[This Transcript is Unedited]
Hubert H. Humphrey Building
300 C Street, N.W.
Room 705A
Washington, D.C.
Reported and Transcribed by:
CASET Associates, Ltd.
10201 Lee Highway
Fairfax, Virginia 22030
Agenda Item: Call to Order, Introductions & Announcements - Dr. Cohn and Mr. Blair
DR. COHN: Well good morning. I want to call this meeting to order. This is the first day of two days of hearings on the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The committee is the main public advisory committee to the U.S. Department of Health and Human Services on national health information policy.
I am Simon Cohn, chairman of the subcommittee and the National Director for Health Information Policy for Kaiser Permanente. I want to welcome fellow subcommittee members, HHS staff and others here in person. We also want to welcome those listening in on the internet and we do want to apologize to those on the internet that we do realize that we're starting a little bit late. Obviously there have been issues relating to traffic and access to downtown Washington this morning that I think have made it difficult for everybody to be here in a timely manner but we do have our full hearing group here this morning at this point. I obviously want to remind everyone to speak clearly and into the microphone.
This morning we are sort of leading off by focusing on the HIPAA electronic transaction standards final rule and the issues and opportunities related to implementation. This is in keeping with our responsibilities under both HIPAA and ASCA, the Administrative Simplification Compliance Act, which has asked us to track implementation and identify both barriers as well as solutions to barriers identified. And under ASCA also to publish reports on effective solutions to compliance problems identified.
In the afternoon, and we'll be having discussions all morning about that. In the afternoon we'll be discussing next steps related to ICD-10. This includes both discussions of a cost benefits study being proposed as well as planning for the next full committee meeting. As subcommittee members will remember we have been asked to synthesize the issues in areas of agreement and disagreement for the full committee, which will be the discussions in the first part of the afternoon. During the final part of the afternoon we will be brief on work underway related to drug codes and terminologies.
Tomorrow we will discuss testimony so far on PMRI terminologies and next steps and Jeff Blair will be leading that session. With that, let's have introductions first around the table, then around the room. For those on the national committee I would ask as part of your introduction if you would note if there are any issues coming before the subcommittee today for which you need to recuse yourself. Karen would you start with the introductions?
MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services, staff to the subcommittee.
MR. BLAIR: Jeff Blair, Vice President of the Medical Records Institute, and vice chair of the committee.
MR. AUGUSTINE: Brady Augustine, Corporate Director of Special Projects, Gambro Healthcare, member of the subcommittee, member of the full committee.
DR. FITZMAURICE: Michael Fitzmaurice, Senior Science Advisor for Information Technology to the Agency for Health Care, Research and Quality, liaison to the national committee and staff to the subcommittee on standards and security.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the subcommittee.
MR. TENNANT: Robert Tennant with the Medical Group Management Association.
MR. GILLIGAN: Tom Gilligan with the Association for Electronic Health Care Transactions.
MR. MCLAUGHLIN: Mark McLaughlin with McKesson.
MS. BURKE-BEBEE: Susie Burke-Bebee, National Center for Health Statistics and staff to the subcommittee.
MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC, and executive secretary to the committee.
DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation. As far as potential conflicts of interest today, it's a big day for me. I'm chair of the Association for Electronic Health Care Transactions and Tom Gilligan is speaking on behalf of the Association. I'm also a member of WEDI and chair of the Security Policy Advisory Group of WEDI and Robert Tennant is speaking on behalf on WEDI. And McKesson is one of our customers and Mark McLaughlin is representing McKesson.
MS. SQUIRE: Marietta Squire, NCHS and staff to the subcommittee.
MR. SAJANSKI(?): Walter Sajanski, I'm an independent advisor to the subcommittee.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC, staff to the national committee.
DR. RADA: Roy Rada, I'm a professor of Health Care Information Systems at the University of Maryland.
MR. PLUIS(?): I'm Tom Pluis, I'm a study director with the Committee on National Statistics for the National Academy of Sciences.
DR. ASTIN(?): Phillip Astin from the Institute of Medicine.
MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics, CDC.
MR. SHUPING(?): Jim Shuping, Executive Vice President with the WEDI organization.
MS. LEON-CHISEN: Nellie Leon-Chisen, American Hospital Association.
MS. PROFFIT-BOWMAN(?): Sue Proffit-Bowman, American Health Information Management Association.
MS. GILFOY: Helene Gilfoy.
DR. COHN: Is that it with introductions? Jeff would you like to take a second to introduce our new consultant?
MR. BLAIR: Yes, thank you Simon. I'm really pleased today that we have with us Dr. Walter Sajanski. Dr. Sajanski is going to be able to help us starting tomorrow with the work that we'll be doing with the selection of PMRI medical terminologies so he'll be working closely with us and Walter if you could stand up so that folks could see who you are and introduce themselves to you during the course of events during today.
DR. COHN: Jeff, thank you. Now before we launch into our first set of testimony, I've asked Karen Trudel to take a moment to sort of brief the subcommittee and others on changes occurring in CMS in relationship to HIPAA implementation and compliance.
MS. TRUDEL: Thank you Simon. As many of you may know, on October 15th the Secretary released a press release announcing that the responsibility for enforcement of the administrative simplification provision, excluding privacy and including HIPAA portability, would be assigned to CMS and that further there would be a new office created within CMS to do nothing but these HIPAA activities and the other outreaching HIPAA activities that CMS already has responsibility for including development of regulations, working with industry groups to maintain standards and performing industry outreach. This new office will be led by Jared Adair(?) and it will have those functions that I mentioned, HIPAA portability, enforcement for the non-privacy administration simplification standards, regulations, including regulations for enforcement of those standards, and outreach.
We will continue to work very closely with the Office for Civil Rights to coordinate activities having to do with outreach, guidance on who is a covered entity, etc., that cross the privacy and non-privacy boundaries.
The press release also talked a little bit about what the enforcement process might look like and I don't want to take too much time but I do want to make a point of this. The process will be complaint driven, in other words, only a complaint will begin the enforcement process. Anyone against whom a complaint is filed will be notified, will have the opportunity to provide additional information, to submit a corrective action plan, to basically demonstrate that they are attempting to comply in good faith. The process will be progressive in that the imposition of penalties would occur at the end, after all other avenues are exhausted. We are beginning to talk already about how this is going to work. What the issues are that we need to look into as far as enforcement is concerned, and since we only received this activity last week, I'm not in a position to answer questions obviously but we're working as hard and as quickly as we can to flesh out what this process is going to look like.
DR. COHN: Karen, thank you.
DR. FITZMAURICE: May I ask the chair a question then? Would it be possible for members of the NCVHS to get a copy of this press release? Thank you.
DR. COHN: I think what happened as I understand is everybody received an electronic copy. I think what Mike was asking for was a paper copy of distribution. I think probably others here have also received either electronic and/or paper copies. Any other questions or comments before we start the testimony?
Robert Tennant do you want to start off by talking about HIPAA readiness and some of your observations at this point? I understand you're representing both MGMA and WEDI SNIP.
Agenda Item: HIPAA Readiness - Observations - Mr. Tennant
MR. TENNANT: Yes. Thank you very much. Mr. Chairman, members of the subcommittee, the Workgroup for Electronic Data Interchange is pleased to discuss the issue of HIPAA readiness and discuss some of the roadblocks that we see as impediments to HIPAA readiness.
What I want to do is first of all talk about general HIPAA readiness and first of all put the caveat that we have not done a scientific polling of the industry in terms of this issue but we are in a good position because we are the forefront of implementation for all sectors of the health care industry and for myself, I travel around the country like many of us do, speaking to group practices, hospitals, community health centers, about their issues regards to HIPAA readiness so I think we're in a fairly good position to comment on this.
In terms of providers, and I just want to credit CMS for their fine work with the ASCA legislation and the model compliance form. I think we've seen an enormous number of providers apply for the extension and I think what that has done is raise awareness within the provider community, not just about the extension but about the issue of compliance. As we all know the model compliance form itself was designed to assist providers as they develop their compliance plan and I think that has had a tremendous affect much like what Representative Hobson expected when he crafted ASCA several months ago.
What we're seeing is a movement towards compliance but at the same time we're seeing a disturbing trend. And that is that providers are relying heavily on their vendors to assist them come into compliance. We're hearing information back from group practices in particular that many of the major national vendors are offering a non-compliance solution for next October. By that I mean that they are suggesting to their clients that they need to go through a clearing-house to allow the HIPAA compliance claim to be sent to the payers, that they are not providing a software solution at this time.
They haven't given their clients a timeframe for if and when they will be bringing their software systems into compliance. We have been hearing that from providers around the country using many of the large national practice management system vendors.
One thing that has happened fairly recently is a number of medical specialty societies, including MGMA, came together in a loose coalition to begin to address these issues and one thing that the group was searching for was some way to find out the HIPAA readiness of the vendor community. With the very gracious offer of Dr. Kepa Zubeldia, we were able to put together a directory of practice management system vendors. It's a non-commercial site and it went live just a short time ago, but we've already had a number of vendors include their information on their systems, in the directory we've had hundreds of providers access this information and MGMA for example sent out a letter to all of our affiliate vendor members telling them to get involved in this directory. This is an excellent opportunity for the industry to find out the HIPAA readiness of the vendors.
One thing that is critical in terms of HIPAA readiness is the concept of partnership. If one of the partners is not ready, it's going to produce problems for all the partners. So when the vendors aren't ready, the providers aren't ready, the providers can't then test with their health plan, so then the health plans are going to have trouble paying claims. So we at WEDI are focused on trying to identify the roadblocks and try to come up with some solutions and towards that we'll talk later about some of our initiatives but one of them will be vendor forums, get the vendors together, find out what is happening with them and see if we can help them on the road to compliance.
Turning to the health plans. I want to say that I've spoken to a number of top level individuals in the payer world and they are relatively confident that the majority of major health plans will be ready by next October. By being ready, and of course I asked that question, they are focused needless to say on the 837, the 835, and somewhat on the eligibility standards. That being said, they are trying to move forward with all of the standard transactions but there's no question that those are down the list in terms of priorities for the health plans.
The feeling is at the top level that 80 percent of health plans will be ready which should encompass something around 90 percent of all transactions so it's a very good positive feeling that we're getting from the health plans. One of the reasons why I think they are moving ahead quicker than the providers is simply because they have more clout in terms of their vendors. They're able to pin these folks down, be able to go forward with their migration, they've of course been forced to customize many of their systems in order to meet their business needs but they've already, according to this individual and others, they've already moved beyond the initial stages and they are looking to begin testing early in 2003.
One group of providers that I did want to mention is the community health centers and rural health centers, these folks that serve the very poorest segment of our society. If there is any group that is in peril I would say it's these folks. They first of all have very little money to begin with to begin moving in the direction of compliance. Second, they have a very small number of vendors that serve their particular needs and some of those vendors are included in the list of national vendors that are not offering at this point a full compliance solution. They are faced with the daunting task of finding a way to meet the requirements of the standard as well keep financial viable.
Turning to just a few of the road blocks that we see right now and none of them are particularly new, we've talked about them before, but I think it's important to emphasize them. Industry uncertainty, of course, has to top the list. There's an uncertainty in terms of what standards to move forward with. If I was a vendor I would be confused about what direction I should go in and I think that's one of the reasons why these vendors are not prepared to offer at this point a HIPAA compliance solution.
There's the costs of these systems, and what we're hearing from MGMA members is the cost are extremely high, up to $80,000 dollars for even smaller practices. Vendors are telling them that their current PMS system is not compliant, therefore, they need to purchase the latest and greatest, and they are also saying that the latest and greatest will not run on their current hardware, so they're incurring hardware costs. And they've got to build this into a system where MGMA data just released last week show health care costs for group practices have increased five percent. At the same time Medicare reimbursement is going down, so you've got all of these converging figures and what it says to a provider is it's very expensive to move forward and so it's hampering compliance.
Just a couple of other comments. Obviously there's the issue of the old HICVA, now CMS 1500 Form, being sort of uncompliant, not having all of the standard elements on it. That's an issue for a lot of providers that are claim system is totally based on the 1500 Form, they need to go back and do a gap analysis, they don't have the expertise, they're looking for their vendors to provide that expertise and it's not forthcoming.
They are also concerned about fines for non-compliance and certainly WEDI's opinion is that fines should be deferred until the industry has had an opportunity to implement fully and test fully all of the HIPAA transactions. And there's also the concern that until just recently there has been somewhat of a lack of national direction coming from the federal government. I commend CMS for doing what they have with their limited budget, but we need to get out to the hundreds of thousands of providers that will be implementing these standards. We've seen that they have an interest through their application for the extension, we need to follow-up now with some constructive advice on how they can move forward.
I look forward to answering any questions that the subcommittee has.
DR. COHN: Thank you very much. Tom Gilligan?
Agenda Item: HIPAA Readiness - Observations - Mr. Gilligan
MR. GILLIGAN: My name's Tom Gilligan and I represent the Association for Electronic Health Care Transactions, which is commonly referred to as AFEHCT. For those of you who may not be familiar with our association, AFEHCT came into being in 1992 to provide a voice for the vendor community in shaping the original administrative simplification legislation.
I started with AFEHCT in 1992 and AFEHCT's fingerprints are all over the original legislation and some of the initial regulations that came out that implement HIPAA. AFEHCT is a vendor oriented industry action group with a special focus on federal public policy as it related to the application of EDI, e-commerce and the internet to the solution of problems associated with the financing, delivery and administration of health care in both the public and private sectors.
AFEHCT members include vendors of software, vendors of services, including clearinghouses and other companies that are actively involved in remediation and in the electronic processing, maintenance, and transmission of health care clinical financial and administrative transactions. Our members' customers are the doctors and hospitals and the payers who deliver and finance the care.
I'd like to turn my attention now to commenting on some these to do with HIPAA implementation. I'd like to start off by giving CMS some well-deserved kudos with respect to their implementation efforts. CMS responded quickly to the requirements of ASCA and made the application for the extension as easy as it could possibly be. Such efforts as the ASCA questions and answers and the Ask HIPAA and the HIPAA Hot Line have been very helpful.
CMS deserves special kudos for the outreach efforts, but as good as CMS has been and as much as they've done, we still plan to ask for more. I'd like to give brief recognition for the issue of the inspection guides and talking to a number of vendors and others involved with HIPAA, there seems to be a problem with the interpretation, different interpretations described in the HIPAA guides. I'm not a technical person, this is a technical issue beyond by ken and other witnesses here today are more able to address it.
DR. COHN: Tom, just for clarification, are you referring to the implementation guides at this point? Ok, thank you.
MR. GILLIGAN: The vendor community, one of the major questions with respect to HIPAA readiness since before the transaction standards were published has been what about the vendors? I wince every time I hear that question and I am wincing once again this morning.
With respect to outreach I think CMS and those others around the table who are involved in outreach, have an endless task. I don't think the size and the make-up of the vendor community is really knowable. Recently in a very crude attempt, unscientific, minimal value, to get a handle on the number of practice management systems, I searched three different search engines for medical practice management systems. And the numbers I got back were 836,000 in AOL, a million in Google, and 500,000 on the MSN. And what that tells me is that nobody has a good handle on the size of the industry and that's all it tells me.
Vincent Hudson maintains a directory of practice management systems and in 1999 and 2000 he listed over 1500. Now he estimates the size of the market to be eight or nine hundred. He said the reason for the precipitous drop is that many of these small, practice management system vendors can't afford to upgrade to HIPAA and are simply dropping out of the market. He expects further such activity in the next few years.
With respect to billings, medical claim clearinghouses, one search engine identified nearly 4,000. I'd be interested in the number that's applied for CMS extension. What this tells me is that outreach into the vendor community is not a finite task.
Vendors in AFEHCT's membership however, clearinghouses, software vendors, tend to be the larger vendors in the vendor community. With respect to clearinghouses, they process an overwhelming percentage of all the transactions that go through clearinghouses. The same maybe also said of software vendors. One of the vendors of hospital information systems believes it has more than 20 percent of the market. McKesson to my immediate left and a member of AFEHCT can share with you what percentage of the market they have.
These vendors are confident about their ability to provide solutions that will enable their clients to become compliant with the transaction and code set standards. They know what they have to do and they are about the process of doing it.
One problem we have identified that revolves around communication between provider clients and their vendors. Some provider clients have been asking when is your software going to be HIPAA compliant? And the vendor community has been saying the answers that we can give you are not that straightforward because saying we're HIPAA compliant opens up a vendor to certain liabilities, so the vendor community is telling me that they have to be judicious in the language they use in response to some of the questions that they are getting from providers. I even had one company tell me that depending upon the language they use in their conversations with their provider clients also affects when they can recognize for revenue they use for the software that they have already sold.
On October 30, we are going to put some vendors and some other folks around the table with people from CMS and from the AMA, from some of the medical specialty societies and talk these issue through to see if we can't get this level of conversation down to a sufficient level of refinement so that vendors and providers are better able to talk to each other.
Another problem seems to be provider education. The vendor community would like to see more done in the way of educating providers about the role of providers and the role of vendors with respect to the implementation of at least the transaction and code sets. One vendor told me we want some help in bringing bad news to the customers and clients that they have to change the way they do business and basically he said we want CMS to absorb some of the heat.
Despite what I have said and what has been said by others here today, there's reason to be confident that on October 16 and 17 in 2003 that compliance, although not 100 percent, will be substantially achieved. AFEHCT pledges it's total cooperation toward that end and thank you for the opportunity to be with you today.
DR. COHN: Tom, thank you very much. Mark McLaughlin?
Agenda Item: HIPAA Readiness - Observations - Mr. McLaughlin
MR. MCLAUGHLIN: Thank. Mr. Chairman and members of the subcommittee, good morning. My name is Mark McLaughlin and I'm a regulatory policy analyst in the Regulatory Affairs Department at McKesson Information Solutions, which is a wholly owned subsidiary of McKesson Corporation. McKesson is a Fortune 35 corporation, the world's largest supply management and health care information technology company. McKesson provides supply solutions and information solutions across the entire continuum of health care, including market-leading businesses in pharmaceutical and medical/surgical distribution, automation, information technology and outsourcing services for health care providers and payers.
McKesson Information Solutions' software applications include enterprise-wide patient care, clinical, financial, and strategic management of software, as well as internet based and networking technologies, electronic commerce, outsourcing and other services to health care organizations throughout the world.
On behalf of McKesson Information Solutions, I thank you for the opportunity to provide comments regarding our HIPAA readiness.
Regarding McKesson Information Solutions readiness. McKesson Information Solutions has been working diligently toward the goals of HIPAA, even before the inception of the law. Our participation in industry groups, such as the Workgroup for Electronic Data Interchange, WEDI, and the Association for Electronic Health Care Transactions, AFEHCT, has helped to drive the industry toward administrative simplification by utilizing industry accepted standards and the protection of the information through privacy and security standards. The McKesson Regulatory Affairs Department has been monitoring and commenting on the regulations as they have been made available.
McKesson Information Solutions formed a HIPAA Project Office for all HIPAA related development coordination, employee education, and customer communication. The Project Office is comprised of four full time staff members and has representation from every product and service area with McKesson Information Solutions. The product representation includes both a representative for transaction-related issues and a representative for privacy and security related issues, so there are two actual representatives from each product line. The Project Office also contains representation from Regulatory Affairs, Legal, Human Resources, and Marketing.
The Project Office staff holds regularly scheduled meetings with a Senior Management, that is acting as a Steering Committee as McKesson believes in the importance of this effort being driven from the top levels of management within the organization. The Project Office also holds regularly scheduled meetings with a select group of customers who also act in a steering committee capacity. These customers provide input to McKesson on product direction as it relates to the HIPAA rules.
Finally, the Project Office participates on, and regularly reports to, the Enterprise HIPAA Compliance Office and that is an internal department actively involved in providing direction for HIPAA requirements to all of McKesson's business and service functions.
McKesson Information Solutions product lines include hospital information systems, practice management systems, home health systems, payer code auditing systems, and a covered entity clearinghouse. McKesson has published, for our customers, a readiness disclosure on the For Customers section of our web site. These documents give specific information related to each product's progress toward general availability, including the gap analysis for each product. McKesson general availability for products' HIPAA enabled release began in mid-2001.
The McKesson clearinghouse is able to accept and send claims, remittances, and eligibility today in the HIPAA standardized electronic formats and is evaluating other transactions, such as claim status and referral certification and authorization. McKesson is conducting third party testing and certification through a third party and is using a third party testing tool to perform internal product tests. The McKesson clearinghouse and several McKesson products have been certified through a third party.
McKesson has voluntarily entered information on a public web site, the public web site that Rob was talking about, that is listing vendor readiness status of practice management software. Please note that the directory URL that I have listed is not the correct one. I know that they updated that, it is now PMS directory as stated in Rob's presentation. As this directory is expanded to include other product lines of interest to McKesson and McKesson customers, we will continue to update the site with our most current product information. McKesson development is moving forward with the integration of addenda items from the DSMO fast track process and expects to issue software updates as those addenda become final.
As related to the extension, although viewed as a necessity to facilitate seamless integration of these standards among all trading partners, McKesson also knows that the extension has complicated the implementation process. Coupled with the questions of addenda or no addenda, NDC codes or no NDC codes, the extension becomes very complex. It is necessary to communicate to all trading partners in order to determine their needs as it is related to these issues in whole. McKesson has thousands of trading partners and the task of managing the directions of each of those trading partners is nearly an insurmountable task. As a hybrid entity, McKesson has covered entity components, as well as non-covered entity components. As mentioned above, the clearinghouse is prepared to send and receive standard compliant transactions today, however, the clearinghouse did not see any downside to filing for an extension.
Roadblocks to Compliance. McKesson, has been actively involved in implementation for some time, has seen the following roadblocks arise in the industry. The issue that I mentioned above related to NDC, Taxonomy, Addenda, and Extension code issues are the extension issues are unresolved. The lack of a final or proposed rules for the remaining identifiers, security, and transactions. The implementation guide interpretation issues that were mentioned earlier. And trading partners with unknown status and I will go into each of those in a little bit more detail.
As mentioned above, the complexity of dealing with thousands of trading partners who each have their own philosophy on implementation related to whether to file for an extension or not, use the NDC codes or not, to utilize taxonomy codes, or incorporate the many changes from the addenda version of the implementation guides is overwhelming. Providers, clearinghouses, and payers know the current addenda may change so they cannot even implement their final system versions until that happens or risk rolling out changes to the customer base and then having to revise. This approach not only adds additional time and costs to McKesson but also to our customers who must go through the process of upgrading. To simplify the issues HHS will need to finalize the addenda and NDC proposed rules as soon as possible. That would narrow the complexity because the NDC, Taxonomy, and addenda issues would be removed from the equation.
Lack of final or proposed rules for the remaining identifiers, security and transactions. Implementing the privacy final rules without the matching security rule will be a near impossibility given that the privacy rule requires appropriate security safeguard to be put in place. Implementing standard systems without the standard identifiers will only cause more challenges because it will increase the number of times providers will need to implement and update their health care software systems. In order to resolve this issue HHS will need to propose and/or finalize these rules as soon as possible. By issuing proposed rules that have not been completed as yet, HHS will aid the industry in beginning the comment and finalization process. By issuing final rules for those that have been proposed, HHS will assist the industry in bringing closure to current unknowns. And I do realize that HHS and CMS are actively working on that, that's totally understood.
Implementation guide interpretation issues. The interpretation of the implementation guides has been an area of contention for a while. Trading partners appear to be phasing-in their implementation meaning the transactions they are requiring to be sent today will not necessarily be the HIPAA compliant version. Many trading partners are requiring elements that, under HIPAA standards, are clearly marked not used. They appear to be adding values to internal implementation guide tables because their existing systems still need that information. Each trading partner is placing their own requirements on the interchange and looping structures of the interim transactions as is currently allowed, however, there is no certain resolution being put in place as to when the fully compliant version will be available. Recently WEDI SNIP and X12 began a temporary workgroup effort to begin to eliminate some of the confusion and inconsistent answers being given as related to the implementation guides. It would be helpful if HHS/CMS could also participate in this workgroup - this would allow for authoritative answers to be easily distributed back to the industry using a mechanism such as the SNIP Issues Database.
Related to trading partners with unknown status. As mentioned above, many trading partners are phasing-in their HIPAA implementation. Many others are still not communicating their actual testing and compliance dates. Rather than having to repeatedly call trading partners to obtain a more current status, it would be helpful to create a directory that's similar in nature to the practice management directory that's already been created that would allow the industry to see the readiness of any trading partner who has entered it. Utilizing industry and HHS listservs to publicize and kick off such a directory would be very helpful.
In summary, the implementation efforts of McKesson have been moving progressively forward. It is expected that as next October nears there will still be issues to be resolved, however, over time, we expect these issues will be resolved.
On behalf of McKesson Information Solutions I would like to thank the subcommittee for allowing us to speak.
DR. COHN: Mark, thanks very much. Questions or comments from the subcommittee? Jeff?
MR. BLAIR: I'd like to better understand, Bob you gave us some statistics. I think one of them was that you felt as if 80 percent of the vendors that you surveyed indicated that they would become compliant as of October of next year. I had a couple of questions about that. Number one, are you saying they're compliant with the claims transactions but not the rest of the transactions? And number two, do you have any data as to the level of compliance as of April, when testing is to begin?
MR. TENNANT: Good question. Actually I was referring to the health plans as opposed to the vendors. My sense is from speaking to some individuals that are at the, again, sort of the upper echelon of the payer community, is that they're very confident that sort of the top national payers are going to be ready to begin testing to meet that April 15th deadline. That includes all of the major health plans that we all know, United, Signa, Aetna, the Blues, it may vary state to state of course, but what was interesting when I was finding out this information was they have prioritized the standards, obviously the 837, the 835 and eligibility. But what I've also found out is again, it varies state to state and plan to plan. Some of them have made a business decision, for example, that their customers are more interested in claims status, so that's going to be a focal point for that particular plan. Obviously the goal is to have them ready to begin testing all of the transactions by the April date. I did not get the sense from talking to anybody, that the plans will be fully ready to begin testing all of those transactions by that April date.
DR. COHN: Let me ask a question then Mike you're on next. I'm struggling a little bit, maybe I've been involved in this too long, but I feel like we need to pull out some of our old letters calling on the final regs, vendor readiness, education, I think I've seen some of these things in letters that we've written and maybe we can just pull them out and just put a new date on them for sending them off to the Secretary. Certainly I've heard from all of you that there sort of seems to be all these pieces that we now need to be moving forward on and certainly there seems to be at least some finger pointing that in some how it's everybody else's responsibility and somehow it's not really our fault. Everybody has sort of made that comment.
The piece that I'm actually a little concerned about as I listened to all of this, and this has maybe been reflective in my own organization, has been the issue that this is really about administrative simplification. And the whole point of this was not to be strictly a compliance maneuver. And as I see people focusing more and more on this it appears to me that it's going to be just a compliance maneuver. And I guess I'm wondering Robert, maybe you and others can comment, there's a fundamental piece here that has to do with administrative simplification, reducing the costs having to do with the administrative overhead, which we know takes 25 to 30 percent of a normal physicians practice expense. What's being done to sort of help everybody realize some of the benefits as opposed to just coming into compliance? Or am I asking too much at this point? Robert do you want to start out?
MR. TENNANT: That's an outstanding point. In fact one of the mixed messages that providers have received over the last few years is the issue of administrative simplification. You've had major national groups, including some provider groups, arguing against this and in fact sponsoring legislation to kill administration simplification, so that sends a mixed message to the provider audience. WEDI has obviously been very focused on the cost savings, MGMA has been one of the few provider groups that have right from the beginning pushed hard to move forward with these standards. We know more than any other group the potential savings and efficiencies from these standards. But it's an uphill battle. We're fighting disinformation campaigns launched by some industry groups but as well, there's been a lot of focus on privacy only and I think that one of the very positive outcomes of ASCA was the refocusing back on administrative simplification. Folks realized there's something going on. But I think it has to come from the federal government. I think Tom raised that point, there has to be some understanding coming from the government to the provider community that there are some substantial benefits here. It's not just a compliance issue and their inundated with compliance issues all day and this is not one of them and it's got to come from more than just the trade associations, it has to come from the federal government, there has to be an ROI argument for this. There has to be a reason for the providers to want to go to their vendor and demand a HIPAA compliance solution. That's certainly what I argue when I got out into the field. I say you should be banging on the door of the vendor demanding to check eligibility on-line as opposed to spending time on the phone. It's these practical implications to these standards that is simply not getting out to the industry.
DR. COHN: Anybody have any more comments about that before we take the next question?
MR. MCLAUGHLIN: I see this very similar, except on a grander scale, of course, because the number of transactions and the scope of implementation, very similar to the implementation that we went through with the NSF from CMS for the Medicare's. Just because, initially it was a compliance effort in order to bring all Medicare's into compliance with national standard format, although we kiddingly called it national similar format, because nobody was implementing it the same. I feel that initially you're going to have some of that fluctuation but as we've seen with NSF over the years, NSF did become national standard format and it did simplify the implementations. And I'm speaking mainly from a vendor and clearinghouse position just because as the industry got more in tune to what NSF was, what the data content should be within that NSF, it became easier for us to implement a new NSF and easier for us to make changes to that NSF as we went on. So I think you're seeing the beginning stages of something that was very similar to what we went through with NSF except again, we're going to be doing this on a grander scale.
DR. COHN: Tom did you have any comments before? Jeff, I saw your hand raised, was it another question or was this in relation to this? Because Mike has his own?
MR. BLAIR: Robert, you would up indicating that MGMA has been having to fight a disinformation campaign. Could you help us understand that?
MR. TENNANT: Again, most of you are familiar with the legislation that was introduced in the Senate back a year and a half ago or so which essentially would have demanded a non-compliance until 24 months following the publication of the final rule in regards to HIPAA which would have pushed implementation back five, six years, probably more, which many of us felt was an opportunity for these folks to essentially kill administrative simplification. And that effort was led by one of the national provider trade associations and I think that sent a mixed message out to the industry, which again, greatly concerned us because, us meaning MGMA and WEDI, since we again have been pushing for these efficiencies for many many years. Again, we've seen studies done, sponsored by industry groups, quoting billions of dollars of costs, and again, if the message is not clear, and I think the message has to come from the federal government, that the message should be yes, there are costs, yes, there could be transition issues, but the overall goal of HIPAA is cost savings. And I think that message has not gotten out yet.
DR. FITZMAURICE: When you're in the federal government and probably also when you're in the private sector you learn that when you get a job to do the best thing to do is to find out how the job was done before and how successful it was and then copy the successful parts of it and then use your own ingenuity to create an even better solution. As I look around for something familiar to this, I'm thinking of income taxes, and Turbo Tax. We've had income tax since I guess the 1920's, maybe earlier, and it's taken a while for computers to develop and then for Turbo Tax and Kiplinger and other competitors to come up with a program that you just insert numbers into the variables and it cranks out through all the rules your income tax requirement for the IRS. The IRS has also have some fill-in forms that you can download in Adobe Acrobat and just insert the numbers, print it off and send it in. So there are things that can be done to make things easier.
So with Turbo Tax as an example I realize there's always going to be work for CPA's, for H&R Blocks, and for the attorneys to interpret these tax questions, but is there enough certainty for the creation of a vendor product for HIPAA? Such as a Turbo Tax for claims, for the other transactions. I think there probably is but I think it's going to take some time to get all the rules pinned down, both by those who set the rules and those who have to comply by the rules.
And so I wondered if you have an urgency that the new office in CMS is adequately staffed and adequately funded to provide the impetus from the government side to develop these rules and these models. Secondly, that there be legal models, such as the estate tax form, the income tax form, be developed as a model so that you know where to put the numbers, so that it's more certain than just paragraphs that may not precisely define the variable that you need. And then thirdly, that keeping up is going to reduce the number of smaller vendors or associations. It will reduce the number of smaller vendors because nobody can keep up with all the complexities but that there's a greater role for associations to provide interpretation of these complexities in a legal format to the vendors who do want to keep up. It's a question of development, it’s a question of resources at the government level and at the private level to get the advantages that we all see. Do you see this coming about? Do you see that the elements are there to make this happen? I'll let anybody answer it who wants to.
MR. TENNANT: I'll start. I think one of the problems is right now people like the tax system more than they like HIPAA. So we have somewhat of a barrier there. But I think you're absolutely right, and that's really why WEDI SNIP was formed, was to develop these, a template approach, a best practice for want of a better term, to allow the industry to move forward in a uniform manner. But we're hampered by a lack of resources. I think we have some tremendous materials I think, Mike, that fits into what your thinking is, but we don't have the resources to get that information out. I think it has to be driven by the federal government much like they developed the tax code, the federal government needs to say here's what you need to have in your business associate contract. Here's what you need to do in order to be compliance with the 837. They've done some of that but it's sort of left to piecemeal of trade associations, private vendors, consultants, lawyers, all with different interpretations of what is the correct way to move forward. I think there has to be more of a consolidation, and we certainly saw that with Y2K, we certainly saw sort of a pyramid approach where they had a Y2K czar and then they had point individuals in all of the departments that were impacted by this. And I think they've started to move in that direction if I read that news release correctly. They've started to say we have a point person at CMS, we have a vision of how we want to roll this out. Frankly, it may be too late, I don't know, obviously the compliance date, the original date has already passed and we haven't gotten that far down the road. So I think there's a need for those types of Turbo Tax type programs. Everyone is different, every approach is going to be different within every organization, but there are some commonalities that we need to point to and I think that's the role of WEDI SNIP. I think there has to be more interaction between the government and WEDI SNIP and other groups that are doing this so we have a consistent message going out to the industry.
MR. GILLIGAN: There's less than 245 working days between now and October 16th, 17th, which is the compliance date. Everybody's got a lot of work to do. As I said earlier, I think by and large it's going to get done. I think we have to remember this is, in my memory, which is only 30 years long in this industry, this is the largest conversion from one kind of system to another kind of system ever, and I've been associated with some large conversions. On October 16th it is not going to look 100 percent smooth like nothing ever happened, everything just chugs along. But I think we're going to get there relatively shortly thereafter. I'm confident that this is going to happen.
MR. MCLAUGHLIN: I would also like to suggest that what I had talked about earlier, the effort that's going on this new task group, is a step toward that direction. Because we have X12 represented and within X12 there are many different types of organizations represented, including payers, vendors, and physicians. We have WEDI working together with X12 to begin to funnel through the issues related to the implementation guides so we can have a plug in the numbers type of scenario or at least come to some agreement on what should be going into those elements as we move forward. So I believe that it's the beginning, it's probably not a Turbo Tax ready type of solution, but it's the beginning of trying to gather some of that so that we can all agree on what should go where and begin to move that way.
MR. GILLIGAN: One of the things that I think is going to solve the problem is that when this, when that transaction finally gets sent to the payer or wherever it's supposed to be processed, if people don't get the answer back, they're going to work that out rather quickly. Being paid is an essential component of this whole process so the political situation will handle that.
MR. TENNANT: I'll just add one thing to that and Tom's absolutely right, excuse the pun, the buck stops, and what's going to happen if there is a disruption in cash flow is there's going to be a disruption in patient care and that's when it's going to become --.
MR. GILLIGAN: There is not going to be a disruption in patient care.
MR. TENNANT: I'm not saying there is, there could be.
MR. GILLIGAN: I have more faith in the hospitals and doctors in this country and more faith in the people who are administering the health insurance plans, they are not going to let that happen. In my own experience in the later days in the 1970's, was implementing Medicaid management information systems in states and when they changed contractor A to contractor B payments stopped sometimes for as long as six months. Nobody was denied care in any one of those kinds of situations, so to say that care is going to stop, I think that's an unfortunate remark.
DR. COHN: Karen wants to make a comment and then Kepa has a follow-on questions.
MS. TRUDEL: I daresay I've probably been talking to more providers over the last month than most of you folks. We were getting about 1700 calls a day on our hot line by the end of this process so I'm speaking in a capacity of relating a lot of the individual stories that I've heard from people as I speak to them on the phone.
I think it's very hard for the federal government or anybody else to make a case for return on investment for administrative simplification when there is no economically feasible product out there to help your basic practitioner to reap those returns. There is an enormous gap I believe in very low end, low cost software like Turbo Tax, for your basic physician. I think the only software of that type that I am aware of is the one that the Medicare program provides to its providers who want to submit electronic claims just to us. And yes, we will have a HIPAA compliant version but it won't help people who have to bill others. There really is an enormous need.
I had a very long and on the other end heated conversation with an optometrist who was saying like, give me two good reasons why I should do this, and I began to explain to him about the fact that you can check the status of your claims automatically, you don't have to sit on hold, you can check eligibility, that you can get back remittance advice that goes right into your system and that it all balances and it takes care of the patient accounts. And he said my software doesn't do that, and if I ask my vendor he'd charge me $10,000 dollars, and the man hung up on me. So that's a perception that's out there.
DR. COHN: Well, I just have a question for Karen and maybe for the others also before we get to Kepa's questions, which is should we be asking CMS or some others in the federal government to try to produce some sort of public domain software that is compliant? Is that, I mean obviously that throws the industry that is represented in the testimony here sort of on their ears a little bit, but is that something we should be recommending?
MR. GILLIGAN: It's an invitation to slice my throat.
MS. TRUDEL: I get to comment first on that. I think that would be doing a disservice to the whole health care industry. I think that the reason that a lot of this has come about is that some of the players in this field, and I would go so far as to say some of the larger players who could probably make this happen the most easily, have not seen an economic business case for getting into this market. And I really believe that that will change.
MR. MCLAUGHLIN: It continually surprises me to hear providers say that they don't have systems and typically it's probably because they haven't purchased a system to bring their remittance back in and automatically balance it, it seems to me like that would save so much in resource on their end. However, we've had those systems in place from McKesson's standpoint since I've worked there, and I started ten years ago. So those types of comments continue to surprise me because we really need to get those types of solutions spread throughout the industry. I agree, it's definitely simplification, it is.
MR. TENNANT: Maybe just to add to that. Simon's comment shouldn't be thrown out so lightly, not that there should be open domain software, but maybe what we can do is provide a framework for what that software should look like and what functionality it should have and then allow the vendors to come in and offer those solutions. Because I think what Mark is saying is their particular software solution handles all that, but many of them don't. So maybe one of the things that could come from groups like WEDI, maybe even CMS, is here's what you should be asking for from your vendors. Here's the functionality to begin to reap the benefits of administrative simplification, not simply the claim, but ask your vendor, demand of your vendor these other capabilities. I think, Simon, that's what you're getting at where you want to get everybody reaping the benefits of this, maybe not with a standard software platform, but at least make people aware of what they should be asking for so they can do a little better shopping when they go to buy their systems.
DR. COHN: Thank you for taming my comment a little bit. Kepa do you have a questions?
DR. ZUBELDIA: Yes, I have problem, Mike's Turbo Tax model. A big difference here though is that there is this variability of interpretation of the guides as we've heard from all three speakers. With a Turbo Tax model the IRS rules are pretty much created and interpreted by the IRS. Under HIPAA, the Secretary adopted transactions that were not developed by the Secretary or by CMS. They were developed by X12. And now in interpreting the transactions developed by X12, there is this constant tension as to how is it interpreted. Is it interpreted in favor of one constituent or is it interpreted in favor of another? They are not CMS transactions, like the NSF was developed by CMS for CMS and then adopted by the rest of the industry for other uses.
So Mark McLaughlin mentioned this new group started at X12 in conjunction with WEDI to try to bring that interpretation of the guides to some sort of common consensus. But that group I believe lacks, I would like to hear more about that, what the panel thinks, but the group lacks the force of law, the force of interpretation, official interpretation of the guides. Without that official interpretation, no matter what the vendors do, will end up with different results. McKesson may have a solution that may work well but it may not work for ophthalmologists because the interpretation for ophthalmology may be different. Who knows? I would like to hear the panel what they have to say on this.
MR. MCLAUGHLIN: I agree that that is an issue and that is why the task group has asked for involvement from HHS and CMS so that there will be an authoritative answer that comes out of all of the resolutions that are produced. And if we're able to put those types of resolutions with an authoritative answer into something like the SNIP Issues Database, I believe that the industry at least will have a place where they can go to get some of those answers.
MR. TENNANT: I think, Kepa, your point goes beyond just the implementation guide issue, I mean it really permeates all of HIPAA because you have industry groups working to develop industry best practices and who's to say that they are accepted as compliant by the government, or worse, the courts. I think Kepa your point is, if I'm not correct, is we need to have a channel for these best practices to go up and then be reviewed at some point by the government and then sort of stamp of approval so then the industry knows that they can go ahead and implement those. Is that kind of where you're going?
DR. ZUBELDIA: It would be similar to the process by which the standards were adopted where the interpretation of the standard would be adopted in a similar manner.
MR. TENNANT: Perhaps maybe then that's a role for the committee here to review those, be sort of the weigh station, make the comments, and then get them to the secretary.
DR. FITZMAURICE: I'd like to respond to Kepa's comments. I see that right now that we're in a transition period and this is a process, unlike taxes in that Congress says implement this tax and the IRS says here is how you will do it. In this case Congress says work with the industry, and the government has to work with the industry to develop just what the formats are and the requirements are for different kinds of claims. Yet I see in five, ten years, a similar form coming out for transactions, a set of instructions for those transactions, the difference is that the industry is working on that and while I can't change my tax rates if I send something in, the industry can change the forms, they can change the instructions. But I think it's important that when these forms and these instructions are adopted that they be adopted with great certainty and with great precision.
As I said, right now we're transitioning to something like that, but I think in five years or perhaps more we should have the same kinds of precision that we have with tax forms. It may be like having a lot of different taxes, not just one personal income tax, but we should have greater precision and work for that differences, we must work with the industry to make that happen.
MR. BLAIR: My question kinds of goes to your perception of where we will be after October of next year. And in listening to the testimony, let me see if you agree with my characterization of where we'll be as of October the 13th, and if you do then give me some feeling for what's going to happen during the next six months afterward. Because to be candid, I was very nervous about what we would be hearing this morning. I was very much afraid that we would be hearing predictions of a train wreck, predictions of a catastrophe, predictions of this is impossible, and I didn't hear that. What I heard was that a lot of the attempts to change the legislation, get additional delays for the most part are behind us, it did cause delays in vendor health plan and provider dedication to moving forward, but now things are moving forward, some of them are late, maybe not all the transactions will be ready and implemented as of October the 13th, but a good portion of them will be. Am I saying, stop me if any of these statements are not a correct characterization, ok?
MR. GILLIGAN: Let me sort of give you some confidence here that up on the Hill who is entertaining another delay of any shape or form. That is a done deal.
MR. BLAIR: Right, so the perception if I'm hearing you all correctly is that by October of this next year, the majority of health plans and providers and certainly claims clearinghouses will be at least compliant on the health claim transactions and on the eligibility transactions and will be well on their way to moving towards compliance on the rest of the HIPAA transactions. Is that a fair statement?
MR. GILLIGAN: I believe so.
MR. BLAIR: If that is a fair statement now --.
MR. GILLIGAN: Jeff, I think, what I'm hearing out there is that yes, we've got problems to deal with and we wish there was a time sensitive situation here, but I hear a lot of confidence of the ability to get there from here.
MR. MCLAUGHLIN: I also work as a commissioner for the Electronic Health Care Network Accreditation Commission and our group accredits clearinghouses and so the comments that I'm providing are as a commissioner and what I have seen with other clearinghouses as well ours. I see that there is still going to be a time when the clearinghouses, with their thousands of payer trading partners, are going to come to October 16th of 2003 and the payers may be ready to accept compliant transactions and the clearinghouses are able to send compliant transactions, however, due to the scope of all of the tests that they need to provide in order to go into production with those transactions by October 16th of 2003 I think you'll see that there are still people who have the due diligence done but they are looking to convert to those transactions. However, the clearinghouse may have another 100 payers to convert, and in the six month timeframe that you're talking about that may be something that they progress toward. I don't see it as a finite cut-off but I also have heard from CMS that there's going to be flexibility for people in that situation, that they will be addressed with the consideration, that they are moving forward and they're not going to be out there fining people for non-compliance unless their thumbing their nose at all of this in general.
MR. BLAIR: Let me get to the second half of my, because you seem to have confirmed the perception that I had about where we will be as of October of next year. Given that that's the case and given that there's going to probably be some health plans that may still be winding up demanding special interpretations of the, or special information that is not exactly within standard, and there's going to be some health plans that may not have the capability to have the standards for remittances and enrollment and some of the other transactions in place yet, would it be correct, is it correct, that what we will see after October of next year will be a considerable amount of pressure from providers on the health plans that if they're not compliant with the rest of the transactions that there will be a demand by the providers towards their vendors and towards the health plans to become compliant as quickly as possible because providers have already made the investment? Do you think that that will be the scenario after October?
MR. TENNANT: A couple things. Looking in my crystal ball to next October I'm not perhaps quite as confident as my fellow panelists. Not, again, not to say that patient care and the health care system are going to grind to a halt but I think one thing that we're recommending to our group practices is that similar to Y2K, they develop contingency plans. If there is a disruption in cash flow, because we don't want an interruption in patient care, and frankly, the smaller practices, the rural health clinics, they can't afford to go 90 days or 180 days and not get paid, so they need to establish lines of credit and maybe work out an arrangement with a clearinghouse to funnel, at least temporarily, claims through a clearinghouse, but I think what I've been telling our folks is you need to put the pressure on the health plans and on your vendors to demand these additional transactions. I don't think we're going to see a lot of the standard transactions outside the 837 and the 835 come October. But I think you're right, I think there's going to be pressure as more information gets out and that gets back to my earlier point about producing the ROI document that a provider can have in their hand and say here's the money I'm going to save when I can take staff away from the phone lines checking eligibility and claims status and get them doing other things within the organization. Here's the ROI, we need to make that case and it hasn't been made yet.
MR. GILLIGAN: Does MGMA have that kind of an argument for its members?
MR. TENNANT: We do.
DR. COHN: I actually have a question I want to follow up with and I see Suzie has a question and then Kepa has a question and hopefully after that we'll break. Robert early on you had mentioned and we sort of glossed over this issue about vendors being HIPAA ready versus HIPAA compliant. And I wanted to come back to that because that's sort of one of the, I think we've all been aware and have mentioned for years that vendors are not sufficient but they're certainly the necessary component of this whole implementation. Can you tell me a little more about that? It seems to be that HIPAA ready means that they have a clearinghouse that they can send non-standard transactions to. Is that a correct interpretation of what that means?
MR. TENNANT: It's a good point. There's more interpretation of the word compliant than there is for the 837 guide and Mark may want to comment on that as well. When I say that the vendors are not HIPAA compliant, of course they don't have to be compliant, their clients do, their customers do. So when I'm saying that they're not providing a HIPAA compliant solution to the practice, they are providing a HIPAA ready solution, and that's very different. One of the things that we're hearing is that these vendors are going to charge, of course, a per transaction fee when they go through their proprietary clearinghouse. And in fact I spoke with some CHC representatives this past week who said that their vendor said oh don't worry, we won't charge a clearinghouse fee for your Medicaid transactions, but for everything else we will. So that's, I hope, their temporary solution to this October deadline. But you go on their web sites, these vendor web sites, and they say nothing about actual, providing actual compliant software and no dates of when they will be providing that, which is exactly why we got this provider, the vendor directory up and running and the goal is to get that information in a public forum where everybody can see where all the vendors are.
MR. MCLAUGHLIN: Related to HIPAA ready versus HIPAA compliant as Rob mentioned, we really can't be compliant. Our HIS products can't be compliant per se. We can enable the customers to have the data content and the data elements necessary for them to be compliant and that's the position that we have taken. As it relates to the clearinghouse issue we also have the ability to supply data content file out of our system so that they can be taken to other clearinghouses although we certainly would prefer that they use our integrated solution but they don't have to.
MR. GILLIGAN: Simon, that's why we're having this meeting on October 30th, to put people in the room and have a discussion about that so we can sort out what is the language that providers and vendors can use so that they can talk to each other and come away with a meaningful process.
DR. COHN: Ok, thank you. Suzie and then Kepa.
MS. BURKE-BEEBE: I wonder if the impact on clearinghouses will be an issue. And what I mean by that is it sounds as though the health plans are ahead of the curve, the providers are possibly behind the curve on being ready or compliant, and so it appears to me after hearing your testimony that they'll be a reliance in some cases on clearinghouses. Are they able to handle the flow in this transition process? Do you have an opinion about that?
MR. MCLAUGHLIN: I do, as it's related to again, I actually go to several clearinghouses sites and have assessed their readiness in terms of e-mac(?) accreditation and from what I have seen, the majority of the clearinghouses have always felt that their readiness is just as critical as the payers readiness and in my opinion they were ready before a lot of the payers that I know of just because they are the middle person in all of this and it almost seemed to me as though they needed to have the data content necessary to be able to handle transactions no matter which way they went, addenda or non-addenda related issues aside. So I feel that from what I have seen the clearinghouses are as at least as far ahead if not further ahead than the payers.
MS. BURKE-BEEBE: And I guess are there enough? You can be ready but there's going to be a flow, a certain magnitude of flow it sounds like and is that an issue?
MR. MCLAUGHLIN: Absolutely. That goes back to what I was talking about before when we come to October 16th of 2003 will the clearinghouses have all their payers in productions at that point in time and the chances are probably not but they're going to be moving toward that within a short period after that timeframe.
MR. GILLIGAN: I'd like to respond to your question by saying the need, when you use the word provider, there needs to be some refinement to that. The Mayo Clinic is probably going to be ready. The small doctors' office is another matter entirely. In the few conversations I've had over the last few weeks it seems to be the doctors are having the biggest problems in realizing they have to do this and they have a deadline.
MR. TENNANT: Just one comment. That's certainly a huge issue, the readiness of the clearinghouse and one thing that WEDI is looking into now is to produce a similar directory as we've done with the PMS vendors for health plans and clearinghouses. Because I think you're absolutely right, come October the demand for clearinghouse services are going to increase a hundred fold and it may be fairly short terms, it may be six months or a year, but that demand has to be met. Maybe one of the things that CMS can do is to start to bring the clearinghouses in and find out what if, what if you get a 100 percent increase in the number of claims. That makes a lot of sense.
DR. COHN: Kepa final question and then we'll break.
DR. ZUBELDIA: First, before the question I'd like to make a comment. We need to look at this HIPAA transition in perspective. Today the health care system works with a degree of imperfection that is tolerable to everybody. Probably about five percent of the claims filed to the payers electronically are bad, incomplete, incorrect, whatever, they need development, they are not perfect. There is only about 95 percent of the claims that are clean and out of those, about 70 percent can be adjudicated without being touched by human hand. The other 30 percent have to be looked at in some way. We shouldn't be expecting HIPAA to correct that. We shouldn't be expecting HIPAA to be 100 percent perfect on day one, probably we shouldn't expect HIPAA to be 100 percent perfect ever. So we need to realize that the system has to have, or will have, some imperfections just because of the nature of the data we're dealing with.
Rob I'd like to get your feedback on the clearinghouse issue in one specific example. I was talking the other day with a medical practice management system that has their own private clearinghouse. They were telling me it took them three years to remediate for Y2K all their sites because they have so many sites and it took them three years to touch them with an update and that update really involved much testing of the site with trading partners, it was just that site that was updated. This same practice management system is looking at sending all of their customers to a clearinghouse because that's the only way they perceive they can even attempt to be compliant on time. I understand they're not going to charge them for the transactions. They're saying as part of your maintenance contract you either get your software updated and we'll put you in a queue and it will happen whenever it happens or you get your transactions sent to a clearinghouse for free. Is that a concern or is that an acceptable solution? In your eyes, what do you think?
MR. TENNANT: Well there's two points. One is we've heard exactly the same thing and that's I think an acceptable short-term solution, that it really doesn't get at Jeff's point earlier, which is this is not all about sending a claim. This is about administrative simplification and that's not administrative simplification, it's a work around and it's fine I think for the short term to make the claims go through but if they're not providing solutions for eligibility and claims status --.
DR. ZUBELDIA: They are, through the clearinghouse.
MR. TENNANT: Through the clearinghouse. Well, it's a proprietary solution and as long as they can use the same standard to find out eligibility from all of their different payers, I don't see it as a problem. As long as the system works and as long as they don't charge fees and that's in question. I don't think all of them are as ultraistic as this particular one you've mentioned. I've heard that many of them are seeing this as an economic opportunity as opposed to a hardship.
DR. COHN: Any final comments from the testifiers? Alright, we're going to take a 15 minute break. I would ask you if you could stay around for the next conversation since we're obviously going to be thinking about some of this as well as talking about best practices and the role of ASCA and what we sort of need to be preparing to publish here so you're input would be appreciated. We'll break for 15 minutes.
[Brief break.]
Agenda Item: HIPAA Extension Request Status - Ms. Trudel
DR. COHN: Ok, we're going to lead off this session by asking Karen Trudel to give us a little bit of an update on where we are with ASCA, otherwise known on this agenda as the HIPAA Extension Request Status and then we'll I think move from there into a conversation more about one of our responsibilities which is to identify best practices and I guess solutions to issues identified and see if there's ways to publish some of that information. So Karen do you want to just start with the ASCA update?
MS. TRUDEL: Sure, thank you. Just to provide a little bit of background, our on-line application system was brought up on our web-site on April 16th and that day we received 134 requests. By the end of the extension period, after September 30th, we were receiving many more than that. The last few days almost 40,000 per day and while there was some slow down in web access the system kept on trucking through the whole thing. Total electronic extension requests that we received is somewhat over 500,000. That number is a little bit misleading because it includes some duplicates and we have not un-duplicated the database yet at this point. We've received over 39,000 submissions on paper, that again is misleading because some extremely large organizations who were filing for multiple entities decided to send theirs in on paper rather than to key all of the identifying information for each one of those entities.
These paper forms are still trickling in because the requirement was that the form be post-marked by October 15th so I expect that we will probably have 50,000 or more when the dust settles. And we will be keying those into the electronic database. The database was brought down early in the morning on the 16th and the keyers began at that time and so we will have when we get finished a complete database holding both paper and electronic.
We expect to have final statistics on the database, it will be un-duplicated and edited and ready for some statistical reporting by early next month.
Of the electronic requests that we've received, because we really can't say much about the paper at this point, most of them were from providers. And we did a few runs that showed that most of the providers reported a Medicare number, they reported something in that field so we believe that an awful lot of providers, Medicare providers, did submit extension plans.
I think that the benefits of this entire process are that over half a million people who didn't know about HIPAA possibly six months ago know about it now and they have demonstrated that by submitting an extension request. And a number of people who weren't sure a month ago whether or not they were a covered entity because they were a small provider, they were a provider that didn't submit any electronic transactions, have gone through that thought process and have figured it out. And those entities are in addition to the 500 plus thousand who submitted extension requests.
In addition, over the last few months a number of health plans have done the math to figure out whether they are a small plan or not and so I think this whole process has raised people's awareness, it's made them start thinking about whether they're a covered entity, whether they're a large health plan or a small health plan and to start to think about exactly what they have to do to become compliant.
As I said before, we were receiving towards the end about 1700 calls a day on our hot line. The Ask HIPAA Mailbox, we were receiving about 200 emails a day and we've been working pretty hard with a number of volunteers to help us keep up with that volume. So I think in all this has had the effect of being definitely an awareness exercise and has jumped started the thought process for an awful lot of covered entities.
DR. COHN: Thank you for your good work. Suzie, question?
MS. BURKE-BEEBE: Just to clarify Karen when you said that most of the providers, the Medicare number that you saw, were those on paper? Is that what you meant?
MS. TRUDEL: Electronic.
MS. BURKE-BEEBE: Electronic, ok.
DR. ZUBELDIA: Karen, do you have a sense for what the common problems are? Any idea of trends or anything like that yet?
MS. TRUDEL: We haven't done any tabulations because we haven't un-duplicated the database yet and we will not do that until the keyers are finished are entering the paper forms.
MR. BLAIR: About how long will that be?
MS. TRUDEL: We think it will take two or three weeks.
MR. BLAIR: Do you think it would be possible at our December meeting that we might be able to hear some of the statistics?
MS. TRUDEL: Definitely.
MR. AUGUSTINE: It's a shame after developing that sampling plan we're not going to need it after all. All those sigma's went to waste.
MS. TRUDEL: We hadn't anticipated having to key them but it does make the process a lot simpler.
DR. COHN: Actually Brady, just speaking of that, I'm not sure that it does change the sampling plan, though I guess I would ask Karen whether or not the ones that were sent in by paper, are they being somewhat differentiated from the rest?
MS. TRUDEL: We can tell simply by the date that they are accredited to the database because all of the ones that came in electronically were accredited before October 16th.
MR. AUGUSTINE: You also have 100 percent sample and you'll be able to differentiate with that date.
DR. COHN: I guess one of the questions that I would like to bring up and I would like to include our panelists and others in the discussion, obviously, the first question I think I'd ask Karen and for others to mull about, I mean you realize how streamlined and simplified the compliance form became by the time it was completed and put out on the web. And I'm, I don't have perfect memory of the form, but I am wondering in my own mind even once we get this information all keyed in, exactly what sort of information it's going to tell us since we know that virtually everybody in the industry applied for an extension. And I don't know that I felt that the, I mean realistically because of all of the issues, I don't know that the boxes that were being checked are going to be necessarily so revealing. Does anybody, Brady, this may be an area that you have some thought about, but do you feel that there's going to be some clear pointers that are going to come out of that that would help guide us in terms of publishing best practices and if we find compliance issues?
MR. AUGUSTINE: I always kind of go by the credo that the data have a story to tell and you just have to wait until they tell their story. We'll have to wait and see what it says.
DR. COHN: Maybe I'm being a little pessimistic as I said with it, but I guess you're right, we will have to hold and sort of see. I guess the question is do you think we would have some data by November, to look at this one for the November meeting or is that a little too early?
MS. TRUDEL: I can ask them to do some really preliminary runs. I would assume the one we're the most interested in is reasons for delay. And again, just from the experience of having spoken to people on the phone I think the top two that we're going to see is I'm waiting for my vendor and I just heard about HIPAA.
DR. COHN: I think I've heard those reasons before maybe in some earlier testimony today.
DR. ZUBELDIA: Karen, wasn't there a question that people were asked the date when they think they will be compliant, the date they will start testing? I would like to see if there is any significant difference between the payers' answers, and the providers' answers, to those days. If the payers' answers are significantly earlier than the providers' compliance dates, then we have some encouragement. If the payers' answers and the providers' answers to compliance at about the same date, then I think there will be some sort of problem.
DR. COHN: Marjorie?
MS. GREENBERG: I wasn't quite clear whether this was mentioned or not but you're keying in the results but even people, either electronically or on paper, could also write narrative right? Couldn't they add narrative to their response or were they strictly limited to check-boxes?
MS. TRUDEL: Electronically there was only one place where we accepted narrative and that was if someone said that in the list of things of reasons for delay, if they used the word other. Then there was a box to fill that in.
MS. GREENBERG: Ok, and then what are you going to do with, how is that handled by the system?
MS. TRUDEL: It's text strings.
MS. GREENBERG: In that sense will it be necessary to sample these text?
MS. TRUDEL: We can.
MR. AUGUSTINE: You can either do that or you can try to categorize them with other responses.
Agenda Item: What Needs to be Done to Move the Industry Implementation Forward
DR. COHN: We have a question from I think the audience, would you introduce yourself?
DR. RADA: My name is Roy Rada, from the University of Maryland and when I saw on the agenda about best practices I got excited and I brought a small document with me which I can distribute, and I wanted to make a comment and question about what best practices mean. I think it could be useful to us to be clear in our terminology, there's a definition here of best practice which says a practice that is quantifiably successful over a prolonged period and repeatable with modification in similar organizations. This would be a definition that would be accepted in professional circles although it's not the, in practice people talk about best practices as just whatever they do, whatever somebody stands up and talks about is a best practice. If you're going to be rigorous about it, best practice is what I said and I don't think this data can give us best practices. You can't with this information from the form but you can get common practice and what I would argue in part is that that's what we actually want anyhow. We're not looking for best practice, we're looking for common practice, and then for that it will be as was already implicit in some of the questions, like maybe Kepa's about payers versus providers, in any case, different entity types will have different practices and I think this will be one of the intriguing things to find in the data by entity type what are they doing.
DR. COHN: Thank you. I guess I'm not maybe quite so hopeful about some of the data only because I think, I guess my hope is that it will identify compliance problems and I'm not sure we're going to see a whole lot about the best practices and indeed our responsibility is to identify compliance problems and we're already to begin to hear some of the testimony today and then sort of figure out what needs to be published or somehow shared around best practices to those compliance problems.
DR. RADA: In ASCA are you not charged with, or was this the DHHS, to come up with a model plan or something like that? Or was that supposedly already done in generating the form itself?
DR. COHN: That was the form itself in terms of the model compliance plan and I believe our responsibility is to identify as I said the compliance problems identified and to survey and analyze the data, identify the compliance problems, and then to publish effective solutions to those compliance problems. I don't think I've quite quoted the legislation but I'm close.
DR. RADA: That's going to be exciting.
DR. COHN: Yes, and I think really part of the conversation today is beginning to sort of see what sort of resources we might be able to leverage that exist out in the community and I think we've heard, I think Karen made a comment in relation to what she thought the data might show and I think we're all aware that there are issues of education, issues of vendor readiness, issues probably around demonstration of ROI that we need to be somehow publishing and make aware to the health care community. And so I thought this was probably a good initial conversation to sort of find out what was already out in the industry and I'm obviously looking at Robert and WEDI, because I'm just not familiar with exactly what you have that we might be able to bring forward but there may be an opportunity for us to begin to jump start some of this by potentially once again identifying some of these things, direction people to come to the web-site for example, to those resources. So I guess I was transitioning a little bit. Brady it looks like you have a comment.
MR. AUGUSTINE: I think it would be really powerful whenever people talk about, we've been talking about taxes a lot today, when they talk about making changes in tax code you'll read newspaper articles, magazines, and it will say for a typical family, if the husband makes $50,000, the wife makes $30,000, if this, this, and this change, this is the probable outcome. Some scenarios that let them kind of empathize or be able to associate with that situation. If we had some scenarios like that for physician practices, maybe in a small group with three physicians, six, seven office staff, this volume of claims, what advantages could the administrative simplification have to them, come up with some real numbers and real values so that we can start getting this information out in the field. Because as I was saying earlier I've been meeting with some leaders in some of the IPA's in South Florida and when I talk about administrative simplification they're all like their eyes are rolling back in their head and they are thinking it's all a big oxymoron. And we need to show them that at least a lot of these components are really going to affect their bottom line in a positive fashion. We just have to communicate that. And we don't know what exists out there today that we can bring together to put forth to them.
DR. ZUBELDIA: In Utah, UHANE has put together a model for a small practice on administrative savings coming from HIPAA and essentially it's an excel spreadsheet and you input how long it takes on the average to get an eligibility inquiry answered, from how long you have to stay on hold to get an answer, how long it takes to get a referral, ten minutes, 15 minutes, 20 minutes, and it goes through all the HIPAA transactions, then how much you pay your employees and how much money you're spending doing that, and then in another column it automatically calculates based on how many transactions you had a month, what it would cost with the HIPAA transactions. The results are amazing, when you see them the first time you say wait a minute, there's something wrong here. You tell me that a single provider office can save about $80,000 dollars a year just using these transactions? And UHANE has been providing the tool for free with a request that the results from the calculations be sent back to UHANE so they are accumulating a pretty good size database on different results from different practices, different specialties, different locations in the state and so on that have gone through the calculations. I think it's pretty high up for any physician that is looking at doing the transactions either as a compliance requirement or as an administrative simplification savings tool. It's really fascinating to look at it.
DR. COHN: Suzie?
MS. BURKE-BEEBE: I've seen that as well Kepa. One of the questions I have though is extending it beyond the provider, the medical provider, has there been anything? I haven't been aware of it that it's extended to an institutional level.
DR. ZUBELDIA: Not that I know of. It's strictly for physicians, that's what they did it for.
DR. RADA: Roy Rada again. I wanted to comment on what Brady had said but since this is the latest topic, the spreadsheet that Kepa describes is very simple in format, it's not specific to a physician, it's just an entity generating claims and the cost of doing it manually versus electronically in terms of labor and then there's also the big money saving comes in if you estimate that you're going to reduce your bad debt, and it would apply to any entity, it's not just for physicians.
But the think I wanted to get to which was more the crux of the discussion here about these best practices and this database, there are different views people take. Brady said earlier that the numbers will tell the story and we don't really hypothesize what we're going to see we'll just wait and see. I disagree, I think that, and this is just is a matter of approach, but I think you get more out, you come to the data you have some hypotheses and in that regard I think we can come up with some quite quickly. And I know that I've been advising people, if they are small group practices, you just tell them you can go through that form and I've filled out the form for them and I distributed it en mass and just tell them to sign it and send it in.
And it's just checked all the whatever, it's going, I forget now since it's been a while since I looked at it, but you can just take all the default things, and I'm going to rely on a clearinghouse, you know they're going to rely on a clearinghouse, and they've not done it yet because their vendor is not ready or something like this and then you're done and you send it in. So you can be looking for a large number, not because of me, but a large number like that because of the situation, right? And then you can, you can think from maybe it would help us if we put ourselves in the position and I know most of you, or some of you at least, Simon would be in this position with Kaiser, you would be involved with filling out these forms, and then you can put yourself in that shoe and think of the people who did and what were they thinking and work through some of the scenarios we're, what are we going to expect in the data, what kinds of entities are going to be sent in and what kind of stuff and do we find that and what's been interesting about it.
DR. AUGUSTINE: I agree, there are a lot of tests that we can run and a lot of comparisons and cross tabs but by statistical hypotheses I don't advocate doing those post hoc after we already have the dataset. That's kind of something you always stipulate going into before you start gathering the data. But there are a lot of different ways that we cut and slice the data and look at it and gather some information. Some of the ones you pointed out and Simon pointed out are some very good obvious first cuts.
DR. COHN: Brady, I think as well, we've said before we look to you to help us with some of the statistical analysis pieces. Not so much doing them necessarily but seeing if you can help us with the patterns and all of that and obviously I'm happy to help. But having said that, I think part of the conversation of having Robert here and others was really to sort of, we've seen some of these things as sort of obvious, I think Karen had mentioned a couple of them and we began to talk about well geez, there's the UHIM form which, I have not seen, but it would seem to be a wonderful thing for us to talk to them about publishing or linking ourselves into that web-site to give the providers an opportunity to look at that.
I guess I'm wondering, Robert, can you talk a little bit about what WEDI might have in relationship, and I'm sort of looking, there's a couple things I'm sort of looking for based on a previous conversation. One is this issue which Brady was talking about which is this whole ROI and not losing sight of the fact that this should be really administrative simplification and how can providers move from just a compliance of you to something that actually gives them administrative simplification. And I'm wondering if WEDI has published things about that. And the other piece is I think some of our vendor discussions, where we were just sort of saying geez, what should a provider, be it institutional or other, be looking for in the way of practice management systems or other systems to support their ability to utilize HIPAA?
MR. TENNANT: Certainly we recognize the need for all of these tools and in fact WEDI's chair, Stephen Lazarus(?), actually came up with another type of, he called it a quick and dirty HIPAA calculator, it does the same kind of thing. You punch in the expected hours that an FTE(?) would spend on eligibility and things like that but there's certainly a need for that. We don't have anything as comprehensive as the UHANE model, maybe we can replicate that and make it more widely available.
The ROI is something that we've always sort of debated within WEDI, trying to replicate what we did in the early '90s which was generate the report that really provided the foundation for the legislation and I know the foundation has, the WEDI foundation has on it's plate trying to replicate that study and come up with new numbers to show the industry what the potential savings are and maybe Jim can comment about the status of that.
But the problem is of course, is resources. That is a massive undertaking to do an analysis of the health care industry to see what the ROI would be on this. It frankly should have been done some time ago in anticipation of people moving forward faster. WEDI has focused on a lot of different issues, a lot of business issues, both in transactions and also in privacy and security. And in fact there's a paper that has just been released within WEDI as a draft document, which is the Small Provider Implementation White Paper. We have an early draft on the web-site, there's an updated version now in circulation and when you look at many of the white papers out there in the industry and you hand that over to a practice administrator of a three physician practice, they look at it like it's Greek, it's too technical, it's not useful information to them. So we had a sub workgroup design a paper that could be read by somebody walking off the street and understand what the implications of HIPAA would be, transactions, security, privacy, on their organizations. And it was just updated because of the recent privacy modifications. So that's I think the type of information providers certainly are looking for. They are able to get it now if they pay for it, in terms of buying products and services from publishers or legal firms, often hundreds or thousands of dollars, so this is an opportunity for our folks to get this type of paper for free. It's not as comprehensive as a thousand- dollar product but it gets them started. That's something we tried to do over the last few months is recognize the need for the uninitiated to get up to speed on this. We have papers on front-end edits, translations, obviously our sequencing white paper is widely dispersed in the industry. Those are very technical, aimed at the converted so to speak.
But we've also initiated some new relationships. We have a relationship with the Council for Affordable Quality Health Care, CAQH. That is a consortium of health plans. That's more their EDI wing of the health plans. I think it's based with the Association for American Health Plans, AAHP, I think they're housed there and they comprise of many Blues plans and Aetna and a bunch of other folks. We've just started a collaboration with them to do a number of things, including I think it gets back to some earlier points, providing a template that health plans can fill in to show where they are in their readiness and their testing. And CAQH and WEDI are going to look at the results of that and that should drive some of our educational efforts.
If we see that, we were talking on the break about maybe health plans are sort of further behind in certain transactions, that template will drive us to some educational efforts. I think that's a good step for us and again, we've got some outreach programs with CMS, I think that's a very exciting prospect. But I think what I'm hearing is there's some need to do some other work. I think Brady's concept of providing a scenario, two physician practice, ten physician small clinic, hospital, rural health center, these types of individual organizations need to have, for want of a better term, a compliance plan that they can sort of fit into their organization that would be all encompassing, flexible enough to meet their individual needs and that's something that I can take back to WEDI and say hey, here's what I'm hearing from the committee, what can we do about it?
DR. ZUBELDIA: I have a follow-up on that because Rob, because I see a problem and perhaps there is something that we could do about it, I'm not sure. Let's say that there is template out there where the payers and clearinghouses can say their state of readiness and they can say I will implement the 837 by such and such a date and the 835 by such and such a date and so on and they go through all the transactions and they'd have testing dates and implementation dates and so on. And they do that as a public disclosure. We run into a problem that both Mark and Tom have addressed earlier today and that's the legal liability of making such disclosures. And the impact on the market valuation, even though they are underground now, but the impact that it could have on the market valuation of making such disclosures and even worse, maybe having to change the dates later because they are not making the date, whatever. And the potential liability from customers that say you said in the web-site three months ago you were going to be compliant or you were going to have product compliance or you were going to start testing by today and you can't do it. How can that be addressed? Let me give you an example. Y2K. Now HIPAA is completely different from Y2K but way back in 1999, right before the Y2K, or 1998, I think it was
'99, Senator Bennett introduced a legislation that essentially said if you make your Y2K disclosure by such and such a date you cannot be sued over it. That was a one- sentence description of the legislation. Would something like that help in HIPAA? If you make your payer, clearinghouse, vendor disclosures you cannot be sued over it? Would that help?
MR. TENNANT: We've talked about that before. I'm not sure there's time to get legislation passed, there's a few other things bottled at the Congress. But I think that was driven by this pyramid concept that we saw with Y2K that I mentioned earlier. You had really a focus on Y2K at the very top levels of government, I don't see that with HIPAA, it would take that type of action. But I think what that would do, Kepa, your absolutely right, would free up a lot of these entities to come forward.
Now the difference is with Y2K there was sort of a maybe two dates, maybe a test date and a final date. There's so many rolling dates with so many rolling transactions it's a little more difficult. But I think your point is valid because there has to be a way to get the information to flow and that's really what you're getting at. As I said before, it's all about partnerships. If a provider knows where their vendor is, where their clearinghouse is, where their payer is in this whole process, it's going to be much easier. If they don't it's all that much more difficult. I'm not sure if that's something that the committee can do to recommend. Obviously, HHS can't initiate legislation but perhaps it could issue guidance on that type of thing.
DR. COHN: I'm going to break in only because I'm probably missing the point of this conversation and the way I'm hearing it is geez, we want to have legislation that makes it ok for vendors and clearinghouses not to meet the deadline as long as they disclose in advance that they are not meeting the deadline. Am I missing something here?
DR. ZUBELDIA: No, it's for them to say when they're going to be ready ahead of the deadline. The problem is that if everybody waits for the deadline, we're going to have a big bang type of approach that will not work. People have to be ready before the deadline. And they need to disclose when before the deadline they will be ready.
DR. COHN: Once again I guess I'm remembering the ASCA legislation and isn't there a requirement in April that they begin testing?
MR. TENNANT: Yes.
DR. COHN: And how does that differ from what we're already talking about?
MR. GILLIGAN: Because that could be internal testing. The debate shortly after the ASCA legislation was passed was what was that testing supposed to mean in the ASCA legislation? And some of us wanted that to mean external testing and it ended up just being testing. Some people can say well, I'm testing, I'm testing internally.
MR. AUGUSTINE: One of the problems is there's a lot of dependencies here. There's a kind of a cascading affect and if there's not a lot of open disclosure then some people will get hung out to dry when the compliance date comes around.
DR. ZUBELDIA: I would like for instance to hear from Mark since you're involved with both the vendor and the clearinghouse side. What would be the benefits or the implication of knowing or not knowing when the payers are ready to start collecting to the clearinghouse? How many payers do you have to deal with, how many payers can you deal with per day and what happens if you don't know when they're going to ready and you have to assume the worst which is that we'll all be ready October 16th? What happens then?
MR. MCLAUGHLIN: Well, I think we already talked about what's going to probably happen on October 16th of 2003. You're going to have clearinghouses that are ready and you're going to have payers that are ready but may not be connected up yet as far as production goes. A lot of what's been going on, our clearinghouse deals with over a thousand payers and a lot of what has gone on to date is the continual calling of these payers asking when they will allow us to test and not only when they'll allow us to test but after that testing is done, are we going to be put into production? And at this point we're not getting a lot of positive responses from the payers that that actually can happen. We've already gone through four iterations of calling all of our payers continually asking for that type of information, so yes a payer directory that would give us that information would definitely be valuable but I think we need to take it beyond when will we be testing and also ask will we be able to go to production at that point, because I think that's the real critical point.
MS. BURKE-BEEBE: So is the point that Kepa's making about having some type of legislative protection important?
MR. MCLAUGHLIN: I think it would help especially as Kepa has pointed out, if you're asking for a prediction on when you're going to be compliant, as I stated, we've got generally released products that have been out there since the middle of 2001 and our clearinghouse is ready, so it would be a post statement for us. Even in the practice management directory that we have made an entry to it states that we had a general availability back in such and such a date.
MR. BLAIR: I think that Kepa raised a valid point, but I think from a business standpoint and from a risk standpoint it may not be as serious. For example, maybe they could reduce their legal liability or legal risk if they don't wind up, I'm thinking of a provider pair or clearinghouse that's winding up saying that they, want to avoid winding up saying when they're going to be ready to do testing or when their ready to be compliant. If they avoid that then they put themselves in the position where they don't have a way to manage the accommodation over time and they are left to the October 15th date which is probably a worse business risk then spreading it over time. The other thing is that they don't have to guarantee that they're ready, they could wind up saying it's a target date or it's an intent or a best effort, so I would tend to think that the business issues would be the driving forces. And even though I acknowledge that lawyers may wind up pointing out there's a certain amount of risk here but I think that the other risks are worse.
MR. GILLIGAN: In this case though it's not only the lawyers are gong to pay attention, it's the Wall Street stock analysts are going to say well, they missed this date, that date, and all of a sudden the value of the stock goes south. Just as a point of information, the value of the stock of the vendor industry has decreased 50 percent since last April.
MR. BLAIR: But what would be the impact if they don't go ahead and say look here's my target date for when I'm going to start testing, and they just simply avoid that and say well, we'll be ready by October 15th, then they put themselves in even greater risks.
MR. GILLIGAN: Not with their stock analysts.
DR. COHN: I actually agree with your comment that that is not something that is helped by legislation.
MR. GILLIGAN: Exactly. I think the liability issue is real. In this October 30th meeting we hope to find out more about it and anybody here who wants to come can come for nothing. But I don't see a legislative solution for this and as a matter of fact, there are no legislative solutions that are going to be available for helping people with the compliance stuff by the compliance date. Legislation is not going to get passed in time to save anybody.
DR. COHN: Mark do you have a comment?
MR. MCLAUGHLIN: Yes, also in relation to vendor readiness as I mentioned in my testimony, there are areas on many vendor sites that tell the customers about readiness, when the product was ready or will be ready and those types of things, gap assessment analysis, those things have been out there for some time so for our own customers we have a special section on our web-site where they can go get all of the information they want about each and every one of those products and it's been advertised as such.
MR. GILLIGAN: Then the customers have to log-in with a customer number, password, what have you.
DR. COHN: Was there a comment on?
MR. AUGUSTINE: No, from working as a director of quality management in the past we had these QI committees within our organization where we would form groups, we'd work to improve the quality organization, improve compliance, and the activities of these groups tended not to be discoverable as long as they were in the effort of improving quality. Now I don't know if bringing outside persons into that where you could have an area where you could discuss openly and not worry about discoverability whether that would work well. I don't know how that works legally but that may be something to think about.
DR. COHN: Not being a lawyer I don't think I can comment generally on this one. The issues that you are describing generally involve patient care I think.
MR. AUGUSTINE: Also I think compliance issue but I'm not sure.
DR. COHN: Compliance issues, ok, not being a lawyer this is an area where I have to defer that. I guess I'm wondering whether now we should move the conversation a little bit only because I think we're getting, I'm just not sure there's much of a, I'm still not sure there's much of a problem here and I certainly don't hear much of a solution coming out of the committee, though if Kepa comes out of that October meeting, I suspect that he will be there, maybe he can share with us sort of what happens out of that.
MR. GILLIGAN: I would like to reinforce the point that Mark said that all these vendors do maintain web-sites for their clients, like I think on your site you key in your client identification number and probably a password and that information about those products are available. Now for somebody just cruising web-sites that information is not available.
MR. TENNANT: One last point. I think the goal here is to let the market force work in the sense that more providers that are aware of the information, the better informed they are to make a corporate decision about what vendor to support. I think Kepa's point, which we don't want to lose, is how can we facilitate that, how can we facilitate that information and maybe that's something that HHS can look at to say if, for example, the HIPAA.org PMS directory, maybe that can get out through CMS to the providers. Once the vendors realize that the providers will be looking at this it will be forcing them economically to try and include their information on this site and therefore drive the information process, not because they want to but because they have to in order to stay viable. I think that's the whole goal in this whether it takes legislation or if it takes CMS activity, some way to get folks to share information on their readiness.
MS. TRUDEL: Who is vetting the information on that web-site? Nobody. So it's just you say what you say and?
DR. ZUBELDIA: The vendors list whatever they want to list.
MS. TRUDEL: So they could say they've done third party testing when they hadn't, it's absolutely open.
DR. ZUBELDIA: Yes, the vendors list whatever they want to list and that's all. The marketplace will vet it hopefully.
DR. COHN: Well, let me ask a slightly different question here because we're sort of, we have this sort of tangled web of, we're sort of talking about geez, what should be on the web-site, what should be published, what should be connected to, obviously the issues about vendor readiness obviously assumes that the provider knows what he or she should be asking for. Robert you started off by this sort of comment earlier about the fact that there are, we've got health plans that are relatively sophisticated, they probably don't need much help here. Clearinghouses, they ought to know what they're doing. If they don't we've got some significant problems and I expect the associations are here saying that they're going to be ready.
MR. GILLIGAN: In terms of clearinghouses, the clearinghouses that are members of AFECHT probably process over 80 percent of the clearinghouse transactions.
DR. COHN: And you're here to say that they are ready?
MR. GILLIGAN: Yes.
DR. COHN: Ok, so we don't have much of a problem there. So now we've got this large group of providers, some institutional, many non-institutional, providers that probably have awoken to the fact that HIPAA exists now, have various software platforms and perhaps partial solutions, are grappling with and what they like is Turbo Tax. But instead they haven't seen anything that quite looks like Turbo Tax on this one and are a little confused about what they should be asking for. Do we have any resources, any list of requirements for these systems that exist anywhere within the WEDI infrastructure or elsewhere that could be publicized around these are sort of the list of things you should be talking to your vendor about and have them just basically say yes, no, or otherwise in relationship to them? I see somebody from the back here. Please identify yourself.
MR. SHUPING: Jim Shuping with WEDI. I don't know whether all of those questions would be answered completely Simon but we just finished a series of three audio casts that were aimed at the small providers and each of those has resulted in cassette tapes which is a product that is readily available for them, all they have to do is contact the WEDI offices and they can be sent out to them.
Rob also alluded to a series of white papers, and there are several in there which kind of walk the people through the types of things that they need to be thinking about in terms of getting ready. So these are tangible resources that are in place right now, they're constantly being updated and so forth and I think, what we try to tell folks is to come to the WEDI site and kind of go down through the resource lists, I mean they have to kind of link their way through to identify what is there that may be readily available that can help them right now. And we're trying to do more and more of that type of thing.
Rob alluded to us trying to update the report that we did many many years ago. What we've done is, we haven't done away with the report but we've kind of parked it temporarily because we've had so many requests for case studies and things that we can demonstrate to these folks how they need to go about getting ready for implementation and that sort of thing. So we're trying to focus our energies now and the human resources that we have on trying to generate those kinds of products. There are many of them listed on the WEDI web-site.
MR. GILLIGAN: One of the other things that should be known is that on all of these vendor web-sites they go on ad nauseum about the products they serve so if somebody wants to get a good idea of what kinds of things he ought to be thinking about, all he has to do is visit two or three web-sites and that ought to spark his imagination.
MR. TENNANT: There's a couple of issues here. One is the scenario that I think Brady is interested of that small physician office, they're not likely to be visiting many web-sites. In fact many of them don't even have internet access in the office. So how can we reach those folks? And I think one thing that CMS did which was extremely positive which was their video. They filmed some offices, some office managers talking about HIPAA and implementation issues and they made that available on the satellite broadcast and also people can write in and get a copy of the video. And they also participated on this WEDI audio conference which was aimed at small providers, myself, David Kibbe(?) and Maury Johnson talking about ROI, how can you save money using the transaction standards and how do you get started on the transaction standards. That has to go out to hundreds of thousands of people, instead of hundreds of people. So the question really is, we have the resources, we have the personnel, how can we reach the providers? I really think it's a partnership between industry and CMS with more outreach.
MR. SHUPING: If I could just build on Rob's comments, we also are right in the process now of launching a series of regional initiatives to try to get out to many of these communities that have been under-served. The local practitioners and smaller health plans that don't seem to find their way to these national programs. One we are doing in collaboration with CMS and I believe the first program will be rolling out in December, we're going to do a couple of pilots in the CMS regions. They have ten regions and we're using our regional infrastructure to coordinate with theirs to deliver these programs and they are aimed at the small provider, it's a full day of information that helps walk them through what they need to do, the questions they need to be asking, how they can get themselves ready and it includes a general orientation just to HIPAA itself.
The second level of seminars is being put on through our foundation and through our regional network of some 30 affiliates. And it's going to be about a day and a half program, the first half a day would be more of an orientation, a kind of HIPAA 101, but then it's going to go to a an intermediate level and a more advanced level with vendor participation. We actually have vendors that are going to be helping to sponsor these programs and they will have on hand much of the software and the tools and so forth that these folks can use and they can kind of get a hands on glimpse of that in how to put it together. So we think the combination of these two types of programs is also going to take a great step toward getting to all of these thousands of providers in particular that are out there that are just not getting exposed to the national programs. And as Rob said they are not making their way to the web-sites or getting a hold of any of the other resources that are available so we're kind of taking it to them. And I think that over a period of months will have quite an impact on bringing more people into an awareness level.
DR. COHN: I think what I'm sensing here, and once again I'm struggling a little bit to figure out what we ought to be publishing, but I think that there's a piece here that's called Listing of Educational Resources, some of which as I said are face to face activities, and I guess I would, if it's possible Jim if you could provide us with a list of both those sorts of activities that WEDI is doing, that the WEDI Board recommends as being ready for prime time. As well as white papers, since I've heard you mention a variety of some being early, some being complete, and certainly if there are, I'm not sure that we want to basically start recommending draft white papers on topics but I think if there are things that are complete it might be useful for us to begin to catalogue them and make it known as part of our publication process that indeed these things exist. And certainly I would open that up to other groups also that are willing to have their information sort of listed, or at least have us evaluate that information and see if it's appropriate for such a listing. Suzie?
MS. BURKE-BEEBE: In looking through Rob's full written testimony, on the next to the last page, it has the heading Other Potential Initiatives, I think that is valuable as well. There are five other potential initiatives listed there which some of them may have address these issues that we're discussing here if we want to turn to that and look at that.
DR. COHN: Suzie your comment here is that these are things that we should be looking at or?
MS. BURKE-BEEBE: I think what you were saying Simon about listing, for instance, WEDI listing white papers that the Board would recommend, the white papers I see it says, I don't know if they're all inclusive but they are within this testimony and in addition to that I saw these Other Potential Initiatives that would be part of this educational component that WEDI has taken on. I just want to offer that there's more testimony from Rob than what he actually gave. The written testimony has some important information in it as well.
DR. COHN: Let me just clarify these Other Potential Initiatives which include review the process by which providers, payers and vendors are communicating their implementation plans, strategies and timelines and agree on best practices. Are these all initiatives that are underway or these issues that you're considering and thinking about doing?
MR. TENNANT: Considering. I think what I've heard from the committee though is that we should go beyond considering them.
DR. COHN: Well, I think certainly the more educational support the better. Roy did you have a comment, question?
DR. RADA: Roy Rada, I wanted to make two comments. We seem to be talking about two kinds of things, one was educational material and the return on investment and the other was all these applications which we've now got in a database. In terms of the first of those two I know Rob was talking about more return on investment analysis. In the transactions rule they had done that, an extensive return on investment analysis. And also this spreadsheet we've talked about, we could go over that today if you wanted, it's very simple.
And I'm not sure, this seems to me to be a different question than looking at this database. And back to the database I had another anecdote I'd like to share with you. At my University we met just about a week ago as we were filling out the application form and we ended up sending in application forms for sports medicine, for student health, for guidance counseling, for one of the research centers, and they all had the same tax payer ID. But we didn't know whether we should be sending them in separately or as one entity and this would be then another kind of hypotheses and I think this will be, many entities will be struggling with this, how they should identify themselves in terms of a single covered, what kind of a hybrid, and you'll be able to tell from this data, you can look for that, it would be another, how are they coming to grips with considering themselves one entity or many separate covered entities in terms of making this application and this would be one example.
I think if we went through other examples of people having submitted these applications we'd get ideas about what were they struggling with, what might we see the patterns, and then we'd have useful advice to turn around and give them based on what happened nationally.
DR. COHN: And indeed we are going to be going through that database and looking for things and thank you for those suggestions. Obviously I think what we've been trying to do is trying to move from there to are there any best practice documents, information or otherwise, recognizing that at least to my view time is relatively of the essence at this point. We're down to less than a year before implementation so if we completely wait for everything to be analyzed, I mean by January people ought to be full scale into implementation and it may be a little late to provide them, at that point you start coming up with educational tools to assist them, at least that's my view. So the question is, are there any we can jump start which is obviously why I'm asking some of you around the table what you might have.
I actually wanted to move even a little bit beyond that and I think Kepa was beginning to sort of move to the next phase of this conversation, which is based on what we've been talking about today, is there anything that as a subcommittee or the full committee that we need to be recommending to the Secretary, begin to mobilize or other, that is sort of beyond just sort of publicizing information or publicizing solutions to compliance problems that comes out of the discussion this morning? Kepa it sounds like you?
DR. ZUBELDIA: Yes, let me throw you something to chew on. WEDI has a lot of white papers and a lot of recommendations for practices, it may be best practices, it may be common practices, whatever, recommendations of things to do. How can we bring some of those to happen? For instance I'm looking at Rob's testimony and WEDI initiatives, the first one that shows up is implementation guide white paper. That's a big issue, which implementation guide to use for which type of service. There are some white papers that have specific recommendations. Would a solution to this be that perhaps CMS implements the WEDI recommendations and leads the industry in that way? Would that be a solution? Are there other solutions? Does there need to be regulation to implement some of these solutions? There's a DDE white paper that has generated a lot of controversy. There is a lot of unsolved problems with direct communication issues and how to transmit this information. Do we need leadership from CMS? Do we need further regulations specifying some of these issues? Do we need to ask the designated standard maintaining organizations to come to a consensus on some of these issues? What are the next steps that you see taking place?
MR. TENNANT: Kepa, I think you're absolutely right. When we talked on the break about a specific implementation guide issue which minutes versus units in anesthesiology and it's a case where it's similar to HIPAA in it's entirety, if the industry can't come up with a consensus than the government needs to step in and make a decision because that's the whole point of standardization. If we can't decide ourselves than the government needs to step in and say it's going to be minutes or units for example. Because the industry needs at some point to bite the bullet and move forward with this. We can't be arguing about everything under the sun because it's just delayed the process and you mentioned the DDE, direct data entry, there's a fine example of a situation where most of the major payers have their own proprietary DDE system and that goes against, it flies in the face of standardization, and there has to be some way to standardize these processes. HIPAA's a good start but the good thing, as Mike said, the good thing is the industry has been asked for it's opinion on these standards compared to the tax system, the bad thing is the industry has been asked for their opinions. And there's no consensus and that's one of the reasons why this has dragged on so I think Kepa your point is valid, at some point we need leadership from the federal government when we can't do it ourselves, and unfortunately we can't. At least at this point. And maybe what we need to do as an industry is at least identify where we need some direction and then that's when the government can step in and say ok, we've reviewed the issue, we've listened to the testimony, and the committee can be the first stage there, ok, here's the recommendation, it's minutes or units. And leave it at that or else we're going to be bogged down for years.
DR. COHN: I for one, and then I'll let Steve and then Suzie comment, would love to see a list from you or others of irreconcilable problems. And I don't for a minute believe that they are irreconcilable but I think at least points to sort of the areas that where so far we have not been able to get consensus. Steve?
DR. STEINDEL: I'd just like to comment on the point of government leadership especially in this specific case. In many cases, and I'm going to speak a little bit out of school because I'm going, and sitting on one of the DSMO's, in many cases the government has taken a position because the Medicare rules are clear. But what we do see is we see disagreement from private industry on the way Medicare wants to do it and that's where the consensus doesn't occur. So there is a government position, the government is showing its interpretation of the way things should be done and industry is not agreeing with that interpretation. I don't have a solution to that problem but in this particular case I don't think government leadership is what is required.
DR. COHN: What is required? Consensus by industry?
DR. STEINDEL: I think there has to be a consensus by industry and a realization of industry that a solution is required. I know one that I like to give as an example and this is one that came up, it's a very real example. But it has to do with the payment for insulin syringes by home health care agencies on whether it should incur on an institutional billing form or on a professional billing form. And I think we're all aware of the controversy of home health care billing and the way it's evolved from an historic point of view and the way it's evolving from a HIPAA payment point of view. And I'm not going to discuss the pros and cons of which solutions it is, all that I'm going to say is if we have to spend that much time discussion the billing of an insulin syringe, we have to take a look and step back and say that there should be better solutions to this problem.
DR. COHN: Ok, Suzie?
MS. BURKE-BEEBE: Stepping back even further than that, Rob, on your written testimony, page five, you refer to the under-served population and you talk about the community health centers, rural health clinics, that traditionally treat the under-served population and their readiness or lack thereof, so rather than the issue of whether it's a professional or institution it seems like there is an issue of whether there is even a guide, a standard. So I'm wondering if your regional efforts have addressed that in any way, possibly if there is any work being done at WEDI on white papers about that. And lastly what can we do, whether it's in our analysis of the data that we've received, hypothesizing something that we could then look into the data? What do you suggest?
MR. TENNANT: Well, first on the CHC's and rural health clinics, again, I pointed those out because I personally have been involved with them over the last few weeks, last few months, in the sense that MGMA has been working with HRSA, Health Resources Services Administration, to provide some outreach to their grantees. And the staggering level of unreadiness in that community is scary because again, they serve a very needy population and again, I'm concerned that there may be some bad outcomes in terms of patient care if these folks don't get funded, don't get the cash flowing in. Only in the last three or four months has HRSA realized that their grantees are under the gun on this and they started to look around to see what they can do and they picked a few nuggets of education to start the process but there are thousands of grantees and their program is only going to reach 300 for the time being and we're less than a year away. I think WEDI has recognized that this is a community that has traditionally not been within the WEDI fold. They don't have money to go to conferences, they don't have money to buy expensive compliance solutions. So we need to be proactive and go to them with some education and some resources. I'm not sure how we can do that but I think it has to be done. There has to be a recognition that everyone is equal under HIPAA but some are more equal than others. The health plans, clearinghouses, we talked them, they're fine for the most part. So we need to focus on the folks that are most in danger and I think CHC's certainly in my mind fall into that category. Again, it has to be driven by resources and WEDI simply does not have the resources to provide free education to five thousand CHC's.
MS. GREENBERG: I just wanted to add to that that at our first privacy hearing we also heard that these organizations are tremendously under resourced and really incapable of even translating the various notices, etc., in the languages of the people that they serve. So the subcommittee might want to think about, I think they were mentioned in the subcommittee's preliminary letter to the Secretary on privacy but I think the combination, and that's only six months away, of the privacy and then these transactions make them very much at risk.
DR. COHN: Marjorie, thank you. Steve?
DR. STEINDEL: Simon if I may add to that, there's an undercurrent of discussion within the public health community about arising HIPAA awareness in some of the programs that we fund may be covered entities or actually are covered entities and then we have not started to become HIPAA compliant. Some of our finance screening programs for instance. We're starting to discuss what to do about it. I know John Lumpkin and I spoke about it at the last NCVHS meeting a little bit.
DR. COHN: So I'm sort of hearing sort of a general call that there are certain groups that are particularly at risk, that need to have focused attention. Mike?
DR. FITZMAURICE: I would focus a little bit of mention on the need for this new office in CMS to have the additional resources that it needs to address these problems as they occur. To be able work even more closely with the industry and to discuss the solutions that CMS has found for the Medicare program with those who are still looking for solutions in the private sector. It's education, it's outreach, and it's being open about processes.
MR. BLAIR: You refer to this new office in CMS, what is this new office?
DR. COHN: That was what Karen briefed us about, the new HIPAA office.
MR. BLAIR: Is there a title for the office?
MS. TRUDEL: Not yet.
DR. ZUBELDIA: Is there a budget for the office?
MS. TRUDEL: It only happened last week.
DR. COHN: Marjorie?
MS. GREENBERG: It's probably recognized, but with the community health centers, the rural health clinics, etc., education, yes they need that, but really that is only part of what they need. Because once they realize what they have to do, they really don't have the resources to do it as far as, at least from what I've heard. So although ignorance may be bliss, but once they get the awareness, they just don't have the resources. I'm glad to hear that there has been some awareness of this now by their funders but I don't think anyone has really grappled with how do we solve it.
MR. TENNANT: Perhaps we can give them Simon's free software.
[Laughter.]
DR. COHN: I'm going to sort of begin to wrap this up just because it is time for us to break for lunch. I guess what I'm sort of hearing and let me just ask the subcommittee members if this strikes a tune or synthetic note anyway. I'm sort of hearing that a, we probably need to send, I'm not hearing any grave issues that necessarily came out of the hearings today but I do think that a, we need to send a letter to the Secretary, produce a letter that first of all congratulates them on the consolidation of their efforts into a single CMS office, maybe indicates that there needs to be funding that goes along with that activity, given that we're down to the last year before implementation. Also points out that there needs to be special attention and focus to, and I'm hearing at least two, one is obviously the rural health care providers and the community health clinics and this issue that HHS also needs to look inward through it's public health entities and others to make sure that everyone is moving forward to being HIPAA compliant.
There may be some other things that go into this letter, but that's sort of what I'm hearing, that we maybe need to be producing, I see this as sort of a short, couple of paragraph letter, probably we could also, I'm sure we could borrow a paragraph from previous letters where we say geez, wouldn't it be nice to have the final regs out, I think that might be a cut and paste, last updated whenever. Mike?
DR. FITZMAURICE: We might think about something, Rob mentioned the minutes versus the units for anesthesiologists, a place to get those resolved. Maybe looking at existing processes and seeing if something can be done to speed up existing processes.
DR. COHN: I'm going to hold that one for December only because I want to, I heard that, and I want the list from WEDI and others that have the list of irreconcilables so far, differences. We're going to have the DSMO's come in December to sort of talk about their processes, their results from this year and recommendations and I thought it was an occasion for us to talk a little bit with them and other entities about how we can improve the processes, streamline the processes, where appropriate. And probably part of that discussion is how in the heck we get sort of issues that don't seem to have any solution resolved or provide leadership to help that happen. So that's sort of part of that December conversation and I see other people sort of nodding their heads, this seems like a reasonable conversation to have.
DR. FITZMAURICE: You might mention that we will be looking at this in the December hearings. Foreshadow.
DR. COHN: Foreshadow, that's right. Ok, well it is now 12:30, which is the time that we had said we were going to break. We will take an hour break and reconvene at 1:30.
[Whereupon, at 12:32 p.m., the meeting was recessed, to reconvene at 1:55 p.m., the same afternoon, October 22, 2002.]
A F T E R N O O N S E S S I O N [1:55 p.m.]
Agenda Item: Prep for ICD-10 Presentation for Full Committee in November - Subcommittee
DR. COHN: The topic for this afternoon is related to sort of next steps related to our discussions on ICD-10. As we know this has not been the easiest conversation we've had in the subcommittee's history, but I want to focus the committee on a couple of different things we need to do over the next hour and roughly 45 minutes.
First of all, I think we need to look at a proposal for a cost benefit analysis that subcommittee staff and HHS has prepared on our behalf to see what our thoughts are in relationship to it and whether there should be any modifications or changes to the proposal. And that's issue number one, I think we need to spend enough time that we're comfortable with this.
Then based I think on our view about the project we at that point need to talk about both back-up material or background material that we are preparing for the full committee for discussion in November as well as I think what we think are really the key issues that we need to try explain to the full committee, has sort of kept us in the midst of, kept us from achieving consensus on this topic. It seems to me that this makes sense in terms of handling them in this fashion only because I think that the cost benefit piece is a key piece of the second conversation.
I guess I should ask, have people seen this proposal, is this something that I should read to everyone? Donna, are you on the phone at this point?
MS. PICKETT: Yes I am.
DR. COHN: Ok, is Dr. McDonald also on the phone?
DR. MCDONALD: Yes I am.
DR. COHN: Ok. Now I think you both have copies of the project proposal. Let me just read it for those who are on the internet, and also in the room who don't have copies of it. Once again, I think our view is to sort of try to see if this indeed reflects I think what we think needs to be done, what changes need to occur. I would expect that if indeed we decide to go forward, we will probably also want to discuss this at further length with the full committee to see if they have any further ideas or suggestions about it, but of course we can decide that at the end. Marjorie?
MS. GREENBERG: I hope that doesn't mean that you feel you'd have to wait until the full committee meeting.
DR. COHN: Did everybody hear that? There was a question about whether we would need to wait for agreement until the full committee meeting. Why don't we decide that based on what we think of the proposal and what sort of suggested changes? If we're all in agreement we could probably could go forward. Marjorie?
MS. GREENBERG: Let me just say concerning the proposal that following the last meeting, the last full committee meeting, I suggested, although I think I had actually suggested it earlier than that as well, since it was a lot of discussion of the need for a cost benefit analysis, that the national committee or the subcommittee could sponsor such an analysis sort of as a neutral party. I had some preliminary discussion with Bill Yasnoff, then both Donna and I have been out of the country for the last two weeks and just returned so I really appreciate that Bill started to take this forward. But what we have here is just a page, it's very preliminary, I think, although I think it's a skeleton for what is needed but I just wanted to people to realize that that's sort of the context and that Bill was in the position of just sort of getting this started in our absence. So we certainly would welcome input.
DR. COHN: Ok, and obviously we're sorry that Dr. Yasnoff is not here today, we understand he is on jury duty, is that correct?
MR. SCANLON: That's right Simon, he actually got selected for a jury so it was one day, one trial, and he got the one trial. I think he'll be back up here in Washington on Friday. But let me add one more thing. I think this idea of an impact study was developed for some reason in the context of RAND doing it but RAND is just one, we have access to a number of contractors, you don't have to, the contractor doesn't have to be part of the decision making today or in the next few, I think almost any, if you could decide on what the tasks are, what the outcome is, what the objective is, then we could find a number of suitable ways to get it done. But RAND is a possibility, we have access to RAND.
DR. COHN: Ok, I think with that it makes sense to sort of go through it and I think really the question for the subcommittee is does this represent all of our thoughts about what ought to be done, are there things missing, are there things that should have greater emphasis knowing that it sounds like based on what Marjorie Greenberg was saying that this will be further fleshed out over the next subsequent weeks assuming we think that it makes sense to move forward. So, let me read this and then as I said we can sort of discuss at the conclusion since it's only a four paragraphs long.
This is entitled Mandating a Switch from ICD-9 to ICD-10 Codes: Costs and Benefits Project Proposal.
In the United States, the five-digit ICD codes constitute the numeric heart of the health care information system. Every billable claim or invoice made is keyed to a service encoded in its format. The universal use of such codes also permits analysis of public health and of medical procedures. ICD-9-CM and ICD-10-CM are international standard for disease classification. ICD-9, volume 3, and ICD-10-PCS are procedure coding systems developed by CMS; while the latter two are not international standards, they follow the format of ICD-9 and ICD-10 respectively. ICD-10-CM is designed for diagnosis coding, while ICD-10-PCS is designed for procedure coding.
MS. GREENBERG: I might just interject one other thing here. And that is that I believe this, what you're reading here, was actually prepared by one of the potential contractors and of course it is not true that ICD-10-PCS follows the format of ICD-10.
DR. MCDONALD: That takes us a long way from it.
MS. GREENBERG: First of all ICD-10 is a diagnosis classification and it's really not true, that whole sentence is untrue because ICD-9 and ICD-10 are diagnosis classifications so procedure classification is unable to follow them. I think ICD-9, volume 3, may follow a previous version of an international classification of procedures, which is no longer in use, ICD-10-PCS doesn't have a direct relationship to ICD-10. There is no procedure classification associated with ICD-10. So I think that, you have to understand that this was actually not written by us.
DR. COHN: Correct, and as I'm reading through this I like you I did notice some issues related to the text. Obviously this stuff will be cleaned up as we move forward. I think, obviously, we need to focus more on what the work products are going to be rather than some of this background material. But having said that, however, let me read the next couple of paragraphs, recognizing that not necessarily everything here is exactly correct.
Over the last twenty years, as medical knowledge and technology have grown more sophisticated, the limitations of the ICD-9 system have gained attention. The categories of ICD-9 are often perceived as too broad, including many different procedures and conditions into one category. This frustrates analysis as well as precise billing. In 1992 the international community under WHO auspices published ICD-9's successor, ICD-10.
The United States, however, has not yet adopted ICD-10, except for the, what it says is, is for the public health community, but really what we mean is mortality.
MS. GREENBERG: What they mean is mortality, yes.
DR. COHN: Specifically, should the HIPAA standard for disease coding be changed from ICD-9-CM to ICD-10-CM, thereby mandating the use of ICD-10-CM for all claims reimbursements? The advantage of doing so can be measured in terms of more precise billing, better analysis, and data comparability with the rest of the world. But thee are also costs: e.g., reprogramming claims processing systems, and retraining people in their use. A further question is whether procedure coding with ICD-9, volume 3, should be changed to ICD-10-PCS.
MS. GREENBERG: A contractor.
DR. COHN: A contractor, yes, will make a first order analysis of the categories and magnitudes of these costs and benefits. The first subtask will be to assess the full range of implications from a mandated switch. The second will be to categorize costs and benefits. The third would be to generate a first-order estimate of such costs and benefits. The experience of Canada, with due regard for the unique features of its national health system, will be used as a foundation for some of the estimates.
Two further assumptions will guide this analysis: (1) there is no confusion about the timing of the mandate, e.g., that would arise from a legal challenge, and (2) that, at some point, say ten years hence, a successor to ICD-10 will be developed.
The last paragraph I sort of wonder about but, comments, questions, suggestions for improvement?
MR. BLAIR: You mean just so far, there's still more to it, especially when it gets down to the estimate and the timeframe. There's another paragraph I think isn't there?
DR. COHN: No.
MR. BLAIR: I thought there was a reference about $100,000 estimate.
DR. COHN: That happens to be a particular vendor consultant that made that estimate. I think all of our intent is that if this were to go forward we would like to have it done by late spring.
MS. GREENBERG: Actually, when I last spoke, when I spoke to Bill before I left, my hope was that we could actually have a preliminary analysis by the February national committee meeting. I think what needs to be discussed is if you do want us to go ahead with an impact analysis, what the implications of that are. One, my feeling is that something like this has to be done for an NPRM in any event and that one would like the impact analysis to be as robust as possible, which would be facilitated by having an outside contractor address both costs and benefits. There are requests on the floor from various parties that the committee not make any decisions until such an analysis is completed. I think how swiftly one wants to get this done, but still done well, is related to what the subcommittee's view is on whether all the recommendations will be on hold until this is completed. Because if that were the case and this were not completed until May, then we would delay by an entire year making a recommendation that the subcommittee was prepared to make in June 2002, initially was prepared to make in June 2002. On the other hand, another view is that this is necessary to do and this will definitely strengthen the impact analysis and the NPRM but one doesn't have to, the committee or the subcommittee would not need to wait for the final results of this in order to recommend going ahead with an NPRM.
DR. COHN: Comments? Thoughts? I think we should sort of comment at least, this proposed timing which I did not read, described a preliminary briefing of findings by hopefully the February meeting so at least the full committee would have a chance to get acquainted with all of this. I think we also, in recognizing that this doesn't fully meet all of the needs I think the industry had identified in some of their letters, is they wanted to be an actual part of all of this, but it does at least give everybody the opportunity to see early on what the findings are, we would obviously have then probably interviewed as part of the process to identify their ideas about costs and benefits and we of course also express I think open willingness to be in receipt of any additional cost benefit studies that might be developed by industry that hopefully would be done in the same timeframe. Is this also what you were thinking of Marjorie?
MS. GREENBERG: Yes.
MR. SCANLON: Simon, I guess the other thing is what you could, you could develop tasks so that you benefit from early completed tasks. For example, you could ask the contractor to get hold of any existing literature or other studies on similar experiences and that sort of thing and then you have to lay out a set of steps or requirements for the contractor to carry through. Again, you don't want, this is to some extent a chess game, you don't want to put yourself in the position of, once you've sort of set out the expectation for a comprehensive impact analysis, you may in fact preempt other recommendations until that's finished.
DR. COHN: Yes Clem. First of all Clem are you able to hear everybody's comments?
DR. MCDONALD: I think so, the machine, the sound processing seems to shut down to silence between speaking, assuming that I am correct on that, then I'm not missing anything. I had a question and a comment. In terms of the specific proposal I'm just a little nervous about the total lack of awareness in the specific document of ICD and PCS and how it differs and the assumption I think implicit in that, that their experience of ICD-10 in Canada would be sufficient to tell them about ICD-10-PCS so I'm just a little nervous. Now the second part, the question is what's the usual way that we would obtain or seek out a contractor to do this? Is there a standard process?
DR. COHN: Why don't we let Jim?
MR. SCANLON: If a federal agency were doing this, and in essence a federal agency is doing this, we would, there are a couple ways. We have access to, within HHS, a stable of about a dozen or so contractors that we have already, our contracts office has already pre-qualified to do this kind of policy analysis, evaluation and cost estimation and so on. One way to do this, and this is usually the quicker way, would be to choose one of them and then we could issue the task to them. It would have to be a fairly full-blown task so they, we knew what we wanted and they knew what they had to do with the timeframe.
The other way would be to do it on a full competition basis where you just announce it as you would any other contractor procurement and you have everyone apply. That adds at least 90 or 120 days to the process.
MS. GREENBERG: Six months at least.
MR. SCANLON: You probably couldn't do it in six months. A task order can be done, the first method I was speaking of, depending on the scope and requirements, it can be awarded, let me put it this way, it can be awarded within 30 days, 60 days, something like that.
DR. MCDONALD: Well would we ordinarily have anything to do, we aren't making any decisions about this particular submission then at this time, correct?
MS. GREENBERG: What did you say Clem?
DR. MCDONALD: Well, we're discussing one potential contractor, is this moot in the sense that the process would have to be done in a standard way anyway?
MR. SCANLON: You shouldn't worry about an individual contractor at this point.
MS. GREENBERG: That's why I was a little reluctant to even have this read, but that's ok. I think really the idea is, would you like to have something like this done? And then what do you want it to do? And then we go about finding someone who can do it. I really wouldn't worry about this particular description of the task because you're right, it's very skimpy on 10-PCS.
I would say, though, that I think as we envision this, I'm just trying really to put the cards on the table so that we know what we might be talking about and what we wouldn't be talking about, the discussion would be and the analysis would be a cost and benefits impact, etc., of moving from 9-CM, volumes 1, 2, and 3, to 10-CM and 10-PCS. It would not include looking at other classifications as alternatives. I think that would, beyond those that I mentioned, I think that would be out of scope as we envision this.
DR. COHN: Kepa then Jeff.
DR. ZUBELDIA: Marjorie, who would put together the project proposal? Would it be something like this or you would do something from scratch?
MS. GREENBERG: It would be more, I mean you have to have some background, so there would be background, a little more than this, and accurate, and then you would have a description of the tasks. That's even something I think we could share with them, without the costs, we wouldn't get into the cost estimates with you all.
MS. SCANLON: If the subcommittee could agree on what you want the tasks to be and the deliverables and then.
MS. GREENBERG: I think the actual scope of the activity is something that we could prepare and get feedback from you on.
DR. ZUBELDIA: That's where I'm going because the results of the project will be directly proportional to the quality of what we ask them to do, the quality of the proposal.
MS. GREENBERG: And that, obviously we have to be a lot more specific than this. I would envision various scenarios possibly as part of the, about the costs and the benefits side, and as you said, Simon, it would include interviewing people, not probably a standard interviewing protocol, because that would also put us into a clearance process that could delay this for a few years. But something that is, I wouldn't worry about what you've got here at all, I would just think about the tasks and what you feel would need to get done.
DR. STEINDEL: This is specific to the procedures that Marjorie is talking about. Do you envision, one of Clem's big questions has been the actual costs that it would be for an institution to code in the new systems. I'm wondering if Clem would accept the literature on the coding costs or do you envision as part of the task or to determining those coding costs?
DR. MCDONALD: There's three possibilities. I don't think there's any data in the literature about it but at the very least whatever data is available could be critiqued as to it's representativeness and whether it's sufficient to give air estimates on it because I think there are some numbers, I never have been able to get at them. I don't know what's possible, it would be wonderful if one could do a sample, to say if this organization could do a sample and do some time motion, it would just probably take a couple days or maybe a week, so that would be my preferred but in terms of the time costs, compared one with the other, but I don't know if that's feasible.
MR. SCANLON: Marjorie was shaking her head.
MS. GREENBERG: I think the intent would be to gather all the information from all the testing that has been done so far. I mean one option I guess is that at the end of the day we might say there hasn't been, we couldn't find enough to answer that question, the intent of this was not to include any of the actual coding, testing of code sets as part of this contract. Among other things. I think probably whoever we get to do this wouldn't be the appropriate people to do that anyway.
DR. MCDONALD: I guess I would like to make sure that they would comment on the adequacy of the existing data and the sample size.
DR. COHN: You mean of work that's already been done?
DR. MCDONALD: Yes, there may be more than I have been able to see but I stated my criticisms earlier so I don't need to repeat that.
MR. SCANLON: There are actuarial approaches to estimate these and people do this all the time. But obviously you get better estimates when you have some actual empirical data to base it on. Otherwise you're basically going to try to simulate, well what would the steps be, what would every step be, who would it affect, what would be the cost to complete that step, and what are the benefits to that versus alternatives, and then you sort of, actuaries do this all the time. The thing is if it's largely assumptions we're dealing with then that's not the same as having empirical information. But there are ways to build this into a, there are ways to build this into a fairly thorough study, but it will take time. And I wouldn't estimate on the low side, the more tasks you give, the more analysis and even testing you write in. It takes time to do this if you want a credible study.
DR. ZUBELDIA: Did I hear Marjorie say there would be no alternatives?
MS. GREENBERG: The plan for this study would not look at alternatives to, well there really is no alternative to 10-CM except to stay with 9-CM and diagnosis, and it would not look at alternatives to 10-PCS.
DR. COHN: Jeff?
MR. BLAIR: Just from a procedural standpoint, I think it would frustrate me if we wind up coming up or asking somebody to come up with a list of questions, the methodologies, to get the answers to those questions, the sample sizes, and then we wind up coming together in a meeting and those failed to address all the questions, methods and sample sizes that Clem is envisioning. So my thought would be the most expeditious thing for us to go forward, Clem would you be willing to set forth an initial list of the questions that need to be answered, the methods that you would suggest we use to answer those questions and the sample sizes which would give you a level of comfort?
DR. MCDONALD: Let me clarify a few things. I would be willing to make some suggestions but I don't think it should be a solo task if I do. But I wasn't suggesting that I specify a sample size, I was only suggesting if the reviewer looks at available data they would comment specifically on the sample size as its adequacy for giving confident answers, not that they specify a sample size.
MR. BLAIR: Well, the overall quality of the study.
DR. MCDONALD: The numbers I see is like 50 to 100 and I think that maybe they think that's fine, maybe it is if we saw the detailed data.
DR. COHN: I think that whatever we're expecting from them should hopefully have enough specificity that we can identify how whatever conclusions were made were made which I think is what you're asking for Clem and I absolutely agree. I think the other piece that Jeff commented which is probably right is that we need, even if we decide today that we want to go forward with this stuff, these questions, I think as this gets drilled down, we need to probably take a look, and this could be handled via email to make sure that the specific questions to get addressed really do meet all of our needs and that there isn't an obvious question that has not, is not being asked that somehow will affect our ability to draw a conclusion from the study. And Clem I presume that you would agree with that?
DR. MCDONALD: I'm sorry I didn't hear that. Was that addressed to me?
DR. COHN: Well, I think you probably agree, hopefully Jeff does also.
DR. MCDONALD: I heard what you said Simon, I thought I heard something else.
DR. COHN: No, we actually paused to let you respond.
DR. MCDONALD: I think what you said is reasonable.
DR. COHN: And Jeff, you're ok with that also?
MR. BLAIR: My only suggestion was I thought, at least, maybe there's something that I'm missing where Clem has already set forth the questions and methods he feels need to be addressed. I just didn't want to see us lose more time by having somebody do that and then submit it to Clem and then only finding out that some of these things had been missed, so I thought maybe if Clem had the first cut.
DR. COHN: I think we all have the first cut.
MR. SCANLON: Do you want to send comments back to Bill then?
MS. GREENBERG: I wouldn't start with this frankly, I wouldn't comment on this. I think what we need to, and I don't think Bill wrote this either, and I'm appreciative to Bill, very appreciative because I was out of the country and I wanted something to bring to you all. I think from both what I've heard from Bill and what I've heard from Jim in light of the task order, which we have actually used for a number of things and is a very good resource, that we have the capacity to go forward in a fairly timely way, what we need to do is develop a scope of work of more specificity, considerably more specificity than we have here, with not only the background but actual tasks and then get input from you all and try to move this ahead expeditiously. First we need to know if you want us to do that and if so, we will do our best to move it along.
The other thing is I don't think that precludes discussing how you want to deal with the presentation in November because I had certainly hoped at least that in doing this we didn't just put everything on hold.
DR. COHN: Ok, well let's deal with issue one first, and then we'll deal with issue two. Number one is, are we comfortable with this direction? And once again, unless this thing starts moving a lot more expeditiously than it has so far, I suspect we may actually have a final chance to look at it in November, only in the sense that it's --.
MS. GREENBERG: It's only three weeks.
DR. COHN: That's right, it's not very long and it's taken a long time to get to where we are now. So, but having said that, are we generally in support of, Steve do you have a comment?
DR. STEINDEL: I just have a couple of questions on this and this is to our historians Jim and Marjorie. Has the NCVHS ever done something like this before?
MS. GREENBERG: Well, they've done contracts, assessments, evaluations, various studies.
DR. STEINDEL: In this type of scope.
MS. GREENBERG: It's not out of --.
DR. STEINDEL: I just wanted to make sure we weren't setting precedent. Then I'm in favor of it.
MR. SCANLON: It basically falls into the evaluation category.
DR. COHN: Well, how do others on the subcommittee feel? Is this a reasonable approach as a next step item?
Mr. AUGUSTINE: Yes.
DR. COHN: Ok, Kepa?
DR. ZUBELDIA: I would like to include in the proposal maybe a request to take a look at other cost benefits analysis that may have been done or may be underway by private industry. It has to be an independent cost benefit analysis but maybe they can take a look at what methodologies other people are using and what populations they are looking at and what are the cost items and the benefit items and so on and use whatever can be re-used from private industry.
MS. GREENBERG: You mean on this topic?
DR. ZUBELDIA: On our topic.
MS. GREENBERG: Obviously to the extent that there are such analyses that have been done, they should draw on them.
DR. COHN: Kepa, my concern here is that in our testimony, unless something that has been done in the last three months, I have not, we have not heard any testimony by anyone who has done a cost benefit analysis on this. At least to my knowledge during the hearings. So I would imagine, and once again let me just tell you what I'm thinking about, is we just have to go forward with this, maybe there is a letter that goes to the Secretary in November indicating that we're doing this one, calling upon private industry, that if they have interest in doing this to either contact the contractor who's doing this to provide input or do their own and submit their cost benefits study also to the national committee so we can review it.
DR. ZUBELDIA: That's exactly what I challenge the Blue Cross Blue Shield Association to do back in August.
MS. GREENBERG: What?
DR. ZUBELDIA: To do their own cost benefit analysis and bring it forward. I challenged them to do that back in August and maybe they've done something, I don't know.
MS. GREENBERG: I would say that no other country in the world found it necessary to do a cost benefit analysis before moving from 9 to 10, so we don't have any international, we have international experience of implementing 10 and a new procedure classification as well, but no international cost benefit analyses. They just felt it was the right thing to do.
MR. SCANLON: We’re going to have, if worrying about doing regulations, we really don’t have an option, regardless of what the rest of the world has done.
MS. GREENBERG: I'm not saying we shouldn't do it but I'm just saying that there isn't that experience.
DR. COHN: Marjorie, I do understand what you say and I guess I'm, we're sort of in an interesting position that we're one of the few countries that has not implemented ICD-10 so far, so clearly that level of reasoning has not been sufficient to implement ICD-10 and indeed when I'm in my own company, and even though we always try to do the right thing, I do want to reflect that when I go to my bosses and put down a tab for a multi-million dollar plus effort, maybe more than that obviously country-wide, and if they ask me why and I'd say because it's the right thing to do, the likelihood of getting that funded in that cycle would not be great and obviously what we're trying to do is try to identify the business case here.
MS. GREENBERG: And that's why I've recommended this.
DR. COHN: Yes, exactly, and we want to thank you for your help on this.
MS. GREENBERG: I just wanted to share that with you.
DR. COHN: Well, thank you, and I've wanted to share my comment with you also. So anyway, I guess, to me one of the issues is if we're going to do this one, let's also create a letter to the Secretary, both saying that we've had the testimony are planning on this, also sort of publicizing it, calling upon industry if they have cost benefit studies that they are undertaking or otherwise to submit it either to contractor review or to the NCVHS as part of their deliberations. And obviously if this moves along as hoped we'll have a chance to look at preliminary data in February, final data in May, we should make sure that we have sufficient time on the full committee's agendas for us to review all of this. Steve you're looking at?
DR. STEINDEL: I'm wondering if it's really necessary to write a letter to the Secretary at this time. It would be better I think after we do the cost benefit analysis and we have some specific things we're going to tell the Secretary. I think right now just writing a letter and saying we've looked at it and we decided we have to look at it some more and we're doing a cost benefit analysis, that's something to report to the full committee.
DR. COHN: Marjorie, then Michael.
MS. GREENBERG: Well, I think the only reason to write the Secretary would be if after the discussion in November you had something more to say to the Secretary than this. I still maintain and it's for your consideration, that one position that could come out of the discussion in November is that the Department should proceed with development of an NPRM because it takes a while to do this, but that meanwhile this project is going on and this will feed into the final NPRM, the expectation is that it would feed into the final NPRM. If there is no recommendation to even start the NPRM process, nothing will happen, nothing will happen. And also the industry will I think get the message that it could be years before an NPRM even surfaces. So although this is your decision, the committee's decision, my recommendation to do this was not to cause as I said a delay of at least a year before the national committee even recommends moving ahead with preparation of an NPRM.
DR. COHN: Ok, Michael?
DR. FITZMAURICE: My thoughts run somewhat along the same line but I wouldn't want us to rule out sending a letter to the Secretary that encourages an NPRM if that's what the committee thought. That's one way to alert the industry that here is what could be coming down the road, here's the Department's best plan for bringing it down the road, and to get their comments on it. If done simultaneous with a benefit cost analysis there could be a lot of information for the Secretary to make a decision after the comments have come in on the NPRM.
MS. GREENBERG: Realistically there would be no way to release an NPRM I don't think before May anyway but you would have, you could get some work going on it.
MR. AUGUSTINE: I agree with Michael on that.
DR. COHN: And Michael's approach was what? He seemed to agree with Marjorie basically.
DR. MCDONALD: Simon, I'm having trouble picking up the drift of the direction. Are we saying we shouldn't do it or we should do it?
DR. COHN: Well what we've done is we've started with the cost benefit proposal and I think that we're, what I'm hearing is general agreement around the room that we ought to proceed with a cost benefit. Now the conversation has sort of suddenly shifted to what it is that we might be recommending in November and we've heard comments from both Marjorie and Michael with Brady supporting that position that we might as an option want to recommend that we move forward even while we're doing the cost benefit, that we recommend the Secretary begin the regulatory process by developing an NPRM. And that's what I think people are sort of mulling back and forth about, or at least we were just beginning to discuss.
Now, I'm trying to think of, Steve you have a comment.
DR. STEINDEL: I think the word that's scaring a lot of people is starting to developing the regulatory process. We might want to use a little bit more neutral word, like the regulatory document because we really won't, we've got to take another step to move it into the regulatory process. Our recommendation from what I'm hearing Marjorie saying right now is simultaneous with the development of the cost benefit analysis is to recommend that the Department start working on the regulatory language that would appear in an NPRM if we choose to go forward with one. So that there would be a second step to go forward with.
MS. GREENBERG: Another aspect of that is you really want the Department to start working on it's own impact analysis, too, because no matter what we have this contractor do, they're not going to do an in-depth obviously analysis of say what the costs and benefits are in Medicare. This is going to be at a broader level. So I think all of this, my sense is, could be going on concurrently. Obviously the contractor would talk to CMS and get input from them but we want them to talk more broadly than that. So I think this is meant to supplement whatever the Department would be doing also. And this just, there's a lot that has to be done to develop an NPRM.
DR. STEINDEL: There's one thing that does concern me about that approach. And that is the possibility, as remote it might be, that our NPRM and the Department's NPRM could conflict with each other.
MS. GREENBERG: That what?
DR. STEINDEL: They could conflict. Excuse me, I meant the cost benefit analysis.
MS. GREENBERG: Well, it might.
DR. STEINDEL: That's the only thing that concerns me there.
MS. GREENBERG: But generally these are all, I wouldn't say guesstimates but I mean you're not, we can't actually do a case control study where part of us implement and part of us don't. There's always going to be a range of costs and benefits.
DR. COHN: Jeff and then Jim.
MR. BLAIR: I lean on the side of having the NCVHS write a recommendation letter indicating that we recommend that a Notice of Proposed Rule Making, that process be initiated for a Notice of Proposed Rule Making in parallel with the cost benefit study. But when I come to that inclination, there's an assumption that's underlying it that we may need to check. And the assumption that I have is that when that cost benefit analysis comes through that it may identify some difficulties or problems but that it, my expectation is that it's not going to wind up saying that we shouldn't, it's not going to lead us to the conclusion that we shouldn't go forward.
But what I'm concerned about is that may wind up saying that if CMS does, I shouldn't say CMS, HHS does not commit to providing migration tools, implementation tools, education, to facilitate the industry in moving to ICD-10-CM and PCS then we may wind up with many of the same difficulties that we're facing with the HIPAA financial administrative transactions. So my question is, in this cost benefit study, are we going to also ask for recommendations for what implementation tools, what education, what types of things will mitigate the costs that they are identifying in this cost benefit study?
MS. GREENBERG: I think you have to include some of that, yes.
MR. BLAIR: I think we need to add that to that, so we don't just stop with identification of the costs, we wind up asking for recommendations on how to mitigate the costs.
MS. GREENBERG: And I would have to say that those who are anticipating implementation have certainly, are thinking about this and if they aren't they shouldn't be anticipating it. The contractor won't have to make this up out of whole cloth but we'll find out.
MR. BLAIR: The key thing is that since we're expecting the cost benefit study to be completed before the Notice of Proposed Rule Making is complete, then those recommendations should be reflected in the Notice of Proposed Rule Making.
DR. COHN: Jim do you want to go first? I'm sorry.
MR. SCANLON: Well, just again, to place this all in perspective because I think the Department would be looking at you to place this all in perspective, too, you have to think of all of the other things that are going on, including HIPAA and its implementation, during the same time span you're considering, all of the other demands on providers and plans and the Department as well and I think you owe it to everyone to kind of put everything in a perspective where you don't suddenly pull one more regulatory action.
The other thing is it's a very serious decision on the part of any Department to decide to pursue a regulatory solution absent a statutory kind of a mandate like with HIPAA. So again, you really need a lot of thought about alternatives, I mean the Department will at any rate, costs, and what else is going on before pursuing and again, I guess my major point is that you're suggesting an NPRM may or may not, in parallel with the cost study, may or may not be enough for the Department to do anything. I think all things will have to be taken into consideration.
The other thing is there's no such thing as the impact study. Those that want to do this will have their impact studies and those that don't want to do it will have theirs as well, it's kind of a body of knowledge, this is quite common in actuarial work and research and in this kind of work as well. So I guess the thing is, in your whatever recommendations you make, I don't know, if you feel that there's great pressure to move to an NPRM, you're hearing it somewhere, you should state that, because it ultimately will have to compete for all the other requirements on providers and plans, as well the same resources that Jeff is talking about that would go into HIPAA implementation or other standards implementation. These are the same providers that you're talking about. In a way you might want to have to step back and look at an overall timing issue and an impact issue in a broader sense. Focusing only on the ICD migration, I don't think it can be done in isolation, let me put it that way.
DR. COHN: Ok. Jim you made a comment earlier about, again, I'm hearing sort of multiple things from you and I just want to make sure I understand. It sounds like you're suggesting some caution in terms of how much we recommend happening at the same time, is that? Or we need to be sure of the priority of the issue?
MR. SCANLON: I don't understand the rush for an NPRM, to recommend an NPRM, I guess is my own issue. If you're hearing from the industry that, it's one thing to do pre-regulatory information gathering and if this is up to the full committee I think, are you convinced or is there some great pressure that you feel you have to propose, I think what you're saying is ultimately we want to move towards adopting the ICD-10 in the United States and it most logically involves an NPRM, but again, we're saying we don't have enough information, we're finding a division in the industry, we don't have a lot of information to estimate what the costs or even the steps might be. I just wonder if a stage approach makes a little more sense. Suggesting we do an NPRM while we're collecting the information we need to do an NPRM, that's my only worry.
DR. COHN: So you're basically wondering whether we ought to do the cost benefit and that be the next step and then recommendations around an NPRM after that.
MR. SCANLON: Yes, the logic of regulatory development would sort of suggest that step. Now again, you may have other, there may be other demands, you look at alternatives, you estimate the costs on the impact, you look at what is to be achieved, doing it in parallel, unless there's some other circumstances, would be somewhat unusual.
DR. COHN: Marjorie.
MS. GREENBERG: Obviously Jim and I haven't coordinated on this because I take an exception to what he said. I think what we haven't discussed is these other documents that we provided to you and that need to be obviously brought before the committee in November which not only reveal the lack of agreement in the industry but also we document I think through several hearings the fact that the systems currently in use are broken. And are not getting any better, they're only getting worse. That's the only reason to think in terms of any type of expeditious behavior because if what we had now was perfectly suitable and acceptable then we could talk about doing this in ten years but I think the committee and the subcommittee heard over a period of several hearings that the current situation is bad and is deteriorating.
DR. COHN: Marjorie, I certainly do hear what you're saying and I, as I remember and once again hopefully had the same understanding, when we brought this to the committee previously and recognized that there was a tremendous amount of controversy and I'm not even sure if there was a common understanding about a lot of these issues. I think that one of the issues we probably need to flesh out for the full committee is really, and I think that there are two sides to this that we've just heard. We could have you and Jim up there debating in front of the full committee representing the issues.
MR. SCANLON: And I don't even know anything.
DR. COHN: That's right. And Jim certainly doesn't want to be against you on this in this debate, but I think certainly one of the issues that probably deserve some further understanding by the full committee is a case for and against there being so much pressure that we can't do a cost benefit before we do an NPRM. I mean that's, I think that's a very legitimate question to probably explore with the full committee.
MS. GREENBERG: Well, you're not going to publish an NPRM without it including an impact analysis which is another way of saying a cost benefit study. So nobody is recommending that, I certainly wasn't recommending publishing one without including that.
DR. FITZMAURICE: Simon, I think what I was urging that the committee consider that in putting together an NPRM you then put the Department's cards on the table. You say well, how would you go about implementing this? And that's an important consideration for the decision of whether you actually go ahead and issue the NPRM and you get those comments back. I would do that at the same time the study was being initiated. So if it's at the end of a certain time we have more information than if you strung it out over three or four years.
DR. COHN: Kepa, I'm sorry.
DR. ZUBELDIA: That goes along with the concern that I have and I'd like Marjorie maybe to educate me on this. Because you mentioned that the cost benefit analysis would be more global and it would not include the impact on Medicare and I think it should include the impact on Medicare. You also mentioned that it would not look at potential alternatives such as switching, instead of the ICD-10-PCS using something else, another coding system, I think that should also be part of the cost benefit analysis. If we're going to look at the entire impact, we need to look at alternatives, and we need to look at the entire impact including the impact on Medicare so help me understand why would it have such restrictions.
MS. GREENBERG: It would look, of course it would have to look at the impact on Medicare and all of the payers but I was just saying that I thought, this doesn't, shouldn't completely get the Department off the hook from doing the work that it has to do to create the NPRM. Because I think just as your asking the industry to contribute to this, the Department has to as well for its own programs. So I wouldn't want the impression left that Medicare, Medicaid, whatever, don't have to look at the impact and just wait and see what this study comes out with.
So I don't think we're really talking about anything different I was just saying that I thought that this would benefit, it would send a message that this needs to be done by all parties looking at the benefits as well as the cost.
On the other subject, I think that is a different study and it's not one specifically if you're talking about CPT versus 10-PCS for the in-patient environment. It's not one that I'm proposing that we do here and I also think that you're not talking about a cost benefit analysis there if the proposal that CPT be used in the in-patient environment is not one that the people who would have to use it could support. You have heard from, you have to remember, the people who have said they are interested, the people who have signed letters, etc., saying they are interested, they would like CPT be used in the in-patient environment, are people who do not report procedures in the in-patient environment, they only report procedures in the out-patient environment so they are not actually stakeholders in the sense that they do not use 9-CM, volume 3, and they would not use 10-PCS. The people who would use 10-PCS, which is, that's the one recommending the CPT alternative, are the hospitals, the in-patient who have strongly come out for 10-PCS and CMS as a payer. Now we do have other payers who have also sent a letter but, which primarily expresses concern about both 10-CM and 10-PCS but it's my understanding that people who deal with in-patient data and report in-patient data do not see CPT as a viable alternative. And so I don't think, it doesn't matter in that sense what it would cost, it it's not a classification that can be used for that purpose. If you want to do, if somebody wants to do a separate study on that they can, I do not see that as part of this study because it is a different issue.
DR. MCDONALD: Marjorie? Could you repeat the thing, I didn't hear the predicator, the noun, who didn't think the CPT was viable for what?
MS. GREENBERG: I said the hospitals who report in-patient procedures and CMS which uses in-patient procedures in DRG's and for other purposes as well as people who use 9-CM, volume 3, for statistical purposes, none of those parties consider CPT a viable alternative for those.
DR. MCDONALD: Based on what, where does that come from? Is that written down, its been looked at?
MS. GREENBERG: It comes from the Hospital Association.
DR. MCDONALD: I've heard the hospital position, there's an emotional, there's an emotional, non-rational part of these discussions that I don't quite understand.
MS. GREENBERG: Well, it also comes from a report, several reports done by the National Committee on Vital and Health Statistics in the past looking at the criteria for a procedure classification system.
DR. MCDONALD: I'm sorry, I wasn't referring to you as the non-rational part, I mean the American Hospital Association has, there's stuff going on that's not on the surface between those organizations. I found it a little disingenuous though that the problem, every hospital procedure is coded with CPT.
MS. GREENBERG: No, no hospital uses CPT.
DR. MCDONALD: I didn't say the hospitals used it, I said every hospital procedure is coded with CPT.
MS. GREENBERG: To capture physician component. CPT was designed to capture the physician to describe the physician component.
DR. MCDONALD: I don't want to get on the emotional side of it, I just want to point out --.
MS. GREENBERG: No, no, I'm not, there's nothing emotional about it, the fact is that CPT, is that CPT is designed to capture the physician component, not the facility costs.
DR. MCDONALD: It's only being used for hospital physician procedures, surgical procedures, medical procedures, for all practical purposes, by hospitals.
MS. GREENBERG: It was not designed to capture hospital or facility costs.
DR. MCDONALD: Well, I don't know about that, but let me go on to the next point of this. The hospital said that the problem, they need much more rich codes, but they're not even using the codes for analysis that are in most of their systems because it's the hospital surgical systems typically capture the CPT code. So there's some just peculiar things in my mind about the reactions that people are saying. The physicians have long, they've memorized these codes, so there's going to be a lot of retreading to do if they have to memorize a new code.
MS. GREENBERG: We're not questioning whether the CPT codes have the support of the physician community or capture what the physician community feels is necessary to capture. We're talking about facilities.
MR. MCDONALD: People did say that the hospitals were not, ICD coding, x-rays, labs, anything except physician procedures, or practitioners procedures, for practical purposes, so to me there just seems to be something crazy in there. We've got two coding procedures, one's already richer than the other and there's two groups battling each other for reasons I don't understand but I don't think it's necessarily for the good of everybody.
DR. COHN: We have Nellie Leon-Chison from the American Hospital Association, if I butcher your name, my apologies, but I think responding to your comments. State your name please.
MS. LEON-CHISON: Nellie Leon-Chison with the American Hospital Association, you know these hyphenated names are always a problem. If I could just clarify how hospitals use surgical coding as well as other coding. Yes, you're right Dr. McDonald that every procedure in a hospital gets coded but there's a difference between the codes that a physician uses to submit on his or her claim and the codes that a facility uses. The physician will use a CPT code to report his or her services to the payer whereas the hospital, for the in-patient side will use an ICD-9-CM, volume 3, code to report that same procedure.
DR. MCDONALD: Ok, but excuse me, sometimes more than one code right? To say the same thing?
MS. LEON-CHISON: Right, right, but however, they're entirely different systems in that CPT a lot of times will refer to services in relation to how much work is involved on the part of the physician so you may find situations where the CPT code will include services, pre and post surgery that are part of the fee that a physician may get but somehow did not relate to what the facility receives because hospitals are not paid on a global package. They get paid on a DRG for in-patient services and on APC's for out-patient services. Now for out-patient services hospitals have been using CPT codes and this is something fairly new with the APC, the Ambulatory Payment Classification system. And what we found is that hospitals have had a lot of problems implementing CPT with APC, there's a lot of confusion because of the descripters don't always fit for facility coding and when they're CPT descripters that have phrases like by physician or performed by physician in some instances it means that the service has to be performed by a physician and billed by the physician so it may not apply for hospital billing. But in other instances it means that the service has to be performed by a physician rather than another type of clinician and a hospital may bill for those codes.
So it's very confusing for hospitals to use these codes because the descripters don't always make sense to the facility. There's nothing emotional about this reaction, it's basically our members telling us what works for them, what they're used to, and what's difficult for them to use in terms of coding and classification. If Dr. McDonald thinks that there's an underlying other agenda, it's a surprise to me because I don't know what it is other than our members tell us that they prefer 10-PCS, it's more straightforward, it's easier to use, it does not make distinctions in terms of who performed the service, it basically describes a service being done period.
DR. COHN: Let me first of all make a comment here. I hadn't expected that we were going to be talking about CPT during this session but I think as you all know since I sit on the CPT editorial panel I need to recuse myself from specific discussions related to that, so I just want to make sure that everybody is aware of that and I'm sure you've all memorized this by now since I seem to be saying it at every single one of our coding hearings.
One observation, though, without, I don't have an opinion particularly on this particular issue in relationship to hospital and patient coding, but this is an issue that seems to come up again and again and again. And I'm just wondering, if we're not going to include it in a cost benefit, is this issue going to keep coming up again and again and again. And Marjorie I would just ask you that question.
MS. GREENBERG: Well, I have asked CMS and they've told me they will come to the meeting in November and be explicit on this issue. I guess I would suggest that maybe we defer this topic until then but I do not feel that this impact analysis or cost benefit analysis that we're discussing should include looking at the alternatives between CPT and the in-patient environment and ICD-10-PCS because I think that's a different, that is not really a cost, I understand that Dr. McDonald feels that this would save everybody a lot of money to use CPT --.
DR. MCDONALD: Can I just clarity that, I'm not necessarily pleading for CPT per se, it's just that it doesn't seem rational that the only principal coding is being done is mostly for professional procedures, it's physicians, dentists, maybe not dentists, there's more than physicians in the package. They don't code anything else, and yes, there may be edge affects that the code says it's got to be done by a physician, but it seems like it would be a lot easier to have one code if you're only focusing on procedures done by a professionals instead of having two, call it QMRLSMFT(?) and it doesn't seem right to be talking about cost benefit without at least addressing sort of the quiet skulked in the whole room which is this other coding that everyone's coding as well as ICD-9.
MS. GREENBERG: If the committee want's to commission another study on single procedure classifications, but that's another study. But I think we've heard in the testimony that that was unlikely to be something that could be resolved in any kind of a short term and that although desirable, it was not probably something that could be resolved in a timely way to allow us to move on past classifications that are out of date and not able to meet the future needs. I don't really see this cost benefit study as being, as addressing the issue of single procedure classification. I think of it as a separate study.
DR. COHN: Jeff and then I have a comment.
MR. BLAIR: Simon said something which I think gets to the heart of the issue. We've been trying to make decision on this and go forward for a long, long time and Simon's comment was that this issue comparing against the alternative of CPT codes, if we don't get that data to facilitate a decision then it just keeps haunting us and so my suggestion is that in order to have the information so we can make a decision and move on, that maybe we have to either expand this or add an additional study, whichever way we go, where we could get that question resolved and we can get all of the data that we need to make the decision on the table.
DR. COHN: And I would certainly volunteer to not be part of that study. I don't think I have a solution to this one. I do know that this is a whole issue that I want to run away from as hard as I can just because of my position here. This may be an issue that we want to bring up and ask the full committee how they want to deal with this one as another piece. I just don't know.
MS. GREENBERG: That's what I recommend. I think we should ask CMS to present the case for why they do not believe that CPT can be used in the in-patient environment, I mean they're obviously using it for professional services so if they felt that it could be used in the in-patient environment they would not have gone to the expense of developing 10-PCS. Now you may not be convinced by their argument and I don't feel that I can say any more than I have said, that we're talking about a classification designed for one purpose and people are suggesting it be used for a different purpose. And then if you're not convinced by that then, as I said, there may need to be a separate study then on single procedure classification. But I'd like to be able to proceed with this cost benefit study and the terms that are generally laid out here.
DR. ZUBELDIA: Marjorie, but the argument between 10-PCS and CPT is I'm sure is not just a financial argument. I'm sure there's all kinds of other reasons and CMS can probably explain that the best. I think that regardless of the other reasons, there probably should be somewhat of a cost benefit analysis of that alternative taking all the other reasons into consideration.
MS. GREENBERG: Well, you have to assume it's an appropriate alternative to do a cost benefit analysis.
DR. ZUBELDIA: Yes. So there's two choices, we either start the cost benefit analysis after CMS presents the CPT as an invalid alternative and then we say we exclude the CPT because it has been proven by CMS that it's an invalid alternative, or we start it simultaneously and start a cost benefit analysis also including CPT in it and then if CMS proves it's an invalid alternative stop it there and continue with the ICD-9. But I think that rather than delaying the entire cost benefit analysis until we have enough information from CMS to know whether we start the CPT or not, I think it's best to start both in parallel even if one of them has to be stopped in November.
MS. GREENBERG: It's unlikely that this would get awarded by the time of the November anyway. So I think that we're prepared to work on the scope of work that would not include the CPT or single procedure classifications analysis. If at the end of the meeting, and as I said I requested that CMS state their understanding of this situation and their position on this and why at the meeting, if when all is said and done the committee still wants to do a study on single procedure then it could either be a separate study that's later coordinated or -- I mean I'm not sure the same people could do both but we can hold off awarding this until after the November meeting because it's only about three weeks now.
DR. COHN: I was going to say, we're going to have to do a final look at it before we sort of go with it anyway so November would be a good time to reach agreement. Let me ask since this is the first time I've heard that CMS is coming with that discussion, is this part of our sort of discussion where we try and synthesize all of the issues around all of this?
MS. GREENBERG: The same person who made the original presentation at the April meeting, Tom Gustavson(?), I felt that it was important that they come forward and that this panel be carried up by the diagnosis side.
DR. FITZMAURICE: The subcommittee might want to consider that hearing from other views as well so at the same time you might afford an opportunity to someplace like the American Medical Association, the Hospital Association, maybe AHEMA(?) to address the same kind of issue, get a full discussion of it.
MS. GREENBERG: Well, I think we've heard from them and I think we agreed that we're not going to get outside, because once you start with outside testimony, there's no end to it.
DR. COHN: Except that I think CMS is considered in this context outside testimony. And I'm fine not to have anybody else, I think the question is whether somebody from the subcommittee needs to represent any other views on this one, but I don't think we need a debate between various sides coming forward on this one.
MS. GREENBERG: You do want a debate?
DR. COHN: No, I actually do not, I'm saying this as I think as you commented I think it's probably fine to have CMS while recognizing that I think the discussion was that this was supposed to be brought forward by subcommittee members as I understood the issues around. But I think it's probably fine to do that but we just need to find out if anybody from the subcommittee needs to make commentary about it. I think that is the appropriate issue there.
MR. BLAIR: At this stage I'm kind of confused. What are we deciding to do?
DR. COHN: Well, I don't know. I think we've decided to hold off any sort of final decisions on this in relation to this particular issue which is do we expand the scope of the cost benefit to seek guidance from the full committee after the CMS presentation has been done, and the presentation by the subcommittee on whatever it is we're going to talk about. Is that sort of, Marjorie is that, I think that's what I was hearing as sort of agreed to.
MS. GREENBERG: I think somebody recommended that and I agreed with it.
DR. COHN: I think we're obviously having CMS as part of the discussion where they're going to more explicitly justify their reasons for moving forward with ICD-10-PCS as I understand it.
MS. GREENBERG: I think they've made their case. I don't think they have to go over that ground again. I particularly, although I mean if they have information that they haven't provided I think it would be welcome but on this issue of 10-PCS versus CPT, I think they have not come forward explicitly on this and I felt that it was necessary. I mean if they consider this a viable alternative and we should know and if they don't consider it a viable alternative we should know that also.
DR. ZUBELDIA: I would concur that based on the fact that I believe you talked to CMS about this issue and you have a lot more information than we do about it and your recommendation is to proceed with a cost benefit analysis without the CPT option, I trust you to say let's go that way and I think that's something we can support, at least I support and that I still want to see that information from CMS but let's start moving in that direction. I think what's become evident through all the discussion is that the issues of ICD-10-CM and ICD-10-PCS needs to be split. That needs to be very clearly split.
MR. BLAIR: Do we need a motion to go forward with that?
DR. COHN: With what?
MR. BLAIR: To go forward without having the CPT codes looked at as an alternative in the cost benefit study for now?
DR. ZUBELDIA: I don't think that actually the subcommittee will need to do that yet. I think that we need to see the CMS information and the project proposal can be, we can start the draft in that way but it won't be really initiated until after the meeting with CMS anyway. So if necessary you can add the CPT part to it after the meeting with CMS. I would not wait until after the meeting with CMS to start the things that you know are going to be necessary anyway. I wouldn't hold those back.
MS. GREENBERG: And I think you're right that obviously we need, the cost benefit impact needs to look at 10-CM and 10-PCS separately but also the costs and benefits of replacing all of ICD-9-CM at the same time or at different times. In that sense you have to look at them together.
DR. ZUBELDIA: But the cost benefit needs to be done perhaps in three parts. One for ICD-9-CM, ICD-10-CM, another part for ICD-9, volume 3, ICD-10-PCS, and another part for doing it together as an independent part of the cost benefit analysis. Doing it together or doing it separate, but independent variable.
DR. COHN: I think the question is are there additional synergies that exist by doing them together.
DR. ZUBELDIA: Yes, and that's the advantage of perhaps doing it together. And I think that the project proposal can get started now knowing that it won't be adjudicated to any contractor or anybody until we have the time to review from CMS what the situation with ICD-10-PCS versus CPT is and at that point if necessary we could add into the project proposal that single coding option.
MS. GREENBERG: That will make the study quite a bit more expensive I think but anyway we'll cross that bridge when we come to it.
DR. COHN: Well, figure that out, I think we'll defer this particular issue, this issue as I said keeps coming up again and again and again, and I'm happy to defer it to the full committee and indeed we're going to have to identify somebody to, if there needs to be somebody to facilitate this discussion for the full committee after the CMS presentation, because I think that there is an issue here that we need guidance from the full committee on but clearly we'll need to identify somebody from the subcommittee to lead that conversation.
MS. GREENBERG: Or John.
DR. COHN: Or John, well either John or I mean one of the subcommittee members, I guess we'll have our option there. I'll query John and see if he wants to be the one facilitating that question is something that we're letting the full committee deal with.
Now we are moving, we are down to about 15, 20 minutes on this session and one would observe that we've managed to talk about everything except what we're going to be doing for the full committee. Obviously, as I say that we have sort of talked about a number of issues. The question is, is how do we want to have a discussion with the full committee trying to synthesize sort of what's happened as well as what are the issues of contention which as I remember is really what the full committee wanted. I mean they wanted to understand why we couldn't come forward with something that was a unified, this is a letter, and of course when we've still spent a lot of time arguing here about issues that we still can't resolve. I mean including I think whether or not we go immediately to an NPRM or whether we wait for the cost benefit and I think that's probably one of them.
Now the question is how should we do this? Are there, do we feel that there are particular issues that need to be dealt with? Now I am presuming as we talk about this one that a, that CMS is going to talk about CPT and about ICD-10-PCS a little more and probably review the document in our pack that relates to PCS. Is that correct Marjorie?
MS. GREENBERG: I don't know if they're going to prepare a document or not.
DR. COHN: Well, we have a document, I am presuming that they would highlight the document that talks about the background of ICD-10-PCS.
MS. GREENBERG: Oh, you mean this document.
DR. COHN: Yes.
MS. GREENBERG: Donna, are you still there?
MS. PICKETT: I'm still here.
DR. COHN: I'm also presuming that Donna or Marjorie would likely go through the part of the document that relates to the background on ICD-10-CM.
MS. GREENBERG: Well, I do think we need comments on this document, this background document. I think Donna's, tell me if I'm correct, Donna has put a lot of time and effort into this document and pulled a lot of this information together that wasn't in one place before but I think you also had planned to do a second document on issues right Donna?
MS. PICKETT: That's correct.
MS. GREENBERG: Do you want to expand on that a little?
MS. PICKETT: The first document that you have as Marjorie said is the background document and it just lays out the history of each of the classifications, why it was developed, and then a very definitive timeline of the steps that have been taken to develop the classification or develop a clinical modification as it relates to ICD-10 diagnosis.
The second document was to put on paper some of the issues that have been discussed during this discussion regarding single procedure coding, whether there is a need to readdress that issue or not with some information about the history that the NCVHS has had in this area related to single procedure coding. Also the issues, the more contentious issues I think is how it was described at one point about disadvantages of waiting for decisions versus the immediate needs that are felt by various providers in not having a classification that represents what they really do.
Issues related to the cost benefit analysis and what should be included in the cost benefit analysis which would obviously include benefits. Some of them, not necessarily tangible or quantifiable, but benefits nonetheless. So there's a number of issues that have been discussed that have appeared in previous transcripts that I have pulled together. I just have not typed them up and put them into a paper because I've not been here but I already have an outline of what additional information would need to appear and if through this discussion there are additional issues that need to be included we can certainly do that.
DR. COHN: Donna, are you talking about cost benefit now?
MS. PICKETT: Well, originally there was the issue of doing a cost benefit analysis and waiting for an NPRM but I think that discussion has already played out so that was not in the paper.
DR. COHN: It has?
MS. PICKETT: That's already been discussed.
DR. COHN: Oh, you mean we've discussed it.
MS. PICKETT: Right, because it was raised at the last meeting but it has been more fully developed in terms of this stage discussion so I would not put that in because you've made a decision that these things would happen either simultaneously or not.
MS. GREENBERG: I think that's still an issue. What appears not to be an issue anymore is, and I know it's hard being on the phone here, but it's even hard being here in person --.
DR. COHN: Marjorie, I guess I'll take that as a compliment, thank you very much.
MS. GREENBERG: I want you to know I came all the way back from Australia to be here with you.
DR. COHN: I won't take it personally.
MS. GREENBERG: I will, sort of my caveat for anything that I've said today is that I'm still on Australian time. But I think whether or not a cost benefit analysis is needed other than the impact analysis that the Department would certainly do for an NPRM, we've moved past that with at least the expectation that this independent cost benefit impact analysis is going to be commissioned. But whether that all recommendations as to how to proceed should wait the completion of this or not I guess is still an open question. And that would go into the issues paper. Is that correct?
DR. COHN: Yes, assuming your willing to write a paper on this one, certainly you can give the pros and cons of moving forward now versus waiting for the cost benefit piece to be completed. Other issues that we wanted? What? Oh, Karen Trudel has a list of issues, here we go.
MS. TRUDEL: This is just I guess a beginning list to start with. I think there has been some discussion about the urgency of the need to move forward to a new code set of some kind, discussion of the extent to which ICD-9 is broken in terms of CM versus procedure, volume 3, so that's one issue I seem to recall some concerns about. Whether there are other alternative candidate code sets, there was discussion about CPT. The timing, including the linking, the need to or not to link a change in CM and PCS. The adequacy of testing that has taken place to date and cost versus benefit. And those are all of the issues that I can recall having been discussed.
MS. GREENBERG: Donna, I don't know whether you have?
MS. PICKETT: I've got them all.
MS. GREENBERG: I don't know if you had others, I realize you're not at the office.
MS. PICKETT: No, I think that gives a good summary of the issues. Now in writing some of those up there may be subsets of that that will be discussed but I think the issues that Karen just outlined are basically everything that we had noted previously.
DR. ZUBELDIA: I have one more, I don't know if it's included in one of those but the availability of help and assistance tools such as a crosswalk between the ICD-9 and ICD-10.
MS. PICKETT: That was a crosswalk?
DR. ZUBELDIA: Yes.
MS. PICKETT: Ok.
MR. BLAIR: Excuse me, could I broaden that, Jeff's groping again here, that is just I think one of the types of tools that might be necessary and I think it just should be phased broader in terms of the migration tools and education and support programs for a migration from one coding system to another. The migration tools and education support programs. And the mapping is just one example.
MS. GREENBERG: What I would suggest, are you looking to wrap this discussion up pretty soon?
DR. COHN: Well, that would be nice, we've got another ten minutes or so.
MS. GREENBERG: What I would suggest is that if people want to comment on this background document now we can take your comments but otherwise we could ask you to send them to us in a week so we can pretty much put this background document to rest. I think there were a few things where it says we have to add something anyway.
DR. COHN: I was actually going to just ask the committee, the subcommittee, I think that a, that should be able to be handled off-line, but I was also, as I looked through the documents, I thought AID(?) include the GAO Report was a very useful view of the world and I also thought the previous NCVHS study, set of recommendations, which I believe are 1993, I thought vastly helpful and I would certainly recommend that we make copies of that and include it in the pack for people to review. Clem made a comment here and I want to sort of second it that there's, this is more than coding, there's a whole set of issues around all of this that have to do with control, ownership, and on and on and on that I thought the 1993 document did a beautiful job of briefly summarizing and helps make some better sense out of the problems we're having. I think that we really need to make sure that everybody has a chance to see that and it doesn't get hidden in a page 47 to 53 in a document that gets included.
MS. GREENBERG: With these two documents that we've been discussing we also want the report, the '93 report and the GAO Report.
DR. ZUBELDIA: You want the photocopies of those pages in the '93 report that refer to this topic.
DR. COHN: Yes, exactly --.
MS. GREENBERG: Excuse me, what?
DR. ZUBELDIA: Only the pages that refer to this topic because we got the entire '93 report.
DR. COHN: The '93 book.
MS. GREENBERG: I don't think we have enough books to send them.
DR. COHN: I was actually just referring to the pages that had to do with classifications which again I thought was a wonderful piece of work.
MS. GREENBERG: I thank you on behalf of Lanette Rocky(?), any of you remember Lanette? She wrote that report for the subcommittee. It's good to know that ten years later almost --.
DR. COHN: It's an excellent document and we really should be bringing that forward as one of the pieces of work.
Now having said all of that, how are we going to organize this discussion? Obviously we're having Donna, you're obviously going to do some write-ups, some work trying to put together the pros and cons and I think we all probably need to look at it off-line and augment, we probably all have particular opinions that we want to make sure get included.
MS. GREENBERG: I just wanted to suggest as I said that you send the comments on this document that you've had now for a little while, like in a week, and then Donna, what's a reasonable timeframe to get them a draft of the second document?
MS. PICKETT: I'm aiming for the middle of next week to have that in circulation.
MS. GREENBERG: Ok, so about a week or so. And then we need comments back on that pretty expeditiously, too, because I believe, when is the meeting the 19th and 20th? Is that correct? Which means that we will need to mail the agenda books probably by the 13th. Is that correct? Thursday at the latest, 14th, because people will be travelling on the 18th, a Monday, so they'd have to get it on Friday or Saturday, with Saturday delivery, so if we, what's the fastest you can turn that document around, I don't know. If you've got it, let's say on Halloween, or the day before, it would be appropriate, then we really would need comments by the 5th or so. That one you won't have seen until you see it, it will be the first time you've seen it, so it may have to go through two drafts.
And it would be nice if they could get all of this, they need to get all of this before, they can't start receiving these things as they sit down at the meeting so all of this really has to go with the agenda book, which I'd say should be mailed on the 13th. So we would get comments back by the 5th on the second document, does this sound alright to you Donna?
MS. PICKETT: Yes.
MS. GREENBERG: And then we would redraft it by the end of the week and we'd have to put it to bed by the 11th, 12th at the latest so it can get copied and go with the agenda books.
DR. COHN: Clem, are you hearing all these dates? Are you still there?
DR. MCDONALD: Yes.
DR. COHN: I just want to make sure you had heard all the dates. Are you comfortable with being able to respond?
DR. MCDONALD: Actually I didn't pick up all the dates, I was I guess dreaming.
DR. COHN: Ok, well what we said was is that we were going to try to have the issues paper out by around by Halloween, the next holiday, about a week after, a little less than a week, we want responses back with the idea that we might have to turn around and get a second version out. Is that ok?
DR. MCDONALD: Ok.
MS. GREENBERG: And then comments by next Monday or so on this background document that I emailed to you right before, or that Marietta emailed to you right before we left.
DR. COHN: Now let's move forward and talk a little bit about, and once again they asked us to sort of facilitate the discussion on all of this stuff, and it's well, these are things where obviously there's some pros, some cons, some of which we feel strongly, individuals feel strongly about, I guess I'm looking for thoughts from the subcommittee about how we ought to facilitate this particular discussion. I mean we could either do it where I divide up the issues and assign various members of the subcommittee to basically go over the pros and cons and then try to facilitate the conversation. Alternately we could identify various members of the subcommittee to represent a pro and a con on some of these. What would be the interest of the subcommittee on how we should do this? Don't all get excited at once here. Jeff it sounds like you're going to say something, come up with an opinion.
MR. BLAIR: You know the background papers that, the two documents that were sent to us, do you not feel as if that provides the full committee what they need and then they could wind up then asking questions of the things that that didn't clarify for them?
DR. COHN: Are you referring to that without the pro and con issue document?
MR. AUGUSTINE: If they read this and they read the GAO Report and the other document is going to be the issues document I guess, they can read this beforehand and then we kind of go through the issues document, you don't really need a pro and con, a person can state both cases, the pluses and minuses of each and let the committee members kind of weigh it.
DR. COHN: Has everybody heard Brady's recommendation? Which is that we divide up the pros and cons, I hadn't expected that we would go through the larger documents but I think the question was is how we were going to handle the issues document, which will likely only be a couple of pages long, likely bulleted I presume Donna, of pros and cons, and I think what Brady is suggesting is that what I will do is try to assign, once we see what the document looks like what we'll do is assign various individuals to lead the discussion on each of those items. Is that, I'm recognizing that I think we can be dispassionate enough I would hope to sort of generally reflect both views and certainly I'm sure other subcommittee members will join in if they don't feel that we have adequately expressed the views to the strength they feel they need to have them expressed.
MR. AUGUSTINE: I would never want to be in a position where I would have to argue with Jeff.
DR. COHN: That's well said.
MR. BLAIR: Or Clem.
DR. COHN: Was this a reasonable process? With that, I think it's time for a break. Let's take a 15 minute break and then we'll --.
[Brief break.]
Agenda Item: Drug Terminologies Under Development
DR. COHN: Everybody please be seated. Ok, our last session, which by the way is only ten minutes late, which is I think very good for this subcommittee, is really a briefing about the various drug terminology work that is occurring. We want to thank Randy Levin, Steve Brown, and Stuart Nelson for coming and joining us and helping sort of give us an understanding of really what's been happening over the last while in relationship to this. I understand Randy that you're going to be leading off, is that correct, or Steve or you leading off? Steve why don't we give you the floor then and thank you very much for being here. Just get near a microphone so people can hear you.
Agenda Item: Drug Terminologies Under Development - Mr. Brown
MR. BROWN: I really do appreciate the opportunity to come and talk with you all today. Some of you have heard some of this before and if we repeat ourselves I do apologize. We're really wrestling with the problems of having no common drug terminologies, surely within VA, whom I represent, but I think we see this on a larger scale, between a large number of governmental agencies, and the picture you see is actually not fully interconnected with arrows between each of these different agencies that use drug terminology. We came up with sort of use scenarios for each of these arrows.
The lack of standard terminology I think is really an impediment. The good news, though, is that some of the agencies that need drug information have started to figure out that by working together we can contribute pieces and move each other along and make our lives easier as a whole. So what this slide is showing is the number of in place memoranda's of agreement or understanding between agencies to collaborate on drug information. NLM for instance is working with both FDA and VA, there's a fully formed triangle between those three. Also NCI has agreed to help collaborate with the information on drug terminology as well, they're particularly interested in the areas of obviously experimental anti-cancer drugs, but have needs for other drug information. Between VA and CDC we have a drafted agreement that's hopefully in sort of final phases of approval.
I'll show just briefly the standard sort of hub and spoke diagram for simplifying things that we've probably all seen in a number of different contexts, but it does sort of I think explain to, we've used it for our management and all, but how we can work to simplify the problems of all this interconnectedness and off interfaces that need to be written and all that sort of thing.
We read the last report very carefully and actually it was right on. So this is from the July 2000 NCVHS report and the good news is, is that's it's been taken to heart and there's action being taken and Randy can probably, if he does it briefly, talk about NDC's and active ingredient classifications and the like. Today I'll be talking some about reference terminology and Stuart surely will be talking with RxNorm about enhanced mapping capabilities between different systems. So all this has been taken to heart and there's movement being made.
The overall purpose of this collaborative initiative is to take information that we already have, it's already under government stewardship, and reformulate it and then distribute it, so to try to make something that's from each of our pieces bigger, the whole bigger than any of these individual pieces by collaborating.
So we're going to talk today about three projects that actually build on each other fairly carefully by design. Stuart will talk about RxNorm and then I'll talk some about NDF RT, which is a reference terminology based on our national drug file that expands the RxNorm model, and then we'll talk about a longer term goal and that builds upon that yet again, getting information directly from FDA and manufacturers. So why don't I let Randy?
Agenda Item: Drug Terminologies Under Development - Mr. Nelson
MR. NELSON: I asked Steve to leave it there because we're going to start with the center of this diagram with the clinical drug. What is a clinical drug? We're going to HL7 meetings and there was a lot of discussion about defining what a clinical drug was in order to enhance the capabilities of each of the different pharmacy knowledge based vendors to interact.
There was a lot of discussion about the standards and so the first thing that happened as a result of that is that we established in the UMLS a new semantic type. We thought that we're going to define a clinical drug as something with an ingredient and/either a form or a strength or both. And we're going to try to express the clinical drug at the level of clinical discourse. Somewhat different than the level of discourse that a manufacturer produces things at, we don't care particularly about lyophilized patterns that are reconstituted for solution, but we do care about the solution that is administered to the patient.
Well, we ended up doing that and using our usual techniques in the UMLS. We ended up with about 80,000 clinical drugs and clearly we had a big problem with lots of synonymy that we missed. We weren't recognizing it. The usual types of lexical processes that we use to identify things that have the same or nearly the same meanings were not working.
So then conceived of the RxNorm form and basically the goals were to develop a standard representation of what that meaning was at a clinical level, relate all the UMLS clinical drugs to this standard format, and this would facilitate cross talk between all the different kinds of all the different pharmacy knowledge based vendors and so that each of them with their various islands of information would, then we would be able to negotiate between one and the other.
So we said we're going to establish this by building up a set of UMLS concepts, we're going to start off with the ingredients, most of the ingredients were already concepts in the UMLS in the medical subject headings which has been the UMLS since the conception of the UMLS, anything that appears in the literature that's discussed as substantially at all ends up in the medical subject heading, so we have most of the ingredients. But then we said, we're going to say we'll have drug components, and a component is an ingredient in a strength and we're going to take the standard drug forms that HL7 proposes as standard and out of that we're going to make a formulation which is the drug component or components and the form. We're going to represent the strength of each of the components in a standard way, have a set of rules, and then we'll establish relationships with all the other names that exist in the UMLS.
So here's the first easy example of how you might do it where we have sulfamethoxazole and trimethoprim as ingredients, and components sulfamethoxazole 800 and trimethoprim 160, and then the dose form of an oral tablet and then the RxNorm form of sulfamethoxazole 800 mg/trimethoprim 160 mg oral tablet. So then we'll have in the UMLS, we'll have these relationships of the ingredient, the component, the clinical drug, and the dose form. And then clearly all these other things that we have in the UMLS that don't match this exactly in meaning needs to have some sort of relationship to the RxNorm form, the standard formulation. So we have to allow that there will have relationships being mapped to, there's some Inverse_IsA relationships and Trade_Name relationships.
So we came up with a notion then that when we had completed this we would have a graph and here is an example of the graph so we can start at the bottom right with Zyrtec 5 mg tablet. If you go to the left you'll see it's a tradename_of Cetirizine HCI 5 mg oral tablet. It has doseform_of an oral table, it consists_of Cetirizine 5 mg, which has the ingredient_of Cetirizine which is a form_of Cetirizine HCI. Cetirizine HCI has form_of Cetirizine and Zyrtec is a tradename_of Cetirizine HCI. So each of the boxes there would represent a concept within the UMLS and each of the arrows, a labeled relationship within the UMLS which would then allow a system to be able to negotiate from one portion of that graph to any of the other portions, to see what were the permissible relationships, what were the things that we knew about.
So where do we start. We started as part of the memorandum of agreement with the VA National Drug Formulary, well they have 80,000 drugs in the national drug file of drugs expressed at the NDC code level. They were able to provide us with an ingredient list that they had and then we took those and mapped those into semantic normal forms. Our second ingredient we started with all of the big five sources for clinical drugs, which was the VA National Drug Formulary and then Multum, MediSpan, Micromedex, and First Databanks drug vocabularies and tested to see how scaleable the approach was and refined, we're working on refining the model and achieving a full map for some of the most common.
So the first experiment with the VA, we started with 80,000, we ended up with 11,300 clinical drugs, 10,000 components and about 8,000 RxNorm forms. Clearly we didn't, in doing this out arithmetically that way we found that we could not, we're not going to achieve 100 percent, we found that we could achieve enough algorithmically to make it worthwhile to leverage the effort involved in trying to build the system up. And so we released that first, the results of that experiment and the first version of the Metathesaurus, it was released this year.
DR. FITZMAURICE: Excuse me Steve? Stuart I mean. On this Experiment 1, you start out with 80,000 and you ended up almost with 8,000, what does that mean? Could you map everything that was in the formulary down to these forms?
MR. NELSON: We went from 80,000 down to 11,000, 8,000 of which we could come up with a standard format for algorithmically. So there's still 3,000 that require human effort. But it says we could get a 70 percent reduction in the amount of work by doing it algorithmically.
DR. COHN: Actually since we're asking clarification here, maybe you can explain the 80,000 to 11,000. Is that there is 80,000 NDC's of which there's really a 7 to 1 redundancy in terms of the actual clinical drugs? Is that what you meant in the VA?
MR. NELSON: Conservatively. I think that Steve has example where he can show that there are 100 NDC codes, meaning one clinical drug. But so conservatively we got it at least an 8 to 1 reduction.
So our second experiment we took all of the different sources, each of which has their own peculiarities and tried to parse them and approach them algorithmically and ended up with about 25,000 forms edited and created. We were able to merge them down into 14,000 and at that point we had up to a 13 different clinical drugs that had been separate UMLS concepts were ended up merged together. Since then we've gone even higher, I think we're about to about 35 different UMLS concepts in previous additions are now merged into the same concept.
We took a list of highly prescribed drugs and started off with some targets of opportunity of the most highly prescribed drugs and have completed in May 20 complete graphs, so the full set of relationships was established and labeled. And that was released in the May release of the UMLS Metathesaurus.
Since then we're continuing to have our growing pains. Since most of this stuff is being done with software that is being built on the fly and modified on the fly you can imagine what that is like. I think where we're going to be is that by the end of this year we're going to have all the RxNorm forms that we need to create created. Achieve in the spring time a full set of complete graphs where everything in the UMLS will be related to one of the normalized forms, every clinical drug in the UMLS will be related to one of these normalized forms.
The next questions that we have are how are we going to keep this up to date? If this were something that was going to be used on a regular basis at a clinical level, then we need to have some method of making sure it all gets in there. And we recognize that there are lots of different forms of changes. They're changes of NDC codes of which there are thousands every month. There are changes where a new molecular entity shows up where there are tens of them a year, maybe 30 or 40 molecular entities in a year. And then there are all these repackaging reformulations which are the new clinical drugs.
The other thing we have started to look at is where we have NDC code information available to us, since we are dependent upon people who are making a living tracking this sort of stuff, they don't necessarily want to release proprietary information. But the FDA does provide access to a great deal of NDC code information and the VA is certainly cooperative with us. Where we have NDC code information available we can then put that in as attributes of these concepts, so that we can say for a given RxNorm form, these are the NDC codes which fulfill that meaning, that criteria. So we'll be able to, we're starting to look at that.
DR. FITZMAURICE: Excuse me Stuart? Are you saying that some companies don't want to give you the information about what's in a pill so that you can code it?
MR. NELSON: No, the knowledge based vendors have spent a great deal of money trying to track what's happening with NDC codes. I think, Randy plug your ears, the ugly truth is the FDA lost control of the process of NDC code creation. They do not keep up, they are not able to keep up with all the new NDC codes so these pharmacy knowledge based vendors have been calling up each of the manufacturers saying well, what have you issued this week, what are the new NDC codes that you're coming out with and so forth and they put that into their systems.
DR. FITZMAURICE: Why should FDA even try, why not just buy this from a private vendor? Congress told them to do it right?
MR. NELSON: Congress told who to do it? FDA to do it? I believe it's a mandate, yes.
MR. BLAIR: Is it that you're not able to get to the active ingredients within an NDC code easily, is that the problem?
MR. NELSON: I think the NDC codes are, there's a whole variety, you can eventually go from an NDC code to the active ingredient, if you have a good knowledge source.
MR. BROWN: And you know how to split it.
MR. NELSON: And you know, the NDC code is, if you take out the hyphens they are non-unique.
MR. BLAIR: So you're managing to do that but what you're saying is it's taking a little extra time because it's not straightforward?
MR. NELSON: What we're doing, we're just taking this and saying this is passive information for something that, physicians when they're ordering don't care about an NDC code. They don't care how many pills were in the bottle that the pill came out of. For a generic they're not even particularly concerned about the manufacturer. All they really care about is the right drug in the right form at the right strength getting to the patient. And the NDC code actually has information about all of those things already in it about what size the package was, who was the manufacturer, what the product code and so forth. So it's really at a different level of granularity.
DR. FITZMAURICE: Do different NDC codes refer to different packages? Do those packages have different information about the same product? Or is the information the same for the same product?
MR. NELSON: I believe that, I'll let you ask Randy that in a minute but I believe that the labeling information for a product, which is a specific manufacturer and a specific clinical drug, it doesn't matter what size the package is, whether it's, for labeling.
DR. FITZMAURICE: And the package insert that explains the information about that drug is the same regardless of the package?
MR. NELSON: Yes. So I think what we've been trying to do with the RxNorm is we're trying to address clinical drugs at the level of equivalence and similarity at a clinical level. And trying to solve some of this problem of islands of various kinds of information sitting around. And I think it might be able to serve as a basis for computerized physician order entry, there's a lot of advocacy these days that we're hearing about computerized physician order entry and reducing the number of medication errors and so forth. I think that it might be able to work in that regard. Steve?
DR. COHN: Steve just make sure you get close to the microphone.
MR. BLAIR: For internet folks, I'm assuming this is Steve Brown.
MR. BROWN: Yes, this is Steve Brown. In VA we actually have a remarkably computerized system. At each of our medical centers we're doing roughly 90 percent of all medication orders electronically by the provider directly, most all the notes are going in, either directly typed or transcribed, but more typed than you might guess.
Just to sort of set the stage for what or interests are in trying to have common terminologies. Right now we're using our national drug file as sort of an interlingua between the local data dictionaries at, believe it or not, at however many medical centers we currently have, somewhere around 170 depending upon integrations and the like. NDF is centrally maintained and distributed. We use it for decision support, rules and interaction kinds of things, but honestly what we mostly use it for is for our mail out pharmacies, we have seven football field sized pharmacies, which did something like 57 million prescriptions in 2001.
I think we see that there are opportunities to improve upon that largely in the area of patient safety and decision support. Right now we have a very hard time exchanging decision support rules between sites because of these local implementations. They need to be modified honestly so it doesn't, it's not a real scaleable process. So to take better advantage of this wealth of electronic information we have we're looking towards enterprise terminology and standardization, of which obviously medications are a really important area.
So we're looking primarily for the patient safety and decision support points of view, we're all recognizing though that in terms maintenance of terminologies and mapping between sites, for instance, to our on-going project for our health data repository which will be a national roll-up, that we faced some real issues and if we don't have some standardized terminology and formal terminologies so that we can do some things algorithmically that we'll be in a world of trouble. And also we have to inter-operate not only between VA's within the system but we have partners and we have patients who are seen in DOD facilities, we also have patients that are seen across the street at the academic affiliate, or move around. So we have a lot of need for inter-operation.
The approach that we're taking is the ingredient centric approach rather than a stock the pharmacy shelves centric kind of approach and Stuart's alluded as to, more than alluded, as to why that's important. But we're also interested in as I said in having computable definitions so that we can formally count on them and know that the operations will return specific answers and our goal is to the knowledge interviewing up front and re-use it at all our sites. As I mentioned there's this sort of the clinical perspective that carries through, what Stuart's talking about and we want a little bit more information. We've also are very interested in collaboration and sharing with this to reduce our load.
So when we're talking about the reference terminology it's in sort of the Keith Campbell sense of it as opposed to something that we just refer to. Using description logics and all that kind of good stuff but I hate to see sort of term creep.
So we've added in reference hierarchies that include mechanism of action, physiologic effect, some idea of therapeutic intent which is of course different than indication and we're working now to figure out just how much kinetics we'd want to have as definitional or at least close enough to be considered terminology model. We've also kept our VA drug classes because we need them and a lot of software is written around those. The numbers of roughly 80,000 NDC drugs and 3,000 active ingredients reflects what's in NDF right now and you notice that most of the arrows are in fact pointing at active ingredients and what that means is we'll do the definitions relatively few times and inherit the characteristics.
In most cases mechanisms of action for an active ingredient are the same for different manufacturers products whether they like to admit it or not as long as there's the same chemical substance.
Here's an example of one medication where we might have that Captopril is an intertension(?) converting enzyme inhibitor, which is a type of protease inhibitor. It also affects peripheral resistance, so that would be its physiologic effect. No point in terribly belaboring that.
Why are we bothering I guess is the important question. If you look at the examples here for order entry and decision support, do not give drug X concurrently with either an MAO inhibitor, organic nitrate, both of those actually got off TV the day I made these slides up. So these are examples of mechanisms of action or chemical class, or don't give it with a negative inotropes is a physiologic effect.
And a lot of the existing drug classifications schemes have these ideas liberally ad mixed, our own included. So for instance using the VA classification scheme we get to know that something is a beta-blocker or an ACE inhibitor or an anti hypertensive and we get to choose one of those. So we thought that by abstracting these ideas out and having a multi hierarchical system that we could do some smarter things with our decision support.
So where are we? We've done a fair amount of work on and in a pretty well advanced reference hierarchies now for mechanism of action. We've just used the chemical structure hierarchy from mesh(?). We're actively working on physiologic effect and therapeutic intent and we'll be working actually starting next week on some additional kinetics modeling.
Right now the NDF RT is being used as the underlying data source for the pharmacogenomics knowledge base data management that is being done out in Stanford. And NIGMS is funding a group of academic centers to collaborate with us to expand largely in the areas of kinetics but in also some other areas I've mentioned to meet pharmacogenomics needs so we can get a little plug working on the kinetics right now.
We've got active ingredients for those 80,000 NDC level drugs algorithmically defined and they are undergoing human review now. As we found out with our therapeutic intent, basically the algorithms that we employed to initialize them are getting about 80 percent right on therapeutic intent best on mining the literature which is not bad, it's better than having to do this dayanovo(?) and it's just not terribly dissimilar from the 70 percent Stuart was getting for algorithmic initializations. And so the name of the game is to try and do as best we can up front using lexical and semantic techniques and then having, then paying humans to refine to try and minimize our costs while getting a good quality product.
We put up a browser on the web if anyone wants to be led through that I can do that off-line I suppose. This really fits into our internal strategy as I mentioned for creating enterprise terminology. We have as I say now, 170 or whatever is, islands where there's slightly different data dictionaries and that makes it very hard to roll-up data and then to also share our decision of support so there's a move underfoot to take terminology services out from the applications themselves and actually mix them in the code the way M(?) works and to have abstracted terminology services, so it fits in very nicely there. And it also into VA's HealthePeople initiative that you probably have heard about in other sessions.
MR. BLAIR: Steve, could you just tell us what an enterprise terminology is?
MR. BROWN: From out perspective, for instance, an enterprise terminology would be one that is applied across all systems in the enterprise. We're very wide spread, so at 170 medical centers, maybe 150 vista implementations, we want to have one way of expressing these medications rather than 150. And there are a number of advantages to that not only in terms of the ability to roll up data and compare sites, but in terms of the maintenance. It's a whole lot better to do it once and share it. If there is a new drug comes out right now and there's not an NDF update, each of the sites is going to have to discover that it's there, put it back in, and then when there is an update, they pay the local update penalty and then all that efforts gone to naught. The idea is that there's a highly reusable way to sort of reduce our maintenance costs and to also end up with more comparable data. It's not just medications, but labs, document titles, all these kinds of things we need to do to knowingly share data between our sites and with our partners.
As I mentioned there seems to be a lot of interest in working together. I mentioned NCI, the pharmacogenomics research network is a multi-institute NIH project and I mentioned how are working to try and develop new use cases and extend the model to meet some of their needs. DOD is actually is interested and they will be do some information modeling on some label sections. We've talked some with Dr. McDonald about the needs of Regenstrief for order entry, and I think those actually parallel some of the needs at other places like Ganderbuilt(?) as well. So I guess as Stuart led in the problem is well, how you deal then with the maintenance burden.
And if there are 32 new drugs in 2001 and our best guess was 4000 NDC level changes it really represents a challenge so in collaboration with FDA and NLM we're having a project now started up for new drug transactions trying to definite message formats and types and all that sort of thing that we hope to do a bit of prototyping with and get some messaging standards and try and reflect those back through the standards organizations. I think that that goes, represented here in the new drug transaction. The idea I think is that we really need get back and get information straight out of FDA.
DR. FITZMAURICE: Clarification question Steve. On the slide there are 4000 NDC level changes per month. Does that mean they have one code, they change the code to another code on a given day?
MR. BROWN: No, the same code but with, there are different packages, the old ones stay the same but that it could be that it's 101 rather than 100 in a bottle and they say new packaging.
DR. FITZMAURICE: So it's a new code? Once they assign a code it doesn't change to something else?
MR. BROWN: I don't know that we can say that. It shouldn't change to something else. They get reused eventually and they can also be split different ways and reinterpreted so there's multiple problems with non-uniqueness.
DR. FITZMAURICE: So they do it because they just run out of numbers?
MR. BROWN: I don't know why they do it. The might have a particular favorite, it's like their lottery number or something.
DR. ZUBELDIA: So essentially every 12 months or so all of the NDC codes, every 24 months, they are all replaced. If there's about 4,000 a month new codes.
MR. BROWN: No, the old ones can stay, there's just lots of new product coming out. It's more of a marketing issue than a molecular entity issue.
DR. ZUBELDIA: Then there's a lot more than 80,000 active at one time.
MR. NELSON: There are about 250,000 that are actively out there right now.
MR. BROWN: We have 80,000 at VA.
DR. ZUBELDIA: And you are saying that they are not unique?
MR. BROWN: They are not necessarily unique.
MR. NELSON: Once you take out the hyphens, it's a ten digit number of hyphens in it to separate the fields, once you take out the hyphens then it's non-unique. Randy will tell you all about this.
DR. ZUBELDIA: Do you insert zeros, when you take out the hyphens you insert the zeros, do you come out with unique numbers?
Agenda Item: Drug Terminologies Under Development - Mr. Levin
MR. LEVIN: This is Randy Levin from FDA. The NDC was started in the late '60's and it was used as a way for reimbursements for Medicare, that's how the NDC started. Basically what the NDC comprised was three different codes. One code is called a labeler code. That's something that the FDA assigns to a company. A company may have more than one labeler code but we give them a labeler code. That's the first code of the NDC, that's the first, and it's either four or five digits. The second and the third code, the companies themselves assign.
When Steve and Stuart were talking about the FDA doesn't have a handle on the NDC's it's because the companies can assign these codes and then we ask them to come to us and tell us what the codes are that they have assigned.
DR. FITZMAURICE? And they don't do that?
MR. LEVIN: Not always. They are supposed to and if actually it's the, if they don't have a valid NDC the drug could be misbranded and have regulatory consequences of being misbranded. But what happens is that the drug companies or distributors, repackagers, relabelers, whatever, they assign their NDC's and they are supposed to come to us and list those products. Sometimes they do, sometimes they don't. Sometimes they'll assign NDC's to non-drug products. So they'll use that same coding system and assign it to devices, or other things that are not drug products.
So this is probably one, that's probably one, so any of these private groups that put together NDC's, they're going out and they are asking manufacturers about their NDC's, some of those are not drug products. And some of them are things that are not properly listed.
DR. COHN: Randy, did I miss it? You talked about the first two elements.
MR. LEVIN: The first one is the labeler code, the second one is what's called a product code, and the third is called a package code. Even the product code and the package code is not controlled, we don't control what people do with those codes. So you can't rely on them as being unique to that product, like a product code you can't say that's unique to that product because they could use the same product code on other products.
DR. FITZMAURICE: But it's unique to that particular box that has certain letters on it and numbers.
MR. LEVIN: The box themselves, when you get down to the box, it should be unique, three codes. Now if you are putting that code into a barcode, and barcode's don't understand the hyphens, so they just read a ten digit number, they don't care about that it's a five digits of the labeler code and package code and product code, there could conceivably be three different NDC's for every one ten digit number. That is possible to have that happen. And again, that's not the NDC's uniqueness, was that it was divided by these hyphens so that you would have, since the labeler code is unique to that company, or that company only has that labeler code, they're in control of the product and package code and those numbers should be, that sequence should be ok but conceivably a ten digit number could find it's way into three different products.
DR. ZUBELDIA: Under HIPAA, the Secretary is adopting an 11 digit number as the NDC standard.
MR. LEVIN: Well what happens is a lot of people, since the package product and the labeler code are variable. Because there are three different configurations you can have for the NDC. What people do is to make it standard in their databases is make it 11 digits and just add a lead-in zero to the one that's short. So if you have four digit package, this is getting complicated, but if you have a four digit labeler code, and a four digit product code and a two digit package code what they'll do is add a lead-in zero to that labeler code to make it a standard five, four, and two configuration.
DR. ZUBELDIA: So are the five, four, two codes unique without the hyphens?
MR. LEVIN: No. Since that is something that you've added into that code, once you take away the hyphens it could be different numbers.
DR. ZUBELDIA: But if you do five, four, two with a zero insertion.
MR. LEVIN: Because someone else has inserted that zero in another portion of the number and you can have, you can conceivably have, remember this is a ten digit code, those are a lot of numbers and we only have 250,000 NDC's, so the chances are that there are not a lot of these duplications out of all the ten billions codes that are available. But it can be done. And the reason is, is because the companies are controlling the numbers themselves, we don't control those numbers. Now what we're looking at is ways to address, we have heard many many times, including from here, this group, that the problems with the code and we are working on ways to improve that code so that it will be unique.
The other thing that was brought up was that you can reuse a code and they are reusable after five years after they're discontinued, withdrawn from the market, a company can reuse that code. Now how often that occurs we don't know but that's a possibility. So some of these issues about uniqueness and reusability of the numbers and those issues, we're looking at ways to address that so that that NDC becomes a reliable code for the packaged product.
DR. FITZMAURICE: Randy if I withdraw the box and never put this drug in that box, I'm going to put a different drug in the box, then it's possible to reuse that code after five years?
MR. LEVIN: The code is specific for the product and the box. If you change anything of the product, anything of the box, quantity, any of those aspects, you have to have a new code, it's a new product.
DR. FITZMAURICE: But if I wait for five years then I can use that old code for anything I want?
MR. LEVIN: If you've withdrawn that product completely then you can reuse that.
DR. FITZMAURICE: You mean out of all of the boxes, I withdraw the product out of all of the boxes.
MR. LEVIN: Here I have 100, a bottle of 100 of some product and now that's withdrawn.
DR. FITZMAURICE: But I can still sell 50 of that product.
MR. LEVIN: If there's still 50 that's ok, but if now if I've withdrawn that product completely, now I can reuse all those series of codes again.
DR. FITZMAURICE: If you've withdrawn the box completely, but you still sell the same pills, can you reuse that box for a different product?
MR. LEVIN: No, that would have, you wouldn't be able to do that.
DR. FITZMAURICE: That's good.
MR. LEVIN: Again, these things are not controlled --.
DR. COHN: This sounds like a stand-up routine, people won't believe this.
MR. LEVIN: Anyway, that's a little bit about the NDC. We are working on improving the NDC so the NDC will be a good code for the packaged product, where it was originally intended to be, the packaged product.
DR. SUJANSKY: Just a quick question about the coverage of the NDF RT comprehensiveness if you will. Since it's based on the AID terminology formularies, specifically the formulary, does it include over the counter medications, pediatric medication and ob-gyn and other kinds of medications that might not be relevant to the VA formulary?
MR. BROWN: Plenty of ob's, some amount of things that could overlap with over the counter medications and not too much in the way of unique pediatric meds, but surely the same active ingredients. So I think the differences are probably not at the level of active ingredient, sort of how big the tablets are. And ob actually, you'd I think would be surprised to know how many women we take care of, which is a large percent and rapidly increasing in an area that is receiving a lot of attention at the department level.
DR. COHN: Randy, continue.
MR. LEVIN: Ok, when I was listening to Steve talk about some of the things that they needed and I went up to him after the meeting, I said that you know, a lot of this information you want, we have. It's in our label, it's in the product label, it's something that the manufacturer and the FDA put out and I described to him and here I'll show you this on the slide of how we currently make that information accessible so you can see how -- I explained this to Steve that you can just go to the label and it's all there.
We usually print this label on very tissue thin paper, used the font that you can see that 6 pt., which is pretty big actually for a label. Make sure that the paper is oversize, we don't want you to copy anything that easily or do a photocopy. We fold it up into a very small size and we paste it on the bottle. Many times we put it in a sealed carton, place it on a shelf in a pharmacy somewhere and we don't replace it if it needs to be updated. So this is how we made our current steps so if you want to talk about stand-up routine, this is what we currently do.
DR. COHN: It sure sounds like Jerry Seinfeld to me.
MR. LEVIN: I couldn't understand why Steve had a problem with this. Why can't you get the information? What's the problem? What's your point? That the package insert has this little tiny font and you have problems with it.
DR. FITZMAURICE: Randy? Did the manufacturers always make sure that you get the complete package insert for each drug so you have a file of packages inserts for every drug that's produced?
MR. LEVIN: Every drug has to have, they have to send us a package insert. We have the package insert for every product marketed in the United States.
DR. FITZMAURICE: So you could put that up on the web?
MR. LEVIN: Just like this.
DR. FITZMAURICE: Well, you could blow it up a little bit.
MR. LEVIN: This is how we have it.
DR. FITZMAURICE: You mean they don't give it to you in a text form or like a word processing form?
MR. LEVIN: They give us the package insert. They have to actually give us a sample of the package insert, so they take one of their package inserts, the long skinny things and they put it on, mount it on cardboard, and they send it to us. So we have all the package inserts, if you want to come look at them, we have them all.
DR. FITZMAURICE: But that's the information that says don't use this drug for this purpose it can hurt people.
MR. LEVIN: It has all the information, a lot of the information that Steve was talking about and Stuart's been talking about for what they want in the drug information is in this package insert.
DR. FITZMAURICE: And if you ask them to give you a word perfect or a word file of that would they do it?
MR. LEVIN: I'm going to get to that. Those are some of the things that we're looking at. Yes?
MR. BLAIR: As we move into the world where there's going to be more and more food supplements and herbal medicines and things like that, will the FDA also be gathering information about the active ingredients in those as well and require some form of accountability and publication codes?
MR. LEVIN: That's a good question. We are going to be, and I'll show you something in this presentation about how we're going to be handling ingredients for all of the products, as many products as we have information on, which includes a lot of the food supplements too.
MR. BLAIR: And maybe I should be asking also will that be in RxNorm as well?
MR. NELSON: It will, in fact all the over the counter pediatric and so forth, we have all of those, that somebody has named, one of our sources is named, we have that in the RxNorm, we're not making a distinction between the over the counter and the supplements. If it looks and acts like a drug then it's in there and we're trying to deal with it. It's the stuff that gives me gray hair.
MR. LEVIN: In the FDA, a food supplement is not considered a drug until the manufacturer want's to make a claim, a drug claim. If they claim, if they want to market their product with a drug claim, then they are handled as a drug. So if you have Vitamin E and you want to say that that's going to help you with dementia, it's a treatment for dementia, we handle that as a drug and we handle that just like any other drug. But if it's just a vitamin, it's handled differently.
MR. LEVIN: We have initiated three different efforts to try to improve access to our medication information. We want to make it more people friendly, computer friendly, and information system friendly, so the next slide talks about doing something to make it more people friendly. One, we have changed the organization of the labeling. Right now if you look at a label the very first thing that's on the label is the description, the structure. It will give you, this is a, give you the chemical name and show you the structure and while that's very important for the chemists, most of the physicians don't use that to make a determination whether to use this drug or not. So what we have done is gone to the users of labels and saying what kind of information do you commonly use from the labeling and trying to take that and reorganize the label so that information is up front. So when you open up, get the label, the most important things that you need are right up front. So that's one of the things that we're doing.
The other thing we're doing is highlighting key information that's inside the label and summarizing that in about a half page, that will be the very beginning of the label that would summarize, not summarize but provide key information about the label, such as what are the indications, where the contra indications, where the warnings, what's the dosing, how is it supplied, so that's right up front so you can see that, it's in a bullet form so that it's easy to read.
The other thing we're doing is getting labeling in electronic format, and that addresses your issue that we have proposed a rule that would require the companies to come in with labeling in electronic format. This will improve the readability of the labeling as well as improve the access and it helps us in many ways, also so we can compare different versions of labeling electronically. Right now we do get some labeling electronically in answer to your question before but this rule would require it to come in electronically.
DR. FITZMAURICE: Now we're familiar with regulations because we do a lot with HIPAA. Where's that regulation in the process now?
MR. LEVIN: The regulation right now is, it was proposed, the comment period is over, we had very few comments, we're addressing those comments and then we want to finalize that. So we're working on putting that back in final form. This has had a lot of support from the pharmaceutical companies because they too do not like this paper package insert and think that there's better ways to get that information out. They are very interested in moving to an electronic labeling as well. They're supportive of that activity.
MR. BLAIR: Could you give me some idea of what options there are for electronic labeling? Are you talking about bar codes, are you talking about what?
MR. LEVIN: The electronic labeling we're talking about right now would be taking the text, the content, that's all the figures, all the tables, all the text, and putting it into an electronic format. Right now we get that in a PDF format, a text based PDF format but we're looking at some other ways to getting that, and I'll show you some of those issues in the next slide, in a little bit. Does that answer your question?
MR. BLAIR: Well, I really didn't ask the question very clearly. Are you saying an electronic format on the particular package or on the particular container where the consumer is able to then wind up moving that into electronic format where they can wind up reading all this information or are you talking about separately the drug companies are sending to you in electronic format independent of the package the information. You're talking about the latter.
MR. LEVIN: It's the latter, independent of the package, but we want to use that as our method to try to improve access in general and this is what I'll show you through here that this is the whole effort is to try to get it out to people to have access to that electronic information.
The next slide just shows you an example of the highlight section from a product that takes the key information and puts it all into a very short area, half page, so that you can now as a prescriber get to a lot of the information that you need to have and then if you need more information you go into the body of the label. So this is one of the ways that we're trying to make the labeling more people friendly.
The next slide shows some of the things that we're trying to make the medication information more computer friendly so that the computer can actually read the label as well. One is that we're taking each section of the labeling and tagging it as a section so if you ask the computer to find the indication section for this label, it can go and find the indication section.
And the other piece is to actually structure is to tag elements within the, or key elements right within the text so we can tag the active ingredients. So if you ask the computer say well find the active ingredients in this label it will be able to read and find those active ingredients. So that's the way we're making the labeling more computer friendly.
So here are some of the structured labeling content. Basically what this is, is the label divided up into the various sections that we currently have. So there's a section on pediatric use, ask the computer to show me what the pediatric use is in this drug and it can bring up that section for you instead of you having to search through that. Or if you had a series of drugs you could ask it that way. Again, this is so the computer can read that and get that information out, how it should be used in pregnancy, what are the drug interactions, it would bring out these sections. But when it comes out to the section, the section is going to be text that you're going to have to read that the computer won't be able to read from this part.
The next slide shows how we're going to try and key in on some of the codes that we've been talking about from the products so we want to provide the ingredient code, strength and form so that, and hand that over to Stuart so that he can come up with the RxNorm and he can keep it up to date because every time we have a new product we hand it to Stuart over at the NLM and he can get those pieces of information from the label, it's all tagged, it's all computer readable, it's all in there.
We also will provide information about the imprint code. Now every solid finished dosage form, no two solid finished dosage forms are supposed to look alike, they're supposed to be different. One of the ways to make them different is to put a code, actually an imprint code on the solid dosage form. Some people have asked that they want an imprint code on every solid dosage form. Right now we don't have it on every one because a company can make a distinction between two solid dosage forms just by the color, shape or size. And that is very, two pills that are the same color, shape, but maybe differ by a millimeter, those are different, but you would never be able to distinguish that so a lot of people advocate an imprint code, that that be put on every solid dosage form. But if it has an imprint code it would be tagged and it would be in the label so that a computer can find that. Also, a product code and the national drug code. So the NDC code will be in the label tag so a computer can read that.
Here is an indication of how we want to work with the National Library of Medicine to build an ingredient coding system that can be used not just at the FDA but can be internationally used. At the FDA we get all the ingredients through, when a company is going to investigate a drug and the first time they give it to people, we get an application, they send it to us. They show us the structure, we assign it a unique code and put it into our system. Up to this point we have never released those codes, we use them internally. And what we're working on is a system that we can share those codes with the National Library of Medicine, that they will publish them so we can get those codes out so people can use them. One of the problems is, though, that we can only release the codes of the products that are marketed. Products that are still under investigation are confidential, we can't release any information about those products. And, there are many products that are outside the United States that are never even investigated in the United States and we would have no jurisdiction over those codes. But at the, NLM can see any code that's in the public domain, NLM can then request to us to assign a code to it and we will be able to assign a code in our system and give it out to the NLM. So that way even if it's not something marketed in the United States or if it's still under investigation in the United States, we can still provide the ingredients code and we'd have one database with these codes. We're working on that based on the structure, the structure of the molecule to identify a unique ingredient code. So that goes back to some of the questions about some of the other products that we have like food supplements because we're going to work with our food section of the center at the FDA and they're going to be included in this ingredient structure database, so we want to include them as well as products that are not marketed in the United States.
Now some of the other --.
DR. ZUBELDIA: Excuse me, you have about 53 new ingredient codes per year? Is that the number?
MR. LEVIN: We get many new ingredients codes, we get many because investigational products coming in all the time and they may not make it to marketed products so, but investigational products many times are in the public domain. We can't release that information, but if it's in the public domain then the National Library of Medicine can ask us for the code and we can provide that but because we are under our mandates as that we can't say anything about any investigational product.
MR. NELSON: May I say something about that? Essentially if it's a known structure we can put, the system will be that if it's a known structure we can put the structure in and get the code back. We don't have to say the FDA already knows about this and it's under investigation. It's just a meaningless identifier.
MR. LEVIN: We were hoping that that system would allow not just the U.S. ingredient but that would be, it can be used by anyone because the National Library of Medicine would be our link to the outside, things that are outside the U.S. domain.
I talked about some of the structured elements that we could put in to the labeling so that the computer can read it but these are some of the other things that we're interested in coding and the labeling so that a computer can understand it. For example interactions. If you take a drug and there's a contributing factor of some sort like you eat a meal and now what's the consequence of that. You're going to have decreased absorption. If we can code that or we can put that in a structured format, then a computer can read that and you can ask the computer what happens if I eat this or take this pill with a meal, what will happen? And then it will be able to tell you the answer.
So what we're trying to do is to take the information, a lot of the information, the key information that was in that structured highlights, and model it such that we can put it in a format that a computer can understand. And then we can update the label and continue it and then continue to send that information out so it's up to date and available.
So those are some of the things that Steve and Stuart have been talking about in their diagrams of all the reference terminology and to try to build that into the label so that we're updating it and making it available to people as part of our usual process.
So the final piece of this would be that the labeling, we're trying to make it information system friendly meaning that we don't know the best ways to present the information to people but we want to give people the information in a way that's better than the paper, that it's accessible, but then someone would take it from there and put it into their system that would feed the information to the public. So that's again, we're partnering with the National Library of Medicine to try to disseminate this information. They already distribute information about drug products and what we want to do is add these labels in the computer readable form to their distribution so that people can get that information in a way that they can just import into their information system, it includes all the marketed products, it's up to date, it comes directly from the FDA and the manufacturer and it's freely distributed. So that's our way of trying to make the medication information, information system friendly. Now if you go, yes?
DR. FITZMAURICE: This means that since you've got this structured labeling elements you know the NDC code for each label, for each package inserts, you can do a cross map, if I give you the NDC code you can go right to the package insert.
MR. LEVIN: That's right. Now one of the things is that we'll provide all this information. What we would like is that people would build the systems that will allow you to do, answer the questions that you have. We will have labeling on our web-site but we'll probably be addressing the issues of our, the people that come to the FDA web-site but people want all sorts of information from the product and we want them to find out the ways how to disseminate that information. Jeff?
MR. BLAIR: It reflects my ignorance here, but what is it that medra(?) codes have that you couldn't provide now with your NDC codes and this NDC file?
MR. LEVIN: Medra we're using, right now we're using for our post marketing safety reports. We use, we have a database where we take all of our post marketing safety reports and put them into our adverse event reporting system where we do our data mining and we do our surveillance of the adverse events. We needed a control terminology for how adverse events are expressed so we use Medra as our control terminology for adverse events.
MR. NELSON: Medra does not have any drug codes in it. It doesn't have drug names in it.
MR. LEVIN: It's just for adverse, we usually use it for adverse events.
MR. BLAIR: I guess I'm still not quite understanding. Because RxNorm has the active ingredients and you're improving the NDC codes so you can wind up having all this additional information. Why would those, both of these systems, not, what information does Medra have that you're not able?
MR. LEVIN: Medra is just a controlled terminology for adverse events.
MR. BROWN: It has more in common with something like COMED(?), it might have nausea or vomiting in it, but it doesn't have aspirin, 325 mg tablet. It's what happens, the problem that results from an adverse event, that gets coded with Medra.
MR. LEVIN: We just use that, right now we use it in our post marketing database so that we have control of the terminology for our adverse events, but we don't use it for anything about coding a product in any way. Now we see one benefit on the codes, if people report now adverse events and supply the codes back to us, then our surveillance capability would be much improved because right now people send back I had an adverse event with this product and they give us a name and many times it's misspelled or it's a brand name that's maybe from a European product that's not the same as U.S. and there's a lot of confusion along those lines. And now we're trying to exchange more of these adverse events internationally so it's good to have these codes that will allow us to build better dictionaries on ourselves. So we see a benefit coming back to us if we are able to have these codes used more widely.
So the information system friendly medication information, this is part of what Stuart has tagged the DailyMed Initiative and this is an NLM piece where it will have, it will include, though, the labeling that we have from the FDA and the manufacturers that will be disseminated and distributed by the National Library of Medicine and this has been a collaborative effort with the National Library of Medicine and the VA. And we look at this as also a collaborative effort with the health care information suppliers because they're the ones that are going to build the systems to get the information out.
If you go, why don't you go two slides, here is the outline of how we envision that, here are the four partners, the manufacturers, the FDA, National Library of Medicine and the health information suppliers. So the manufacturer sends us a change in their labeling and all changes have to come through the FDA. And then we have a system where we're going to review the labeling change, we put it into a database where we have these structured elements that we talked about as well as a structured labeling, we work with National Library of Medicine to use some common terminology and the VA and the Department of Defense and other people who come up with these common terminologies, try to use those, pass them on to the National Library of Medicine who will distribute them to the health information suppliers, who will then make them available to the public. So our effort is to get the information out of that paper and put into a computer friendly information system friendly system so that people can then make that information available to the public. That's the end.
DR. COHN: Any questions that haven't been asked so far?
DR. FITZMAURICE: Just a comment. This is a remarkable partnership between NLM, VA, FDA, the manufacturers, the information suppliers, it's just what public/private partnerships ought to be. I can see now why you didn't mind us laughing at your expense at your stand-up routine because you're providing a fix for all of those. This is quite remarkable.
DR. MCDONALD: This is Clem. Could I just kind of applaud too? That's spectacular.
MR. BLAIR: Let me get to one other piece here. You mentioned Medra deals with adverse events. I had the impression Medra was dealing with international drug enforcement.
MR. LEVIN: What happened, we have an organization, the FDA belongs to a group that's called the International Conference on Harmonization, which involves the EMEA, the Japanese regulatory health authorities, as well as the major pharmaceutical associations in those regions. We came up with a standard way of presenting adverse event reports, which we receive from the manufacturers. Part of that effort was to come up with some kind of terminology that we would all use when we report adverse events, just adverse events. So Medra was the medical terminology just for these adverse events. Since there was not a terminology at that time to use, at least that's what was described, they came up with Medra and are using that. So in a way that we can then communicate adverse event reports, so a drug company could or now international, report the same adverse event to all of the different regions using the same type of terminology. That was the idea behind Medra. So it's just a terminology, that's what Medra is.
DR. MCDONALD: Could I chime in? It really has an awful lot of symptoms, diagnoses, it's really fairly big. It's not a skimpy little terminology.
DR. COHN: Ok, Kepa, and then I have a question.
DR. ZUBELDIA: I'm going back to my hyphens. I have a concern now because under the HIPAA standards adoption of the NDC the five, four, two, I haven't seen the final rule but I believe that the recommendation was to use five, four, two with zeros inserted to make up the 11 digits and without hyphens.
MR. LEVIN: I've never seen it talked about without hyphens.
DR. ZUBELDIA: Would it work if it's without hyphens?
MR. LEVIN: Well one of the problems with the, another problem is bar coding. If you want to, right now the way the system is for bar coding it only allows for ten digits, so there would be an issue between something that has 11 digits, 11 digits won't fit on our current bar code standards, I mean the current bar codes that people use on their products. This is delinear bar codes. I'd have to look at that, the HIPAA rule, but it was, I don't think it was ever meant to be without the hyphens, it's three different codes.
DR. ZUBELDIA: If it is in fact without hyphens, are you saying that it won't work? That it needs to have, the hyphens need to be transmitted with the data?
MR. LEVIN: If the hyphens are with the, one is that we probably need more control over the NDC to make sure there's no redundancies but if you have, if you take away the hyphens, from the NDC, the companies couldn't assign the NDC's anymore, they would have to be centrally assigned. They wouldn't be able to do that, they need that labeler code, the very first part of the labeler code in order for that to be, for them to continue to be unique.
DR. ZUBELDIA: But if the presumption is that the format is five, four, two, and that's what the qualifier specifies, that the format is five, four, two, and that's specified by the qualifier that transmits the data as a data unit, do you still need the hyphens because it's fixed five, four, two, it cannot be interpreted in any other way.
MR. LEVIN: You need those hyphens to maintain that you would have the same, since it's really a ten digit number, it's a ten digit number, you're artificially adding that extra zero and someone else is going to add that extra zero on their product code and someone else is going to add it to the end of their pat labeler code and it's going to be, there could be overlap.
DR. COHN: I don't mean to get into this one but I don't know that Randy is necessarily the one to answer this question. I think this is actually a better question to ask of our NCPDP(?), our pharmacy colleagues I would think to see if there's some problem. I somehow have to believe that if there were major problems with drug identification with the rule they would have made a comment previously. That may be asking, assuming too much, but we should certainly ask them. I don't know that Randy is really, I don't want to get you off the hook, but.
MR. LEVIN: The issue actually has come because the 11 digit and ten digit has all been that there are three separate codes, and as long as it's separate, those three separate codes are all considered, there is no problem with redundancy. Once you remove the hyphens though then there's problems and what we have also a problem with is then if you remove those hyphens you have 11 digits, bar coding is an issue, not so much the identification which is in the database, that's not an issue, it's when you want to put in a bar code.
DR. COHN: Follow up with NCPDP. Is there another question on this particular item?
DR. FITZMAURICE: I read in the paper that the FDA is working on bar coding as a way to reduce drug errors and I wonder do you have any insight as to how FDA is going to solve this problem when they push for bar coding of drugs.
MR. LEVIN: We're looking at the different options but one of the options would be to, that we would have to take more control over the NDC in order for it to use bar coding because it doesn't read and those hyphens have to be dealt with because that information is not conveyed in a bar code. So that information has to be, both those issues have to be addressed.
DR. FITZMAURICE: So it's a problem FDA is working on.
DR. COHN: Let me ask a question because I'm listening to all of this stuff and I find it interesting, certainly much of it's very academic and I do appreciate that and I think there's some value here. But I'm not sure exactly what yet. Now my memory was that back when we did the original HIPAA rules we at one point said that the industry should abandon J codes and go to the NDC. And we have considerable resistance to that, in fact to the point that in our most recent proposed rule, we obviously suggested the industry go back to J codes but that there was work being done on a drug terminology that might meet the needs in a better way than J codes. Now I've heard a lot of things here but I'm not quite sure that I see a replacement for J codes. Or do I see a replacement for J codes? Are there ways to identify that somebody got an injection of 25 mg of a drug? Or am I still sort of left with well the bottle has 15 mg in it but I only gave him 25. I mean are we dealing with some of these issues or am I missing the point here? Do we have part of the solution but not all of it?
DR. ZUBELDIA: Can I add to that because another of the recommendations was relating to prescriptions and the prescriber doesn't prescribe an NDC code.
DR. COHN: He prescribes 30 mg of X. So tell me, do we have a solution here? Not to get in the way of your presentations but.
MR. NELSON: Well I think that the RxNorm form does address the prescription. I'm not quite sure how we're going to deal with Simon's problem of there was 25 mg was ordered but it came in 50, that's essentially 25 mg can be ordered and it can be taken out of a 50 mg vial and that's fine and I think that that's still a reasonable thing to say that they took half the vial. We're not representing what the vial is, we're representing what the concentration is. We say ok well this is 50 mg in two ml so it's 25 mg per ml so somebody orders 25 mg injectable, they get 1 ml. So we're representing the concentration. So I think that the implementation will support that type of thing that you're referring to. We don't really care how many pills are in the bottle or how many mg per and how many ml are in the vial we care about the concentration so that we can support the administration.
DR. MCDONALD: Can I chime in? This is Clem. I think that the J codes are really sort of a special case for billing and I would look at that as a historical remnant five years from now. It may or may not work with this, but this approach of sort of unifying the information from the PRD, well it used to be the PDR, the package insert to the prescriber, is just sort of a magnificent kind of opening to make everything better. So I don't think -- the J codes, because of regulatory, and there is one field for it, I don't have any idea whether this could replace it or not, and I don't really care -- it might -- and the neat thing about it is we could start with prescriptions and medications and writing orders and just unify all the knowledge. I mean it's just a great opening to the future.
DR. COHN: Clem, I don't have any disagreement but obviously we were hoping that this is replacing, eventually be a possible replacement and was actually listed not by name but by reference in one of the Notices of Proposed Rule Making. I think I'm seeing and Steve Brown actually put up an overhead here which leads me to believe Stuart's comment that actually does sounds like it's a solution.
DR. MCDONALD: Ok, good.
DR. COHN: At least as I understand looking at that particular piece.
MR. BROWN: There could be a variety of codes that could be applied at different levels. For instance in VA our pharmacists are going to care about packages and products but when I write for a medication, I really don't care so our order entry system should be able to accommodate my needs at the clinical drug level using RxNorm form and if the pharmacists wants to pull it out of a different package or whatever, fine, and let the system keep that straight. That's better for the computer to keep straight then for us and that may be some way where you get the 50 mg out of a larger vial and you know that there was 2 mls taken, you also know that it came from this bottle and there you go. So I think there are ways to do that and the idea is that there really are different entities, different abstractions that need different codes and that's what this column of stuff is all the way from active ingredient all the way down to the packaged product with finished dosage form and this sort of RxNorm clinical drug stuff in the middle.
We tried to address those needs with these codes here for the ingredient clinical drug and the package.
DR. COHN: Karen actually has a question at this point.
MS. TRUDEL: I'm just thinking about this in terms of administrative transactions. A number of the things that you're referring to as codes are rather voluminous and is there any consideration being given to assigning an analog non-intelligence numerical indicator that could mean the same thing as the RxNorm, which might be pretty big, that you could put in a claim and have it be less than 30 bytes long?
MR. NELSON: It's the unique identifier in the UMLS, which is a unique identifier and it's a meaningless number.
DR. COHN: How many digits is it?
MR. NELSON: It's few then ten, I think it's nine.
MR. LEVIN: And we're going to do the same with the ingredient, it will be a code, a meaningless identifier.
DR. COHN: I guess the other question is looking at this particular piece, and I'm actually looking, since we were just talking about the finished dosage form, the example I was giving, I was noticing that actually it's not part of the UMLS RxNorm project, is that correct? But is actually part of the VA reference terminology piece. Am I missing something?
MR. LEVIN: We won't get that piece until we all three come together to get the finished dosage forming code.
MR. NELSON: Where we have names for finished dosage forms, you know the trade name, the Valium 5 mg tablet in the UMLS, where we have those names, they all will have established relationships to an RxNorm form. We are trying to do the RxNorm forms really at the level of generic equivalence. But still at the same time, physicians order all the time, they order essentially a trade name and that sort of information is going to be there as well.
MR. LEVIN: And if you look at the chart here, the RxNorm comes right before the manufacturers put in their inactive ingredients and their mark on the drug, so this is before they put in any of their parts.
DR. COHN: Just to make sure I understand it sounds like we're getting closer but in terms of, regardless of whether it's ten digits, nine digits, eight digits, seven digits, we still have a way to go before we could really have a drug terminology that might be a viable replacement for what we currently have.
MR. NELSON: Ask in a year.
DR. COHN: Ok, that's good, thank you. Jeff?
MR. BLAIR: Stuart, it sounds like what you're describing using UMLS as a basis for RxNorm is a major evolution, major change in UMLS, at least as I understand it, so let me describe my understanding and you tell me whether I'm on track or not. UMLS was originally with the Mesh codes was originally established for the purpose of facilitating literature searches and you had the cooeys(?) and looeys(?), all of those things to facilitate that and it was a mapping to a lot of other code sets. But when people started to look at it originally and said well maybe this will be a data dictionary for electronic health records and folks said no, it's not exactly that purpose, but now you seem to be adapting it, at least in the area of drugs with RxNorm where it could begin to be used for patient care. Is this correct or am I not quite understanding what's happening?
MR. NELSON: I think you are correct in one statement. That this is quite revolutionary for UMLS but let me go back. The original purpose of the UMLS was to facilitate inter-operation with all sorts of electronic systems for all sorts of information and data related to health, which is why it went out and picked up all these different vocabularies to be included in it.
MR. BLAIR: So it's broader than just literature.
MR. NELSON: Always, from day one, it was broader than literature. It's interesting because when I wore my other hat as head of medical subject headings and people asked me is UMLS going to replace the medical subject headings the answer is quite clearly no. That the medical subject headings have a unique structure and are formulated precisely for one purpose, organizing knowledge and information and supporting the retrieval of it. The UMLS was always bigger that it in that regard. Now when the UMLS was originally built, we talked about the notion of navigating from one vocabulary to another, that the idea was that you would use the UMLS, you would go in with some idea, some name, and find the name that was appropriate in the appropriate vocabulary. That goes back to a paper that I wrote a long time ago called, it was something about semantic locality. Now nobody has ever really used the UMLS all that well in terms of being able to navigate from one to another partly because the relationships have never been well established. What is happening now in the drug vocabulary is that we are setting out and saying we're making a concerted effort to establish all those relationships in the drug vocabulary. We've never, we can do this because it's a circumscribed portion of the UMLS. It's a little harder to do it if you look at it and say we've got 800,000 concepts here and we have to develop mapping for all of them. But if we say ok well we have 80,000 here and we can do this in a way that we can leverage our computer applications to make it feasible to do that and it looks like a reasonable target, so I think that's what's revolutionary or evolutionary if you will in the UMLS view of the world.
DR. COHN: I think it's getting to be way beyond time, no Michael I think we're done with our questions. I think what we're going to do is to wrap up at this point. I really want to thank our presenters, I think you've done a great job. It sounds like we are, we need to follow you along, it sounds like we may be able to hear from you again in the next six, eight months, maybe with some definite progress. Obviously I think you can hear we have a variety of interests here, some of which is electronic medical record, some of which is order entry, some of which is solving some problems we have with the HIPAA transactions, obviously we wish you the best and we'll be rooting for you.
MR. BLAIR: Outstanding progress.
DR. COHN: Outstanding progress and I want to thank you very much. Ok, we stand adjourned.
MR. BLAIR: Susan Beebe has?
DR. COHN: Oh, I'm sorry, Susan?
MS. BURKE-BEEBE: There was an email that came around to the members and staff that had two files to prepare for tomorrows agenda. It ended up being a three page document and an excel spreadsheet that is actually six sheets. Those documents are behind me if anyone would like to pick them up from the staff and the members if they want to review them tonight. And they will be available tomorrow.
MR. BLAIR: Could I strongly encourage that the members of the subcommittee, if you haven't had a chance to review those documents, it would really be helpful if you look them over before our session tomorrow because there's a lot of information there.
DR. COHN: Jeff, thank you for reminding me. And Suzie, thank you. This meeting stands adjourned until 9:00 tomorrow morning.
[Whereupon, at 5:30 p.m., the meeting was adjourned, to reconvene at 9:00 a.m., the following morning, October 23, 2002.]