Hubert H. Humphrey Building
Room 505A
200 Independence Avenue, SW
Washington, D.C.
Agenda Item: Call to Order and Welcome and Introductions - Simon Cohn, MD
DR. COHN: Good morning, everyone. I'm going to call this meeting to order. This is the second day of three days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The committee is the main public advisory committee to the US Department of Health and Human Services on national health information policy.
I am Simon Cohn. I'm chairman of the subcommittee, and the National Director for Health Information Policy for at Kaiser Permanente, and a practicing physician.
I want to welcome the subcommittee members, HHS staff, and others here in person. I believe this morning we are also starting out on the Internet, just to let everyone know. And since are on the Internet, I want to remind everyone presenting, as well as asking questions, both from the subcommittee and from the audience to speak clearly and into the microphone. As you notice, I am very close to the microphone, because these microphones, unless you get very close to them, they don't project very well.
This morning we continue our work regarding prescribing standards. We start the day with a session and discussions of software vendors, which I think will take most of the morning. After lunch we continue with presentations and discussion to look at drug knowledge base vendors.
After the afternoon break we will have an open microphone session, and following that we move into some HIPAA issues, a number of which were sort of left over from our last meeting, one related to some WEDI implementation issues and recommendations, and another relating to a specific DSMO issue that was once again, an issue that was initially brought up at our last session, and we are hearing more information coming forward about that.
I want to emphasize 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 obviously have time for an open microphone later in the day, so obviously, there will time for open testimony from those in the audience.
Finally, for those on the Internet, we do welcome e-mails and other communications from you on any of the issues coming before the subcommittee.
Now, with that, let's have introductions around the table, and then around the room. For those on the National Committee, I would ask if there are any conflicts of interest relating to any issues coming before the subcommittee today, would you so please publicly announce during your introduction.
Jeff.
MR. BLAIR: Thank you. Jeff Blair, Vice President of the Medical Records Institute, and Vice Chair of the Subcommittee on Standards and Security. There are no conflicts of interest that I'm aware of related to our topic that e-prescribing.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the subcommittee, and liaison to the full committee.
DR. HUFF: Stan Huff, Intermountain Health Care and the University of Utah in Salt Lake City. I have potential conflicts, because of my involvement as the vocabulary co-chair in HL7, and also as a co-chair for the LOINC committee, if those subjects come up.
MS. AMATAYAKUL: Margaret Amatayakul. I'm an independent consultant assisting the committee.
DR. HELM: Jill Helms, All scripts.
DR. KAUFMAN: Peter Kaufman, DrFirst.
DR. FAUGHNAN: John Faughnan, McKesson.
DR. DOERR: My name is Tom Doerr. I'm a physician with an electronic prescribing company called Wellinx. And my only conflict is that I like to sell my products.
DR. COHN: Those members of the audience do not need to mention conflicts, just the subcommittee members. You're off the hook.
MR. TRUSKY: Good morning, Larry Trusky with All scripts.
MR. NAYAK: Rohit Nayak with MedPlus, a division of Quest Diagnostics.
MR. NUTKIS: Dan Nutkis with Zix Corp.
MR. MANTOOTH: Mark Mantooth, Health and Human Services, also on general counsel.
MS. PICKETT: Donna Pickett, National Center for Health Statistics, CDC, staff to the subcommittee.
MS. AULD: Vivian Auld, National Library of Medicine, staff to the subcommittee.
MR. REYNOLDS: Harry Reynolds, Blue Cross-Blue Shield North Carolina, a member of the subcommittee and no conflicts.
DR. WARREN: Judy Warren, University of Kansas, member of the subcommittee. And I'm not aware of any conflicts today.
MS. FRIEDMAN: Maria Friedman, Centers for Medicaid and Medicaid Services, and lead staff to the subcommittee.
[Additional introductions were made.]
DR. COHN: So, welcome everyone.
Jeff, do you have any introductory comments for the morning?
MR. BLAIR: I just wanted to welcome the testifiers. I wanted to just briefly indicate for those folks that might be here today that these hearings are in response to the directive to the NCVHS from Congress via the Medicare Drug Prescription Improvement and Modernization Act. The NCVHS is charged with the responsibility of evaluating, selecting, and recommending standards for e-prescribing.
While it didn't give the committee a date, the secretary has a deadline of September 2005, to set forth initial e-prescribing standards that will support demonstration projects in 2006. And this is the second of an array of hearings. If you would like to have the perspective on that, you could go to the NCVHS Website. There is a work plan that we are at least working with. It's not cast in concrete, but at least you could get some idea of the sense of the hearings that are scheduled for July and August and September.
And with that, I just want to thank everyone for being here. Thank you, several of you that filled in the written testimony. And for those testifiers that have not yet filled in the written testimony, can I please encourage you to fill that in, and get that to us as well.
DR. COHN: With that, why don't we start our first testifier? I'll go from left to right. Tom, why don't you start out?
Agenda Item: E-Prescribing: The Software Vendors' Perspective - Tom Doerr, Wellinx
DR. DOERR: Thank you.
My name is Tom Doerr. I'm a physician with a part-time internal medicine practice that is limited to Medicare beneficiaries. I am also one of the two physicians who founded an electronic prescribing company called Wellinx.
I read the March 31st testimony, and also the April 14th e-Health initiative reports with great interest. So, my goal in my oral testimony is to complement those sources. I will briefly mention a few issues that those sources addressed, but I would really like to discuss two issues that those particular sources have underweighted or under recognized.
Near the end of the March 31st meeting there was discussion about the Medicare Modernization Act’s directive to provide the patient's history along with the prescriptions. Most of my prepared oral testimony will address the benefits of writing prescriptions that are associated with diagnosis codes. And the other topic I would like to address is the barriers to creating real time interfaces between practice management systems and electronic prescribing software.
The bottom line for my presentation is it's my recommendation that at a minimum, prescriptions should be accompanied by a list of the patient's diagnosis codes, assuming the patient has signed a HIPAA release. But I think it's optimal that along with the electronic problem list, prescriptions should be accompanied by a diagnosis code that indicates the condition that is being treated with that particular prescription.
The value that can be created when physicians write electronic prescriptions and associate them with diagnosis codes is enormous. This value deserves some emphasis and some explanation. Basically, with diagnosis-driven work flow, the safety and the cost effectiveness of prescribing can be substantially improved, and that can happen in four ways.
First, we can automate the checking for drug-disease interactions, and also deliver messages about omitted drugs that would typically be appropriate for those diagnoses. And that can happen at several points in the prescription process. Ideally, this will happen at the point that prescribing decisions are made, and then that way the prescribing decisions can be reconsidered and changed most efficiently.
Secondly, we can improve the level of discussion in communication between PBMs, pharmacists, and payers, because they will all be able to better understand the patient's health condition that is being treated with a particular prescription. So, this can facilitate understanding, and improve the appropriateness of communication among the stakeholders. I think unnecessary phone calls can be prevented.
And the third point I would like to make is that we have an opportunity to dramatically lower the costs of treatment if we can deliver intelligent messaging about high quality, cost effective pharmacotherapy, and if that kind of messaging is delivered at the point of prescribing.
The Medicare Modernization Act clearly calls for electronic prescribing standards that accommodate messages about lower cost therapeutic alternatives. I think it's going to be more effective if these messages are delivered to doctors that are specific to the diagnosis that the doctor is trying to treat.
It is optimal to give physicians objective comparative information about the efficacy of treatment alternatives, and about the trade offs between the costs and the efficacy and the adverse effects for that particular diagnosis, rather than having it focused on the drug.
We physicians need something analogous to Consumer Reports for doctors integrated into our work flow. This kind of content must be transparently evidence-based in order for it to be credible. And the most logical way to do this is to promote a diagnosis-driven work flow. And the most effective way to promote a diagnosis-driven work flow is to set a requirement that the standard is that the prescriptions are associated with diagnosis codes.
My company implemented diagnosis-driven electronic prescribing in a 70 doctor group in Missouri several years. We measured a significant improvement in the prescribing behavior. So, we set out to study the impact of this system in a more rigorous, controlled trial. This was a trial of about 38 physicians who were practicing at an integrated delivery network in Wisconsin.
So, in that study, compared to the control group, the cost for new prescriptions and their refills of those new prescriptions decreased by 8.3 percent during the first six month period. And during the next six month period the cost to the payer decreased by about 16 percent. In this study the payer had a 40 percent market share, so the savings to the payer were $584 per doctor per month, averaged over each of the first six months, and then $1,101 per doctor per month, averaged over months 7-12.
Then we found there were almost identical improvements after the system was implemented in the control group in that integrated delivery network when we completed that study. Overall, in this particular study the payer measured their return on investment to be about 6 to 1.
These results were then subsequently confirmed independently in a study of 100 doctors that was sponsored by a payer in Maine. Now, both of these studies are limited by the small size, they are 100 doctors or less, and they were focused on commercial population, because the sponsor and payer in these studies was not CMS.
Nonetheless, there is a remarkable consistency of the results here. And when we consider all of the physicians who are using our system, looking at all the prescriptions that are written, this is a system with a diagnosis-driven work flow that has something analogous to Consumer Reports for doctors integrated in the work flow, 65 percent of the prescriptions that are written on this system are for generic medications. That could be referenced to a national benchmark that is probably somewhere around 50 percent.
And in this particular slide, if we follow the blue curve, that is the very first 70 doctor group in Missouri. They started with a generic prescribing rate of 57 percent, and they settled in about 10 points higher, the upper 60s. The green curve is the group in Wisconsin in the integrated delivery network that started at53 percent, and they are up around 64 percent. And then the red curve is a study of a high performing group in Maine.
Now, during this time period several important brand name drugs became available in generic form such as Prilosec and Prozac, so that it is important to have a reference group or a control, and that is why we did the control trial in the IDN in Wisconsin. And that's why we also did a control study in Maine.
I think that requiring diagnosis codes will not impose an undue burden on physicians. We doctors are routinely associating diagnoses codes with our orders for blood tests, with our orders for radiology tests, and with our bills for our professional services. It's not that difficult to make that work flow pretty smooth.
And many of the electronic health record companies already have diagnosis codes associated in their work flow. If you looked at just electronic prescribing companies, three of the companies on the market already are generating prescriptions that are associated with ICD-9 diagnosis codes.
I think most of us are aware that that less than two months after the Medicare Modernization Act was signed into law, the OMB estimates in the cost was about a third higher than the costs that were estimated by CBO. So, we have to figure out some way to reel in the costs of pharmacotherapy without compromising the quality. And I think that nationwide adoption of diagnosis-associated prescriptions will enable the promotion of fiscally responsible, high quality care.
The next topic I would like to discuss is this issue about the interfaces that are needed between electronic prescribing systems and practice management systems. And I think this is probably going to be the greatest hurdle to widespread adoption of electronic prescribing.
As far as I can tell, this is a matter that has not been discussed very much before this committee, and it was only briefly mentioned in the April 14th e-health initiative report, which is why I bring this up then. If you don't have a real time interface between the doctor's scheduling and billing software and the electronic prescribing system, the office staff has to do double entry of the patient data before the doctor can write prescriptions. And this is usually too time consuming to be practical.
My written testimony describes some of the alternatives to real time interfaces that are sometimes used, and the problems that are associated with each of those. The current standards for interfaces between practice management systems and electronic prescribing systems are inadequate, even when the practice management system and the electronic prescribing software are compatible with HL7 2.4, which is what is commonly in use. It takes at least two to three person days of labor, and sometimes a week for each of the two vendors to complete the transactions.
So, Version 3, when it’s available, will reduce this labor requirement. And most importantly, Version 3 of HL7 will require performance testing. But it doesn’t address the other aspect of the problem, which are the exorbitant expenses that are often charged to the medical groups who need these interfaces.
The total cost of these real time interfaces typically run between $5,000-10,000, but in some cases they are as much as $30,000. And when you get to higher figures of in between $10,000-30,000, they are usually arising from anti-competitive business tactics, or price gouging, or other reasons that are discussed in my written testimony.
But even if you are at the level of a $5,000-10,000 charge for the interface, that's just a huge barrier for adoption of electronic prescribing for the 1 to 2 doctor offices that make up most of the medical practices in this country. So, we have an issue here with business practices, and we also need to hoe to hasten the completion of the work on the HL7 version for interface.
I have a few other brief comments about Dr. Tice’s (?) testimony on March 31st and the April 14th e-health initiative. I just want to touch on three of those issues.
The first issue involved the code sets for drug names. The government has encouraged the existence of several competing code sets for drugs at higher level of abstraction than the NDC codes. And we saw this when the government forced the divesture of MediSpan from First DataBank. And this encourages competition, but it also causes some barriers to interoperability, and thus to rapid adoption of electronic prescribing.
My understanding is the NCPDP protocol doesn't resolve this interoperability issue. This is a significant barrier to smooth communication among stakeholders, specifically in between the prescribing applications and the pharmacy network, and the pharmacy management systems and the PBMs and practice management systems.
Ideally, there would be one, well defined, hierarchy of numeric identifiers and associated text descriptions that is supported by all the payers and the commercial drug database vendors. I think RxNorm promises to be the solution for this, but it's very important that we resolve this issue.
We have been blocked with some attempts to do some implementations because of these incompatibilities, and had to just turn away certain customers. It's really a barrier, the way the system is currently in place.
A second concern I would like to emphasize is the welter of state requirements for the detailed printed facts and electronic prescriptions. Each state pharmacy board has its own approach to really the same essential needs. The result is a bewildering set of sporadically changing requirements that act as barriers to rapid implementations and adoption of electronic prescribing. These really need to be standardized at the national level.
And finally, the need for standardized tables for managing formulary status information is becoming increasingly apparent. Insurance companies, PBMs, and application vendors, and formulary data vendors do not share any widely accepted standards. I'm specifically referring to the definition and sharing of the formulary lists, and the special policies that go with them to define a formulary. Setting standards for describing formularies will significantly reduce the cost of managing this irregular information.
So, in conclusion for my oral testimony, the challenges here really are formidable, but pharmacotherapy is really well positioned for improvement. And the potential to create value here is very exciting. Evidence-based medicine is often admired in health care, but it is seldom practiced. And in order to get evidence-based medicine out of academia, and get it into patients' bodies, we need to give doctors informational tools and incentives to embrace the fiscally responsible care.
We are at a crossroads here with electronic prescribing standards. We have an opportunity to create standards that would include a framework for seamlessly weaving context-specific decision support information into the work flow of prescribers, and that is a huge part of the battle. I have additional comments about incentives in my written testimony.
Thank you for considering my opinions, and I would be happy to take any questions as time allows.
DR. COHN: Tom, thank you very much. We'll just have discussion after everyone has had a chance to testify. Thank you for your testimony.
John Faughnan from McKesson.
Agenda Item: E-Prescribing: The Software Vendors' Perspective - John Faughnan, MD, MS, McKesson Provider Technologies
DR. FAUGHNAN: Thank you. Thanks again for inviting me to speak today. I'm John Faughnan. I'm a physician and informaticist, product architect at McKesson Provider Technologies.
McKesson is a big company. Provider Technologies is one part of it. We are by some measures, the world's largest health care services and health care IT company. And we span the whole spectrum of e-prescribing from our robotic automations, through our medication and supply management services, through software use by nurses and physicians, and other health care workers at the point of care. So, we have a lot of perspectives.
For the testimony today, in addition to my written response, I have written up my oral testimony, and I will provide that in an electronic form. It is based on discussions within the company, with our business partners, and in some cases on my personal experience too.
I chose to follow the outline we were given, so I'll proceed with the questions, with emphasis on the latter part.
The first set of questions was to ask what were the best standards for code sets. And I combined the ones that we use. In brief, to provide an orientation, we have a longstanding relationship with First DataBank, and we have made extensive use of NDDF Plus, their medication terminology in one form or another really over the past eight years. And we have seen that evolve quite a bit over that time.
We are using now, SNOMED-CT to represent patient conditions that may impact e-prescribing. We expect to use SNOMED-CT and LOINC to represent measurement and test results that also affect medication usage. We recognize that in the real world, you frequently have to deal with ICD-9, however, our experience with ICD-9 as a way to represent patient conditions to support indication and contradiction checking was quite negative. We didn't find it satisfactory for those purposes.
We use NCPDP Script, and we expect to continue using it as it grows and evolves. I will talk about that in a minute. And we expect to use emerging standards for medication history, drug utilization review at the point of care, and queries and responses and structures really, around formulary and tiered formulary inquiries. And we have a history of using those in the past, but expect to be moving more standard methods for those.
We do support RxNorm as an external representation of abstract and dispensable medications when we must communicate with the outside world. And I look forward to seeing that develop with more support for the SIG and aspects of clinical prescribing beyond the dispensable, including things like the clinical route.
We are big supporters, and perhaps me particularly of the National Library of Medicine's effort to facilitate interoperability and coordination between First DataBank’s commercial versions, NCPDP, SNOMED-CT, and RxNorm.
Dealing very briefly with some selected strengths and weaknesses, and I go into more detail in the written terminology. We know that there are some process and structural issues with regard to NDC, and the particular versions of NDC. However, we also recognize that NDC is deeply embedded in all of our applications and all the different aspects of medication transactions. So, we would ask that as those issues are addressed, they are done in an evolutionary way to preserve NDC.
We know that it's possible to use NDC codes as a substitute for a dispensable identifier. I mean you can use it. You can take any old NDC that works for the dispensable, send it, and recover the dispensable at the other end of the transaction. But we do look forward to a true dispensable identifier.
And we have used NDDF Plus for quite a while, and we are very pleased with how that is evolving. And we applaud the collaboration that may emerge with the National Library of Medicine to enhance RxNorm's management of packaged medications and medication ingredients.
We also likewise, talking about collaboration, encourage a collaboration between SNOMED-CT, the National Library of Medicine, and vendors like First DataBank to facilitate communication of patient conditions. Prescribing vendors represent patients typically in an internal terminology that has been optimized for medication use. SNOMED-CT has a very basic terminology that's somewhat different, and we need to bring the two into alignment.
We see mapping errors when you transmit patient conditions between the medical record and a decision support system are a big issue. We really can't have mapping problems. So, we need to get this terminology integrated so that there aren't mapping issues.
Then moving along, is nationwide adoption necessary? Yes. I won't go into detail there.
What are the code gaps? Well, with Script we know that it works. It has evolved to fit people's needs. But primarily it came from the communication between the pharmacies and the payer, although it has quite a bit of support for communication between the prescriber and the dispenser. And we expect that it will evolve to include a number of important additional data elements, including acknowledgement of receipt, so that the prescriber knows that the dispension was received in the transaction.
The clinical SIG, in other words doses, tags, frequencies, clinical routes may be different from dispensable routes. An IV medicine may be dropped in the eye instead of injected in a vein. Text messages, and in particular the encoding of prescriber review of a warning note and formulary notes. What those prescribers warned about, what they overrode, and why, so that when the pharmacists get the same kind of warning messages, they can understand what the dispensing physician had in mind.
Other gaps we are looking forward to seeing completed is standard transactions for formularies and tiered formularies, medication history messaging, a politically acceptable method for identifying the patient, electronic signature and authentication that is accepted nationally, standardized encoding for the reason the claim was rejected, and identifiers for durable medical equipment and supplies that would be analogous to NDC code and dispensables, ideally consistent with RFID standards.
What are the barriers to the development and adoption standards, and how can they be addressed? There are many, but I have chosen to emphasize four, a little different perspective perhaps.
Number one, customer readiness. Are customers ready for these transaction sets and these standard terminologies? Even if we vendors are, even we are personally, we would like the customers to be eagerly demanding these solutions, rather than passively accepting them. We hate being too far ahead of our customers. We like to be a little bit ahead.
In some cases, although perhaps less for e-prescribing than in some other messaging structures, the message really does come to dictate the structure of the application. What has to go in the message, the way the knowledge has to be presented, the terminologies and feedback can alter the deep structure of the application. And so to implement fully some of the more powerful standards requires new applications, often difficult to reverse engineer to existing applications. So, that has some issues of how long it takes us to bring on those board.
Coordination and collaboration between messaging standards and terminology standards. People who have worked in this world know that messaging people and terminology people come from different points in the world. Folks on the committee understand this. And they needed this. The borders are sharp and demarcated. There is a lot of give and take that has gone on back and forth, a lot of painful things that we encourage support and mutual acceptance of.
I do worry, perhaps myself more than others, about how we are going to put together all of the diverse terminologies and transaction standards that have been partitioned by domain. So, we have had things that are partitioned by procedures, partitioned by some kinds of tests, partitioned by conditions. And I think in practice, how that is all going to be maintained, how that is going to fit with different messaging models. How, since patients have all those things together, and since they overlap domains in medicine, I think we will discover some issues there.
How can we address these things when we are concerned that licensing costs and business models have to work for the standards bodies? We, of course, like the costs to be predictable for the long-term and sufficient to keep the standards bodies healthy, but not to add a lot of extra expenses, which after all, gets passed onto our customers. And we would also ask for consideration of management of international licensing costs as well.
The incentives would be graduated and include partial credit. It's going to take a while to get to the full solution. We would like to have some good milestones with partial development.
We would like to support the delivery of knowledge of all types to prescriber, dispenser, and patient. We know that there has been some concern about the volume of data that might be going to the prescribing physician. And perhaps some of that will be overwhelming, particularly on the formulary side of things.
We have done this in the past at McKesson. We have had products that dealt with that flow of data, and we do think it's manageable, and want it to be provided to patients, providers, and dispensers.
In the near-term we recognize that detailed payment information with actual co-pays costs for the patient may initially be first provided to the dispenser, as a first step. We also recognize that some of that information commercially is very sensitive to payers, and sympathize with the need to recognize their business needs.
The last thing I would like to mention is the incent to collaboration. Again, we think the National Library of Medicine is playing a major role with RxNorm, NCPDP Script data, and SNOMED-CT medication data, and we would like to see a trusted agency or organization monitor the health of all of these terminologies and messaging organizations over time, including relationships to the administrative code sets of ICD-9.
Thank you very much for the opportunity to speak today.
DR. COHN: John, thank you very much.
Our next presenter is Peter Kaufman.
Agenda Item: E-Prescribing: The Software Vendors' Perspective - Peter Kaufman, MD, DrFirst
DR. KAUFMAN: Thank you for allowing DrFirst to present the vendors’ perspective on e-prescribing and the need for standards. We greatly appreciate the work you are doing, and believe this is a critical step in improving the deployment and adoption of electronic health care. DrFirst is a four and a half year old company, focusing on connectivity and electronic prescribing.
There are three points I intend to stress today, and hope you agree with their importance. They are that connectivity is critical to efficient and safe e-prescribing, that RxNorm should be supported for standard naming systems for electronic prescribing, and that a standard SIG, or how a patient is to take a medication will improve interoperability of electronic prescribing.
I am giving the vendor’s perspective. You may hear like it sounds like I am giving the physician’s perspective. It’s not because I am a physician. It’s because we realize that in order for this to be successful, we need to be physician-centric. That the company has to think about what the physician wants, what the physician will use, because if the physicians don’t use the applications, then all is lost.
I don’t think I need to dwell on the need to improve safety and efficiency in medicine. With over half a million preventable events, 40,000-100,000 preventable deaths, there is room for improvement. As a member of the EHI Zion Implementation Working Group, I had the privilege to help create the report that was discussed a few weeks ago by Dr. Tice. I support that report fully. Today, I appear as a vendor, and emphasize those issues most important to the vendor community.
From a high level, it is obvious that the impact of prescriptions which are directly touched only by the physician, the patient, and the pharmacist is much wider. For the vast majority of providers, even most of those encountered in surveys as using electronic prescribing, this is how the process works currently.
Paper is involved somewhere in the chain, and communication is limited internally to the applications being used, and perhaps the pharmacy. I just want to point out quickly that even if the prescription is using electronic prescriber that is often faxed to the pharmacy and sometimes the patient will fax their handwritten prescription, but there is often paper involved there, and all that it entails.
Handwritten prescriptions are especially prone to errors. Almost 25 percent are never even filled. Having the prescription checked for insurance coverage to allow the lowest co-pay, and sending it directly to the pharmacy so the patient does not need to wait may improve the compliance. Finally, electronic prescribing is far more efficient for the pharmacy and medical office staff.
How many times have you seen this pyramid so far? I thought the two previous speakers were going to show it also. So, let me just go into what the levels that we discuss in the pyramid are. Here is a breakdown of the different levels of electronic prescribing as depicted on the previous slide.
I want to point out that level six, in order to be superior to level five in terms of prescribing efficiency and probably safety, must also contain the connectivity to pharmacies and payers described in level five.
MR. BLAIR: Peter, for my benefit since I can't see it, could you elaborate slightly more than the levels, and tell me what each of the levels are? Then I'll be able to follow you.
DR. KAUFMAN: Absolutely, I apologize.
MR. BLAIR: Not a problem.
DR. KAUFMAN: Level one is reference only. Basic electronic information only. Drug information, dosing calculators and formulary information available, but not automatically assumed nor prescribed.
Level two is stand alone, searching by drug name, and creating a prescription, but there is no long-term data involved. Level three is stand alone plus, where you do provide basic patient information for demographics, drug list, allergy list, and a non-specific formulary.
Level four goes to medication management, where the prior medications are available not just for renewal, but also for checking interactions against those prior medications. Level five is connected e-prescribing, integrating with a practice management system for patient demographics and schedules, the pharmacies for new scripts and renewals, for pharmacy benefit managers and payers for eligibility, patient specific formulary, and drug history.
Level six is EMR, electronic medical records, integration to prescribing into a full electronic medical record. Our current systems don't often have the full connectivity of level five. In fact, I'm not aware of any that have the full connectivity, but they are getting pretty close. But some that say that they are e-prescribing really are just creating a printed prescription and handing it to the patient, or faxing it to the pharmacy.
We believe that the next level will also involve connectivity across the continuum of care between inpatient and outpatient, between different providers and health systems. And this is where connectivity really is critical.
This is not easy. You can help. Appropriate standards for data exchange and electronic prescribing will ease this exchange of massive amounts of data through markedly disparate systems. We need a unifying naming system like RxNorm. We need standardized classifications, like RDFN T, which I will mention a little later, and we need a mature descriptive language like Scripts with a fixed standard.
I would like to mention continuity of care record at this point. As you can see from this slide, which shows a million different -- prescription manufacturers, pharmacies, physicians, distributors, hospitals, and everything with lines in between them all, the e-health connectivity is a daunting prospect.
The CCR is a small, but exceedingly important early step. Not only is the data in the CCR critical for health care, but the fact that so many organizations have signed on to the concept is equally recognizable. This demonstrates the importance of connectivity.
Some connectivity is happening already. You heard yesterday from SureScripts and RxHub. Their backbones were in place, although neither had complete and universal functionality yet. These both work well, but connecting to them was not straightforward, because there was no standardized connection. Still, their value to the electronic prescribing process cannot be discounted. This is what we are talking about.
People think e-prescribing is simple. Pick a patient, pick a pharmacy, pick a drug. Truly, e-prescribing is much more than that. To illustrate the importance of connectivity, let me walk you through what happens during the generation of a typical prescription.
Demographic information, as we heard earlier, about the patient comes to the e-prescribing application from the patient's practice management software, or directly from the hospital information system, or through an intermediary application like Patient Keeper. Of course, it can also be entered directly.
Eligibility, patient-specific formulary, and medication history are available through RxHub directly from the patient's pharmacy benefit manager.
The medication database provides a list of medications from which the provider chooses, and he or she can access further information about the drug from an integrated drug reference application such as Hippocrates.
As the medication and dose are chosen, the system will utilize information from the medication database and the insurance formulary, as well as the patient allergy list, and generate alerts regarding interactions, allergies, and formulary coverage. The provider can follow these alerts, or can choose to ignore them.
The prescription is then sent through SureScripts or NDC Health to the patient's pharmacy of choice, if local or to RxHub to a PBM mail order firm if desired. Currently, pharmacies that are not accessible electronically are accessible by fax.
Connectivity is key to the e-prescribing process. It improves the efficiency of the process, and improves value for the end users -- physicians, patients, and pharmacists. The number of connections is not trivial, but the number of connections is less important with appropriate standards making those connections easier to build.
Now, I'm ready to discuss specific standards. Except for RxNorm, these are the standards which we use. HL7 is a loose standard, because many vendors use the optional fields for important information, which must then be specifically coded by other vendors' applications.
The Scripts standard from NCPDP is great, but it needs a way to describe how the medication is to be taken. We use NDC codes for naming medications, but they are not really appropriate for the prescribing process. If the physician is trying to prescribe Amoxicillin 250 milligrams, there are multiple NDC codes to describe it. There are separate NDC codes from each manufacturer of Amoxicillin 250 milligrams, and even separate NDC codes for different sized stockpiles.
DrFirst transmits an example NDC code to our communication partners, and that example code is then exploded to encompass the other way of describing the medication which the physician chose to prescribe. This is not an efficient way to pass this information. That is why RxNorm should be useful for e-prescribing.
This is one of the points I really want to stress today. RxNorm is a standard for naming each medication. It is designed to specify the medication as prescribed by the physician, and should allow various entities to share information regarding this information. Providers do not care about the number of pills in a pharmacy stock bottle, or even the provider of a generic version of the medication.
There is an area in my written testimony where I mention that RxNorm doesn't yet include specific packaging, such as for tampering doses of oral steroids for oral contraceptives, when actually it does. According to Dr. Stewart Nelson at the National Library of Medicine, these packages are considered drug delivery devices rather than medications, but are linked to the drugs that are in them. For example, Ortho Novum 777, contains 7 pills each of three different combination of formulas.
RxNorm does not include radiopharmaceutics or radiology contrast materials, and may not contain the materials used for compounding of drugs. They also are still adding over-the-counter medications.
We believe, however, that RxNorm is the strong solution for a drug naming standard that should be supported and adopted. NDFRT, or the National Drug Trial Reference Terminology, specifies the contents of medications and other features of the medications that is classification. This potentially will simplify the interaction and formulary management used in e-prescribing applications. Standardization of medication classes would also allow more accurate interpretation of drug-drug and drug-allergy interactions, and insurance formulary lists.
Current insurance formulary lists vary from payer to payer. While not the highest priority, we would like to see a uniform format specification, even if the suggestion or example that would include a standardized tier rating scheme, as well as an exclusion list, that is, if this drug is not in the formulary, what drug is on the formulary to replace it?
The thick(?) standard is another important point I hope to make today. Different vendors describe patient directions differently. Some use abbreviations, some use data elements, describing full language text, and some just provide a text string allowing anything the provider wishes to write without structure.
We agree that e-prescribing systems should be flexible to allow prescriptions as the provider wishes them to be. The point of having a free text field is for outliers. But most things should be described as data elements and shared as XML. I have included an example in my written testimony.
As more and more physicians utilize electronic health care applications, there will be more need to share this information. By utilizing the data elements, SIGs written in various applications can be converted to appear native in any application the provider is using. This may further reduce errors by adding homogeneity.
An XML-based SIG standard will also increase the value of the CCR by allowing native display and the importation of prescribing information between e-health applications.
There are three other issues I wish to address. I continue to see pricing for electronic prescribing in the press listing a very high cost for the first year. While it is possible to spend that much, especially if you want to buy a car, many e-prescribing applications, even with hardware, are less than $1,000 per provider per year.
Physicians need to understand the benefits of e-prescribing. Our experience is that once they understand these benefits, they sign up for it, and they are willing to pay for it. It is a misconception that doctors are technophobic. Doctors are not unwilling to pay for and use technology, but they require the technology to be simple, powerful, and fast.
Finally, there are concerns, especially among physicians, that the speed of e-prescribing applications is not fast enough. While nothing is faster than using a roll-based system like ours to have someone else write the prescription for you, let me show you how fast it could be to write prescriptions electronically.
This next slide is actually going to show you a very quick video of writing prescriptions on a PDA, and I will describe it as we go through it. This is me prescribing, but we have many users who are faster than me, because they write 250 scripts a week, not 10.
First, I’m going to select the patient. We can select the patient from the schedule, or by hitting prescribe. By typing in a couple of letters, I can sort the list to the appropriate patients. I can choose a patient's medication list, and see their current medications, and request for a one touch refill.
I can use of favorite list, and pull up the medications on the favorite list. The bottom shows more information that is prescribed, and that’s the summary screen. I can put in a new medication by typing a couple of letters of the name, and the list of the sort of that medication. I can choose the medication by double clicking, show the drugs it is available in.
I can pre-fill the top of the formulary for common drugs, the quantity and the number of refills. And I have just written three prescriptions. I can review the prescriptions and edit them after they have been written, and I can send them all at once to their various pharmacies.
In summary, connectivity is critical to efficient and safe electronic prescribing. Appropriate standards will improve the process and maximize value. RxNorm and NDFRT should be supported and considered for naming and classification in e-prescribing. Finally, a SIG standard will improve interoperability in e-prescribing.
Thank you very much for allowing me to testify.
DR. COHN: Peter, thank you very much as well. And also, thank you for the demonstration.
Our next presenter is Jill Helm and Larry Trusky. You're doing a joint presentation.
Agenda Item: E-Prescribing: The Software Vendors' Perspective - Jill Helm and Larry Trusky, AllScripts
DR. HELM: Well, thank you very much. Larry and I thank you for the opportunity to testify before you on the AllScripts experience. I'll be presenting our oral testimony this morning.
To give you a little background, AllScripts is a provider of clinical software and information solutions for physicians at the point of care. AllScripts has significant numbers of physicians using one or more of our solutions. We have offered e-prescribing software and medication management solutions for physicians since the early 1990s. And we are currently creating and routing millions of prescriptions a year.
We represent a very broad physician experience. We have single physician and small physician practices, all the way to very large, multi-specialty groups utilizing one or more of our software solutions. We develop and deploy stand alone e-prescribing systems, as well as fully integrated electronic medical records.
We work with a number of health plans that provide funding for adoption of e-prescribing. We have seen funding for systems and utilization-based incentives effective in getting physicians started. Continued use depends on recognition of benefits by the prescriber. We have discovered that even free isn't good enough.
There is much evidence to suggest electronic prescribing can improve quality and reduce health care costs. We have seen successful physician groups utilize electronic prescribing to prescribe more cost effectively by increasing generic utilization, and driving formulary compliance, reducing costs to both consumers and health plans.
Automation of the prescribing process and the refill process has reduced the number of calls received by clinics from pharmacies by up to 50 percent. We have experienced tremendous growth in the number of prescriptions written electronically using our application. But we can do better.
There are a number of components we would like to cover today, including transmission and messaging, drug history, eligibility, prior authorization, formulary, and identifiers.
Eligibility -- identification and association of patients with a health plan and drug benefit is key to driving information delivery. Formulary, co-pay information, and pharmacy benefit information are all driven off of eligibility. Today, there are member IDs, plans, and group codes for prescription claims submission. But these identifiers are challenging for physicians to collect and enter at the point of care. A standard health plan identification number would be helpful in this process.
Prescription plan identifiers are not always highly visible on insurance cards. We should not have to depend on clinic staff to be experts in deciphering prescription drug benefits. We support companies like RxHub that offer solutions to this via X12, 270, 271 exchange, and it's important that we move forward in identifying formulary and benefit information at a patient level, as well as a plan level, because the plan level information alone does not meet the need.
Moving on to formulary and prior authorization. Standard formats for formulary information need to be adopted to facilitate the consistent presentation, and to provide as much formulary information as is practical to the prescriber at the point of care.
Today, we take formulary information from a number of sources, including RxHub, direct feeds from PBM and health plans, as well as independent third parties. We believe that health plans and PBMs will continue to offer a variety of formulary designs and co-payment options to meet the needs of the marketplace, but there needs to be a core set of formulary attributes that can be used to describe preferences, or to designate those products with an unfavorable formulary status.
Prior authorization should be communicated to the prescriber electronically prior to the creation of the prescription. We are supportive of developing standards for electronic prior authorization, and for exchange of that information between the interested parties.
Medication history -- this is another transaction that we support. It's a real benefit to jump starting the physician experience. It can serve as a proxy for patient compliance. A challenge with this is the reconciliation of multiple sources of information to a single medication list for a patient.
Given the diversity of sources for medication, for example, patient reported medications, ambulatory medications, including those prescriptions created within e-prescribing systems by the physicians, as well as inpatient medication histories, we anticipate that we will have to support multiple standards for these transactions. But that just highlights the need and the importance of having standard data definitions for the data elements within those transactions.
CBI transmission of prescriptions and identifiers. We feel that NCPDP Script standard is a solid and established format for communication between physicians and pharmacies. It's expandable, and it is maintained by a well represented body.
Some of the challenges we face today are really a result of lack of appropriate national identifiers for lapses in operational processes. Success comes when we have a targeted campaign of physician and pharmacy education, and a coordinated roll out of script standards.
Continued acceleration of e-prescribing will be contingent on the adoption of national identifiers for drug terminology. Today, the NDC code is useful for pharmacies to communicate dispensed medication information to a PBM or payer for claims processing and reimbursement. It specifies the manufacturer, brand, form, and even package size of the medication.
Current drug classifications are based on mechanism of action or chemical structure, a classification that is meaningful for pharmacists, but not all clinicians. A more meaningful classification for physicians would be based on therapeutic use or indications. Drug databases need to expand their listings to include a more comprehensive list of prescribed treatments to include medical devices as well as DME.
A couple of data sets which hold promise for the future. RxNorm is a compilation of clinically orderable drugs described by its project team as capturing what the doctor ordered. It contains a high level of things that someone might find on a pharmacist’s shelf.
The NDFRT or National Drug Trials Reference Terminology from the Department of Veterans Affairs also establishes detailed facts about active drug ingredients, such as mechanism of action, physiological effects, therapeutic indications, drug class, and other ingredients. This of course is substantial information to understand the effects, group allergies, interactions, and contraindications. RxNorm listings are built from NDFRT components, and together should provide substantial amounts of clinically relevant information for electronic prescribing.
Pharmacy identifiers. Today, identification of pharmacies is via the NCPDP script number. That has worked well for us, and we don't see this as a standards gap for prescribers.
As you have heard from other testimony, the DEA is the most prevalent identifier used for physicians with all of its accompanying limitations. The national identifier, like the proposed NPI would go a long way towards enabling the entire prescribing base to transmit electronic prescriptions.
And last but not least, I would like to address some of the regulatory challenges that we face. Today, we support a variety of different prescription formats to meet the state and federal requirements. Even within states, there are differing requirements for printed prescriptions, faxed prescriptions, and electronically transmitted prescriptions. We support all of these today, but it's a complex process.
At the federal level, the DEA does not recognize electronic signatures for controlled substances. States have drafted regulations without fully understanding electronic prescribing, or the technology involved. States also impose requirements such as approval of e-prescribing systems prior to their use, which can slow implementation efforts. Accelerated adoption of electronic prescribing depends on simplifying these requirements.
There is an evolutionary aspect to messaging standards. Not everything can be expected to be there day one. Also, electronic prescriptions need to be seen as comparable to other methods of prescription communication in order for adoption to occur. State and federal regulations need to address and recognize electronic prescriptions, but not to make the requirements so insurmountable that they are too cumbersome for anyone to implement.
Also, all parties involved should not hold electronic prescriptions to a significantly different standard than other methods of prescription creation and transmission.
In conclusion, we have processes today that are creating and sending millions of prescriptions a year electronically, but there is room for improvement. Standards must create value through meaningful expansion of available information to drive measurable outcomes, and promote sufficient connectivity to a diverse group of health care providers, while maintaining flexibility and allow for a national condition path is guided by provider incentives for adoption.
I thank you.
DR. COHN: Thank you very much.
Larry, did you have any comments, or were you just here for questions and discussion? Okay.
Our next presenter is Rohit Nayak.
Agenda Item: E-Prescribing: The Software Vendors' Perspective - Rohit Nayak, MedPlus, Inc.
MR. NAYAK: Good morning. My name is Rohit Nayak. I'm the Vice President for Clinical Information Solutions for MedPlus, which is a wholly owned subsidiary of Quest Diagnostics.
Unfortunately, as you might have detected, I don't have any written statements or haven't submitted any of that. I seem to have fallen out of the loop in terms of the submission cycle over here. So, I will make an attempt to catch up with this process after this meeting. I apologize.
My background, or at least the pertinent part of my background is that I would be a co-founder and CEO of an e-prescribing company that I started in 2000 called Rx Nuts and Bolts. And I followed that adventurous journey through to the summer of last year when the company was acquired by Quest and MedPlus. So, a lot of what I'm sharing with you today is my experiences as a part of that journey, and what I see as a lot of momentum, driving factors that occur in the industry today.
Clearly, the fact that this committee exists and that we are all here today has gone a long way in demonstrating that we all believe that e-prescribing provides significant value to all of us in the community, from a quality standpoint, as well as from a safety standpoint, so I won't really go into that in any detail here.
When we started deploying our software many years ago, there were several companies out there at the time. E-prescribing was already a buzz word. And as a lot of you can recall, there were a lot of pictures out there with a physician in a white coat, carrying a PDA, and that was the presentation of e-prescribing, suggesting that the physician and the PDA can solve all problems associated with e-prescribing.
As a lot of the other speakers over here have already recounted, e-prescribing is more of what I like to call prescription management, the management of prescribing that occurs inside of a physician's office. And so, we spent a lot of time trying to understand the work flow issues that occur inside of a physician's office.
I will admit that I am not a standards geek. I don't understand them, and I haven't spent a lot of time appreciating the various aspects of various standards. But what I have spent a lot of time in looking at is various adoption issues that occur inside of a physician's office.
As a result of being number five on this list over here, one of the drawbacks is that most of the good points have been covered. And so, what I will do is reiterate some of those points, and maybe expand on that a little bit with my perspective.
One of the points that we believe bears some attention is one that was just raised a few minutes ago, and that is associated with the physician identifier. Clearly, we have the DEA number that uniquely identifies a physician, but it doesn't necessarily uniquely identify a physician in a particular care setting, which is key when we are trying to have a two-way communication between a physician practice and other entities such as pharmacies, for example.
Pharmacy board issues have been mentioned a couple of times today, and as a small company that started out regionally, we were lucky that we operated in Ohio. We found that the state board of pharmacy in Ohio was extremely forward thinking. They had an approval process. The good news was once I went through that, it became a lot easier for me in other parts of the country.
Nevertheless, there are significant legal and compliance issues now that I'm part of a larger organization, that I have to look at very, very careful. And it certainly is a detriment to a widespread deployment. So, we would certainly encourage any effort in that particular direction.
The whole concept of controlled substances relating to drugs as well is a sticky issue, because we can do a lot with the electronic prescribing today. Organizations such as RxHealth we believe, and SureScripts lately are doing a lot to make this real for us in a lot of different ways. But if we have a manual process that is inserted in a large electronic process, efficiencies are limited in a natural perspective.
Some of the things that we have learned in communications with pharmacies is that while we are talking about a lot of different information and technology issues that occur within a physician's office, surely the pharmacy would love to get more information on their patient as well, because right now, what we have is multiple entities maintaining similar sets of information on a particular patient, but sometimes they are not complete on either side of the spectrum.
So, for example, I believe it was the first speaker who talked about diagnosis information. And certainly, health the ultimate dispensing entity with that additional piece of information.
A second point that I believe was also mentioned here in the last several minutes is some information based on the physician's actions that were taken while they were prescribing a particular medication. For example, if they were allergic with a drug contraindication, and the physician chose to override that, that piece of information would be extremely useful to the pharmacy, because that will alleviate a lot of the touch points that occur back and forth.
The NCPDP Scripts standard does have I guess the ability to incorporate allergy information, but I know for a fact that it is seldom used. So, that piece of information, or the receipt of that information at the pharmacy will certainly help a lot from a safety standpoint.
A couple of people have talked about NDC codes, and I've got to tell you, it was extremely puzzling to me when I got into this business, that you have numerous NDC codes that represent a particular drug. And for all the good stuff that we do in the physician's office in terms of selecting an NDC code and representing that as part of the script, ultimately when it is dispensed, we know that the chances of it being the same NDC code are extremely slim.
So, I guess that's just to reinforce some of the concepts associated with NDC. While I have made my comment about the NDC, I would also like see modifications to that be gradual, because we have invested a heck of a lot in utilizing those codes as part of our technology black box. So, a little bit of selfishness there.
There was a lot of activity over the years with respect to the various stakeholders, especially the PBMs and the payers on one side that are trying to promote formulary compliance at the physician level. And we have gone through a lot of evolution on that, and I believe RxHealth as an entity, has made that real to a great extent.
One of the key pieces that I recall that was missing from earlier deployments relatively simple to incorporate formulary lists, there was no specific mechanism to identify a patient with that formulary. And that went all over the board. RxHealth has, by virtue of its MPI, has made that, by using standards that are out there a lot more real, so that we have a real time ability to check for medication insurance, which as most of you know is very, very different than health insurance information.
On that point, we certainly encourage, and I think everybody here will join me, other plans and payers to join up with RxHealth, because I believe that clearly will help us from an adoption standpoint.
We talked about the medication history here as well, and the aspect of getting medication history, and maintaining medication history. Clearly, there are at least a couple of mechanisms to do that today. So, some attention on that particular note will certainly help us as well.
On the pharmacy side, SureScripts has, by virtue of its technology platform, and its associations with various retail pharmacies, has certainly allowed for the two way communication to occur between pharmacies and prescribers, specifically with respect to the renewal of a particular script.
One piece of information that would be neat that I believe doesn't exist today is a notification back to the prescriber when a particular drug is dispensed. We do get receipt of when a particular prescription is received at a particular pharmacy, but the dispense information will certainly help make medication history the true history. And I believe there are enough statistics out there about the number of prescriptions that are really not picked up.
With respect to adoption issues, and I made a reference to that when I started off my conversation here today, price is something comes up with respect to whenever anybody talks about adoption. I firmly believe that e-prescribing or integrated e-prescribing in conjunction with the EMR systems that category five or six alludes to provide a distinct value if done right, to the physician and the physician practice.
And as long as a value is there, I believe that physicians are going to pay for it. So, I see a lot of the different initiatives around the industry today that are around offering free -- and free is not good enough sometimes, right? -- free hardware or software to promote e-prescribing. Money talks, and that is certainly a good thing.
But I do believe the implementation and the deployment issues associated with software are equally important, because we do know that there are a fair amount of PDAs out there that are absolutely not used, and it has not a significant impact, if you will, on adoption for the country.
Adapting to the work flow that occurs within a physician's office. I'm not sure how standards fit into that particular domain. I'm sure there is a way. But that is clearly an important part of making it all happen for us. There are a lot of touch points that occur inside of a physician's office with staff and medical assistants, in addition to the physician. And clearly, we have got to be cognizant of that. It's not just the physician and the PDA that makes this thing work.
These applications truly need to be integrated, and I think the EHR report and its gradations make a good statement of what integration means. Though I would like to caution us technocrats, and that's clearly my background, do not get too excited about providing a lot of information to the physician, because that's not what they are used to today.
I think a lot of what we have to look at is where is the industry today. We certainly know where it need to be at some point in the future, but we believe that there are incremental steps that take place in the middle before we get to that particular point.
So, for example, providing a lot of what I would believe to be onerous pop-ups to the physician, informing them of very assets about the medication, or what the treatment that they are doing might now help adoption, as much sense as it makes to all of us from an information, safety, and quality standpoint. So, a little bit of a precautionary note over there. That's my experience in observing physicians practice medicine.
The other aspect about workload is that no two physicians do the same thing in the same way. We have heard that many, many times, and I can assure as a part of the sales and the development role, I found it extremely frustrating. The good news is it makes us as software vendors, provide better technology that is adaptable and flexible. And that's clearly something that we need to observe.
As we develop and deploy standards, we should always think about what the physician needs. We have a lot of stakeholders in this room today, and they are the right stakeholders, there is no question about that. But we have to focus on is this going to be a hindrance to the physician to use a particular piece of information, or is it going to take more time?
And when I say time, I'm not talking about the aspect of writing a prescription, as was aptly demonstrated, but just the general scheme over the history of a prescription, through its life cycle, through its renewal cycle, and everything from there.
I think I have covered the various points that I wanted to cover in my presentation. Thank you for the opportunity.
DR. COHN: Thank you.
Our last presenter is Daniel Nutkis. Thank you for joining us.
Agenda Item: E-Prescribing: The Software Vendors' Perspective - Daniel S. Nutkis, Zix Corp.
MR. NUTKIS: Good morning, and thank you for letting me participate in these proceedings.
My name is Dan Nutkis, and I am Chief Strategy Officer. It's interesting, we didn't send our CTO or CMO or head of regulatory affairs. We sent the individual that drives our business strategy. And anything that either enhances or impedes that strategy becomes my problem.
I really don't have responsibility for implementing anything, but I do have responsibility for insuring that anything that either can accelerate or detract from our ability to meet our goals is considered either as a positive assistance, or as a potential threat to our success.
We have provided -- I did spend quite a bit of time last night throwing away the testimony. I apologize to the three people that are here from Zix or the four that wasted some time on my old oral testimony. We have provided I think 22 or 23 pages of written testimony, which goes into I think substantial detail of our position on the various standards, where we think there are deficiencies, where enhancements are, where we believe that in fact it can be enhanced.
Let me give you a little bit of sense of the experience, and therefore our perspective, because I do believe, since I don't have a medical degree, although I do have an informatics degree, and a minimal amount of time in that area -- so, I'll take Zix first, since most people have no idea what Zix is, except for the ones that remember it as your video store called Blockbuster Entertainment, and some of you may remember it as Toll Tag Company, EZ Pass. And Toll Tag is also one of our products as well.
So, we have now made the transformation into health care, and we're in various lines of business, of secure messaging. About a third of the Blue plans or health plans in this country use our secure message portals, the technology behind the technology. Actually, BASF uses our technology as well.
We provide a suite of other protection services, transaction services. And then we have a division that provides care delivery services. And in that group, there are a suite of services supported by e-prescribing, or a whole suite of services we refer to as e-prescription management, online doctor visits, patient education and compliance and adherence programs, laboratory ordering and results reporting, and a whole bunch of secure messaging infrastructure.
Our e-prescribing services are currently in use in about 20 states in this country, and we have specific focus in 8 states, a large focus in Massachusetts, Maryland, Connecticut, and New York. And now with our recent partnership with Microsoft and Wellpoint, we have expanded to Missouri, California, Georgia, and Wisconsin.
We, probably like many of the others, work closely with the plans, PBM, ICA Health Systems in whatever structure there may be to get to a physician or to find a model to promoting e-prescribing. In certain cases we are working -- I think this was discussed yesterday -- as part of something that is referred to here as a collaborative, where plans are banding together as in Massachusetts, where Blue Cross and Zix have come together to try to coordinate an effort, and I think you will see additional organizations become part of that, to promote e-prescribing within the state of Massachusetts.
We also have activities as well in Massachusetts with the Mass Share Program, specifically their Medsinfo, which is an initiative to provide drug dispense history to patients admitted into the emergency room of local hospitals, and that is to be with all the plans throughout the state of Massachusetts. Initially, I think that is starting with four plans, and I think three emergency rooms.
Today, we connect to various sources to get the information we need from the PBMs. So, we use RxHub. I believe we are still the only organization that transacts will three big PBMs. We also go direct to other PBMs in a number of cases. In a few cases the data is actually stored in one of our data centers, where they provide us with their eligibility, drug dispense history, and formulary information, and we process it.
So, from our perspective, the that we want people to understand is that we have found a way to work around what would be considered a lack of standards. And have found that that has not been a substantial impediment to being able to deliver our services, although as you will see in the oral and our written testimony, we believe that there is certainly a substantial amount of progress that can be made.
We, as I think was discussed, like many others deliver our services either in Web-based, PDA. We use various wire line and wireless services, either cell-based or WiFi. We are relatively platform agnostic. We do today, and I think was also discussed, have the ability to deliver contract level formulary information, patient co-pay at the point of prescribing. We can do it in a real time manner. And as was also discussed, we have the ability to provide real time laboratory results through our laboratory results reporting systems at the point of prescribing, and we link that with the diagnosis code.
The other thing that I would also point out is that the functionality is evolving at a relatively rapid pace. And we see that as the formularies continue to evolve, and we see new models that are starting to exist in the marketplace, we will see the technology and the functionality need keep pace.
So, as we see new formularies, as we see new trend management programs, and we see more drugs that are becoming step therapy drugs, we are seeing that the requirements from the plans and PBMs to be able to keep up with that is at a relatively feverish pace. And therefore, again, as we consider standards, and as we consider implementing guidelines, that they take into account honestly, things that probably I am not qualified, and I'm not sure who is at this point, to decipher and determine what they will be.
Just to give you some background, I am the chief strategy officer. That does make me extremely difficult to do this, as my background is making sure, and my responsibility that these impediments don't take place.
Just to give you a sense where I draw my experiences from, I did start out years ago relatively active in the health care standards drafting organization, a part of HISDT, which was the old health care informatics standards panel, one of the original members of WEDI, and the Computer-based Patient Record Institute.
So, I do have at least some experience in the standards process and understanding the complexity in being able to draft and fine commonality around standards. I also did spend some time as the national director of health care emerging health care technology for Ernst and Young. So, I was also very good at taking anything that was simple, and making it complicated.
But I also have some experience in understanding what the lack of standards would do in emerging markets, especially in health care, where we were trying to work with at the time, computer-based patient records, and a lot of evolving technologies with a lack of standards.
Also, I think to discuss what the subject matter was yesterday with the panel on the merits and virtues of e-prescribing, I'm not sure that anyone will question the fact that e-prescribing has enormous potential with health study. And there are obviously a number of other studies that have been released on the merits.
The thing that I thought was interesting yesterday was, and it something that comes out from time to time, is that the standards were not, or the lack of the implementation was not related to standards. I remember hearing that the pharmacy didn't know what to do, and the physicians wanted to be more incented. And there were a whole bunch of obstacles that were preventing widespread adoption.
And although there was some question about nomenclature or terminology and vocabulary in some standards, I think we would support the fact that our limitations are not related to standards. That’s not in anyway to say that the standards process is not extremely important; not that we don't support it 100 percent. But the pain that we see today, and the pain in the marketplace was around being able to put technology, emerging or not, there is a lot of question around the fact that it is emerging technology.
People like me would say the tipping point has just occurred, and we're now on the down swing. Some people, of course people that were here long before me in 1998 and 1999 developing this technology, would clearly say that it started some time ago, and this has been a very long road.
So, just from a standards perspective, and as I said, I have gone into a fair amount of detail in the written testimony, NCPDP Script standard, HL7, and the AST X12, there are three standards by which we operate today, and are able to perform the majority of our functions either through the various PBM partners. Obviously, as was discussed, RxHub has their own set of standards, and we also work with those as de facto standards per se.
Specifically, I think everyone has gone into the details on the NCPDP Script, so I'm not sure it makes sense for me to spend a lot of time on going through the NCPDP, the X12. We use the 270 and 271. And with regards to the HL7, a transaction set, and some of the other standards, we currently are faced with about 120 either hostile information practice management or EMR systems through standard interfaces or proprietary interfaces.
It is heavy lifting, it was what we need to do. And interestingly enough, we don't charge for our interface. We provide the HL7 interfaces. We provide our interfaces all free of charge. Our experience has been, and certainly others here have greater experience, has been that it comes out to be a sophistication and cost issue at the practice guide, not always the availability of an interface.
Irrespective of a standard or not, theoretically, the standard was so simplistic, and the interface was so easy, that the costs would not be prohibitive, and it would be much easier. We have actually found that people have said there is no incentive, there are no dollars, there is no sophistication.
I think we recently did a poll of the facilities that we work with, and the majority of the smaller practices weren't even under maintenance, so they couldn't call the vendors to even find out if they had an interface, and in fact, to get any resources to try to work with the standard, to work the interface.
So, we looked at some of the standards. We also looked at levels of sophistication, and the ability for organizations or institutions to be able to use the technology or tools that are provided to them. And that is certainly one that we have found irrespective of the differences, such as the HL7 standards.
I'm going to spend a lot of time going through the strengths and weaknesses. It's in my written testimony. And again, we find that the standards have not been a significant limitation. There is no question that we would like to see nationwide adoption. We run into it all the time, especially in some of the cross-border states where we've got a lot of people in New York, New Jersey, Connecticut, Massachusetts, Rhode Island, New Hampshire, and so on and so forth. We have the Washington, DC area as well.
Some other areas, I'm not going to spend a ton of time here, although there is one that hasn't come up, so I will bring it up, and I am surprised, given the magnitude of the vendors that are here. We have a significant problem with authentication. Because of organizations wanting more integration, and wanting to have seamless access, either on the privilege side or the access control side, they are asking for e-prescribing and a lot of the other functionalities be more indebtable in what they do.
So, the doctor that is currently doing lab ordering, and also wants to be able to also write the prescription. And they have already signed now for a third time on their PDA, and they don't want to have to sign on a fourth, or on their browser.
And there is -- obviously, there is X7 IT standard, or digital certificate. And as someone mentioned yesterday, they were using the AMA Verisign digital certificate or digital identity program. But there is really no standard in that area for vetting and authentication, and we can determine what the control space should be, and then have a single vetting and a single authentication.
Formulary, it's been mentioned and I'll mention it again that clearly for us, formulary is a significant issue. The bigger issue is misunderstanding where formularies are going.
Co-pay, obviously in drug benefits this is another area where standardization would be important for us as we looked at being able to assure that we can display the information and understand the potentials.
Drug utilization review. This is one that we have spent a fair amount of time trying to I think internally determine what role standards groups should play in the whole area of DUR. I think we would like to put it out there that DUR is an area where there should be standards, at least for the messaging, for the protocols, and at least for being able to identify how best to report this. As everyone probably knows, some of the standards on the adverse events reporting system probably would also have potential to be carried forward for some of this.
The area that also, and I'm not sure where it goes, but it's kind of a consistent issue for us in the market space is we operate a number of certified data centers. We operate them within pretty stringent guidelines. And it's just a consistent issue on standards for what is appropriate for transaction sets.
This is more an area of SLAs, but the problem is as we develop these more complicated and sophisticated standards, 36 seconds for a DUR transaction to come from point to point, negates the whole transaction, because people put the device down. So, we looked at some of these to try to understand what in fact people's expectations are for being able to allow the transactions to take place. For simpler transactions it's not an issue; more complicated, timing becomes an issue.
Incentives -- we are very much in favor of incentives. As was mentioned yesterday, there is a number of PCPIP programs or PIP programs, physician incentive, or primary care incentive payment programs that exist today. Blue Cross talked about one. We are now involved in a number of them where physicians are being compensated on a pay for performance basis for using e-prescribing, and we see that those models probably will continue to evolve, as there does appear to be significant interest.
The question will be the limitations that are put on those programs. We have some organizations that want to incent for writing scripts electronically, some that want to incent for writing scripts in accordance with formulary, and then you see some ratcheting up of some wanting to do incentives based on enrolling in adherence or compliance educational programs where the numbers can be substantial, where the physician can be compensated. And the question is, where do those programs fit into the model?
We also believe that the adoption by the Medicare program and the federal government will become de facto standards, so the acceleration in adoption by Medicare will in effect, take care of that.
And I think that's really the extent of my testimony, and I would obviously be willing to answer any questions.
DR. COHN: Okay, well thank you. I think I'm going to allow everybody to take a break, and then we will come back for discussions. It is now 10:30 am. Why don't we give everyone a 15 minute break?
Thank you all for great testimony. We will continue with questions and discussion after the break.
[Brief recess.]
Agenda Item: E-Prescribing: The Software Vendors' Perspective - Discussion
DR. COHN: Jeff, you have one comment, and then we are going to get into questions.
MR. BLAIR: Yes, since the topic of the continuity of care records came up, I need to recuse myself from any comments or discussions related to the CCR. It is an apparent conflict of interest that I may have on that.
DR. COHN: Okay. Does that mean you will not be able to ask any questions for the remainder of the session? No, I’m sorry.
Any questions from the subcommittee members? Jeff do you have any questions or comments?
MR. BLAIR: Let me pull my thoughts together a little bit further. Let me give someone else the time.
DR. COHN: Judy.
DR. WARREN: This is for Jill. You had mentioned that you wanted to include medical devices. Could you just talk more about that?
DR. HELM: Sure. We would like to expand the available data standards to accommodate those items that are traditionally orders on a prescription pad today. So, those would be devices that would be prescribed in an ambulatory care setting as part of a treatment plan, or devices that would be used to administer medications, and include things like oxygen, DMEs, home health.
DR. COHN: Great. I think Jeff has a question, and then I'll follow-up afterwards.
MR. BLAIR: I think Jill may have mentioned the issue of prescriber identifiers. This really is open to all of you who could help me understand this. Yesterday in our testimony there were three standards mentioned that get at the area of prescriber identifiers -- the DEA, the emerging, upcoming NPI, and something developed by NCPDP which is called HCIDEA.
The comment yesterday was that none of the three is ideal. They all have certain strengths or weaknesses. I would love to hear from all of you regarding your perceptions with the strengths and weaknesses of those three prescriber identifiers, and any guidance or recommendations you have for the subcommittee in terms of our recommendations on that topic.
MR. TRUSKY: I guess I'll take a shot. Larry Trusky.
Certainly, I think yesterday some of the challenges were mentioned about the DEA number, and I think those are common challenges. Not every prescribing entity will have a DEA number, so it doesn't cover the entire base.
The NPI, that is intended that every prescribing entity could have a unique identifier. The challenge I think that Richard mentioned yesterday from ProxyMed was that doesn't really represent a clinic. So, does a patient belong to the physician, or do they belong to the clinic? When the physician leaves, how does the pharmacy system target back to the clinic, versus targeting back to a physician?
And I'm not going to say that there is a great answer for that yet. I think that requires more study and more understanding of how the pharmacy systems operate. Today, I believe they do target by DEA number, so I think that is the challenge either way with the DEA or NPI. And HCIDEA, I believe is similar to the NPI. It's another representation of the unique provider ID.
So, I don't think any of them answer the question that Richard was asking yesterday, which is if a physician leaves, how does that targeted message from the pharmacist back to the site, stay essentially with the patient chart -- the patient chart is going to stay in the office. How do we keep targeting, or how do we message back to where that chart is going to be?
MR. BLAIR: Let me prompt you a little bit. My understanding is that HCIDEA is able to identify the prescriber may order from many different sites. And that the facility and the site is important, as well as the prescriber ID. However, they say that there are some shortcomings, and that is what I'm not familiar with. And of course, the NPI won't be available for a couple of years in terms of usage. And it doesn't identify site. It would just be the individual.
MR. TRUSKY: My guess on that, not knowing enough is that even the DEA number today, you can have multiple DEA numbers based on your location. You can, state by state, get a DEA number. I don't think that's how people operate. I think even though the standard may allow for it, there may be challenges in implementing that, because as I understand HCIDEA now, they are just taking data feeds from multiple sources, and trying to match the patient and provider. I don't think that accounts for multiple registrations. Again, the standard may, but I don't think the data support that today.
DR. KAUFMAN: This is one of those instances where the message structure is probably going to determine what identifiers are needed to fill it. So, certainly we need an identifier that is going to uniquely identify a prescriber. When as a message model evolves to support the use cases, we'll identify the need for additional identifiers such as the location or ownership of the patient's persistent medical record, site at which the care is provided, and other things like that.
But I think it will be more coming out of the use cases and the messaging models that will define the additional identifiers that may be needed beyond the obvious one of the prescribing agent.
MR. BLAIR: Peter, you are with DrFirst, and you gave us this demonstration of how quickly you could wind up going through the flow to order a prescription, which has tremendous value, and is really important.
On the other hand, we also saw the pyramid where we could go up levels of that pyramid and improve patient safety in doing so, and quality of care, and previous costs. But as we do so, we are giving more information to the prescriber to make decisions with.
Could you and the other folks please give me your thoughts about as we go up the levels of the pyramid, and increase value from that standpoint, are there concerns that we have to consider when we are selecting standards which would make the process of prescribing more time consuming? And is there a threshold where the physician will feel uncomfortable that it's taking too long?
DR. KAUFMAN: Those prescriptions that I wrote, at the time I was writing them, were checked for allergy, drug interactions, and insurance formulary. None of them had any alerts, or the alerts would have come up. The level six in the pyramid, which is including the full EMR, would allow more data to be placed into the system without the physician or the prescriber, whoever it is, having to specifically enter it, notably the patient's weight, the patient's age, although our system does contain the patient's age, and the diagnoses.
Some systems get around this by adding value using the diagnosis to help to choose medications, where they are able to capture the diagnosis without the doctor minding that they are actually having to add a little bit of extra data.
But if the system is not doing that, the doctors really are concerned very much for safety, but even more so with their time, and being able to change their practice patterns to include electronic prescribing, without having to see fewer patients, without having to -- but I do think that it's very valuable.
However, I think we can add more value to the system by getting doctors to accept and adopt electronic prescribing in a connected form level, than requiring doctors to jump through the hoops it takes to do level six, which most doctors are not ready for. But I do agree that we should always at least mention the use of comparing the patient's weight and the patient's age and the patient's diagnoses with the medication and the dose prescribed, and not just allergies and drug interactions and insurance formulary.
MR. BLAIR: And Dan Nutkis, on this issue you referred to 36 seconds doctors would have to wait for something. What were you referring to?
MR. NUTKIS: Well, that was theoretical. I think it was mentioned yesterday that we held some focus groups and we brought the physicians in recently to go through some of this. And we have been given a whole bunch of anecdotal information. And the information was the physician didn't want co-pay. And all of these alternative messages that may change their behavior would be negatively perceived by the physician.
Now, again, in this commercial society that we have, that means the physician puts our device down and they pick one of the other devices that doesn't in fact require them to do all these other things. By the way, our devices don't require any of those things. But having it mandated by a third party appear to be somewhat difficult for us to accept. Our focus groups have said about 20 seconds.
But what we have found now is there are a number of things that will change that factor. It's called value composition. So, again, it goes back to the analogy of cell phones. They were big, and they had bad battery life, and they had terrible coverage, and they cost a lot. And there was a dipping point, or there was this curve when the early majority and the late majority and then your adopters came in.
And there were some things that have been added now, so we know it is 22 seconds. We know they want full blown DUR. We know they want prescription history. But the biggest function that we have now found that they are willing to wait for is real time fire up. And this is the one now that we have found that they will wait a significant amount of time for real time fire up. So, we have been developing it. We're testing it now for doing step therapy.
So, we'll be able to tell them real time in fact what the step therapy is. Now, for a physician, they just don't know, right? They go and prescribe Celebrex. You know that 10 percent needed to be a prerequisite, and they get the call. And the pre-authorization call is the most difficult to deal with, because of the charge, the formulary.
So, we have now found that even though 22 seconds -- and by the way, 5 seconds is what we strive for. Five seconds, bar none, is what we absolutely try to get everybody in and out for in 5 seconds; 22 seconds is about enough time the physician will do before they sit down the pad, and walk away.
MR. BLAIR: Is the prior authorization work that you are doing, is that being done in conjunction with X12 or HL7, where it could be a standardized message?
MR. NUTKIS: I think the answer is yes, X12.
DR. COHN: We have a couple of other comments. Are you done, Dan?
MR. NUTKIS: Yes.
DR. COHN: Tom, do you want to go first?
DR. DOERR: Yes, I'd like to suggest that the market is going to find several sweet spots in the trade off between the complexity of the work flow, and the value that is created when physicians use the particular combination of features and functionality. And I think that one sweet spot may well be what Peter shows us with DrFirst, where you are highly connected. You have this very fast work flow.
And in my oral testimony I have been lobbying for arguing there is another sweet spot that says let's make the work flow diagnosis-driven, because then we can hook decision support information to combinations of diagnoses and drugs, and create a lot of value.
And the third sweet spot would be the full blown integration with the EMR, the level six. So, level five is what DrFirst offers. I'm suggesting there is a level five plus that says that in the big picture, physicians are directing about 80 percent of spending in a $1.7 trillion market. I saw three estimates that were in that range of around 80 percent published.
And the information that we doctors are bringing to our decisions in terms of I've got to make a decision here to treat a condition. What are my alternatives? How effective is each of these options? How expensive is it? And what are the short-term side effects, long-term side effects? Because I don't have information.
So, that my vision in founding my company was to bring this into doctors' work flow. And what we demonstrated in one controlled trial that I sent in earlier, it's in press with The Annals of Family Medicine, was that the payer was saving about $1,000 per doctor per month when the payer had a 40 percent market share.
And so that the proposition that I make payers is that it's not enough to have the payer pay for the cost of the system. The payer needs to be sharing some of the value that is created when physicians are conscientious and practice evidence-based medicine, and invest in these tools. So, that there is a sweet spot there where the payer will get some of those savings from physicians above and beyond the cost of the system. And I think that the market has been finding sweet spots, and I would say there are trade offs.
DR. KAUFMAN: I simply would affirm that we want to provide all of the information. Let vendors figure out how to make that very efficient and effective for providers. We have done that in the past. I think it's doable.
Two really detailed things that actually might pertain to things you could look at doing, two of the things that we found out -- well, the act of prescribing -- are spurious or unwanted alerts. And that is the decision support system is warning prescribers of problems, which they don't want to hear about. And frequently, we know that it's pretty well demonstrated that once people start discarding and missing these alerts, they stop paying attention to them altogether, and they stop being effective.
There are two things that tend to produce those that you guys might be able to impact. One is when we used to use ICD-9 to try to -- it was kind of the interlingua between our applications and knowledge-based vendors' applications. It produced a wide array of false alerts for indications and contraindications, because of the big problem with ICD-9, the fact of the classification, the fact that you have codes which about 2,000 out of -- they don't know what they mean. So, that is a delusion problem. We had to turn off contraindication checking.
So, going into a clinical terminology like SNOMED-CT, integrating that with the knowledge-based vendor representation of patient conditions can really decrease the amount of false alerts, and reduce the time span of dealing with them during prescribing.
My understanding of this, I ran into this in acute care applications we had, the Food and Drug Administration over years of work, has provided these black box warnings that go on package inserts. These are warnings of drug interactions or contraindications in which you are never supposed to give it.
Well, what I was told by people who work with this, and clinicians who work in this domain is that many of those probably are not correct any more. Some of them are historical data of studies that were done in the fifties or sixties with 10 people. They have identified them, but they are still there.
And neither we, nor our customers are comfortable turning those off as long as they are on that black box on the package insert. And so, they are constantly producing unwanted alerts, and nonsensical warnings that people turn off. And they are category one, and they interrupt work flow.
So, the only way I can see that getting cleaned up is going back to the FDA and saying, we've got a problem with these black box alerts. Can they be re-evaluated for ongoing clinical reasonableness?
DR. DOERR: I'd like to briefly add I very much support that idea of going back to the FDA, because they are driving the standard of care. There is no physician who is going to ignore a black box warning, because of the threat of malpractice liability.
And I would like to amend my earlier comments to add that the Achilles' heel electronic prescribing systems has always been utilization. There was a whole wave of these companies that came out in the late 1990s. And they came and they went, because they weren't creating enough value. The value proposition to the physician was inadequate.
And there are work flow challenges that are important in making the system usable, but there is this whole other concept of how much value is being created when a physician uses the system in any one of these sweet spots? And then what happens to that value? How much of it gets back to the doctor?
With the system that my company made, which is ICD-9 diagnosis-driven, we average 15 new prescriptions per doctor per day across the entire user base. And in two of the studies we did that involved payers, they told us that those represented capture of more than 98 percent of all the prescriptions that were associated with those doctors. So, that we think it's very close to the whole utilization.
And there were some work flow efficiencies that made that happen, but the other thing is this whole concept of the doctor can create several thousand dollars worth of value per doctor per month using a system such as ours, or others could develop something similar to that. Give some of that back to the doctor, and then we'll get their attention, because my own belief is that it takes about $10,000 a year in new revenue to get primary care physicians' attention, and really get them to want to change their work flow.
Really, it comes down to the concept that I believe primary care physicians are economically stressed enough that we are economically driven. And it is just the brutal truth.
DR. COHN: Tom, thank you very much. Obviously, most people are driven economically.
Larry, I think you were going to comment?
MR. TRUSKY: The only other comment, Jeff alluded to it, the other transactions that happen during the process. There was pressure early on for some of these formulary drug histories that some of this is just too hard. You can't do that. You need to hit up against our databases while the prescribing is happening.
And of course, we worked through that, but I worry about the danger of saying that some of these transactions, that these standards are too hard to evolve, and not allowing for that data to come down to the prescribing system, and get through these as fast as you can, in three seconds, five seconds, whatever the right time is. Not be 20 second transactions for a drug history, or a 20 second transaction for an eligibility, a 20 second transaction for formulary. That's all got to happen pretty quick.
DR. COHN: Final comment on this one before we move to another question?
MR. NAYAK: Actually, the previous question I guess, and that was related to work flow and adoption, and the fear that standards might impact that. I just wanted to provide by way of example of the instructions, the directions that are the meat of the prescription that we have been referring to.
There clearly are many, many ways to do that, and you will find that the prescribers use different -- everybody does it slightly differently. So, the ability to provide recommendations of things, this is how it needs to be done, but also providing sort of the release valve to say, yes, you can also do it your own way, in some way, shape, or form might be the right balance that you are looking for in standards and so forth. Just a commentary.
DR. COHN: Harry?
MR. REYNOLDS: Can you put your presentation back up again, and put up that level -- if you're disconnected, fine, don't worry about it.
MR. NUTKIS: The pyramid?
MR. REYNOLDS: No, the other one that had the levels. While we're getting it set up, I'll up what Jeff had to say and some of the other comments. And then yesterday, for some of you who weren't here, Stan Huff got up towards the end of the session and talked about this is a journey. And the pyramid is a long journey. And segments of the pyramid are not a long journey necessarily, because some of you are pretty much already there.
Also, since you happen to be the segment of the industry -- if you look at this, this is really in the end, all about whether the doctors will use it. The rest of the industry has pretty much said we're going to circle the wagons, and everybody is kind of involved in one way or another already. So, it's really about who touches the doctors. It's a similar issue to what we ran into with HIPAA and other things. It's really where it meets the road in the care setting.
So, if can even in just short period of time, and playing again off Stan's comments yesterday, are there things on that pyramid, going from level one to level six, that you think are things that could be set down, could be put in place that would allow you to develop the rest of the things on the pyramid?
I'll just use an example. You can pick NDC for example, just using a layman's example. That could be put in place so that we are not developing standards right now all the way to six, which are going to take a long way to do, which means that your process is longer. Again, just to try to play off a little bit of our discussion yesterday. And then what time frame roughly would you have on some of these?
DR. COHN: Harry, just to make sure I understand it, are you talking about low hanging fruit?
MR. REYNOLDS: That would be a real succinct way of asking it.
MR. BLAIR: Just one clarification with respect to low hanging fruit, because this is a very good question. But the pyramid is really saying levels of functionality. It is not necessarily saying that the top of the pyramid is a lot way off compared to other things. There are folks that have EHR systems today that are adding e-prescribing, and they have some of the aspects of five and six, but they may not have number one, which is the separate referencing information.
So, I'm not sure that it's a linear path line from the bottom to the top, but it is a very good, useful way of representing functionality. Did I make a misstatement here, or do our testifiers agree with what I have said?
DR. KAUFMAN: You made an excellent point. Level one is kind of separate from all the other levels. I believe that from 2-5, they are inclusive. You can't really have level five without level four. You can't have four without three. The level one is something that some e-prescribing applications, even level five applications do not have. And as I mentioned during my testimony, level six EMR applications have that.
MR. BLAIR: Thank you.
DR. HELM: I would submit to you that some of the gradations on the pyramid actually are independent of standards and availability of standards. Level one, if you are going to have any type of stand alone formulary information, any application that is functioning in isolation, standards are much less important than when you have an integrated set of applications, and you need to exchange data between multiple applications and multiple partners.
And that's where I would argue that standards become critically important. It's really so that we can play at those higher, more sophisticated levels of functionality, and to get there more quickly. Now, does that mean that I think we need to have universal adoption of a standard across the entire health care delivery system? I really don't know if I feel that way.
I think there needs to be interoperability. I think we need to be able to talk to one another. But I don't think we need to always speak the same language. And I would argue that there are certain attributes of different standards that may play well with certain health care delivery systems or for certain applications, where I don't know that you would want to make that trade off between that level of sophistication between that data richness for the sake of uniformity.
DR. KAUFMAN: Can you give an example?
DR. HELM: I think that ICD-9 or SNOMED, I think vocabulary for diagnosis is the perfect example. You may want to use nomenclature that is more symptom-driven if you are a clinician practicing at a health care delivery setting. You may not -- when a person walks in with a runny nose, a physician may not want to say, oh, this is allergic rhinitis. They may want to say this patient has a runny nose.
Now, that eventually needs to lead to an ICD-9 for purposes of billing, for purposes of transactions. But it doesn't necessarily have to be the only identifier that is utilized.
DR. COHN: Harry, I'd like to get back to your original question, because I think we are sort of going off. And I apologize, but really, I think what Harry was asking was really a very reasonable question having to do with low hanging fruit. And I would like to redirect this there, rather a more general discussion about the value of standards.
MR. REYNOLDS: And again, as was pointed out yesterday is sometimes low hanging fruit is taken as a quick way to an answer. I have heard everybody on this panel talk about things like NDC is embedded in your system. Well, if that doesn't become a standard, it's obviously going to be a burden on you, and change what you do or don't do. And it's going to cost a lot more, and it's going to take a lot more time.
So, I'm just trying to understand you as a segment, what do you have that you like? How does it relate to what we are talking about here, which was kind of the end game. That's why you are all walking around with the same pyramid. It's kind of the end game in all facets. That's kind of what I was after. So, it's not just a quick answer and we all go home. It's which are the pieces. And I think that's what Stan touched on yesterday.
Which are the pieces? If we had passed earlier standards and said those are in place. You don't have to worry about those coming out from under you, you could move forward. That may not be an easy answer. It may not be a clear one, but it's at least a discussion we are having.
It came out yesterday, and I would at least like to see it explored by the people who are actually dealing directly with the care setting, because you are going to be the ones that have to deliver to them, and they are going to have to pretty much agree with it.
DR. FAUGHNAN: There are a lot of sophisticated systems that have been in place throughout the nineties and continuing on to this day. So, we can't have left off what's out there. If you look at the very minimal things that most systems that are in place today have used that you would want to put in your standard, NDC11, certainly.
And there are some issues with NDC, issues with how the codes are assigned and packaged throughout, process issues with who handles that. Is it the manufacturer? Is it the FDA? There are ways this can be done to work around those process issues. There are improvements that may perhaps be needed in some domains, when they might be running out of digits they could use for packages.
But by and large, work can be extended and grow. Script works, and CPDP Script, and they've got a lot of pieces in it. It hasn't been fully tested or fully used. They have a good starter and a good process to direct it.
If you want to send diagnostic information, most people -- and you are not worried about contraindication checking, you can use ICD-9, and that is traditionally what people have done, or just a text string, at least to give something to the pharmacy. But probably you wouldn't want to do automated contraindication checking on it.
And then you've got all the X12, and the well defined transactions on demographic, and probably the biggest one -- they are not so much essential. We can and have worked without them, but they reduce costs for implementation. And speeding implementation are the standards around formulary transactions, drug utilization review. Getting the medical history back to age you are prescribing. They're nice. They're good to have.
MR. NAYAK: If I can just focus on one, maybe people know it's important, but just to sort of try listing these out. The listing of formulary items for one would be extremely beneficial, just because it may be some done formats, but it would certainly be great to get people to correlate and manage to a single file. It would certainly help the cause.
MR. REYNOLDS: Are there dominant ones out there?
MR. NAYAK: I know RxHub has done a great job of trying to normalize this between the three largest manufacturers that they have, between MedColi(?), SI, and Care Mark. So, that's the reference point.
DR. KAUFMAN: I think if you are talking about low hanging fruit, we really need to deal with a couple of issues. One is patient safety. What is the low hanging fruit in terms of patient safety? We are talking about allergies, drug interactions, diagnosis perhaps, but I don't view the drugs for disease complications as low hanging fruit, because it's hard to get the data in there.
Whereas, if you have medication history and an allergy history, which is very little data, and its persistence, that is the low hanging fruit. And having a good classification of medications, that would be a standard across different systems, and I know you will hear this afternoon from the drug database vendors, is extremely useful.
I heard this morning during our coffee break about a company that is using one of the vendors. And they want to supply the e-prescribing to a practice that has EMR, that uses another vendor. And it's very difficult to compare those classifications of drugs. So, that's for safety, I think some of it would be useful, and would help with low hanging fruit.
For sharing prescriptions, and I know that over on my right I want to talk to a couple of privacy people. And one of the things that I think this committee is not, I believe responsible for doing, but it's a really big issue, how do we get this one patient's medication list to be shared between different providers in a way that is safe, and still values the patient's privacy.
The Scripts would say delete the patient, and carry it around with themselves, as long as they didn't get it the day they end up in the emergency room. But having some way for a good medication history, RxHub is doing this now, but it's limited to the PBMs who are their partners. And RxNorm I believe also to have a way of calling the drugs the same thing between applications, so that prescription medications would be shared and be analogous.
And the last thing is formularies, in terms of low hanging fruit, providing value. E-prescribing doesn't help if the prescribers are not using it. We want to provide them with the greatest value, with the least cost. And that's not just monetary. Sometimes they are willing to pay for something that works better for them, but time as well.
And the comment made earlier by Dan about the prior authorization and automated step therapy, all of this is extremely important to provide value so that the physicians will use the system. And then the system can have the medication history shared between the different doctors, however we're going to do that, and provide the safety that is inherent in electronic prescribing.
MR. BLAIR: Could you elaborate slightly on that last one? With prior authorization, exactly what are the messages that need to be standardized? And who do they go from, and who do they go to?
DR. KAUFMAN: I believe the TH Links are going to be testifying tomorrow, is that correct?
DR. COHN: That was yesterday.
DR. KAUFMAN: Yesterday, too late. They are trying to put together a standardized prior authorization system. And they have had some difficulties with it. Many of the medications, the prior authorizations sustained between many of their -- 24 I believe it is now members -- some of the members have it a different. And then there are other medications where every member has it a little different, and they require prior authorization for different drugs.
At least if there could be a standard format, the format might require a patient's diagnosis. The company could require or not require it. It might require prior medications if the patient has been on medication or medications.
It's very easy for the vendors up here to write a format like that, which would appear differently for different vendors, different medications based on which of the specifications were stipulated by the payer. But it's complicated to do it when each of them has a different specification, just like each state is not a state, but many of the states have different requirements for a faxed prescription, and it has to be in a specific form, for a controlled drug it has to be on a specific form.
It makes it needlessly extra work, and it's just because different people are writing it. While the whole purpose of having a great standards committee is that they can make at least suggestions, if not standards, to say why don't we all do it this way. And then we vendors can all yell at the companies who don't follow along.
MR. NUTKIS: Let me give a slightly different perspective. I guess in my little experiment how we have defined pyramid is really an evolution of functionality. It's really how people look at this, and how they evolved. And I think that was really the perspective that we had, and again, e-prescribing is a good example. What we consider e-script writing, what we consider e-prescribing, and it's vernacular, terminology. And the pyramid gives us a commonality around the terminology.
So, now I think the question about I guess I look at it as the prioritization of obstacles, or increased value propositions, or anything to increase the value, which is what I think we put in our testimony, which is from our perspective, it's all about adoption.
Adoption is about value. Obviously, someone has got to find value, either to pay for it or to use it. And what are the obstacles for me to be able to find that value? I think as we went through those obstacles, we again would highlight the same issues.
DUR is one that continues to come up in patient safety. But it is one that there is an inconsistent formulary. And again, formulary us, we look around. We would like to see it standardized, but by the way there are some there are work around and some there aren't.
And that goes to I guess really my main point, is I guess being somewhat jaded, having been there with Richard Dick when the computerized patient records, those that were there -- Paul Tang, Peter Whately(?), I think you were there, right, Jeff? We had this grandiose plan. And I want to say that was 1991-92, but again, I don't remember anymore.
And we had this great plan of a computerized patient record. And I think it's all quite a bit now. We haven't gotten that criteria. That's fine. And there were some spin offs, I think it was with the MCC program, the Microelectronics Computer Technology Consortium. We were going to get all the technology vendors.
And I guess it comes down to is complexity, comprehensiveness, versus speed. And where is the happy medium here? Are we better off defining less -- and I think that was the point -- that the standards be slightly less effective, but get out there sooner, so that they can meet the specific component of our requirements? Or do we take the time and really develop comprehensive standards, and take the extra year to do them right?
And again, the cost of re-implementation and upgrading. And those are some bigger questions that I think someone has to give a lot of consideration to. But for us, we get by with heavy lifting. So, formulary, and we talked about prior authorization. And by hook or by crook, we make them work, because there is a business justification to do so.
DR. COHN: Steve, I think you had a question, and I have one after you.
DR. STEINDEL: Actually, I have developed several questions during the discussion, and I think they are somewhat related in the sense that I have heard multiple opinions about standards expressed as we go through the panel. We hear NDC. Everybody uses NDC. But then we hear that RxNorm is a better way to order. Let's get RxNorm into place.
I asked the group yesterday, and I'm asking this group the same, last year both the CHI process and the NCVHS process coordinated on a recommendation for medical terminology that involved FDA terminologies, which include NDC, but the improved form of NDC, RxNorm fully implemented, and the FDA also included structured product labels in its expanded form.
And I haven't heard any of that mentioned in any of the discussions. I would like to know how that fits in with your strategies, especially when I hear at one end of the table that we can work around most standards. Will this help standardize the medication issue?
I have also heard with regard to the diagnosis code, various forms of this expressed. One is that ICD works. That's what we use for a diagnosis code, and that's what we should continue to use. And then I also heard that we need to go to the granularity of SNOMED to talk about medical history.
But I have heard that more in the context of running physician support systems than in the context of actually providing that information for making this decision whether to dispense or not. And I'm wondering if what I just made is a true statement or not?
I'm also concerned about the use of the diagnosis code, which gets to the discussion that came up earlier about the temporal nature of FDA recommendations, and how they change in time. And this is with regard to all places that use the drug. If we are requiring diagnosis codes, and then we're looking at an off-label use of the drug, which also gets in line with the drug-to-drug interactions that have been proven over time to be false.
Where should the medical literature come into this system, and where should the regulatory system come into this system? And if we are going to bring in the medical literature, what's actually going on in practice, we have no standards to do that. How do we do it? How do we make decisions?
So, I would just like your comments on what I see as some of the confusing issues that are coming from the panel on how we should resolve them.
DR. FAUGHNAN: What do standards let you do? We already do a lot. Standards let you do it much less expensively. It reduces the cost of implementation. And it reduces the cost of interoperability. So, typically if you have enough money, and you have enough time, you can g