[This Transcript is Unedited]
Hubert H. Humphrey Building
Room 705-A
200 Independence Avenue. S.W.
Washington, DC 20201
Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, Suite 160
Fairfax, Virginia 22030
(703) 352-0091
Call to Order, Introductions & Announcements - Simon Cohn, M.D., Jeff Blair
DSMO Reports - Maria Ward
ASCA Database and Best Practices - Subcommittee Discussion
Improving the HIPAA Process - Jack Rovner, Maria Ward
Scope of Work for Cost/Benefit Analysis For Migration to ICD-10-CM and ICD-10-PCS - Subcommittee Discussion
Preparation for Complementary and Alternative Medicine Hearings in January 2003 - Richard Nahin, M.D.
DR. COHN: Good morning everyone. Happy post Thanksgiving and holidays. I want to call this meeting to order. This is the first day of two days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The Committee is the main public advisory Committee to the U.S. Department of Health and Human Services on national health information policy. I am Simon Cohn, Chairman of the Subcommittee and a member of the full Committee. I am also the National Director for Health Information Policy for Kaiser Permanente.
I want to welcome fellow Committee, Subcommittee members, HHS staff, and others here in person. I also want to welcome those listening in on the internet. And I want to remind everyone, as I usually do, to make sure to speak clearly and into the microphone so people on the internet can hear us. I also want to welcome for the last time Brady Augustine, who will be I think going off the Committee after this meeting, so obviously we’re pleased to have you here. Sorry that you’re going to be moving off to CMS, but we’re also delighted for you in your new occupation.
This morning, I just want to go through sort of the issues we’re going to be discussing very briefly in the agenda, and then we’ll do introductions around the room. This morning we’re focusing on the HIPAA electronic transaction standards final rule. We start with a report from Maria Ward, who is Chair-person of the Designated Standards and Maintenance Organization Steering Committee, who will present the yearly report and recommendations.
Afterwards, we hope, I think there’s some question about the timing on this, but we hope to have the presentation of the full analysis on the ASCA database that CMS has been developing. As you know our responsibility is to identify implementation issues coming from an analysis of that database and published reports on effective solutions to compliance problems identified. Now I will just warn everyone that apparently there seems to be some problem in the communication in terms of getting some of the early reports to us this morning, so either we’ll have it at the time of that conservation or we may need to flip the agenda around a little bit and handle it either later today or tomorrow.
After the morning break we have Jack Rovner and Maria Ward will be back to talk some about the issue of improving the HIPAA process. I think all of you recognize that that has been an issue on the Subcommittee’s sort of to do list, and it really isn’t just improving it, it’s the issue of really stabilizing the process as we move forward. In sort of looking forward to beginning that conversation today, we’re likely to spend a half day on it also in January, when we again hold hearings.
Now in the afternoon we will discuss the scope of work for the cost/benefit analysis for ICD-10-CM and for PCS in the context of it being used for in-patient hospital procedure reporting.
Finally we will discuss the upcoming January hearings on provider and payer needs for code sets for complementary and alternative medicine.
Tomorrow we will discuss the scope and criteria of our work on PMRI terminologies, and we’ll be asking Jeff Blair to lead that session, which we’re thankful that you’re taking the lead in that area.
With that, let’s have introductions around the table, and then around the room. As is usual, I would ask those on the National Committee as part of your introduction, if there are any issues coming before us today that you have any conflict about, let us know and publicly recuse yourself at that time. Jeff would you like to start with the introductions?
MR. BLAIR: Jeff Blair, Vice President of the Medical Records Institute, Vice Chair of the Subcommittee. I’m a member of HIMSIS, HL7, ASTM, and AMIA(?) and there’s nothing that I can think of to recuse myself.
MR. AUGUSTINE: Brady Augustine, Biostatistician and Medical Economist from Gambro Healthcare, member of the Committee, member of the Subcommittee.
DR. FITZMAURICE: Michael Fitzmaurice, Senior Science Advisor for Information Technology, 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, Senior Advisor for Standards and Vocabularies, Center for Disease Control and Prevention, staff to the Subcommittee.
DR. FERRER: Jorge Ferrer, Medical Officer, CMS, staff on a number of the NCVHS Subcommittees.
MS. WARD: Maria Ward, Price Waterhouse Coopers, representing Health Level 7, and Chairing the DSMO Steering Committee.
MS. AULD: Vivian Auld, National Library of Medicine, staff to the Committee.
MS. BEBEE: Suzie Bebee, Health Informatics Specialist with the National Center for Health Statistics, CDC, and staff to the Subcommittee.
MS. GREENBERG: Marjorie Greenberg, NCHS, CDC, and Executive Secretary to the Committee.
MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services, staff to the Subcommittee.
MS. SQUIRE: Marietta Squire, NCHS and staff to the Subcommittee.
DR. SUJANSKI: Walter Sujanski, Independent Consultant and Advisor to the Subcommittee on issues of terminology standards for patient medical record information.
MS. PICKETT: Donna Pickett, National Center for Health Statistics, staff to the Subcommittee.
MS. BARTLOW(?): Melissa Bartlow, Association of Health Plans.
MS. WALWORTH(?): Shelley Walworth, Unicorn Medical.
MS. SCHULMAN(?): Roslyn Schulman, American Hospital Association.
MR. EMERY: Jack Emery of the American Medical Association.
MS. MOLINA: Synthia Molina, CEO of Alternative Link.
MS. GIANINI: Melinna Gianini, President of Alternative Link and Board Member of the Foundation for Integrative Health Care.
DR. COHN: And I should just announce since I’m asking people to publicly recuse themselves that I’m a member of the CPT editorial panel and therefore I will be recusing myself, not so much from the discussion related to the January hearings, but I’ve actually asked Kepa and Stan to sort of chair that discussion because of any apparent conflicts of interest. I won’t participate in the discussion as much as I’m interested in making sure that questions that need to be answered will be answered in the hearings and that will be my role in that conversation.
I guess I should ask if that’s ok with the Subcommittee. Ok, well with that, Maria would you like to lead off with the DMSO Report?
MS. WARD: Good morning and thank you for the opportunity to provide the Committee with the annual DSMO Progress Report as is required by the Memorandum of Understanding signed by all DSMO’s and HHS. In this update will address three major areas of work that the DSMO Steering Committee has undertaken over the past year. Number one, DSMO change request volumes and status from July 2001 to November 2002. Number two, non-change request initiatives undertaken by the DSMO’s. And number three, specific DSMO requests that warrant additional consideration due to the nature of the request. An example of this would be the request to standardize insurance cards.
This has been an extremely busy year for all covered entities that are in the process of implementing the X-12N and NCPDP transactions adopted by HHS for HIPAA. As a result of the increased level of awareness, and activity around these transactions, the DSMO’s have been equally busy in trying to accommodate all reasonable requests for changes to the implementation guides adopted for use under HIPAA. In addition to this, we’ve become involved in many other activities, such as working with codes that maintainers, interested in having their code sets named as standards, supporting HHS in the NPRM comment period for the addenda, NCPDP and NDC changes, and discussing new requests made through the DSMO process that the potential to affect all covered entities exchanging these transactions.
We believe that we’ve been successful in all these endeavors and of the recommendations coming from the DSMO’s have and will continue to serve the health care community, as well as move forward with HIPAA implementation.
The first item that I’m going to talk about here is the DSMO change request volumes and status. The numbers reflected in this update represent change requests starting in July 2001 and continuing through November 2002. We elected to begin with July 2001 since that was the first monthly batch of requests that was not part of the fast track process that began in December of 2000. The July 2001 through April 2002 batches have completed the process and the following totals are for that time period.
There were a total of 143 change requests entered from July 2001 through April 2002, and then beneath that we’ve indicated the disposition of those. Nine of the 143 were withdrawn by the administrator before the DSMO discussion and that’s usually been when somebody enters two or three words on a request and then doesn’t finish it, or somebody gets confused, or maybe two or three or four requests come in for the exact same thing because they entered it several times. So Washington Publishing has the ability to sort of weed out those kinds of things for us.
52 were withdrawn by the submitter before it entered the DSMO discussion period. And 82 were the total number completed through the process. Below that you see that there was one appeal withdrawn by the submitter and five appeals that were denied. Included as an appendix to this report is a detailed breakdown of all the change requests that were completed through the DSMO process including the DSMO responses.
In summary, these requests were categorized as follows. And that’s the bound handout that you have. I don’t know if you want to get too caught up in the detail, but those are all of the change requests that I’m referencing here, and then their DSMO response.
31 requests were classified as modifications necessary to permit compliance with the standard. According to HHS, necessary items include something in the adopted standard or implementation specification conflicts with the regulation, a non-existent data element or code set is required by the standard, removal of data content that is not supported by the health care industry any longer essentially, a data element or code set that’s critical to the industry’s business process, and has been left out, there’s a conflict among different adopted standards, or there’s an internal conflict within the standard.
Four requests were classified as maintenance which is defined as items that do not impact the implementation of the transactions. Items classified as maintenance will require no further DSMO action. Items are to follow the standards development organization process.
47 items were classified as no change. That being items that the implementation guides do meet the needs requested or did go through the consensus building process originally to meet the need. May request follow-up by the submitter for further action. That really talks about the opportunity to appeal by the submitter if the original disposition wasn’t something that they were comfortable with.
In the appendix you will see the complete listing of categories and their definitions, a guide to reading the DSMO requests, and the actual requests sorted by category type.
In addition to the requests referenced above, there are batches from May 2002 through November 2002 that have not yet completed the process and are therefore not included in the volumes I just discussed. There are an additional 88 change requests that fall into this category.
The second work item that we have been addressing this year is regarding non-change request initiatives undertaken by the DSMO’s. As stated previously, the DSMO’s have also been engaged in a number of other activities throughout the year. We believe that it’s important for the NCVHS, as well as the industry, to be aware of these activities. Below is a listing and a brief description of each of the activities referred to here.
Number one, first and foremost, the DSMO Steering Committee assisted the Department of Health and Human Services for preparing for and responding to comments on the proposed rules for addenda to the X-12N version 4010, and changes for NCPDP and NDC. This proved to be a significant undertaking, not only on the DSMO Steering Committee, but also on each of the individual DSMO Committees who had to consult with their members throughout the process. We met weekly for two to three hours and sometimes even up to three times per week in an effort to respond to public comments on these NPRM’s. Coupled with the individual committee meetings required and preparation for each of the DSMO meetings, this became nearly a full time job for some of the DSMO’s throughout the summer. As a result of this process, we recognized that there’s room for improvement, if and when we are called upon to do this again.
There were some significant challenges that we faced in this comment response process, in particular X-12N is currently addressing items they consider to be issues with the process. Once they have completed their analysis of the issues, they will bring that to the Steering Committee and we will address those issues as a Committee.
We believe that it was appropriate to be involved since the NPRM addressed issues that were a result of the DSMO process. We also feel that it is important for the NCVHS and HHS to recognize the significant effort that was required to make the NPRM process and subsequent final rule successful. As mentioned earlier, and also requested by CMS in a letter to the DSMO’s following the comment response period, we will be addressing any issues around this process that the Steering Committee feels require attention.
Item number two, the DSMO’s have also been working to develop guidelines for those requesting that new code sets be names as HIPAA standards. DSMO believes that prospective terminology maintainers should meet the guiding principles that were expected of all the current maintainers of the selected HIPAA standards. For example, to improve the efficiency and effectiveness of the health care system, by leading to cost reductions for or improvements in, benefits from electronic health care transactions.
In addition to meeting these guiding principles, we believe that there should be every effort made to consider the use of existing code sets to meet the business needs before adopting additional code sets. We believe that these requests are different enough from data element requests that the process available to the public for making such requests should be tailored to meet the specific need. We are working on the final draft of the code set guidance and also with Washington Publishing Company so that it can be added to the DSMO web-site.
Item number three, the DSMO’s are in the final stages developing a charter for the Steering Committee. In this charter we will formally document the operating procedures of the DSMO Steering Committee, including its organization, officers, voting procedures, and meeting guidelines.
Number four. The DSMO Steering Committee has been working for some time now to develop a new contract that can be signed with Washington Publishing Company for the maintenance of the DSMO web-site. The DSMO web-site has been operating for two years now and the Steering Committee feels strongly that some kind of formal written agreement between Washington Publishing Company and all the DSMO organizations needs to be in place. Because we are not a legal entity, it has been a challenge trying to come to agreement on how this should happen. We’ve discussed multiple possibilities regarding the issue and have not yet come to closure on it. Some of the DSMO organizations have also engaged their legal counsel on this issue and we are still working through the details.
The third significant work item undertaken this year involves requests affecting all HIPAA stakeholders. While the vast majority of DSMO change requests have been adjudicated, that have been adjudicated, address data element or segment changes. There have been several that are much more significant and have potential to affect all entities involved in HIPAA. Because these particular change requests are so significant, the DSMO’s have invested a great deal of time discussing them, both at the Steering Committee level and within the individual DSMO organizations.
We believe that the requests of this nature warrant a separate resolution process. In light of this the DSMO Steering Committee will also be developing a process to consider requests that fit into this category. The requests considered this year are provided below.
Number one, NCPDP submitted two change requests regarding the use of their standard. The first was to allow the use of the NCPDP standard for the billing of professional pharmacy services. That specific request was denied by the DSMO but the recommendation was to continue current business practices. The second was to allow the use of the NCPDP standard for the billing of supplies, and that was request was supported.
Number two, there were several change requests entered by the same submitter that requested the adoption of new transaction sets under HIPAA. All of these items that I’ll discuss under number two came actually from the same organization and the same submitter. The first of which was the health care benefit coordination verification request and response transaction be adopted as a new standard under HIPAA, that’s the X-12-269. In short what that is, is a transaction that goes from a primary payer to a secondary payer to indicate the EOB information so secondary payers don’t request paper EOB’s from the provider.
The second request from that submitter was the 277 unsolicited implementation guide or standard as an acknowledgement. The same requester also submitted requests for mandating electronic funds transfer and for the use of standard ID cards.
The third request was made to replace the NCPDP standard for claims with a specification that was developed by one sector of the pharmacy community. This change request has not yet been adjudicated by the Steering Committee.
Again, the DSMO’s feel that the nature of these requests were so significant that a separate process, in particular different timeframes, should be established for considering them, just as we are doing with the consideration of new code sets.
In closing, I would like to thank you for your attention and your continued support and guidance as we work through the initial years of implementing the HIPAA standards. It has been an honor to lead this group of dedicated and extremely hard working volunteering organizations over the past year. And I’m certainly happy to take questions.
DR. COHN: Well, Maria, first of all, thank you very much and I want to sort of acknowledge your efforts as Chair of the DSMO group this year. I know it’s hard to sort of bring together a group of diverse views and diverse interests into a single organization, but we really appreciate your leadership on all of that. And we know that this is probably not been the easiest year on record but we really do want to thank you and the other standards developmental organizations that have been participating in the efforts. So please make sure that you convey that back to the various respected organizations also.
MS. WARD: Thank you, Simon.
DR. COHN: Now, are there questions or comments, and welcome Stan Huff, questions or comments from the Subcommittee? Michael.
DR. FITZMAURICE: One kind of a technical nature, on page four you talk about the DSMO’s are in the final stages of developing a charter, and then in the next paragraph, paragraph four, because we’re not a legal entity it’s been a challenge. Once you have a charter, can you then apply for some kind of status such as a non-profit status and then become a legal entity, and that might help resolve this problem that’s in paragraph four?
MS. WARD: The contract, yes. The reference to not being a legal entity is the challenge of signing a contract with Washington Publishing Company. The answer to your question, I don’t know, we haven’t really discussed I think the desire for or the possibility of going down that path.
DR. FITZMAURICE: But it may be that you want the charter to reflect what the requirements would be under the contract so that you’d say we’re chartered to do this thing. So there might be a tie-in that they should consider.
MS. WARD: That’s a possibility. We’re considering some creative alternatives right now at the advice of legal counsel of some of our organizations as well. But that isn’t something we’ve discussed, that is a possibility.
DR. FITZMAURICE: And along with Simon I’d like to say, praise the great work of the DSMO’s, without the DSMO process we’d probably have to have another, maybe not another government department, but another government officer certainly, and we probably might not be as good at understanding and developing solutions as you have been. So thank you.
MS. WARD: Thank you.
DR. COHN: Steve?
DR. STEINDEL: Maria, thank you for your wonderful report. As a person who is just recently started to sit on a DSMO, I’ve become aware from the other side of the tremendous work you’ve been doing, and the Steering Committee has been doing in this process. And second, both Simon and Mike’s comments on the excellent work. I have a couple of questions. Number one, I noticed with Washington Publishing you were talking about setting code sets guidance. Would you be willing to share that with the Subcommittee? Because the Subcommittee is also looking at PMRI terminology, and we think this might be helpful in our deliberations. Thank you.
MS. WARD: And just so you know for clarification, Washington Publishing’s role in that would really just be sort of getting it out there on the web-site for us, so it will really be the work product of the DSMO.
DR. STEINDEL: Right, I think it would be useful for us. And then in the requests, that significant DSMO requests affecting all HIPAA stakeholders, you mention a standard ID card. What do you mean by that? Is that just respect to the electronic transfer of funds, because it’s in that paragraph or in general?
MS. WARD: It was a request that came in from a covered entity, I believe they represented, actually I think they represent both a health plan and payer mix, and the request, I’m trying to think now if it’s even in your appendix handout, it may not be. The request itself was for, with no reference to electronic funds transfer or any of the transactions, it was actually a request for a standard for health care identification cards in this country. And so that’s why it sort of fell in that bucket of well we can’t just quick talk about this for half an hour and come up with a recommendation for that. So that was literally something that came to us from a member of the health care community, a covered entity under HIPAA.
DR. STEINDEL: Thank you.
DR. COHN: Other questions? Well, Maria, I guess I have a question or two. Karen, why don’t you go first?
MS. TRUDEL: Maria, now that you’ve had a chance to look at a fairly broad range of requests, how does the skill set of the people who are actually doing the work line up with the kinds of requests you’re getting? I guess I’m asking which ones are easier and which ones are harder, and if there’s some that are harder, is there a way that the skill sets could be augmented some?
MS. WARD: Referring to the skill sets of the members of the Committee?
MS. TRUDEL: Or whoever’s actually doing the research and participating in the discussions, yes. I guess I’m saying are the ones like the request for a brand new clinical code set or a health insurance ID card standard, are they much more of a challenge than the ones that are asking you to have whatever it is repeat a 100 times rather than 50 times?
MS. WARD: Yes, absolutely, I think the way you’ve summarized that, that that’s accurate, which is why I tried to segment out those kinds of requests that we found took a great deal of time in discussing, both with our own Committees and then back to the DSMO Steering Committee. So the request for standard ID cards, or even the request example for mandating electronic funds transfer. Right now the 835 accommodates that but there’s no requirement on a payer or a health plan to engage in electronic funds transfer. So those are more significant, you have to really make a concerted effort to go back to the affected entities and understand how that will impact them.
And I think my only experiences with the Committee where I’m very involved in HL7, very involved in the NUCC as a member of the NUCC, and pretty involved in X-12, as a member of X-12, so I had the opportunity to see how those Committee’s deal with these in their own Committee level and I think that it’s working well. And I think that what needs to be done is getting done within those Committee’s. I can’t speak for the other Committee’s because I don’t have the opportunity to observe their process, their individual process that closely. But I think that’s why we’re suggesting there might be a separate process around those more complicated and probably more universally affecting everybody in this covered entity status if you will, a separate process around dealing with those requests.
DR. COHN: Michael?
DR. FITZMAURICE: We’ve asked and you’ve given us a good report on how the process works and milestones, volumes, on the other hand, you’ve given us your output and we’ve taken it as input and we have yet to give you output. Speaking that the addendum is not still out, do you have suggestions or maybe curious questions about the process once we give it and any tips for us on how we might either speed things along or be open with what the drawbacks are and maybe get additional information to speed along those drawbacks?
MS. WARD: Right. I think your question probably will lead into the next discussion as well, right? Just generally around improving the process around, and certainly I have given that a lot of thought, members of the Committee have given that a lot of thought. We saw a number of comments that came in through the NPRM period that actually didn’t have anything to do with the proposed addendum but said things like fix this process, make this work faster, this is not benefiting the health care community, just really unrelated to actual addenda type subjects. I think that our expectation is that the Committee does everything in its power to influence and to make sure that what needs to get done gets done as quickly as possible. I’ve never really been party to any conservation that would imply there’s any kind of a breakdown at this level.
Although, you make an interesting point in our responsibility to sort of advise and update and provide status for you and maybe there’s some room for us, sort of get that people kind of feedback back from you in terms of how we are operating as a Committee. I think that’s important to us, too, to understand, and we hear your, like today, your sort of compliments I guess on our work and on our process, but there’s always room for improvement, and I think that that’s important for us to know when the Committee thinks that there’s something that we could or should be doing differently, we could or should be doing better.
Now, back to improving the process, I have several points that I’ve sort of made note of in expectation of talking about that when Jack Rovner’s here. I don’t know if you want to get into, I mean I think there’s a lot of things that we can talk about around that.
DR. COHN: Why don’t we talk about now and then we’ll if we have time we’ll get into those other comments that you have. I agree with you it would make more sense to have Jack here, to have the two of you sort of discuss some of them as we go forward.
Maria, I guess I have a question on, and I’m sort of looking at what we have and obviously the, maybe I’ll be asking some of the same questions Mike is asking, but clearly issue number one is sort of stabilizing things and moving towards the actual implementation. What’s your view of the process that the DSMO’s are going to have to go through when we actually start moving new versions of the implementation guides, new versions of the standards? I mean is the thing going to turn out to be one of those big areas that’s going to require a different process or do you see it that that actually fits very well into the process? And what is your view of the timeframe when we actually need to be towards, looking to for that?
MS. WARD: I wish I could answer that, I’d like to answer that both ways. I’d like for it to fit into a process that’s very expedited and quick and done so we can keep moving. But at the same time, when we are, for example, considering the use of the 269 as a new transaction set, or version 4050 or some subsequent version of X-12N, right now our process calls for any of those future versions actually going through the DSMO. So they wouldn’t make it, the Secretary essentially wouldn’t adopt the next version of anything until it went through the DSMO, the recommendations came to the Committee, sort of the same process we have right now. And I think if X-12 were to say we want to introduce version 4050, it probably won’t be 4050 but a subsequent version of the implementation guides. And there’s a suite of them, and there are eight of them, let’s say. I don’t think it’s reasonable to expect that within 90 days we have analyzed all of the data, any implications, and looking how one transaction affects the different transaction, looking at how NCPDP actually does inter-relate with X-12 in terms of some of their transactions. And certainly HL7 has a relationship to X-12 in terms of some of those transactions. So to explore all of those things in a 90 day period and come up with a very sound recommendation on adopting the next version, I don’t think is very reasonable. So that says that it probably would require additional time, but at the same time, that’s the last thing we want to do is keep adding additional time onto our processes because that’s one of the biggest problems I think we have right now.
So I think, and I think the Committee agrees, that that’s going to be one of those things we carve out, for example, new versions and new transactions, that we carve out and try and develop some guidelines around or some guidance around how to consider those change requests.
DR. COHN: I guess sort of following up on that, do you sort of, I mean right now do you have a single process that works for any change request coming in, be it a small request or a giant request? Move from X-12 to something else completely would still be in that request. Is your view that in the near future you’re going to be moving to sort of a grading A, B, and C type of request with different ways of handling each? And maybe a D for code sets?
MS. WARD: Yes, and that was actually implied in my testimony, that there is this separate sort of grouping of requests that warrant a different kind of a process. And those processes haven’t been worked through yet or developed yet, we’re actually just coming to the realization, having gone through this this year, that there are some items, like new versions, like should be replace the NCPDP standard for claims in pharmacy. That’s not an insignificant thing, that’s not add a loop or add patient weight to the claim, that’s a very different kind of issue, so yes, it is our expectation that there will be sort of the typical add data content type things, or add structural type things to existing transactions. And then a different kind of a process, probably involving different time frames around the more complex universal kinds of requests regarding transaction versions and replacing transactions and brining on new transactions. I think that that is the understanding of the Committee right now.
DR. COHN: Ok. I think we would appreciate when you come up with how you’re going to handle all these things and how you grade them, if you could either send us a communication back about how this process is going to be changed or your thoughts on that, I think we’d be very interested.
MS. WARD: Absolutely.
DR. COHN: Now other piece, and the other question I have has to do with, obviously you’ve been dealing at a very specific level with a lot of these standards that we’re moving forward for October full implementation. Is there anything that you are seeing, and once again I’m asking you as a representative of the DSMO’s, so far that is something that we should be, is a major, should be of major concern to us in terms of either stabilizing or ambiguities or otherwise for the implementation coming up in October?
MS. WARD: I think that in the context of X-12, I think that the addenda do a very good job at addressing a lot the significant holes if you will that were in the 4010. What is becoming frustrating to covered entities, and this is really sort of not my official DSMO capacity, but in my person who deals with implementers, who is constantly on HIPAA related list serves, what I’m seeing a lot of traffic about is the timing of this. In other words, the final rule for addenda is not out yet. There are very few organizations that are investing in programming to and beginning to test with training partners on the addenda because there is no final rule. They’re waiting for the final rule to begin to do that. They all know it’s there, they know what the changes are, but they’re not investing in moving forward. And the expectation that they will begin testing on April 1 for the ASCA requirements when it’s mid-December and there’s still no final rule, that’s beginning to frustrate covered entities. I mean, realistically speaking, that’s probably the biggest frustration. It’s being able to get that final rule, absorb it, make whatever changes you have to make, and then set up a testing schedule and begin testing with your training partners in essentially three months. I think that’s going to be a challenge. I’m sure Karen’s heard similar stories.
DR. COHN: I think one of our CMS representatives is nodding her head in sort of agreement on that.
MS. WARD: So that isn’t a statement about anybody’s willingness or desire to really get things done and get them done the right way, it’s just the way it is right now.
DR. COHN: Ok. Now are there other issues beyond the X-12 implementation that are things that we need to be concerned about?
MS. WARD: In terms of implementation for next year?
DR. COHN: For October.
MS. WARD: I think probably the biggest issue around this, not even specifically tied to a final rule, is just the volume of testing that needs to take place before everybody can actually turn the switch on October 1. And there are a variety of vehicles to assist covered entities in that endeavor, testing vendors and certification vendors, and those provide certainly some level of assistance in all of this. But the reality is if you can’t move data between trading partners, you’re not going to get paid if you’re a provider. You’re not going to be able to do what you need to do around eligibility and enrolling and all of the stuff that these transactions represent. So I think that to expect the entire industry, between trading partners, to be not only tested but in production, in fairly short order when you think about the volume of trading partners there are, I think that that’s going to be an interesting thing to observe over the next 10 months.
And I also, for what it’s worth, I think everybody is very invested in doing this, and nobody is sort of sitting back and taking a lackadaisical approach to it, I mean I really think people are trying very hard to do what they need to do for October of next year. But there’s been, particularly around the changes in the last year and a half, there’s been a whole lot of flux in all this, and so the element of stability is something that people I think are sorely looking for in all of this. And you know what? This is the growing pains of getting through this in the in initial round. I think that it will be much easier in subsequent, once we’ve got our feet on the ground and we’re moving with this, it will probably continue to get easier and easier. I hope. No more fast tracks, no more addenda.
DR. COHN: Other questions? Karen?
MS. TRUDEL: Maria, could you talk a little bit about the request for an alternate NCPDP implementation guide for the members that may not be aware of the issue there?
MS. WARD: Sure. I actually had the opportunity to hear members from, they're not even an organized if you will, it’s not like it’s a group or an organization, it’s a number of the actual pharmacies, pharmacy associations and retail pharmacists, that are members of NCPDP, but that sort of got together and created a specification and proposed it as an alternative to the NCPDP standard for claims. And their rationale for doing this was that the usage of data elements in the NCPDP standard right now, many of them are optional. And apparently, under the privacy regulation, there is concern on their part about sending data that is not either required or situationally defined, as the X-12 implementation guides are. So they got together and they created a specification and offered through the DSMO process and as I understand from talking to them, they have also appeared before the Committee at some point. I think it’s been over a year, quite honestly. I saw a chronology of events that were part of this development and a gentleman from the National Association of Chain Drug Stores talked about speaking to the Committee on this particular topic. They are apparently very concerned about exchanging data that’s defined as optional and thinking from the pharmacy perspective that they will be in violation of the minimum necessary requirements.
DR. COHN: And actually I’m trying to think in my own mind whether that was testimony before the Subcommittee on Standards and Security or the Subcommittee on Privacy.
MS. WARD. I don’t know. You know Simon, they came to NUCC about a month ago, I don’t know if you were not in the room, or I don’t know. But that’s where I learned a little bit more about this in talking to that group. NCPDP predictably had some very strong and good arguments as to why they believe this was not an acceptable approach to standard claim for retail pharmacy, and probably the strongest argument that they made and certainly one that I am in support of, is that there was absolutely no sort of consensus if you will or process from the industry around this, in so much as it was just one sector of the. It wasn’t all of the stuff that comes with ANSI accredited kind of organization in terms of balloting and rules and membership and consensus. It was sort of one group of that industry going off and writing a specification that they believe should replace NCPDP. Now that hasn’t come through the full cycle yet, so we haven’t had our DSMO discussion on that yet, but I believe all the individual Committee’s have had their Committee discussions on that particular item.
But that will be interesting because there is some leeway for adopting standards that are not developed through ASNI accredited organizations if they meet certain criteria. So it will be interesting to see how this evolves.
DR. COHN: And just to clarify, my understanding is that that’s actually a new implementation guide as actually as opposed to a new standard. Is that correct?
MS. WARD: You know Simon, technically, I mean if you want to be literal about it from the standards world, I don’t know what you’d call it. It’s not coming out of a standards and accredited standards organizations. It’s sort of if you were to say Kaiser got together with this group and that group and the other group and the other group and they said here, we think this is better than the NCPDP one. It isn’t any formal group, certainly not ASNI accredited or a standards development group. So it’s intended to replace whatever’s out there right now for NCPDP, that was the intent, or claim, NCPDP claim.
DR. COHN: Just to make sure that I understand, because I actually did sit through a presentation about all this stuff, but was the intent actually that this be implemented in time for the October implementation date? Unfortunately, if we’re going to have this discussion, we ought to have NCPDP here to discuss it. But if it becomes an issue we’ll obviously be happy to invite all interested parties, but it does sound like it’s in the middle of process right now.
MS. WARD: Right, it’s certainly in the middle of our process. I think that they would have the developers of the specification would have like to see that, but just if you look at a calendar you realize that that’s not realistic for that to be something that would supercede, I don’t even know what kind of regulatory or other action would have to take place to enable that. So I honestly think one of their bigger issues is around the privacy requirements and the minimum necessary versus the NCPDP, but then you sort of get into a lot of that’s open to interpretation and how people are interpreting.
DR. COHN: Maria, thank you. Michael?
DR. FITZMAURICE: I must say that there are a lot of things that I hear around hearings, I’m not sure I fully understand because I don’t have the background of the people testifying or people around them. On this one I’ve heard, as Simon has, different testimony, and some of the concern I think centers on the use of patient identifiable information, that is identifying the patients names, maybe addresses, and so forth. Is that true? Is that one of the focuses?
MS. WARD: I believe some of those elements are the ones that have a usage defined as optional. So in other words, if it was required, that’s a question I asked of them. If these were all label required would you have the same concerns and the answer was no. It’s because of their usage as optional in the standard, or in the implementation.
DR. FITZMAURICE: So it’s not the concern over having the name and say addresses or something on the claim itself and then that makes the claim information more valuable for other purposes, such as marketing, such as disease management and so forth. It’s a technical issue of whether it’s an optional or a required or a situational variable. It seems to me that a lot of things have to hinge upon the value of the data in uses. That a technical argument could be resolved in a back room somewhere and then reported out. But the use of the data for purposes other than paying claims may make it much more valuable and therefore there may be more at stake than just a technical argument.
MS. WARD: I think with the technical argument, what they’re doing is they’re directly linking the technical argument to the minimum necessary provisions of the privacy rule, therefore saying pharmacies will be in violation or potentially in violation of the minimum necessary if they provide this patient identifiable data that is not “required.” It is optional, up to trading partner agreement on whether or not to send. That is the main premise of the argument they made to the Committee that I heard when they argued it. It was about the minimum necessary provisions of the privacy rule and optional data.
DR. FITZMAURICE: And so incentives dealing with the value of the data, with or without those identifying information elements, doesn’t seem to be a part of the argument.
MS. WARD: There was not a tremendous amount of discussion about that. Again, in the context in which I heard it, which was at the NUCC.
DR. COHN: Karen, do you have a comment on this one also?
MS. TRUDEL: I think the arguments are very inextricably tied together. In some of the correspondence that the Department has been receiving, the concern about the use of certain data elements like email address and the fact that that would be a very appealing piece of data to have for marketing purposes, did raise a concern. The thought was back there some where.
DR. FITZMAURICE: Thank you Karen, that’s helpful.
DR. COHN: Brady?
MR. AUGUSTINE: That’s what I needed to know. What type of information are we talking about here?
MS. TRUDEL: I don’t have a list of the specific data elements that are of concern to the various parties, but certainly demographic data like name, address, phone number, email address, certain things like that were mentioned.
MS. WARD: Right. There’s actually a fair amount of documentation around this issue that came from the group that developed this alternative classification. If you all are interested in considering that a lot of that was forwarded to the DSMO in support of the request. I’d be more than happy to forward that on to the Committee if you’re interested. I don’t know if their intent is to appear before the Committee again on this subject, I don’t know.
MR. BLAIR: When this issue came up had the group that was raising the concern about the violation or potential violation of the minimum necessary rule, had they already gone through exploring this with the Office of Civil Rights and gotten some type of an opinion or ruling that in fact it really was an issue?
MS. WARD: I don’t know the answer to that Jeff. Karen might know better than I because I know they were working with the Department on some level as well.
MS. TRUDEL: There is a specific discussion about this issue in the preamble to the first privacy regulation that specifically talks about the distinction between situational and optional data elements, and was very clear on how each one was to be treated. So I believe that that probably was the origin of the issue.
MS. WARD: Another thing that NCPDP did when it was brought to their attention that this was a concern by the constituency was they went through the process of creating, I don’t know what they call them, technically what they call them, but supporting documents if you will to the standards so they could actually try and define situations around these optional fields and provide guidance so that that hopefully could alleviate some if not all of the issues. So I know NCPDP exerted a fair amount of energy in trying to sort of narrow in on that and provide some additional clarification in situations around the optional fields. I do believe that’s available to folks that are implementing their transactions.
DR. COHN: Michael, is it on this issue?
DR. FITZMAURICE: Yes. I’m wondering about the relationship to the claim and the claim payment. I wonder that something like a patients email address would be important for a claim payment. On the other hand, a payer might say I will pay you more money on your claim if it has specific personally identifiable information that enables me to undertake certain processes. And so it might influence the claim payment, not because of the value of the drug per se, but because of the value of the information obtained.
MS. WARD: Right. The example that you give is a very good one. I don’t know to what extent they have had conversations about sort of the motivations or incentives if you will, other than what is being sort of stated as the obvious optional minimum necessary. There is, obviously from a technical perspective, there’s a direct relationship between the X-12 claim payment transaction and the NCPDP claim transaction. If you have, and in fact they do, required data elements on the payment transaction, I think you’ll all recall that before NCPDP the standard payment advice is the X-12 under HIPAA, it’s not the NCPDP. So you’ve got an X-12 payment advice that requires, for example, name. But you’ve got an NCPDP transaction that might not give you the name. One way or the other you’re going to have a problem with technical compliance to the standard. So that was sort of my reference to making sure that the standards organizations as we go through the evolution of these transactions, the standards organizations are working together too. NCPDP and X-12 are working very closely on the claim payment and claim issues that have been identified. Just from working with Margaret Weicker(?) and the folks at X-12 I know that that’s something that’s already something that’s underway.
DR. COHN: I am going to make a comment on this one because I think it’s very possible for us to spend a lot time talking about this specific issue, and it’s obviously inappropriate without having all the players in the room to really explain it. My own view is is that what we want to do is we want to support the DSMO process in terms of arriving at a reasonable solution, adjudicating this particular issue. And so Maria the real question is as it goes forward if there are any issues that you need to bring forward or your successor needs to be forward to the Subcommittee, we’re obviously here and happy to discuss it. But I really do want to sort of say geez, this is not an NCVHS issue at this moment, this is still going through the DSMO process, and I think only at such time as it is unresolved or there are outstanding major issues, at that point I think we should get involved, but probably not until then. I presume that would be your --
MS. WARD: I agree. At least at this point, that’s sort of the process that we’ve all agreed to. I suspect that it will be resolved, but one way or the other, one constituency is going to be very unhappy about the resolution, so it may find its way to a bigger forum here just from either NCPDP or the folks who wrote the specification, it may find its way here just from some level of dissatisfaction with the ultimate resolution.
DR. COHN: Are there any other issues? I just want to take a minute and talk about the next, really I guess it’s going to be ten months, 11 months, I think there’s 11 months between now and October 15, which is the implementation date. And certainly, as I’ve commented, I think we want to be, first of all we feel very much responsible for helping to ensure a successful implementation. Even though we know CMS at the end of the day and obviously everyone in the industry really needs to be the ones doing it, certainly we are on call if there are major issues that appear to be show stoppers or appear to be sort of intractable issues in the industry. So I mean obviously I know that you’re going to be I believe stepping down from your position but remaining on the DSMO activities next year, but you can certainly communicate to the DSMO Steering Committee that if indeed there are issues we will put them into whatever agenda that we need to to get them heard and try to give guidance on resolution as we can. I also know CMS in their Office of, HIPAA Office, standards ready to help and help ensure the successful implementation also. So just know that we’re behind you on all if this.
MS. WARD: And CMS is a very active participant in the DSMO, so there’s very little that takes place in our organization that doesn’t almost immediately get elevated if we think that needs to happen, so we’ve got a great communication there with them. I’m sure we will probably find reason to take you up, in the next 11 months, to take you up on that offer.
DR. COHN: Other questions? Well, Maria, I want to thank you, and as I understand this is sort of the end of your term as Chair-person --
MS. WARD: It’s my Christmas present.
DR. COHN: Well, we really want to thank you, we think you’ve done a great job, so everybody give her a round of applause.
[Applause.]
MS. WARD: Thank you, Simon.
DR. FITZMAURICE: Simon? Might we inquire if there’s been an election and we know who the new Chairman will be?
MS. WARD: Yes, there has been an election. The way our process works right now is the Vice Chair holds that position for a year and then becomes the Chair, and that will be the American Dental Association Dental Content Committee, that organization, Frank McCorny(?) from that organization. We have not yet determined who his Vice Chair will be, that’s going to happen next month.
DR. COHN: Well, hopefully you might stand for election for that one.
MS. WARD: Don’t give anybody any ideas.
DR. COHN: Maria, I think the one other thing just in terms of sort of a heads up, I think as you know the Subcommittee has been deeply involved with a number of different code sets issues. And obviously, as part of the HIPAA process, we’re obviously looking for input and others from the DSMO groups as we move forward on any of those. So certainly I notice that you’re in the process of developing sort of a set of principles in relationship to the code sets, we’d obviously be very interested in that as you develop those, and for more than just the PMRI issues, but just generally, I think we would be interested. And certainly as we begin to get involved in ICD and others I think we will be wanting to hear the DSMO perspective on some of this.
MS. WARD: Just about a week or so ago I had a conversation with folks at CMS asking, essentially indicating that they wanted to bring the ICD-10 issue to and through the DSMO, so I think we’ll probably see that on our task list very shortly. So whenever, I think probably whenever the Committee feels like they’re ready to have that discussion we can do what we need to do to support you in that. So maybe we’ll just talk to you about the timing of that and when you’d like to hear from us on that.
DR. COHN: Are you here for the day or just for the morning?
MS. WARD: I’ll be here for most of the day.
DR. COHN: Ok, because this afternoon we’re going to be talking some about the ICD scope, quick turn around cost/benefit, and as part of that conversation we may be I think sort of looking at when we think we’re going to have that study done and it may be appropriate in the context of that to figure out when it makes sense to hear formally from the DSMO’s about that.
Other issues on DSMO? Maria, thank you so much. I think we will move now to talk about the ASCA database and best practices and I want to thank Karen for to put it mildly, the just in time reports there. Which for those on the internet, you have to realize that it was basically put in front of us about five minutes ago. You want to talk a little bit about the sorts of reports and where we are with the reporting process?
MS. TRUDEL: Yes, and I do apologize for the last minute delivery. Apparently the contractors email was not working yesterday and they thought that we had it and we didn’t.
What I asked them to do was to look at the database of the ASCA requests, and if you recall we had over 500,000 that had come in electronically. We had another possibly 50,000 that we had on paper. We have had people going through since the deadline, since the deadline ended, and keying in those paper requests. And I’m going to step back a second and explain to people that ASCA is the Administrative Simplification Compliance Act, which was passed last December, and it gave people the opportunity to submit a request for a one year delay in the implementation of the HIPAA transactions and code sets. They needed to do so by October 15th of this year, and they needed to do so by providing certain pieces of information that would give us an idea of what was happening with respect to national compliance and also the ASCA statute tasked the National Committee with looking at these results and trying to come up with some possible assistance to address compliance challenges. So that’s what we’re doing now, we’re just beginning to look at some of this data to see what it tells the Subcommittee about what compliance problems there should be and what solutions should be provided.
The data is a little bit raw, it’s a little bit rough, and the reports are a little bit hard to read, but let me just summarize. We also had the contractor un-duplicate the database, there were a number of people who for one reason or another submitted multiple requests. In some cases they didn’t realize that they had already received a confirmation. In some cases they felt that they had made mistakes and they had to change something, and so they entered again. Although we were entering a lot of the paper ones that we received, the total that we’re reporting on here is roughly 540,000, something like that.
I asked them to supply a breakdown of the budget question, where we asked for a variety of ranges where people would estimate what they thought implementing HIPAA would cost and those that said less than $10,000 was about 196,000. About another 110,000 said between $10,000 and $100,000. 27,000 said between $100,000 and $500,000. About 8,000 said between $500,000 and one million. And then over a million was about 11,000. 189,000 said that they didn’t know. So obviously most people are spending either less than $10,000 or $10,000 to $100,000 or they just weren’t able to tell us at that time.
MR. BLAIR: Should we ask questions now?
MS. TRUDEL: Why don’t we ask questions as we go?
MR. BLAIR: In our favorite category, the one that’s over a million, you said there was 11,000 folks that, 11,000 respondents, has there been any analysis, or can we do any analysis to find out whether that represents, heaven forbid, 11,000 institutions?
MS. TRUDEL: We certainly can do a breakout. This is an initial, sort of an introduction to the Subcommittee members of what is in the database and what can be done with the database. I would say that what I’m hoping to take away from this session is some questions and some things that you want to drill down into.
MR. AUGUSTINE: From my understanding on the form, like for my company, when they submitted, they would submit one time and then would attach all the clinics, we have 600 clinics that would go into one filing. Therefore if my company spent over a million dollars it would include 600 clinics. Would that show up once or would that show up 600 times?
MS. TRUDEL: It would show up 600 times. And then the whole Medicare fee for service program will show up as one time, too.
MR. BLAIR: Then maybe I’ll just ask the general question of do you feel like we could make an additional cut at the data so that we can begin to get a better feeling by the size of the institution, what kind of implementation cost their expecting to deal with?
MS. TRUDEL: Sure.
DR. COHN: Steve was that --
DR. STEINDEL: That was basically my question, too, a cut of this data with regard to some practice characteristics, size of institution, size of practice, type of practice.
MS. TRUDEL: Ok, now that we do not have. We didn’t ask anybody about their size, but we can do type.
DR. STEINDEL: Whatever demographic data that you have that you can break this down further.
MR. AUGUSTINE: Like in the instance of my company, could we split it like a per clinic cost or per location cost?
DR. COHN: You know what? My understanding is I think that organizations had the option to do as you described, submit 600 times, or they could have also just submit once.
MR. AUGUSTINE: We submitted once, which includes you list them all.
MS. TRUDEL: And they all appear separately, they all appear as a separate.
MR. AUGUSTINE: Even though you only had one submission.
MS. TRUDEL: Yes. We can try to do some refinement there, where if we begin to see, for instance if we did an additional un-duplication on either the name of the organization or the name of the authorized party, we could distill that down a little bit more. I would need to talk to the programmers on how to do it, but I’ll check on that.
MR. AUGUSTINE: Like what Jeff said, I’m just very sensitive to the million dollar and above costs in the movement of Administrative Simplification. I’d just like to better understand who’s in that bucket.
MS. TRUDEL: Right, ok, so who’s in the bucket for over a million.
MR. AUGUSTINE: Can I ask a question about the next section or do you want to move on to that?
MS. TRUDEL: Does anyone have any other points to make about that first one?
The second point is I asked for a tabulation of the number of covered entities who said they were using a contractor or vendor, or would use. 158,000 said yes. 65,000 said no. And about 215,000 said they were undecided.
MR. AUGUSTINE: That’s concerning, that about 48 percent don’t know if they’re going to need help yet or not. That’s concerning me.
DR. STEINDEL: Karen, as some breakdown information on that, I’d like to know how many of the undecided are don’t know in the budget category. Because I think there might be a correlation there. And then also the correlation between the budget category and the people who said yes, they’re using a contractor.
MS. TRUDEL: Ok. The other thing that I think I’m going to ask them to do is to provide a breakout of that undecided in terms of when the requests were filed. Because the request that was filed last May, if they were undecided, does not bother me nearly so much as one who keyed their information in on the 15th of October and is still undecided.
DR. STEINDEL: And also by demographic category, too.
MR. BLAIR: I really don’t remember all the questions that we asked, so I don’t know if it’s possible to do this. But especially for the folks that are going to spend more than a million dollars, is there any data that we have in there where we could flesh out whether that is just to implement the transactions sets or whether that involves broader process enhancements, business process improvements, and that, beyond just migration to the transactions sets?
MS. TRUDEL: We didn’t ask that question, Jeff. We did make it clear was that all we expected them to give us was the cost of implementing transactions and code sets as opposed to privacy and security. But whether people are just doing the minimum necessary to implement the transactions, or just the claim, and whether they’re doing a lot of business process re-engineering to take advantage of some of the benefits, was not something that we ask, even try to quantify.
DR. STEINDEL: Well, we didn’t directly answer it, I think we can find some inference on it if we look at the budget categories versus the reasons for delay, for looking at people who are saying they need more staff, need more hardware, need more systems, and then all fall into the million dollar category, that might be saying something. I don’t know, it’s on quick cross tab on SAS.
MR. AUGUSTINE: When they provide this next time --
MS. TRUDEL: If I give you the database will you volunteer to do this?
DR. STEINDEL: If you give it to me right now, I can run, I’ve got SAS on my computer, we could have it at lunch time.
MR. BLAIR: The other thing that we might do is there might be a very small subset out of that 11,000 that are almost like outliers, where they’re especially high, and maybe we could just do some direct follow-up with the individuals that responded to say, try to understand why it might be so high to see if that leads into the general process re-engineering business.
DR. COHN: Well, I think we just had a box that was over a million, wasn’t it? We didn’t actually ask people to put specific numbers there, so it’s hard to know. I guess I’m sort of scratching my head, remember I represent Kaiser Permanente, we take care of eight million people, we have 30 hospitals, 120,000 employees, so I’m looking at the one million and I’m sort of wondering, that’s doesn’t sound very high. And Stan Huff represents Inter-Mountain Health Care, has what, 20 some hospitals?
DR. HUFF: 22.
DR. COHN: 22. I suspect that you’re probably spending more than a million dollars on HIPAA implementation also.
DR. HUFF: We are. The other thing that strikes home is that it will be very difficult, if you ask the number you’re going to get a big number and there is going to be a bunch of re-engineering and other things that go into there. I know within our own institution, once the budget category is there and it’s mandated in some way, people tend to flock to that as a way to get projects that they haven’t been able to fund otherwise, and they float it under that banner and so, I know in our case, yes, it could well be over a million dollars. It wouldn’t be unexpected because if you looked at the budget, for us doing financial transactions over the last ten years, that’s probably been one or two million dollars a year for a long time, and now people are saying that’s all HIPAA. I think it would be very hard to separate out the true costs versus the incremental cost to what they were doing in terms of EDI, financial transactions before that.
MS. TRUDEL: This is Karen again. I agree, and I know we’ve had those same discussions within CMS. Is something EDI or is it HIPAA? And at some point, we stop having HIPAA and it just becomes the way we do EDI, but we’re not really there yet.
DR. FITZMAURICE: I would suggest taking the undecided out of the budget categories and seeing if those who think they know how they’re going to do it with or without a contractor, might be interesting to look at those cost figures to see if there’s any difference between the two. But again, like Karen, like Stan, I take the numbers with a grain of salt, they may be the best estimates but they may also include other things. It’s hard to get anything definitive from these numbers.
DR. STEINDEL: Karen, as a quick reality check, I haven’t totaled it up, but if we just look at the over one million category we’re talking about over $10 billion dollars to implement HIPAA, and just a quick addition of the others, we’re probably talking about $20 to $30 billion dollars that the people are estimating of those that have decided. How does that compare to the original cost estimates?
MR. AUGUSTINE: Steve, let me clarify something, like in the example of my company, we show up 600 times in there, but only one million dollars. So this number, that 10,000 is probably closer to 1,000 or 500 or something.
DR. STEINDEL: That’s why I was asking as a kind of reality check on the number that appears here.
MS. TRUDEL: My mind is going blank on what was in the cost estimate, so I can’t --
DR. STEINDEL: Mine is, too, I was trying to picture it as well and I couldn’t.
MR. BLAIR: I thought it was $4.5 billion, wasn’t it?
DR. STEINDEL: I thought it was quite a bit less than $20 billion. So I think this is an interesting reality check on these numbers, because I agree with the comments that Stan and Simon have made, I think there’s, and Karen reinforced, that there’s a lot within these budget estimates that may not be directly related to implementing the transaction, that it’s going to be an excuse to re-engineer business. And one of the things that actually HIPAA was intended to do was make people think about re-engineering their business, so that’s not necessarily a negative statement.
MS. TRUDEL: Shall we move on? The next breakout that I had asked for was on the reasons for delay, and again, people could check as many of these as they thought was appropriate. Understandably, the results tended to cluster around several of these. The one that’s marked needs standards, which is about 250,000, I believe that’s an abbreviation for needs more information about the standards. Waiting for vendor, 254,000. Need more time, 368,000. Need time to test, 226,000. And need additional clarification on standards, 185,000. Those were people based on the additional guidance we gave, who were waiting for the addenda, need more additional clarification on standards.
Interestingly enough, problems completing additional data requirements was relatively low. That was 51,000. Problems implementing new clinical code sets, 36,000, and probably a lot of that had to do with local codes. And the money, staff, and hardware were fairly low, less than 100,000 for each of those.
MR. AUGUSTINE: This is better than I thought it would be. Most of these are just people waiting for things, they’re not like systems issues.
DR. STEINDEL: Karen, this is my ignorance, this was a check all that applies question?
MS. TRUDEL: Yes.
DR. STEINDEL: So there’s probably a lot who are checking multiple weight categories, because they all seem to correlate with each other.
MS. TRUDEL: Yes, I think, I’m trying to remember the CMS extension request, I know we checked need time to test and need additional clarification on standards because we were waiting for the addenda in some cases, too. And of other, there were only 46,000. Any additional comments on that?
I also asked them to do a distribution of the month and year that testing would start and the month and year that testing would be completed by. And it sort of raises some questions about the data, considering that about 20 covered entities said that they had started testing in months before the HIPAA legislation was passed, that is prior to August of 1996. We had several, we had five eager beavers who started eight months early, and went on from there.
DR. COHN: Is that an interpretation that they might have using X-12 standards already?
MS. TRUDEL: Could be, could be.
DR. COHN: We should give them an award as opposed to comments.
MR. AUGUSTINE: This could be one of those infamous data entry errors, too.
MS. TRUDEL: It could definitely be. The number that are beginning to test then steadily picks up starting in December of 2000 and by January of this year it’s doing pretty well. By April 2002 we got 9,000 in a month. August of 2002, 10,000 in a month. September, 20,000. October, 39,000. November, 22,000 and so on until April when we have a huge spike of 211,000 in one month. So these are not added to obviously numbers, we can redo it that way if that’s what you’d like to see.
MR. BLAIR: Actually, probably what I’d like to see would be what percentage of the total respondents will be starting on or before April, and if it gets to 80, 90, 95 percent then that’s --
MS. TRUDEL: It’s going to have to, people would not have entered anything after April because the ASCA, that’s when they’re supposed to have, that’s the requirement, right.
MR. BLAIR: So they did when they responded show that they were, then you’ve basically answered my question.
MS. TRUDEL: However, the entities completed testing data was not similarly limited, and so some people are saying into 2004.
DR. COHN: Is there a way to identify who those are and send them a letter reminding them that the due date is October of ’03? No.
MR. AUGUSTINE: There’s a big spike in October of ’03.
MS. TRUDEL: No. I would repeat, the enforcement process is complaint driven. However, the majority of the, the vast majority of the respondents would be compliant in time and when I have these re-run I will have them re-run it as percentages of the total, I think that’s a good idea, Jeff. It gives you a much better view.
So what do I do next?
MR. AUGUSTINE: When you get those re-run, can you run them as cross tabs? Because really, of these major categories, that’s going to tell us a lot of the information.
MR. BLAIR: The other thing that I think would be helpful to us is getting a profile of the other end of the spectrum, which is the small solo practices. What kind of a profile do we get on those in terms of their readiness and how much they’re spending? I’ve just always felt this concern about the perception that HIPAA is a burden on small solo practices. I think that information would be helpful.
MS. TRUDEL: Again, we didn’t ask for practice size because we, we couldn’t figure out how to proxy it. It would have been net revenue, or gross revenue, receipts or something like that. And we were trying to keep this reporting requirement something that people wouldn’t mind telling us. And we thought that was a little bit on the sensitive side. So the only proxy we have for size at all would be either provider type where physician practice could be a one physician office or it could be the Mayo Clinic, or the amount of expenditure. You’re making an assumption there that a small office is going to spend less and that’s not necessarily the case. So I’m kind of not sure how to get where you want to be.
MS. GREENBERG: Simon?
DR. COHN: Yes, Marjorie.
MS. GREENBERG: First, thank you for the information here, it’s interesting. What I’m wondering is if there’s anything, I mean some of the things we know what the solutions are, now that the final standards out. But if there’s anything here that might guide, testimony that we need to receive, or solicit for the January meeting, like do we want to hear from, are we planning to or do we need to hear from vendors and clearinghouses? This whole testing issue that Maria brought up, also I heard a very interesting presentation on that by Larry Watkins at the NADO(?) meeting last week, and it was sobering to say the least. He kept referring to this as, I guess he has a number of children, he kept referring to this as transition. Sort of like when you’re in transition, it’s stressful but you just have to forward, you can’t stop.
But I think, I actually thought he might be here today, but I guess not, but I think, and perhaps some of what he reported is going to be discussed, since I know you all work together, but later, improving the HIPAA process. But I felt that what his testimony or his presentation was worth sharing with the Subcommittee, because there were a lot of concerns about the --
MR. BLAIR: Marjorie, was this information from WEDI that Larry was presenting?
DR. COHN: Or Claredi?
MS. GREENBERG: I think it was a combination, it was actually, it was a session on HIPAA and it was on the new health care service data reporting guide actually, but he was talking more generally about what all the challenges are to implementing HIPAA. In particular, the issues related to the testing and we can probably, I can, we can get a copy of his testimony. For some reason, as I said, I was under the impression that he was actually going to be here for this hearing. But as I said, I found it rather sobering.
So I’m just wondering, since we are obligated to provide solutions or best practices, etc., and a number of people are here waiting for their vendors, or waiting for their clearinghouses and need time to test, whether we just need to pursue that a little bit more. I mean that seems to be the one area where maybe guidance or best practices or whatever could be provided.
On some of the others, needs of standards and need additional clarification on standards, there’s really not too much we can do other than press for the final rule. I mean not that many really are saying problems completing additional data requirements. It seems to me the testing, the need to do the testing with all of ones business partners, as Maria suggested, is probably the big area where maybe guidance, best practices, etc., needs to be disseminated. Maria may get me out of this.
DR. COHN: Maria?
MS. WARD: I think that you’re right Marjorie, but I also think that the waiting categories, waiting for vendor, waiting for clearinghouse, are absolutely tied to the addenda, because the vendors and the clearinghouses aren’t ready to jump full speed into a version that hasn’t been mandated yet. So you’re waiting for clarification on the standards, which is addenda, but so are your vendors and your clearinghouses. So the covered entities, the providers and the payers are just playing a big waiting game basically. So I think it’s all, if you’re talking about best practices and what we can do, what we need to do is get the rule out. And then all of the waiting goes away.
MS. GREENBERG: That’s an easy one for the Committee. I’m just wondering if there’s something else we can be doing.
DR. COHN: I think Marjorie, this is one obviously we’ve been thinking about a fair amount and I think we had talked in a previous hearing, previous meeting about the issue, our concern around vendors. And my understanding was that it was actually Kepa, who obviously is not here right now, but will be here later this afternoon, was I think having a meeting with AFACT(?), with the vendors to try to get a better handle on that. So maybe we need to talk to him about that. I think at our January hearing we’re going to be spending some time both talking about it, another discussion about improving the HIPAA process. But probably a piece of that is asking for issues that have to do with being successful between now and October. And I think you’re reflecting on a number of them right now. And it’s also a good transition to the other issue, which is are there things that we can do around publishing because if we don’t watch out we’ll be publishing after it doesn’t matter anymore. Other things that we can do to publish, since that’s one of our responsibilities, that might be helpful to the industry. Which I think is something that you’re beginning to bring up.
And I guess I would just ask the group, are there things that you think would be helpful? I think what we’re, what Karen and I had been talking about is potentially putting something on our NCVHS web-site, probably it involves links or probably also, and may involve sort of a listing of those sites where we think best practices are, and maybe there’s some additional information that we can provide, which is sort of our idea of what the publishing of best practices might be. Is that a reasonable or useful frame? And maybe we could also get a link from the CMS HIPAA web-site to that spot, or vice versa. Is that sort of the frame of publication? And hopefully, I’m seeing many people nodding their heads, is that? And obviously one of the things I think we’re going to take to WEDI and others about is are there some things that they have or do we just connect in with their web-site and give a description of the web-site, and that will be one of the questions.
MS. GREENBERG: That’s actually my concern. If we don’t, we’re told we’re supposed to disseminate solutions and best practices, and if we don’t address that pretty quickly it’s not going to be that helpful.
DR. COHN: Yes. Maria?
MS. WARD: In reference to, you were talking about perhaps speaking with WEDI around best practices and some of these issues with implementing HIPAA, I think that it’s ok for me to say this now. There is a joint effort that was underway for about the last three or four months between WEDI and the Council for Affordable Quality Healthcare, CAQH, which are 26 of the largest health plans in the country who sort of work together to develop standard ways of doing things so that their shared provider base has a common way of doing certain things. They’re working on credentialing and formularies and things like that.
But WEDI and CAQH teamed up and my role in this was actually, it was a project of mine from my day job at PWC. WEDI and CAQH teamed up to come up with best practices document for the thing we call companion guides that are used to supplement the X-12N implementation guides. And they also came up with a template where the hope is that all covered entities, particularly health plans, will issue their testing and implementation schedules in one central web-site location that we’re going to support, so that anybody implementing can go out there and see when is Anthem, when is Prudential, when is United Health Care, when is so forth and so on, going to implement tests and implement each of the transactions.
So that, again, that’s a joint WEDI, CAQH initiative and it’s just beginning to be publicized now and we’re hoping to have it roll out and be ready for the world in the beginning of January. So I would strongly support I think those two initiatives being something that were also part of your, if your looking for best practices, part of what you look for. They’ve done a really great job as industry representative organizations in pulling this together in the last three months.
DR. COHN: Well, thank you. It sounds like you’ve been doing good work during your day job.
DR. FITZMAURICE: Maria, did you call this CAQH?
MS. WARD: Yes, it’s the Council for Affordable Quality Healthcare. They’re CAQH.org if you’re interested in seeing what they’re doing, but again, the biggies, one of the real interesting ones is coming up with a common credentialing format for all payers and that’s something that they’re starting to roll out, CAQH is also, so they do great things on their own, but this joint initiative around trying to help people into the areas around transactions for HIPAA that we thought were really important, testing and companion guides, we hope will be very valuable. But the biggest challenge will be getting the word out and then getting people to actually -– they’re likely to say hey this is a good idea, I think the support of the committee in that would be very helpful.
DR. COHN: Great. Any questions? Brady?
MR. AUGUSTINE: I just want to say I think that’s a really good initiative. It’s always good when industry comes together to kind of develop their own standards and we see it in the hospital industry with NAHIT and in managed care, and I guess it was, we pushed down on them and so they realized and they started developing their own organizations to support themselves, and that’s heartening to see.
DR. COHN: Agreed. Ok, please.
MS. TRUDEL: Before we finish I will have these additional reports prepared and sent to everyone. Is there any other research that you want staff to be doing between now and our next meeting?
DR. COHN: Well, I guess my comment would be it would be nice if we had mocked up something, and not necessarily a web-page, but something that began to put the resources that we’re talking about together so that we can look at them at our January hearing with the idea being that we could soon after January get something up on the NCVHS web-site that relates to the publication.
MS. GREENBERG: Who’s our web-master? I work with I guess Catherine Jones on our, the NCVHS team, who works with our contractor. Suzie is that something maybe you could work with Karen on?
DR. COHN: Yes, because I think we’re all in agreement that if we wait too much beyond the January hearing dates, this is going to be sort of less than relevant. Does that make sense? Ok. Suzie?
MS. BEBEE: Just a question to Maria. Hi Maria. You mentioned that there would be a posting of the results of your project. I wasn’t sure if that was going to be a Price Waterhouse Coopers or if that was WEDI who is going to be posting that?
MS. WARD: Actually, what’s going to be posted is not the results of the project, but one of the initiatives is for all health plans, to encourage all health plans to post their testing and implementation schedules on one central location. So what the group did was they created a template for that and then the trick is to get health plans to get out there and populate the template for each of their transactions. That will be hosted, we’re pretty sure, on a WEDI web-site that will also link to CAQH but it will be a separate section of the WEDI web-site that is sort of titled WEDI/CAQH Joint Initiative. But the intent is that it’s sort of one stop shopping for when is everybody implementing all of these and testing all of these, and it’s all right there for everybody to see.
If you’re at all interested in that, Simon, I think we’re about a day or two short of having final documentation on all of this, including mock-ups and everything. I would obviously have to discuss it with CAQH and WEDI first, but if the Committee is interested in seeing that and perhaps providing some sort of endorsement of it as a best practice, I think they would welcome that. So that offer is there for you if you want me to have that conversation with them.
DR. COHN: Well I think you certainly should have the conservation, I think we’ve already had a conversation with Jim Shuping about coming in January, so I don’t know if maybe he can put this in as part of the sort of general discussion. I mean once again, it sounds like a good idea, maybe there’s some ways, I don’t know that we should necessarily take Committee time, or Subcommittee time to review web-sites, but it may be something more that we, let them take a look at the web-site before the next meeting, and then we can sort of reflect on how it relates to the work, the other things we want to promote.
MS. WARD: Ok, I’ll just make sure to coordinate it with Jim and the folks form CAQH.
DR. COHN: Ok, super. Ok, last question before we break, Marjorie?
MS. GREENBERG: Are we now, I know we don’t estimate anymore or guesstimate, but are we estimating that this final rule is going to be this month?
MS. TRUDEL: It’s nearing the end of the review process and I know it’s on our post publication schedule for the end of the month, that’s about all I can say.
MS. GREENBERG: Is there any benefit to the Subcommittee or the Committee weighing in on any kind of letter or anything? No, ok, fine.
DR. COHN: I would say that the first time that the full Committee could send a letter which would be February.
MS. GREENBERG: We could exercise that, I think there’s going to be an Executive Subcommittee meeting.
DR. FITZMAURICE: But we are hearing that the lack of certainty about the addendum is a problem, and this survey does show it, and Maria has said it as well.
MS. WARD: A comment about that, and I have always been adamantly opposed to any conversation that suggests that this rule won’t get out in time. I won’t even have those conversations with people because I am confident that it will. But, in the event that it doesn’t, it’s more than just well how are we going to test, its we’re going to have to implement with 4010. And as the last two years of DSMO work have demonstrated, 4010 doesn’t work. So that’s even I think a more significant concern than we’re going to scurry trying to test and maybe not make a testing date. The real concern is what are we going to do if we back up six months and then a Congressional review period, and we back it all up far enough that it actually doesn’t get out in time for us to implement in October. I can’t even describe how significant of a concern that would be.
DR. COHN: Karen, would you like to comment?
MS. TRUDEL: We’re well aware of the issue and what all the fall-out would be from lack of time for implementation.
DR. COHN: And certainly, I think the Subcommittee and full Committee have sent more than a couple of letters to the Secretary, and the previous Secretary, just at the beginning of the timeframe trying to get all of this moving. So I guess we’re hopeful that by the end of the month we will have the addendum. I think that Marjorie actually may be right that if by early January it hasn’t hit the street, I think that the Executive Committee needs to, Executive Subcommittee, may need to take upon itself to send off a letter, but I’m hoping that that won’t be necessary. Steve, before we break?
DR. STEINDEL: Simon, that was going to be my suggestion, that maybe the Executive Subcommittee might want to prepare a letter in anticipation and just can it if it comes out before January and send it if it doesn’t. So it’s ready to go very quickly.
PARTICIPANT: What good would it do?
MS. GREENBERG: Probably the kind of letter that could be written real fast.
DR. STEINDEL: Yes, if that’s the case, then forget about my suggestion.
DR. COHN: Ok. Well, why don’t we break. It’s right at 11:00 right now, so we’ll break for 15 minutes, and come back and we’ll talk about improving the HIPAA process.
[Brief break.]
DR. COHN: Welcome, Jack Rovner, who is here to join us in the conversation. Jack and I as it turns out were together on an AAHP(?) panel, I guess, he’s reminding me it was six years ago, I thought it was only three, talking about HIPAA. And as we’re all beginning to be aware that the HIPAA implementation, rather than an aspect of our careers, is turning into a career in and of itself, just because of the timeframe, and the length of time its taken to get this all implemented. And indeed as we think about claims attachments and all of this that are just coming out as an NPRM, this really may take many of our careers.
Really, Jack, thank you for joining us and really the conversation which we’re just going to be starting today and we’ll continue on into January is this issue about improving the process now that we’ve had a fair amount of experience with it, reflecting on how we can start doing this better and stabilizing the process knowing that you really have to have a stable predictable process as we move forward. For this conversation, Jack, we’ve actually obviously invited you, and Maria Ward is obviously going to stay with us and comment from I think the DSMO as well as probably her own personal perspective on this.
Jack do you want to introduce yourself for a moment?
MR. ROVNER: Yes, I’ll be happy to. Thank you, Dr. Cohn, it’s nice to see you again, and I appreciate the opportunity to be invited here to talk to you about the work of the Secretary’s Advisory Committee on Regulatory Reform, particularly with respect to what we recommended on the HIPAA transaction rules. I have to start off by telling you I can report to you what the Committee has done, in fact we have submitted our final report in November. I obviously cannot speak for the whole Committee, they did in the report, but there are two reasons. One, only the whole Committee can speak for itself. Second, we’re over, we’re done, we’re abandoned.
I’d like to give you just a brief overview of the recommendations that we did make and I passed around to you both the report of the Subcommittee that I Chaired, the Coordination Subcommittee, which studied the HIPAA Administrative Simplification issues and made the recommendations to the full Committee to consider. And then the actual four recommendations of the full Secretary’s Advisory Committee with respect to the transactional rules, and I will report on those very briefly in a moment. I’d like to give you an idea of how we got to where we were.
HIPAA turned out, based on public comments, which we reviewed many of, was one of the most commented on issues that the Secretary’s Advisory Committee examined, and we examined a very broad range of regulatory issues, which resulted in fact in over 255 recommendations to the Secretary to improve the regulatory process, everything from Medicare, Medicaid, dually eligible beneficiaries, MTALL(?), etc. My Subcommittee, the Coordination Subcommittee, was given the task of examining HIPAA.
I would also like to just give you background, the Secretary’s Advisory Committee, consisting of 29 appointees, was actually a very diverse Committee in terms of representing every segment of the health care industry and the consumer interests, both in terms of representatives of the Medicare community and Medicaid community, and the disabled community, representatives of hospitals, rural and urban, faith based and proprietary, physicians, long-term care, home health, medical product equipment and pharmaceutical manufacturers. We were very broadly based.
When it came to HIPAA, we examined the public comments, we brought our own experience from that broad base to the issues, and we also held a hearing on it in Denver during the WEDI meeting in Denver, and had presentations in fact from CMS, Karen Trudel was there, and from various members who were active in WEDI. My Subcommittee took all that and issued a report to the full Committee of recommendations, which you have a copy of. There were three recommendations made on process and three on the transactions themselves.
The process recommendations involved both a defined schedule, which I’ll come back to, and then two others, which we ultimately withdrew for further study and in some sense, unfortunately, we ran out of time in our Committee and never got back to them. The further study we needed was input from CMS and other segments, and they covered two areas that were concerns expressed. One was how do you improve the process in terms of automatically updating standards and code sets without having to go through the relatively cumbersome regulatory process of issuing proposed rules, notice periods, analyzing the comments, and then finally issuing final rules and then having the two month period, etc. And then of course there’s the requirement under the law itself that changes to the rule should take at least a year to implement.
So we were looking for a way to determine if certain changes, say in the ICD-9’s, or the CPT-4’s, if they were updated by the standard setting organizations, could they be simply adopted automatically, or in a process that would allow, for example, 60 or 90 day notice period with CMS having the ability to veto them if for some reason they didn’t think they should go into effect, but otherwise would actually go into effect without having to go through the long drawn out regulatory process. That recommendation of my Subcommittee never got to the full Committee because as we examined it, we needed more input on the practicality of it both from like the American Medical Association, from CMS, etc., who were handling the code sets. So that lays as an idea that did not become a recommendation.
The other area that our Subcommittee looked at but was withdrawn and not submitted to the full Committee was the concern that was expressed in many public comments, and that we found in examining the issue, about the lack of code sets for a number of segments of the health care industry, and in particular for the introduction of new technology. Again, the statutory framework for updating the regulations, is quite long and cumbersome. There was great concern about what do you do about new technology that’s introduced, approved by FDA, approved by CMS for Medicare reimbursement, but there won’t be any codes for them. You basically then end up doing what, mapping them to some existing codes. That is a cumbersome if not very practical or realistic approach in terms of trying to properly code for reimbursement of new technology, or for these other industry groups that apparently do not have as code sets yet, like long-term care, etc. Again, we did not proceed with a recommendation on that because we needed more study and we ran out of time to determine what a real option might be.
That left us with the four recommendations, one on process and three on the rules, that were adopted. And those are, I’ve given you the page from the Secretary’s report that presents them. They’re recommendations 185 through 188, and they cover one on process, which perhaps of all the recommendations that we made on HIPAA, was the most soundly endorsed, and that was that CMS adopt a defined schedule, with dates certain, for the issuance of any updates of code sets, data elements or standards themselves. That there be a date certain every year. That proposed changes would be issued in the Federal Register, if you have to go through the regulatory process. That the process have a certain period, and we got some feedback indicating they think they can do a 30 day public comment period on this. And that the final rule then be issued again on a date certain so that it’s implementation date or effective date and implementation dates would all be predictable on an annual cycle, so that from the industry’s perspective, from budgeting, preparation, planning, it would be very predictable.
After we made the initial recommendation, we worked with CMS because of the inherent issues of inflexibility in the regulatory process to revise the recommendation, the one you have before you. Which essentially still urges that there be a defined schedule with dates certain, but builds in more flexibility for exactly what that schedule would be because of CMS’s various legal and other constraints.
The other three recommendations really go to the rules themselves, and reflect what we found to be, and I certainly in my own practice, have found to be an area of great controversy and uncertainty and confusion in the rules. They relate to certain of the rules that lack what we call the four essential elements that usually appear in a standard. Each of the transaction standards, most of them at least, have four elements. They have a sender requirement, a receiver requirement, a content requirement and a purpose requirement. The claim is the best example, the 837 requires that the sender be a health care provider, the receiver be a health plan, the purpose be to get paid for delivery of health care and the content be the information for which you need to have to get paid.
Unfortunately, at least two and perhaps three of the standards, lack all four of those, which has created some confusion. They are the claims status, which has neither a sender nor a receiver requirement. And the referral certification and authorization standard, which also has no sender or receiver requirement, which suggests that anybody can send it or receive it. And the coordination of benefits is also somewhat confused as to exactly what the sender and receiver elements are.
The problem with that comes to one of our other recommendations, and that is as the rules exist, they require that a transaction that meets a definition of a standard that is sent within the same covered entity, be a standard transaction if it meets the definition. Well, for claims status and referral certification, which don’t have a sender or receiver requirement, it would appear, for example, that if you were running a health plan and your customer service department had a call and made it a computer inquiry down the hall to the claims department to find out what the status of the claim was, it would have to be an internal standard transaction.
We could find no rationale for that, nor could we find in our investigation and hearings, anyone, including CMS, who could explain why there is a within the same covered entity requirement in the rule, nor could we find in the explanation in the preamble a rationale for it other than it appears that CMS was concerned about multiple function covered entities, for example, a hospital that happens to also have as a division a HMO. And because of the difference in payer/provider function, or clearinghouse that was run by a health plan, they were concerned that they would be when appropriate standard transactions used in what would appear to be an intra-corporate transaction.
We believe, if that were the issue, could have been addressed the way the privacy rules address that issue, is you define multiple function covered entities and address that issue directly. So we found a great deal of concern about the meaning of within the same covered entity and particularly because it creates confusion about when you have to comply with a claims status, a referral certification, and perhaps coordination of benefits.
The other area which I know it continues to be extremely controversial at WEDI, which we made a recommendation on, was to clarify the regulations with respect to direct data entry exceptions. There is broad based confusion and misunderstanding about exactly what is allowed and not allowed by that exception, and in fact how it will work. The result of that being, from what we found is that there is investments being made that may be wasted or that may take the purposes of the standards down directions that may defeat or not defeat, not clear to us, the achievement of standards in the industry. So we urged that there be greater clarification, for the industry, of exactly what direct data entry means.
Those were all adopted as recommendations of the full Committee made to the Secretary of Health and Human Services. We then, of course, disbanded in November. It is my understanding and certainly great hope, I know my fellow former Committee members sure that, that the Department of Health and Human Services are taking our recommendations across the board, from my perspective and HIPAA to heart, and will be addressing them.
That would conclude the overview I’d like to give and I’d certainly be happy to answer any questions or participate in any discussion you’d like. Thank you.
DR. COHN: Jack, thank you. That’s, I can say that you’ve certainly taken HIPAA to heart since I’ve last seen you also, it’s like it’s become a career for you also.
MR. ROVNER: In many ways it has.
DR. COHN: A question, Maria did you have prepared testimony or comments that you wanted to make? And then we’ll maybe discuss it all together.
MS. WARD: I did not have prepared testimony Simon, I was asked to talk with you about this topic just last week, so I didn’t have an opportunity to have that developed through and by the DSMO Committee formally.
There was a work group that was convened under WEDI this summer that talked about I think version control was the name of it, but it talked about many similar issues and I don’t believe that they have issued a final and approved report yet, but representing HL7 I was part of that Committee and a number of the findings, particularly around a predictable, what they called predictable or defined schedule, for implementing these transactions, I think that was number one on our list as well.
But there was also an interesting recommendation, again that hasn’t been finalized through WEDI, but it’s something to think about. And that’s in terms of how we actually process the types of changes and the evolution of these transactions and all of those things. And one of the suggestions was perhaps that we come up with some sort of a triage system, where the approval process is consistent with the magnitude of the change. And I think that’s fairly consistent with what I was referring to this morning in terms of the DSMO, the process around considering that being consistent with the magnitude of the request or the change.
In initial conversations this summer through this work group, one of the preliminary recommendations was that the DSMO Steering Committee would initially assess the magnitude of the change and then recommend the appropriate approval process, meaning if there were things like what we call errota(?), typos, but actually somehow has to be changed in an implementation guides. Those kind of things shouldn’t require any kind of regulatory process, they should just be able to be updated and changed with the next version or publication of the standard specification.
So the suggestion was perhaps that the DSMO Steering Committee was the right place to assess the magnitude of change, and then recommend which process it should follow. And those recommendations would come to NCVHS, now understanding that that introduces another layer I guess if you will in all of this, and that implies time, right, if there were going to be some sort of a triage step before something actually went through the DSMO process, for example, the regular DSMO process. But that I think is a creative way perhaps of looking at putting these kinds of changes in buckets and saying some can be addressed in a far less time consuming way than others.
They also talked about the idea that there should be no more than two versions of the standards in production at any one time, and then recommending dates for prior versions no longer being acceptable. We don’t have that challenge right now because we’re still trying to roll out the first version, but once we have that we’re not just going to cut over on date certain and all of a sudden everybody is magically migrated in 24 hours to a new version. So there will be some parallel between versions and this particular work group talked about the need for some structure around that and some dates to be defined around that.
And then this really comes more from my own experience, not in terms of the DSMO Steering Committee, but in terms of there are still two transactions that were named in the initial, initial legislation, one of which is so near and dear to my heart, it is claims attachments. I had an opportunity to reflect on the timeline for a minute about this. It was February of 1998 when we appeared before the National Committee and proposed the recommendation for claims attachments. We got the endorsement of the Committee, we went forward and by I would say summer, late summer of 1998, we had that draft ready, and turned over to the Department.
Now I don’t expect that we will see a proposed rule before probably second quarter of next year. That’s five years since the point in time when we created the standard to recommend, I think you probably have to add on another three years for the comment process, the resolution of comments, the final rule, OMB clearance, so you’re talking about mandating something eight years after it was in its prime. And I think, I’m speaking very personally now, I’m not speaking on behalf of HL7, I’m not speaking on behalf of my co-chairs, nor on behalf of DMSO, but I have to wonder if in good conscious I would tell you that eight years from the date that I was party to agreeing to something that if I still thought it was the right thing to do eight years later, particularly around advances in technology and just the kinds of things we’re doing within HL7 itself.
So I think that’s a big concern. This isn’t about rolling in a new transaction or updating an existing transaction to a new version, this is just about getting it out there on the street and really being able to get moving with it. It’s becoming problematic.
DR. COHN: I’m sitting here sort of smiling only because I’m reflecting that obviously HIPAA was passed in 1996 and I think we, if I remember the timeframe as such that we thought that we’d have final rules by 1998 or 1999, and here we are in 2002, almost 2003, so we’re talking about similar sorts of timelines, I think.
Other things? I didn’t mean to break into your conversation.
MS. WARD: I think that Jack actually touched on a couple of very important things, and I had an opportunity to read, I think probably an earlier draft?
MR. ROVNER: No, that’s the Subcommittee’s draft, it would not be the full Committee’s recommendations.
MS. WARD: And certainly the areas that were highlighted are areas of concern. Confusion around understanding the exception for direct data entry and what that means and what the requirements are and what the incentives are. Are you providing an incentive for doing direct data entry versus batch EDI? And if you you’re not supposed to be doing that under HIPAA. So there’s a lot, at an industry level, there’s a lot of confusion around that.
The desire for actually naming what I like to call the participants in these particularly transactions, who’s the sender, who’s the receiver, that also does create a lot of confusion. It creates opportunity for me to work with clients. Part of understanding as a covered entity whether or not in this situation you are covered is reading the definition in the regulation of the rule to understand whether or not when you exchange this transaction it’s a covered transaction. And without naming the participants, that becomes a little bit challenging, so I think that’s a great recommendation.
And again, I think probably the primary one is around, if we can, being able to put some definition around when these, going forward, when these transactions are going to continue to roll out so there can be some predictability to that for everybody involved, all the way down the line, from the vendors to the clearinghouses to the providers to practice management systems, anybody who has to deal with that data and changing that data for future versions. That’s a big area of I think frustration for people right now who are implementing.
MR. ROVNER: If I just may make a comment to pick up on what Maria said, I think it’s interesting to look back at the HIPAA statute. February 21, 2000, was the date that all the regulations were supposed to be issued by statute. One of the areas, we did not, and I will say, let me preface it this way, having worked for nine months through the Committee with the staff at HHS, I have developed an enormous respect for their capability, their dedication, and the fact that they are grossly overworked, and have just not enough time to do everything. And on top of that a lot of the processes, which are legitimately there like the Administrative Procedures Act, etc., but create a very cumbersome process by which rules can be implemented or changed, etc.
But one of the consistent concerns we heard but we did not address because it wasn’t really a regulatory reform per se although actually I take it back, I think our Flexibility Subcommittee examined it and may have made recommendations, was with respect to trying to be more timely and fluid in the issuance of regulations. We did not address formally in the HIPAA process the problem of the fact that rules would be coming out on a staggered basis. We had proposed rules on transactions and identifiers back in ’98 and then we end up with the privacy rules and nothing else is, the transaction rules get final in 2000, the privacy rules come along, we still haven’t got security rules, supposedly the end of this month. No identifiers yet, which just from a personal level, I’m not a technology person, but it’s hard for me to understand how you can have standard transactions if you don’t have identifiers to make sure you know who you’re talking to.
There is this process as HIPAA’s been, or problem as HIPAA’s been rolled out that we certainly found in our examination of public comments, public hearing and looking at it, that as originally perceived in the statute, it is not been realized that the rules coming out of the Department have not been consistent, they’ve been too staggered, they have not allowed for effective planning and budgeting of the industry, exactly where the problem is, hard for me to say certainly.
But I think there’s probably an issue here that can very, symptom that can be spread around is what’s caused this particular disease we’re dealing with, whether it’s the industry itself and it’s inability perhaps to come together and make uniform positions that CMS can adopt or I like to think that one of the problems with the DDE exception is that by the time the final rules came out, which is when the DDE exception showed up, it wasn’t in the proposed rule, that everybody realized technology had moved tremendously ahead, and you needed to deal with the internet.
And it almost to me, and reading regulations and trying to interpret them is what I do for a living, but to me it looked like it was an afterthought that somebody felt we had to stick in there, and the problem that we encountered in our Committee looking at this is the afterthought doesn’t tell the industry enough to understand what it means in the context of implementing standards.
So whatever, I guess what I’d say is if this Subcommittee and the National Committee can pick up some of the concerns that we just didn’t have enough time to deal with, and try to make this process more predictable and transparent and consistent with each other, it would be I think a great service to everyone in achieving what HIPAA was supposed to achieve.
DR. COHN: Well, I think you bring up some very good ideas. Questions or comments from the Subcommittee?
Michael Fitzmaurice.
DR. FITZMAURICE: In some of this length of time between 1996 and now, it’s a matter of priorities. That is in 1996 when HIPAA was passed, there were not resources allocated to it. That has persisted for quite a long time and so anybody running a bunch of processes within the Department has to set priorities, and in some cases HIPAA standards move to the top, some HIPAA standards move to the top at times, and other times, other things move to the top. You can’t have everything being a priority. Do you have any suggestions about the priority setting or do you accept the priority setting as it was but note that there was a disadvantage to the way the HIPAA standards have come out and the length of time and the uncertainty and offer suggestions as you have for improving that process? In other words, it’s a two stage. One is what’s most important? And secondly, given the priorities, how can we do better?
MR. ROVNER: You actually bring up one thing that my particular Subcommittee did examine but ultimately was not adopted by the full Committee because our purview was not to discuss if you will money issues but to look at regulatory reform. But one of the strong things that came out of my Subcommittee which had interestingly a representative of the state health care organization on it, was the fact that Congress has in the ASCA Act, appropriated, authorized money for appropriation but never appropriated any. So we became very aware in our work that one of the real problems is Congress has said thou shall do it and never gave anybody the money to do it, and that requires a lot of prioritizing and I don’t know that I’m in a position to address how you shuffle the deck on that.
I do think that if you look at, I guess my own perception is that there is a strong, if you will political/public constituency behind the privacy rules, so they were going to get out, and they’re going to get enforced, they’re there. My perception is that it’s not a public constituency behind the transaction rules, if it’s anything it should be an industry constituency to achieve what HIPAA is after, which is more efficiency. And if I were I guess looking at the priories and lack of resources, I guess one would have to say how could you in retrospect, and this may help you then looking how you can improve the process forward, better align the issuance of the rules, so that even if something were delayed in transactions, things came out more closely together as final rules. I hear a lot about well, the rules going to change anyway. Why should we spend the money now, nobody can make up their mind, everything’s going to be different. And in fact there’s proposed rule changes as you know on the transaction rules which hopefully will be finalized this month.
In many ways perception is reality and because I think the process has not worked very well, we’ve sent a message to the industry, the perception is that this whole thing isn’t really going to happen or work, so you’re getting I think a lot of reluctance about well, why should we make the investment, do we actually have in place all the things we need to make it work anyway? And I think in retrospect it would have been nice if the identifiers were in fact issued the same time or within a period of very shortly, as they were when the proposed rules came out, with the transaction rules. That has not happened, but I think going forward it would be nice to see something like that happen.
I think at this point what needs to happen is that the, as many of the final rules can get out, get out. And then as we recommended in our Committee, we need a predictable schedule, date certain, everybody’s going to know every year if there’s going to be a rule change, exactly when it’s going to come.
DR. FITZMAURICE: Let me follow-up asking a question about, you brought up the identifiers and I think that’s a good example, it’s probably been known for some time, with some degree of certainty, what the identifiers would likely look like, the shape, the size, the kinds of variables that would be included in an enumeration process. But does it serve the industry to publish a final rule let’s say on identifiers if the Department hasn’t the resources to carry it out?
MR. ROVNER: Again, this is probably beyond my competence in the sense that I’m not a technology person, but if I looked at it from the world that I’m most commonly used to, which is the businessman’s decision, should I spend money on this, the fact that HHS may not have the funds to carry it out is not so much my concern as I’ve got to do something now about complying with transaction rules or I have a violation of the law. That’s going to take budgeting money, resources, and planning. If my IT people come back and say well we can spend all that, but we don’t know who we’re sending this stuff to, so we either have to come up with our own identifiers now, which means that if the industry, and we can try to guess that they’re the proposed rules, but if we’re wrong, it’s going to cost us all this extra money to re-change it and everything.
What I do as a business person is say, this is not the way I can plan, this is not the way I can budget, so I’m going to do in a sense what HHS is been forced to do, I’m going to spend my money somewhere else, you come back and tell me when you have something I can count on. And then we’ll know how much money to spend on it. So I think whether HHS can actually implement, because they don’t have the money to implement the identifiers, if you know what the identifiers are the industry can implement it.
DR. COHN: Maria, do you have a follow-up on that?
MS. WARD: Yes, I think actually a point of clarification, Michael. Were you referring to, when you talk about HHS implement, were you referring to the Medicare and Medicaid, CMS implementing as a covered entity? Or were you referring to HHS being able to support the enumeration process?
DR. FITZMAURICE: I’m talking about the latter.
MS. WARD: Ok. From an implementation perspective in terms of the transactions, I don’t think it’s a big deal, quite candidly, to implement these transactions, people have been exchanging these X-12 transactions for ten years without standards. We have ways of identifying one another already, we have fields for that, we have rules based on those fields.
If you were to come out and say well here’s what it’s going to look like but we can’t enumerate yet, I don’t know that from a, again, from the technology side as an implementer, I don’t know how much that would help me because my job is really going to be all of the mapping from existing numbers to standard numbers, and that’s the work I have to do as a covered entity. So unless I have those standard numbers available to me, the actual numbers, I can’t do any of that cross-walking and mapping. So I have place holders for all of those kinds of things in my transactions now and I’m able to send and receive those transactions now.
I think that from, again, from the business perspective that Jack provided in terms of planning and budgeting and resources, and all of those things, it is tremendously valuable to have some expectation of when this is going, some reasonable expectation of when this is going to roll out. But I don’t think it’s a reason to not go forward with what we have right now.
And in response to your comment on priority, I think that it’s been done right. I think that privacy and the initial set of transactions were the ones that needed to get out there and be adopted and move forward. Obviously I’m partial to the work that we’ve been doing and concerned about the timeframes and delays for the other sort of remaining transaction that still continues to be talked about, which is the attachments, but I don’t think that should have come out ahead of anything else. I’m just fearful that if it doesn’t come out pretty soon, it’s going to be an interesting situation that we find ourselves in.
MR. BLAIR: Jack, I really appreciated your recommendations that you shared with us. One of them, which was that there at least should be dates that people could plan on, and I guess I’m thinking of that not only from the standpoint of the health care providers and payers and clearinghouses that would implement the HIPAA standards, but I’m also thinking from the standpoint of the SDO’s, because Maria wound up indicating to us the conundrum that the claims attachments groups have been in, where if it was known that there would be that much of a delay in getting out the NPRM for the claims attachments, that would have allowed additional time to enhance, modify that standard, and if we still know, if we were to know today that that’s not going to be getting out for a year or two, then things could be done in the meantime, other constructive actions could be taken, so I guess I’m echoing --
Jack, I really appreciate your standpoint. I’m also saying it from the standpoint that HHS is at a tremendous disadvantage because it didn’t get the appropriations and the funding for HIPAA. I think maybe Congress and the rest of us didn’t really know how much these things would cost to be able to do NPRM’s and final rules and provider identification, dissemination, and so I understand that. And I also understand the fact that other major issues come up and priorities change but least, at least if there’s some way to share the dates with the SDO’s, the DSMO’s, as well as the industry, that at least could help us to make the most of what we have with the resources we have.
MS. WARD: That is an excellent point, Jeff. If, and you made the point, I didn’t actually come out and say it, but if the Department were to come to us today and say look, there is no way we’re going to have that proposed rule out for claims attachments before 2004, it just isn’t going to happen, I think we would at least entertain the idea of considering should we be doing something, or multiple things, differently because we have some time to catch up now. But the challenge has been well, it’s going to be next quarter, next quarter, next quarter, next quarter, next quarter --
MR. BLAIR: And you don’t want to delay the process by enhancing the standard.
MS. WARD: Absolutely not. So maybe one level of the communication is really with the standards developers and that just assumes, the presumption is that the Department actually knows that it’s going to be a year from now, which I don’t think they do. I think when they tell us next quarter, that’s what they think and that’s what they believe. Somebody, somewhere --
MR. BLAIR: I think maybe the distinction might be, and I don’t know the answer, but if the answer is are the dates that are put forth what they’d like, or what they have the capability to commit to? And I think at this stage with the experience that we have, instead of giving us the dates that they’d like, and they know we’d want to hear, is to give us what the could commit to, and that might allow the industry to plan better.
MR. ROVNER: In our recommendation originally, and your comments are exactly where we ended up in the Secretary’s Advisory Committee, in our initial recommendation, we actually picked dates just to force the issue, including the entire cycle. Now it turned out, because we’re not expert on the entire process, we didn’t have all the dates right, but we were actually adopting this approach based on the fact that, for example, the prospective payment system comes out every year on exact date that regulation is issued to update the PPS reimbursement schedule. That’s what we wanted to achieve.
It’s not what the particular day is that matters, it’s that day be set so that every year on that day the proposed rule is issued and that within a defined period, whether it’s 30, 60, whatever the public comment period is, that ends and then 30 or 60 days thereafter, the final rule is issued. No waffling on that at all. Now because as we learned from CMS that the nature of the modification, whether it’s a significant modification or just a sort of technical fix, allows them some flexibility to shorten the schedule, we withdrew that sort of drawn out annual cycle and ended up with the recommendation which gives them a little flexibility to set that schedule.
But we are adamant in our recommendation from the Secretary’s Advisory Committee that there would be an exact date every year. And what I have just heard is that even from the point of view from the standards setting organizations, if you know that that’s the date that something is going to happen and it’s missed, well now you know you have essentially another year to go back and revisit what you might want to do to update a standard.
I think as you look at what happened with the security rule and all the promised issuance dates, what I finally heard a lot from people in the industry is that they’re just going about doing their own thing on the security and they’re not sure it will ever come out. Unfortunately, we learned that the internal process of rulemaking, it’s not always HHS’s fault, by the way, there are the whole internal process of rulemaking and other agencies that have to be involved, OMB etc., lack of funds, whatever, hangs things up that staff may never actually have anticipated. We took that into account with making our recommendation, because what we basically wanted to have is that if those kind of things happen, then based, unfortunately it will have to wait another year, so that the industry always know the predictable date for change.
By May that backs into another area of concern which my Subcommittee had looked at but as I said withdrew the recommendation. And that is to, because we needed more technical input, and that is to determine if the process of doing things like updating code sets, CPT-4’s, whatever, can be done as some sort of automated basis without having to go through a formal rulemaking. Because you hear it’s not the government that sets the standards it’s the AMA or I guess it is CMS for HCVA, for the HCPCS, but whatever. You’ll have a process where one assumes there’s a lot of industry input anyway and where it’s not clear to me why you would need a rulemaking for updating codes, because you’re not really setting the standard, the code is already there and supposedly the implementation guide is adopted by reference anyway, and one could even say if you update the implementation guides, does that have to go through rulemaking, which is what they’ve just done, is there some sort of process, legally accomplishable, which would allow those updates to be done on an automated basis, without having to go through the formal rulemaking process.
We have for example, if WEDI or the DSMO’s come in and make a recommendation that we ought to make these changes, ought to be implemented in six months, you can somehow establish a structure that CMS can publish that as a Notice, get it public comment, and have the ability say at four months out to veto it, otherwise it automatically is going to implement two months thereafter. I may have the schedule wrong, but the idea is just take a lot of the technical aspects of the standards out of the rulemaking process and make them act kind of automatically, which is what you would hope to have in an industry driven rule or standards setting environment. Instead we now have a government driven standards setting environment with industry input but inherently the rulemaking process is extremely cumbersome.
MR. BLAIR: The key is we want to have government enabling instead of government driven.
MR. ROVNER: Well put.
DR. STEINDEL: I have two clarification questions. The first one, I was starting to think about this date certain update process, and I think you’ve just clarified it, so let me see if I understand the clarification. If let’s say we wanted to introduce a new rule concerning the thingamabob transaction, and we produced this rule in whatever form and we went through the process and we created, and we introduced it and it was going to be on date certain this year, because that’s the way, and all of a sudden the public comments come in and they’re overwhelming. What you’re saying is that in response to that, the date certain would now move at the minimum a year in the future.
MR. ROVNER: Correct.
DR. STEINDEL: So what we’re looking at is a date certain but we’re not looking at a time period certain. That was my concern because a lot of these regulations have introduced changes that were not foreseen and could not be accommodated in a short period of time, and what you’re saying that would extend it at the minimum a year.
MR. ROVNER: Yes.
DR. STEINDEL: But we could be certain that it would occur on that date the next year or the next year or the next year.
MR. ROVNER: If I may, if the standard rulemaking process were going into affect, for example, let’s say, and I think CMS picked the date December 1 for our recommendations, December 1 every year you would know that if there’s going to be a proposed modification or adopting a new standard or whatever, something that requires the rule, that’s when it would be issued. There would be a 30, they say they can use a 30 day comment period because they have already have industry input on these. And then you’d maybe tack on another 60 days and there would be a final rule on that date certain. Not just 90 days out, it’s a date. If you miss that date because you say there’s overwhelming public comment, you’ve gone another year.
DR. STEINDEL: I think I can concur with that type of process. The second question, clarification question I have regarding code sets, is as I understand the process, and I’m not a HIPAA expert, I try to stay out of the nitty-gritty in that area, but as I understand the process, the approved code sets are modified on date certain, every year there’s a new addition to the approved code sets. What you’re talking about is a process to introduce a new code set?
MR. ROVNER: Well, as I said, we never could get enough information in our work in the Subcommittee to truly understand it, which is why we never pushed for a final recommendation. We don’t know the answer to that. I talked to the rep, for example, on our Committee from the American Medical Association, who did confirm that the CPT-4’s are updated on a certain schedule, etc. Then we had the question well what happens if you move, for example, to the CPT-5’s, what’s the process for that? Is that a rulemaking or is that not? We just never got enough information and we ran out of time to truly get an understanding of that process.
DR. STEINDEL: And now I can understand, because I can agree with your questions concerning that, because I have the exact same questions.
MR. ROVNER: We think that’s an area that needs examination.
DR. STEINDEL: I mean we’re trying to get that going this afternoon after lunch with regard to the transition from ICD-9 to ICD-10. Is that evolutionary or revolutionary?
DR. COHN: Well, I guess most of us tend to think that a yearly update of an existing code set is probably an evolutionary, and I think is basically under HIPAA does not require any rulemaking as far as HIPAA is concerned. It requires rulemaking as far as payment and RVU’s(?) and everything else in the world that have to do with patients, but obviously I think most people would think that moving to a whole new version of ICD probably would be a little bit bigger than that. Maria do you have a comment?
MS. WARD: I had a question actually for you Simon. Is the yearly update synonymous with a new version? In other words, CPT-4 to CPT-5, is that a yearly update or is that something more significant?
DR. COHN: I’m sorry I guess I missed your question. A yearly update of the same code set as opposed to --
MS. WARD: Right. So if all of a sudden, because it’s CPT-4 that’s named in the regulation for transactions. So when the world moves to CPT-5, I don’t know the answer, will that be what happens next year or could it just be an update to four?
DR. COHN: It’s strictly an update to that same version, but if it ever did move to CPT-5, just as there are new versions of ICD every year, ICD-9 every year, which include modifications specifically to the procedure area, and that’s not considered to be part of the HIPAA rulemaking process, though it is part of payment processes that do occur that do require a rulemaking.
Jack, you’re right, this gets to be very technical.
MS. WARD: Right, because the actual code set versions are named in that transaction rule, ICD-9, CPT-4, HCPCS.
MR. ROVNER: And I can pick up on Maria’s comments, that’s actually what kind of got our Subcommittee involved in trying to understand this because with the regulations specifying CPT-4, ICD-9, you couldn’t change to CPT-5 without going through a rulemaking. And we did not understand therefore what does that mean. Why would you need to go through a rulemaking to change the code set and we never got enough information so we never pursued it.
DR. COHN: Well, Jack, I can certainly understand that, and I reflect on our last, our testimony over the years, I would say that there are some people in the industry who feel that for example moving from ICD-9 to ICD-10 to be about equivalent to moving from where we were in 1994 to the implementation of the EDI transactions. And they consider that to be about of equal significance, so I think it does probably fall into one of those areas that require a little longer than a six month period.
But you’re right, I think it is a very reasonable question, and I think you could probably even more bring up the issue of are there ways to streamline the process of getting revisions to code sets out and all of this stuff. And I’m sorry that Karen isn’t here and I’m actually sorry that many of our initial code sets gurus aren’t here, like Pat Brooks and others, because they might reflect that, at least my sense is that part of the problem of updating gets to be the ability of the industry to handle updates, and that certain large payers as well as the provider community, can’t handle issues of sort of simultaneous ongoing real time updating of code sets.
Now that may be changing as we get more and more computerized, and Donna you may have a comment on that also, but I think that everybody sort of looks to those date certain and then puts the new stuff in, but nobody’s very happy about how long it all takes, which I think is what you’re commenting on.
MS. PICKETT: For ICD-9-CM it is date certain. We update effective October 1 of every year. That’s a given, and new codes are implemented either for diagnosis or procedures. The rulemaking that was being mentioned is specific to the changes to the prospective payment system. The code set is updated independently and then the new codes are included in the Notice of Proposed Rule Making for changes to the DRG system, and it’s a comment period for the changes to the DRG system, not to the codes that have already been approved.
DR. COHN: Right. Steve?
DR. STEINDEL: I’d like to change topics.
DR. COHN: Good. Thank you.
DR. STEINDEL: Dramatically, to something a little bit mundane, and this is to Maria, and I compliment her comments on trying to introduce some triage system into the DSMO’s and how they do things, I think that’s very necessary, and I would like the Steering Committee to perhaps think even further on more triage instead of just the levels of magnitude of change, but perhaps some things like which specific DSMO’s should take lead on certain, just kind of like, I understand a bidding system, for what comes in. It might be better to look at a lead DSMO and the other DSMO’s taking, looking at it after the fact. And maybe some more guidance given to the DSMO’s from technical experts with the process itself. And we can talk about this off-line.
MS. WARD: Ok, sure, I’d like to talk about it.
DR. STEINDEL: But I encourage you to think further on the triage system from the Steering Committee point of view.
DR. COHN: I’ve actually really appreciated the conversation today, as I look at the issues and it sounds like both of you are coming up with many of the same ideas of trying to, like let’s, we do realize that rulemaking is a cumbersome process, so are there ways to de-bulk some of it and turn it into more routine updates, they occur without the whole regulatory process. But let’s also not completely abandon the whole rulemaking process for things that are much more significant. And obviously we’ve talked about a couple of them probably already.
Obviously it’s too bad that we didn’t have the wisdom of Solomon six or seven years ago when we got into this, but well, it’s hard in the circumstance where there’s no appropriate funding for the effort and I think we’ve all reflected on that many times. But I think that these are, right now we’re trying to sort of institutionalize and stabilize the process and I think your examples and ideas are very, very good. I’m sure that we’ll be talking about them in January. Hopefully there will be a letter following up your report to the Secretary, hopefully supporting many of them and maybe refining some. I am sort of reflecting on this issue 187, which is within the same covered entity recommendation, and I actually remember talking to one of the staff at HHS who has now left to go into private practice --
MS. WARD: Go ahead and say it.
DR. COHN: Who’s name will not be mentioned, but his reflection actually on this particular issue was is that he had wished when the administrative and financial transactions had been initially published, if they had had the thinking that went into the privacy rule around all of this, and that this probably already should have been brought together, which is I think, and of course it hasn’t happened yet, but now you’re bringing the issue up again. So I think it was reflected on at that point the recognition of not taking that back and redoing it all and trying to move forward was I think probably part of the rationale.
MR. ROVNER: That’s an interesting comment, because there are again, this was from the work of my Subcommittee, we concluded that many of the definitions that unfortunately only appear in the privacy rules would clarify a whole lot if they went into section 160, which is are the general administrative provisions, but even with the amendments that came out from the Office of Civil Rights on the privacy rules last August, unfortunately didn’t move any of the definitions except for individually identifiable health information. I don’t know why.
DR. COHN: Well, I’m actually sorry that our representative from the CMS HIPAA office isn’t here with us right now, but certainly when we recognize that the work going on for the privacy rule is in a completely separate compartment, separate area than is the rest of the HIPAA rules, than obviously this is an area where probably some cross fertilization would be very useful. Mike, it looks like you may have a --
DR. FITZMAURICE: I will note that the same lawyers that I’ve talked to about the transactions and codes are the same lawyers I talked to on the privacy rule, so there is an overlap of thought, and I think there’s probably thought, I can’t really say that. My opinion is that it would be well served to do what Jack said, is to have common definitions across the transactions codes and the privacy and the security.
MR. ROVNER: They didn’t pick up on that. There are certain, just to get on the record, there are certain definitions in the privacy rule that would greatly aid in understanding of the transaction rules. Many of them are actually in section 164-504, which is where they define things like hybrid entity, multiple function covered entity, and to sort of call back on my practice, which is now pretty much overwhelmed by HIPAA, one of the problems with the rules generally is in fact understanding what a covered entity is.
And the problem is that the only way to make sense of it under the rules is to look at function. So then you end up with trying to figure out exactly what the entity is doing to determine if it is a covered entity or acting as an employer, or not acting, and in the old rule before they amended the hybrid entity provision, where you had to, you’re primary function how to not be a covered function to be a hybrid entity, that created all kinds of problems.
But it particularly created problems to figure out whether that applied in any way to the transaction rules because in the real world, for example, many covered entities may actually act as business associates, which changes the relationship between the covered entity doing the transaction and the business associate and the other side of the transaction. And those definitional problems have created in my experience dealing with HIPAA and compliance etc., in the industry, a huge amount of confusion, which I think is unnecessary. A lot of the definitions, such as hybrid entity, multiple function covered entity, were brought into section 160, and then essentially applied to determining under the transaction rules the nature of the entity by the function it’s doing, you would be able to answer a lot of the issues, including for example, as I said earlier, within the same covered entity, what we thought in our Subcommittee had to really be attempting to address the multiple function covered entity, where it makes sense that if you’re doing a provider transaction with your own owned payer, you might want to have it as a standard. But it doesn’t make sense to us that if you’re doing a claims status inquiry from one computer to another within the same corporate entity you would have to be standard. Yet the way the rule reads that seems to be what’s required.
MR. BLAIR: I remember making a similar point in the privacy regs.
DR. COHN: Well, it’s 12:30 and I think we’re going to wrap up the discussion. Jack, I really want to thank you for coming and sharing I think some very good work. I think we’ll obviously be talking to people and groups in January about it, and I would suspect that this will be part of a letter that comes from the National Committee to the Secretary, which will probably be looked at, I mean finalized in our February timeframe for the full Committee.
But I think it will be this probably plus identification of any areas that really need some focused attention between now and October. Obviously are interest first of all is obviously to stabilize the process, ensure initial successful initial implementation in October, but let’s also at the same take a look at how we can sort of streamline and improve the process. And really thank you for taking so much time last year to hold hearings and sort of refine these proposals.
MR. ROVNER: Well, I very much appreciate the opportunity to come before you and share what the Advisory Committee did, so I appreciate it and thank you.
DR. COHN: And Maria, also thank you, do you have a comment?
MS. WARD: A question actually, since it was just last week that we were asked as the DSMO to come and talk about some of these issues. Like I said the Steering Committee hadn’t had an opportunity to have a focused discussion about this. Would it be valuable to you for us to send you something prior to January hearings with recommendations from the DSMO on this topic?
DR. COHN: That would be great, we would value them without question.
MS. WARD: I’ll forward that to the new Chair.
DR. COHN: Well said. Ok, any other issues? Why don’t we adjourn until 1:30 then? Thank you all.
[Whereupon, at 12:33 p.m., the meeting was adjourned, to reconvene the same afternoon, December 10, 2002, at 1:30 p.m.]
DR. COHN: Why don’t we get started for the afternoon session. Excuse me, we’re going to get started now. We have sort of two agenda items for this afternoon. The first is to review some work that’s been done developing a draft statement of work for the cost/benefit analysis that we’re going to be commissioning related moving to ICD-10-CM from ICD-9, and then for what is currently being used now is Volume three of ICD-9, which is for in-patient hospital procedures billed by institutional providers moving to ICD-10-PCS for that use. So that’s the first topic.
Then we’ll be moving after our break this afternoon into a discussion around our upcoming hearings planned for complementary alternative health care and the hearings related to code sets needed by that part of the industry.
So anyway, that is the topic, now Dr. McDonald, you’re calling in, are you still there? Dr. McDonald, you’re going to have to so indicate.
DR. MCDONALD: I was actually trying to quiet down my office area for a second there, I didn’t hear what you said, I did hear your overall thing and I got the fax.
DR. COHN: Ok, great, that’s what I also wanted to check. And obviously thank you for being willing to call in.
DR. MCDONALD: Thanks for letting me not have to fly.
DR. COHN: We do understand, it is December. Anyway, probably the best way to approach this I presume is just sort of read through the draft statement of work. Donna do you want to lead us through or do you have any introductory comments that you would like to make?
MS. PICKETT: Well, actually what you have before you tries to capture all of the comments that have been made at previous meetings about the issues and concerns that should be part of the scope of work or the statement of work, and so it’s fairly simply laid out, I hope, and captures some of that information. But I think you can just start from the top and go right through it.
DR. COHN: And I think for all of you who have been on the Subcommittee as well as listening in on the internet, you’ll realize that we have both had hearings on this issue earlier this year as well as had a relatively spirited discussion at the last full Committee meeting, sort of reviewing both the scope as well as pertinent issues, which I think has resulted in this somewhat streamlined statement of work.
Anyway, let me just sort of start at the top, and there’s three main areas, and we’ll sort of go area by area to sort of see what we want, to once again reaffirm this before it goes out I think for it to be done, and then we’ll talk a little bit about timeline after that.
So let me just start. It says Draft Statement of Work, and the work is to assess the impact on the health care industry of moving to ICD-10-CM and as described to replace Volume three of ICD-9 with ICD-10-PCS.
First is to assess the full range of implications on current users of ICD-9-CM, Volume 1 and 2, which is diagnoses, to implement ICD-10-CM, including costs and benefits, quantifiable and non-quantifiable of change. And the bullets under that include identification of affected entities and the degree to which they will be impacted. The next one is identify costs associated with transition, including, but not limited to, information system changes, recalculation of reimbursement schemes, training, changes to forms, probably etc. Third is timing of transition, and the fourth is identify immediate and future benefits of improved data for, but not limited to, patient safety, outcomes analyses, reimbursement, disease management, utilization review.
So that is the first bullet we have here. Any comments, questions, concerns? Jeff?
MR. BLAIR: Maybe a clarification. One of the things that I felt was important that I mentioned last time, is that there be a separate quantification of the transition costs from the ongoing cost of using ICD-10 after the transition is complete. And I didn’t hear that in what Simon just read.
DR. COHN: I think what you’re describing is something, a need, we have a bullet here that says timing of transition, which I was actually going to ask because I wasn’t sure exactly what that meant, but I think maybe we need --
DR. MCDONALD: Jeff, could you restate that what you just said?
MR. BLAIR: Yes, and Clem, what I’m getting at here is that I felt that it really wasn’t useful to just wind up saying well what’s the cost of using ICD-9-CM for the next ten or 15 years versus the cost of making a transition to ICD-10, where you have all the burden of the implementation costs for ICD-10 but you don’t separately show, after the transition is complete, what is the cost of using ICD-10, because once you’re at ICD-10, if there is a cost saving that would accrue over five, ten, or 15 years with ICD-10, or quality improvements, or patient safety improvements, then we really need to see that clarity and measure that against the implementation costs.
MR. AUGUSTINE: In other words, show a return on investment.
MR. BLAIR: Exactly, exactly.
MR. AUGUSTINE: Now Jeff, your first point is actually in this second bullet where it says identify the costs associated with the transition, including but not limited to, IT changes, recalculation, training, changes to forms, etc., so you’ve got the transition costs, we just need to more clearly define, delineate the ongoing benefits, which is really kind of the fourth bullet, but could be stated a little more clearly.
MR. BLAIR: Maybe I would state it that the transition costs need to be isolated and separated --
DR. MCDONALD: Jeff, could I suggest, I think that the truth is you’ve got transition costs and you’ve got ongoing costs, and we’re talking about the first bullet now, ICD-9 to 10-CM as the diagnoses part, right?
DR. COHN: Yes, Dr. McDonald.
DR. MCDONALD: So why don’t you ask what could be the benefit, what benefits which would be ongoing? The truth is, the difference between those codes is not very large, you’re not going to have huge differences.
DR. COHN: So Clem you’re sort of saying that you think that the ongoing costs, yearly costs, are going to be basically the same and therefore we don’t need to separately quantitate them?
DR. MCDONALD: Well, I don’t, I think as this is stated, it says some of the transition costs and tell us what’s the benefits and ongoing, I guess it should say benefits and ongoing costs, which are the opposite, that’s the side that Jeff wants to know. As it turns out, though, and I’ve looked at, the CM is enriched in a few areas, but it’s not a radical difference from ICD-9-CM. A number of codes actually is close.
MR. BLAIR: Clem, if that is the case, then that puts a very heavy burden on bearing the implementation costs to migrate to ICD-10 if there’s not much of a benefit after we’ve gotten there.
DR. MCDONALD: Well, I think that’s one thing we should ask them, to tell us what the benefit is, I wasn’t thinking that the cross-over benefits would be very huge, I think the argument for doing it is commonality with the rest of the world, probably more than, others can speak to this, but I think we’d like the work, this work to identify that. What are the benefits, ongoing benefits? I think they’ll be some, I’m not trying to be negative about this, I just don’t, I think that the bullet four talks about the benefits, it says it, identify the future benefits. What you’re trying to get a sense of is what do you get out of this for these transitions costs, right?
MR. BLAIR: Yes.
DR. MCDONALD: So I think you want to ask that, I think you’re asking it, and they’re separated because you have four separate bullets.
MR. BLAIR: Yes, I’m asking for it to be prepared in such a way that we could compare apples to apples to wind up saying ok, if we make the transition then five years, ten years, and 15 years from now, what’s the cost if we stay with ICD-9, what’s the cost if we go to ICD-10 and so I’m trying to break it out where we can compare apples to apples.
MR. AUGUSTINE: And I would like to be able to say within two, three years, you’re going to get a return on your investment. As well, I’d like to also state, this is my last meeting, but also I want to kind of let my feelings be known. I don’t want us to back-slide at all today, I want us to keep moving forward. From my understanding from the full Committee the guidance was to move forward with this, so I don’t want us to put any negative light on it, I think we need to clearly define what we want to look at, how we want to assess the impact analysis and then keep moving forward and not be thinking about any other avenues and stay strictly within this scope moving in the right direction.
DR. COHN: Dr. Yasnoff?
DR. YASNOFF: Could I suggest in the bullet that says timing of transition, I think Jeff what you’re arguing for is to expand that bullet in the following sense, for example, if you said timing of transition including impact on costs and benefits, potential return on investment, and interaction with other major health information implementation tasks. That’s really I think what we want in terms of evaluating the timing of the transition, and that would bring in, I think, the points that you mention, Jeff.
DR. COHN: I sort of didn’t quite understand how that's related, read it again, please?
DR. YASNOFF: The issue here is, as I’m hearing Jeff, is that we need to take into account the benefits that accrue over time in evaluating this. That you can’t just look at here is the cost of the transition, and here are the benefits, we need to kind of quantitate those over time. Now it does say, the first point says, basically what it says is first identify who’s going to be impacted and to what degree. Second, to identify the costs of the transition. The third point is just timing of transition, and the fourth point is identify immediate and future benefits. So future benefits certainly takes that into account. But what we haven’t said is that with respect to timing, we haven’t been explicit about what is it about the timing that we want evaluated. And so maybe this is a different point than what Jeff is making, let me read it again.
And Jeff, if this is a different point, I’ll just drop it and wait until we come to that. Timing of transition, including the impact of the timing of costs and benefits, potential return on investment, and interaction with other major health information implementation tasks. This is, the timing issue, I mean if we time this to coincide with some major HIPAA implementation, that obviously is going to change the costs and benefits substantially.
MR. BLAIR: Bill, thanks again. As usual you’re very helpful. The other piece that I was thinking of is that if we do a cost/benefit comparison, and I’m not exactly sure how to do this, you could compare dollar expenses with dollar expenses, but I don’t know how to quantify improvements in patient safety, or improvements in quality, but I would hate to ignore those because they are important. And somehow, we need to find some way to have those reflected as part of the benefits.
DR. COHN: Ok, I’ll make a comment, I think Steve has a comment, Marjorie has a comment, and then Brady has a comment. I guess my first comment is that I actually think that people are actively trying to quantitate patient safety and quality and that’s what the NCQA for examples does with their HEDIS reports and all of this, so I don’t think this necessarily lacks quantifiability. Sometimes there’s an issue of how to equate that to money, but I think they are quantifying those other issues. Steve you next, then Marjorie and then Brady.
DR. STEINDEL: I had, I think several have expressed this. I had the same problem with the statement timing of transition and felt there needed to be an expansion. I think Bill has helped with the ideas behind that timing of transition, but I think there’s also a sense of the people who want this cost/benefit analysis, that they actually want dates. If the transition occurs on this date, what would the cost be, if it occurs on this date, and I think Bill put a sense in that in his last explanation, which is very good, but I’d like to see that timing of transition statement expand out so that we’re looking at various options, both in terms of the transition costs if it occurs on this date, and also the future benefit costs if it occurs on this date. For instance, if we decide not to do the transition to 2010, and everybody in the room just died I’m sure, we may have introduced all the patient safety benefits before that time, and we will accrue no benefits by changing to ICD-10. That’s a hypothetical statement but an example of what I mean by what I’m talking about. Likewise if we introduced ICD-10 tomorrow, we may accrue tremendous patient safety benefits by 2010.
DR. COHN: I think we’re nodding our heads. Marjorie?
MS. GREENBERG: Just a few things. One following on to this topic, I think what you’re talking about is included Bill in the terms you suggested, which I thought were good, would that do you think encompass basically the opportunity costs of delay? Or the opportunity costs with associated with doing it later rather than sooner or what have you? I think we had talked about that as well.
On the issue of ongoing costs, I partially agree with Dr. McDonald in that I think a lot of the changes are significant actually but I do think that once the transition is made, I can’t, it doesn’t seem that there would be much different than currently. But I think that’s worth looking at to see if it’s going to put an additional cost on people, or a lesser cost on the ongoing coding, or use of the classification system. That isn’t here now and I think that’s what Jeff had suggested, I think that certainly can be added.
And just on the last thing that Jeff had mentioned about the difficulty of quantifying, which I think we all agree, it’s always easier to quantify costs and benefits, but I think it does mention here quantifiable and non-quantifiable, and also my feeling is that we should explicitly ask for some scenario development, that then can possibly be used to project and as to if you had, if you currently have this information, if you had the information provided by the new classification, to sort of try to get, because I think that will be important also, people to try to understand what really will you have and what you have and then I think you could cost out, I think you could try to quantify some of the impacts in those scenarios and then maybe project that to the health care system in general. I think that’s the case for both 10-CM and 10-PCS.
DR. YASNOFF: Would it expedite the process to have the statement on the screen and then we can just edit it so that we can come to closure on it? On the screen? Since we are making changes in it?
DR. COHN: Are you willing to do that?
DR. YASNOFF: I’d be happy to do that.
DR. COHN: Sure why don’t you do that, that might get us from going through this four or five times with sort of the same thing.
DR. YASNOFF: Otherwise, we’re going to be reading over and over.
MR. AUGUSTINE: One thing Marjorie hit upon, but in a different realm and I want to talk about, is the phrase opportunity costs. You were talking opportunity costs in the sense that moving forward, the opportunity of not moving forward is foregoing those benefits of moving forward. Now I’m going to use the phrase in more the economic term, that from a business perspective, what is the cost to them of utilizing those resources to move to ICD-10, those same resources could have been utilized in other areas to improve their business. That’s the true definition of opportunity costs and something that we haven’t put in here that would be very difficult to quantify, but to the business, to the industry, would be very, very interesting to them. Does that make sense?
MS. GREENBERG: Well, you’re talking about other activities related to classification or just in a completely other area?
MR. AUGUSTINE: Other uses for that investment that they’re going to have to make to make the move to ICD-10. I don’t, I haven’t done this in a long time so I don’t remember how to quantify that, but maybe there are others that do.
DR. FITZMAURICE: Maybe a benefit/cost analysis of the next best alternative use of the funds. A benefit/cost analysis of the next best alternative use of the funds, or the individuals affected. That may get us pretty broad and pretty far down the road, to do that, but that is the proper sense of opportunity costs.
DR. COHN: I’m fascinated. I’m trying to think of how you do that. Stan?
DR. HUFF: A different question altogether. In the first bullet it talks about identification of affected entities, and I wondered if that, what that list of folks were. Is that insurance companies, hospitals, nursing homes? Or is that physicians, coders, nurses --
MS. GREENBERG: All of the above.
DR. COHN: Well for ICD-10-CM, it’s all of the above.
DR. HUFF: Organizations as well as sort of roles of workers, the impact of this is all of those.
MS. PICKETT: It would be all of the above and in the writing of this the other thing that struck me in going back through much of the testimony provided by other organizations, some of them listed out certain provider types or certain types that should be included, but there was another whole range of people or types that were excluded. So the sentence here was to try to make sure that we were covering all aspects of people that would be, entities that would be affected that also include public health and others that not necessarily have been mentioned in some of the other testimonies.
DR. COHN: Donna, I have one other question, and I will apologize if I in any way say anything that’s inappropriate here. I guess, I actually agree with all the bullets and I think we’re doing a good job focusing them in. One of the questions that I had had, obviously there’s an issue of timing of transition and all that’s related to that. Recognizing that ICD-10-CM, though, is different than the international standard, which is ICD-10, obviously both with additional digits, some of which are sort of are things that were developed on the basis of perceptions of need by NCHS, and I was just noticing, once again, I’m not, I’ve not looked at the overheads recently but some of the additional digits are related for example laterality and things like this.
I was actually just wondering as part of this work, if for example as it may turn out that there’s a tremendous cost associated with re-work related among other things to the number of digits, would it be useful for us also to look at costs as well as benefits if we somehow either by doing something or other reduce the number of digits, what we win or lose by reducing our digits in terms of functionality, is that something that we should look at or does that extend the scope so much as to turn this into the ten year project?
MS. PICKETT: I think it extends the scope of this project, and the things that have been added to ICD-10-CM were by consensus of the users of the classification for the most part, and those things have been posted previously and we’ve received additional input form the users on those things, so I’m not sure whether going back to the actual content of the classification was really within the scope that we were looking at here.
DR. MCDONALD: I think that’s actually a reasonable thing to think about because if there’s additional costs, it will have to because there’s additional detail that has to be coded, and if we’re talking just about the costs, we should pay attention to that.
MS. GREENBERG: I think that’s part of the costs, but that’s a different thing than looking at different versions, the costs or benefits of different versions of 10-CM, which I think would be sort of beyond the scope.
DR. MCDONALD: Well then maybe in answer to that is specific looking at the costs of additional digits of precision. When going from 9-CM to 10-CM might be the way to ask it.
DR. COHN: I’m happy not to include that in the study, it may be something that as we look, and once again, I have no idea what this study is going to look at, but one would imagine just knowing the industry as we do that there’s going to be extreme costs related to sort of re-working everybody’s information system, adding digits to many of the codes, so I was just sort of thinking of ways, we could look at it now or we can wait for the data to come in, and then if there’s an issue we can look at these things further. It’s find to hold it until then.
DR. MCDONALD: Could somebody clarify how many, I hadn’t quite appreciated what you said Simon. There are more digits in 10-CM than 9, is it a really much larger coding system? I know 10 isn’t as large as 9 --
MS. PICKETT: ICD-9-CM for diagnosis is a numeric five digit. ICD-10-CM has six digits with a seventh digit as an extender for additional information, and it’s alpha-numeric.
DR. MCDONALD: What are the number of codes in it compared to 9?
MS. PICKETT: It’s more than double.
DR. MCDONALD: I think maybe what we could do is focus on the costs, especially the costs due to the additional number of digits in precision that will have to be coded.
DR. FITZMAURICE: Now doesn’t that depend upon what information will be requested? And that seventh digit as I understand what Donna said doesn’t specify what the additional information is, it’s there as a place holder for additional information in the future. Am I right on that Donna?
MS. PICKETT: No, there are specific extensions for the injury codes, the external cause of injury codes, that address whether the encounter is an initial counter versus a subsequent encounter. And that’s part of the codes, so it’s not a place holder.
DR. FITZMAURICE: Is that fewer than half the codes, fewer than a third of the codes?
MS. PICKETT: It’s fewer than half the codes.
DR. MCDONALD: I mean what those things do is they require more time to start out, figure out, I don’t know if people appreciate detail costs, but I think we ought to focus, at least ask the question is when we talk about the costs of the differences, would there be perceived to be additional costs to get additional detailed coding? We have to check whether it’s a current encounter or old encounter, that’s not necessarily come out, it doesn’t necessarily pop out, the patients’ unconscious, to tell they’ve been here, they don’t always say it right when you ask them.
DR. COHN: I’m trying to think whether this is already included or not, what is your --
MS. PICKETT: Well, the information as added to the code set itself was based on requests from the current code users who are doing work-arounds to obtain that information and trying to report it out in different ways. All we’ve done is included within the code set itself for its use, so it’s not that the information isn’t there, it’s that other people now are using various and sundry ways, which are not standardized I might add, to capture the level of the detail that is now in ICD-10-CM.
DR. MCDONALD: Well then that’s either a benefit and/or cost, but that’s highlighting the fact that there’s a significant difference to the person who’s going to do the work and we want to know the affect, good and bad, I think it’s a good thing.
MR. AUGUSTINE: So, Clem, you’re looking at adding maybe a fifth bullet. The fourth bullet looks at the ongoing benefits, maybe there would be a fifth bullet that looks at the ongoing costs.
DR. MCDONALD: Costs and benefits related to --
MS. GREENBERG: We already have future benefits.
MR. AUGUSTINE: Yes, you could put that in that fourth bullet or you could have --
DR. MCDONALD: Maybe fourth bullet, specifically, especially pick attention related to the additional detail and structure of the code that will have to be correctly filled in.
DR. COHN: Actually, Dr. Yasnoff just added costs and benefits to that fourth bullet, which I think addresses I think the issue. Steven and then Mike.
DR. STEINDEL: A couple of comments on this discussion. The first is in response to Clem’s comments, which I think are very good, I don’t see how we can derive those types of figures without going into some type of actual coding demonstration project. It would be difficult from a pencil and paper point of view to figure it out. And if we start and if that is the way we want to go we also need to consider what is the timeframe for this report and what is the cost for this report, because the cost and the timeframe will expand if we do that. And my concept of this was that you wanted a report back in the May timeframe.
MS. GREENBERG: Well, let me just say we are going to be doing some pilot testing concurrently with this study, and in fact try to get some time studies about coding with the two different classifications, so that --
DR. STEINDEL: Concurrent or as part of?
MS. GREENBERG: Not as part of this, it’s part of our overall development work, now we’ve posted the pre-final version and the next step is to do some pilot testing of it and particularly testing the training materials, but we also will get some data on the experience people have coding the same records with ICD-9-CM and with ICD-10-CM.
DR. MCDONALD: That’s wonderful to know about and that will relieve I think everybody to know that there’s a clearly, if you have more details that we match this to it and if it doesn’t cost very much no one’s going to care.
MS. GREENBERG: And the reason we’re calling it a pre-final version, too, is that if some of the additional detail that people have asked for and is being accommodated turns out really not to be readily available or to be overly burdensome, then we would clearly consider removing that.
DR. MCDONALD: It will be nice to have some empirical real experience.
DR. COHN: And so we very much need to make clear to whoever is doing this that they’re not supposed to go off and develop the protocol with more leveraging existing data.
MS. GREENBERG: Under this contract we had not intended to have any dual coding or anything like that.
DR. COHN: Dr. Yasnoff?
DR. YASNOFF: Along those same lines, my assumption has been, and we’ve heard from a number of organizations, expressing support or opposition to this conversion, that they have some information about what the costs and benefits might be, and we would certainly want this contractor to be in touch with those organizations, as well as NCHS, and so why don’t we put that in the statement of work that the expectation is that the affected entities will be contacted to see what information they have and are willing to provide about this, and also we can specifically state that NCHS will be providing information to this process, so that the contractor doesn’t feel, so it’s very clear to the contractor that this information is available and we expect them to go get it as opposed to develop it.
MR. AUGUSTINE: I just want to feel comfortable that their work is independent, which is one of the reasons why we’re doing this in the first place.
DR. COHN: Well, I think their compilation is an independent act but I don’t think that they’re doing it in a clean environment, I think they need to get as much information from the all the affected entities as possible. And I think that’s a great addition to the document.
DR. STEINDEL: I think they should get it as a separate bullet.
DR. COHN: That probably applies to all of these.
DR. STEINDEL: One of the problems is that if they rely on the NCHS studies on implementation, you need to provide that to them by a date certain.
MR. AUGUSTINE: That’s the new phrase of the day isn’t it? Date certain.
DR. STEINDEL: Date certain is a government phrase, you’ll learn it.
DR. FITZMAURICE: Two things, one is that under the immediate and future benefits, I heard in the testimony that one of them was greater detail for fraud and abuse, so that should probably be listed, being included as a benefit.
DR. MCDONALD: Some may take that to be just a trap, to take the practicing physician view, that if you have more little details you have to code, you have more places to make a mistake, and then you’ll be accused of fraud and abuse. I don’t think there’s any benefit to reducing false accusation of fraud and abuse through a more accurate, more highly detailed coding system.
DR. FITZMAURICE: Are there benefits to detected true fraud and abuse and reducing that in our system?
DR. MCDONALD: Well, that begs the question about well that’s where we save all kinds of money.
DR. FITZMAURICE: That’s the main question.
DR. MCDONALD: But the question is if we’re going to add costs, we ought to then know what we’re doing with it. Most of my colleagues think it’s a game and it’s just a way to detract people who are doing their best job. There’s an awful lot of anger about that.
DR. FITZMAURICE: And the second point is that I want to just echo what Steve said, it’s a time limited study, a resource limited study, and we should frame it with an idea of getting it done by whatever date that we set, for example, mid-May, and you can also have a section saying here are additional avenues that could be explored, so that we can see where the study might have gone if it had two years and two million dollars to do.
DR. COHN: Other thoughts, issues here before we move on to the next bullet? Marjorie?
MS. GREENBERG: I think this was mentioned but I don’t think it’s up there --
DR. YASNOFF: I’m just asking if in this discussion there was some other language --
DR. COHN: I didn’t hear anything that needed to be added to this.
MS. GREENBERG: Of course that last point about affected entities would be relevant to the entire study.
DR. YASNOFF: I can repeat the bullet, but let me read that for Clem’s benefit, and also Jeff. The bullet I added says affected entities, including NCHS, should be contacted to provide input to the contractor about their own assessments of costs and benefits within their organization.
DR. MCDONALD: Perfect.
MS. GREENBERG: Where you’ve added the various areas for, I think it’s a little redundant there, the immediate costs, you added cost to that fourth bullet. But you’re saying those are different costs than the costs of transition, so that’s why you added costs there? Ok. Although immediate sort of seems like transition, but anyway, I think in that list of, probably should add, you’ve got patient safety, outcomes analysis, reimbursement, disease management, utilization review, I mean I would add health statistics, international comparisons, I mean that’s one of the uses of the classification.
DR. YASNOFF: You want me to just say international?
MS. GREENBERG: You could just say health statistics and that would include international and domestic I guess, and addresses the issue of mortality and morbidity data using different --
DR. YASNOFF: These bullets are pretty much repeated and so, in the other sections, so I can copy them as necessary if we agree that these changes should be repeated.
DR. COHN: For Clem’s and others benefits who can’t see this on the screen, Bill do you want to read the first paragraph? Which I think is actually fine and I think we can probably move to the second.
DR. YASNOFF: You want me to read the whole thing?
DR. COHN: Would you please?
DR. YASNOFF: So it says, this is the first section. Assess full range of implications on current users of ICD-9-CM diagnoses to implement ICD-10-CM, including costs and benefits, quantifiable and non-quantifiable of change. First bullet, which is unchanged, identification of affected entities and degree to which they will be impacted. The second bullet, which is also unchanged, identify costs associated with transition, including but not limited to, information system changes, recalculation of reimbursement schemes, training, changes to forms, and actually I guess I need to add etc., just to make sure we’re not excluding anything, and that is a change.
And then the third bullet which originally said timing of transition now says timing of transition, including impact of timing options on costs and benefits, including opportunity costs, potential return on investment, and interaction with other major health information implementation tasks. And then the fourth bullet, which has been changed slightly says, identify immediate and future costs and, which has been added, costs and benefits of improved data for, but not limited to, patient safety, outcomes analysis, reimbursement, disease management, utilization review and health statistics, health statistics having been added.
And then there’s a new bullet that says affected entities, including NCHS, should be contacted to provide input to the contractor about their own assessments of costs and benefits within their organization.
DR. COHN: Mike?
DR. FITZMAURICE: I have a concern about the last --
MR. BLAIR: Make sure that Clem heard that and feels comfortable with it.
DR. YASNOFF: Did you hear all that Clem?
DR. MCDONALD: Yes.
DR. YASNOFF: Is that ok with you?
DR. MCDONALD: Yes.
DR. COHN: Mike?
DR. FITZMAURICE: I have a concern about the last one, I’m worried about the independence. Let’s suppose that you’re the contractor doing the study, and then you get flooded with a bunch of other studies, comments, it’s almost like a review and comment period for a regulation that would take all summer to do. It might be better to have a separate test saying here’s a contractor, here are the specifications, go out and give us your best estimate. Enter contractor number two, go out and collect all the other studies and all the other information that’s done, and then we’ll have a consensus process at NCVHS to sort out that information, as opposed to having a contractor sort it out for us.
DR. COHN: I guess my own view, not living in Washington, DC, but confronted with the opportunity to do it, it sounds like if we did it the way you were describing, I think it makes sense to have the contractor get input from the industry. I think we heard during our testimony that most of the people in the industry and most of the industry groups wanted to be able to provide input into all of this. So I can’t see how we’re going to avoid it. I mean we could in May keep this separate and then spend, have everybody present their own cost benefit studies, and then try that one to figure out how they relate.
DR. FITZMAURICE: That will likely happen anyway.
DR. COHN: That may happen anyway. I think it’s important since this group is not going off and doing independent research, they’re doing more analysis and writing things together.
DR. FITZMAURICE: I also think there’s an issue of having another contractor. I mean we already have the issue with this that we’re targeting, we have talked about having this go to RAND because any contractor that we would get that knows anything about this issue has a conflict of interest, which is a perfect example of the type of research that should be done by a federally funded research and development corporation. So to find, we’d have to essentially find another one of those to do a different part of this. The idea here and maybe it’s not stated right, is that rather than have this contractor independently create those numbers, we expect them to go get them and not charge us for creating them from scratch. That’s I think really the intent, at least that’s my understanding.
MS. GREENBERG: I think we also expect them to assess, they should have the skills to gather the information, the scenarios, basically the cost and benefit studies, or assumptions that have been developed by others, and then to assess them and to come out with ranges or their best sense of what, where truth lies, and of course it will probably not lie on a precise number, it will be in a range. So I don’t think we want them to just gather all this stuff together, I think we want them to gather it, look at it against each other, and see where it conflicts, where it’s similar, and make an assessment.
MR. AUGUSTINE: I just don’t want them regurgitating other people’s numbers. I want them to look at it, assess it as you stated, for the validity of the study, and then put that information together and say this is what we believe, but studies have shown it to be from here to here, and put each number forward for its own merit.
DR. COHN: I think Dr. Yasnoff is actually writing an additional sentence there to help us here. Steve?
DR. STEINDEL: I’m not sure, I haven’t finished yet, but the overriding charge is to assess, and the bullets represent things that we would like assessed, so I don’t know if it’s necessary to really add that.
DR. YASNOFF: That’s why I tried to put that in by saying they’re going to provide input to the contractor, but not the contractor isn’t obligated to do anything with the input except to look at it. I mean we can, I think you can say too much, too.
DR. STEINDEL: The contractor is obligated to assess by the overriding.
MS. GREENBERG: The assessment is the riding, overriding.
MR. AUGUSTINE: Well not to, well actually to go to a different point, I want to go back to what we were talking about earlier, which was the notion of opportunity costs. I think we need to have that relayed in there. Now we wouldn’t be able to, they could quantify it easily by not going from a case by case or entity by entity basis, but say in general if the ten billion, or two billion dollars that was spent implementing this was put into the health care sector that had a three percent return, to balance it in global against each other like that, because they do have other uses for this money or other ways to invest it, foregoing that rate of return and implementing ICD-10, and that needs to be quantified.
DR. FITZMAURICE: Alternatively they could give it back to the stockholders by putting it as dividends, and make it a bigger benefit because it increases the value of their stock and their bonuses. So we run into the problem of what are social benefits and what are private benefits.
DR. COHN: Brady, don’t you think the opportunity costs up here represents a lot of that idea or do you feel it needs, I said I think you were referencing the opportunity cost issue, and I guess, does that need greater precision you think? I think it’s sort of ok the way it is.
MR. AUGUSTINE: It’s not covered in what we have there present.
DR. YASNOFF: It’s in this point only. It’s right here, and I would ask if you think it should be, but maybe does it need to be in a different place or does it need to be repeated?
MR. AUGUSTINE: I was thinking it would be in the second bullet, because it’s really all the costs with moving would include not only the actual costs but opportunity costs.
DR. YASNOFF: I think the sense of opportunity cost as we have it in the timing bullet has to do with how the costs would change if you delay the transition. Whereas I think what you’re talking about may be something else, which is the alternative use of the same investments, which is really the time value of money, in a sense.
MR. AUGUSTINE: Like what Mike was saying, it’s the next best alternative. If a company had put that money to a different use and been able to make money as opposed to spending it for ICD-10, and not been able to make an immediate return, there’s a difference there that we’re not catching. It should be in the second bullet, it wouldn’t, in the third bullet what you’re talking more about is foregoing benefits, you’re not speaking of opportunity costs, in the strict sense.
DR. YASNOFF: Can you give me some language that you’d like me to put in some place?
MR. AUGUSTINE: On the second bullet just include identify costs including opportunity costs associated with the transition. Really you don’t even need opportunity costs in the second one, I think the impact of timing options on costs and benefits is going to capture that. What you were discussing, foregoing, anyway --
DR. YASNOFF: So I don’t need that.
MR. AUGUSTINE: And that’s got me covered.
DR. COHN: Good, thank you.
MS. GREENBERG: I think you want to remove it from, did you want to remove it from two or you wanted to remove it from three?
MR. AUGUSTINE: I want to move opportunity costs in three to two.
MS. GREENBERG: I see what you’re saying but that’s a really tough one, in the sense of just any number of things one could use one’s money for.
MR. AUGUSTINE: I’m sure they could come up with some global average like what was return for the industry at large in health care, and so they could do some approximation like that, three or four percent, I don’t know, but they could do something that would make this a more accurate measurement.
DR. FITZMAURICE: Do we want to address what discount rate they should use when looking at money in the future versus money --
DR. COHN: Should we move on to the next set of bullets? I’ll read the first piece, but it sounds like it’s basically going to be all the same sub-bullets, or ought to be. Let’s reflect on that. Basically the next one is assess full range of implications on current users of ICD-9-CM, Volume 3, which of course is the hospitals users primarily, to implement ICD-10-PCS for, it says for surgical procedures in the hospital in-patient setting, though it actually is beyond just surgical procedures I think.
DR. YASNOFF: Yes, it should be all procedures, right?
DR. MCDONALD: That’s not what it’s proposed for. It was not proposed for all procedures, ICD-9-CM is not used for all procedures.
DR. COHN: Well, let me think about that, Clem, I think it actually is used for all procedures in the hospital in-patient setting. Are there procedures where it isn’t?
DR. MCDONALD: -- x-ray reports, the only time you really use it is medical procedures. They never tested it at all in the preliminary things or anything but it’s really not surgical, it’s too narrow --
DR. COHN: Well, Clem, I guess I’m struggling, I think surgical is the wrong one. Currently Volume three has things for example like x-ray of the abdomen or x-ray of the lower --
DR. MCDONALD: [Comment off microphone.]
DR. COHN: Should we call it medical and surgical procedures?
DR. YASNOFF: What’s wrong with procedures in the hospital in-patient setting?
DR. COHN: Procedures in the hospital in-patient setting?
DR. MCDONALD: Well, because, at least the original report stated that there was no testing done on that of the ICD-10-PCS, and no one has gone over it.
MS. GREENBERG: It was tested for all the purposes that ICD-9-CM, Volume three, are currently used.
DR. MCDONALD: Right, which is medical/surgical procedures.
MS. GREENBERG: Medical/surgical is probably fine.
DR. COHN: I think, the thing I’m struggling with here is that I want to make sure that we’re evaluating it as a replacement for Volume three, and Clem you’re in agreement with that right?
DR. MCDONALD: Yes.
DR. COHN: It seems like what we’re doing is arguing about what the uses of Volume three are, which I’m struggling, I think we should wordsmith this in a way where we don’t have to address --
DR. YASNOFF: It already says the implications on current users of ICD-9-CM, Volume three.
DR. STEINDEL: Why don’t we just say as a replacement?
DR. MCDONALD: Don’t we think we know what ICD-9 Volume three is used for?
DR. COHN: We’re sitting here arguing about whether it’s med/surge or what exactly the right terminology is.
MS. GREENBERG: We’ll get it right.
DR. STEINDEL: My suggestion is on current users of ICD-9-CM, Volume three, to implement ICD-10-PCS as a replacement in the hospital in-patient setting.
DR. COHN: Ok, that sounds good.
DR. STEINDEL: That way we don’t have to worry about the procedures.
DR. MCDONALD: -- they specifically accepted, they specifically said that those weren’t tested in all the reviews and all the tests, and they didn’t really have feedback on the other areas. I don’t know whether we should say then look at all of it, because if does have codes for things that aren’t just the things it’s used for, PCS has a lot of codes --
DR. STEINDEL: Clem, let me read you what we’ve got now, see if this is ok with you. Assess full range of implications on current users of ICD-9-CM, Volume three, to implement ICD-10-PCS as a replacement for procedure coding in the hospital in-patient setting, including costs and benefits, quantifiable and non-quantifiable of change.
It’s clear we’re only directing this at current users of ICD-9 for --
DR. MCDONALD: But not current uses. See the current use is as I understand it from all the testimony and the books I read that CMS reported, is being used for effectively professional medical procedures only, medical/surgical. I don’t mean medical in the absolute capital M really but dental, osteopath, that kind of stuff. It is not being used to code lab tests, it’s not being used to code radiology tests, it’s not being used for codes, that’s what everybody said. And they didn’t look at that at all in the coding studies they did.
DR. COHN: Well, we have a comment which may hopefully clarify this a little bit from AHIMA.
MR. RODE: This is Dan Rode from AHIMA. Hospitals use Volume three hard coded into charge masters for procedures that don’t require a coder to evaluate the record, so a x-ray procedure is hard coded into the system so that it’s not handled by a coder. So if you’re going from Volume three to PCS, chances are you will still hard code that procedure into your computer, and those code changes are made whenever CMS makes their annual updates. When it was tested, they didn’t look at the things that wouldn’t be done with coders using and looking at the chart, they just looked at the surgical/medical piece, because that’s what the interest was. Everything else is something that most of you learn to do in your first year of computer science. So that’s why you don’t see testing done in that way and I think that the presumption that you could look at how it’s being used in Volume three and then look at how you want to use it in PCS would certainly work for both what would normally be coded by a coder versus what would be hard coded, so you might as well look at the whole thing, but the process would be essentially the same, it’s just using a different code set.
DR. YASNOFF: Is this better? Clem I’m going to read you some alternative language I just came up with. Assess full range of implications of replacing ICD-9-CM, Volume three, with ICD-10-PCS in the hospital setting. In-patient setting. That’s essentially saying we’re just going to take 9-CM, Volume three, replace it with 10-PCS for whatever it’s being used for.
DR. MCDONALD: Ok, I would still elaborate a little bit and say of both for the hand coded results that are medical/surgical procedures and for the automated uses which are for the other procedures, so that they address both, if it would really say both of them that they really do address both of them. One tends to get forgotten.
DR. COHN: Well, Clem, I’m struggling only because we’re saying assess full range of implications, and I’m trying to think is there a bullet here that we can --
DR. MCDONALD: -- different categories, and I don’t think it hurts to be explicit about there’s two parts to this as they are described.
DR. COHN: Maybe there’s a bullet underneath this which would allow us to sort of state what you stated, and that’s what I’m sort of struggling with, but I don’t think it’s in the title sentence.
DR. MCDONALD: As long as it’s explicit that there really are these two parts because I had it that it was only applying to the surgical. And it’s fine if it should apply to both, it should, but then we should make sure that it does look at those categories, because they are different kinds of issues.
MR. GUSTUFSON: This is Tom Gustufson, and I just wanted to offer a friendly suggestion here. I think you could capture Mr. McDonald’s point and make it clear to everybody by putting two words in, in the sentence that was just added here at the bottom. Replacing, or maybe it’s three words, replacing current uses of ICD-9-CM.
DR. COHN: Ok, thank you. Tom, thank you very much. So do you want to read that?
DR. YASNOFF: So now, Clem, what I’ve got is, assess full range of implications of replacing current uses of ICD-9-CM, Volume three, with ICD-10-PCS in the hospital in-patient setting, including costs and benefits, quantifiable and non-quantifiable, of change.
MR. BLAIR: Clem, you feel ok with that?
DR. MCDONALD: Well, I think that’s better, but I still worry, since we’re ambiguous about, after the testimony, about what they are, to make sure we highlight them somewhere in these bullets to the reviewers that both things are being considered.
DR. COHN: Well, let’s go through the bullets and then we’ll sort of see if we need to add one.
MS. GREENBERG: I would say that one thing you always do after you award something like this is you have a kick-off meeting and certain things can be clarified at that time, too, certainly since we’ve told them to look at the current uses they would have to make sure they were clear on what those were.
DR. COHN: Well, as I said, let’s see if there’s a place still in the bullets that might reflect some of Clem’s thoughts there. So let’s look at the bullet, and I guess the question is were we using the current ones or are we using the ones above?
DR. YASNOFF: Let me copy the ones above.
DR. COHN: I think the ones above have been wordsmithed a little better.
DR. STEINDEL: I would like to make that a friendly change, that with the same sense appears that we use the previous worked out bullets.
DR. COHN: Ok, so this is basically the first bullet is then identification of affected entities and degree to which they will be impacted. Second is identify costs, including opportunity costs, associated with transition, you can’t move it for me, associated with transition including, but not limited to, information system changes, recalculation of reimbursement schemes, training, changes to forms, etc. The next one is timing of transition, including impact of timing options on costs and benefits, potential return on our investment, and interaction with other major health information implementation tasks. And the next one is identify immediate and future costs and benefits of improved data for, but not limited to, patient safety, outcomes analysis, reimbursement, disease management, utilization review, and health statistics. And the final one is affected entities, including NCHS, shall be contacted to provide input to the contractor about their own assessments of costs and benefits within their organizations.
DR. YASNOFF: Should change it to CMS in this case, right?
DR. COHN: Yes, including CMS. Actually Tom, do you have another suggestion?
MR. GUSTAFSON: Just jump in here in a moment. I think in reference to the Committee’s earlier discussion on this and the various parties that you’ve been hearing from on this, it’s not just CMS but third party payers in general would perhaps be the appropriate --
DR. COHN: So including but not limited to CMS.
MR. GUSTAFSON: Blue Cross/Blue Shield currently has an interest here and --
DR. COHN: I think they have an interest in all of these.
MR. GUSTAFSON: It’s not an automatic thing but it’s more likely explicit.
DR. COHN: Ok. Now I think the only question is is do we need, and Clem help us with this one, I’m trying to think if there is a bullet here that might reflect I think your concern, say something like analysis should include both traditional medical/surgical uses of ICD-10-CM as well as, and I’m struggling with the right word.
DR. MCDONALD: -- are not coded, typically coded by hand. I mean the reason this becomes important, I think it’s just a handful of codes in the 3,000 codes that apply to say radiology, and there’s probably 50,000 in PCS. That’s going to be a different kind of work than just the coders, we have some data on what the coders will be 1/10 or 2/10ths slower to code. It will be one time, but it’s going to be different kind of work.
DR. YASNOFF: Clem, could you state again, clearly, what it is the two things that you want so I can capture that?
DR. MCDONALD: It’s not what I want, I guess, it’s that all the discussion focused on the only real practical use and this was both discussed and in the documents, was for the coding of medical/surgical procedures. And I wasn’t worried until just now, and I’m still not sure that it happens everywhere, that these codes won’t go into the master file, I just feel on the local codes to those things. But if that’s the case, just to analyze what the issues would be for those, which is different, because it won’t be hand coding, or maybe it will have --
MR. AUGUSTINE: Make it simple, just say analysis should include both hand coded and hard coded --
DR. MCDONALD: -- or medical/surgical, the codes that are traditionally hand coded are, the medical/surgical procedures are traditionally hand coded.
MR. AUGUSTINE: Analysis should include codes that are --
DR. MCDONALD: And use of automatic matching as might be applicable.
PARTICIPANT: How about all uses of ICD-9-CM including?
DR. MCDONALD: Does anyone else know really what the issue, how they do it now?
DR. COHN: Clem, I think what they’re talking are uses of charge masters, which is sort of the term that I sort of grew up with, where you actually have already done the mapping for things that are not actually surgical procedures --
DR. MCDONALD: But is there any reason why, does anyone else can contribute to whether that’s what really happens in an institution? Because CMS doesn’t’ care about that, because the DRG’s and they don’t have any place to report that, maybe 92’s. The charge masters are much more detailed already than anything --
DR. COHN: I’m looking to see if Donna Pickett maybe has a --
MS. PICKETT: I would like to suggest that you allow staff to work on the wording and then redistribute it to the Subcommittee rather than to try to wordsmith it here. I think we get the intent of what Clem would like included and I think we can work on that and return it to you, so that we can continue with the discussion.
DR. COHN: And I think this is also an issue of fact, which we’re I think a little fuzzy on. Steve?
DR. STEINDEL: I somewhat agree with Donna, I also would like to point out that this contract will be implemented by a project officer, and I think the project officer is very acutely aware of the various uses of both ICD-9-CM and ICD-10-PCS, and will instruct the contractor accordingly. So all uses should cover us.
DR. COHN: Ok. So are we comfortable recognizing that we’ll have a last look at this via email?
DR. MCDONALD: Well, the word now is not current uses, right?
DR. YASNOFF: What it says now, Clem, is and we’ll work on this, is analysis should include all current uses of ICD-9-CM, Volume three. So I think that covers all current uses.
DR. COHN: Shall we move on to the third bullet? Which is assess full range of implications required to implement ICD-10-CM and ICD-10-PCS simultaneously.
MS. GREENBERG: We probably should say there or separately, then he’d look at both.
DR. COHN: I think we were doing separately above.
MS. GREENBERG: Not necessarily. You want to make a comparison.
DR. COHN: Ok, should we say separately, versus separately, fine.
DR. YASNOFF: Do you want me to copy those bullets again? The first three?
MS. GREENBERG: No, I don’t think they’re --
DR. YASNOFF: You don’t think it’s relevant?
DR. COHN: Well, actually I think that they probably are.
DR. YASNOFF: Well, the first three as we change them are still probably better than --
DR. COHN: Ok, so let me read them. Identification of affected entities and degree to which they will be impacted, identify costs including opportunity costs, associated with transition, including but not limited to information system changes, recalculation of reimbursement schemes, training, changes to forms, etc. And then timing of transition, including impact of timing option on costs of benefits, potential return on investment, and interaction with other major health information implementation tasks. And let’s see, is there, what else might we need to put there?
DR. YASNOFF: The other ones are immediate and future costs and benefits. That was not included originally in the third section.
MS. GREENBERG: Yes, I would include it.
DR. YASNOFF: You want to include that one, too?
MS. GREENBERG: Why not?
DR. STEINDEL: Is it going to be different than what they would give us under the first two bullets?
DR. YASNOFF: Maybe not, but we should probably include it.
MS. GREENBERG: There might be certain things you could do if you had both, that you couldn’t do --
DR. YASNOFF: Right, there might be additional benefits of having them both at the same time.
DR. COHN: Ok, so identify immediate and future costs and benefits of improved data for, but not limited to, patient safety, outcome analysis, reimbursement, disease management, utilization review and health statistics. Let’s take a look at the, and then basically the last one is affected entities should be contacted to invite input, I think that probably needs to be added also, because we’ve just added them all.
DR. YASNOFF: I’m not sure we should name any in this case.
DR. COHN: Yes.
DR. YASNOFF: So we won’t name any in particular, how’s that? So we’re just going to say --
MR. AUGUSTINE: Maybe you don’t want a separate section for that, maybe you just do the first two and then have like a master statement at the bottom that says and also these will be assessed as to whether doing them simultaneously or separately would have an impact on the cost of the benefit analysis.
DR. YASNOFF: That’s an edit, we can edit that. That doesn’t change the sense of what we want the contractor to do.
DR. COHN: Are we ok then with this, Suzie?
MS. BEBEE: Just one minor comment. I believe that we lost rate negotiations and I didn’t know if that was important or not in that last grouping.
PARTICIPANT: We lost what?
MS. BEBEE: Rate negotiations is in the second bullet of the original.
DR. COHN: Let’s see, second, recalculation of reimbursement schemes, is that what you’re?
MS. BEBEE: Rate negotiations --
MR. AUGUSTINE: Negotiate a better rate from both as opposed to just --
DR. COHN: Oh, ok.
DR. YASNOFF: Ok, fine, I’ll be happy to add that back in. Rate negotiation. Sorry.
DR. COHN: Are we ok with this then? I mean I think this looks pretty reasonable now.
DR. YASNOFF: Since all three of these are very similar, I think we’ll reword it and make it much simpler.
MR. AUGUSTINE: Can we change the word, the phrase from reimbursement scheme to something else? It makes me feel like the government’s out to get me or something.
MS. PICKETT: Methodologies?
DR. COHN: You don’t like schemes?
MR. AUGUSTINE: Not when it comes to something the government’s doing.
DR. YASNOFF: Would you prefer methodology, is that?
MR. AUGUSTINE: Yes, that would be good.
DR. COHN: Let’s talk about next steps for a second at this point, and I think, we’re sort of working backwards from what I’d like to see which is that in June we have some recommendations to bring to the full Committee. And I don’t now if it’s recommendations or whether we’re sending in the cost/benefit analysis, we’re going to have to struggle with that one in May, but the hope that we’ll have something in June. The idea will be we would expect this to come back to us in a more or less final form in May for our review. And I think at that point, even though we’re obviously asking the contractor to obviously talk to many of the affected entities and organizations involved in all this stuff, I think we should probably also provide an opportunity if there have been other separate cost/benefit analyses done, to sort of hear about them and get presentations about them, as well as allow these people to reflect on this work if they have opinions or otherwise. Does that make sense to everybody? And then sort of working back from that, I guess I would hope that at the January meeting, hopefully we will have identified a contractor and hopefully that contractor could meet with us for a little bit to talk about what their plan is. Hopefully they may have been already starting at that point.
DR. STEINDEL: If they want to get done by May.
DR. COHN: If they want to get done by May. Is that a reasonable timeframe and set of activities? I’m sort of looking at everybody to see people nodding their heads.
DR. YASNOFF: I think a reasonable timeline is that we could get the contractor mid-January and have a report, I’m looking maybe May 12th, which is about ten days before the May meeting, so we could distribute it to the Committee before the meeting, so people could read the report and then discuss it at the May meeting. I think that’s really pushing it, because you’re giving them four months to do this. This is a lot of work. But I think it’s possible, it’s reasonable, but I’d like to make it as close to four months as possible. The other thing is of course, my assumption is that the Committee is happy to assist or participate in sending letters to all the people who are going to be asked for information, kind of alerting them to the fact that this is coming, so that they can be prepared and not be surprised or have to evaluate the authenticity of the request and so on. So we can do that in parallel with, as the study starts we can sent out letters and so on, so as to speed things up in terms of the response.
DR. COHN: Ok. I think we’re nodding our heads saying yes, obviously this is being done at the behest of the NCVHS, so I think we will do what we need to to help make this all happen.
Other things that we need to deal with in terms of this? I’m sort of, Steve?
DR. STEINDEL: My question, Simon, with regard to what you were talking about future schedules, does the Committee want to have a separate meeting to discuss and perhaps evaluate and ask for clarification on the report from the contractor before we pass it to other people and ask them to prevent their own cost justification studies and discuss this? What I’m thinking about is we may want to do this at two separate meetings, the first one an internal review and a second one is when we ask outsiders to come in and comment. And we can do them both simultaneously, it’s of the opinion of the Subcommittee.
MS. GREENBERG: I would hope we could get a draft prior to May 12th.
DR. YASNOFF: The idea, well, I don’t know. I think that realistically we’ll get this study in May and then we can evaluate it at the May Committee meeting ourselves, and then we can have testimony, there may be further work that needs to be done or refinement and so on and then when that’s done we could then essentially release the study, send it to people who we would like testimony from, and get comments on it at the following meeting which is --
MS. GREENBERG: Well, that, though, will preclude having a recommendation or bringing it to the full Committee at the June meeting.
DR. YASNOFF: Oh, at the June meeting, I see. Well, I think, my assumption is that this is going to take four months to do, but we can ask the contractor if it can be done faster. I mean we can ask, and if so, we will try to do that. And if it could be done faster than maybe we could evaluate a draft earlier and have a conference call, is that? The goal is to have, or, how could you structure it so that we give sufficient time for the study and still have a chance to both review it internally, have changes made, send it to outside people, get comments, and make a recommendation to the full Committee, by June.
MR. AUGUSTINE: That will be tough. The study is going to take some time. Four months alone is pushing it.
MS. GREENBERG: The question is just how long you want to drag this out. The study will be input to the NPRM, first of all people are going to be asked for their input to the study, the study itself will be, and the Subcommittee will review it and make suggestions, then presumably finalized before the June meeting. It will also be input to any NPRM, at which point people can disagree with, as they do with any NPRM, agree with the impact analysis, disagree with the impact analysis, I mean if you think we’re going to get consensus from everybody prior to putting out the NPRM, first of all that’s not happened with any other NPRM, and I think that could delay things forever also.
DR. YASNOFF: So do we really need to have this step of having people testify about this or could we just evaluate it at the May meeting? We’ll make our recommendation to the full Committee in June, the full Committee will say, I mean of course it depends on what this study shows, but let me suggest that if the study shows things that are sufficiently, that indicate to the Subcommittee that testimony is needed, then we have the option of delaying our recommendation to the full Committee until the September meeting, and then that would give us a chance to have testimony, if we need it, so I think we ought to delay that decision until we see what the study shows.
For example, if the study showed overwhelmingly that it would be tremendously beneficial to do both these conversions as soon as possible, and that the benefits clearly outweigh the costs in every way that was analyzed, not that it would say that, then I’m not sure there would be any value in having testimony, we could go right ahead. If the study said the opposite, that this is the worst idea that anyone has ever seen, it’s going to cost billions of dollars, there’s no benefits, again, I’m not sure that we’d need any more testimony. It’s only if it’s kind of murky that we might want to, so why don’t we put that decision off, recognizing that if we need another cycle of testimony we may have to delay our recommendation to the full Committee until the September meeting. This is already, this issue has already, how many years old? I mean this transition was recommended at least as far back as ’93, and maybe further. So another three months is not going to destroy the world I don’t think.
DR. STEINDEL: But I think we can also state that another four to six months is not going to destroy the world. I think what we’ve heard from the testimony is that this is a controversial subject, even though it’s been around since 1993, and one reason it’s been around since 1993 is that it is a controversial subject. And what we want to do is try to turn in some type of quality study, and I don’t see shortening the time of the study just to have it around versus losing some quality.
DR. YASNOFF: I agree with you, are you essentially agreeing that we should wait until May to decide what to do?
DR. STEINDEL: I think we should not put an earlier date on the study, I think it should go until May. I personally feel that given the controversial nature of the testimony that we have heard, and if they do a good job of assessing the opinions of outside people, it’s going to be murky.
MR. AUGUSTINE: Bill, I agree with the timeline you just laid forth. I think not getting the external input until after, like Marjorie said, after it gets into the NPRM process would be best, because we don’t want to get a murky, let’s go ahead, get the study, the contractor can reach out and get information as necessary, and then it comes to us for us to review and then based on that information we’ll either make a recommendation, or in panel, or do further investigation. This things gotten murky enough, and I’ve only been on this Committee a year, and --
DR. YASNOFF: I think, Marjorie is certainly right, and Steve also, that there is not likely to be consensus on this issue, ever, but essentially what we’re saying, make sure I understand, is that we’re going to make every effort to put this study in the hands of the contractor as soon as possible, which helps to provide more time, and get a report about mid-May, which should be at least a week in advance of our scheduled May meeting. And then people will have time to look at the report at that time, and then at the May meeting we will then make a decision whether we’re ready to make a recommendation to the full Committee for whatever, for an NPRM, or whether we still have additional questions that need testimony and then we can schedule more testimony and essentially delay our recommendation until the September meeting. Is that essentially what people are agreeing to? I’m sure the contractor will not be terribly pleased about even four months, so I don’t think you want to push it any further than that. Thank you.
MR. AUGUSTINE: Now that Simon is out of the room I’m going to temporarily Chair. I don’t see anything else we really need to discuss covering the scope of work for ICD-10.
MS. TRUDEL: Can we just confirm what’s happening? We have changes that we need to make, we can re-circulate them electronically to the Subcommittee members, there’s been agreement to move forward with getting the contractor on board and started as quickly as possible, with a projected end date in the middle of May.
MR. AUGUSTINE: Right, and I think we will try to have a new version by this Friday, and we’ll ask for, how much time does the Committee need to look at this? Could we make it just a few days? Ok, so we’ll say maybe by next Wednesday, if there are any comments we need them by next Wednesday, and by then we’ll have it set up to go to a contractor, and perhaps we could even get the contract awarded early in January as opposed to mid-January.
So we’re going to circulate a revised version of this scope of work this Friday to the Committee, this Friday being the 13th, and we’ll ask for comments by the 18th, which is next Wednesday, if any.
DR. STEINDEL: Would it be possible for you and Donna to have a revised version for the Committee in the morning? Because then you could actually start the process this week. From a practical point of view the government shuts down next week.
DR. YASNOFF: Ok, we can do that. Donna will present --
DR. STEINDEL: I don’t want to burden on the two of you, but --
DR. YASNOFF: Sure you do, but that’s fine, that’s fine, so we’ll present, this will not take much time, we’ll present a revised version in the morning and get concurrence, and then we’ll move head. Is that acceptable to everyone?
MR. AUGUSTINE: We’re going to go ahead and take our break, it’s scheduled for 3:30, Simon will be back to chair the 3:45 session, which includes the discussion on Alternative Link and the hearings for January of next year, so we’ll reconvene at 3:45.
[Brief break.]
DR. COHN: The last session is really devoted to planning and just sort of discussions related to hearings that we plan to schedule in January on the issue of complementary and alternative medicine. And to really be more specific, it’s really not complementary and alternative medicine, it’s code sets for complementary and alternative medicine, and what are the needs by providers, by health plans, etc., as well as what are national needs.
Now I think as I mentioned at the beginning of the day this is an area where I really am recusing myself from taking a lead in terms of planning the session and all of that, though I am obviously very curious and want to help make sure that we’re getting the right questions asked as well as having a successful hearing. What I have done is ask Kepa Zubeldia, which I had anticipated would be here to take the lead on that and we’re actually delighted also that Stan Huff who is our newest member of the Subcommittee, would be working with Kepa in terms of putting together the hearing. We’re also obviously delighted that Richard Nahin is able to join is able to join and become involved in this process, and obviously Richard thank you for being here.
DR. NAHIN: Your welcome.
DR. COHN: Sort of in the spirit of this I’m also asking Brady if he would be willing to Chair, even though I will participate I think it probably is better if I not try to put this whole hearing together per se. Having said that, Richard do you want to start out and talk a little bit about your list or any comments you have at this point? Is that an appropriate start?
PARTICIPANT: Maybe introduce yourself.
DR. NAHIN: My name is Richard Nahin, my title is Senior Advisor for Scientific Coordination and Outreach at the National Center for Complementary and Alternative Medicine. I work in the Office of the Director, Dr. Steven Straus of the Center, which is one of the 27 Institutes and Centers of NIH. We were created by an act of Congress in calendar year 1998, fiscal year 1999, with a budget of about $48 million at that time. Our current budget is about $104 million for fiscal year ’02, fiscal year ’03 is still pending, but probably about $114 million.
Primarily we fund clinical research versus basic research, which is slightly different than the rest of NIH. About two thirds of our portfolio is clinical research, and this reflects the fact that alternative medicine is available to the U.S. public and is being used by the U.S. public. So from our point of view, health policy point of view, it’s more important to test things that are currently being used than to try to discover mechanisms of actions of why things might work or might not work.
Having said that, as we do put things in clinical trials we also go back and do start basic science studies to try to develop mechanisms of action, but as I said, those generally follow the clinical trials.
We have approximately something like 150 clinical trials of various sizes in progress, from small developmental pilot studies of maybe 20 to 30 people up to large clinical trials that might have 3,000 or more individuals involved. We study everything involved in with complementary and alternative medicine, from botanicals and vitamins and other forms of dietary supplements through procedure based interventions, such as acupuncture, chiropractic, massage, as well as energy type therapies such as Rakage(?), Chicung(?) or therapeutic touch. We’re also interested in investigations of placebo, since it’s very possible that many types of alternative medicine have some aspect of the placebo effect in them and of course we don’t know what aspect, but it’s our assumption that there is some aspect of that.
We work closely with the other institutes at the NIH. We of course, according to our mandate, are supposed to look at alternative medicine across all disease areas. It’s not possible for us to have an expert in every given disease, so we actually rely greatly on the expertise at the other institutes. For instance, in our large trials of osteoarthritis, we work closely with the National Institute of Arthritis, Musculoskeletal and Skin Diseases. The same thing in our trials of different cancer therapies, we work closely with the NCI. Sometimes this involves co-funding, sometimes it’s just scientific expertise, but it is still close collaborations.
We also work with other agencies within DHHS, we have collaborations ongoing with AHRQ as well as the CDC. CDC mostly looking at the national health surveys and AHRQ looking at evidence based reviews.
Anything more you’d like to know about the center itself?
MR. AUGUSTINE: What are some of the studies you’ve done? I haven’t really seen a lot of the results of that in mainstream media. Is that partially because there hasn’t been a lot of positive aspects, or probably because there’s been a bias in the media, or just not enough time?
DR. NAHIN: Well, if you think that our very first study was funded in 1999, and the average of one of our clinical trials might be three to four years, in fact most of our early clinical trials are still ongoing, are very first clinical trial that we started was one looking at St. John's Wort or Hypericum for major depression, that was actually published in JAMA I believe about nine months ago now. That was the first, and we hope to have trials coming out every year, but partly you haven’t seen data from our research because the research mostly is ongoing. The early grants have just ended, it takes a year, year and a half to write up the results and have them published, so hopefully in a few years you’ll be seeing a lot of our papers.
MR. AUGUSTINE: Some exciting results coming out.
MR. BLAIR: What code sets do you use?
DR. NAHIN: We don’t code in the way that you code. We have developed an in-house coding system to code our grants, so that we could produce reports for Congress and other federal requirements that is necessary. Our coding systems, we have divided alternative medicine itself into five large domains. Mind/body medicine, traditional systems of medicine, which would include things like traditional Chinese medicine, biologics, which would include all forms of dietary supplements, botanicals as well as non-botanicals, energy based systems, and manipulation and other body based systems, which would include massage and chiropractic, osteopathic manipulation, such as that. And then with each of those we have sub-categories, and I couldn’t begin to list all the different sub-categories in each of those. And then we also cross tab the alternative medicine coding by dimensional diagnostics, so we might code an acupuncture grant by acupuncture and then cross code it by amesis caused by chemotherapy, for instance. That’s how we code. We code both conventionally and according to alternative medicine to try to allow us to produce the reports that we need to produce.
MR. BLAIR: Well then let me ask another question, did you give us a handout by chance? I haven’t had a chance to have it read to me, so maybe it’s going to be in the handout. But my question essentially is do you have any guidance or advice for us on what characteristics we should look for in terms of coding systems for alternative medicine? Am I jumping ahead?
DR. COHN: Well, I don’t know whether you are or not. No.
DR. NAHIN: The question is asked and I guess my answer is I have no specific advice. I’m not familiar enough with the kind of coding you’re involved with to make a recommendation. I mean this is my first meeting, I’m just beginning to understand the systems. Maybe in six months I could offer a thoughtful recommendation, right now I don’t know if I could do that.
MR. AUGUSTINE: And Jeff, remember that he’s primarily talking about clinical trials, even though their coding procedures are things that occur to patients, they’re not looking at it in terms of procedures for reimbursement, which is mainly what we’re looking at it for.
DR. COHN: Can I make a comment? I’m obviously very curious about this area and I will admit to large extent my ignorance and I find myself sort of as I begin to sort of try to figure things out not necessarily jumping to well what is the right code system for X, Y, or Z, but more like geez, who exactly are complementary and alternative medicine providers? How does one differentiate that from someone who isn’t a complementary and alternative medicine provider? Sort of very basic questions. What sort of coding needs do both they and the financial world have, which is something that I just don’t even know, and so I’m sort of going geez, do they, I mean recognize that we have a whole bunch of different coding initiatives going on in this Committee, some of which are more towards clinical terminologies and others which are more billing terminologies, what are the needs, are there payers who want to pay using codes as well as providers who want to code, it’s all those sorts of very basic questions that I had which were sort of way before well what is the right coding system for complementary and alternative medicine.
Those are I think questions that I had sort of sent off to Stan and Kepa as well as Richard is sort of like geez, can you give us some background. Those may be the wrong questions, there may be more sophistication on the Subcommittee than I have, so I find myself just sort of starting at the beginning and sort of building from there. I don’t know, Jeff, does that make any sense?
MR. BLAIR: Absolutely, and I obviously jumped ahead.
MS. GREENBERG: Yes, I had a question that is kind of indirect question as related to how you meet your needs for collecting information. It sounds like you’re primarily involved in doing clinical trials?
DR. NAHIN: About two thirds of our portfolio is clinical trials and the other third is basic mechanistic studies.
MS. GREENBERG: Is there a desire or a plan or considered a gap or whatever to collect, as you pointed out there’s a lot of alternative, complementary and alternative medicine now being delivered, a lot of people receiving these services, and is there an interest at the center to collect information from, about people who are receiving these services and the setting in which they’re receiving them and the utilization and even potentially outcomes in a non-clinical trial environment in more of a real time environment? And in that case, do you find that such information is available? Are you limited by the lack of coded information? Just generally.
DR. NAHIN: We have a small health services research portfolio, which does involve some outcomes research in which a clinic that happens to be providing alternative medicine might be looking at outcomes in a specific patient population versus some kind of historical control or whatever their comparison group happens to be. My guess is, and I’d have to go look back at these grants, is that they’ve all developed their own coding systems based on their own clinic or own practice needs. Certainly there are some big providers, primarily on the West Coast but also up in New England, such as Blue Shield/Blue Cross and Group Health of Puget Sound, which both have very large patient populations that are using alternative medicine and they actually provide some services, some limited services. So I’m sure those HMO’s have developed their own coding systems, again. I’ve tried to include some people on that list I handed out who had some experience with those kinds of codes.
MR. AUGUSTINE: Marjorie, I kind of see the health services research component falling after clinical trials component because you kind of need to have a code set or accepted standard before you can really start aggregating data across locations.
DR. NAHIN: Well, we use health services research and other types of epidemiological studies to help us set our research agenda. We use six criteria to help us in our research agenda. We look at the use of a given intervention by the U.S. public, and there’s a number of surveys you can look at. We look at the specific disease being treated and we give greater weight to diseases associated with high mortality or chronic morbidity, whatever they might be. We look at both the quality and the quantity of the preliminary data, in some cases it’s actually a substantial amount if you’re willing to go outside the United States, and we try to take that into account.
We look at the availability, at least for clinical research, of patient populations who are willing to be randomized. We’ve actually found in some of our clinical trials that people don’t want to be randomized to conventional care, they have a bias towards alternative medicine, so that’s actually a problem. We look at whether there’s investigators who have the scientific expertise that we think is required. And then we look at the broad definition of politics. I’m not talking about politics Democrats, Republicans, but the politics within an academic center, whether it’s willing to allow studies, and that’s been changing over time, but initially there’s resistance. We look at the politics of the regulatory process for botanicals and dietary supplements. Under the current guidelines, the Food and Drug Administration allows dietary supplements to be sold as foods as long as they are not making clinical claims. So a product like Eckanatia(?) can say that it’s going to increase wellness in its labeling but it can’t say it’s going to cure the common cold or decrease the systems of influenza. Once it does that, the FDA treats it as a drug and then there’s a whole different process involved, so we are very aware of claims that investigators can make and whether or not they need to go to the FDA. So sort of creating some algorithms from those six different variables, as well as cost. Every year we prioritize what we think needs to be done and we issue initiatives for RFA’s, for grants or contracts, to try to fill those gaps.
DR. FITZMAURICE: It’s not unheard of for health services researchers to go fishing through let’s say large files of claims by diagnosis code in order to find candidates that might be suitable for a clinical trial, then you get permissions, then you contact the patients, then you go to a clinical trial. But I sense the same isn’t true for those who engage, who are treated with alternative medicine, because there aren’t an awful lot of claims for payment for that kind of treatment, and so we may be in the infancy of how to categorize patients, if they’re categorized differently by alternative medicine diagnoses. Again, I’m ignorant of are there different diagnoses for alternative medicine? Likewise for procedures, I don’t know how you categorize treatments of alternative medicine patients, but if things are scientifically effective, if there’s an evidence base for it, then it probably argues for having them categorized, it probably argues for labeling the kinds of treatments they get. So do you sense that it is in the early stage and that more scientific evidence needs to be brought to bear before we can categorize diagnoses differently and before we can categorize treatments differently than we currently categorize them under ICD and CPT?
DR. NAHIN: That’s actually a complex question, maybe more complex than you actually realize. A practitioner of a traditional system of medicine, and I’ll include chiropractic and naturopathy, even though they are only a couple of hundred years old in that, they actually diagnosis the patients in very different ways than the conventional physician will, and they’ll have very different diagnostic categories. One of the things that we’re trying to look at is whether there’s correlation in these kind of diagnostic schemes, in particular for certain diseases in which the conventional diagnosis system isn’t very accurate, such like irritable bowel syndrome or fibromyalgia, which are really diagnosis of the absence of anything else in some ways. Having an alternative medicine diagnosis on top of that might actually allow you to produce more homogeneous groups of patients for instance. So we’re interested in that.
But in terms of what an alternative medicine practitioner is going to do for insurance claims, I would think under the systems they would have to use the conventional diagnosis even though it didn’t match how they diagnosed their patient within the clinic. For instance, a traditional Chinese medicine doctor is interested in the balance of chi within the body and without going into the whole system of how they do it, someone with something like osteoarthritis might have a problem, a stagnation of their chi going to their liver. Obviously an insurance company is not going to know how to deal with that. But the alternative medicine practitioner would probably be smart enough to use osteoarthritis as the diagnosis, not stagnation of chi to the liver.
DR. FITZMAURICE: Is it because chi is hard to measure or there’s no coding system that has chi in it?
DR. NAHIN: To my knowledge there’s no coding system has chi in it. Chi is definitely difficult to measure.
MR. AUGUSTINE: Any questions?
MR. BLAIR: The only other question that I might have is do you have information about, let me preface this by saying I have heard from time to time that the use of alternative medicines is very widespread and growing, and that most individuals typically pay for complementary and alternative medicine therapies and procedures themselves because it’s typically not covered by their insurance companies or Medicare and Medicaid. Is that consistent with your understanding of the industry is that we’re really dealing with something that a large number of Americans are either investing in or using?
DR. NAHIN: The data you’re just citing is actually out of Harvard University by David Eisenberg and his colleague, it’s probably the most cited paper in alternative medicine from 1997, saying about 42 percent of the U.S. public is using some form of alternative medicine, and the definition of what that is is arguable, at a cost of approximately $13 billion dollars a year, most of that out of pocket.
The CDC as part of the National Health Interview Survey came up with a lower figure of about 22, 25 percent, which is still substantial. So if you want to take those as being a range, you can figure some place between 20 percent and 45 percent of the U.S. public is using some form, some how, now the question is are they seeing practitioners, which is a very different story than self medicating. Probably most alternative medicine use is either through use of dietary supplements or the use of prayer. And if you take those out, the total figure drops substantially. The MEPS study, Medical Expenditure study from I guess AHRQ, I think they came up with a much lower figure, I can’t remember off the top of my head, but it was certainly much lower than the 20 percent or the 40 percent that the other two national surveys, because they were just looking at practitioner use not self medication. So again, depending on how you want to define alternative medicine, you’re going to come up with some different numbers.
MR. AUGUSTINE: Now, you say that the data are more prevalent in Europe or they capture better data, how do they do it for diagnoses and procedures? Can you kind of describe that?
DR. NAHIN: I meant the research data was more prevalent in data in Europe. Within many countries in Europe, including Germany and Italy, Germany and France, alternative medicine is part of standard care. In Germany, I think all physicians are required to take courses on how to use botanical products, and a large number of them use them as part of their practice. A large number of German physicians use homeopathy as part of their standard practice. Acupuncture is part of the National Health Plan in France. I can’t tell you the history of that, but that’s just a fact. You would think because of this that they must have a lot of data within their insurance systems. I can’t tell you how they code them but it might be interesting to try to identify people from those countries to come testify.
MR. BLAIR: If I understand alternative medicine properly, a lot of it is focused at wellness and preventative therapies. And if that’s the case, then getting outcomes data in many cases would need to be from the individual whereas with traditional medicine, individuals would visit a health site and especially if it’s surgery you wind up not releasing the patient until you wind up seeing that the patient at least has, if not completely recovered, at least the wound is closed. So I guess where I’m going on this is that you probably have to come up with completely different ways of gathering data than with traditional medicine because you’re not often going to wind up getting the most meaningful data from the practitioner, you’ve got to get it from the individual.
MR. AUGUSTINE: The variability there is going to be huge. I mean how many people are going to want to enter in what alternative therapies, what self medication they give, the only way you’re really going to capture this data realistically is if when they go to an alternative provider, or even a conventional provider, and they ask them what meds they’re on or they include alternative meds, or alternative therapies, and they could enter it somewhere at that time. But I don’t see how you’re going to get someone to enter their own information, or submit their own information on alternative therapies.
DR. COHN: I’m just trying to think of, I’m sort of trying to think in this January hearing, I know obviously Stan and Kepa are going to be taking the lead on it, and I’m sure Stan is already mulling over what he’s gotten himself into having joined the National Committee at this point. But I am sort of struck with the sort of the size and the sort of vagueness of the boundaries of complementary and alternative medicine, and I was, you know being from California I’m going I never really thought that acupuncture was an alternative therapy, I thought it was pretty well accepted, so I’m sort of going, I’m having trouble about what the edges are. I’m actually curious about how you think we ought to sort of begin to explore this area. It appears that it may be heterogeneous enough that it’s hard to take off as a single bite, am I off on that one? Do we handle it in a specially specific fashion? Do we seek guidance from payers that, one of our questions is geez is there likely to be sort of transaction oriented activities going on? Do we start by talking to the payers to see what they’re needs are? I don’t mean to wring my hands like this, we can obviously talk to a bunch of provider groups, what is your guidance in all of this?
DR. NAHIN: I think the best use of your time might be to talk the groups on the West Coast as well as Oxford Health in Massachusetts that are currently reimbursing to some degree for different alternative medicine procedures. Again, the Blues don’t feed into the CMS coding system, so their system may not be directly applicable but they may have some, they could probably offer the group something because they must have worked out many of the problems that you’re facing now. They have a huge subject, patient base to work with. The list I gave you is really just listing alternative medicine providers. I can also put together a list of contacts, various HMO’s and third party payers that are reimbursing and try to get that to Donna. I could also give you the list of researchers we know who are doing outcomes research in this area and how they have addressed this in developing their protocols.
MR. AUGUSTINE: I think, I would like to hear from all three of those, even though I may not be here, I may just drop in.
DR. COHN You can sit in as a guest, from CMS.
MR. BLAIR: What about some of the institutions like in New Mexico we have a school that teaches oriental medicine, mostly I believe to folks that already have traditional medicine credentials. Are there other academic institutions like that that you think would be helpful to us?
DR. NAHIN: In the list I passed out I did list individuals from schools of oriental medicine as well as schools of naturopathy. I don’t remember if I put anyone from chiropractic colleges, but I could certainly identify them also. And I think I have individuals from schools of massage therapy, too, yes I do. So again, I write in names from the four predominant alternative medicine practitioner groups, there are many other groups that are practicing in the United States but these groups tend to be licensed and certified in the most states and tend to have the most structured education programs, and tend to be most involved in research.
MR. AUGUSTINE: Any more questions?
MS. TRUDEL: I was just going to clarify what we frequently do when we start to spec out these hearings is to get a sense of a certain number of panels addressing a certain number of issues, and that may be a good place to start and then we very often will come up with either a common set of questions for all of them or separate questions for each panel, and then that gives the staff sort of the bones of how we want things to look and we can start making contacts with people.
MR. AUGUSTINE: Now is that something you were going to do today or Kepa and Stan were going to do?
MS. TRUDEL: It might be helpful to just get a few, just get your off-the-cuff thoughts about does this seem to be going in the direction of one or more panels with providers, one or more panels with plans that pay for this, one or more panels to talk about outcomes researchers, research or is the thought to mix them up, or just any kind of guidance you can give us before we go off and try to do this.
MR. AUGUSTINE: Personally, I see two panels, one of providers, listening to all the different provider groups, and one of payers and/or outcomes researchers. You know Oxford is going to have some good reimbursement information, but also Oxford’s probably got some health services researchers that looked at that information, could give us input there. Also some of the outcomes health services researchers that were mentioned previously.
MR. BLAIR: One of the things that I would like to see, and I would almost think that the provider panel might turn out to be two different provider panels. One that is those individuals that specialize totally in alternative medicine, possibly chiropractors or, I don’t know all the terms you have them divided. And the second panel with those individuals that are practicing complementary medicine where they have both a medical degree and an alternative medicine credential and they’re doing both. I think that would be very helpful to have that perspective in addition to just alternative perspective.
MS. MOLINA: Synthia Molina, CEO of Alternative Link. I just wanted to offer a little help. Our organization obviously has done a lot of research in the area of complementary and alternative medicine, so the first thing I want to do is just offer to make a presentation to the panel about the alternative medicine nursing and integrative health care areas. And from our perspective, the real issue is integrative health care and some elements of integrative health care are conventional health care nursing services, alternative medicine, alternative health care, complementary health care, and a variety of other areas, spiritual interventions, etc. So that is a standing offer and I think we could probably save the panel, the Committee a considerable amount of time since we’ve been doing this for a lot of years just by giving that basic presentation.
We also have a very large market assessment that we’ve done of the complementary and alternative medicine arena, so it has statistics in it, it categorizes different health care stakeholders, and what this area of care means to each of them, etc. But for right now there are just two things that come to mind. One is I just want to make sure that I understand what question the Committee is trying to answer in this panel so that from our perspective we can be of service in answering whatever that questions is. So I didn’t get a clear sense yet, is the panel just trying to get a basic understanding of this area or is the panel already having a sense that this is an area that has a coding need and you’re trying to understand the nature of that coding need? That’s just a question. And then why are we trying to answer that particular question?
In support of who might be on the panel, just off the top of my head, because I didn’t know exactly what we’d be doing here today, there are really three categories of uses for coding in complementary and alternative medicine from our perspective. And the first area is for research, and that can be scientific research, which could either be health services based or clinical trials or a variety of different forms there. Then supply chain management, which on the product size tracks the flow of products from a manufacturer or a grower or botanical all the way to the end user. And on the services side everything from in supply chain management would be everything from collecting data on diagnostic, on disease prevalence and incidence to actuarial data within an insurance plan in order to construct health benefit plan design or do a variety of sort of infrastructure activities, so the main ones are health benefit plan design, managed care and provider contracting, utilization management functions, claims management functions, etc. Those are all sort of in the supply chain management side. And then an overlap would be business transactions. There are business transactions that codes are needed for. So again, those three key uses are research, supply chain management, and business transactions.
In terms of who might be on a panel, we’ve identified some users of codes as the following. There are billers and coders, claims management services, practice management systems and companies, third party administrators, administrative service organizations, self insured employers, health plans, integrative health care clinics, independent CAM and nursing practitioners, insurers, sort of the relative value studies, incorporated, or RUT(?) type experts, centers of excellence, including academic research centers and schools, etc.
And another way to potentially categorize this is the importance of the code to maybe pressing public health matters like disparities in minority or ethnic health care, because we know we’ve gotten some interest from minority health experts in the code set. And things like bioterrorist response, where having knowledge of all of the practitioner types available to the general public is of national security significance.
And then finally, I think that our expert today already talked about the different ways to categorize the practices, whether they’re mind/body traditional systems or biologics energy based, manipulation or body based, as well as the different practitioner types which are in our coding manual and you can probably go through and just look at that.
I think one other area that I don’t think we could under emphasize the importance of in assessing both the market and the codes that might be needed for this are dynamics that will influence different players perspectives on capturing data around coding. And here the key issues are economic incentives, political incentives, and social imperative or moral/ethical incentives, and I think if you’re going to be getting panels up here one of the important things you’ll want to be doing is determining whether the perspectives of the people presenting are based on experiences they’ve had economically or politically or whether they’re based on issues of public health, and having a way to sort of differentiate between those I think is ultimately going to help the Committee make some good decisions.
Let me just give an example because I really want to emphasize that particular point. There are financial incentives that are sort of inherent in the current coding systems in this country that make some practitioners get paid more than other practitioners. And while I think a lot of practitioner groups recognize the public health benefits of getting very specific coding for their services or ways of identifying them as the caregivers, many of them are also terribly afraid that they will be financially discriminated against if there is more precise coding around what they’re doing. Or politically discriminated against, because there are histories of both of those that have been sort of set up by the coding systems that we’re using in this country. So that’s just a large two cents, two dollars worth, based on our experience.
And again, we would be really pleased to be able to present to the Committee. We have presentations that focus on the market, we have presentations that focus on the health policy issues and dynamics that both are sort of moving forward issues and dynamics and what’s happened historically that’s contributed to our public health challenges and our financial challenges. We offer that to the Committee.
MR. AUGUSTINE: Thank you, Synthia.
DR. COHN: Synthia, thank you. I think you’ve sort of laid out a number of the issues very well. You asked at the beginning well geez, are we talking about have we already identified that there’s a need for X, Y, and Z code and now the question is is what code set versus more basic questions of trying to identify the needs and all of that stuff. I guess I would just speak for myself that I think that we’re sort of starting out probably at the beginning. I don’t know how far we’re going to get in terms of the actual code set issue at the first hearing. But I think that really, at least as I was talking to everyone, I guess my own thought was we needed to sort of understand what the needs of the users, needs of the payers, needs of sort of everybody, as well as desires were in all of this stuff. And I look to others because I don’t know what all of your view is but I think we sort of need to start with that typically, and then the question of course gets to be is the, the other issue I was asking before which is like is this a bread box, is this a MAC truck, how do you scope the thing so that we can make some progress. I was obviously seeking some advice from our consultant on that.
I guess I should ask, am I obviously, that’s my two cents at this point.
MR. AUGUSTINE: No, that’s exactly the way I feel. We need to get an idea by talking to the people that need to use that information, see how that impacts them being able to do their job and provide the best holistic health care that we can. That’s why we’d like to talk to the people, not only the payers who analyze the data, look at the data, but also the different types of providers so we can get an idea of how they use that information and how they do the coding. We’ve heard from Synthia, thank goodness she’s been around to help us through a lot of these and help educate us, but we want to hear from some other people that are involved in that area as well.
MS. BICKFORD: Carol Bickford, the American Nurses Association. I would like to suggest that you may wish to speak to representatives from the National Library of Medicine, as they try to grapple with inclusion of the complementary and alternative medicine languages, therapies, outcomes, in their literature. How have they dealt with that in an existing mesh, and that language piece? I would also invite you to think that you may need to have a different view of the world, not the pathophysiology medical model, but looking at the world from a different a view or you will close out your thinking and your evaluation of the environment and what needs to be accomplished.
And clearly we have to be looking at other clinicians, other players in this environment, not players, that’s the incorrect word, other practitioners in the integrative health care environment. You may wish to also include the health care consumer, because they are looking at the health perspective, and what does that mean to them as they walk into their clinician and try and describe their care delivery process or as they try to record their information in their own personal health record as we’re talking about the PMRI. What web products are out there for those who are vendors promoting internet based health care information? So those are a couple other areas you may wish to think about.
MS. TRUDEL: Just to clarify this from a staff perspective, we appear to be talking about a MAC truck issue, in other words, the needs of complementary and alternative medicine, all the way through this continuum that everyone’s laid out, that starts with research, it doesn’t start with, but goes, spans from research to business transactions and the supply chain. And I just want to clarify that that is the Subcommittee’s intent here, that we are to look at the full scope. So as it affects PMRI and as it affects clinical terminologies, as well as how it affects the health care claims. Right?
MR. AUGUSTINE: That was my understanding, just like when we evaluated --
MS. TRUDEL: I just want to make sure I don’t go down the wrong road.
MR. AUGUSTINE: Just like when we evaluate ICD-10, we looked at it from that spectrum as well.
MS. TRUDEL: Gotcha.
MS. GIANINI: Melinna Gianini, I was one of the developers of the ABC Coding System and I think that one way to take it from MAC truck down to van is to only look at those services that the states license as health care services. I believe that will get you down to a path that you can chew on instead of just trying to look at all of the woo woo things that could be out there. Because these are transaction and code sets for a specific purpose which seems to be Administrative Simplification, I really do believe that the best way to put your arms around alternative medicine is to only deal with the health care practitioner types that have a license to provide health care as a starting place.
MS. TRUDEL: Just a follow-up questions, Melinna. Who does that exclude?
MS. GIANINI: Well, let’s say our reflexologist, there’s no license in any state for a reflexologist, a Rike(?) master might have two courses that they took over a weekend, and it doesn’t mean that they can’t affect a change in somebody’s behavior, it means that they can’t participate in health care. Now an M.D. who took a Rike course on top of his M.D. license needs a code probably if you’re going to research if Rike is effective, you probably need to start from a core license or a plenary license to start your research, and then you might look at Rike from a health practitioner, such as a massage therapist or an M.D., or a chiropractor. But to start your initial evaluation I believe it would be very useful and take it from the MAC truck down to the van to just deal with licensed health care practitioners and then blow it out into the different modalities from that point.
MS. TRUDEL: Richard, does that kind of make sense from your perspective, too?
DR. NAHIN: That’s actually what I did with the list I gave you. Those four practitioner groups probably are 99 percent of licensed practitioners in the country. I left off nephrologist, nephropothists(?), who are licensed in one or two states. Homeopathy is actually licensed in one or two states. But the groups I gave you are by far the major licensing groups.
DR. COHN: I was just going to comment, I think you had made a comment before about the full spectrum of uses, and I was just going to say that I guess I sort of agree though, I do want to make sure that at a certain point we have a pretty good understanding about all the financial pieces, knowing that one of the main issues has to do with the HIPAA transactions, and if we don’t at the end of the day, or at the end of one of the days, and I don’t mean just January but at the end of some point, get clear about what the uses are, the needs are, in relationship to the administrative and financial transactions, we obviously haven’t done our purposes, and I hope you --
MR. AUGUSTINE: That was the next question I was going to ask, is if you’re on the research side, you’re going to try to capture everything. If you’re on the payment side, you’re only going to really want to capture information on things you’re going to reimburse for. And so what side are we on? I’m thinking that we’re on this side, so we really need to concentrate on things that some by licensed providers that maybe some health plans are looking at or are reimbursing for presently. Maybe that’s more manageable than going out and trying to get an idea of about the MAC truck.
DR. HUFF: Especially in the context of PMRI, I would have thought that we want to look at least at what codes we would need to have available to accurately represent what was done to the patient. If I’m going to keep this data as coded data as part of my EMR, I’d like to not just know what I billed for but know what was done to the patient, or the patient may even be pejorative coming from the wrong perspective, but I need somebody to bend my mind correctly so I can do this. But anyway. Just a counter-point.
MS. GIANINI: One of the things I think that’s challenging about how limiting or expanded code sets should be is we live in a managed care environment where contracting for services is based on predetermined fees for the services that a practitioner can provide. And I think that when you limit or expand coding in the administrative billing area, you need to be cognizant that in order to go negotiate fees for services, and to pay for those services, the coding needs to be specific enough to get down to a fee that’s appropriate for the service that was provided on the administrative side. And then on the PMRI side it needs to be specific enough so that if there’s new ways to do things that save money or are not effective, we need to be able to find out that information.
MS. GREENBERG: I understand the desire to make this manageable, and I do think one of the questions before the Subcommittee, I mean I know one of the questions before the Subcommittee is are there gaps in the current code sets designated under HIPAA for the administrative and financial transactions, and so I think that’s a question that as Simon said that at the end of the day or at the end of your deliberations, needs to have an answer to. Either yes, the current code sets meet the needs or no, they don’t, and then what could fill those gaps. But also as the Committee as a whole attempts to have a population focus and of course includes issues related to quality of care and public health and the whole range, and so if you, and this Subcommittee itself is looking as Stan said at patient medical record information as well, or the information for clinical records, so I think that you need to be looking at the other as well or the next group, the Population Subcommittee is going to come back and say yes, but what about quality, as they have on a few other things, and as you said you’ll be addressing it under PMRI. But I think probably the first tier of responsibility is to address this issue of gaps under the, if there are gaps, and how to meet them, under the administrative and financial transactions. And that probably should maybe be the initial focus but with the idea of gathering information that will also address issues related to the whole national health information infrastructure, which includes quality, public health, and as somebody suggested if personal records become, more people start entering information into their personal records, then they may want some kind of more simplified coding system also. So you can’t escape the whole range, but the first, probably the priority is to address the HIPAA related --
MR. AUGUSTINE: Now I thought we were already to the next step. I thought when we did our gap analysis, gap hearings last year we determined that there was a gap and it provided some guidance on how to try to get, work with certain existing groups to get codes into those existing code sets for alternative therapy and now we were just trying to gather more information that we can provide better guidance. That’s my understanding. Is that incorrect? I thought we had already determined the --
MS. GREENBERG: We never really received testimony from, we did hear from the code developers, but we haven’t actually heard from practitioners and plans on this topic, and that’s what we’re, we have reason to believe that there are some gaps because of testimony we’ve already heard and because of what we know about the existing code sets, but we actually had not had testimony in the past from plans, from providers to speak of, have we?
MR. BLAIR: This is a question I think really for Melinna. You gave us guidance that you felt that we should focus on the areas where there’s licensed practitioners, and forgive me I forget the name of our other testifier from the National Institute of Health. Richard, you indicated the list that you gave us had most of the areas of licensed practitioners, except for a few, such as for example homeopathy, I don’t remember the other ones, so the question that I have really is how fast is this health care domain changing? Should we also include areas of homeopathy, which have one or two states that license them, or some of the others, because they’re growing very rapidly? Or do you feel comfortable with the list that Richard has set forth for us?
MS. GIANINI: What the priority of the person using the code set would determine that, but from the perspective of why the codes were developed in the first place, was to allow those insurance companies who chose to pay for these things to have a tool that fit within the tool set that they use for conventional medicine to relay information that was needed for NCQA certifications, for managed care contracting, for capturing data, for looking as an underwriter at information that was coming in, so that premiums could be priced appropriately for health insurance. Those are the types of pieces of information that we felt strongly were missing and we didn’t make a value judgment on whether or not it should be studied, we went strictly by if a state licenses these people as health care providers and they have the right to participate in health care, that was the stance that we took. If one state licensed a practitioner, then that practitioner was considered a health care practitioner by us.
MR. BLAIR: Let me rephrase my question because essentially I’m asking Synthia whether you feel comfortable with the list that Richard gave, he indicated there’s a few domains that are left off, because they only had one or two states that licensed those areas. Are those situations where there’s one or two states, are those rapidly growing areas where we should add them to the list? Or do you feel pretty comfortable with the list that Richard has outlined?
MS. MOLINA: We’ve switched people on you now. That was Melinna Gianini who was speaking before, who was the Founder and President of Alternative Link, and a Board Member on the Foundation for Integrative Health Care, and this is Synthia Molina, now, our names are really similar. I think this gets back to my earlier question, which is what is the Committee really trying to focus on, because the answer is different depending on what you’re trying to focus on. What Melinna was trying to communicate in my view is if you’re trying to focus on administrative simplification and transactions, that aspect of HIPAA, then probably the highest priority practitioners are those practitioners who are licensed as health care providers in a specific state. If what you’re trying to do is create an infrastructure for studying the delivery of health care and which approaches to health care generate the most significant economic and health outcomes, where you’re trying to design a system that automatically generates data on health promoting and cost effective interventions, then I would say that you would want to focus on bringing in a whole range of practitioners types.
I think one of the Committee members in a former hearing said to one of the CMS folks you know if people are painting someone toenails red is a health care intervention, we want to be able to capture that intervention. So from a scientific perspective, the goal is to get a code on everything, just like in a grocery store you want a code on every product so you can evaluate demand and support consumer choice, and also a pure supply chain management. But getting back to what Melinna was saying, if what you want to do is in an efficient way get a reasonably good answer out to the public to support state law and licensed health care practitioners, that could be a starting point, and you could make sure those individuals have coding and then perhaps works out from there, so it really depends on what your priorities are.
MR. AUGUSTINE: Thank you.
MS. MOLINA: Did I answer your question?
MR. BLAIR: Well, not really.
MS. MOLINA: I think my, what I would say is that his list is absolutely appropriate based on licensed practitioners, but it’s incomplete based on scientific evaluation of emerging technologies.
MR. BLAIR: Ok, thank you.
DR. COHN: Well, I was actually going to begin to close, finish the conversation, actually trying maybe for the first time in our history finishing on time. I guess the question is are there other things? Stan I guess I’m sure is staring at us, but you have other questions, concerns, as obviously your hearing staff beginning to put together plan, and sort of a focus, certainly we would look to you to provide additional guidance around it, working with Kepa obviously.
DR. HUFF: I don’t have additional questions now. My questions aren’t questions these guys can answer, questions about why as a junior member, what’s my role in organizing this with Kepa.
DR. COHN: Well, we can talk about that off-line, certainly, your role, but I think we’re beginning as I said to get a frame, and I think what we’re also seeing is let’s have a bias towards the HIPAA pieces but let’s not forget the research and other needs, just so that we make sure we begin to get sort of a view of it all, knowing that we’re probably not going to reach perfection after a first day of hearings. Now, Suzie, do you have a question?
MS. BEBEE: I guess I would agree with that Simon. One of the things that I found participating in SDO’s and looking at the needs of plans and providers, research plays off of that. For instance, health services researchers look at claims data, and if they weren’t included in the process, we wouldn’t have that knowledge of what their needs are and how that could fold into the Administrative Simplification. So we have providers listed here for alternative medicine, and the gentleman said that he’d provide health plans and researchers, and I think researchers would be beneficial to be included.
DR. COHN: I guess basically for January what I think we’re planning is to devote, it sounds like it’s going to be a day’s worth of hearings on this issue. I think that’s what it sounds like.
MR. AUGUSTINE: It seems like three panels.
DR. COHN: It probably is about three panels. It may not be a full day, but it will be darn close. And obviously Richard thank you for being willing to help us on all this. Obviously I do want to warn the Committee that the second day is likely to be a relatively full day also, just as a warning shot on that one. I don’t think we’ll not get off until 5:00, but we’re probably not going to be finishing at 12:30 on the second day, just because I’ve already seen agenda items coming up that are likely to fill that.
MS. GREENBERG: What day of the week is the second day?
DR. COHN: You know, I have no idea.
MS. TRUDEL: Simon, while you’re looking that up, Richard and I will talk and we’ll see if we can find any other staff volunteers to help us set this up. And then
we’ll set up a conference call with you, Dr. Huff, and with Dr. Zubeldia, and start talking over some of the specifics and look at the list in greater detail and see if we can start drafting some of the questions. So that would be my recommendation on how to start.
DR. COHN: The dates for this hearing will be January 29th, and then the 30th, which is a Thursday, will do that.
MR. AUGUSTINE: Also before we convene, I just want to make a recommendation, since it’s my last meeting, on this maybe kind of as Synthia was mentioning at the end of her discussion a few seconds ago, to start in and kind of work your way up, because I know it’s important to capture all the information for the PMRI, but as Simon said, we need to kind of lean towards the HIPAA and transaction piece now, and maybe work our way out as time goes on.
DR. COHN: Yes, I think we’ll obviously try to get some touches here, but clearly the first issue is the HIPAA issue. Now the meeting tomorrow starts at 9:00 a.m., at 9:00 a.m., thank you Jeff, and hopefully it will be adjourned by about 12:30. Brady are you going to be joining us for that? So today is not your last day, tomorrow will be your last day. Ok, with that I want to thank everybody and thank you for advice, guidance on all this. Suzie?
MS. BEBEE: I wasn’t sure if we were ending or --
DR. COHN: We are.
MS. BEBEE: I was going to suggest that there’s a paper that’s been handed out that’s Walter Sujansky’s product that is revision, so that the members and staff can read it, because I think this is the topic of discussion tomorrow. The scope and initial criteria for selection of PMRI terminology.
DR. COHN: Well, thank you. And the meeting is adjourned. Thank you.
[Whereupon, at 5:00 p.m., the meeting was adjourned, to reconvene the following day, Wednesday, December 11, 2002.]