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 get around most of the things.
Now, some translations between terminologies are just impossible. You can get around a lot of things, you can work around a lot of stuff, but it reduces cost, and let's us start to do more advanced things somewhere further down the road. That's what they are about.
In terms of the diagnosis codes, it depends on what you are trying to do. If you are trying to take those diagnostic conditions and throw up a list of medications that might be indicated, we still do that with using ICD-9. Every so often you get some really whacko recommendations that way, but prescribing, for someone who knows about medicine, and so they can sort of guide those recommendations.
If you try to do contraindication checking, and that does not work. I can definitely tell you, that does not work. You can't use ICD and do contraindications. In terms of RxNorm, I think it's really about interoperability. Within our world and our applications, we work with First DataBank; if we need to work with Multum.
If we need to send drug allergy information to a pharmacy, we can always use NDC codes to fudge, because you can pick and NDC code, any one of 100, and back reference it, and you'll find that it's dispensable in a local representation. But I've always been a little nervous about that. I think it would be maybe a little safer to have a standard way to represent the medicine at the dispensable level at least.
In terms of regulatory, the issue that I raised about the black box labels and drug interactions. I don't have a process recommendation for that other than I think that you guys are the experts in knowing how the government works -- or doesn't work. It's seems to me it's something the FDA has to be tapped to address. I don't know how to do that.
MR. TRUSKY: I guess I would add I hope you heard today that NDC is an available identifier. It's not a good one for our group. And there are plenty of organizations that refuse to use them. One of the script messages are renewal requests from physicians. Imagine if you can get that drug identifier, and you are not using free text. You can save that physician a whole lot of time reconciling things to his database.
And going back to this pyramid, I think you can get to level four through a lot of heavy lifting. When you try and get to level five, that's where I think the most that it's going to be connectivity. The message is crucial here, is interoperability. The minute we start to go there, we have to rely on national identifiers for drug or for allergies or for diagnoses.
That's the biggest thing in the bucket we can come out of here with is getting those identifiers in place such that we can allow the interoperability to happen.
MR. NUTKIS: Just as a clarification on the point, I think that my response was related to prioritization. And the question is prioritized based on the pain today, where things are inefficient, and we can do some heavy lifting, or do we do areas that actually do require new standards, although they may not be the greatest pain, but there is no work around other than standardization.
That was really where I was going with that, is which one do you attack first? The rest of the domains, including standardization is very beneficial, but we it today, but there are some things that we just can't. And as I was looking at the list of the presenters from the data sources that is coming up later, I realized I think we actually contracted every one of them.
And that's really become the model for us, because we do have everyone accepts different models, everyone wants reference guides. And we have a hard time with assistance in that area.
DR. HELM: Just one more thing to add about NDCs versus RxNorm. Today we force electronic prescribing into an NDC model. So, we ask physicians to make a level of drug designation that may or may not be clinically meaningful to them, and that they may not necessarily want to make.
So, we are competing with the paper prescription pad, and we want to be able to emulate the functionality that a physician has with a piece of paper, that if he wants to write a prescription for Tylenol, and doesn't particularly want to specify whether it's a tablet or a capsule, that he is free to do that, and an electronic environment can communicate that to the pharmacy of the patient's choice.
So, that's really -- as we heard and as we speak about different standards, what we have today is very good, but it's just kind of what it's going to take for us to get to the next level, and with that, increase adoption.
DR. KAUFMAN: Just a quick point. One is yes, we can work around using the NDC codes. I say we shouldn't. RxNorm is basically just about done, and we should certainly take that. But the more important point is that if we step back for a second and look at the whole process, we have to do e-prescribing right. This is just the very beginning.
When we talk about the national health information infrastructure, and sharing the data with an electronic medical record and prescription data, we are talking about a much bigger deal. You have to get it right with electronic prescribing to eliminate all the heavy lifting we can, because the real heavy lifting is yet to come.
DR. DOERR: I'd like to comment, I'm supposed to be answering questions, not asking them. But what seems to me what has emerged from all this is this question of how much juice do you get from this squeeze of these various standards that are being tossed around here?
And I think it might be fruitful, to keep on with this metaphor -- no, I think that in the case of RxNorm, the advantage that is enabled is you have some electronic prescribing companies who are very well connected. You have some electronic health record companies who have gotten diagnosis codes. They have physician support, but they are not connected.
And the problem is if the electronic prescribing is using First DataBank, at least for my company, and here an EHR company that wants to replace their electronic prescribing module with ours, we can't, because they are using MediSpan.
And when those systems for naming drugs, they change at different times, so it's just not interoperable. So, that I think that in the case of naming drugs, my opinion is there is a pretty compelling justification to go forward with RxNorm. It's pretty well worked out.
I think there is overwhelming justification to have a nationwide standard for presenting prescriptions. This idea that every state has their different way of doing it, that's just incredibly wasteful now. And sure, there are work arounds, but there is not a good reason to keep it the way it is.
In the case of formularies, there is benefit in standardizing the expression of formularies. It really comes from the payers who want to have formulary status information that is granular down to the level of the employer group. And there are services that license formularies that information like MediSpan.
So, in the case of formularies, there is a work around. It gets the job done reasonably well. So, there is an alternative to forcing the standards there. In the case of physician identifiers, it's really problematic, when we can't, and I think there is a need for that. And I don't have the expertise that John has to comment on all the standards, but these are my thoughts about these few. I don't know if you want to add any comments on any other ones?
DR. FAUGHNAN: Script we have mentioned a few times, and everybody is okay with that. Along with that, signatures, electronic signatures and authentication. And then the way to uniquely identify the patient, however that is done. And with X12(?) we have algorithms to try a unique way to identify patients that seems to work well, and we are not in a position to suggest an approach to take. There is a need for a way to do that.
MR. NAYAK: I've heard the questions and listened to the responses. My general question back is are we responding to the questions? The question is what are the low hanging fruits that we can tackle? And then there was an expansive question on specific standards that you asked.
But the general response that I think all of us tend to give is that we have working around this for a long time. We can do it, and don't develop something that will hurt us all in a particular sense.
Are we really responding to the questions? I think in the earlier testimony that we all gave, we sort of identified five or six points that I think you can boil down that there are areas that need attention I guess.
DR. COHN: Well, I don't know if we are going to pursue this any further. I think Steve was asking about some additional areas, and I think we got some fair response on that.
I have a question I want to ask. This follows along from Dan, your comment about this issue of authentication and all of that. And obviously, it causes me to think about sort of an issue we haven't been talking about. It really gets beyond our agenda for later on, but it's this issue of controlled substances.
And I'm curious about what happens in your experience when a physician has to write a controlled substance. You said potentially there are systems where you couldn't write it, but are they going down to paper? Are there ways that they use it? Are there things that we need to be thinking about as of now or a little bit down the road to enable this one, or what?
Peter, do you want to start out?
DR. KAUFMAN: Well, our system is written mostly by Brendan Berloski(?), who wrote PubMed. He at the National Library of Medicine. Some of you may know him. And we put a lot of rules into the system that will take care of these issues. They take care of it, but again, work around is horrible.
If someone writes a prescription for a new drug, and then sends it to the pharmacy, they will get an alert that says it can't be sent to the pharmacy, please print it out. And you have to print it out, sign it, and hand it to the patient. Of course that's a problem in New York, which is triplicate form. But it can be done, it can be worked around.
We are scheduled to do 325, those can't be sent electronically either. The SureScripts, those can get faxed using whatever standard form the state has, as long as it has been in triplicate form for the 325, and New York has I think a number of drugs that are required to go on the triplicate form. But again, that can be faxed on the state standard form.
Again, I understand that end of it. I understand the basis of it. It makes no sense to me, given how much states -- the digital signature, and we are requiring a separate PIN code, user name and password, and it's a two password system. Biometrics is a possibility. Our system is triple scripted for strong SSLs.
This is so much more paper than paper prescriptions. I have had patients in the past take paper prescriptions and write their products on them, or change the refills and stuff like that. This system is preventing that.
Yes, it's not perfect, but it's much, much better than what we had, and I would strongly urge for some -- I don't the FDA is supposed to be coming out with regulations. I imagine everybody at this end of the table and our company are very good on security, but we're a little worried about what they are going to come out with, and how strong those requirements are going to be for authentication, biometrics, TKI, things that really are not ready. The infrastructure is not in place yet, and the machinery is expensive.
I know people don't want to hear it's good enough, it's better than what we have. I'm going to say it's certainly much better than what we have, and I would hope that we could figure out some way to accept firm authentication for controlled substances.
MR. NUTKIS: I always find this kind of interesting. This actually came up in a focus group last week or the week before. We were talking about our security now. We are rooted at a security company. We have full time cryptographers with various certifications from the Department of Treasury. The messaging goes to our data centers as does a number of other large financial institutions as well. We take security very seriously.
It was very interesting when we were in the focus groups, and I think in this case it was the physicians and maybe some of their office staff as well, who were not really sure that the technology is really secure. And we're all looking at each other behind the glass going, you mean more secure than picking the phone up, calling the pharmacy?
And we weren't even talking about controlled substances here. We are just talking about regular prescriptions that they, for some reason, thought that there would be the possibility of abuse. And what was interesting to us is that there are a number of pharmacies now that will take things like Vicotin(?) and others, and will take them as call ins if they happen to know the physician or the nurse.
So, it was interesting, the perception, and I think people from the security side will know that security-wise we can, there is no question with a standardized authentication and authorization process, this isn't an issue.
We have implemented TKI and strong encryption, Defense Department systems already that have extremely -- a greater degree of requirements. And a lot it comes as what is the authentication process? What are the security mechanisms? How do we vet the individual to know that the individual actually writing that prescription is in fact the person that they say they are, and is in control of that device at that time?
And there are standards that exist for various other related topics. So, there is the Federal Bridge Project. There are a whole bunch of other projects that are already at the federal level. We level it's something that can be overcome pretty quickly with education.
I think there also is a VHA -- isn't the VHA doing a pilot right now?
MR. BLUSY(?): Luca Blusy from VHA, the Pharmacy Benefits Management Group. Right now, they are writing a pilot. They are just about ready I think to test it, with the hopes that by the end of the year they will have requests to electronic prescription. It may be tried first at the VA. That's some of the information that we have received, and work out the wrinkles.
But they have been working on it for about four years now. The main concern that they have is that they don't want to put up a window of opportunity. They know that the prescription process as it is now, is not perfect. But they don't want to come up with something that can really open up it for people to do fraud(?).
DR. COHN: Thank you. We'll just sort of note that as an ongoing issue that we'll be talking about I think later on this year. I guess I'm not hearing from any of you that it's a major barrier to the success of your systems, which is good.
Other questions, comments? Lynn, did you have a question? Come and introduce yourself.
MS. GILBERTSON: Hi, I'm Lynn Gilbertson from the National Council for Prescription Drug Programs. Jeff, you had some questions about DCP IDEA. I don't know that I can answer them, but I will be glad to provide to both you and Maria, the contact people, so that you can get any questions you have answered about the DCP IDEA.
MR. BLAIR: Thank you.
MS. GILBERTSON: Just a couple of just very brief comments. The Scripts standard does have the ability to do a compliance transaction. It's a fill, no fill, partial fill, and refill information. For example, if a new prescription is sent from the prescriber to the pharmacy, and the patient never picks it up, a no fill transaction can go back to the prescriber. Likewise with a refill that the patient never picks up, that's refill one, that can go back as well. The standards of course is just when the industry is ready to play together on that.
On prior authorization, one of the things that complicates it is well, who is doing the prior authorization. Some authorizations are required at the pharmacy to perform it, and there are standards for doing that, and they are normal telecommunications standards. There is also the prior authorization by the prescriber itself. So, even prior authorization, like formulary, is not an exact science either, and there are different flavors to it, depending on what the health plan has set up.
And the last item is I have a plea. And that is over the last couple of days I have heard lots of comments about Scripts should be enhanced, to Scripts should support this. Please don't be afraid to submit changes to the standards, because for example, I just want to make sure it is clear for example, NCPDP, the organization, does not create the standards for the industry. The industry creates the standards.
So, if there are things that need to be added to it, anyone, members, non-members, anybody breathing can submit a change request, and get it discussed in the consensus body for what you might need. So, don't be afraid that you have to wait for somebody else to do it, because if it's not you, who?
DR. HUFF: Now, I do have a question. Why would they want the pharmacist to be responsible for pre-authorization? They are scared of the physicians?
MS. GILBERTSON: I'm going to rapidly get over my experience in this. There are a couple people in the audience who I think can probably answer a lot better. There are requirements at the prescription level, at the drug level that is related to the number of prescriptions allowed in that particular time frame. That might be one example of something that needs to be prior authorized.
There are some situations where the pharmacy can submit the prior authorization. They may go back to the prescriber and ask for further information, and then provide that, submit the prior authorization transaction, and then bill the client.
DR. HUFF: Half of it doesn't make sense.
MS. GILBERTSON: I don't claim to understand why things do or don't make sense.
MS. BURN(?): This is Carrie Burn at RCloud(?). I'm actually speaking from my PBM experience. I'm not sure that the pharmacist can actually ever prior authorization something. I think typically they will get a prior authorization by running the claim, or by calling the payer, and then put the number on, or tell the doctor at Scripts that they need one.
But I think typically the prior authorization is most likely questioned between the doctor and the payer. And criteria needs to be met. The pharmacy sometimes intervenes and makes the phone call for help. But I'm not sure that the pharmacist can actually ever give the prior authorization. Is that new? Not in any system that I know of.
MS. GILBERTSON: The pharmacist requests the prior authorization. That's the function.
MS. BURN: Right, that's the process, because they are the ones running the claim, and the claim comes back and says prior authorization is needed. The prescriber should understand that prior authorization is needed, and then prior authorization should be requested at that point. The pharmacy would not intervene in that case.
DR. COHN: Good.
DR. HUFF: This may be a level of detail that maybe we shouldn't try to do here in this meeting. It's hard to design something in a meeting this big. But it seems to me that there are things in the work flow that are work arounds, because you assume that somebody isn't available, or can't do this.
It would seem like that if you could get all the information to the prescriber, the pre-authorization information, the formulary information, the drug utilization review information, all of that at the point where the prescription is being done, and then the right prescription is done, and you know that that prescription is now correct according to what the physician wants to do, what the co-pay is going to be, what the benefits are allowed in this program, all that sort of stuff.
Then it wouldn't have to be redundant at the pharmacy, it wouldn't have to be redone and rechecked. Now, it might be that we have to put a pre-authorization number then with the prescription that flows all the way down, so that they know that that met requirements, and there might be other things like that, that need to be happening.
But I guess I would appreciate your perspective on that. Is that really true? Or are the things that really need to be redone in the pharmacy and at the payer in order to make it work right?
DR. COHN: Can I maybe try to deflect this one just a little bit in the sense that I'm looking at the issue as really pertinent for what is more academic in the sense that for the next many years, you are going to have to enable the pharmacist to do a prior authorization if a physician isn't using e-prescribing. Right now, the pharmacist is wired and the physician isn't, so that we are always going to have the capability in case the physician is not wired for e-prescribing capability, for the pharmacist to be able to handle it.
So, am I off on this one?
MS. GILBERTSON: I think that would be an excellent question to pose, especially to the pharmacy and perhaps the prescriber testimony as to what functions do they perform that they feel are pushed down to them, or pushed up to them, or what could be performed early or later in the process.
I think there is a lot of de facto stuff that -- it would be interesting, because you are going to hear positive, and you're also going to hear negatives about somebody coming in between something that is an established practice. So, I think that would be very interesting to ask them for responses back.
DR. HUFF: You're right, we need to allow the transaction to happen the way it's done today.
DR. COHN: I agree with your redesign. It's just the flexibility needs to be in these standards.
DR. KAUFMAN: I just had a quick comment. You are talking that if the people who write the software for the backbones, and the people that write the software for the physicians to use.
And I don't know whether you have any power over the people who write the software that the pharmacists use, but perhaps the pharmacy software could be required or at least asked to have the capability in their system to score a serial number and company name for each prescription. And then the ability to match that when a prior authorization comes in directly from the insurance company.
So, the 26 seconds or so that Dan talked about before, could happen actually offline, and the prior authorization could come directly from the insurance company into the pharmacy computer system, and the pharmacist could see that the prior authorization was received.
MR. NUTKIS: And by the way, that is how our system works. That's how we have done it again, based on the limitations that existed today. We built around that.
DR. HELM: And I think the way we see prior authorization working is that there is as much information as practically available to the physician at the point of care, so we can do that prior authorization. But then communicate that information to the pharmacy, because they are going to be the ones that are going to be seeking reimbursement for that particular medication from a health plan.
So, not to have them redo the work, but to know that the work is there, with sufficient confidence that they are going to get reimbursement, which is kind of the whole purpose for prior authorization anyway.
DR. FAUGHNAN: And speaking from the pharmacy side, one of the things I have heard from our group who works on that side is that -- and this is I think more in a nice to have, not in the essential stages -- is encoded reasons for refusal of prior authorization.
Pharmacists just that are handlers of a lot of transactions, that are doing authorization requests could then interpret the coded response and resubmit in some cases without human intervention. And so, that is desirable for some of our high volume pharmacies who automate response to an initial denial. That's a potential standard.
MR. RODMAN: Bill Rodman with Express Groups. I just wanted to clarify -- I don't know how seriously you are considering standardizing prior authorization as part of the electronic prescribing, but there are probably a lot of issues that haven't been raised here that need to be put on the table if we are even thinking of going down that road.
Sometimes it's as simple as it has been described, where it could be automated. But very often it isn't. There are different reasons for prior authorization, and there are different payers with different philosophies about prior authorization, that you can't fit everything into a neat little bucket.
So, if it's a simple step therapy and all you have to do is confirm that somebody did the first step, then you might be able to automate it, assuming all the payers that are doing the prior authorization, have done the work to automate it. Sometimes there are quantity level limits. There are different kinds of things that might fall into a bucket of prior authorization that you might not be able to standardize. And there are certain payers who use prior authorization really to drive different utilization decisions, as opposed to just making sure the people get the right drug at the right time.
So, some payers would welcome the opportunity to do automated prior authorization. If you answer the questions right, you get the prior authorization. And others would rather have a barrier in place, because what they really want is the physician to prescribe something else.
And so, I don't think you can talk about automating prior authorization in a vacuum, because what you are talking about is standardizing benefits, and you can't really go there, I don't think.
DR. COHN: Well, I think there is a difference between standardizing the benefit, and enabling the process.
MR. RODMAN: If you say prior authorization has to be done in a certain way, be careful not say the answer has to be preordained, because people need the flexibility to be able to use prior authorization the way they want to use it. So, it isn't necessarily always something that putting those rules in place, would --
MS. GILBERTSON: And whether or not it would be offered in the Medicare program at all. If it's not part of that, you may put that aside for a while.
DR. COHN: Jeff, did you have a final comment?
MR. BLAIR: I just think that one of the observations that you made is something that I think there are many portions of this e-prescribing community has anxiety about. And you mentioned that there might be intentional barriers related to this issue. And so, I think it would be good for us to discuss this later at another time, as to whether those barriers were appropriate barriers, or whether standards need to be developed to address them.
DR. COHN: Okay, with that note, we want to thank our panelists for really fascinating presentations and discussion from a lot of people, and a lot of information. People are taking notes all over, so we'll be putting this all together. So, once again, thank you.
The meeting will adjourn for lunch. We will come back at 1:15 pm. Thank you.
[Whereupon, the meeting was recessed for lunch at 12:15 pm, to reconvene at 1:15 pm.]
A F T E R N O O N S E S S I O N (1:15 pm)
DR. COHN: Well, I want to welcome everyone to the afternoon session, post-lunch. I want to thank you all for coming, and I would like to welcome our presenters for this afternoon. Obviously, the topic here continues to be e-prescribing, and really the focus here is the drug knowledge base, the vendors and your thoughts or perspectives on all of this, and we want to thank you very much for coming.
Now, could we just have you introduce yourselves?
MR. BIZZARO: Tom Bizzaro, pharmacist, and I'm Vice President of Sales and Marketing for First DataBank. I'm also very active with NCPDP, as a representative of First DataBank.
MR. ROBINSON: I'm George Robinson, Vice President of Knowledge Base Development for First DataBank. I'm also a pharmacist.
DR. MILLIKAN: I'm Mark Millikan. I am the Editorial Director of Product Development for Medi-Span.
MR. HOBSON: I'm Gerry Hobson. I'm the Research Manager for Cerner Multum. I'm also a pharmacist.
DR. COHN: Okay, well, thank you for joining us. George, you are leading off the discussion? Please.
Agenda Item: E-Prescribing: The Drug Knowledge Base Vendors' Perspective - George Robinson and Tom Bizzaro, First DataBank, Inc.
MR. ROBINSON: Certainly, it's a pleasure to be here. And I think both Tom and I have really seen a very constructive attitude taken by participants and committee members in the last couple of days. So, it's a very encouraging development.
I think the drug knowledge base vendors have been really working very hard over really the last 10 years trying to prepare database structures to support full electronic prescriptions, and not only ordering, but order fulfillment. So, we are very pleased with what happened here.
We have had several vendors talk in detail about work flow issues, and I think I'm going to take a little different approach here. I'm going to talk about the current role of knowledge base vendors in the industry, and then talk about what I think our continued role will be once standard terminologies become present, once we start seeing increased standardization of messaging, and see if that makes sense.
And then Tom will jump in and save me when I make some egregious mistakes, and also he has some comments to share.
Fundamentally, what we do is we collection information, we codify it. We link it to concepts that are useful at point of care applications, distribute it to the industry, and that is used within point of care applications. So, in a nutshell, that's what we do.
From the drug formation collection, what we rely on is we really come through the product labeling information that is distributed by the manufacturers. We also look at information related to over-the-counter medications, alternative medications, and a limited subset of medical supplies.
Above and beyond that, we also look at primary literature. We look at FDA publications such as MedWatch. We look at manufacturing letters and publications, the dear doctor letters, as they come out. We'll also compare our information with the official compendia, as more of a measure of are we in the right ball park with that we are doing.
As far as drug information codification, our roots go back really supporting electronic claims and inventory management for retail pharmacy. So, we have a well developed database of NDCs that also extend to the universal product codes and health-related identifiers. So, in the NDC field of our products, we also have numbers of abandoned DCs, to make that clear.
In addition to that packaging information, we also link other knowledge based content such as images, imprints, pricing information for drug form information, which defines it as a HLM or gram, which is a central component of electronic plan installments.
What we do with the clinical contents that we gather, we aggregate to a formulation level. It would be analogous to a clinical drug level of RxNorm. That particular concept includes a distinct set of active ingredients, route of administration, dosage form, therapeutic classes, and also related to clinical knowledge. So, you have a National Drug Code or package product that is linked to a formulation-type of identifier that has further relationship between drugs(?).
Also, over the last few years we have started using of use of content in either nursing applications, prescriber applications, order entry applications. We observed that the world used drugs differently than the pharmacist. In other words, drugs are used as a name base type of identifier, not as a number for an NDC. So, many of the drug knowledge base vendors through the years have introduced name-based concepts that are very useful, and are used today in several prescribing applications.
We also have introduced several versions of therapeutic classes that have been used through the years. Many of our therapeutic classes are actually imbedded either in state Medicaid plans or in Medicare. I think somebody in Part B was using the enhanced therapeutic classification of First DataBank.
The way we use the therapeutic classification system, it's more a process of looking at how drugs are most commonly prescribed by class. So, it can be all over the place. It can be chemical. It can anatomic. It can pharmacologic. So, it's a hodge-podge of grouping things.
Most knowledge base vendors also have a drug indications database. And embedded with the drug indications database are the actual nomenclature describing condition. It may be a higher presentation of conditions, so they roll up. You can look at cardiovascular drugs, and then just take it down to hypertension or to whatever type of specific indication you want.
I just want to get that clear that there is drug indications database, and then there is the therapy classification. And they really serve separate needs.
We provide allergens information. It really covers three or four different domains. There is an allergy class, which is the most general way of capturing an allergen; individual ingredients are put in the context of the patient allergy; or either a name-based drug identifier, or actually an NDC. An NDC can actually be put in the context of the patient allergies.
As of this date, there is no national standard representing allergen information. We have worked cooperatively at least with one customer looking potentially at SNOMED-CT as an interoperability layer for that. But as of right now, there is no standard.
In order to support point of care screening applications and navigations related content, we really break I guess our vocabulary content into four different areas. There is the drug contents that we talked about, allergens, which we have discussed, and there is the domain of disease, and the domain of lab.
As far as the disease space content, in order to respond rapidly to our need to present concepts that are condition-based which described what indications, precautions, drug-disease contraindications, and side effects, we maintain our own proprietary disease vocabulary. It's a fairly small, controlled subset. Our strategy with that is to be able to express the sort of concepts with a lot of flexibility, and then link that disease database back to standard terminology.
So, through the years ICD-9-CM is all we had. We are now looking at cross-referencing to SNOMED-CT. So, that will take us a few months, but that is something we are looking at.
The important thing I guess about the disease is where the knowledge is aggregated is you will take a drug concept, and you will relate it to for example hypertension in the context of a drug to treat. For another drug, hypertension could be presented in the context of a side effect. In other, that context can be as a contraindication. So, they are the same term, but they are linked to the drug concept, depending on the relationship that you state, and they have a different purpose.
Also, behind the scenes the hierarchical relationship that you maintain with the disease vocabulary may lead to differences based on the purpose you are trying to resolve. You may make one approach, and when you are rolling up the condition for the contraindication screening, and another functioning when you are rolling a condition to do drug indications.
I think a lot of the issues that perhaps we had raised over how difficult it was to do drug contraindication screening with ICD-9 is based on perhaps the roll up, and the lack of granularity in the ICD-9.
As far as lab based content, it's similar to the disease database. Our attempt is just to provide the lab concepts that we need to describe the context of labs that in combination with the drug, may give you a false reading with the drug-lab interference. It may be there in the context of if you are on this drug, and you have an elevated lab result, perhaps we should do something with your drug therapy. Should you continue the drug, hold the drug? It's more of a drug-lab warning.
The other type of link that you do between drugs and labs would be drug therapy assessment. For example, if I'm on a particular statin, then I should have a liver function that is done every three months or whatever that is.
As far as dosage information and screening, again, we use our proprietary drug concepts. It may be linked to our disease concepts, because based on diagnosis you may have a dramatically different dose, especially with some of the antibiotics, with end use priority methods of prescribing a dose string, and also representing that dose in discrete parsed elements. So, that's the state of affairs as far as the knowledge.
I think commercial of the knowledge base providers --
DR. HUFF: You mentioned you use lab codes, that you have lab associations. Do you use an internal coding system?
MR. ROBINSON: We use a proprietary system and provide links to moiety(?) strategy. And it's a fairly small database. One thing I did want to mention, because one of the requirements that were discussed was drug-lab interference. Pure drug-lab interference, we are talking about analytical effects. You need to go all the way through methods used for the lab.
So, in other words, if you are looking at serum fat, and there is a drug honestly that may give you a false reading, it's not on that that you measure the serum fat, and have that problem. So, if you are actually trying to introduce this in the screening environment, what you actually need to do is associate with your lab information system, the actual methods used to measure the lab through the particular vocabulary codes that are used in the system to do the true screening.
So, I guess what I'm just trying to throw out there is some of the complexity of doing screening at the point of care environment are not necessarily as easy as it looks from the outside. There are some factors that have to be considered.
Common to most knowledge based vendors is they may provide API codes, application-program interfaces that encapsulate the data, and they may use object technology that are based on an input parameter that will pass into the program, and will retrieve the text and discrete messages of screening results. So, that's a convenience option that we provide to our customers. What we cannot do is provide the actual user interface. That is up to either our self-programming customers or our vendors.
Our product delivery, it's pretty common I think with the vendors that pricing may be delivered as frequently as daily for the more high volume type of enterprises. They may get our information on a weekly basis, or you may get a monthly or quarterly delivery schedule.
Once the vendor or self-programmer receives our content, what they need to do then is load our content into their database. Some large vendors actually maintain their own centralized terminology layer, so they may be doing some interfaces there. And then once they have integrated the data into their internal database structure, then they push it to their customers. It may be CD. It may be an Internet push. There are all different ways to do that.
So, that's the state of current affairs. Is there anything you want to add, Tom, before I go into how we see the world changing a little bit?
MR. BIZZARO: I think what we wanted to do was to show the complexity of what we as database providers give to our customers, and the breadth of the screening functions that we have. I think that this committee's -- one of the committee's roles is going to be to see how much of that is part being prescribed, or is that a separate function, and not an e-prescribing function.
Because by improving patient care by providing screening at the point of care in the physician's office for all these different things, you also enter a level of complexity and a time issue. So, what is e-prescribing, and what is a screen that is separate from e-prescribing?
MR. ROBINSON: Okay, moving forward in the future enlightened environment that we hope comes our way soon, is we welcome of course the structured product labeling that is coming from the manufacturers based on the new labeling standards that are being I guess approved as we speak, this week.
What this is, is perhaps the means to get some internal efficiencies in looking at the product labeling itself. We still will have a process of needing to review that content and import it essentially to our database structures. And along with that also, continue the compilation of complementary content that comes again from primary literature.
So, for example, we would not get into the structured product labeling with the optimal uses. So, that type of information, again, we would take an evidence-based approach, and broaden the scope of the information we delivered to be more than just what limited the manufacturer information and the labeling.
We do see the opportunity that we could perhaps build additional links to another proprietary database in the structure product label. So, that may give the opportunity for an end user to make a direct call to perhaps a black box warning section of the labeling, or the side effects, more from a reference perspective. So, I think that would be in the real of possibilities.
As far as drug information notification, we are not really seeing anything changing with the product ID or the NDC other than we may be in a position to redistribute links between the NDC and the RxNorm clinical drugs. That would be in the realm of possibilities.
As far as formulation base or clinical drug identifiers, I think we would see the opportunity to public links between our FEBC(?) code, our DECFC(?) number, or clinical simulation ID, and the generics of some clinical drug that will be coming from RxNorm.
And at the ingredient level we would see the opportunity to provide a cross-walk between the FDA UNI created as an identifier, and our ingredients.
So, the trend we are seeing here is in order to minimize the impact to our current knowledge base, is that we would like to have the opportunity to continue to use our contents really without any apparent change to the end user, but have links to the interoperability standards set, so that when they are working with other trading partners, the information can be translated and communicated in that fashion.
Name-based identifiers, this is where we would have the opportunity to link with additional branded semantic clinical drugs' IDs that may be coming from RxNorm.
As far as therapeutic classification, this is still kind of an unknown. I understanding in reviewing the act that the USC has been challenged to rate some therapeutic classifications. I think we'll have to see how that turns out. One therapeutic class compared to another can be really be an apples and oranges situation, so I don't know if that's a situation where we'll actually be able to offer a cross-reference or not. I guess we'll just have to see how that pans out.
Allergen information, again, that's an open issue I think from a standards perspective. All I can say is First DataBank would be willing to cooperate with whatever standard is selected there, or work with our standards customers to on a case-by-case basis cross-walk.
Disease-based content, we certainly have plans to link to SNOMED-CT. One issue with SNOMED-CT will continue to be the issue of how willing the College of American Pathologists is willing to modify their editorial policy to introduce pre-coordinated terms. If you look at a lot of the drug indications, they actually can be very specific and sometimes creative in how they are published in the labeling.
There may be a reference to a co-morbidity. So, it may have a particular indication for an infection in combination with immune-suppressed populations or with HIV. So, those are concepts that many times you may not find in exact SNOMED-CT concepts. So, there is that dilemma of do you do post-coordination of qualifiers, or do you join multiple SNOMED concepts, active mapping.
The more post-coordination we do in the mapping, the greater the complexity is going to be. Again, someone making a call using a SNOMED-CT concept into our knowledge, needs to get additional information.
As far as laboratory, we are already committed to coding for the LOINC database. As far as dosage information, we would be happy to cooperate with any third party that would want to step up to the plate and come up with a standardized grid terminology.
API tools, I think about the only change I would see there is what we may need to do is code to handle standard terminology as the input property. In lieu of coming in with proprietary drug code or proprietary disease concepts, we would need a handle to recall using SNOMED-CT as I have this problem, what are drugs to treat? So, then we would make crosswalk for indications database and provide the information.
Product delivery. We would be open to potentially delivering some of the standard terminology along with our proprietary content. I think we have to get down to obviously the copyright issues. But what I am seeing is that it may be somewhat of a dilemma for customers to coordinate delivery of standard terminology when they are getting it from virtually five or six different courses. So, there may be a convenience opportunity for a drug knowledge base to redistribute some of those in a terminology.
Finally, at the customer level, again, what we would hope is that we could do this in a way that is somewhat transparent. One of the big mandates that's on the actors, can this be done with minimal impact existing systems? Obviously, they will have to code in order to send a standard code set, and to use it as an inference parameter. What we would hope is that we could minimize the impact at least to the user interface.
The goal would be for an end user to write a prescription as they had previously, but behind the scenes the miracle happens. The drug is converted to an RxNorm concept. They make the call to formulary if they need to, or it gets sent to the pharmacy. And all those things that can happen behind the scenes, and not mess up the physician's day would certainly serve us all.
So, based on that, I'll turn it over to Mr. Bizzaro.
MR. BIZZARO: What I have found in the last day and a half, and I want to tell the committee that I found its testimony both very interesting and educational. I've been taking some notes in some areas I see as problematic, and I want to just comment on them from both my experience with First DataBank, and also with my experience with customers, and from the standards organizations that I have dealt with.
RxNorm I think is a name-based identifier, and is an identifier that hopefully represents the way doctors think. It makes an awful lot of sense, and George has talked about our willingness to cross-reference to it. I also need to keep in mind the NDC does not go away. We still need to have links to the NDC, to the RxNorm, because in the pharmacy eventually you have to bill for it, and to bill for any packaging spotting information at the NDC. And I think we have heard that reiterated a number of times here.
The issue of who sets the standard I think is going to be a very thorny problem. NCPDP, over the last six or seven years, has tried to get consensus between the payers, providers, and other organizations that attend that meeting for standards today. And we could not come up with consensus for establishment of a standard set.
The main issue was that in other systems, and I guess any system now that is writing orders, there are numerous code sets used within those systems right now. And they are all individual proprietary code sets. And the problem that pharmacy had, even if we could come up with standard code sets for SIG, they thought there was a difficulty in cross-referencing what they currently had in the pharmacy, and which of the standards that the code set would be. And they were worried about the liability of making an error in that cross-referencing.
So, the standard SIG I think is a great idea, and I think it has great value. And I also think it's very difficult to get.
I also believe the pharmacies -- and I wish there was more representation here from retail pharmacies -- it is my belief that retail pharmacy is going to require a contextual representation of the prescription even if it is codified. I think they are always going to want the name of the drug. They are going to want the SIG in the contextual format, because they feel that that gives them a fall check, and it helps them avoid the liability if you would have an error in the code, the identifier. I think we really need to keep that in mind.
I think we are going to have to also deal with the duplication of effort with clinical screening. We do clinical screening in the physician's office, and then we do clinical screening once it gets to the pharmacy. And we do clinical screening once it goes out to the PBM, whatever order that happens. I think we are going to have duplication of effort there that we are going to need to learn to deal with.
I think there is an opportunity for messaging that goes back and forth between those entities that says I've already forgotten this alert. I have reviewed it, and I have decided to still go forward with it. So, that messaging complicates issues, but I think that's the only way you will get these entities to give up what they would see as their responsibility to clinical screening. And also, again, the liability issue if they would not do that clinical screening themselves.
Yesterday, Harry Reynolds mentioned that he thought that there seemed to be in the industry, an acceptance to this e-prescribing initiative. And I would absolutely agree with that. I think that we all can see the benefit of e-prescribing, both as a patient safety issue. Also as the efficiencies that we gain by doing e-prescribing.
I also think that in the industry there is a concern that we may make the requirements for e-prescribing so complex that it becomes very difficult to implement, and also very difficult to get acceptance in the marketplace. So, I think those are some of the things we need to look at as what can we do to make e-prescribing an advantage in the business place to those who want to use it, because we keep talking about the economic impact, and I think that is certainly true. And there are certainly benefits to e-prescribing that we can make the physician aware of.
And in closing, I would just like to again thank the subcommittee for the opportunity to speak here today.
MR. ROBINSON: I have one additional closing though. I think I read yesterday from the complexity that we are seeing with so many components of the standard terminology coming from different providers. So, speaking for First DataBank, we certainly would be open to a champion for aggregating this information. If that's UMLS or the National Library of Medicine, that would be great.
And perhaps bring together a work group or a forum where we could have a roll up our sleeves meeting between all the participants to really figure out how we are going to make this work, because there are several dependencies. You have to have an agreement for example, before you can link the ingredients in a packaged product. We need that therapeutic class in place. If it's a new, innovative drug, the therapeutic class has got to be figured out before we can associate drug to the therapeutic class.
If it's a new and unique indication, there has to be a SNOMED code to represent that indication on the labeling. So that we have all these interdependencies that if we are trying to build systems around it, you've got to be able to get that information out quickly, and also figure out how that is going to passed then to the entities that are actually distributing standard terminology, and getting it to these under systems, and eventually sort of the eyeball for the end user.
So, my humble suggestion would be probably the National Library of Medicine is probably in the best position to do that in a non-proprietary, competitive form. So, that would be useful.
DR. COHN: Thank you very much.
Mark, I believe you're next.
Agenda Item: E-Prescribing: The Drug Knowledge Base Vendors' Perspective - Mark Millikan, PharmD, MBA, MediSpan
DR. MILLIKAN: Thank you. I am Mark Millikan, the Editorial Director for Product Development of MediSpan, a part of Wolters Kluwer Health. With me today is my colleague Karen Ebhart, which many of you may know from previous NCVHS meetings, and she is a project manager at MediSpan, and my technical back-up for these discussions.
MediSpan has been in the business of providing drug product information since the late 1970s. My initial comments will focus on NCPB Script standards, which MediSpan recommends for the transmission of electronic prescriptions. Script's wide use and acceptance is our strength, that to physicians, this standard for the enhanced e-prescribing as specified by the Medicare Prescription Drug Improvement and Modernization Act of 2003.
The Script standard developed a foundation to build upon, and contains the data necessary for basic communications between organizations involved in e-prescribing. As noted in previous testimony by NCPDP in March 2004, enhancements to the current Scripts standards are needed. MediSpan recommends the following enhancements, with the proviso of Lynn's comments earlier today, that all of this is subject to the normal processes at NCPDP, including the balloting process.
First of all, MediSpan recommends that nationally adopted drug products and prescription instructions, terminology code sets be added to the Script standards, which already include proprietary drug terminology code sets and text descriptions for the purpose of identifying drug products. The inclusion of nationally adopted code sets will facilitate interoperability between e-prescribing companies that use different proprietary drug and technology code sets.
The current Script standards allows drug products to be identified by proprietary drug terminology code sets such as those MediSpan. In addition, drug products and prescription directions are also identified by text description of the drug product. MediSpan supports the addition of a nationally adopted code set such as RxNorm to the Script standard for the purpose of identifying drug products.
MediSpan also supports the addition of a nationally adopted code set that would identify prescription instructions for the SIG. At this point, this is a limitation of the Scripts standard, the ability to transmit descriptions and instructions by any means other than a text field, and is an area for enhanced support.
In addition, a code set that tries to take elements of the prescription instructions has yet to be adopted on a national basis, as we have discussed over the last couple of days.
We believe that continued inclusion of text fields and proprietary code sets will facilitate quicker adoption of e-prescribing systems. Limiting the transmission of electronic prescriptions to nationally adopted codes sets code slow down the adoption. While nationally adopted code sets are evolving, the proprietary code sets and text descriptions are available for use today.
In addition, this approach also provides the opportunity for a human to read the transmitted text field against the transmitted code sets, therefore, providing the health care professional the opportunity for a final check against the transmitting codes.
MediSpan recommends that drug utilization review alerts, summaries, and communications between organizations involved in e-prescribing, as noted in the act, be incorporated into the Script standards. The Medicare Act describes the change of information on drug-drug interactions, warnings and cautions, and dosage alerts.
We recommend that this information be supplied as a summary of the DUR screening alert generated in the prescribing, dispensing, or reporting processes, along with the actions taken. For example, if a prescriber is alerted of an interaction between a new prescription and a drug already on the patient's profile, but decides that the use of the prescription is appropriate, this action should be transmitted to the dispensing, so that the dispenser, the pharmacist is aware of the prescriber's position.
As a part of NCPDP's health communication standard, it is routine to transmit DUR results between pharmacies and insurers or payers. MediSpan's recommendation is to incorporate this same approach into the Script standards by allowing for the transmission of actions resulting from the DUR alert from the prescriber to the dispenser.
We do not, however, recommend transmitting complex monographs of DUR information. This information should probably reside locally in the e-prescribing system, but is not necessary for the electronic transmission of a prescription.
MediSpan recommends that the version of the Script chosen for e-prescribing include a longer drug product description, or that the dosage form, dose strength field available in Script standards are made mandatory. Currently, the drug main field of Scripts is mandatory, while the dosage form, dose strength, and dose strength information fields are treated as conditions.
There are, therefore, implementations of Scripts that incorporate the dosage form, dose strength, and dose strength unit measure into the 35 character drug name or item description. Thirty-five characters for the drug description is not sufficient. Recent JCAHO and IECC guidelines and recommendation are to remove dangerous medical abbreviations from drug orders. These guidelines cannot be accommodated within the constraints of a 35 character field length.
We recommend either the addition of a drug prescription extension for drug descriptions longer than 35 characters, or changing the dosage form, dose strength, and dose strength unit of measure fields to be mandatory in the Scripts standards.
And finally, with regards to the Scripts standards, NCPDP's portfolio for standards includes a standard for transmitting an entire formulary. Based on information that we learned yesterday about RxHub and CAQH, we could see that incorporating what NCPDP is already begun to develop in the various formularies, as well as what RxHub and CAQH are developing should be eventually rolled into Scripts.
I would now like to answer questions that we were asked to address during our testimony today. First of all, best standards for codes sets meet the requirement of the law. As stated in my earlier comments, MediSpan recommends the use of the Scripts standard, along with the necessary code sets to meet the e-prescribing requirements established by the act.
A nationally adopted drug terminology code set isn't necessary for the interoperability between proprietary drug terminology code sets. We support the use of RxNorm for this purpose, and are exploring ways that we will be able to make use of that, and be able to create mapping between RxNorm and the MediSpan code set that we provide to our customer base.
Which of the standard code sets do we use? MediSpan has a long history of supplying drug-related code sets for use within standards established by NCPDP, including the Scripts standard. And this spans current and future use of standards, along with the further development of proprietary code sets and mapping to nationally adopted code sets are customer-driven.
What are the strengths and weaknesses of the standards and code sets? As we have mentioned, the strength for NCPDP is it's widespread use and acceptance. And I have also touched on some opportunities for enhancement, including the 35 character drug product description when it is implemented as the full description of a drug product.
In later versions, separate fields were included for strength, strength units, and dosage forms, as well as repeating fields for longer product names. It appears, however, at this point in time that these later versions of the Script have not been widely used. So, it's therefore, our recommendation that these later versions and future versions be adopted for the purpose of e-prescribing.
Another opportunity, as we have also discussed a couple of times today, would be enhancing Scripts standards for the addition of codified or partially codified field of the prescription instructions or SIG. Partial codification of the prescription directions would frequency per day, unit per day, and duration of therapy information to be included or expressed in separate numeric fields. This would then allow checking to dosage alerts and that sort of thing. We could do the appropriate match.
It is our understanding that HL7 is starting to create structured prescription instructions with the cooperation of NCPDP. MediSpan would support this effort, and recommend that this be considered for inclusion in Scripts some time in the future.
What are the e-prescribing standard and code set gaps? Again, several things have already been mentioned for the past couple of days. One would be what we have talked about with the SIG in terms of being able to map for the purpose of checking, and some kind of standard way to represent SIG information or prescription instructions.
And second would be a code set for drug allergies, which again is required for interoperability between the different proprietary drug allergy screening tools. It is MediSpan's understanding that such a code set is available through SNOMED. It is not available under the federal government's licensure of SNOMED-CT for terminology.
And then just to close, I would like to echo George Robinson's comments in that MediSpan is open to mapping to interoperability code sets, and cooperating with organizations that are developing those, because we are very interested in advancing the cause of e-prescribing.
Thank you very much for your attention, and the opportunity to present today.
DR. COHN: Mark, thank you very much.
Gerry, our last presenter of this session.
Agenda Item: E-Prescribing: The Drug Knowledge Base Vendors' Perspective - Gerry Hobson, Multum
MR. HOBSON: My name is Gerry Hobson. I'm the Research Manager for Cerner Multum. Cerner Multum is a subsidiary of the Cerner Corporation. I'm a pharmacist by training. My responsibilities at Cerner Multum encompass the management of our clinical content creation process. I appreciate the opportunity to testify before the NCVHS on electronic prescribing standards today.
The Cerner Corporation is the leading supplier of clinical and management information knowledge systems to health care organizations in the United States and abroad. Services include more than 2,000 clients in the US and around the world. These clients include: health delivery care systems, community hospitals, inventory clinics, physician practices, health management organizations, blood banks, laboratories, and some health agencies.
As a subsidiary of the Cerner Corporation, Cerner Multum specializes in the creation, maintenance, and distribution of clinical drug information. Cerner Multum's clients include the Cerner Corporation, other health care software vendors, as well as several private and public organizations. These would include: electronic medical records systems, physician offices, hospitals, insurance companies, PBMs, and government organizations. These entities license our drug and production information.
Cerner Multum's drug terminology is a reference terminology in the National Council of Prescription Drug Program, NCPDP, and its map requires terminology with UMLS Medical Thesaurus.
We even supply our drug information to electronic medical records solutions and buyers, giving some experience and some insight into clinical decision support opportunities. Some of these opportunities have been previously addressed.
For some of our clients, patient medical history already exists today. Patient medical history is the basis for providing patient-specific information. This information would be valuable in decision support. The level of content can be as basic as providing common prescriptions or physicians, which improves not only the efficiency of writing the prescription, but also the accuracy of the prescription.
It expands to provider the prescription writer, and by taking active choices in the prescription, they can use logical choices to come to appropriate drug therapies. For example, for given drug, it can be available with over many routes, many dosage forms, many frequencies may be appropriate.
If a route is selected, and those dosages that are appropriate for that drug are narrowed down to a specific number of dosages. The specific dosage is selected. The frequency for that order narrows down to a limited number of frequencies. If the frequency is selected, the ratios may be narrowed down as well. Having this information available will improve the work flow of a prescriber in implementing electronic order entry.
The next point to consider centers around the choice of the drug. A listing of the appropriate drugs to treat a condition is the starting point. After the selection of the drug, the appropriate dose for the patient based on condition being treated, the patient's renal and liver function, their age, their weight, and a variety of other factors can be used to come up with a recommended dose for the patient to provide safety and quality in the ordering of the product.
These recommendations can be developed based on these parameters. Based on clinical evidence, these parameters support this data. In a model where this information exists in the a patient record, use applications can be developed, and are developed today.
Moving onto dose range checking. Dose range checking provides an invaluable service for patient safety. Dose range checking can be granulized based on patient-specific information which makes it a more valuable service. Particularly when you are dealing with pediatric patients, often times information on dose range checking is not available on the package insert for appropriate dosages.
This information available in the patient's electronic record can be utilized to narrow the range of the dose for pediatric patients. For patients that have a renal dysfunction or liver dysfunction, a dose range for the medication can be narrowed down to a more appropriate range, thereby eliminating and streamlining the number of alerts that are displayed to the clinicians with the order entry.
This is a very important point. As we move on to more advanced clinical information, the time that a clinician gets to process this needs to be streamlined as much as possible.
For drug interactions, there was an interesting statistic yesterday that the CHUA reported that all but 4 percent of drug interactions were overridden. At Cerner Multum, this is not surprising to us. We have various severity levels of drug interactions, between 5-10 percent of those fall under the major interactions category.
We can easily see how 4 percent of the interactions, all but 4, could be overridden. Now, that doesn't mean that interactions at a majority severity level aren't important interactions in a subset of the population. For example, the geriatric patients, when multiple drugs are ordered that cause sedation, that's a very important interaction to display.
If the patient in fact receives an ACE inhibitor and has a potassium level that is elevated, that's a very important interaction to display. A drug interaction, subsetting them to those that have the most majority severity is an important thing to do, but also coordinating them with patient-specific data to make a much more robust system for determining and improving the patient safety.
At Cerner Multum, the terminologies that we use for the NDC codes mentioned before. The NDC code has several limitations. Number one, they are not readily available from any one source. The initiative that the FDA is seeking to provide these NDC codes will go a long way to streamlining our processes in gathering these NDC codes.
The structured product labeling will help dramatically in listing inactive ingredients for products, and active ingredients are valuable in certain alerts such as allergy checking, where an inactive ingredient may be available in one NDC code, but not in another. Having that information come directly from the FDA would be invaluable.
Other areas for structured product labeling that would help range from FDA approved indications, black box warnings, side effects, drug interactions, and as I mentioned inactivity ingredients.
Some areas for consideration of the FDA in creating the structured product labeling is inconsistencies that the manufacturers provide and their product labeling. One area that comes to mind is drug interactions. Psychoactive drugs may be listed as a drug interaction, but what drugs are constituted in psychoactive drugs.
Another area would 2t-interval polymers(?) which received a general statement which might include a couple of examples of what are those drugs that are 2t-interval polymers. The last example might be, which is prominent in drug interaction is the actual liver enzymes that are used to metabolize drugs. If a drug is considered a cytochrome p450 inhibitor, which drugs are included in that list? So, if the FDA goes on to create structured product labeling, we would like them to clear up those implications.
In conclusion, I would like to support use of RxNorm in connecting different databases' content with the drug products and the common drug terminologies. We support the NCPDP's Script standards and SNOMED terminology for conditions.
Thank you very much.
DR. COHN: Well, thank you all for some very interesting testimony.
Steve, I think you had your hand up.
DR. STEINDEL: Yes, before we get into any more substantive questions, I just have a clarification question for Mr. Millikan. You mentioned that the SNOMED allergen tables were not available under the federal licensing. And yet, I'm looking at SNOMED right now, and under the disease axis, there are drug-related disorders, adverse reactions to drugs, allergic drug reactions, and then an extensive table under that. And that's available under the license. So, I would like some more information about where you got that.
DR. MILLIKAN: I spoke to a representative of SNOMED last week about the allergy information, and clarified that this is not available nationally.
MR. FONOW(?): There are three parts to it. There is the --
DR. COHN: Who are you first?
MR. FONOW: I'm John Fonow, speaking about SNOMED. There are actually two parts to it. The medications of course could be part of the thing that you are allergic to. My understanding is, is it not part of the license. The allergen subset, which is defining like substance identifiers, that subset -- so, that's what tells you which of all the SNOMED classes are considered part of the allergen subset. That is not covered by the license, although it's very cheap.
So, the concepts themselves are covered by the license. So, you get SNOMED-CT, you download in the UMLS, and you get it from SNOMED, and you would get all the concepts. But what you wouldn't get is the definition of which particular portion of all of those different things are considered to be part of the allergen subset for the use in a physician support system.
MR. ROBINSON: Can I jump in here? I've been looking at SNOMED as well. What is available, and there are allergen descriptions all over the place in the content and different domains. What we found is in the best work with is in the substance domain. There is a relationship of allergen class in the substance domain that you do get with the core set. So, that's where you may see betalactins, penicillin, cephalosporin. That is there. What you have to pay an additional fee to get is a default tick list that includes ingredients, classes, many different things pulled together.
Now, in the model that we have been doing, the most effective interoperability standard would be just simply at the class level itself. What you are trying to do is if you express the class, that's kind of an abstract concept, penicillins for example. If you are defining an allergen using a particular ingredient, probably the best path for that would to be use the ingredient that is related to the proprietary system that you are using, and then ultimately tap the Unicode from the FDA.
Similarly, if a clinical drug is in the context of an allergen, again, the best thing to pass would be an RxNorm concept for that. So, when I looked at SNOMED, I believe there were about 400 concepts right now that are in the substance hierarchy.
What the caution you live is kind of stay away from the disorder domain, because first of all the relationship of the ingredients in a substance hierarchy is not consistent when you start looking at causative agents for example, which would be in the disorder domain, versus I think what you see in the substance hierarchy if they have ingredients in relationship.
That's probably more than you want to know, but the point --
DR. STEINDEL: Thank you. As you point out, those subsets and specific for the US drug domain were excluded in the license.
DR. COHN: Other questions? Jeff?
MR. BLAIR: Could you help me understand what work has been done, if any, on the possibility of standardizing the messages that go from each of these drug knowledge bases for DUR? What is the status of those?
MR. BIZZARO: Let me speak a little bit, because I'm going to talk about it from the point of view of NCPDP and the way messaging happens there. You make the telecommunications standards, and I believe this is true in Script also, there are qualifiers that identify what the source of the information is.
And so, those qualifiers identify -- First DataBank has a source of the drug interaction information. We then have values of let's say severe, moderate, minor, and I can't remember if those are the three actual values, but there are three different values that give you three different levels of interactions. But those interaction levels are specific to that proprietary organization giving you the alert.
As far as I know, Jeff, the only --
MR. BLAIR: The interaction with the proprietary message is a standardized NCPDP message?
MR. BIZZARO: That's correct.
MR. BLAIR: Thank you.
MS. EBHART: Can I add onto that? Karen Ebhart.
I believe also for the message -- I'm looking at Lynn as I say this -- there is a codified field telling you what type of DUR was found. What's the drug interaction. Was it too high of a dose, too low of a dose? As well as a pretest field that currently allows you to identify in the case of a drug interaction, what drug it was interacting with on a profile. You know the drug coming in is one half of the interaction. You need to have somewhere be identified what drug it is interacting with. And so, the structure allows you to identify that portion of all this.
MR. BIZZARO: This is part of where my concern is as we looking at messaging, and what we're going to do in e-prescribing, and what type of electronic messaging is going to go back and forth between the physician and the pharmacy. It can become very complicated and time consuming as you send that messaging back and forth. And how do we manage that and still meet the requirements of a timely message for presenting an electronic prescription to the pharmacy?
I'm going to give a personal opinion here now. I think that the FDA's initiative regarding the linear bar code on packaging got through the rulemaking office on a very short period of time. I think that happened, because it was really a simple description of what they wanted.
I think the benefit from having that linear bar code on packaging for drugs is going to provide both economic and patient safety value in the future. And as it changes and becomes more sophisticated, that will create -- but its simplicity is its greatest value. And I hope that we do the same thing with the e-prescribing. We've got to get people doing e-prescribing. We've got to get them doing.
Being a classical pharmacist for 15 years, I can't tell you how many phone calls I made to a physician simply because I could not read the prescription, or I couldn't read the strength, or he forgot to put the refills on. If we look at what we gain by just doing something that simple.
And then let's add some of these things we've talked about, some of these added-value we can do here. Let's do that also. But let's keep it simple enough that we get physicians writing scripts electronically.
DR. HUFF: I'm going to ask the question I thought Jeff would ask. Were there any standards for distributing the knowledge or the relationships, or however you want to describe it, of a drug interaction database or an indications database? So, the idea being that at some point it might reduce the work everywhere of having one group or one consortium do that, and then you guys can distribute those value-added parts. But there would be a standard way of representing.
And I wonder if any work has been done in that area, or people have talked about making standards for distribution of the knowledge itself?
MR. ROBINSON: The only standards discussion that has taken place is --
MR. BIZZARO: AMCP in association with a number of other organizations a few years ago tried to come up with a methodology to come up with a common list of drug interactions that we could all, on a national level, agree upon as to their severity and what those drug interactions are.
My understanding on that -- this is kind of an untimely question, because I have a meeting with them Friday when I get back to the office, to talk about what they decided to do going forward. My understanding now is that what they have decided to do going forward is to see if they can come up with a methodology that the different compendium would agree to as they develop their own proprietary drug interaction databases, but use that common methodology, and see if that can kind of get partway to where you want to go, but not all the way. And I'm not sure where they have gone.
The issue with not doing that on a national basis was the timeliness of the information, and having a national group coming together every six months. And we all know that in the drug world, our business depends on the timeliness of the data on a daily and weekly basis. And trying to do that I guess using a non-proprietary national standards body where a blue ribbon, it was just too difficult to do.
MR. ROBINSON: I think we need to get on the table what we would be willing to work with, and what we would consider an infringement on our right to being a viable business. And I think we are open to common messaging standards. I think we would be open to if a third party wants to say here is the standards criteria you should use. I'm saying something is a severe drug interaction, or something falls into a particular category. So, perhaps that actionable knowledge can represented in a common way.
I think each of us want to reserve the right independently to research and codify drug knowledge and medical knowledge as an intellectual property asset, and distribute it in a competitive environment. So, we kind of again, broke into the standards and the communication, but we really need to protect our business for intellectual property.
MR. HOBSON: I would agree that standards would be helpful in this area. I agree that intellectual property is helpful. It's important as well. As I mentioned before, interactions vary based on the patient taking the two drugs. And use of that information, though it may not be a severe interaction, it may be very important.
MR. ROBINSON: You mentioned don't go too far. So, I'm going to take the opportunity and say from an alert standpoint, what does far enough mean?
MR. BIZZARO: For me, I'm very pragmatic and practical. As I see -- and some of the things again, are going to be personal opinions -- but I don't know how you make that decision, Gerry, I really don't, because different practitioners have different levels of experience and knowledge.
For example, if you are in a hospital that has an oncology unit, your specialty is those oncology patients, the doses that you are going to use for certain products is going to be way out of the range of what you would normally see in the retail pharmacy.
That's probably the most difficult question is how do we take care of this message overload of our physicians and pharmacists are just hammered with, but still protect the patient, so that we don't give them too little information? I wish I had an answer for that. I don't know, although we never want to -- in our business, we don't ever see ourselves as the experts in the practice of health care. Our customers are those experts. They assume the liability and the responsibility for the care of the patient. We see ourselves as providing the information that helps them do their job.
But I think that's the million dollar question, who do we cut down on the useless information that physicians and pharmacists see day after day, without getting into a liability issue?
MR. ROBINSON: Do you see a demarcation between e-scripting and e-prescribing? In other words, e-scripting to me came across as the process of electronically submitting prescriptions, electronically passing the information around. Whereas, e-prescribing to me goes one step further, which is helping understand the medical side of the situation.
MR. BIZZARO: I actually see it as four different, distinct things that you do as a physician. Not being a physician, I may be speaking a little from just my impression. But when we are talking about e-prescribing, I see four different things that can happen that benefit the physician.
One is eligibility of that patient for a particular health plan. Second is access to preliminary(?) for that patient. Knowing what drugs are covered for that patient, and what it's going to cost them in general. I don't think we get the exact price for that patient, but we tell them about what it's going to cost if we know which plan and group information.
The next thing is DUR. And that level of DUR happens in physicians' offices up to that vendor who is supplying that information to that physician, and what the physician wants. And I think the fourth thing is what you are talking about as e-scripting, I think that's the simple part of it.
Now, what we want the physician to do before they get to the point of sending that old time prescription to a pharmacy. The infrastructure was not available for years. And that was the biggest problem I saw with it, and that was because RxHub and those organizations didn't not exist.
DR. COHN: Jeff?
MR. BLAIR: It's my understanding that the Anilin(?) with the UMLS will be mapping RxNorm and the drug classifications to each of your drug knowledge bases. But there are two things that I wanted a little bit of clarification on if I may, because one of you -- I don't remember which one -- I think said it as if it was going the opposite way around. That you were mapping to RxNorm, and so I wanted to understand that a little better, if I heard that correctly.
But the other piece is a second question besides that, is could you give me some feeling for the time frames when you feel like you will be able to use those mappings? And what's behind the second question is if we are to be ready for the demonstration projects beginning in 2006, January 2006 for e-prescribing, does it look like we are on track to have those mappings in place for the demonstration projects? So, those are the two questions.
MR. ROBINSON: This is George Robinson. First of all, I think we need a representative from the National Library of Medicine to address what progress has been made as far as RxNorm, as far as when it's going to be ready for prime time.
My understanding of its development is it's focused first on the generic and semantic clinical drug level, and that there may be some relationships to brands I think as a synonym. And then coming down the road would be the branded clinical drugs.
The importance of that, if you are trying to write a prescription as a dispense as written, and you're stuck with a particular brand, that function has got to be there. So, from a cross-mapping would be one approach if you are linking to the generic clinical drug, and then you are also having to link to the synonym brand name versus an entire concept.
As far as the process of mapping right now, this is the part of the roll up our sleeves meeting that I'm saying that we need. Initially, my understanding is the National Library of Medicine -- speaking for First DataBank, and making our generic formulation identifiers, and we'll be assimilating them so to speak. And what we would get back from them would be the clinical drug with a relationship back to a First DataBank concept.
That being said, we still, I think, will need to work with it, and offer for example mapping back to some of our other concepts. I don't have a good handle yet on the ingredients side, because I haven't seen the Unicodes yet. So, I'm not quite sure what the time table is for that.
But, Jeff, you are exactly right, you work backwards on a timeline according to project management methodology, to the present. There are several tendencies before this could work. Now, we have had several people say repeatedly they found a way to make e-prescribing working in the absence of standards. But if the goal is to create a model program that uses all standard terminology, we have a short timeline all the way across, especially when you're not turning up recommendations to the secretary until September 1, 2005. This is what I heard.
MR. BLAIR: Well, the interim will be in November of this year.
MR. ROBINSON: I guess there will have to be scope setting on what the initial pilot program will actually be achieving.
MR. BLAIR: Right. Other perceptions on these two questions?
DR. MILLIKAN: Yes, this is Mark from MediSpan. First of all, we are interested in doing the mapping to RxNorm. The mapping is available currently through the UMLS to one of our drug concepts. And some of our customers have already begun to ask if we have had an opportunity to validate that. So, we are going to want to be able to do it ourselves.
Initially, this seemed to be a fairly simple situation, because it was mapping to the clinical drug. Now, RxNorm is becoming a more robust drug terminology code set. It can link into -- or I should say map to various drug concepts that MediSpan has. So, it's not just a matter of linking to one particular drug concept.
In terms of our timeline in terms of how we are looking at RxNorm, we are in the evaluation stage for 2004, and trying to start work on it in 2005. But again, I would agree with the comments of George, that we are not quite sure yet what the scope of all of this is. And there are also other things to be considered besides RxNorm.
MR. HOBSON: This is Gerry from Cerner Multum.
I believe that our identifiers have been mapped by RxNorm for the generic name, as well as the products. And we are in the same boat as the other providers in terms of how we use that linkature of content. So, I do believe there is very close mapping work on content concepts through the product level. And we'll be looking at the branded levels, and what level of that information that applies to the drug content.
MR. BIZZARO: One of the vendors this morning talked about not having just drug products in that database, but also those things that are commonly prescribed medical devices. He even mentioned DME. And I think that presents another level of complexity, because syringes are very often prescribed by physicians. We don't have syringes in RxNorm. Is there going to be a different methodology to write a prescription for a syringe than there is for a drug?
So, that was a good point that I hadn't thought of before. In our database, we are not a DME database. We are not medical devices. We are a drug database. But in it there are thousands of non-drug items that are commonly prescribed and commonly paid for by third party payers.
DR. COHN: Well, Tom, just to remind you, those aren't in NDC either.
MR. BIZZARO: And that's another conversation.
DR. COHN: Steve?
DR. STEINDEL: Yes, Simon, this is not Steve. This is our distinguished colleague, Mike Fitzmaurice, who I'm afraid couldn't make it to this meeting. He had to attend a meeting in Jackson Hole, Wyoming, and I couldn't convince him to trade places with me.
But I would just like to point out in somewhat response to Jeff's question, and Randy should chime in a little bit, because he is on the receiving end, AHRQ this year provided a bit over I think $6 million through the National Library of Medicine and the FDA for support of developing the drug terminologies that were recommended by CHI and NCVHS. So, we expect to see an acceleration of that project in the next year. So, AHRQ took the recommendation of NCVHS and is moving forward with it.
DR. COHN: Thank you. And I think we will be hearing from them in September, if not before, with more information on how they are doing.
MS. AULD: I think we are scheduled for September to testify. And I'm going to go back and talk with Dusty and see if we can't get something in writing that gives kind of status report of where we are, what is the schedule for this year.
DR. COHN: Yes, I think based on this conversation, that would be helpful.
MR. BLAIR: Could I ask for one additional thing? Maybe in preparing the comments on the status of how far along RxNorm is, and the representation of actions and physiological effect of drugs from NDFRT for mapping, maybe if a conversation could also take place with the drug knowledge base vendors, where there is some feeling for how much time they need after RxNorm and the other actors from NDFRT are ready. Is that going to be enough time for them to have all those mappings in place by January 2006?
DR. COHN: Other questions or comments from the panel?
DR. STEINDEL: Simon, I don't have to ask my question. They did a very good of addressing it in their presentations.
DR. COHN: Okay. Just following up on a comment that Mike Millikan made, where you were talking about the way drugs or dosages are handled within the transactions. You were describing Script. I'm just curious, you were the only one who brought up this issue about how the information is bundled together appears to be an optional feature of Script, which I presume has some implications for other knowledge base vendors when you are trying to alert some reminders.
Does everyone have that issue? Is that just a MediSpan issue, or is that others?
MR. BIZZARO: Actually, it's more an issue for those vendors who are using our content within their applications, and then sending information into Script. Mark mentioned about the drug name. We talk about it not being long enough with the 35 characters currently, and having repeatable possibly to take care of that.
Let's look at it from the pharmacy's point of view. Well, the pharmacy doesn't care if you send them 35 characters, because most of their systems can only effectively use a maximum of 30 or 28 characters. But even though we may be building a system on the standards side for Script, provide more information to the pharmacy, and not to be able to automatically remove that directly into their dispensing system, because their dispensing system is going to have limits on the application itself.
I mention it only to give a sense of the complexity of what we are talking about here in all the different applications that are affected, and what they may already have in place as a standard for field lengths and repeatable fields and messaging that we are talking about.
I must have said something wrong.
DR. COHN: Lynn.
MS. GILBERTSON: Lynn Gilbertson from NCPDP.
The standards development process really works. The things you asked for are in the most recent, almost approved standards, so they are already there.
MS. EBHART: Aren't they conditional, and it's still not safe that everybody's program can hit the correct version, and a lot of people are on an earlier version.
MS. GILBERTSON: Right, that is correct. It's one of the newest ones available, but in response to the industry, there is room for label names, as well as the longer names. And previous versions had the support of all the DUR codes, as you mentioned earlier.
MS. EBHART: I think that was part of a recommendation that as a version of Script was identified that we want people to map to such as it was in HIPAA, there were versions and standards, as the PDP Version 3.1 or 5 or beyond. It's our recommendation that the version of Script that we recommend being implemented would be this version or one later that has these additional identifiers, and not use an earlier format where that's the only field identifier.
DR. COHN: Yes.
DR. HUFF: The fundamental issue is, or the fundamental complexity maybe is that when you order a drug, you need to allow lots of different levels of things. And so, you can put a pre-coordinated code into that drug code that is like a clinical drug, or you can use a branded clinical drug if you want to specify that it be dispensed as ordered if you are trying to fix the brand names in the prescription.
Or you can do it in pieces. So, instead of saying penicillin 500 milligram tablets, you can say penicillin, and down in additional fields you can say 500 milligrams oral tablets. And so, you want that flexibility in the ability of how people might prescribe things. But at the end, you want all of those to be computable.
And in some cases, what that probably means is you put in the drug, but then you redundantly put in the pieces that are parsed out, so that you don't have to go to a knowledge base to find out that this -- ultimately, there is a knowledge base behind there.
DR. COHN: Yes, and my issue was the computable part. If you put it in as one long stream, including the dose, the question was how you deal with that. Of course NDC has a solution, but beyond that, how do you deal with that issue if you are looking for dosage issues and all of that.
DR. HUFF: It always gets back to what do you put in what slot. If you put that code there, what does it mean for the other slots?
DR. COHN: Thank you.
MR. BIZZARO: Stan has a good point. I think we look at the NDC. The NDC in my mind, was meant to be for the package modeling. And you had this discussion in the past in this organization at the full committee. But we do need to make sure that as we kind of look forward, we are doing this.
And I think we are all doing this with the idea that we do want to have those tiny little boxes that are very distinct, and they mean exactly what they mean, and they don't have multiple uses. And you try to design your system so they are computable with their standards. But that's looking to the future, and we've got all these issues that we need to deal with.
DR. COHN: Any final questions or comments? Now, we are running about 15 minutes early. Why don't we take a 15 minute break, and when we get back we'll have open microphone, and then we'll move on to our HIPAA topic? We'll be back at 3:00 pm.
[Brief recess.]
DR. COHN: I guess I should ask, does anybody want to testify or give some comments about the e-prescribing testimony, at least until now? Well, okay. I think we're going to get more information between now and tomorrow morning. We'll be having more e-prescribing discussions. We will have another open microphone tomorrow.
With that, what we are going to do this afternoon with the remainder of our time is to follow-up on some HIPAA implementation issues, and then we were going to talk about an NCPDP, DSMO issue that we had talked about at the last session.
So, Jim, would you like to introduce yourselves?
Agenda Item: Follow-up on HIPAA Implementation Issues - Ed Jones, Jim Daley, Jim Schuping, and Steve Lazarus, WEDI
MR. SCHUPING: Jim Schuping, Executive Vice President for WEDI.
MR. JONES: Ed Jones, I'm Executive Vice President of Vizicure(?), and the chair of WEDI.
MR. DALEY: Jim Daley, vice chair of WEDI Planning and Operations. I spoke here at the WEDI HIPAA hearings we held earlier this year on campus.
DR. COHN: Please lead on. We actually have a copy of a document from you it looks like.
MR. DALEY: This is the letter. When we here before, as you recall, you asked at that time to take the primary recommendations and try to make an attempt at prioritizing some of the ones that we thought were most important. So, what you have in front of you here is a draft document. We are presenting a summary of that.
I think Ed is going to lead off with some background for the folks here, and then we'll get into it.
DR. COHN: Okay, fine. I wasn't sure if we should use this as a guide, or just to start the conversation.
Thank you.
MR. JONES: We're pleased to be back here before the subcommittee today to follow-up on our earlier meetings. Just as a little background for everybody, WEDI held a one day hearing in Tampa in late January to evaluate the challenges and successes of the HIPAA administrative simplification implementation of the transaction and code set standards.
Following that hearing -- we had testimony from I believe 56 persons and corporations, both in oral and in written format -- we sent a letter to the secretary, and brought it here in late March, indicating a variety of areas that mainly were challenges and some successes with regard to the implementation of the transaction code sets.
We were asked at I believe it was the March 29th meeting to prioritize the recommendations that we were bringing forth, and to return today to go over those, which Jim Daley and I will.
We have broken these down into three areas: things that we believe need immediate attention in one way or another; ongoing issues; and then some strategic longer term issues. There are four issues that I would highlight and turn it over to Jim, that we believe are current implementation issues. And these are in some sense of order of priority.
The first is to continue the focus on full compliance while maintaining the contingency plans, but with some set of timelines to move away from that. We also believe, especially based on the WEDI meeting we had in LaJolla last week and talking to people, that progress is being made.
One of the areas that does need attention here is there is a need for a definitive, authoritative source for frequently asked questions. And if that is CMS, we need to get the word out more on that.
The second priority -- this came up quite clear in the meeting in Tampa -- is that everyone in terms of focusing on implementing the transactions, is really focusing on implementing the claims transactions, and not any others. So, we think that a renewed effort is needed to identify and promote the net benefits of these other transactions, and to have movement on those. And this relates to contingency plans, because if those aren't being addressed, obviously the contingency period is going to be somewhat longer.
With regards to this area as well, and this was a great concern last week in discussion at the WEDI meeting is we need to really bring some standardization to the data content, particularly with what are the situational variables. And there is a lot of variability with it.
The third is to focus on -- and this really did not come up in the implementation specifications -- we really need a requirement for the use of a standard acknowledge, such as the 997, and we need some more definition on area reporting, because a number of transactions are being kicked out as part of this transitional phase of implementation.
And then the fourth area is to conduct a comprehensive review of coordination of benefits issues. And probably the most immediate concern here is getting the health plan identifier out, because without that particular identifier, you really cannot move efficiently in electronic formats from plan to plan.
I'm going to turn it over to Jim to give you a little more context on these, and on the ongoing strategic issues.
MR. DALEY: Thanks, Ed.
Ed has pretty much described the highlights of this first item. Again, the rest of the document, the final four or five pages have a little bit more context for those particular items. I would rather just go over these first couple of summary pages, and then open it up for questions.
In regards to COB, there were a couple more recommendations that we did have, including clear instructions to Medicare contractors on how to populate crossover items in a standard manner. That's been a real problem in industry, getting information from the various contractors through those payers, and having those items accepted.
And another major COB issue is associated with serving the various claim form types. If a claim comes in, in a professional format, crosses over to another payer who requires that in an institutional format, it does cause some problems for the provider. Now, many other things in there in terms of code value, whether they do COB at line levels, claim levels. There are a whole bunch of items in there that are causing problem when you do try to cross from one payer to another.
In terms of ongoing implementation issues, I do want to make one other statement before I go into this. Even though we have separated these into various categories, some of the strategic issues do apply to some of the current issues as well. You can't do one without the other.
For example, looking at getting the right input, as you might want to make a change to the standards. Making sure that there are no unintended consequences at either a pilot, or some measure such as that. You really do have to look at all of these together.
Developing the standardized test data is an ongoing issue. It would be great for the industry to have a way to say if you can accept this information into your system, we can send it out with these standards. Everybody would be able to use it. We have it certain to be that way with some of these testing facilities out there.
But even that is not going sufficient to really guarantee acceptance from one entity to another. It would be good to develop some kind of a test bed, set of test data that would accomplish that. I guess I could liken that to your light bulb. You plug it into your standard socket, and know it's going to work.
Expediting change standards. Our recommendation is that CMS, WEDI, and the DSMO stress the standards development process to determine whether an expedient change process should be developed. There is a need at times to fix what's wrong with the standards. But again, we shouldn't disregard the regulatory process as we are doing so.
We do need the industry input, and concurrence that it's the right thing to do, because even minor changes can result in significant efforts. Even a new value in a field means maybe some different edits, and changes the value of the entry screen, possible business changes. There are a lot of implications of even minor changes that need to be thought out before we just make a quick fix.
We need to address in a timely manner, some of the data content issues that exist. One of the big things to come up recently is the fact that the 835 remittance does not have enough information in those code sets to really tell providers what went wrong.
Some of this complicated by what Ed just mentioned in terms of the acknowledgement and the error reporting. Some may get accepted, some may get rejected. Some lines may be accepted. Some may not be paid. And in the long run, remittance by the system with a limited set of codes may determine how much money you are getting.
Tracking what really happens during that whole set of processes has been very difficult, because a lot of the problems in getting everyone transitioned to the new HIPAA standards.
Code set maintenance would be restructured to a new schedule of only once a year where appropriate. We look to the implementation guides for some internal code sets, which are maintained by the DSMO. They issue the guide, and you've got to issue the guide to change those. That wouldn't be a problem.
But there are many external code sets, for example CPT codes, zip codes, you name it, there are many in those guides, each with potentially different schedules. And since they are incorporated as part of the HIPAA standard, conceivably we can change the HIPAA standards every month. And if we could bring some order to that process, that would be helpful to the industry.
Code values on instructions should be specified. One of the examples I've heard is that yes, we are specifying too much with the CPT code for your procedure, for the professional services. But there are apparently specific instructions as to when and where you use those procedure codes.
And I recall for anesthesia you can either code that as a surgical charge, or you can use a separate CPT code to say this is the anesthesia, so there were some questions about that. And one of the suggestions was that there is a standard way to say this is the way you do those codes, and that's how it should be followed. And we're doing things somewhat differently.
Then there were strategic implementation issues. The first three listed down here can be somewhat grouped together -- in way in which the providers are included in standards development; balanced representation on the DSMO; and encourage decision-making and participation in standards development.
In other words, we really need a good, balanced industry representation to come up with standards that are workable for everybody. We don't just need testimony from people. We don't just need those who can afford to attend the meetings for both the dollars involved and the time involved. We don't just need people such as the vendors or payers or the associations.
We need the people right out there, the real doctors for example, to say this is how it affects me. How can we get all of those people in here so we really get a standard that is workable for everybody involved?
We just pilot standards prior to issuing the final rule. In other words, a standard is out there on the table. Let's see if it really works before we tell the entire country to adopt that standard. Through that pilot, we will be able to see if there are changes needed before the standard is adopted, and we can validate the costs and benefits of that proposed change.
One final recommendation, that we really do look at enhancing the implementation process. Specifically, we need to look at the realistic time frame for all aspects needed to complete the implementation. For example, if a standard must be implemented, the vendor products need to be designed and developed and rolled out and published in reported sites. Those can be provider sites, clearinghouse sites, payer sites, whoever needs the crossover in order to perform their function.
That takes some time. Once that is done, everybody believes they are compliant, we still need to migrate all the different trade department connections that are out there. There could be thousands of connections for a payer, a clearinghouse. Even providers have dozens or hundreds of connections they have to deal with, and that takes time as well. All that needs to be rolled into the process, so that when we say make a change by a certain point in time, we have a real expectation that we'll meet that particular role.
Accept high level economy(?) of what the recommendations are.
And I would able to give Jim one last chance to add a couple of bullets, if they have any, otherwise we'll answer questions.
MR. JONES: I thought it was interesting listening to the discussion this morning and earlier this afternoon, and in particular I think it was Harry's question on the difference between e-scripting and e-prescribing. And it seems very similar in context to what we have been dealing, the transaction, the code sets from a format standpoint if you look at e-scripting, and a content standard if you look at e-prescribing.
And I think we have learned a lot of valuable lessons that may be applicable to this. And I remember on May 6 when Sec. Thompson had his summit at the Willard, he said he wanted to expedite the time frame for dealing with the e-prescribing. That we have been working on these transactions for eight years, which is I think kind of like the time frame we are dealing with in the MMA.
But we really need to focus on what is the standard, and getting that common content together for the format to make it work.
DR. COHN: Well, just a reminder. As you remember, HIPAA was supposed to be implemented by 1999 completely. Sometimes complete implementation takes a little longer than initially anticipated.
I do want to start out with rather than discussion, since we didn't have any microphone for e-prescribing, but I did just want to make a couple of comments. Obviously, I have not recused myself from any of the conversations so far today.
At the last meeting, I, at that point, recused myself from being the chair, only because at that point I was at least nominally on the board. I do want to disclose to the committee that while I was elected last year, because of being unable to ever get a satisfactorily read from HHS about the impact that that might have on my station and involvement with any recommendations, I really never served. And I have since vacated that seat.
My understanding from Marjorie Greenberg, our executive secretary, is that since I didn't serve, I really am able now to take testimony in all of this. So, if you any of you have any questions about that, I'm happy to chair the hearing for the moment.
The other thing is obviously with the code guidelines and instructions, which as you know, I sit on the CPT editorial panel, and a lot of those actually relate to CPT, although I do have to say that I consistently see this one, so I should understand what this is, but my memory of the reason why there were no guidelines specified for CPT at the time that came out as a final rule is that there were separate guidelines for CPT. And to my understanding, there still aren't.
So, I guess at some point I will give the chair to someone else so, maybe we can the AMA come and explain to us what this is all about.
Anyway, having said all that, I guess to me the issue that I'm most concerned about as I listen to all of this, and I know Karen may talk a little bit about contingency plans hopefully when she returns, is really this issue of moving to full implementation of all the HIPAA regulations.
I think I actually spoke at the meeting last week, and at that meeting actually asked -- in two weeks, full implementation in two weeks -- but I actually asked people to raise their hands about how many were working on things beyond the claims transaction. And I would say it was not a majority in the room that were raising their hands at that point.
Clearly, it was a situation where people are striving to have compliance of claims transactions. And I really think being somewhat forward looking, as well as responsible at the NCVHS, the subcommittee for monitoring how we are doing with administration simplification, really the focus we all need to have to now is both how to monitor, as well as promote the implementation of all the regulations.
And I guess as I look at that one, that's really the area I think we really need to be focused on. And I am curious about what thoughts WEDI had, in terms of our subcommittee thoughts. I do know as I'm listening to all of you, it seems to me that maybe one of the things we need to do as a subcommittee, given that we are responsible for monitoring this for Congress is to launch some sort of an evaluation, or I would say not really a model(?) of the industry, but getting a very clear view of where we are in terms of implementation, so we can report on that.
But I'm open for ideas, because that really, of all the things I have seen here, that's the one really galvanizes me.
Steve?
DR. STEINDEL: Yes, Simon, this question came up at the NUCC discussion a couple of weeks ago as well. And as people are aware, CMS publishes I think approximately a weekly list of the compliance with primarily the 837, and how it is improving on a monthly basis.
But it also has several other transactions, one of which is coordination of benefits. And the NUCC meeting, we pointed that it would be a good idea for them to start doing the same type of effort that they are doing to put the 837 into widespread use by tracking and trying to improve the figures on coordination of benefits.
In part because as we understand it, some of the other claims also involve coordination of benefits, and will probably go into effect at the same time. So, that was our suggestion to try to improve it, to have CMS start tracking more vigorously.
MR. SCHUPING: Simon, I think you will probably remember there was one presentation early in the program last week where the comment was need made that some of the feedback they were getting was that some of plans already were hitting like 90 percent or better on a lot of the compliance conditions. And that they were thinking of discontinuing their contingency plans.
But my guess is that the eyes are going to be on CMS, since they are the big player in the game. And when they put the stake in the sand, I think that's what is going to create the momentum for the full implementation. But I think we are going to see some of the plans begin to discontinue their contingency plans if they are hitting those kind of percentages. I don't know when that will be.
DR. COHN: Yes. And that obviously needs to be the 837. Did they say anything about all the other transactions?
MR. SCHUPING: They were just referring to that.
DR. COHN: Okay.
MR. SCHUPING: That's the dilemma that we're in right now. We need to get moving on these other transactions.
MR. DALEY: I think from a perception standpoint, one of the positive developments that goes back to the dialogue we just had on how long this has taken, since August 1996. And my feeling on that is that the Administrative Procedures Act is really not a useful guide when you are using technology, particularly when technology is moving very rapidly.
The market is outpacing the ability to promulgate regulations. So, I think one of the important things beginning last year, particularly on the clinical side was the federal government taking the initiative through a variety of vehicles, the EHR, the SNOMED-CT, the CHI initiatives, et cetera, to use its market power if you will in the health care field to show an impetus, a need to move forward.
And I think one of the interesting things, going back to that May 6 meeting with 15 CHI initiatives were adopted, one them happened to be the HIPAA standards, which puts that in the context of the overall health care environment. And I think particularly on the provider side, where they kind of look at it, and see these electronic transactions, but they really don't have any context on the administrative with what they are doing.
All of the sudden they think you have put the whole thing together in a whole. And I think if you look at the provider initiatives that have been taken, and the data that flow through those clinical processes in a practice or in a hospital, those data that really populate the administrative transactions, and I think over time that's where we are going to see the benefits.
But I think we really need, from an educational and outreach standpoint, to really hammer that message home to push these HIPAA transactions. Otherwise, I think other than the 837, these things are just going to kind of move at a relatively slow pace.
MS. FRIEDMAN: I'm interested in the second goal under full compliance on page 2 about the FAQs. Because CMS and OCR both have a number of FAQs on their Websites. And I know ours are updated frequently in response to inquiries we get, both ones that come on e-mails or "Ask HIPAA," and also from the hotline. OCR does as well. I'm not so sure what you are referring to, and how would this work?
MR. SCHUPING: I think what we need to do is designate one particular source. There are a number of sources that people look to for guidance for this area. And not everyone is looking to CMS or the FAQs that CMS has out there. It does not over the issue, and you are dealing with a vendor, and you want to get an answer in a couple of days, this type of thing.
So, we have just found in the testimony that was given in January, and in the discussions last week, people want more information. So, we're positing this as an idea that would have some immediate benefit. And it probably is a greater outreach effort.
MS. FRIEDMAN: Well, one of the challenges, having managed the FAQs is that a lot of people want us to solve their business problems for them. And there is just no way that we can do it as the government. But more importantly, I think people want a very down and dirty call on every business decision they make, and I don't see that happening.
MR. SCHUPING: Well, I can give you one example, then Jim can comment. This came up again last week. It's been coming up for quite a while, is what is the status of a bank as a covered entity? Is it a covered entity? What are its responsibilities? And this has been hanging out there, and has been an issue on the payment side.
That's just one example, but that's a fairly significant example, because all of the sudden what I like to call the medical banking sector is really heating up in terms of wanting to be innovative in terms of transactions with the 835 in place, et cetera.
MR. JONES: One of the things I've heard is that the FAQs are a great reference source. However, it does take some time to develop an appropriate answer in many situations. Sometimes the questions really aren't a policy question, a business question, or a regulation question, but the fact that were told to use the IG. And I'm not quite sure what the IG says.
And someone is going to have a different interpretation from may have meant. And with the hundreds of thousands of people reading the IG and trying to comply with HIPAA, there are a lot of interpretations floating around. And often, they just want to say by reading this language, we read it that way.
And I seen some of the IGs go to lawyers to say legally, what should we or shouldn't we do in putting the IG. It doesn't sound like the right way to implement HIPAA. If we had a source that we could go this is a policy decision, a regulatory decision. We really need CMS, the government to write an FAQ, then fine.
But for the other ones, as we said, this is strictly just what did they mean when they wrote this line in the IG? Perhaps whoever wrote the line could say that's what we meant, and clarify that maybe more rapidly. To coordinate the resources of WEDI, DSMO, and CMS to come up with a more expedient way to answer the various types of questions that exist.
MS. FRIEDMAN: And that's an example of what I just mentioned before about the business issue. I want to find out if I can do X. And the implementation guide may or may not help me. This is kind of a gray area, a new area. So, CMS, tell me what I can do, so I can go make money. And we see that a lot actually.
MR. SCHUPING: Obviously, some of the questions that you are going to get, we experience that on the WEDI's tip list. So, we get just thousands and thousands of tips every week, and people looking for answers and solutions. And some of them you just flat can't answer without doing a fair amount of research.
But I think the message that was coming through here again and again in the hearing and what we got is that they would like to be able, to the extent that it's feasible, if industry and government could coordinate to have a central point where they could go to so they have a reasonable change of getting some of their questions answered in a timely fashion, instead of kind of having to go to a dozen different Websites. Well, I go over here to find this, and I go here to find that.
If there was some way that collectively we could work to bring a reasonable amount of data together, so that we have a chance to answer the questions.
DR. COHN: I want to change back to I think our previous frame, if that's okay. Karen, what we were talking about, WEDI was proposing obviously what they saw as current issues. And obviously, on the one hand there is the issue of complete compliance of the 837. And I think you might have some recent statistics on how the Medicare and CMS is doing in terms of all of that.
But then we were also returning to this issue of how are we going to be mobilizing the full compliance of all the recommendations? And I want to open that up for brainstorming for everyone. I think everyone has a role in all of this. Certainly, the role of the National Committee is try to get that published and monitor what is going on for all of that.
But I think you might have some ideas both in reference to how we're doing with the 837, what your sense is of how all this is going, and all of that.
MS. TRUDEL: The statistics for last week in Medicare compliance in terms of the inbound claims were published and were at about 85 percent, which is excellent. And we continue to inch up week after week, so that's good.
The Medicare interim steps that we have put into place, where we will pay electronic non-compliant claims effective July 1 as though they were paper, in other words, we'll pay them more slowly, I think is beginning to have an effect. And that was intended to be an interim measure that was not as dire as cutting off the contingency altogether.
I think what we are trying to do right now, what all payers are trying to do right now is to get over the hump with the claims, and to work with clearinghouses and vendors, and providers have all of that. That has to be taken care of. Get everyone into production, and let's begin to turn our attention to other transactions.
I know we are tracking percentages on the remittance device and the outbound claims, COB claims, as well as the inbound claims, because we have already identified a number of COB issues that are causing our trading partners to not be able to process our files, and have therefore put in some system changes which will also go into effect in July, which we think will really improve that percentage.
And I think that we and everybody else in the industry is going to keep having to keep chipping away at these other transactions, at the claims status, at the eligibility. And to make sure that providers understand the benefits of using those transactions, and to constantly think about doing outreach, or even putting incentives into place possibly. Some plans may think that they can put incentives into place to encourage people to use these transactions.
MR. REYNOLDS: A couple of comments. A couple of on the ground comments first, and then maybe questions for the gentlemen from WEDI.
The other transactions are slow in our environment, however, people are waking up, and we are seeing much more action. The thing that I think is still out there that is real, we just held eight seminars across the state, 1,150 people attended from provider organizations. The most heavily asked question was exactly how do my work?
Please don't underestimate the difference in what we heard in e-prescribing, where they are saying we have an industry. We've got a lot of things in place. Let's add to it. HIPAA was the rebirth of everything related to what we wanted. And that rebirth is coming slowly. And it's coming really slowly in the individual environments.
So, remember, that's 1,100 people that came of their own choosing, and it's 1,100 people who asked of us -- this was not a prompt question, this was not what's your biggest issue, this was open forum. And those asked the question, we have all rebuilt so many new relations.
I can tell you for example, our second largest submitters, two major clearinghouses, one that was here yesterday, have yet to submit an 837, not because of their strategy, but because they can't get around the country, all the way around to get everybody going, because everything is a little bit different.
So, as you look at what we've got here, the exciting thing to look at this is this is a short letter. I mean that. That is very important to keep in mind.
The other thing that's exciting, if you listened this morning, we are talking about e-prescribing, and we heard 270, 271. You didn't go mainstream. So, we can't lose sight.
So, I think as you look at what they have here, and you look at the contingencies, and I know I have testified, Karen says 85. I'm at 45. Three of my top five haven't submitted any claims yet. I can go pretty quickly, but the 1,100 people that attended probably make that 15 percent, and don't even know where their claims are going, because a lot of times their IT people have made some contract agreement with somebody, and the actual person working on the ground doesn't have a clue. So, their claims are flying around.
But as I look at the successes on the ground, it was sobering. It was very sobering to get that list of the top questions.
MR. BLAIR: But their number one question was what is the claims process?
MR. REYNOLDS: Yes, what is the claims process for my plan. How do I get them to you? How do they get there? Because what you have is there are many vendors, when the claim goes to the vendor, hospitals and doctors don't necessarily know that the vendor sends it to a clearinghouse, because you've got all these arrangements.
So, understand we have literally from them, out of all the EDI we used to have, and it is being built back. We are consolidating them in industry. And it continues to be consolidated. So, what happens is the H5 is good. We've got some questions, and I think a lot of those will be answered by the COB, because that will take Medicare from they are. That level may then become philosophically a little more of an industry thing.
This is really starting to go, but panic is not a key. But I do have some questions on what you actually said here. So, that was just kind of an on the ground, day-to-day, all day, every day looking at it.
The contingency plans that you are going to see, I think you guys are recommending that once Medicare does what it does, everybody else needs to make sure that they are far enough along to make their own decisions. That's what you're here for. I think most people aren't going to blow their business up.
MR. DALEY: That recommendation is based on the fact that the average physician, about 43 percent of the claims going to their Medicare-related -- unlike at the turn of the 20th century in Philadelphia, where if you lived in the north and the south, you had two phones, because they didn't interconnect. In the physician's office, they are going to be using the same system. So, I think we can piggy-back on that benefit, but that's only one of them.
MR. REYNOLDS: Yes, but I think it's going to take another key though is they have clearly stated, these vendors have clearly stated they are doing Medicare and Medicaid, but then the commercial. For example, we had Medicaid actually attend the conference. We actually invited them from North Carolina, both the Blues and Medicaid.
Second, I wondered on your second, your non-claims transaction, are those in priority one?
MR. DALEY: No, there is no particular order. Because from the ROI benefit to the providers, we can get the right information to them from the payer. The eligibility is going to have a huge pay off.
MR. REYNOLDS: Because I think another thing that is occurring in reality is that now that HIPAA is real, free enterprise is going to get on it I think in a lot of ways. So, you are seeing a lot of people expanding these. I know for example the Blues are. We have requirements. We have I think I have read six requirements over the next two years from the standards transactions.
CAQH is in the process of answering the CAQH questionnaire that is out right now on eligibility, where the industry groups have grouped up and said here is what should be in the eligibility terms. So, again, the standards are there. None of them said yes or no. But the industry is going not really.
Now, we are kind of there, and that's not the right answer from industry. We need to move. So, there are no frequently asked questions that you've got to move. There is no IG change that you've to move. But there is a groundswell that is moving. Because yes or no is a problem.
Now, the next question I have is you mentioned that the health plan identifier for COB, because that would help COB, but right now the COB process that has always gone on, most of the Medicare intermediaries have taken a number from the payer, and have been able to do that.
So, I would say that probably 80 of the COB transactions are probably Medicare-related. Is that fair? So, I think that even without this as a new identifier, it's good to get the new identifier, but I think once some of these COB things are settled, we're probably going to make an 80 percent move as an industry without having to wait for the national provider ID -- or excuse me, the health plan identifier to be there.
Because Blue to commercial or commercial to Blue or commercial to commercial isn't going to flow nicely, because there is not enough volume that people usually pass their individual number.
MR. DALEY: I think the self-funded it is not quite that high. At least from what I'm getting from the TPAs and most of the large companies are self-funded and they are multiple plans and so forth. That would not be that high.
MR. REYNOLDS: One of the things that I'm aware of in a number of states, the prompt pay laws in states says -- you look at number three on your paper where you talk about a timely manner of data content coding assessment. One of you mentioned the 835. The prompt pay laws in the states require certain messaging going back on remittance devices to the provider.
So, I would be anxious to see WEDI work with the people who are establishing the code sets' meanings for the 835. So, it's not a code, it's an identifier, because I know in at least two or three prompt pay states, I know we will be required to send a paper notification of payment, as well as an 831.
That is not where we are trying to head, because what the state does with their messaging are not included in the federal codes that are under the 835. So, what happens is -- now, we are working with our department of insurance and others are too, but those kind of costs, where you get inside the transaction and you have like we talk about the DSMO and everything, where you have the messages that aren't -- they are just message codes. Anyway that WEDI and others could help with those things.
I think also it starts to take these rough edges, and starts to take these frequently asked questions, and these things start going away.
MS. FRIEDMAN: It is the same situation in our state, where you have to do the papers on electronic billing.
MR. REYNOLDS: Yes, I don't remember the exact ones. In other words, there are probably 30 states -- 20 or 30 states that have prompt pay. I can guarantee you this prompt pay law went in ahead of HIPAA.
So, the size of the letter is exciting. The fact that you did roll down versus what you had is exciting. And I think that we have these recommendations, and I guess I'm going to be interested in what is WEDI asking us to do with these recommendations?
MR. JONES: May I add to comment to what you said, Harry? Many people would agree with you. You really hit on something I said earlier, that some of these recommendations are interrelated. The real problem I see, and many of the things that I have heard from the people I have talked to is getting the money side working.
Just getting the claim in, getting something back that is a remittance. And then also knowing am I ever going to get paid through the eligibility impacts? So, between those three, to know upfront that the patient is covered, you are able to submit a claim that can be processed. You can track through the process to know that it actually got to the payer. And then that's how you get remittance that says here is how much you are going to paid.
That would solve a lot of the problems and make people move forward. Some of them require the use of these proper codes or recodes on the remittance, so they get more information, and they understand it perhaps a little bit better. They are all interrelated. Given that we can direct the money in place is the key to making people move forward.
DR. COHN: Karen, did you have a comment?
MS. TRUDEL: I would just like to make two points. One to build on Harry's, and I think that having the standard transactions, standard code sets, standard data content has served to cause people to be able to realize that there are perhaps slight nuances and differences in business practices from plan to plan that aren't necessarily relevant to their actual operation.
And it presents an opportunity for people to begin to look at clarifying and making the eligibility business process more consistent. I think that the transaction standards are serving as the best kind of harmonization processes where that makes commercial sense.
The other thing was, although it wasn't necessarily directly related, there have been some questions about the Medicaid contingency plan, and when at some point in time we announced that we are going to lift that, how that leaves physicians other plans. And it has come up often enough that we have drafted, and in are in the process of clearing a frequently asked question that will address that.
MR. DALEY: I think that would be useful. There is a lot of uncertainty about that, particularly with regard to the various percentages of compliance on these other standards. And it is obviously going to take time to deal with that. I think that would be very helpful.
The other point, based on what you were talking about, what Harry was talking about, and it really relates to some of the discussion earlier today. In the health care industry there is a lot of confusion about what the standards are. There is a lot of confusion about what the standards are. There is a lot of confusion. People believe that a lot of the electronic processes, and data systems, software, et cetera, somehow lend a competitive advantage.
There are lots of counter examples, such as in a very recent in the way kiosks are used at the airport for getting your ticket, and those more or less standardized. The way ATM networks now are seamless around the world, the way cell phone technology is evolving, although there are three different world standards.
And I think that's what we have to convey to get people to move ahead in the health care industry is we are not taking away competitive advantages. What we are really trying to do is create a tool or a utility that is going to convey benefits to the investment in this, and that there are other business-related factors that are going to have an impact on competitiveness.
This is a very confused notion in the health care market. And I think as we do outreach and education, we really have to get that message across, and use examples that people see in everyday life.
DR. COHN: Harry did ask an interesting question, which is I think you asked what should we do with the recommendations. What would WEDI like us to do with these recommendations? And obviously, there are various views on all of this stuff.
Harry is happy with only one page. I'm not sure I'm happy because this is a two page summary, but anyway, it isn't a 100 page book.
But what are your thoughts? We actually heard from you. There are things that I have already commented that I think there is a need for us to be monitoring, though hopefully not in extending hearings. We getting sort of hearing-ed out. But we need to come out with a better methodology to do more in-depth monitoring.
MR. DALEY: WEDI is prepared to put together task groups. And in fact what I called kind of a herd of true confession of that May 6 meeting when we all went and volunteered to do something under Sec. Thompson's 120 day schedule, probably in a fit of madness I went up to the microphone and said that we would be delighted to marshal our troops to work on incentives on both the provider and payer side, to look at how we could foster faster movement on compliance.
And so, we, at our board meeting last week, put together a group that will be meeting. I believe we have a conversation with David Brailler(?) coming up to focus on this issue, and to kind of get his thoughts on it. I think the incentives, and that was brought up earlier, is going to be very important for moving the industry faster in this. So, that would be one thing that we would bring back to the table.
I think a second issue here, and we talked about it just a minute ago is diminishing the uncertainty with regard to these contingency plans. People, I think, if there were for example sequencing, if we are going to go -- as Harry said, are these in priority order -- if we are going to go from eligibility into however we end up going down the certain time frames or ranges of time frames, I think that would focus industry attention, and move out of kind of this uncertain zone.
MR. SCHUPING: I would just add that I think we would be very interested in getting any feedback that the committee would care to offer as to how useful these are these recommendations and priorities. We have found that we've had a lot of success by just moving with task groups, where you kind of focus on a single project like this, give them a timeline, and give them the resources to get it done and make it happen.
A lot of these things I think we need to have it sooner, rather than later. And in some instances, as you look at the different recommendations and see that they are not going to be solo flights, they are going to require collaboration with more than one organization or entity, and many industry and government stakeholders.
So, if you feel that these are on target, and they make sense to you, then with that blessing, we would be happy to take a lead role in making any one or several of these happen, because we think they are critical. This is the feedback that we heard from our constituency. These are the things that were important to them, and we would like to move it forward.
MR. JONES: Simon, just a couple of comments as well. As Jim indicated, we would certainly like NCVHS to endorse these recommendations. One of the other things that we consistently heard in the testimony and other places is that with the outreach that CMS has been doing in various ways, anything that the committee here could do to help enhance outreach and continue the support of outreach programs, that would be very beneficial.
Was the answer acceptable, Harry?
MR. REYNOLDS: Obviously, the devil is in all details. There is no question that each of these subjects, I feel is very valid. But they are issues that are clearly out there.
I think that if WEDI works with CMS, because I think we're all kidding ourselves, the whole initiative is kidding itself, CMS, whether they want it or not, has the ball, since they are upfront, working with them.
So, if WEDI works with them, because one of the things I think is interesting about one of the recommendations, the recommendation that CMS do the frequently asked questions, in many, is that CMS site of care, or is that the CMS? Because remember, some people out there don't know the difference.
MS. TRUDEL: It could be both.
MR. REYNOLDS: That's right. But I think the key thing is the recommendation that you team up with DSMOs and WEDI, and then team up with CMS so it evolves with the frequently asked questions, even if there is a new frequently asked question coming out from CMS, it is vetted, at least so that you could comment to your constituency about what you think it means.
One voice -- the one voice doesn't have to be agreement. One voice has to be all understand what we're saying and we all do it. So, that recommendation I think moves people along. But the rest of them are valid. It's just my opinion, I don't think there is anything in here that either CMS or WEDI has the authority to do without any recommendations.
DR. COHN: Say that again Harry.
MR. REYNOLDS: I'm not sure if there is anything in these recommendations they don't have the authority to continue to do.
MS. TRUDEL: That's absolutely correct.
MR. REYNOLDS: In other words, that was my last question, because none of these recommendations, these are all good recommendations about good business process. And there are already ways to do it now. Speeding up additional ones, things are clearly identified. And then staying close with CMS, so that their message when it comes out, comes out to an entire industry and a group.
Like you mentioned a contingency. On the contingency matter, the CMS changes its own, well, that isn't clear which CMS has. That one is a resounding message.
MR. DALEY: See, most of the private health care community, irrespective of what CMS says, is going to view that as the federal government and the imprimatur. And on the same token, if some sort of schedule is laid out that people could anticipate. Right now they are in an uncertain zone. And they don't know how to proceed.
MR. REYNOLDS: That was my point. And you guys, the three of you worked directly with CMS to help as they are about to come with something -- I would hope between the two of you, before it comes out. You are representing the industry, and they are representing the government aspect.
But there needs to be some reviewing so that the message that comes out -- I think CMS will say obviously whatever CMS wants to say. But you guys being side by side with them, explaining what it really means, because I would a little bit disagree. I don't think most of the private sector is going to do a dramatic link when Medicare pulls off there compliance if their client level is not sufficient to keep their business going in a reasonable way.
But the messaging of that is still key. I'm not playing point-counterpoint. And so, those are the things, that you guys working together with CMS especially, and then industry on these other things, I should keep going, and keep going more vigorously. I think you should set your committees up, and I think they should go, because all these things still have to get fixed.
But I don't think that writing anything, putting together a letter and writing to the secretary, or WEDI writing to the secretary, I don't think that's changing. I think that's changing. I think now that we're in the business process, making sure that the right people are grouping up.
DR. COHN: Actually, I think WEDI has already written to the secretary about this, as I understand.
MR. DALEY: We haven't. We do have an excellent collaborative relationship with the Office of HIPAA Standards.
DR. COHN: I think Karen also has a point. My own view is that you are doing absolutely the right sort of thing. You are an advisor to the entire process as identified in the legislation. This sort of advice, and work in the industry, which is I would say WEDI at its finest, but one of its finer moments.
And as I look at all of this, I'm not sure I think it's necessary just only working with CMS. But really your strength is working also with the industry. A lot of the things are things that we need to be working directly with DSMOs about. This issue of external code sets, which we have already gone on record sort of saying, gee, there needs to be improvements to the process, improvements to the updating, and all of that. I mean you are dealing with very specific examples at ground zero on that.
And it's something where I would think by bringing this to them, and working with them around all of this, that one should be able to get resolution. And if not then CMS, and NCVHS might need to get involved. But again, there are really a lot of things here.
As I said, I don't think this is something we should approve or disapprove. There are too many pages here, too many nuances, including a number of things I would have to recuse myself on anyway. But having said that, I think the direction is correct.
MR. REYNOLDS: I totally agree. I wasn't excluding any of those others. Since they represent the industry, I would agree.
DR. COHN: Karen, any comments?
MS. TRUDEL: I just wanted to reassure some committee members that HHS is already looking at a whole 20 page report or whatever, and analyzing the recommendations. So, that activity is ongoing irrespective of whether the committee chooses to or not to make any of a recommendation.
MR. DALEY: Using Harry's model, that shows how much progress we've made over the last two months, fewer pages.
MR. JONES: On some of these items there has also been progress. For example, the announcement on error reporting, WEDI has done a white paper on that, and several other things are still being worked on.
DR. COHN: Is there something anybody else wants to comment on? Is there agreement with everything that has been said so far? Jeff do you have any comments?
MR. BLAIR: No, I feel very comfortable with your observations. I think WEDI has just done an outstanding job in a very tough situation in trying to help and shepherd the adoption of HIPAA standards. So, no, just complete support.
DR. COHN: Yes. Stan? No.
Lynn, I saw you had your hand up. Do you have a comment or a question? Come to the microphone.
MS. GILBERTSON: Lynn Gilbertson from the National Council for the Prescription Drug Program.
Just one or two things I wanted to make brief responses on to the summary document. And that is when you talk about the frequently asked questions or the industry place to go to, NCPDP members saw the need immediately when HIPAA became real. And as part of the standards development process, since we could not make modifications to the main standards, we created a document lovingly called the Version 5 Editorial.
That is available on the public Website. It's available to anyone who purchases standards. And as it is updated, which is usually on at least a quarterly basis, industry is notified that this document has been updated. It contains editorial corrections, with some typos. It contains clarifications. It contains new examples. It contains anything that comes forth.
We have an industry task group that spends a lot of time going through questions that come in from the public and say, how do I do this, or what did you mean by, or whatever. So, we have already built that model so that the industry has some place to go to. Because basically, to be honest, NCPDP and its members are the experts of this standard. So, we didn't feel a separate body needed to formed.
One of the things to make you aware is that the DSMOs have spent an enormous amount of time with the Office of HIPAA standards discussing information that could be put into the next NPRM having to do with a modification and maintenance process, and trying to build as much into moving forward with the industry as quickly as possible within the realm of what we are allowed to under the regulations.
We have spent an inordinate amount of time doing that. So, that will be available when HHS is ready to publish in an NPRM, hopefully later this year. So, it's not like there are complaints, and no one is listening. We are spending a lot of time trying to make things, recognizing that when it comes to naming new versions of existing standards, for example, the rulemaking process has got to take place.
So, as long as we're under those guides, we have to work in that time frame. But as far as maintenance type things, there might some suggestions we can offer in industry comment.
The other is as I look at the certification, and when you post-certification maintenance should be restructured for a version release scheduled only once a year. But where appropriate, it's real important that NDC better not be that way, or we'll shut down the industry.
The other thing, just as an FYI, there is a comment in the COB section, and we are still trying to track it down. Someone made a comment about the NCPDP standard. And we have not yet been able to find who submitted that comment so we can take action on it. So, it's out there. It's in the document, but until we can track down who submitted the comment, we can't take a lot of action on that.
And then I guess the other thing, in the summary, just as a question, item number two says balanced representation in the DSMOs. And when I went back to the original testimony, it asked that the maintenance committees should insure balanced representation. And I'm wondering if new information came in that something will be sent to the DSMO about this item? Or was it just a typographical change from under the code set, maintain a committee that acts in the biz(?) mode?
MR. DALEY: That's a typo.
MR. REYNOLDS: At the last meeting we had, Jack Embry(?) testified, and I'll paraphrase what he said. I can't quote him. His comment was that it's hard to figure out how to get providers involved in WEDI or any of these other things, because who really represents them. And his comment was we're so diversified, who represents us?
But I continue to ask as we move forward, especially with WEDI, whether it's CMS, whether it's the DSMO, that we somehow don't forget the people that are actually on the ground. The same thing we talked about with leaving scrap(?) where we can do all the dancing we do, but if we don't make that work, we don't do that electronic prescriptions, we don't have a deal.
And so, I think as we go forward and make these changes anyway, any of the three main groups that can reach out and make sure that they at least make extra effort to touch some segment of that provider group, I think is going to be a plus. Because otherwise we will continue to hear testimony about we really weren't involved. We didn't get involved. We didn't know how to get involved.
So, I continue to recommend to WEDI and others that they would push this to make sure that they work with the main associations, that the people either get involved, or they had a chance to get involved in this. Because I think that absolutely uninvolvement is not going to be a positive for us as we continue implementing, especially with the questions I mentioned that we heard in the seminars. And especially as we try to go forward and make changes to something that is not even done yet.
MR. DALEY: Can I comment on that? I learned early on in the early nineties when I started a company, I had two young doctors who wanted to make an investment. And I asked them why, and they said, well, when you go home at night, your meter is still running. When we leave the office, our ability to generate revenue ceases.
So, in terms of outreaching to physicians, you've got to get them on the weekend. You've got to focus on their office managers. It's a totally different outreach and marketing. We did a seminar for OCR in March 2003 in Chicago on a Sunday that was snowing. We had 1,202 mainly providers show up from a five state area. We certainly wouldn't have had that response on a Wednesday or other week day.
So, we have to kind of bait the hook to suit the fish. And down at HIMS, when there were a number of very good presentations on the electronic health record, Linda Schady(?) of VA was talking about they made an extra effort to go out on these weekends and so forth, to draw the providers on getting their input on the EHR. So, I think we need to do more of the same to get them here. And we are doing a lot of that in collaboration with CMS.
DR. COHN: Thank you. I have been called many things in my time, but never a fish.
I just want to make a comment. First of all, I want to express I think for the full subcommittee and the full committee that we really very much appreciated obviously your advice and guidance as we move through all of this. Obviously, this continues to be a very important relationship.
We don't always vote on all your recommendations, but I think we can certainly sense that you have made an impact with these recommendations. They are being significantly scrutinized by the CMS Office of HIPAA Standards, as well as by the secretary. And I think that that's an important piece here.
Obviously, there is a lot you can do without anyone else, without us saying anything. But I think the important thing to keep looking at what's going on, and figure out ways to move forward. Now, certainly to my view, as I look at all of these things, my sense of the subcommittee, obviously, our main goal in all of this for the moment needs to be to figure out some robust way to do monitoring of the industry.
And if you have ideas that can be of assistance in that, that would be very helpful. You know, one of our main responsibilities really is that monitoring and advising Congress and the secretary about how things are going. I know for a number of the years involved, implementation was just sort of in all of our minds' eye. That was really more of a pro forma activity.
But given the issues that I think we are all talking about, I think it's going to be very important for the next while for us to be doing this in a more active sort of fashion. And as I say that, we also realize for the next three or four months, you know what the subcommittee is going to be doing. We are going to be meeting nights, weekends, and every day of the week on e-prescribing.
So, we will need to figure out some way to do this a little bit offline, and it will be discussions that we have with our staff and all of that. But we obviously have to find an efficient to really understand how the industry is moving forward on all of this.
Also, certainly if you have some ideas about consensus. Once again, I don't know about that in terms of NHII or e-prescribing or whatever, but it may make sense, knowing that I think we repeatedly commented that a lot of the benefits of these transactions actually doesn't go to those who are actually having to implement them, at least in the providers' offices. And so, if indeed there is significant value to be derived from the industry as a whole, it's something that we all ought to be looking at, and going from there.
Anyway, I want to thank you. I wonder if any subcommittee members have any final comments to make? We will obviously continue the conversation, and we're just going to have some very good way of keeping our eye on how the implementation is going.
MR. DALEY: We appreciate the opportunity to be before you.
Agenda Item: Follow-up on DSMO Request - Donna Pickett, NCHS, CDC
DR. COHN: Thank you so much for joining us.
Okay, our next item is the DSMO issue from before. Donna, should I remind the subcommittee of where we are at this point? If you will remember, it was an issue that came before us as a request from the DSMOs back in 2001, related to the issue of use the NCPDP transactions in building and supplies. That was an issue in the year 2001, that the subcommittee, for a variety of issues, decided to defer a recommendation on. And it was brought back to our attention late last year or early this year.
There have been sort of two issues that we have been mulling about in relationship to what to do with that recommendation. One relates to the actual use of the standard for the building and supplies. And then the other one had to do with the issues related to use of the code sets in relationship to those supplies.
I think last time we talked about the use of the standards, but we were sort of left waiting for HHS further evaluation and assistance and guidance with the issues of the code sets, and what sort of recommendation we should have around those. I think at this point Donna Pickett has done some work for us, and has come forward with some conclusions.
MS. PICKETT: Thanks to Lynn Gilbertson and Karen Ebhart, Tom Bizzaro, and also John Roberts at the Uniform Code Council for being so patient with my questions and my phone calls. We had a wonderful time trying to connect with all the meeting we were attending.
Basically, what I have tried to do is pull together a broad overview of the Universal Procedure Codes, UPC codes, and the HRI codes, again, kind of like a high level overview. Fortunately, Lynn, Karen, and Tom are still here, so if anybody has questions that are down in the weeds, I guess turn to them and say help. So, thanks for your help in advance.
I'm going to start with a description of the Universal Product Codes. The UPC codes are assigned to over-the-counter products such as vitamins and St. John's Wort. To obtain a UPC code, the company needs to become a member of the Uniform Code Council. And the Uniform Code Council is the not-for-profit organization that administers the UPC.
In order to become a member of the UCC, the company needs to provide some basic information. That information includes current or projected sales revenues, the number of products that will be identified with a UPC symbol, and the number of locations. And the fee schedule is based on that information.
And as mentioned earlier, both the UPC and the HRI codes are used within the NCPDP standards. They are external code sets to the NCPDP standards.
There are guidelines for the use of the UPC codes. The manual is on the UCC Website. The UPC consists of a labeler portion.
Well, first of all, it's an 11 digit number. The first six digits are assigned by the UCC, and the last five digits are assigned by the manufacturer and represents the item reference number. The number identifies the individual products for the company's prefix. Each product has its own item reference number in order to be uniquely identified within the UPC bar code.
The HRI, Health Related Item code sets is a system for identification and numbering to market device packages. That is a category of other numbering systems such as the NDC or UPC. It is a 10 digit code and can appear in two formats, a 4-6 format or a 5-5 format, and is assigned for such things as syringes and band-aids.
Manufacturers who desire to use an HRI number for a unique product identification must first apply to the FDA for the labeler code, which is the first portion of the code. Participating manufacturers and distributors then complete the code by identifying their devices with a sequential number.
The manufacturer or distributor assumes responsibility for maintaining the number. There are specific directions governing the use of the product package sections of the NDC HRI codes that are prescribed by the FDA in voluntary compliance regulations.
The other thing that I have written in reviewing these two code sets was to look at the codes as it relates to the 10 guiding principles that we had under HIPAA. And for those of you who may not recall of them, I will just read through them quickly. There are ten.
The first one is to improve the efficiency and effectiveness of the health care system by leading to cost reductions for or improvements and benefits from electronic health care transactions.
Number two is to meet the needs of the health care data standards user community, particularly health care providers, health plans, and health care clearinghouses.
Three, be consistent and uniform with other standards required under this part, data elements, names, definitions, and the codes, and the privacy and security requirements, and with other private and public sector health data standards to be the extent possible.
Four, have low additional development and implementation costs relative to the benefits of using the standards.
Five, be supported by an ANSI accredited standards setting organization, or other private or public organizations that will insure continuity and efficient updating of the standard over time.
Six, have timely development, testing, implementation, and updating procedures to achieve administrative simplification benefits faster.
Seven, be technologically independent of the computer platforms and transmission protocols used in electronic health transactions, except where they are exclusively part of the standards.
Eight, be precise and ambiguous, but as simple as possible.
Nine, keep data collection and paper work burden on users as low as is feasible.
And ten, incorporate flexibility to adapt more easily to changes in the health care infrastructure, such as new services, organizations, provider types, and information technology.
The UPC and the HRI codes do not meet two of the ten principles -- not being precise or unambiguous, and lastly, though it's not specifically identified within the 10 guiding principles, inherent through the updating process was the fact that the updating process should be an open process. And obviously, since these code sets are product-driven, having an open process obviously does not lend itself to how proposed sets of these supply codes would be updated.
The codes have been used successfully for a number of years. And I think as Lynn Gilbertson's presentation at the last meeting, she had referenced issues related to what would happen in the industry if they were not able to continue to use the UPC and HRI codes.
That is kind of the high level overview of each of the two code sets. And hopefully, I have not done anything inappropriately.
Agenda Item: Development of Potential Letter - Simon Cohn, MD
DR. COHN: You know the issue of supply codes, I think we have all realized this one is a difficult area. It seems to be particularly problematic in health care. Having said that of course, NDC is really a supply code. And the bar code has recently was approved by use in the hospitals, is once again another application of supply level codes.
Certainly, this issue has brought to me, I think the way we need to take a hard look at the whole issue of supply codes. We have already had some conversations about how late in this year or early next year, or whatever, we probably need to have a session where we take a hard look at the whole issue of supply codes.
HCPCS is part of it, but there is really a whole lot more there that relates to the world of supply codes as it relates to health care. This is not in any way to say that there is a solution that I have to offer. But more just to sort of set the stage for a letter that we tried to draft.
Once again, I wasn't quite as on target as I think we should -- once again, I think we should mull over where it represents some of the potential subcommittee views on what is it that we might want to say. As you all know, we have waited from coming forward and showing the letter on recommendations until we had at least a little more information on the various code sets.
Now, I will say just sort of by introduction to the letter, and I'll put it up here so you can read it, this letter is intended to give the department some latitude in terms of moving forward, and really it's designed to do that, recognizing that I think we all thought that there needed to be some further evaluation aspects of all this as the department moves forward and considers any possible rulemaking.
Does anybody have a comment about this before we go into the letter? Tom?
MR. BIZZARO: I think part of the confusion that was caused because of us identifying NDC as the code that we would use within the telecommunications standard has been brought about because when we talk about the files for proprietary drug files, we talk about those files as NDC files.
Those files across the board I believe for all the competitors in that arena, have always continued NDCs, UPCs, and HRIs, because even though we are drug databases, the industry demanded certain medical devices and items that had UPC codes and HRIs as identifiers.
Donna mentioned that there are not unambiguous codes. And that's a true statement, because there can be duplicates of those codes, and they are not strictly regulated in the way that they can be reused by the member organization.
I guess I would argue in a more practical sense that they are unambiguous, because in the databases we are required -- we use those as unique, either UPC codes, HRI codes, and NDC codes. We do not have duplicates in the codes at a single point in time.
So, I think that the industry, and retail pharmacy especially, when they talk about how they use the telecommunications standards, and we talk about NDC codes, we inadvertently did not also say well we use NDC codes, we use HRIs, and we use UPCs. It's been a common practice for as long as I know there has been electronic telecommunication and adjudication of claims.
DR. COHN: Okay, any questions? And I think that's exactly the issue that I think we are confronted with.
Anyway, should we read through the letter, and just sort of go from paragraph to paragraph, and we can sort of see if indeed this captures the sense of where the subcommittee wants to go with the letter of recommendation on this.
The first paragraph hopefully can be relatively non-controversial. As part of its responsibilities under HIPAA, the NCVHS is responsible for studying, selecting, and recommending standards under HIPAA. This letter addresses a request made by the DSMOs with NCPDP 5.1, the adopted HIPAA standard for electronic link for supplies via retail pharmacy.
Is everyone okay so far?
MR. PACE(?): Scott Pace with the National Community Pharmacists Association.
I would it just to be consistent with the language of the second paragraph, and Ms. Gilbertson's testimony back in March. It probably ought to be reflected as certain supplies, rather than saying -- it should say certain supplies.
DR. COHN: Okay, thank you.
Okay, next paragraph. The NCVHS did not make a recommendation to the secretary on this issue when it was first raised in 2001. In response to a second request by the DSMO steering committee in February 2004, the issue was revisited in a hearing on March 31, 2004. Testimony indicated that a business case by retail pharmacies to have a real time standard under HIPAA for building and for supplies, and the current widespread use of the NCPDP telecommunications standard by the industry for this purpose.
NCVHS recommends the continued use of NCPDP standards for building and supplies that are consumed or used during or a consequence of the administration of a drug therapy or commonly dispensed via a retail pharmacy channel.
We further recommend that the department investigate this issue further, especially as it relates to possible overlaps and redundancies in the use of NCPDP and X12 standards for the building and supplies by pharmacies.
So, we changed therapy to pharmacy, correct?
MS. FRIEDMAN: Do you want to say just certain supplies?
MR. BLAIR: Yes, please.
DR. COHN: And it probably isn't redundancies, it's probably just overlaps. And I want to get rid of redundancies. I think it's really more overlaps, on the second line from the bottom in the paragraph.
Okay, Jeff, do you have a question?
MR. BLAIR: Yes. When we indicated that we didn't make a recommendation, but that we revisited things, I get the impression that we/and or NCPDP Script, and/or both of us overlooked -- somehow it was overlooked that these codes were being used, and therefore that they were not included.
And I think that if we include that in the letter, it would strengthen the fact that really they should have been in there from the beginning. Is what's said correct or accurate and/or helpful?
DR. COHN: Jeff, this is not an issue related to the beginning. The beginning was many years before 2001. This has to do with issues that came before the subcommittee as a result of the annual DSMO review process. That was a fast track process, or it's part of the DSMO review. It was an issue that came before us.
So, this is not an issue of well, there was something neglected in the initial regulation. This is more a request by us for specific of use here. So, I would speak against trying to go back as far as you are describing in terms of records. Is that okay? I think this is fine letter without trying to improve the strength of it.
MR. BLAIR: Okay.
DR. COHN: Are there any other comments, questions on this one? If we need to strengthen it, we'll go back and do other things.
The next paragraph is the DSMO steering committee also requested that when supplies are billed by the dispensing pharmacy, the NDC be designated as the standard code set that must be used for supplies with the NCPDP standard when the NDC number is available. If there is no NDC, they recommend that the parties may use any codes in the NCPDP standard that they mutually agree to such as the Uniform Product Code or the Health Related Item Code or the HCPCS Code, where non-specific codes will not lead to potential problems in patient care from their use.
MR. LEVIN: This is Randy from the FDA.
There shouldn't any NDCs for supplies.
DR. COHN: Tom, do you want to come to a microphone and clarify that?
MR. BIZZARO: Yes, there are some items that have NDCs, that I believe were assigned many years ago. And the thing that comes to my mind, and I am not in that part of the business any more, but syringes have NDC codes on them. In fact, syringes may have an NDC code, an HRI code, and UPC code.
MR. LEVIN: A number of years ago there was series of lay bar codes that was given for devices to be coded. And this is the not an NDC per se, but codes with the other code that you had described. It's not a NDC specifically. So, whether you want the same type of codes for supplies, that's another issue, but as far as it currently is right now, those are not officially NDC codes.
MS. FRIEDMAN: Does somebody have the original incoming from them, so we can double check the language?
DR. COHN: Well, Lynn is here. Let's ask her for --
MS. PICKETT: Lynn, do you have yours? I'm not sure that that is the language that was in the testimony from March.
MR. LEVIN: They may say that they are NDCs, but they are not. The health related items are the series of supplies that were given a set of labeler codes so they could provide codes for them.
MR. PACE: I believe Becton-Dickinson(?) actually uses the NDC as a break in the number on their syringes. In fact, they do on their Website.
MR. BIZZARO: In fact, their labeling still says NDC, and then gives the code.
MS. TRUDEL: I need to clarify this with Randy, because it sounds as though an HRI code is about as close a relative to an NDC code as you can get. It has still got a manufacturer labeler code in the first position that is issued by the FDA in just the same way as the NDC. And they are not the same structure, but the same size codes.
MR. LEVIN: The same size. So, by looking at it, it looks like it could be an NDC code as a labeler code. But they are there -- officially, NDCs are reserved for a drug, and the HRIs were for supplies. And that was many, many years ago when these were first given out, and I don’t even know if the Center for Devices even continues that activity now.
MS. TRUDEL: Are they included in the same database?
MR. LEVIN: At the FDA?
MS. TRUDEL: Yes.
MR. LEVIN: No.
MS. TRUDEL: Okay.
DR. COHN: Steve.
DR. STEINDEL: Randy’s discussion brings up a very perplexing question. Since these aren’t considered NDC codes by the FDA, are they a HIPAA code set?
DR. COHN: I’m sorry, what does that have to do with this?
DR. STEINDEL: Think of the user then, external code sets.
MS. TRUDEL: No, this is where we are going to have to get some expert legal advice, but at least on a very amateur version of the reading of the regulations, we adopted HCPCS as kind of a catch all for devices, supplies, and other whatever you use in health care, regardless of the setting. So, it’s sort of devolved. If you are talking about something that is a medical item, and there is no other code set in place for it, it is possible to argue that it is HCPCS, simply because of the way we wrote it.
Where my question comes is in is although the FDA says that these aren’t NDCs, it appears to some of the people who are using them, that they are NDCs.
MR. LEVIN: There is one caveat. Certain drugs have devices that stay with them. So, there may be some mix there. But in general, there is a whole group of supplies that have a code that looks like an NDC, and could be an NDC, but it’s not.
DR. COHN: Well, Randy, I think this is sort of an issue, fact that the individual users don’t know the answers. I think for the moment I would just leave the wording the way it is, but if you can present – once again, the committee will simply do what it chooses to do with this letter. Obviously, it will to go the full committee to pass in mid-June.
And there is certainly ample time that if you can bring forward information, we can certainly modify it. But this is what I think the industry thinks is going on. So, we probably ought to keep it that way.
MR. LEVIN: The statement is okay actually. If there were no NDCs, you would just go on – I think that NDCs are solving an issue for supply.
DR. COHN: Okay, so the next statement? Currently, the NDC is the HIPAA standard for reporting drugs and biologics by regional pharmacies, while HCPCS codes were adopted as the HIPAA standard for supplies, equipment, and other items without regard to setting. Testimony indicated that the UPC and HRI codes currently are used by the industry to identify items on retail pharmacy claims. These codes are used within the NCPDP standard, but are external codes that are separately being included and updated out of the NCPDP standard setting process. Their continued use is necessary to provide the industry with the level of detail needed to handle claims processing, ordering, supply management. Testifiers noted that HCPCS codes do not provide the specificity needed for the day-to-day operations for retail pharmacies. NCVHS anticipates holding hearings on the use of supply codes in the near future.
Are we okay so far? The next paragraph is NCVHS urges the Department to investigate these issues, and determine if they need to be addressed in future rulemaking.
MR. REYNOLDS: We state a position, and then we talk about holding hearings. And then we ask the department to investigate. Are you a little confused? In other words, we’re asking them to investigate, I’m not sure we wouldn’t have hearings until after that. But once we ask them to investigate it, I don’t think we need to have hearings, because once they look at it, they decide something.
DR. COHN: Yes, I think what we are trying to do, and this has not quite come together yet, but I think what we are trying to say is we want the department to further investigate all of this, and come to some future rulemaking on this, knowing about our feelings and general views on this. And the last part, the NCVHS anticipates holding hearings on these supply codes in the future.
MR. BLAIR: Investigates these issues to determine whether they would require future rulemaking. That, I think, clarifies the distinction between holding NVCHS hearings and what we are asking them to investigate.
DR. COHN: Okay, so we’re saying that we’re going to move that emphasis on NCVHS after that. Now, I think that maybe the sentence, maybe it’s a separate paragraph. What do people think? I’m sort of thinking about the first sentence in the second paragraph needs to be moved up to the last paragraph, but I’m not sure about that as I’m looking at it.
Margaret?
MS. AMATAYAKU: What are NCVHS hearings going to do? Are they going to make recommendations then to the department in terms of their thinking about whether they want to –-
DR. COHN: No, maybe it’s hold hearings on the larger issues of supply codes, not the specific issues. NCVHS holds hearing on the larger issues.
MR. BLAIR: Larger issues surrounding.
DR. COHN: Surrounding is it use of supply codes or just supply codes?
Margaret?
MS. AMATAYAKU: Can I ask again, first of all, you might want to separate those two into two separate paragraphs.
DR. COHN: Absolutely.
MS. AMATAYAKU: So, what are these hearings on the larger issue going to do with respect to this specific issue?
DR. STEINDEL: Simon, by filling in this letter, will you ask the department to investigate the issues and determine if it needs to be addressed in future rulemaking, and not say anything about us holding hearings. Or we should say we are going to hold hearings about this issue, and not ask the department to do it. One or the other.
DR. COHN: Should we get rid of all comment about our upcoming hearings? Okay.
MR. LEVIN: The question is about having codes for the supplies, which codes to use. Is that what the question is? Right now, we can supply codes for the license, and that’s a supply. It’s different than saying we need those codes. Are you looking at what the need is for the community as far as having codes for medical supplies?
DR. COHN: Are you asking about our hearings?
DR. LEVIN: Yes, what are you asking the department to do? If you are talking about supplying codes for the medical devices are supplies, we already can do that. Now, whether you want those codes, do you want people to supply those codes?
MS. PICKETT: I think what Randy is getting at is there is already a process for creating the codes, using the codes. But I think what we are talking about might be the use of the code sets in HIPAA transactions, which we haven’t really quite said well in the sentence. And I think that is what Margaret is talking about. What is it we want to do with it?
And we have NDC which is in the docket as the HIPAA code, and it is the supply code somebody mentioned. But then we have these two, plus there was another one that we referenced in the final rule on transactions and code sets that we said bears watching, but because it wasn’t being used in the claims environment, we would wait until after the pilot was over. So, we’ve got a couple of supply codes that have all been sitting out here together.
DR. COHN: Yes, that was my sentence about when we talked about this later on.
MS. AMATAYAKUL: Would it help to say NCVHS urges the department to investigate whether the specification of the UPC and HRI code sets need separate or additional future rulemaking to be used? Is that the crux of the issue? Because they weren’t included in the rule specifically? You only mentioned the NDC and not these others, is that the issue?
DR. COHN: I think it’s because of how they use it. How should this go forward? I think what we are saying is that the idea of the NCPDP uses those supplies is I think a reasonable step forward. We are trying to give the department fairly wide latitude in terms of what it wants to do to further investigate and figure out this issue with the code sets. That is really sort of the intent here. And obviously, we are not seeing it very well, because we are sort of falling over ourselves.
MR. BIZZARO: Remember, we are kind of biased about how we see this being used. But we know that industry in the past has used telecommunications standards, first 5.1 and in earlier versions using all codes and CPCs, as well as NDCs. So, we are not asking for the creation of any new code sets. What we are asking for is simply permission to use the telecomm version 5.1 UPCs, NDCs, HRIs for those appropriate products.
MR. BLAIR: So, you’re saying you’re asking for HHS to recognize these code sets as the code sets?
MR. BIZZARO: Actually, I think what we’re asking is that within telecommunications, within the NCPDP telecommunications standards, we are asking permission to use these three code sets to identify drug products or supplies.
MR. BLAIR: How is asking for permission different than recognizing them as HIPAA code sets?
MR. BIZZARO: I guess in my mind maybe it’s the terminology, because I’m not familiar with the rulemaking process. In my mind, I’m not sure the committee wants to make UPC codes entirely in the NDC code set as a HIPAA main standard, because UPC codes are on bananas and just whatever you can think of. So, I don’t know if you need to name that code set. We are really talking about health-related items in some manner.
Now, I don’t want to limit that, because we are talking about diapers. We are talking about certain things that a Medicaid agency identifies as a necessary supply, that they will pay for it, but it’s purchased through the pharmacy for the pharmacy benefit.
DR. COHN: Let me try this one, because this sort of makes sense. NCVHS recommends that the department further investigate the use of these specific code sets in the NCPDP transactions, and if appropriate, initiate the rulemaking process.
Margaret, you are laughing.
MS. GILBERTSON: Here is a comment. Just to come full circle, the pharmacy industry that is needing to use the HRIs and the UPC codes are now under contingency plans, because that was the guidance given, continue doing business. So, without a rulemaking process or something, we’ll have contingencies forever, heaven help us. We need that step of the rulemaking process or something to get it moving, because we have to get out of contingency at some point.
So, I think you have backed into the fact that it’s got to somehow go through whatever process OHS has to go through, because we can’t stay on contingency forever.
DR. COHN: Right, so you are agreeing about the rulemaking process.
MR. PACE: Scott Pace with NCPA again. My only comment to Lynn was that I think she said it pretty well back in March when she related it to the Kleenex. Everybody picks up a Kleenex, whether it’s a Puffs or a Kleenex, and calls it a Kleenex. And I think that’s how the industry is with these three code sets. We just call it an NDC.
And it seems to me that maybe what happened in this case, it was called NDC, and it is referring to everything, but in literal translation we are only taking it as the National Drug Code as it applies to prescription products approved by the FDA.
It seems to me that if there was just a clear definition of NDC as interpreted by the industry, that would alleviate this.
DR. COHN: I don’t think that’s going to be our solution here. Interesting, but I don’t think it’s going to quite work.
MS. EBHART: Karen Ebhart with MediSpan. I again agree with what Lynn was saying. The intent of this request here was to allow us to continue doing business today. This is the de facto standard that we are using. Just as we acknowledge that there are problems with the NDC, and there is an NPRM in the future coming to help clarify that, we also know that there are problems with these code sets that we would like to hopefully identify and also resolve in the future, but that’s the future.
This is for business today. So, for me, part of the investigation is where do we need to go in the future to make it better, but also, we need to acknowledge what we need to do to continue business today. So, again, just trying to clarify what you mean by investigate the code sets. Investigate to make them better in the future? Or just to include in the NPRM that this is a valid way to build certain supplies into the pharmacy sets?
DR. COHN: I think I need the assistance of the subcommittee here in terms of how we want to go. I think our intent here initially was to try to create something that said the standard needs to go forward. We obviously think that there is a business case here, but want the department to further investigate the use of these code sets, and moving forward with rulemaking.
Yes, Margaret A.?
MS. AMATAYAKUL: I have another suggestion, just because this is a clear brain. I haven’t heard this discussion before. I don’t know if this is right, but NCVHS recommends that the department grant permission to continue use of the UPC and HRI codes, or whatever codes as part of whatever full compliance with the NCPCP telecommunications standard version 5.1.
MR. BIZZARO: That’s exactly what we are asking. Now, I’m not sure I understand the rulemaking process, but that’s exactly –
DR. STEINDEL: And investigate the use of rulemaking if necessary.
DR. COHN: Why don’t we take a look at it here? You know what I’m going to suggest for the moment? It’s now 5:06 pm. I’m going to suggest that we take a break for 10 minutes. And then we’ll get back to this when we get back at 5:15 pm. Let’s take a 10 minute break.
[Brief recess.]
DR. COHN: Okay, everyone, I think we are ready to come back for our final session.
I think when we were last talking, we were up to the last paragraph here. Let’s read the last paragraph and see if it meets everyone’s needs.
The paragraph now reads, NCVHS recommends that the Department allow continued use of UPC and HRI codes within the NCPDP telecommunications standard, and investigate rulemaking if necessary. This is important for current business. However, NCVHS acknowledges that there are limitations in how the UPC and HRI currently are assigned and managed. We recommend the Department further investigate these issues.
NVCHS appreciates the opportunity to provide these recommendations. Sincerely.
Comments from the subcommittee, questions? I think we need to specify telecommunications standard 5.1.
MR. REYNOLDS: This is important for current business. You could add maybe a couple of words.
DR. COHN: Maybe it’s important for current pharmacy operations?
MR. REYNOLDS: Yes, I guess current business just kind of says you know – if I was reading it, sitting in an office somewhere, that could say they don’t want to change, and we’re going to let them be okay. It’s really sustaining current business practices. I don’t know.
MS. FRIEDMAN: Why aren’t you saying sustaining current business practices?
DR. COHN: I don’t know that that’s a – okay.
MR. REYNOLDS: Did industry accept it? How about industry accepts it as business operations?
DR. COHN: Okay, so this is important for sustaining current business operations?
MR. REYNOLDS: Well, the reason I say industry is –
DR. COHN: Well, I guess the question is do we need this sentence? I don’t think we need the sentence.
MS. FRIEDMAN: Do you want it gone?
DR. COHN: I think so. I’m looking to see if anybody thinks it a –
MS. PICKETT: Simon, I agree, because the information is in the previous paragraph. It’s already there in the previous paragraph.
DR. COHN: Okay, any further changes, modifications, wordsmithing? Hopefully, the full committee will tear it apart in mid-June, but you never know.
Do you want to take one last look at it here?
MS. PICKETT: Well, just one question. The word limitations, is it limitations or something else? And I pose that to Lynn and Tom and Karen.
DR. COHN: Well, what would you –
MS. PICKETT: NCVHS is acknowledging that there are limitations in how the codes are currently managed.
DR. COHN: Are there issues?
MS. PICKETT: I think it’s more like issues, as opposed to limitations.
DR. COHN: I guess maybe I should ask you, these two last sentences, where it says acknowledges that there are problems with how the UPC and HRI codes are assigned and managed. We recommend that the Department further investigate these issues. Is that helpful to the department?
MR. LEVIN: At least it says to me that current codes for how you deal with supplies are not sufficient, not adequate, and need some help. And so, we have to look into ways to enter the codes for supplies.
MR. BIZZARO: Because I wouldn’t want to give the impression here that we are talking about UPC codes in general. I would think that John Roberts from UCC would probably argue the fact that there are problems with the way that is assigned, because they do a really good job in managing those UPC codes.
Our issue comes with abuse of the UPC codes, and representing bar codes as UPC codes when they really aren’t, so I think there are some issues there. I think if you notice now on some linear bar codes on products, you will see that there is either a UPC copyright, or UPC mentioned, that it is a UPC code. There are a lot of bar codes out there that don’t necessarily represent themselves as actual UPC codes.
MR. LEVIN: Then how about they are currently assigned and managed by companies?
MS. FRIEDMAN: As opposed to the government?
MR. LEVIN: As opposed to the UCC.
DR. COHN: Steve, did you have a comment? Is it about the same sentence?
DR. STEINDEL: Yes, it’s about the same subject, because I don’t see any other place in the letter where we mention anything regarding limitations, or anything related to whatever word we want to use there. So, we are introducing a whole new topic in the end. So, I think we should either eliminate that sentence, or we have to add another paragraph.
MS. AMATAYAKUL: I guess my question is are you recommending that further investigation be done after they accept your recommendation that it’s okay to use these for now? That this is really a recommendation sort of in the future. This is a temporary fix.
So, if that’s the case, I would separate those, as Steve is suggesting, and then indicate that it is recognized there are issues associated with this, and it is recommended that the department investigate these issues in the future.
DR. COHN: Though I think Steve has brought up a good point that we say nothing about the problems prior.
MR. BLAIR: Grant permission now. Investigate whether rulemaking is necessary after.
DR. STEINDEL: All we are saying is that for the time being, we recommend that the present process continue. If it doesn’t continue, it’s going to be harmful for business practices, and we have already stated that.
Then we go on and we say that the department should investigate this further. And at that point, the issue may come up concerning usage limitations, or whatever word we want to use regarding these codes.
MS. FRIEDMAN: Why don’t we move this sentence and say NCVHS acknowledges, and move that up here with this other stuff related? It would get the idea that there are these issues, and then leave it as it is.
DR. STEINDEL: What issues?
MR. BLAIR: Yes, if you don’t say what the issues are, it’s just like there’s a problem here, but we don’t know what it is.
DR. STEINDEL: If I read this letter, and I’m saying that there are issues in using this code, and then I read the next paragraph and they say go ahead and use it, the question that is going to come to my mind, why should I continue using it if there are problems?
DR. COHN: Well, I guess there are many ways for us to handle this one. I’m sort of struggling, because I’m not sure that even despite Donna’s wonderful 10 minute summary, that I feel that we have enough to really talk very substantively about any limitations or issues.
Maybe we need to go back to where we talked about earlier, which was a sentence saying we recommend continued use. That we are going to go do further investigation of the larger issues of supply codes, and leave it at that. Or we could just leave it even without that.
DR. STEINDEL: Simon, my feeling is we can just leave it with we recommend the department investigate this further, because I know the first thing that the department is going to say is NCVHS hold hearings on it.
DR. COHN: Oh, that’s true. Knowing who responds to us, that’s a likely outcome.
MS. EBHART: I think again, the problems we were trying to acknowledge here is more the business practices of how UPCs are assigned and managed by the manufacturer organization. There is not a problem with the Uniform Code Council, of how they administer their portion of it, but the fact that UPCs can be reused. Like we have all talked about NDCs, and we want to get rid of that aspect.
And what constitutes when you can reuse and when you can’t reuse, how far of a change there is. As well as clarifying to make sure that we can never have duplicates between HRIs and UPCs and NDCs, to make sure that we don’t have those number collisions that we were all very concerned about with the NDC. This was more the business practices that was in that problem scenario; just trying to clarify why that sentence has been added.
DR. STEINDEL: I feel that there is an issue, that there is something we need to discuss. The question is if you want to resolve being recommended as continuing, I think that’s something to leave out at this point, and let them make a decision on continuing, because they will come back to NCVHS, and we’re going to have to confront the issue.
MR. REYNOLDS: I move we approve it as it is.
DR. COHN: Okay, is there a second?
MR. BLAIR: Second.
DR. COHN: Further discussion? All in favor say aye. Opposed, nay. Abstentions? Okay, the letter passes.
[Whereupon, the letter was unanimously approved.]
Thank you all for your help on this.
It’s 5:30 pm at this point. We meet again tomorrow at 8:30 am. Thank you for your help. It’s been a long two days, and we’ll see you in the morning.
[Whereupon, the meeting was adjourned at 5:30 pm, to reconvene the following day, Thursday, May 26, 2004, at 8:30 am.]