that they think may be best for that individual patient when the shared decision making is between the patient and the physician? For the pharmacists to challenge on errors or on drug interactions and on these sorts of things that makes a great deal of sense but there are many times when a physician and a patient decide to do something with a therapy that may not necessarily be within the knowledge base of that pharmacist and at that point in time again the responsibility both legally as well as in an ethical manner rests with the patient and the physician and not necessarily with the pharmacist there. You would only create an extra step in the process.
DR. FITZMAURICE: I am not saying I disagree with half of what you say but I am saying are you arguing -- I would argue it is a good thing to give this information to the pharmacist because nobody is 100 percent perfect. I am not 100 percent perfect and if somebody catches an error that I make then I am happy for it. I may be embarrassed but I am happy to catch it and try not to do it again, and it may not be my error. It may be a typo or it may be something else. So, I am saying in the spirit of patient safety isn't it useful to give this information to the pharmacy?
MR. WEINBERGER: I can add a viewpoint on that. I think it would be extremely helpful to provide as much information to the pharmacist as possible including if supported and if appropriate a rationale for why certain products may have been prescribed and the reason that I say that is that in having visited numerous pharmacies over the years I know that pharmacists are often interrupted in their work by the systems that they use back behind the counter. They are being asked by, during the adjudication process to validate that a certain drug that was prescribed really should have been prescribed. It is not that the pharmacist him or herself was questioning the wisdom of that drug being prescribed but rather that they are forced to take an action to provide a validation back to the PBM through the adjudication process and if the physician could provide that up front it would seem to me that that would be very helpful.
DR. FITZMAURICE: Last question, but before I get to the last question I want to say how much these sets of hearings yesterday and today are just invaluable for helping guide us to how the system works, what standards are needed and what things that you can do that will put a monkey wrench in it as well as how you need to put oil to make these things go through.
The last question is structured product labeling. The manufacturer submits the drug information electronically, maybe fixed headings, maybe structured vocabulary. I think, Mr. Brandt in your testimony you emphasized the structure product labeling and since this doesn't mean to preclude information from other sources than the structure product label being included with the information available to the prescriber such as recently peer reviewed articles that is coming from say another information source than just the structure product label. Do I understand that right?
MR. BRANDT: Absolutely correct. Again though that was a point that I was alluding to before that as long as those are appropriately sourced and going a step further if you wanted to have a panel that in essence okayed them like we have with the FDA for anything that we say about our products, peer review journal, absolutely. It is when it is far short of that that it is a big concern to us.
MR. MARTIN: In that context it is a good example of what we are talking about about the third party influence. There is a large difference between say a drug compendia company that is reviewed that they have an editorial board. They make their money off selling their compendia. You know, First Databank makes money off the licenses of their compendia. They do not make money necessarily, at least I hope not by making editorial decisions on that compendia based on what is going to happen when somebody decides one thing or the other. So, if there is a new journal article out that they think is relevant they are going to put it into their database and when that drug comes up it is going to be available for the prescriber to review but if somebody is telling them hey, we want that to always come up when they prescribe this drug and we will give you 30 cents every time they do it that becomes a problem. That is when a third part takes over and that is what we think is wrong.
DR. COHN: Judy, last question and then we will wrap up.
DR. WARREN: Actually it is more of a comment in support of Dr. Jaffee. We need to consider that it probably is very important that we communicate a problem list with the prescription because we have just said that the pharmacist is practicing by providing patient education. If they have no idea what the drug is prescribed for then that impedes their ability to practice and it puts one more opportunity to confuse the patient. Here we are trying to clarify things and go for safety. So, I just wanted to make that point because we are getting into standards of what should be passed without sometimes thinking about what different people's responsibility is for in practice.
DR. JAFFEE: The practice to which I was alluding was more than linking the problem list with the prescription list but linking the problem with the prescription.
DR. WARREN: Yes, that is exactly what I am talking about, the prescription and the problem linkage so that they can provide their practice as well.
DR. STEINDEL: I have a highly specific question for Peter. In your written testimony you recommended the US Pharmacopeia therapeutic classification list that we should use for standards and how does that compare with NDFRT or have you not even looked at that?
MR. BRANDT; It is being written up right now, isn't it?
MR. MARTIN: Yes, it has not been fully baked yet I don't think. It is hard to know.
DR. STEINDEL: That is the reason why you would prefer going with one that you know instead of one that you don't?
MR. MARTIN: The USP one is still being developed for Medicare specifically. It is just it was the one listed in the legislation and since it was indicated as the standard classification schema it could be NDFRT if they had mentioned that. It seems like that would have been fine but there has to be one that people base their work on.
DR. STEINDEL: Yes, I know there had been some hope that there would be mapping between those.
MS. CRONIN: Yes, I just wanted to mention that I know that USP specifically will be looking at NDRFT. So, that will be one of their many considerations but there are in the statute right now PDP sponsors who will be delivering the benefit in 2006, will have the flexibility to define their own therapeutical category. So, they will not have to comply with whatever USP recommends which could present some problems that the Committee has to consider down the road.
DR. COHN: Thank you. That is an additional complexity that we need to keep in mind. I think we will take one comment. Would you like to introduce yourself and you need to get to a microphone.
MS. WHITEFORD: Donna Whiteford from Medco Health and I actually just have a clarifying question for the panel because you keep talking about messaging and I guess I am just really quite sure what it is. I know when a lot of the e-prescribing vendors came into being a number of years ago they were all about sort of marketing messaging but as far as I am aware they have all either gone bankrupt or have really completely changed their model so that they really understand that physicians at the point of care have little interest in seeing lots of those messages pop up because they will stop using those systems if that really does happen and I know speaking for myself on behalf of Medco and the clients that we are managing the benefit for they have no interest in seeing those kinds of messages occur.
So, if you could help me perhaps there are vendors out there who are doing this today that I am just not aware of but I am really not quite sure what kind of messages you are referring to.
Thank you.
MR.BRANDT: You can fill in the blanks in the examples. I will tell you I have personally been offered the opportunity by those vendors that you are saying are not doing it anymore often over the last year both on behalf of Pfizer and at Amacorps to take advantage of a pay per message type of environment where you just bombard the physician with those types of messages. I agree with you that it got a lot of press and it got a lot of sunshine on it and a lot of went away. It has not died by any means.
MS. WHITEFORD: I guess maybe I should have made myself a little clearer. I know one of the things that we have been very explicit about with regard to those technology vendors with whom we work is the fact that during what I will call sort of the patient-physician visit or event on behalf of members that we are managing care for we would not want to see any of those messages but that is very specific to sort of the visit, the event and what they are prescribing. However, if the physician would happen to choose a system where at some other time in the process either before or after they have made those prescribing decisions they are going to pharmaceutical companies or other to provide information I can't control that and I have no idea if that is still occurring and perhaps that is the process you are referring to. I don't know.
MR. WEINBERGER: May I add a comment? In my presentation when I was referring to messaging it was a slightly broader definition. I am not talking only about advertisements from manufacturers. I am also referring to messages that pop up and attempt to post the physician deciding on what to prescribe, attempting to get the physician to switch that to something else based solely on a financial motivation and what has been discussed and certainly has been discussed with me is that there are vendors who could be paid on a per script basis to make that switch happen. So, they are highly incented to pop up a message and say, "Doctor, are you sure you really meant to prescribe druy Y because drug X is actually the preferred drug?" and again based on the model that I shared we would have assumed that the physician was made aware of all this information before writing the prescription and made what he or she felt together with the patient was the best balance of clinical and financial sense in making the decision.
MS. WHITEFORD: I would agree with you and I guess that perhaps that is why there are vendors out there with whom some of us in the pharmacy benefit industry won't work because perhaps they are doing things that we wouldn't approve of. I don't know.
MR. WEINBERGER: I am thrilled to hear that that is your position on it.
MR. MARTIN: And that is exactly, I mean I think there are plenty of reputable companies that will not play that game or dance to that tune but it would be much easier if it were just not permitted and that way we wouldn't have to be dealing with it.
MR. BRANDT; Since we are all in agreement it seems like an easy policy to enact.
DR. COHN: I think in addition MMA also includes much of that in legislative language.
A final comment and then we will take a break.
PARTICIPANT: I just wanted to echo Donna's comments because we have the same position and my feeling is that the vendors who are trying that have sort of gone by the wayside beside because they realized it was a failing model. There may be some out there trying it. They are not trying it with us anymore. Apparently they are not trying it with Medco. What I think it points to and what might be a more productive discussion is the need for a viable business model for these companies and that is where I think we can talk about incentives coming from different places in the chain and your comments about getting better safe harbors so that more people who can get value from these systems can help to support the business model of these vendors I think is very important.
DR. COHN: Jeff has a very brief comment and then we will take a lunch break.
MR. BLAIR: The concern that has been expressed about having commercial messages pop up in any form that it might occur at the time that prescribing is taking place is not in my mind a standards issue. It is an issue related to the software application and how the software application is designed and/or the software vendor or the network vendor that is prescribing in the e-prescribing systems.
That does not mean that I don't think it is an important issue because from what we just heard if we are blind to the effects of these it not only hurts the different pharmaceutical companies that may try to be ethical in not doing this but it could be a deterrent to the acceptance of e-prescribing and on that last point in particular not only both points are important but that last point is one where in my mind I am inclined to indicate this. We have a category here of important related issues and I think that this does qualify as an important related issue although I would not say that it is an issue that directly affects interoperability standards for e-prescribing.
MR. WEINBERGER: I think it absolutely depends I guess on the definition of standards. It was our reading of the statute that it, just our understanding that it did fall within the purview of this group. That absolutely depends on the definition of standards.
MR. BLAIR: That is why we are very happy that you brought these issues forward.
DR. COHN: Yes. Okay, I want to thank this panel for a very interesting set of presentations and it will be very useful. I think the reality is of whether it is a technical standard or a policy standard is something for all of us to discuss but certainly it has been brought to our attention.
So, thank you very much.
Now, we will adjourn for one hour coming back at 2 o'clock.
(Thereupon, at 1:05 p.m., a recess was taken until 2 p.m., the same day.)
A F T E R N O O N S E S S I O N (2:07 P.M.)
DR. COHN: I just want to tell everyone about the structure of the remainder of the day. This is actually our last formal session or panel. After this, well be taking a break and then having open microphone and subcommittee discussion. So - and for those of you wholl be sticking around until tomorrow, I, once again, do not believe we are going to be having any formal testimony, but it is really going to be an opportunity to talk about what we have heard, next steps, identify sort of basically what the subcommittee needs to do to move forward on its recommendations and next steps related to that.
Agenda Item: Pharmacy Perspective
DR. COHN: Anyway, our panel this afternoon is the pharmacy perspective, and we are delighted to have you here. I see we have - gosh, we dont have any names out there. So I will get some. We have Mike Simko here from Walgreens. David Kilgo from WalMart. Mark Gregory - okay - from Kerr Drugs, and Lonny Wilson good, okay - from Pharmaceutical Providers of Oklahoma.
I believe we are going to start with you, Mike.
MR. SIMKO: No, we are actually going to start with Lonny.
DR. COHN: Okay.
MR. WILSON: Good afternoon. My name is Lonny Wilson and I am testifying on behalf of independent community retail pharmacies perspective on electronic prescribing.
To introduce myself, I am CEO of Pharmacy Providers of Oklahoma. PPOK operates a group-purchasing organization, a pharmacy benefit management company called Max Care RX and PPOK Select Chain Network Provider on behalf of over 500 pharmacies in Oklahoma.
I am also President of RX Link, which is a nationwide high-speed provider of telecommunications network services for the submission of pharmacy claims to the various pharmacy-claims processors across the nation. RX Link will provide front-end aggregation network services to SureScripts for the e-prescribing interface between many participating pharmacies and SureScripts.
I currently serve as First Vice President of the National Community Pharmacists Association, which represents over 24,000 independent community pharmacies nationwide, and I am past Chairman of NCPAs Task Force on Innovation and Technology.
I am a registered pharmacist, and I own and operate two retail pharmacies in Oklahoma City.
I want to thank the committee for inviting me to testify on behalf of independent community retail pharmacies perspective on e-prescribing.
Electronic prescribing and the exchange of clinical information between pharmacists and physicians represents an opportunity to enhance the efficiency and safety of the prescribing and dispensing processes, but it can also alter the professional roles and decision-making process of both pharmacists and physicians.
Policy standards must be developed and enforced to ensure these roles are preserved and that our focus continues to provide the most cost-effective therapy and the maximum positive outcome for patients.
We believe policy standards should assure that the information shared and communicated between pharmacists and physicians remain unchanged to protect the integrity of the prescribing process. No commercial messaging or advertisement attachments should be allowed, thus eliminating financial incentives for drug-product selection, which can result in increased costs without benefit to the patient.
E-prescribing policies should not be about driving market share and profitability. It should be about providing safe and cost-effective treatment.
Some side comments about the formulary process. We believe that the formulary process should be based on the quality of outcome, and cost is a secondary consideration. Theres other factors involved - drug interactions, potential adverse effects, pharmacol-kinetics, the ease of use and the cost of the drug - but it shouldnt be driven just by manufacturer rebates or promotional dollars promoting the product.
Policy standards should assure patient freedom and the right to choose a pharmacy. E-prescribing should not be used to direct or route prescriptions to PBM or manufacturer-owned, mail-order pharmacies, nor should it be used to direct prescriptions to chain or independent retail pharmacies, other than those chosen by the patient.
Policy standards should be implemented that facilitates the collaboration of physicians and pharmacists to provide the drug utilization review or DUR process.
The Medicare Modernization Act indicates that physicians complete the DUR prior to transmitting the prescription to the pharmacy. This model may not provide the most comprehensive DUR process. The retail pharmacist is uniquely positioned to provide the most comprehensive DUR. Patients routinely use multiple physicians from various specialty practice areas. Family physicians, gynecologists, dentists, ophthalmologists, rheumatologists, orthopedists, cardiologists, internists comprise just a few.
Retail pharmacists routinely monitor and coordinate multiple physician drug therapies.
PBMs claim to have comprehensive DUR processes. However, they do not have access to prescriptions obtained by cash, prescriptions paid by other plans, over-the-counter drug purchases or physician samples.
Both physicians and pharmacists should be involved in the DUR process. E-prescribing allows for bidirectional exchange of information between physicians and pharmacists. This collaboration, coupled with patient contact by both physicians and pharmacists will provide the most cost-effective and comprehensive drug-utilization review process.
Community Independent Pharmacy has embraced and invested in the use of technologies to improve efficiencies and safety for many years. Nearly 100 percent of our pharmacies are computerized. We have been electronically transmitting prescriptions for claims payments since 1988. Many of our pharmacies utilize bar-code scanning and dispensing automation technologies. These technologies have improved the efficiency and safety of the dispensing process, but have also required a tremendous financial investment.
Pharmacies currently pay for almost all of the telecommunication costs associated with claims transmission to PBM processors. Gross profit margins have eroded for the last 20 years to dangerously low levels as a result of the PBM take-it-or-leave-it contract offering and our inability to negotiate.
PBM and Medicaid contracts account for over 90 percent of all prescriptions dispensed in community retail pharmacy. While community retail pharmacy embraces and supports the implementation of e-prescribing and has financed a significant portion of the infrastructure, we can no longer afford to fund a disproportionate share of the ongoing costs associated with e-prescribing transactions. We would like to recommend to the subcommittee that the financial grant provisions of MMA be expanded to include pharmacies to offset some of these costs.
Community independent pharmacy would like to thank the subcommittee for allowing us to express our concerns and share our perspectives on the implementation of e-prescribing. We would like to offer our continued participation in the development of policy standards which assure retail pharmacies ability to provide the most cost-effective patient care.
Thank you.
DR. COHN: Thank you very much.
I wont even hazard a guess who is next.
SPEAKER: Go ahead. Try.
DR. COHN: (Laughter).
MR. KILGO: Good afternoon. Im David Kilgo. I am Director of Third Party Operations and Systems at WalMart. With me today is my colleague, Bill Rampy, and Bill is Director of Pharmacy Services for WalMart and has responsibility for - prescribing within our company.
WalMart has over 32,000 pharmacy associates which we represent here today, and we very much want to express our appreciation to the committee for the invitation to testify before you on a very important topic to pharmacy and to retail in particular.
WalMart operates over 3,400 pharmacies in 49 states and Puerto Rico. Our - include WalMart discount stores, WalMart super centers, WalMart neighborhood markets, WalMart clinic pharmacies and Sams Club pharmacies.
Our stores operate in trade areas as small as a small town in Oklahoma with a population of 8,000 to central Los Angeles.
Of our 3,400 pharmacies, 1,165 operate in trade areas of less than 50,000 population or non-metropolitan statistical areas, according to 2002 data.
The patients our pharmacies serve include the full range of income demographics in areas where we operate.
The smaller stores in these towns are -
DR. COHN: David.
MR. KILGO; - officially known as the WalMart DNA(?) -
DR. COHN: Can you move the microphone just a little closer?
MR. KILGO: since they represent the root(?) of our company. The small towns prove the vision of our founder, Sam Walton, who believed in bringing value-priced goods and services to the smaller towns across our country.
The software used in WalMart pharmacies and Sams Club pharmacies varies only as required by the state boards of pharmacy regulations. Enabling e-prescribing hinges on the permission of state boards of pharmacy and the ability of the local prescribers to send and receive the electronic messages.
And earlier, we heard comments concerning the importance of getting some standardization across those rules, and that is going to be a very important part.
WalMarts success has been largely attributed to the companys commitment to serving the wants and needs of our customers. It was in our companys early years that WalMart recognized the opportunity to add pharmacy services to our stores. The commitment to serving the needs of the customer was instilled in the pharmacy associates from the inception of the division. The pharmacy is about relationships has become the unofficial mantra of the associates.
Since its inception, the divisions growth has been fueled by the relationship of our pharmacists with the patients they serve. This relationship is fundamental to the success of our pharmacies. Pharmacists in rural and urban areas value the relationship with a WalMart or Sams Club pharmacist. Pharmacy associates have, for years, partnered with customers to seek the best treatment options for our patients. In a sense, our associates become advocates for the patients they serve. This advocacy has included working with prescribers for alternatives with less-expensive medications, when available, prompt conversions of brand products to lower-cost generic equivalents and treatment with less expensive over-the-counter options. This thought of consumer advocacy must bear heavily on our minds as we consider e-prescribing.
From the perspective of the patient, we believe several considerations are important. These are freedom of choice, safety, efficiency, privacy and the sanctity of the patient-physician relationship.
Freedom of choice is not just about selection of the pharmacy. Choice also includes selection of appropriate therapy at the point of care. The Medicare Modernization Act addresses the need for appropriate messaging as it relates to prescribing. A narrow definition of appropriate messaging is important to limit the potential noise that can develop if this step of care is commercialized. Inappropriate messages from payers or manufacturers potentially interject payers or manufacturers into the physicians office elevating financial costs and issues over patient safety and quality of care.
This is problematic in an environment where decisions have been made using relevant clinical and financial data.
Patients have the right to choose their pharmacy. This choice must be from a level playing field across all pharmacy disciplines, including retail pharmacy - and specialty pharmacy.
For a segment of the population, mail order is a viable option. They enjoy the convenience of home delivery and are sufficiently savvy to seek answers to their questions. The evolution of specialty pharmacies is becoming more important as science advances the knowledge and treatment of rare and deadly disease. Many customers need the special service with the advanced care, but for the vast majority of the public, the retail pharmacist has been and will continue to be their choice for their pharmaceutical care.
Sufficient safeguards must be built into electronic prescribing so the choice of the retail pharmacist remains available without financial penalties to the patient for their choice.
Patient safety is a very important consideration. As even more important drugs become available, the risk associated with name or dosage confusion or adverse drug events can be deadly.
Each week, it seems, there is a new entry in the list of look-alike, sound-alike drugs, due to similarities of names or dosages. E-prescribing must address this and develop reasonable safeguards to ensure the drug displayed on the pharmacy computers is consistent with the physicians intentions.
Drug utilization review must be mandated. The retail pharmacist will have the most complete record of medications taken by the patient. Many patients require the care of different medical specialties, the integration of the treatment regimens into one record is difficult. When the patient chooses one retail pharmacy, as many do, that pharmacy has the most complete record available.
Though many pharmacy benefit processors have portions of the medication history, the patients retail pharmacist has the most complete record of the medication history.
The pharmacy benefit processor will not have a record of prescriptions submitted for payment to other insurance not submitted for payment to insurance and may not have regular prescriptions due to Workmens Comp.
Some other things that the pharmacists have need of is diagnoses. There has been some discussion this morning of the reason why a drug was prescribed. The diagnosis is increasingly important as patients are receiving more and more counsel from pharmacists. With proper diagnosis, the patient receives a much better counseling session with the pharmacist.
As well, the DUR portion is very important in the counseling as well, because the customers, many times, will ask a pharmacist about will I see any drug interactions? If the pharmacist has not done a reasonable DUR, then they cant answer that question nor can they caution the patient about how to safeguard themselves against adverse drug events.
Pharmacies generally have a well-documented list of patient allergies. I am not familiar with a pharmacy benefit process - has knowledge of an ability to check the potential adverse for allergic reactions. Knowledge of these allergies can and will prevent severe reactions that can develop as more medications are added to patient regimes.
Our society has become a real-time world. This is applying more and more to healthcare. Speed of delivery is an important attribute of any service, except if the e-prescribing will be heavily dependent on the efficiency of the system at the point of care as well as the real-time connection to the pharmacy of the patients choice.
E-prescriptions must contain relevant information to allow the pharmacies to provide the safety measures mentioned above and fully prepare the prescription for delivery to the customer. The NCPD script standard, when fully implemented, will provide the necessary information for preparation of prescriptions.
Privacy issues comes to ones attention every day. With concerns of identity theft or inappropriate release of health or other personal information, privacy is very important. The e-prescription must transmit over a secure network with validation of the identity of the sender and receiver. The envelope containing the message must only be opened by the receiver.
Retail pharmacy for 15 years has been sending and receiving electronic claim information through secure network connections using standards developed by NCPDP. This expertise was instrumental in developing the script standard.
You have heard described the patient-physician- pharmacist triangle. Though simple, this triangle reflects beautifully the relationship necessary for optimal patient care. With the patient at the apex of the figure, the physician and the pharmacist provide the patient with the diagnosis, care and counsel necessary for optimum outcome. E-prescribing technology should be used as a tool to enhance this relationship. There are entities that would prefer to supplant the pharmacist or physician for their economic agenda. Standards for e-prescribing lets prevent interference with the right of the patient to make decisions concerning their treatment following the advice of the physician and pharmacist.
The committee has sent a series of questions. Ill now address those questions.
What are the best standards or code sets to meet the requirements of the law?
The NCPDP script standard is a national standard developed collaboratively by pharmacy providers, pharmacy benefit managers and software providers. This effort began many years go and was in response to the recognition of the importance of electronically connecting prescribers and pharmacies. The standard is sufficiently robust to allow messages containing relevant information about the patient, drugs, prescriber, including e-prescription and refill authorization requests and free-form messages between the prescriber and pharmacist. The standard will meet the requirements of MMA who are electronically sending prescriptions between pharmacies and prescribers.
For prior authorization, drug utilization, review messaging and copay information, the NCPDP Telecommunication Standard 51 is currently accepted, fully implemented and is HIPAA approved.
Drug products are identified through the unique NDC. This set is used effectively to identify drugs throughout the industry, including claim billing.
The code sets in use by our company include NCPDP script, NCPDP Telecommunication 51, the National Drug Code, Universal Product Code and also DEA.
Strengths and weaknesses associated with the code sets we use. The script standard has sufficient fields for transmitting the information necessary for pharmacists to serve the patient. The decision of NCPDP to add the drug code to the field adds a level of granularity that can present problems to a physician -
MR. BLAIR: Could you just - could you slow down a little bit?
MR. KILGO: Okay.
MR. BLAIR: We are really interested in what you have to say -
MR. KILGO: Okay.
MR. BLAIR: - and we dont want to miss it.
MR. KILGO: Ive got it. That is a habit I have of speaking too fast.
The decision of NCPDP to add the National Drug Code to the fields adds a level of granularity that could present problems to a physician. How many prescribers want to know there are more than 40 versions of Fluoxetine 20 milligram?
An alternative identifier could be an industry number such as the generic product indicator, the GPI. These numbers adequately identify products, including name, strength, dosage form and grant to the pharmacy sufficient flexibility for selection of specific product. Though this level of specificity can rob the process of efficiencies the system was designed to provide. For example, if a drug product is chosen to a specific NDC level, if that specific NDC is not available at the local pharmacy, then a series of messages could be necessary to secure permission for dispensing the generically-equivalent product at inventory at the pharmacy.
Is nationwide adoption of these standards necessary?
The standards should be recognized and identified as a legal standard, so that there would be no doubt of what we should use.
What are the e-prescribing gaps?
Two glaring gaps in the code sets are patient identifier and prescriber identifier. Though customers are loyal to their pharmacist, they occasionally must use the services of a different pharmacy. The lack of a national patient identifier creates difficulties in developing and maintaining central data repositories with full patient history. Efforts of maintaining these databases require elaborate algorithms to create a unique identifier for each patient. The risk associated with failure to properly identify a customer using these algorithms are great. Adoption of a nationally-recognized patient identifier separate and unique to the Social Security number is necessary to fill this gap.
Further validation of this gap is the action of many states adopting legislation prohibiting the use of the Social Security number for identifiers for any reason, including healthcare.
Rules for the NPI were issued this spring. The NPI becomes the HIPAA-sanctioned identifier for healthcare provider. A gap in the use of this number is the lack of ability to associate it with multiple practice locations over prescriber, and not all prescribers must apply for an NPI. SureScripts and other e-prescribing vendors felt it necessary to develop their own system for uniquely identifying practice locations.
The directions for use or SIG is another gap that must be addressed. A large portion of the directions given with a prescription are conveyed using commonly-used abbreviations. Standardization of these abbreviations will improve the process and reduce potential error.
Barriers that could develop for adoption. In rural markets, a barrier could be insufficient resources for the medical practitioner, physician or pharmacist to purchase new or upgrade their current practice management system to include the functionality of sending and receiving e-prescriptions.
Though many of the practices have associated themselves with hospitals, there still are those who remain, independent, and I believe that the government should consider making grant money available to assist practices in rural areas in the purchase of new PMS or upgrading the existing PMS to allow e-prescribing.
Additionally, funds should be available for training of all practice settings to educate the users of the full range of functions e-prescribing can offer. This training should assist with more rapid adoption of the technology.
Many of the messages currently sent through the e-prescribing network are refill requests. This type of e-messaging adds efficiency to the prescriber and the pharmacy. The Medicare population traditionally uses a higher number of maintenance medications. A typical Monday morning in a retail pharmacy requires many hours of associate time in making calls to prescribers to request authorization from prescribers for refills. These authorizations go by fax or phone. Messaging through e-prescribing allows the request to go directly to the PMS of the prescriber and the response approving the refill goes directly into the workflow of the pharmacy system. Training support staff in the prescribers office on the efficiency of refill authorization will speed adoption of this message.
Adoption of refill authorization should grant quicker acceptance of sending new prescriptions for e-prescribing and facilitate e-prescribing options available in the future.
The current technology base of script offers a launching pad for e-prescribing. Use of this technology will leverage an investment many stakeholders have made. This also will - implementation and phases as many other technologies and shared data bases are available.
Success of e-prescribing will hinge on the continuity of regulation of state boards of pharmacy, but also of payers. For example, several drug products have coverage under Medicare Part B. A fundamental requirement of Medicare Part B is the presence of a signed order by the prescriber. This effectively removes these products from the e-prescribing realm. Without concession on these regulations, when a pharmacy receives an order for a product with coverage in Part B, someone must convert the electronic message to a paper format, fax that paper to the prescriber who must sign and fax back to the pharmacy to properly make the documentation requirements of Medicare Part B. This removes all efficiency gained through the e-prescription.
In conclusion, e-prescribing is and will continue to be a step of efficiency for health care. As the process gains acceptance, cost savings will quickly follow.
WalMart presently is expanding this functionality, and it is our plan to continue expansion as quickly as possible to include all states where regulations allow e-prescribing.
There are barriers to e-prescribing. Many resources have been committed to developing the current process, though much still is to be accomplished for a system that can meet the demands of an ever-changing healthcare environment. Because of the multiple questions to answer, I propose the committee consider time lines and milestones for adoption and implementation in phases. This approach will allow the current functionalities to be a base for building future enhancements.
Again, we express our appreciation to the committee for allowing us to present here today.
DR. COHN: Thank you very much.
MR. GREGORY: My name is Mark Gregory, and I am Vice President of Pharmacists at Kerr Drug. Kerr Drug is a regional chain drugstore located in North Carolina.
I appreciate this speaking opportunity, appreciate the subcommittee doing a great job, a thorough job and due diligence associated with the benefits of e-connectivity and what that benefit can bring to physicians and pharmacists.
Again, Kerr Drug - that is Kerr Drug - the only person probably pronounces it Kerr Drug, but everybody else says Kerr Drug - is a regional community pharmacy chain with over 100 pharmacies located throughout North Carolina, and a dozen of those pharmacies in Charleston, South Carolina. Many of the small towns where our pharmacies reside, we are not only the whole pharmacy, but also the destination where our pharmacist is the key healthcare provider.
I would like to break my discussion into three main areas, first highlighting the role a community pharmacist plays in the prescription-fulfillment process, then talk about efficiencies and tools utilized in the current dispensing process and conclude with a perspective on the e-prescribing process and standards.
To begin, I would like to start my discussion by providing some background regarding the role a pharmacist plays as a safety net in the fulfillment and distribution of medications. Some common questions often arise out of a visit to a pharmacy, and one which is usually puzzling to a consumer is what does go on behind the counter.
I might answer that question by listing a small subset of events that occur in the sequence of filling each prescription.
Number one, there is an intake of prescriptions where there is an establishment of allergies, health conditions and gathering of information like OTC products. A role which we play is also gathering prescription insurance coverage information.
Then we begin the fulfillment process, which requires building of a patient profile base, based on the intake information. Fulfillment also includes internal drug-utilization review, checking for items such as drug interactions, dosage checks, compliance with medication and appropriateness of medications.
Often during the fulfillment process, there is communication to the physician regarding any of the numerous DUR concerns or where there may be no refills remaining on a prescription.
And, then, finally, one key item in the fulfillment process is adjudication of a prescription and interaction with a prescription-benefit manager for reasons such as eligibility, copay clarification, drug coverage or a prior authorization requirement.
Thirdly, and most importantly in the fulfillment process is delivery of the prescription to the patient, which entails proper face-to-face exit counseling as required by state laws or requested by the patient.
Now, when those three sequences are clean and no alerts arise, the process is very efficient. When the process detects an issue such as a drug interaction, the important safety-net process is initiated.
Community pharmacists have accepted these processes as part of filling a prescription, a perception that any of these processes can or is able or is willing to be handled by another stakeholder or dispensing model could burden the system, jeopardize safety or create tremendous inefficiencies.
Todays pharmacy practitioners graduate from a pharmacy school with a minimum six-year doctor-of-pharmacy degree qualifying them as a drug experts on the healthcare team. The demographic reality of our aging population shows that the number of prescriptions that will need to be dispensed will continue to increase significantly. This increase in prescriptions positions the community pharmacist to play a larger role being accessible to the aging population and managing complex medication regimens from a compliance, quality-assurance and cost-effective perspective.
Secondly, I would like to point out the investment which has already been made by retail pharmacy operations to make a dispensing process safer and more efficient.
In an effort to surround the pharmacist and the pharmacists team with some prescription-fulfillment tools, our drug and community-pharmacy industry has integrated numerous dispensing efficiencies into our processes. An illustration of some of these efficiencies may best be accomplished by itemizing a number of these tools with a short definition.
Number one - and we have talked about electronic adjudication, which is a standard communication process that has been in place for over a decade, allowing pharmacies to establish insurance coverage - that is drug coverage, patient eligibility and copay information, and to initiate an expected receivable from the benefit administrator. This process, which may seem complex, takes seconds utilizing high-speed communication networks and utilization of an NCPDP transaction standard. This communication network is also the vehicle for e-prescriptions.
Workflow. This is utilization of technology and ancillary personnel like pharmacy technicians where we create workstations and targeted responsibilities in the filling process.
Within the workflow resides bar coding and prescription scanning technology for quality-assurance checkpoints. Workflow cues reside in our pharmacy dispensing systems where e-prescriptions are posted for fill.
IVR is an interactive voice response which allows patients to phone prescription refills in efficiently. The technology also allows patients to know if refills remain and allows pharmacies to automatically outbound faxes to physicians offices requesting refills for patients. This outbound fax is replaced by electronic requests as the physician practices adopt electronic connectivity.
Other efficiencies are counting automation, where we utilize a wide range of technology from counting devices to robotics for prescription-filling purposes.
We have pre-fill, which allows patients to opt - technology which allows patients to opt into a program where maintenance medications are filled based on when the prescription is due to be refilled, increasing patient compliance through their medication. We have all made an investment in electronic signature capture, which is electronic documentation storage of signatures for situations to comply - for example, HIPAA - and offered to counsel requirements.
We utilize central fill and central processing where we leverage central sites to offload prescription filling and administrative tasks from each individual community pharmacy.
So these efficiency tools have all been integrated into the fulfillment process at a significant investment by community pharmacy and technology, time and manpower.
As you can see, e-prescriptions are already incorporated into some of these processes. The additional acceptance and further development of electronic connectivity between the physician and pharmacy is a natural next step in streamlining and eliminating an antiquated paper-based prescription-writing process.
Next, importantly, we must use the script standard for transactions involved with physicians and pharmacists e-connectivity. The script standard has gone through rigors of adoption, through the NCPDP process, agreed upon by pharmacy software vendors, community pharmacy organizations, database providers and many other stakeholders.
At Kerr Drug, we have adopted and partnered with SureScripts to not only use the script standard, but also be the entity to put in place a secure network identify and develop technology platforms to complete the transaction, connect treating providers and implement comprehensive community marketing and adoption programs.
SureScripts, which has been organized for almost four years, has a tremendous head start in this effort by having individuals within their organization experienced in transaction standards. They have leveraged the current communication networks already in place, connected key industry partners that are critical for completion of the transaction between the physician and pharmacy and have approached the development of the technology by consensus. This consensus is minimally witnessed by the adoption approval of all independent chain pharmacies.
Importantly, the SureScripts system allows patient freedom to choose the pharmacy where they would want to have their prescription filled.
At Kerr Drug, currently, all of our pharmacies are prepared to receive directly into the workflow queue new electronic prescription and refill approvals. Integration of these transactions into our dispensing pharmacy system is critical. New prescriptions and refill requests are only a first step for the SureScripts platform. The platform is built and can be built upon due to its open architecture. It is important not to adopt an alternative standard or model which does not allow to build upon that which is currently in place and has significantly been invested in by community pharmacy.
Patient, physician and pharmacist relationship is increasingly critical today, but has been clouded by stakeholders interested in driving market share or incorporating marketing messages into the medication distribution process. We should make sure that e-connectivity standard and model does not allow that to be an element of prescribing rationale. Communication endpoints in this transaction only involve treating entities.
My final three recommendations to move the standard and process along quicker are.
One, find a way to enhance physician adoption through financial grant opportunities for investment in training, purchase and acceptance of the new technology.
Number two, supplement investment pharmacy providers are making by providing grant incentives for successful adopters.
And, number three, provide funding to entities to measure outcomes which are studies to measure safety and efficiency successes.
Thank you.
DR. COHN: Thank you all.
Questions from the subcommittee?
I apologize. I must be having a hypoglycemic attack or something. My apologies.
MR. SIMKO: Good afternoon. My name is Mike Simko. I am manager of pharmacy systems for Walgreens. I have been a practicing pharmacist for about 25 years, and speaking for our entire company, I just want to thank the subcommittee for inviting us here to share the experiences and conclusions we reached over the years from our continuous efforts to deploy electronic-prescribing connectivity nationwide and improve the delivery of quality healthcare to patients.
Walgreens was founded in 1901, currently has over 4,500 locations in 45 states and Puerto Rico. We fill over a million prescriptions a day. That accounts for over 14 percent of all retail prescriptions in the United States.
We currently open a new pharmacy every day. Actually, we open one every 19 hours. Nearly 30 percent of our pharmacy locations are open 24 hours. Our company focus is pharmacy.
Walgreens has a history of pioneering technology in the practice of pharmacy. All our pharmacies are linked by satellite. Actually, Walgreens is the greatest user of satellite communication in America outside of the United States government.
Our mission is to provide the highest quality pharmacy services to our patients in the most efficient, cost-beneficial manner.
Walgreens, long ago, recognized the benefits of electronic prescribing. Nearly 15 years ago, Walgreens initiated electronic communication between pharmacies and physician offices utilizing an email-like structure to message physicians for refill authorizations. This was accomplished to bring an efficient solution to a time-intrusive task of phone calls from pharmacies to doctors offices for the purpose of obtaining refill authorizations for their patients.
Clinics experience delays in responding back to pharmacies through phone calls because of the large number of phone calls and resultant inefficiencies of busy signals and prolonged phone hold times. These delays negatively impacted patients timely receipt of refills, often taking several days, in some cases, up to a week, for the pharmacy to receive call backs with refill authorizations as well as increasing stress levels for both the pharmacy staffs and physician office personnel, as well as the patients.
Once this initial electronic messaging system was in place, the resultant benefits were quickly identifiable. Refill authorizations were accurately obtained in less time with less effort. Pharmacy and clinic resources were freed to engage in improved patient contact and services.
Although the system achieved efficiencies in time saved, it became apparent that there were other compelling benefits to the automation applications of electronic communication between pharmacies and physicians.
The important results of this connectivity were an improved prescription communication process, a safer method of ordering medication for patients and delivery of pharmacy services in a more timely manner, along with improved quality assurance through the reduction of errors due to an improved method of transcription, interpretation and communication of prescriber orders.
From this early email application, Walgreens looked for enhanced ways to facilitate the prescription writing and delivery process. A refill authorization form was created and formatted for the clinics to standardize the information requirements for the pharmacy from the clinic. This format saved key strokes by prompting the clinic to fill in critical information needed to provide the patient with the correct medication as prescribed.
Pressure-sensitive label printouts were developed for the clinics medical records, allowing the clinic to peel off recorded responses to the pharmacy, place them directly on the patients chart resulting in both a time savings and improved workflow processes.
A DOS application we named Prescribe was developed and provided to physicians. This application allowed the prescription writing and refill authorization software to be integrated in existing office practice management systems that were already being used by physicians. By making use of the existing applications and technology already present in the physicians practice settings, barriers to entries were reduced, the startup time was shortened, and the application was more readily accepted.
Office personnel quickly adopted electronic prescribing recognizing the important resultant improvements in patient care. Phone hold time with pharmacies was reduced. Turnaround time for obtaining refill authorizations were lessened and patient charting was easier and more accurate. Clinics began using the application to transmit new prescriptions to Walgreen pharmacies. The software prompted doctors for drug name, strength, dosage form, direction, refills, quantity. Both the pharmacies and the clinics realized the importance in the communication process. Complete prescription information was provided, eliminating call backs to physicians offices. Patient wait time was reduced. Pharmacy and clinic resources, again, were freed for other patient-care responsibilities. The result was a noticeable reduction in call backs to physicians for clarification on medication orders.
A windows-based program was then developed, allowing more user-friendly screens, which led to further increased adoption by clinics and integration into additional practice management systems.
It soon became apparent that to improve adoption and usage, clinics wanted the ability to utilize this functionality for all their patients, regardless of the pharmacy of choice.
Realizing that the benefits of electronic prescribing were so compelling, Walgreens made the decision to sell Prescribe to a message-content-neutral company that was outside the drugstore medical industry that other pharmacies would not view as a competitor.
In order to increase acceptance and use by physicians, a critical mass of pharmacies was needed. Those pharmacies must have a comfort level that the prescription message was safe, secure and the patient retained their freedom of choice.
In response to the then growing industry need for greater market acceptance, the benefits to patient healthcare and the critical need for efficient and safe methods of prescribing, Prescribe was sold to Proximet(?).
The success of electronic prescribing and the ultimate improvement in quality patient healthcare depends on several key areas of commonality. There must be standards in the prescription messaging process to ensure complete and accurate information. To realize the benefits at the pharmacy, those industry standards must be carefully and successfully integrated in pharmacy operating systems to achieve the intended efficiencies and quality assurance benefits inherent to electronic prescribing.
Part of the issue with the slow adoption of electronic prescribing by pharmacies and prescribers is the myriad of formats and methodology that exist in the field today. There is a disparity between what is a true EDI prescription versus an electronically generated faxed(?) prescription. Agreed-upon standards will help facilitate widespread adoption and integration of e-prescribing into both prescriber practice management and pharmacy-operating systems.
Today, there are standards in place regarding electronic prescription transmission between both pharmacies and physicians offices. The NCPDP script standard provides a viable foundation to meet the MMA requirements and is currently widely adopted by pharmacy and physician office practice management systems. The use of the NCPDP script standards provide safety, improved quality of patient care and efficiency that has been adopted by pharmacies today, and its use eliminates any undue administrative burden on prescribers and pharmacies.
Walgreens believes the NCPDP script standard is the best standard to meet the electronic prescribing needs of Medicare patients and the pharmacists and physicians who serve them. Those benefits extend beyond Medicare patients to that of the general population.
The current NCPDP script standard is already adopted nationally and addresses a core functionality required in the Medicare Modernization Act. It addresses bi-directional(?) functionality in the transmission of prescription information between prescribers and pharmacies.
Standards were developed to address the potential for additional functionality, including patient benefits information, medication history, allergy and health conditions.
Efforts are underway to interface NCPDP script with HL7 to encompass inpatient in long-term-care settings.
Regarding code sets, the NCPDP provider identification number is already adopted by pharmacies for processing and payment of prescription drug claims and works as a pharmacy identifier code set for electronic prescribing.
The NCPDP provider identifier is used nationally to identify pharmacies by boards of pharmacy payers, telecommunication switches, processors, for a variety of purposes. We believe the identifier should continue to be used.
Regarding packaged drug code sets, NCVHS should adopt the NDC number as a standard for medication identification, which is currently used by pharmacies and payers and has been in use for an extended period of time.
However, the generic drug issue will need to be addressed. Generic medications represent a growing cost-effective healthcare delivery area.
Pharmacies carefully select generic manufacturers, based on safety, efficacy, costs and product availability. This process controls costs to the patient and the healthcare industry. It would be a barrier to pharmacy providers resulting in requirement of pharmacies that carry multiple manufacturers of the same generic product if manufacturer-specific generic prescriptions were electronically sent to pharmacies. This would result in delays to patients receiving their medication and, we feel, impede the acceptance and adoption of electronic prescription services.
The elderly will most benefit from the MMA, who are on chronic-care medications and depend on the cost savings from generic alternatives. Inhibiting generic-manufactured product selection in pharmacies may result in the segment of a population being the most adversely effected.
Some ways to address the generic medication issue could be the use of the GPI, generic product indicator, the mapping of an RxNorm to NDC numbers sent to the pharmacy. However, RxNorm is not used in the pharmacies today. It would be problematic for that to be adopted in pharmacy use.
A current gap in electronic prescribing is the lack of a nationally-accepted, non-proprietary sig prescription database.
The directions are a standard part of a written prescription, at times using Latin abbreviations or full wording in English. Codifying and standardizing the instructions are important for medical informatics. However, it is critical that the pharmacy receives the exact instructions from the provider to prevent errors that occur from ambiguities and definitions of various abbreviations.
Often, medication directions must be sent as full free-form text. It is apparent that an NCPDP script sig standard or translation methodology may need to be adopted at some future time.
Pharmacy systems, both proprietary and non-proprietary, need to integrate electronic prescribing to realize many of the intended benefits. Minimization of keystrokes to process e-prescriptions is essential to the efficiencies, including the quality-assurance aspect of any change to the prescription, other than what the prescriber intended.
Likewise, the generating of refill authorization requests - an essential aspect of the patient, pharmacy, physician connectivity - must be automated to ensure no interruption in patient compliance, critical monitoring of patients progress as part of electronic medical records and the reduction of stress levels in pharmacies and physicians offices.
Pharmacies traditionally keep highly-accurate, comprehensive medical records regarding their patients. Pharmacy systems not only monitor which medications patients receive at the pharmacy, along with the patients compliance, but have the capabilities to add allergy information, health-condition codes and non-prescription drug usage. This feature provides a comprehensive profile to the pharmacist and physician regarding the patients medical condition, compliance with drug therapies and provides a foundation for effective DUR review.
Pharmacies perform DUR each and every time a patient receives a medication order. It is important to note that the - 1990 act and applicable state laws and regulations require pharmacies perform DUR and offer to provide clinical consultation to the patients.
Earlier, there was a discussion regarding the pharmacists need to know diagnosis and disease states, and I believe that, contrary to some of the commentary that was made, a pharmacist represents a very important function in the dispensing of medication to the patient and, in some cases, has more thorough knowledge of medication and their treatment of diseases than a physician does, and I believe that any information that can be given to a pharmacist, along with a prescription, only benefits the patient.
We heard some testimony yesterday regarding patients having access to their medical records. Today, at Walgreens, patients can update their medical information. They are given a sign on and a pin number. They can access their medical information. They could put updates into health conditions, allergies and add other prescription information of medication they may have received from other pharmacies, as well as any other OTC medication that they are on.
Although third-party payer groups claim to represent an information source to physicians regarding DUR, at the time of prescribing, those databases do not contain non-third-party medication orders, such as cash-payment prescriptions, prescriptions that may have been paid by a different third-party payer or OTC medications the patients may be taking.
Regardless of what occurs at the prescriber-patient point of care, pharmacists will continue to perform DURs before the medication orders are dispensed to the patients. This is the current practice of retail pharmacy.
Future enhancements to electronic prescribing may include additional messaging, providing the physician with patient medical-record information, also lab results, patient weights and diagnosis may become future features added to this connectivity.
However, rapid adoption of electronic prescribing will only occur if there are not significant barriers to entry.
We believe the connection is important, starting with refill authorization requests from pharmacies to physicians, refill authorization responses from prescribers back to the pharmacy of the patients choosing and transmitting new medication orders. Additional functionality, once part of the standard, can easily be added.
There can be no barriers to these processes that may hamper this connectivity, interfere with the patients freedom of choice or delay a timely implementation of the e-prescribing process.
We want to stress that, at the point of prescribing, the transmission of an electronic prescription must be direct from an authorized prescriber to the pharmacy of a patients choice. No undue influence from message pop-ups should be allowed that would alter the patients choice. No alteration of the message may occur in the transmission process.
To maintain confidentiality, electronically-transmitted prescriptions must have adequate security and system safeguards designed to prevent and detect unauthorized access, modification or manipulation of these prescriptions.
E-prescribing has a huge potential to positively effect patient medication therapy. As methodology matures, various additional features can and should be added to further improve patient care. It has been our experience that more patients actually have their medications filled when e-prescribing is utilized. I believe it is IMS statistics estimate that between 20-30 percent of written prescriptions are never brought to a pharmacy. This results in ineffective therapy and potential increased overall healthcare costs.
By nature of e-prescribing, 100 percent of transmitted prescriptions arrive at the patients designated pharmacy, which provides for better continuum of care and increased compliance. Consequently, there is a larger potential beneficial outcome to the greater number of patients. This critical drug therapy and resultant compliance will lead to an over all reduction of healthcare costs.
Physicians utilizing electronic prescribing technology should have ready access to neutral and unbiased information and a full range of covered, outpatient medications.
Physicians should be able to view with ease all necessary information, including information about drugs that are preferred on formulary, non-preferred on formulary and off formulary without burdensome search through multiple screens.
Any information provided to physicians should be fact based, transparent and identify the source of the information. This information should include disclosure of any incentive payments given to technology vendors to display information in any particular way. Any banners or advertisements should clearly be labeled as paid advertisement.
Any COB information transmitted to the pharmacy should be granular enough to provide the pharmacy with the correct payer ID number. There should be a fair depiction of benefit structures at the point of prescribing.
As we have experienced firsthand with our initial efforts in the area of electronic prescribing, success in connectivity and usage depend greatly on the ease of transition from the current non-electronic practices.
As with most technological changes, there exists an important change-management issue; that is, changing the methods prescribers and pharmacies use to communicate critical patient information and prescriptions.
The success in adoption of new functionality must include an ease of transition. Today, standards exist. They are widely accepted and commonly used in the electronic transmission of refill authorization requests, refill authorization responses and new prescriptions. There should be no undue burdens placed on practitioners and pharmacies to reinvent an already successful process.
A key to rapid utilization and critical mass of participants, both from the prescriber and provider sides, is the natural adoption of processes already in place. Additional features and functionality can and should be applied over time. However, a critical change-management piece is the transition for prescribers and pharmacies to communicate through existing NCPDP script standards.
No undue burden should be placed on the processes as they exist today. The transmission should be seamless and easily adopted.
Pharmacies must be allowed to participate on a level playing field. Although there are many pharmacy systems that are proprietary, there exists a significant number of pharmacies that purchased their operating systems from an outside vendor. Changes from already-existing standards may result in barriers to participation, which may lead to a reduction in the critical mass of participating pharmacies.
The relationship between a prescriber, the patient and the pharmacist is built on trust that exists through the patients choice. The presence, capabilities and uses of electronic prescribing must first address that relationship, bar any interference in connectivity and facilitate a smooth transition from the current inefficient manual processes.
Historically, Walgreens has pioneered the use of technology to promote the highest-quality care and service to our pharmacy patients. Walgreens has traditionally led the industry in innovative methods for promoting healthcare. Walgreens is ready to be a willing participant.
Walgreens would like to thank the NCVHS committee for this opportunity to speak here today and the ability to participate in any future discussions, including any initial pilot programs that may result.
Thank you.
DR. COHN: Try this again. Thank you all very much. Appreciate the testimony.
Questions from the subcommittee?
DR. FITZMAURICE: Mr. Simko, you mentioned that a current gap in e-prescribing is a lack of a nationally-accepted proprietary - or non-proprietary, sig prescription direction database, and I am wondering if the physician filled this out from a pick list and then sent it, that would contain the content of what the physician wants - physicians directions to the patient. You say in your testimony this might need to be adopted at some future time.
Yet, earlier today, in response to a question, the response was, well, if you change the legacy systems, it is much more expensive and people dont want to change what they already have.
Is it better to have such a standard now, so that vendors can incorporate them into their systems or is it better to wait and see what kinds of things physicians do want?
MR. SIMKO: I think the second part is the preferable route. I think we should go slow with it, see what physicians want to do. I am really concerned that the translation of sig codes used in the clinical setting are translated correctly in pharmacy systems as they exist today.
Today, we can receive either the sig as the doctor wrote it or it can be translated into free-form text, and I think, first of all, step one - like to take a crawl-walk-run philosophy, and step one should be lets make sure we get the - lets make sure we get exactly what the prescriber is intending and work towards - very carefully work towards agreeable standardized -
DR. FITZMAURICE: Are you saying that the pharmacist translate what the physician has written down into something that is already automated, then, for the pharmacists system?
MR. SIMKO: In some cases, yes, and some of the abbreviations that are sent electronically, because we integrate and - integrate electronic prescribing into our pharmacy operating system, those fields are pre-populated with what the physician sent, and what happens is if those codes the physician transmits differ from what the pharmacy system interprets them as, then you may have a disparity between what the pharmacy system is reading on that sig versus what the physicians say.
DR. FITZMAURICE: Then I am a little confused. Would it not be better then to have the physician choose the codes in his or her office and send them to the pharmacy, so that there is no question of the misinterpretation?
MR. SIMKO: I think that is what we should be working towards. I just dont think that is possible to do today, and I think that, in order to address the needs for safety and the efficacy of the system in ensuring that we are receiving exactly what the physician is requesting, that that be - at least start off to be text and then change over to the sigs.
DR. HUFF: A couple of you mentioned a generic product indicator, and I wondered if you could say more about that, where it originates, how it is used.
MR. KILGO: I believe it is a proprietary number generated by one of the database companies. Medispan, I believe, owns that trademark, and what it allows, it allows a group of generics to have a same number. I think it is a smart number. I think there are some people in the room that can speak better to it than I can, but it is a series of two-digit numbers that identify a specific drug down to a dosage form and to a strength.
DR. HUFF: So it ends up being a proprietary number then.
MR. KILGO: Yes.
DR. HUFF: Okay. Another issue that several of you talked about was the routing of prescriptions to mail-order pharmacies, in particular, manufacturer-owned mail-order pharmacies. Could you educate me more about the issues related to mail-order pharmacies and the dangers you see and the things that would be permissible or not permissible in relationship to mail-order pharmacies?
MR. WILSON: I guess thats mine. I made that comment.
We have a concern that if you talk to practitioners, you talk to pharmacists, you talk to many manufacturer reps and you ask the question what do you think is the optimum care given to a patient in the dispensing process? Is it the face-to-face dispensing, DUR counseling component that you receive at community retail pharmacies between the patient and the pharmacist or is it something that comes through the mail into your mailbox for distribution? And our input tells us that the best quality patient care is provided by that pharmacist-patient relationship in the dispensing process.
Many insurance plans have developed very high copay incentives either - or even mandate that they can get the prescription filled once at the retail level and then the rest of the time they have to get it at mail order.
Our concern was that they would use a messaging component that would tell the physician that they have a mail-order component added to this patients profile, and then the e-script component would direct that submission to the mail-order facility and put community retail pharmacy at a tremendous disadvantage as a result of routing those prescriptions away from the retail sector.
DR. HUFF: Okay. Another issue that several of you touched on was the fact that pharmacies may be in the best position to know the complete drug profile, if you will, in terms of what the patient is taking, but it seems to me that they might be in the best position, but they still have lots of things they wouldnt know. Unless we change flow, for instance, unless you ask me about my over-the-counter drugs, I dont know anybody who - you know, if I pay for over-the-counter drugs with cash, there is no record of what my over-the-counter drugs are.
Number two, as long as they are coming to your pharmacy or a pharmacy chain, you know, but if I go to different pharmacies, you dont have any better idea than anybody else who asks.
MR. SIMKO: If I could respond to that. Actually, we have a system in place where patients can access their records on line, and they can fill in, if they get prescription medication from another pharmacy - they dont have to indicate which one - is the medication that they are on, and the same with OTC purchases, and, in fact, the largest sector of the patients that do do that in our pharmacies that we have additional information actually do it on line.
DR. HUFF: But anybody could do that. I mean, that is not something that has to be done by a pharmacy. In fact, one could argue that that should be done independent of a pharmacy, that it would be nice to have an online service where patients could enter that information and then any pharmacy or any physician, any care provider could access that information, rather than having it be part of the pharmacy system.
MR. SIMKO: And perhaps that information could come from the pharmacies to those providers.
DR. HUFF: But, more to the point, I mean, I guess I would like to speculate about do you see a way that - or have you thought of the easiest way that a true comprehensive history could be obtained? Because it seems like there are things that the physician knows - for instance, it would seem that they would be the only one who would know for sure if they dispense samples. The pharmacy has lots of pieces of information that you know and are the best source for. The PBMs and benefit managers see across pharmacies in ways that the pharmacist may not. So are there - have you thought of strategies that would really lead to a comprehensive list of medications that could be equally shared between pharmacists, providers, benefit managers, et cetera?
MR. KILGO: I think there has been a lot of discussion about an electronic medical record of some sort and until you could make prescription drugs a part of that record, I think therell be many different players that has a piece of the puzzle, but no one player will have it all.
MR. SIMKO: Just to add to that, you are right that a pharmacy may not have all the particular prescription medication records that a patient may be on. However, if that is being processed through a third-party payer, at the time that pharmacy does fill the prescription, they will get DUR messaging provided from the third-party plan in PBM. At that point, then, the pharmacy does have that information across different pharmacies and the additional information that particular pharmacy may have on the patient, and, at that point, that may be the best source for physicians to receive patient medical information.
DR. HUFF: Well, I guess if - I mean, I am a physician. I mean, I would rather have that knowledge at the time I am prescribing, than be without that knowledge, have it go to the pharmacy and then you guys see it, and so, you know, it would seem to be a better flow to have messages that would go from whoever has the most knowledge about the drug list to the provider at the time of prescribing. It would be great to have pharmacies have it and be able to double check that, but it would seem to me that the goal should be to get that comprehensive list to the provider at the time of prescribing, and not have it happen after the fact only within the pharmacy.
MR. SIMKO: True.
MR. REYNOLDS: Okay. I have one clarification question.
On NCPDP script, is the sig field free text?
MR. SIMKO: Yes.
MR. REYNOLDS: Okay. I think most of you were here earlier for the testimony from the PBMs where they laid out a recommended set of standards. I didnt hear anything from any of you that negates any of those or I also didnt hear anything that added to the list. Is that correct?
MR. SIMKO: I dont have any specific issues with anything that was brought up earlier today, outside of the fact that a pharmacist is an important part of the prescription process and is in the best position, I think, to provide good medical, patient, drug therapy to physicians and the patients, and they just dont represent an additional step, I think, that are critical in the treatment process for a patient, and the passing of something as health conditions or disease or diagnosis along to the pharmacy, I think, helps improve that process, and that was really the only - the largest issue I had regarding this morning.
MR. REYNOLDS: And, again, I am mainly focused on the actual standards that they cited, less than the process.
DR. STEINDEL: I have, first, a comment. Well, actually, it is two comments. One that doesnt have to be addressed and the other you may wish to address, and then a question that is not really involving standards.
The first comment was I always thought WalMart was the largest user of satellite communication. (Laughter).
MR. SIMKO: Ill meet you outside. (Laughter). We opened one more store today.
DR. STEINDEL: (Laughter). And then the comment that you might want to comment on is I heard a message, a background message from all of you that sort of translated to me as go slow, and I do want to state that we got a message from Congress that said go fast, and, last week, we got a message from Secretary Thompson that said go faster, and I think that is the way we are moving. So I think you need to be prepared for that.
MR. SIMKO: I think going fast to establish electronic connectivity between physicians and pharmacies, we couldnt agree more and wish you would go even faster than you think you are given.
What we are saying is dont try - we think its better to go a little slower at what all the features and functionality are in that connectivity process, and we have had the best success where we start out low, carefully add those features that best serve the physician, the patient, and, hopefully, the pharmacy; and going slow just means the additional functionality, not making the connection. We are ready today. All our stores are enabled, and we wish - we cannot wait until physicians are also connected.
MR. KILGO: I would like to agree with that.
DR. STEINDEL: I was going to ask -
MR. KILGO: The connectivity part, tomorrow, would not be soon enough, but the adding the other features that I think we want to see, some of the centralized medical record, some of the DUR checks at the doctors office, some of those things will be gradual steps that you have to take because the standards do not exist, and I am not so sure even the workflow processes exist today.
MR. SIMKO: Just dont wait til you build the whole system. Start and then add to it.
MR. GREGORY: I would agree that theres - I mean, some of the standards that need to be developed, like we talked about the sig standards and things like that. Theres a process that works right now.
DR. STEINDEL: My question actually doesnt really concern standards, because at least three of you brought up the issue of some type of incentives, especially in rural areas, to help rolling out e-prescribing, and, as my colleague on my left from AHRQ can say is, the HHS has embarked on initiatives to roll out electronic health records in rural communities. Can you see piggybacking on that to help the people in your communities? Because I know, in particular, WalMart, specifically, mentioned improvement of the physician practice management systems, and I personally do not see, with the Secretary giving us this mandate for rolling out EHRs in rural areas, to put investments in two different types of systems. Would that cause a problem with any of you?
MR. KILGO: I dont think it would. I think the key is getting the capability at the doctors office and the physicians office to ensure that the connectivity exists. I think that is going to be the right limiting(?) step, because the pharmacies are ready, by and large. I know Walgreens is ready. WalMarts ready. The step that is going to be necessary - someone mentioned earlier that 200-plus or the long list of management systems that the doctors offices had - getting assurances in the capabilities instilled in those practices, which - a legacy system. So it is not going to be a sudden transition.
MR. WILSON: Kind of look at that as a component. You get the IT component of internet access with the computer system at the physicians office and the integration component and standardization is, to me, the key to make that happen.
DR. STEINDEL: So am I correct in translating what you said is what we are mostly interested in is getting modern IT into the world of physician offices, and the way we do it -
MR. WILSON: Absolutely.
DR. STEINDEL: Okay. Thank you.
MR. KILGO: And, also, dont forget the small pharmacies in the rural areas as well, because theres small pharmacies in many rural areas that are much smaller than WalMart will ever go may need the assistance as well.
MR. WILSON: We have a lot of small communities in Oklahoma and we have been trying to buy them satellites, but they were on back order. (Laughter).
DR. FITZMAURICE: In Mr. Kilgos testimony or in the filling out of the table in the back, there is a note on the drug-to-lab checking that lab information isnt included in the common drug databases, and this is a standards gap. How important is it, do you think, that the pharmacists have some of the lab information?
MR. KILGO: We havent routinely had it. I think, as more and more drugs become available, though, theres many that the lab values are very important. I can see it transitioning in that direction, but, today, we get by, but as more certifications for use of certain drugs come along that you must have as documentation to support dispensing again, even though the physician has ordered the drug, there still is the additional check at the pharmacy.
Im trying to think of one drug right now that rolled out a few years ago that all the pharmacies had to maintain lab values on record. Osareal(?) I believe it was.
MR. SIMKO: And with the emergence of the specialty pharmacy is going to require lab values be transmitted and kept at the pharmacy, and as we are seeing more and more specialty-type medications emerge, that will become more and more important.
DR. HUFF: Following up, just picking at more the drug codes that are used in prescribing, I mean, all of the prescribing systems I know about are, in fact, the physician is choosing from a set list of things. Now, that might be ultimately, then, transmitted as text in the prescription, but they are choosing from a code. So it seems - from a finite set of entries, which have internal codes, and so it would seem to me the problem actually is not that they are free text, because its - I mean, basically, it is too slow to have physicians type in the whole name of the drug. So people choose from a list. It may get converted to text, but the real problem then is is that - not that they are not coded. It is that everybody is using different codes, and so would a strategy to overcome that be - I mean, essentially, in the spirit of phasing this in, I mean, standards that we would adopt probably wouldnt be binding on people for three years or four years. It would seem prudent to go ahead and specify standard codes that could be used in ordering, but not have those be binding until people had a chance to basically translate whatever codes they are using to the standard codes, because it seems like so much of what we are trying to do really depends on the use of standard codes, if you are going to do automated DUR and allergy checking and all of that sort of stuff.
MR. SIMKO: I agree, and I think that is consistent with our earlier comments as we phase things in and transition to the more acceptable methods of transmission of prescription information. So I agree with what you are saying.
MR. KILGO: As well, also, how granular do you want that information to be? And if its - you want to take it to the level of a specific NDC number, then I think you are going to remove some inefficiencies. When you are talking about branded products, it is probably not that big a deal, but when you are talking about a generic alternative, again, theres probably 40-plus versions of Fluoxetine that is available in one strength, that, if a physician identified one specific generic -
DR. HUFF: Yes, I dont - I envision it being similar to the kind of information you get now from the drug knowledge base vendors, where they have condensed that - I mean, RxNorm, essentially, would be one code and you would see that code, and only if they were trying to prescribe the proprietary medication would you then invoke -
DR. COHN: Okay. Other questions, comments from the subcommittee?
Okay. Well, I want to thank everyone. I think this has been a great session. Well obviously be talking over, I think, some of your recommendations as we move forward. So thank you very much.
And I think, with that, we will take a 15-minute break and come back.
(3:28 p.m.)
* * * * * * * * * * * *
(3:52 p.m.)
DR. COHN: Id like to call this session back to order for the late-afternoon session, I guess is what well call this.
Now, let me just talk about what we are going to be doing over the next little while. I mean, first of all, we actually have a guest testifier, and let her introduce herself in just a minute, from the American Academy of Pediatrics.
Then, we are going to go into sort of an open-mike session, and then the committee will finish up by just sort of a discussion or a reflection on lessons learned today.
Now, as commented, we do start tomorrow morning again at 8:30 in the morning with the expectations that well be done by 12:30, and, hopefully, be able to - at that point, well be talking about next steps and all of that. Okay?
Okay. With that, Jeanie, would you like to introduce yourself and -
DR. MARKUS: Thank you.
My name is Eugenia Markus. I am a practicing pediatrician from Newton, Massachusetts. I am a past president of the Massachusetts Branch of the American Academy of Pediatrics, and I currently serve on the Executive Committee of the Steering Committee on Clinical Information Technology for the Academy nationally.
I have been practice for over 30 years, and I sort of live on the edge of using a lot of technologies in my office, including an electronic medical record, and I do e-prescribing from the EMR platform. The vendor product that I use in my office is Nextgen(?) and I have helped them a lot with development stuff, so that it will work very well for pediatrics.
There is written testimony from the Academy which goes into some background on safety issues and the impact of e-prescribing on pediatrics, but there is the - one take-home message that I would like to deliver from the Academy is that, please consider children from the beginning and meet all the needs that children - that pediatricians need to be able to write prescriptions safely for children. The needs are different from adults, and, too often, pediatricians are given the products that have been designed for adults and then have to make modifications and often those modifications dont work.
The other thing that we would like to leave you with is to involve a clinician, an end user right from the beginning in terms of the design. People who write prescriptions every day, because there are so many nuances in terms of dealing with prescriptions and the different things you have to do for different items that only people who do it every single day will be able to contribute, and we think that this will bring you faster to a more successful conclusion.
So those are some of the main points that I wanted to make, but I wanted to also let you know about some of the things that are different for children. For instance, you need to be able to track in the demographics not only the childs name, but the parents name, and the parents name may be different than the childs name, and the child may live at the residence of one parent or another, if the parents are split, and each parent may be filling prescriptions for the same child at a different pharmacy, sometimes even in different states. In Massachusetts, where the states are so close together, it is not unusual to get phone calls from pharmacies in New Hampshire about our patients in Massachusetts or otherwise. So that the parents can have different addresses, different names from the child and so you need to be able to verify all of this, so you can tie it altogether.
You need to know the weight of the child and the date at which this weight was taken. Childrens medications are often prescribed in milligrams per kilograms of body weight or ML per kilo of body weight, and without that information, you cannot give an accurate amount, so -
And the other thing that is very important is having the age of the child, so a birth date and a calculation of the age of the child on the prescription, so that the pediatrician can look at it and say, okay, pick out the right one.
But the other thing is that within the code of the product should be written a range. So, for instance, if the total amount of the medication per day is out of range for the weight of that child, youll be able to see that right away. So, for instance, you wouldnt be able to write a prescription for 10 times the amount that the child could safely get for that weight and that age, and, you know, the program that I use actually does that. I can check the dosage and itll say that, you know, this is the range for that child, and if I write for more than that, Ill get an alert to say that there is an error here and you need to go back and correct it.
The software should do the same kinds of things that it does for adults, which is to do drug allergy checking, drug interactions and drug diagnosis checking as well to - and also the other thing is drug food interactions, which is pretty important in kids.
The other thing is that some medicines are not approved by the FDA for use in children under particular ages, and there are certain medications that we just dont use under a certain age, like, for instance, a tetracycline prescription is almost never used under the age of eight because it interferes with bone development. So that if somebody were to write a tetracycline prescription for a six year old, they should get an alert that this might not be an appropriate choice, but it shouldnt prevent them from writing that, because, you know, the child may have some particularly serious illness for which tetracycline is the drug of choice, and so you make a risk-benefit decision there and you should be able to override the alerts when it is necessary.
Also, you have to be able to put the diagnosis on there, because, at least for controlled substances, in Massachusetts, the diagnosis of attention deficit disorder or hyperactivity disorder has to be on the prescription before it can be filled. So there should be a way of tying that diagnosis to that.
Also, we need to have the capacity to be able to write in fractions of a pill or fractions of an ML like a half a teaspoon or .3 ML of something. So, for instance, in the product that I use, when I have to write the sig, a number pad comes up, so that I can put in whatever amount I actually need and just pick it off the number pad.
There also needs to be a note section, so that the pediatrician can communicate with the pharmacist electronically if there are some special circumstances. Like, for instances, theres some liquid medications that once you mix them up, they have a short shelf life. Like a bottle of amoxicillin, after two weeks, starts to lose its potency, and, for instance, we are treating a lot of lyme disease right now in Massachusetts, which the recommendation is for three weeks of medicine. So you need two bottles of amoxicillin to get through the three weeks, and the parent cant pick that up all at once. Well, but Im going away, and I am not going to be there to get the second bottle at the same pharmacy, and so there is a solution to this. We just tell them to dispense the second bottle dry and in an additional bottle put in the right amount of water for - to mix it up, and then when the parent needs it, they just mix them together and they now have the second bottle of antibiotic to finish the course of treatment, even though they are visiting grandma in California now. That happens every day or - you know - several times a week, I should say. At least this is summertime. So that using the notes section on the prescription is really important.
Also, having the formulary from that patients insurance come up or a way of checking the medication against that is pretty important, but it shouldnt prevent you from making other choices if the medication you need is not on formulary.
And also the prescription should be able to be sent to the pharmacy electronically, including electronic signature and contact information for the prescriber, so that the medicine is ready when the patient is there to pick it up. That is a huge, huge patient pleaser. You mean itll be ready? I dont have to wait at the pharmacy? Oh, my gosh, they are thrilled, and also there are programs that can be used prospectively to track errors and that is important.
The other thing is there needs to be some software - and my software doesnt have this yet - an ability to recall a prescription. Right now, if we make a mistake on a prescription and we hit that send button too quickly, I have to call them and say, you know, you are going to pick up a prescription on Joey, and, you know, it was really intended for Stevie, forget it, you know, we made a mistake.
One of my colleagues actually has a whole talk on errors that happen with electronic things, because you have pick lists, but you can pick the wrong thing off of a pick list or you can - you know - you can sit down to write a prescription, and if you didnt make sure you were in the right electronic chart, you could write the prescription in a different patients chart and then you need to go back and undo it, and these are some of the things that happen in real time, and so to have a way of recalling a prescription electronically would be useful. Now, we have to pick up the phone and talk to the pharmacist about that.
We have one compounding pharmacy in the area where I work, and that actually doesnt pose a lot of difficulty for us, because if we need to use the compounding pharmacist, the prescription is so specific that I call them and I discuss it with them, because we do have some reluctant participants who are tough customers in terms of giving medicine, and theyll only take anything if it has peanut-butter flavor and the stuff comes in raspberry flavor, so you have to accommodate them, and it is better to spend the money - because one mom came back and she says, do you know how much that prescription cost? It was $100, and it wasnt covered because they are not covered - the compounding pharmacy. I said, yes, but he took it, didnt he? Yes, he took it.
So those are specialized situations. I dont think - they are sufficiently specialized that I dont think you really need to deal with that thing, and, on a lighter note, the compounding pharmacy also does things in tuna, liver, chicken - because they are - they have another market of reluctant participants, which is the veterinary profession. (Laughter). Have you have ever tried to put a pill down the throat of a German Shepard? Youll be very happy for the tuna-flavored medication.
So one of the biggest barriers that I see, though, is that most of my colleagues offices are not connected. They dont - and the other thing is dont try to do this on a dial-up. It will drive you crazy. I couldnt stand it, and we were just using the EMR, printing off the prescriptions and handing them to the patient. We werent - this was before the electronic transmission, because I have been doing this, you know, writing it in the EMR for a long time, and then we started faxing them, and the thing is that if you have to wait for a dial-up connection to send off a prescription, you will go nuts as a clinician. Youve got to move on to the next patient. You want to make sure that the prescription is out. What happens - my system is in transition right now. It is still faxing, but it batches the prescriptions, and then it dials out and it does it and I dont see it anymore. I am on to the next patient, probably, before my computer system makes that connection to the pharmacy, but Next Gen(?) is about to finish their contract with SureScripts, I think, and then itll go electronically, which will be a lot easier.
The kids are actually somewhat disappointed about this system, because before they leave the office, they start to negotiate for what else they are going to get at the pharmacy, and when there is no time to stop at the pharmacy or some of the pharmacies now have pick-up windows, so that they dont even have to get out of the car. The parents love it, but the kids are not so keen on that.
So that is what I have to share with you from the trenches and from the needs of the pediatrician, and so, please, the take-home message is consider the kids right from the beginning, write the standards so that pediatricians will be able to use it without having to make major modifications.
DR. COHN: Well, thank you very much. I am actually an emergency physician, and so the memories of the multiple flavors of amoxicillin are - but, actually, I have always been very thankful for chewable amoxicillin -
DR. MARKUS: Yes.
DR. COHN: - which has - been very thankful.
Stan, did you have a question?
DR. HUFF: Well, I wondered if you or Lynne Gilbertson could comment on how many of these requirements are already accommodated in NCPDP script?
MS. GILBERTSON: I didnt write them all down. I know there is free text available, which I would assume could be used for the notes. Lets see. We have height and weight, so we could get that kind of information on the patient.
DR. HUFF: Track the parents name as well as the childs name?
MS. GILBERTSON: That would be translated to the cardholder information perhaps, and, lets see. We had drug information.
SPEAKER: (Off mike).
MS. GILBERTSON: Yes, Ill hit that one next.
SPEAKER: (Off mike).
MS. GILBERTSON: That is all in there, yes.
And the other one is the standard supports the canceling of a prescription, so it is a matter of probably implementation in the system, but, yes, we recognize there might be some oops-es and backouts that would need to be done. Did I miss anything?
As far as the drug and the dosing and - I think all that is in there based on what the physician would choose.
SPEAKER: The date the height and weight were taken.
MS. GILBERTSON: It is measurement, date and time. So I think that is already covered. Yes.
DR. MARKUS: And you can do fractions of medications?
MS. GILBERTSON: Could you pull those off databases? Fractions or give instructions for the fractions?
MR. BIZZARO: Tom Bizzaro, First Data Bank.
One of the comments I was going to make here today, and Ill make it now is that I wish I was an application designer, because what I have heard here is a list of requirements for the applications that reside in the physicians offices. So can you use fractions? Yes, depending on the design of the system that you decide on to buy. Can you send fractions? Yes, you can, but I think that there is kind of a confusion on what is this committee going to have to mandate as a standard or make recommendations.
I like the term I heard today for the first time as functional standards, so that we can try to give some guidelines on what the committee thinks is appropriate for those different designs that are going to come into your physicians offices, and then I think that what will happen is that the marketplace will make sure that the best designs and those products that meet the customer - in this case, the physician or prescribers - needs will then come to the forefront.
So I guess that I was very encouraged by what I heard today, because I heard groups from a lot of different organizations, organizations who dont, in some cases, have the best relations between the organizations, talking about a lot of the same things. Each of them have a direction they would like to see the committee go, but I think there is a lot of commonality there, but I really think if we can stick to minimum numbers of standards, then the marketplace itself will take care of a lot of the issues that you are talking about, because you cant sell a system to a physician that doesnt work, and I have heard this over and over again, that they are going to be impatient about how fast and how much time it takes them to get that script out the door. That is absolutely true.
I also would like to comment that you folks from Massachusetts are a very active group. (Laughter).
SPEAKER: Yes.
SPEAKER: I thought we sold that state off.
SPEAKER: We tried to yesterday.
DR. COHN: Yes. Okay. Well, thank you, and I think, actually, just in the frame, we, actually, I think, tend to think of things as technical standards, which, of course, at the end of the day is, really, what we want to be able to enable all of this functionality, but, youre right. Functional standards is another bucket, and then we were hearing about policy standards. So, I mean, I think those three frames were probably - at least know what buckets to stick what in.
MR. BIZZARO: And I think the industry is changing. I mean, I made comments to this committee before that I thought it would be very difficult to get retail pharmacy to accept that sixth standard, and we have heard from the committee and we have heard from others the need for a sixth standard, and we heard two very large pharmacy chains today talk about their willingness to work towards a sixth standard, something that may not happen in the very short term, but something that they are now willing to work towards. I find that very encouraging.
DR. COHN: Okay. Other questions or comments on this, before we move to open mike?
Okay. Well, thank you.
DR. MARKUS: Thank you.
DR. COHN: Well, now, this is our period for open mike. I see Bill Braithwaite standing up here.
I apologize to those in the back. I - obviously, Im - you have to come over to the side here, so I can see you, if you want to make comments.
DR. BRAITHWAITE: Hi. Im Bill Braithwaite, and Ive got a whole long list of things, but I just wanted to hit two of the ones that dont seem to be in the discussion, and the first one is the need for ubiquitous, secure connectivity across the healthcare field. You cant do everything on a point-to-point, virtual, private network, which is kind of the way things work now. We have to enable the internet connectivity between every player in the healthcare organization to every other player in the healthcare organization, and that is going to take a lot of work and a lot of standards that are not really adopted yet. So that is my technical standard point.
The other comment is many of the workflow assumptions that the people who have been discussing e-prescribing here are leaving out the patient. No, I shouldnt say that. They are leaving out patient choice or they are constricting patient choice. Right now, the doctor talks to the patient, writes a script on a piece of paper, hands it to the patient. The patient goes home and tears it up or they decide later what pharmacy it is going to go to or they send it in to their mail-order pharmacy, and we are forcing the patient, a) to choose the pharmacy in the doctors office, before they have had a chance to really think about it, because the system requires it, b) you gotta know that the pharmacist is going to have this waiting for you even if you dont really want to pick it up, and you dont want to tell the doctor that you dont want to pick it up, because that would affront someone who you have built a relationship with, and, you know, patients dont like to tell bad things to their doctors. In fact, they dont like the idea that the doctor is going to find out that they never went and picked up this prescription or that they never refilled it, because we are taking away a privacy concept from the patient. We are interfering with their relationship with a physician in a way that people might not be appreciating.
So I would just encourage that in the future, as you look through these workflows of how data flows, be very careful about where the patients thought process is involved in, where the physical things the patient does now involve decisions that we are not allowing anymore.
Thanks.
DR. COHN: Well, it sounds like we should at least allow the people to print these things out manually and hand it to them if they -
SPEAKER: And you can.
DR. COHN: I know, and I know. I know.
Karen.
MS. TRUDEL: That was my question, if you have an option to allow the patient to say, I dont want it to go to a pharmacy, just print it out and Ill take it with me, does that meet your requirement?
DR. BRAITHWAITE: Well, it can. I think the idea of printing out a prescription and letting the patient take it to whatever pharmacy or none that they want to is wonderful, but it better be bar coded so that when it gets to the pharmacy, you dont have to reenter anything all over again. It ought to be automatically readable, so the prescription gets entered from the paper into their system without error. Okay?
And, then, maybe talk to the patient about the idea that the pharmacy is going to report back to the doctor about when they picked it up and when they refilled it and stuff like that, and maybe the patient should be given a choice about that.
MS. TRUDEL: Okay. One more question, the notion about the ubiquitous interoperable access to the internet, et cetera, who can disagree with that, but if that is the perfect, what is the good? Because that does take a long time and it does take a lot of resources and a lot of standards, and, I mean, we found when we did HIPAA that a lot of people dont have internet-enabled offices right now. So what would be the good that we could move forward with soon?
DR. BRAITHWAITE: Well, I cant imagine an office in any location today that can get connected to a pharmacy virtual network that cant get connected to the internet. Theres lots of ways to get connected to the internet, and some of them are expensive and some of them are cheap, and some of them are fast and some of them are slow, but the opportunity and the options for connecting to the internet are much, much broader than the options for connecting to any other kind of network in this country. So I would say that that question is moot. The real question is what about the security aspect of it?
Now, clearly, as we get into prescriptions, the question which we ducked in the security rule about electronic signatures has to be raised, because it is a requirement for certain prescriptions, if not all. So that has to be dealt with, and if you have to deal with that, then dealing with the security of communications over the internet, which means they have to be encrypted, is something you can do today. It is not a big deal. You can buy a system today for almost nothing, and, in fact, doctors can get them for free, for encrypting email communications. So it is not that big a deal.
The difficult part of it is authentication when you are dealing with one person talking to a bunch of others out there. How do you know who you are sending an email to is really the person you are intending to send it to? And that is not just a healthcare problem. I would say a broad problem across government and industry that hasnt been solved in a cost-effective way that could be implemented in healthcare, and I hate to see healthcare have to stand out and say, look, we need it now, and we are going to have to find a way to bring it together and make it work, and all the other industries will follow healthcare. That doesnt seem right, but we are at that point now.
MS. TRUDEL: Okay. Thanks.
DR. COHN: Just a general comment, that, obviously, we are going to be looking harder at security as well as that whole issue of authentication in October. So that area has not been forgotten.
Oh, I thought that one of you were going to comment, and I think you are next - okay - after that.
DR. COHN: Okay.
MR. BECKLEY: Im Bob Beckley with SureScripts.
I agree with the comments about the need for security and stuff, but they are in place now. They are being put in place. People are using the internet. They are using secure connectivity. They are using encryption, HTTPS, you know, SSL technology, VPN networks over internet. Those are all secure. They are all encrypted. I believe they are covered as part of the HIPAA security piece. So there is quite a bit already being used.
And I agree with you on the internet. There is no excuse for it anymore, not having the internet, but we are seeing more and more. So I dont know if a standard needs to be dictated. I think a level of security may need to be dictated, but that may be - that is already kind of covered under the security in HIPAA. So it is there.
And as far as the routing goes, that is what, again, I think the industry has stepped up and addressed. In talking from our personal experience at SureScripts acting as a deliverer of messages, when a message comes in, we have a unique identifier, and we know that identifier has to come in on a certain portal, and if it doesnt come in on that portal and it is not the identifier that we know, then that message is dropped, and, you know, alarms go off, and then we check to where it is going, and we ensure that it is delivered to the right location, again, based upon unique identifiers and portals they go out on.
So the routing mechanisms, the industry is addressing those and making it more and more secure all the time using current - very current technology, the technology that is available to address those issues, and, in some places, the point-to-point lines are still used, because people are just more comfortable with them or they already have them in place, and it is cheaper to use the existing bandwidth and put something else in.
But I agree. The security is needed. There is no excuse for internet anymore, but the industry is addressing those, that, I mean, when - whether it is a pharmacy provider or a prescribing partner comes to us and says we want to hook up, we sit down and we go through all the technical things and all the security has to be in place and how we ensure where they are coming from, et cetera.
So I think the industry is addressing those issues. They are all valid, but I think there is progress being made, which is my message. The industry is stepping forward. So I think it is covered, for the most part, under security right now, the current security rules that are out there under HIPAA. Okay? Thank you.
DR. COHN: Thats good - Did you have a question?
MS. WARREN: Yes, from the comment of access to the internet, it just occurred to me, in Kansas we are beginning to have -
MR. BLAIR: Would you identify yourself?
MS. WARREN: This is Judy. (Laughter). You just never recognize my voice.
MR. BLAIR: Its just a voice. I couldnt tell.
MS. WARREN: I must change it every time.
MR. BLAIR: Yes, and I know who Judy is.
MS. WARREN: I know. I am going to start making funny voices.
One of the problems we are having in Kansas is part of our state is still classified as a frontier level, and so there are -
SPEAKER: What does that mean?
MS. WARREN: That means that there arent very many people per square mile. I mean, there is urban, suburban, rural and frontier status levels of population per square mile, and in some of the western states, we have frontier status, which means theres probably more cows than there are people, probably more veterinarians than there are physicians, but access to the internet there, in some areas, they still dont have it, and if they do, it is only through a dial-up, and so it is difficult. So I think probably we need to pay attention. Im not sure that effects too many physicians, but, as we start putting these things into place, I am sure there are Medicare patients that live out in very rural areas, especially in states like Kansas, Nebraska, Wyoming, where their populations are fairly elderly.
DR. COHN: Yes, well, you know, I think our previous panel could advise us on satellite technology.
MS. WARREN: There you go. (Laughter). Well have to see if they have Walgreens up or WalMart.
DR. COHN: I think that actually a lot of that is moving very rapidly, seriously, just in the sense of wireless technology, but I think it is something well need to keep an eye on.
Yes.
MR. SHEATH: My name is Tony Sheath(?), and I introduced myself yesterday, but I am going to refresh - for the folks in the audience, I am going to refresh that, and I am also - for the people on the internet. So my name is Tony Sheath. I am managing partner of Point of Care Partners. I have been in electronic prescribing for more than 10 years.
In the mid-1990s, I was a product manager for an e-prescribing application that was built on DOS. The gentleman, Mike Simko from Walgreens, talked about another product that they had prescribed that was not the one I worked for. We competed with them. So we were two of the sort of pioneers in e-prescribing, and then I worked for five years for Medco Health Solutions.
My consulting practice, I - well, over the last 10 years, I have been employed by just about every stakeholder that we have in this room today, whether directly employed or as a consultant. So I am speaking on this from a level of sort of experience, and what I want to do is I want to make two points of references, and then I want to make a recommendation.
My first point of reference is that over the years, you know, there are a lot of barriers that still exist in electronic prescribing, and I want to talk a little about those barriers, but, over the years, we have overcome five incredibly large barriers to e-prescribing, and I want to point out what those are.
In the very early days, we would hear from doctors, look, this is great. Prescribing is really great, but my problem is that I have to take the eye off the patient. Gee, if I had something that was mobile that would be so cool.
So in the late 1990s, when Palm PDAs came out, and, now, e-prescribing in the doctors office is exceptionally mobile. That really overcame an incredible barrier that maybe some people that dont have the history that I have understand, and, also, there has been an issue of workflow flexibility. The doctor would say, I dont want to go back to my office where my computer is and write a prescription. I want to be able to do it in the exam room.
Second thing is that there was an issue in the mid-1990s or late 1990s about formulary, and the issue was the doctor would say, I dont just want one formulary. I want a multi-payer solution, and, today - yesterday, we talked about there are two solutions right now that provide a barrier, and this number we came up with in the late 1990s was that there had to be formulary information for 70 percent of a physicians patients. Okay?
We have two solutions today that do that, the combination of Rx Hub and CAQH, which we talked about yesterday, and Medimedia.
The third thing is that over the years, retail pharmacy - you know - Mr. Simko talked about Walgreens was one of the first players in it. Theres been sort of an ebb and flow where retail was really aggressive about this, and then the physicians office and whatever, and, right now, as a result of Proxy Med, SureScripts, NDC and the ERX networks, you know, weve got, I think, the latest number is 55 percent or more of retail pharmacies that are participating.
The fourth thing is there have been challenges of state boards of pharmacy rules and regulations, and, yesterday, when the folks - when Carmen Catizone was here, he talked about - and if you look at that list, 48 of the 50 states now allow the electronic prescribing.
And the fifth thing was medical history, and it wasnt so much a barrier, but everyone would say, in the early days of e-prescribing, gosh, if I only knew the history for the patient, I would start using electronic prescribing, just for that reason, and give a lot of credit to Rx Hub for being able to provide that to the e-prescribing solutions.
I am saying all this, and I have a point. My point is we still have a number of barriers in electronic prescribing, and as we think about standards, my point is I think that there needs to be prioritization based on those that will overcome barriers - the huge barriers that exist in prescribing today.
At your last round of testimony, one of the presenters made the point that, look, we have worked around not having standards. Our challenge right now is adoption and utilization, and I would concur with that, to a degree. I definitely think there needs to be standards, and I think standards can address challenges with adoption and utilization, and I am going to - in a minute, I am going to give my personal recommendations for the five standards that will aggressively address barriers that still exist in the marketplace, but there is one other point of reference that I would like to make, and I read the testimony, both what Dr. Teich(?) gave to you guys, what you had last time, and I have sat through the last two days, and I am not sure anyones ever made this point of reference. Electronic prescribing - a doctor can write a prescription electronically in three broad categories of solutions today. One is electronic health record CPRs. There are a number of different names for those. The second is CPOE or computerized physician order entry solutions, and the third I am going to call e-prescribing solutions. These are point-of-care applications that they dont just do e-prescribing. They do many different things.
CPR or EHR adoption, right now, is a new one from 14 to 39 percent, and my reference point for that is a study that Dr. Brailor(?) did for the California Healthcare Foundation. He looked at a number of different studies on electronic health record adoption and his - it ranged from 14 to 18 percent of adoption.
CPOE adoption right now is four percent, and my reference for that is KLAS, the consulting firm. They did a research study and this was recently published at the Tepper(?) Conference.
There is no definitive - you know, how many companies are doing e-prescribing? There is no definitive number. As a consultant that works in this business, I am going to tell you that it is somewhere around two to five percent of doctors in the country are using handheld devices or e-prescribing-only types of solutions. What we have here is not a lot of adoption, because, even though we have overcome five key barriers, there still exists barriers in the marketplace.
Now, I think my recommendation or my opinion is that the number one barrier right now is lack of adoption. It is a conundrum - okay? - and I think that the way to address that, in my opinion, is - are things that I dont think are the responsibility of this task group or this committee, incentives for utilization and assistance in purchasing.
If you go back to the three different categories where a doctor can prescribe electronically, in electronic health records, I am going to argue that the biggest challenge with EHRs is adoption, not utilization. With CPOE, they have both utilization and adoption challenges, and the e-prescribing systems, they dont have as much of a challenge with adoption as they do with utilization. This is an observation based on my personal experience, and let me elaborate for a second.
With electronic health records, the cost of an electronic health record - and this, again, goes back to Dr. Brailors report. Im quoting from there - is anywhere from 20,000 to 50,000 per physician per year in the first year. It is a substantial investment that doctors need to make.
Once they have made that investment and they have gone through the process of being trained in using the system, utilization isnt an issue. So I think my observation is that, over the course of discussion about this, there has been a little bit of a skew towards electronic health records and adoption. Adoption certainly is an issue with electronic health records, but once they adopt, once they make the decision to purchase, to make that sort of an investment, by gosh, the leaders in the practice - whether it is a one-doc or a two-doc group or its a 14- or a 50-doc group, they are going to make sure every doctor uses. That is my experience.
Electronic prescribing solutions, they dont have as much of a challenge getting an adoption, because, very often, they find somebody that is willing to sort of pay for the solution for a doctor for one year and give it to them for free, and so the doctor says, sure, Ill give that a try. Why not?
But, then, once they get the solution, sometimes you have trouble getting them trained, sometimes because they dont associate any value to something that they have just gotten for free. So sometimes you have trouble getting them trained, and, oftentimes, what happens is they start using - a founder of one of the companies that is still in existence today says, if I can get a doctor to write 50 scripts, Ive got him hooked, but the problem is I can never get - oftentimes - sometimes, I cant get the 50 scripts. Why? Because something comes up. One of these barriers that I am about to talk to comes up that discourages the doctor and they put it down and they never pick it back up. So the electronic prescribing solutions have a big problem with utilization.
Now, in my opinion, the top five things that you, as an organization, can do to address barriers are the following:
Number one, I strongly agree with the adoption of NCPDP script, HL7 orders and the crosswalk between them, and I commend - you know, I know Pfizer had something to do with the group getting together and the folks from HL7 and NCPDP have worked together. That is my first recommendation.
My second recommendation is, as I talked about yesterday, I think it is absolutely critical that there be interfaces between the practice-management system and the e-prescribing or electronic health-records solutions. There is no need - I think theres no need to build another standard. HL7 is a standard that is used by some of those. It is a cottage industry, as Mr. Reynolds talked about earlier, and I think thats number - my second recommendation.
My third recommendation was brought up today. I strongly believe that there needs to be MMA preemption, because I really think that the challenges of understanding laws - board-of-pharmacy laws in different states is still a barrier for the e-prescribing companies.
My fourth recommendation - and this goes, I think, to the EMR challenges, and that is it is important that there be standards that - HL7 standards for the systems in the hospitals who the electronic medical record companies interface with, laboratory systems, the radiology systems, those kinds of things. I think that is a - I would place that as number four.
And then my fifth priority would be the identifiers that Dr. McDonald talked about yesterday. He talked about patient identifiers, prescriber identifiers, SIG, insurance-company and plan identifiers and drug identifiers, and I know that is kind of at a high level. I am not going to go granular, but I strongly agree with Dr. McDonald that once those things are in place, everything follows from there.
So I thank you for your time, but I wanted to get that opinion in.
MR. REYNOLDS: You say what number four was again?
MR. SHEATH: I gotta look.
DR. COHN: I think it was HL7 standards in the hospital.
MR. SHEATH: With hospital systems. The electronic medical record companies. Thats a real challenge for them.
DR. COHN: Thank you.
Other questions before -
As I commented yesterday, we do appreciate all the expertise with us here to help make decisions.
MR. SHEATH: Thank you.
DR. COHN: Okay. Thank you.
Other comments from the audience? I think - didnt you have your - Okay. Ross.
MR. MARTIN: Thank you.
I apologize, first, in advance, for missing the afternoon. I had another meeting I had to attend, and I just got back. So -
DR. COHN: Ross, you need to introduce yourself.
MR. MARTIN: Im sorry. This is Ross Martin from Pfizer. I provided some testimony earlier in support of Peter Grant, and I just wanted to touch on one issue that was brought up during the PBM discussion that we didnt touch on in any detail during our Q&A that I would like to just kind of respond to.
Basically, it is page 27 in the hymnal of the PBM presentation about prior authorization, because I thought they brought up some interesting points that I am still not convinced - they have not convinced me that this is the onerous burden and unnecessary standard that needs to be applied to this about trying to - at a level - automate this process, so that it doesnt become an obstructive burden.
In fact, some of the comments sort of reinforced my thinking about how it is used more as a tool to obstruct behavior than it is to really be a tool about making sure that the right thing is done clinically, not that they are trying to make the wrong thing happen clinically, but they are using the process itself as the barrier to going down that route, that you really have to have a huge amount of pain to need an expensive medication, and that is the only way you are going to go through this burdensome process to get what you need, and just using the example that they brought here, which was the growth-hormone-therapy 11-step process for prior authorization. Looking at the process, I dont necessarily disagree - I am not a pediatric endocrinologist, so I cant speak with some authority, but I would imagine that a pediatric endocrinologist was consulted in the development of this profile in this prior authorization step, and it looks reasonable from that perspective. It is a clinical guideline about when you should be using this. I am assuming that. Lets just make that assumption.
There is, it looks to me, like branching logic, which can be structured, which can be codified, and, in fact, I would submit that if you are asking a question of a prior authorization that could not be codified according to an HL7 or HL7-supported controlled vocabulary, you are probably asking something of a clinician that you really dont have an appropriate role to ask them clinically, if you cant articulate it in a structured way. I think that that really does get complicated, and that gets pretty unreasonable.
So, ultimately, all of these things are yes or no questions of, yes, data points that are a little bit complicated, but they are structurable, and you can at least do that.
Further, I would assert that, at the minimum, you could have - here is one example. You could take this whole thing, give it to the doctor and say, do you assert that you qualify, that your patient meets this criteria, and say, with the click of a box, yes. That is asked and answered.
Now, that is something that could be - just like they are asking about audit trails, they are saying, dont - you know - lets not look for digital signatures - and I agree with this - lets not try to create some - you know - public/private key authentication infrastructure necessarily. We can use the e-prescribing system itself to be an auditable, verifiable structure that will help with the authentication and the reliability of the signature of a doctor. Okay? Lets do the same thing with this. Lets make sure that a doctor who checked that box, who happens to be a pediatric endocrinologist who knows something about this subject can click that box and say, yes, I have looked at this. I have reviewed the prior authorization responsibility, and I agree, and that is the conversation that happens, and then follow up with it, and if they have - you know - done bad behavior at some point or if they are prescribing out of the norm of a - maybe a doctor who is specializing in stature problems would do, then you do what you would do with anybody. You would confront them with bad clinical practice, but that conversation, I think, in honor of the doctors many years of training, should be something like that and a lot less like a conversation with some person on the other end who is looking at a computer, who is going through this question set, who probably has no idea what - you know, they would look at one of these things and say, you know, what is an epiphosial(?) growth? You know, they may not even know how to say the word in the guideline, but theyll read the thing and theyll say, yes, and - okay. This branches to the next question, and theyll ask the next question, and that 20-to-30 minute process will be the thing that is obstructionary.
So in support of Jeffs earlier comment about how - he wants to find that balance. Yes, there are going to be things that are very complicated that you really cant do with the click of a button, but I would submit that if we dont at least deal with the ones like the H2 blockers for pediatrics, where you say, is this somebody who cant swallow a pill? And you say, yes. That is the only question you really need to know. That is why they need the syrup that is available only by prescription, as opposed to something over the counter. Those we should be able to do, and if we cant do those, I really think we are missing the point of what we are trying to do about efficiency and supporting that.
So does that make sense? Im seeing some nods and Im - It doesnt make sense to Mary. (Laughter). I was kind of hoping Phil would come up, just because we have had such a great exchange over the last couple of months, but -
DR. FITZMAURICE: Ross, I must say that when they went through that example, I was thinking that is what I go through when I get automobile insurance, when I try to get to a lot of places, press one, press two, press three, and that is what a computer is for, have somebody - and I would have changed it to say, does the medical record show this? Does the medical record show this? So that that is something that is auditable.
MR. MARTIN: Thats right, and, ultimately, a lot of those things, as they are codable, when we get to this next level, the doctor will not have a PA required little icon next to the drug. Itll say, PA fulfilled, meaning that it checked the electronic medical record and confirmed that all these assertions are true, and, therefore, all you need to do is say, I prescribe this, and the correct clinical information will go along with it.
Now, obviously, we are not there yet, but that is what you build toward, and you are right. I wouldnt have any problem if this 11-step thing were a flow chart that the doctor went through, because I think, for very complicated prescribing that you would need to do that. I would say that there should be some sort of standards about what percentage of your overall formulary requires it and is it becoming an undue burden, and what is the time requirements? How long does it take? That is what I would suggest.
DR. COHN: Okay. And it looks like you have a comment -
MS. CRONIN: I would just like to also briefly comment while she is coming up.
DR. COHN: Sure.
MS. CRONIN: I think there are going to -
MR. BLAIR: For my benefit, could you just tell me who you are?
MS. CRONIN: Oh, sorry. Its Kelly Cronin.
I think there probably will continue to be very grey areas like beta serin or one of the beta interferons for progressive versus relapsing and remitting MS. May be very difficult to tell the difference between those two conditions, and it may be difficult to even come up with an algorithm to make that determination or a series of questions. So there might be some complexity that could only be really determined through either conversation or some kind of joint clinical judgment.
MS. RYAN: This is Mary Ryan from Medco.
Yes, there are those kinds, but I want to clarify. We dont object at all to codifying these things and making them part of the electronic prescribing system. What we are saying is that they are complicated and they are not there now, and we would rather you didnt delay standards or require this as part of Phase One, because we want to get electronic prescribing adopted now, and it is - right now, I believe it is under two percent of the prescriptions fall under these prior-authorization types of categories. So for two percent are we going to delay the adoption of standards? I think that is an inappropriate thing to do. So that is - we dont disagree with Ross. That is the point I am making, that we should have these more codified and able to do electronically, but they are not there now, and rather than delay everything, we would like to see us go forward and do them at some point when it is more appropriate.
MR. BLAIR: One thing - and I dont know the answer to this question, but it occurs to me when you say two percent, I dont know whether two percent is a reflection of how difficult it is to go through the preauthorization process or not.
MS. RYAN: Well, it is two percent of the prescriptions, approximately, and that is a number that I havent validated, so let me just say that, but it is approximate. It is not, by far, the majority of the drugs - the majority of the - in the 98 percent plus level are just simply formulary or non-formulary drugs are not - they dont require any kind of special decision making, other than if a pharmacist or physician wishes to protest the benefit level, in other words, take a non-formulary drug and move it up into another tier. When I say non-formulary, I mean a non-preferred drug.
DR. FITZMAURICE: But you know the flip side to some of this is that lets not do it now. Lets wait, and then you wait and say, well, now, weve got our legacy systems all built up, and we cant put the functionality in because we would have to change all these variables.
MS. RYAN: Understood, yes.
DR. FITZMAURICE: So theres balancing that has to go on.
MS. RYAN: I understand that.
DR. STEINDEL: Yes, and I think the question that Jeff is asking is when you quote a number like two percent, that is two percent of the prescriptions that are dispensed.
MS. RYAN: Right.
DR. STEINDEL: That doesnt necessarily represent the end percent that has not gone through the process, because they feel the process is too burdensome.
MR. BLAIR: Yes, for example, maybe if it was automated, maybe it would be five percent or 10 percent or 15 percent. We just dont know what the answer is.
MS. RYAN: It also is probably less than two percent in that two percent are those of - the prescriptions that are dispensed, and you only go through the process one time. So the actually process only happens the first time the prescription is prescribed.
MR. MARTIN: I just want to be clear that I am not suggesting that we delay the implementation of electronic prescribing until we get this problem solved. I do think that weve got a number of basic building blocks that are working today, and I think our testimony reflects that as well.
I agree with your questions, though, about where will it lead in terms of level of prior authorization, and I would fully expect that when we automate prior authorization that prior authorization - the percentage of drugs requiring prior authorization will actually increase, which, if it is done in an appropriate clinical way where there is a lot of transparency about what those rules are and they are based on generally-accepted clinical practice and not on the rebate scheme or whatever it might be, then that is - and it is not an undue burden on the doctor while they are doing it, that is a great thing, because it is strengthening the likelihood that somebody is going to be practicing according to a generally-accepted best practice, and so I dont think - it sounds like we are going to need a group hug after this thing - (laughter) - because I dont think we are in that much disagreement.
I did, however, hear different kinds of objections from some of the other PBMs previously, but they specifically wanted it to be a little bit of an obstruction and they didnt want any control over the structure of a formulary, and this is what I am suggesting is that this is part of the structure of the formulary.
DR. COHN: Well, and I guess what one has to observe is that probably there needs to be work on a standard to support all of that, though, certainly, there are probably low-hanging fruit thats simple. We have heard that there is a fair amount of complexity, and I think Kelly came up with one example of something that was probably very painful and you really would not want to handle in just a routine fashion.
I guess I am sort of - I find myself struggling a little bit only because I think it is sort of like the exception seems to have become the focus of all of our conversation.
I do know that, obviously, pre-authorization, one hopes, is a relatively unusual occurrence, but, you know, it seems to me sort of odd that we seem to be leading with decision support in terms of enabling preauthorization as opposed to I think what I always saw as the vision of e-prescribing that it would help physicians find the best, most cost-effective medication, help enable the Medicare program to live long beyond its current date for becoming - going into financial problems.
SPEAKER: So when do we get there?
DR. COHN: Yes, so we all can use it when we need it, and so I just wanted to keep in mind that the point of e-prescribing is to not enable everything to happen easily. It is really to try to make everything that is appropriate happen easily.
MR. MARTIN: But please understand that that burdensome, inefficient process costs us money, and that is a cost savings that, no, it is not about the PBM benefit, but that doctors time, in terms of the amount of time that they are able to churn through patients, and so the overhead is allocated to every patient they see. It is part of the cost of healthcare.
DR. COHN: Well, that is true, but I think - I have been reflecting that theres a number of costs of healthcare, and I think, once again, we, unfortunately, dont have the stats with us here, but there is the cost of dealing with preauthorization. There is also costs to the whole healthcare system of inappropriate prescribing. So, I mean, we sort of need to see - and see where the focus should go on this one.
But, as I say, I am not saying that we should not try to deal with the low-hanging fruit on this one.
MS. RYAN: Just to make a quick point, too, prior authorization drugs are not on the formulary. Formularies are generally tiered. They are covered drugs and they either have one copay level or another. They are not drugs that require prior authorization. Those drugs are not covered at all. They are exception drugs, and that is why I say they are significantly small amounts.
DR. COHN: Sure, and, as I say, all this stuff, I am really not disagreeing with you, Ross. I am just concerned that this issue seems to have taken over-
DR. STEINDEL: Simon, if I can make an observation, I, unfortunately, had to miss a large portion of the PBM discussion this morning, and it was the first time I have looked at that algorithm, but when Ross pointed us to that page, my immediate comment to myself was we are talking about a decision-support algorithm. We are using it for the area of preauthorization, but we have already identified the need for decision-support algorithm standards. So we can move decision-support rules between systems, and I think that has been generally implemented.
I think Kelly pointed out at one time that we are starting - that we are going to have a meeting on that some time really soon, if I recall correctly, but this is something that has been identified, and to move the whole EHR system forward, we are going to have to do that, and if we can ride preauthorization as part of that, great.
MS. CRONIN: Yes, I mean, I dont know that it has been specifically talked about in terms of including it in the scope of the discussion that will likely take place on September 9th in San Francisco as a part of the Med Info meeting, but it is - given the attention today, it might be good to put it in scope.
DR. COHN: Please.
MS. WADE: If I can just comment - Donna Wade(?) from Medco - how, as Mary said, we have no issues with standards, but I dont think we should standardize how clients or PBMs look at and the decision support algorithm they ask a physician to go through when looking at a particular product, because different clients may want it to be a tighter algorithm than others, because prior auth is really a client-based program. It differs by client by the drugs that they decide to put prior auth as a requirement for. So you can standardize the process in being able to put it in place, but you shouldnt - I guess I wouldnt expect that there would be standards around what kinds of questions would be part of every algorithm, because that may be unique to each individual client and what they decide to do, potentially, all based on clinical guidelines, but some may be tighter and others may be looser than others.
DR. COHN: Thank you very much.
Did you have a comment or do you want to -
DR. HUFF: I have a question.
DR. COHN: Sure, please.
DR. HUFF: There were proposed that - you know - on the diagram from the presentations this morning, there were proposals of standards from Rx Hub that we should adopt, and I wondered if those are identified specifically somewhere else; that is, so that there is a name and a version number and whether people could tell us how we could access those if we just wanted to review them.
DR. STEINDEL: Stan, I have asked Rx Hub if they would make it available to the subcommittee for review. I think they have agreed.
SPEAKER: Yes, we plan to send it. Well probably send it to Maria -
DR. HUFF: Is it a single standard or a series of standards and - I mean, if we got to a point where we wanted to recommend them, then we need to know - identify them appropriately.
SPEAKER: So the actual name and the version number and however you track version numbers and that sort of stuff, along with - yes, and I would love to see the content.
SPEAKER: Yes, and well send that to Maria as well. As we take these standards through the appropriate SDOs, we can also submit our requests to the SDO, so, in the case of NCPDP, it would be called a DURF(?). We can actually submit the information that we are submitting to those organizations to the committee as well, if that would be helpful.
DR. HUFF: Yes, that would be. Thank you.
SPEAKER: Okay. Well plan to do that then.
DR. HUFF: Good. Okay.
MR. BLAIR: Great, and if that could include the status of the implementation guides as well.
SPEAKER: Implementation guides for the SDOs or -
MR. BLAIR: The status of the implementation guides that support each of the Rx Hub standards.
SPEAKER: Within the SDO staff or the -
MR. BLAIR: In other words, which ones have implementation guides and which ones may not and what the status is of those guides if there has been any indication of balloting or whether they have been implemented or whatever.
SPEAKER: Okay. Lynne, are you comfortable with that?
As part of the submission of the request, I would assume that we would also help develop the implementation guide for NCPDPS part of that submitting that standard.
DR. COHN: Yes. Maria.
MS. BYRNE: I may have missed this yesterday, because I was in and out, did you have a time frame for when you are going to submit this to the SDS?
DR. COHN: I dont think this was a yesterday conversation.
MS. BYRNE: (Laughter). Based on Jeffs recommendation today, I will go back to Rx Hub and we will come up with a time frame.
DR. COHN: Okay. Thank you.
Tom Sullivan.
DR. SULLIVAN: Tom Sullivan. Im putting on my hat as a practicing physician, speaking from that perspective.
I just want to make a couple of observations about some of the things that were said.
Prior authorization is a much bigger issue with my Medicaid patients. I think I havent heard a lot about Medicaid today, but Clem McDonald mentioned it yesterday, where he said there wasnt a big deal with the other payers, but with Medicaid, and that certainly is true in my personal experience in Massachusetts. Not only prior authorization, but getting Medicaid to be able to have the funds to participate in formulary aggregation. Again, my personal experience in Massachusetts, even though we have been doing it on paper for eight years, was that it was only a year ago that Medicaid agreed to - that they even had enough funds to do a paper formulary, and even on paper they had to do it in a different format than the other 10 health plans that agreed to participate, and getting them to do it electronically is just like a nightmare.
So I am not saying - I am just saying anything you can do to help the Medicaids of our states would be a big plus.
My second point is I guess - I hesitate to get up and speak at these, because I know there are a lot more experts in this room than I am, but I also want to make a plea as someone who has been involved with organized medicine, particularly in my own state with the Massachusetts Medical Society and heavily with the American Medical Association, I ask you to invite practicing physicians to these kinds of things. We may not know all the standards and the codes and terminology, but we know what the workflow is. We know what our patients represent, what they need, and if we dont know, they let us know and they walk through other physicians.
I have been to a lot of these informatics meetings over the years, and many of the people who get up are real authorities, even physicians, but they often - they dont have very much experience seeing patients. So I just appreciate the opportunity to speak, and Jeanie Markus and I, theres a bunch of us in Massachusetts who, thanks to the New England Journal of Medicine - so keep reading it, for those of you who read it - were able to get together as practicing physicians and talk about these issues that are sort of normally foreign to us, but because we recognize and have a strong commitment to quality and safety and efficiency, we recognize the importance of health information technology and the tools that it is becoming. It is changing the way all of us practice medicine and the way our patients perceive us.
I have actually tried to influence the New England Journal to write articles about that, but they have editorial independence, so - (laughter) - I tread very lightly in that area.
Another specific point I would like to make, we talked about electronic signatures and security and the difficulties surrounding that, and perhaps that is not exactly your purview when you are going to deal with it in September or October, but just to give you an example, once again, as a practicing physician, I am a cardiologist. I have a lot of elderly patients. Unlike Jeanie who is a pediatrician, my patients, in my experience, often die, and carrying them through the dying process and allowing dignity and having them make their choices and alleviating suffering often involves prescribing controlled substances and narcotics and sedatives and being in a hospice program. I mean, most of these are Medicare beneficiaries, and the hoops that we have to jump through to do - you cant do electronic prescribing. I mean, that is basically it.
I represented the AMA for approximately four years, coming down and talking to the DEA about a PKI identifier, something to authenticate controlled substances electronically, and it just isnt happening, and I just dont understand it.
Now, Bill Braithwaite said it is a problem that is bigger than healthcare, and the rest of the industry hasnt attacked it, but, gosh, I have said it to Tommy Thompson, who says, you know, I am impatient. You people arent working fast enough. Well, I throw this ball back in your court. This is something that the DEA and the federal government ought to be able to resolve.
So I wish that you would help that movement to make them move faster, rather than slower. They have been working on this for years. I know they want a biometric identifier. I know theyve got contracts with private companies, but to the extent that you can move them forward on controlled substances, that would be great.
I personally lobbied in my own state to get the state law changed last December to allow electronic prescriptions, but, obviously, we cant do anything about controlled substances. I am glad to hear that 48 of the states allow it now, but there are still problems with each state board of pharmacy. So in spite of the fact that I am sort of intrinsically or genetically against preemption, I think that preemption might be good for our patients and good for the whole industry in terms of model electronic prescribing.
Another comment. We heard lengthy discussion about not putting anything between the doctor and the patient in this relationship, but we also heard that the pharmacist wants to be in there, too, and I am very reluctant, at this point, to go along with sending a diagnosis to every pharmacist and every pharmacy technician in the world. I can see their need to know that, but I would prefer that that is one that they send the message back to me or talk to the patient more or call me, if they need to know what the diagnosis or the problem list is.
I have great hesitations about the expanding need to know and privacy that goes so that every prescription we have for every drug includes a diagnosis.
I think it is great for an internal system, you know, lets say within Kaiser or within the staff model HMO that I was director of for a number of years, where I can control, to some extent, what the pharmacist does with the information that I send him. I have less difficulty with sending them a diagnosis or a problem, but sending it out to the world, I have great difficulty with that.
I heard, I think, Tony say that we have solved the mobility problem. All those doctors love PDAs. Well, I have my PDA, but, frankly, the real estate is just too small. I have been doing this electronic prescribing for well over a year, and I like the desktop, big screen real estate, so dont force - you know, these PDAs with phones, they are like the sizzle, they are not the steak. You know, it is what - you tell a physician they are going to get a free communicator with all the world and they can call their cousins in Africa or whatever, and they say, oh, great. Thats free, you know, but they dont want to write prescriptions on a lot of them.
I go out of my room and I write it on a desktop that is much faster than - and I get so much more information. You talk about a complete list of drugs and all these neutral things and priorities of sorting. I can see much more on a desktop real estate or a tablet. A tablet is sort of a compromise. So I like the idea of tablet.
Oh, and other - just a little observation here how complex our system is, I heard the representatives of the big pharmaceutical companies which I love, again, because they support the New England Journal of Medicine, but, you know, they are saying dont insert anything, again, dont put these messages between the doctor and the patient when they are prescribing.
You know, at the same time, I am thinking to myself as they are saying that, if only one fraction of the money that they have spent on direct-to-consumer advertising was spent on helping subsidize some of these standards and information systems, we wouldnt be here today talking about the difficulties of adoption. So I see direct-to-consumer advertising as inserting a message between the doctor and the patient, and, you know, sometimes it is good, but I am not so sure that it is all good. You know, it is just incredible the number of questions I have to ask about which is better, Dr. Sullivan, Viagra, Sialis(?) or Lavitra(?), and, God, I dont have that kind of experience. I do know that they wanted Viagra to treat angina, and, as you probably know, that was an unanticipated benefit of trying a drug for angina. All of a sudden, they found another benefit that far outweighed its benefit of treating cardiac pain.
So, anyway, just a couple of observations from a practicing physician and thank you very much.
DR. COHN: Tom, thank you very much, though I will warn you, we do reserve the right to quote you, so - (laughter).
DR. SULLIVAN: Okay.
DR. COHN: I also just want to comment that we have, I think, had a steady stream of practicing physicians informing us as we have gone forward, and I cant think of any session that we have had where there hasnt been a couple of them.
DR. SULLIVAN: Thats great.
DR. COHN: And good or bad, this session is actually chaired by someone who is a practicing physician. So -
DR. SULLIVAN: Thats good.
DR. COHN: Well -
DR. SULLIVAN: Thats not bad. Its good.
DR. COHN: Thats good. We do what we can.
DR. SULLIVAN: Thank you.
DR. COHN: Yes, please. Are you going to make a comment about the practicing physician piece?
MS. BYRNE: No, no, no. Just - I do have a couple of comments. This is Teri Byrne from Rx Hub again.
First of all, this is just to reiterate something that we said or that PBM said in their testimony. There is a standard that exists for requesting a prior authorization today. There is an X12 standard that exists. It doesnt have high utilization, and probably for a good reason, but - you know - so as far as this committee is concerned, there is a standard that exists, so it is not a gap, at least as far as our research has shown.
I dont know if it provides all the needs of electronic prescribing, but that is because nobody has looked into it to see if it can be used, because the request hasnt been there to have a standard for that.
I also have another just kind of a concern, I guess, and this is even as a representative of Rx Hub. It is really more based on my experience in software development for the last 22 years. I have been in healthcare for 10, and I am a technology person. I am a software developer - okay? - and I have a lot of experience with standards, but I have heard a lot of requests and pleas and comments to dictate or to set standards for workflow or things like that within prescribing applications, and I am curious - I mean, I havent seen that really in a lot of other areas, and my question is there are things that these technology vendors need to do to be competitive and I think it is really important to allow them to develop their software and work with their physicians and meet the physicians needs, but if you do decide that you should - you want to develop workflow standards or standards for what electronic prescribing applications can do, then I think you should probably expand that to all of the players within the prescribing industry, including the pharmacy software, because they also receive information - or my question is would you do that? I dont believe you should, but, you know, you should expand it upon all of the players within the electronic prescribing industry, I guess.
DR. COHN: Okay. And let me try to answer, and Ill see if the subcommittee agrees with what I am going to say. I mean, first of all, the committee does not itself develop standards, neither the subcommittee, nor the committee. Our job and really our request as part of the MMA is to identify standards and recommend those standards to the Secretary. So, you know, where there are standards, we identify and recommend the best or the appropriate. Where there are issues, we may identify gaps and recommend improvements to those standards.
Certainly, the issue of workflow for functional standards or whatever we call it is an area where I dont know that we have heard testimony on that specifically, and I really dont know that theres really much out there for us even to hear testimony on.
Having said that, you know, there may very well be some pronouncements that need to be made, not as standards pronouncements, but as sort of recommendations that things need to be considered that really do relate to workflow.
MR. BLAIR: Could I just add one thing -
DR. COHN: Jeff, am I off on this? Please, go ahead.
MR. BLAIR: No. The thing that we have heard testimony on is a number of folks that were saying we should have workflow standards, but when we have asked if any exist, no one has identified that any exist. It is something that they are saying should be developed, and just as Simon says, and maybe I could just expand a little bit, I think the low-hanging fruit would be to focus on standards that facilitate interoperability where we can move forward more quickly. If we ever look at workflow standards, if there ever are standards to look at, I think that would be some time in the future.
DR. COHN: Harry, were you going to comment?
MR. REYNOLDS: Yes, I think the benefit of the discussion so far on workflow is that we make sure whatever standards we consider we understand the issue that we are facing, and I think when you really - you continue to hear from the practicing physicians, and, much like you, I have also developed a lot of software, and, in the end, if we build it, if we standardize it, will they come? And so, in considering those things, it is not so much setting standards as making sure that we understand the barriers, the issues and the concerns that are out there, so that when we do recommend standards, we know that this thing has a chance of getting off the ground. So that would be my comment.
DR. COHN: Yes, and let me make a final comment, because I think you can sort of hear that we are all sort of converging, but, you know, the other piece is when you are talking about technical standards, you want to make sure that they support workflow, and, for example, when we heard Jeanie from the American Academy of Pediatricians, and she was talking about being able to back out of prescription, now, that, for her, is workflow, for my view is lets make sure that the standard supports that, like that is a functionality that we need to make sure supports that workflow, and it is that sort of thing that we seem to keep going back and forth on.
MS. BYRNE: Absolutely, and I agree, and I have spent the past three years at Rx Hub developing technical standards to support information needs, and those information needs are dictated by the workflow. So I completely understand that.
My concern is more with specifying that technology vendor cant do advertising, not that I support that, okay? Im just saying that these applications - I dont know if theres other software in the industry that does advertising, I personally wont go to a website that pops stuff up to me all the time, but my point is that you shouldnt dictate what the software vendor can or cannot build.
DR. COHN: Well, okay. Youve just talked about now what we would describe as a policy standard, and I think that would be something that CMS would take care of in the regulation as well as the MMA takes care of in the actual legislation. So - thats a different -
MS. BYRNE: Yes. I was kind of including that in my comments -
DR. COHN: Oh, okay.
MS. BYRNE: So - you know - I just - but if we do set policy standards, and, you know, I am not saying whether you should or shouldnt, Im just saying if you do, it needs to be across the industry, not just the technology vendors developing electronic prescribing, because they can be influenced in other areas as well.
DR. COHN: Okay. I think Ross has a comment, and then I actually do begin to want to wrap up.
MR. MARTIN: Yes, just in terms of policy standards and about commercial messaging, as we move toward electronic voting, is it appropriate to insist that those electronic voting tools not have commercial messaging in the voting process? I think, clearly, we would not want them to have vote-for-me little pop-up ads while you are voting. Are you sure you want to vote for Kerry? Dont you want to vote for Bush? I just - I think that would be extremely problematic, and this is an exact example of we have an industry that - where there are people who are making purchase decisions using somebody elses money for the treatment of a third person. You have to have some guidance in that.
DR. COHN: Okay.
MR. MARTIN: And in terms of policy versus technical standards, we are not suggesting that you go out and look for standards that exist out there for policy, things like this kind of policy. We are suggesting that in your comments that you say, this is the public form that we think we should be talking about these things, and so we want you to recommend, make sure that you have this in the policy standards you are setting for this. That is what we ask.
DR. COHN: Yes, exactly, and probably - Ross, and thank you. I was actually - was just going to read a paragraph or two from a letter we received from Senator Charles Grassley that I think sort of relates to this, and I think he sent us a - as I commented earlier today, he sent us a letter basically reminding us of certain things that was both in the legislation and in the conference report, but it sort of seems appropriate, based on our conversation.
And it says here, In crafting the electronic prescribing provisions, Congress sought to address a number of issues that could undermine the potential of improved quality, patient safety and efficacy that electronic prescribing holds. It is my understanding that the NCVHS Subcommittee on Standards and Security is holding hearings to inform its recommendations for the initial uniform standards for the electronic prescribing program. As the subcommittee continues its work, I want to call your attention to specific MMA provisions aimed at addressing issues that could compromise electronic prescribing programs and the underlying intent of these provisions.
One, permitting use of appropriate messages. The MMA requires that electronic prescribing standards allow for the messaging of information only if it relates to the appropriate prescribing of drugs, including quality-assurance measures and systems to reduce medication errors to avoid adverse drug interactions and to improve medication use. The provision is intended to preclude the transmission of commercial information and to ensure the presentation of neutral and unbiased information with the ultimate objective of protecting patient choice. The conference report clarifies Congress intent by stating the following: The conferees do not intend for electronic prescribing to be used as a marketing platform or other mechanism that could unduly influence physicians clinical decisions. The conferees intend for prescribing health professions to have ready access to neutral and unbiased information on the full range of covered outpatient drugs available.
So that seemed an appropriate time to sort of read that from the letter.
Now, are there any other discussion items we have today?
I would like to - Since we are going to be starting at 8:30 tomorrow morning, I would like us to get out at a reasonable time today.
Is there any other comments? Margret, do you have any summary comments, other than well be starting at 8:30 tomorrow morning?
Okay. Well, with that, I want to thank you all. I really appreciate, as I said, the expertise both around the table and in the room to assist us moving forward. With that, we will adjourn until 8:30 tomorrow morning. Thank you.
(Whereupon the meeting was recessed at 5:20 p.m., to reconvene the following day, Friday, July 30, 2004 at 8:30 am.)