[This Transcript is Unedited]
Hubert H. Humphrey Building
Conference Room 705-A
200 Independence Avenue, S.W.
Washington , D.C.
TABLE OF CONTENTS
Agenda Item: Call to Order, Welcome and Introductions - Mr. Reynolds
MR. REYNOLDS: Okay, why don't we go ahead and get started since we've got a full agenda. I'd like to welcome everyone to the meeting of the Standards and Security Subcommittee of NCVHS. NCVHS is the statutory public advisory body on health information and policy for the Secretary of Health and Human Services. We are being recorded and are on the internet this morning.
As we begin our introductions I will ask each of the members of the committee to note any possible conflicts of interest. We also have a few of our members and others on the phone today and after I do the introduction around the table I will ask them to introduce themselves. Is anyone on yet? No one is on yet so we won't do that but as they come on we'll make sure that they identify themselves.
I am Harry Reynolds, co-chair of the committee along with Jeff Blair. I'm from Blue Cross and Blue Shield of North Carolina and I have no conflicts. Everybody around the table, you'll need to push the on button if you want to speak and please turn it off when you don't want to speak or you will be speaking anyhow.
MR. BLAIR: I'm Jeff Blair, I'm director of health informatics at Lovelace Clinic Foundation, and co-chair of the Subcommittee on Standards and Security, I do not have any conflicts that I'm aware of.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, I'm a liaison to the full committee and staff to the Subcommittee on Standards and Security.
MR. BECHTEL: I'm Don Bechtel, I'm with Siemens Medical Solutions, I'm representing today X-12 where I co-chair the Health Care Task Group.
MS. GOSS: I'm Alex Goss representing ASCX-12, I work for Payformance Corporation and I'm the chair of the Insurance Subcommittee for ASCX-12.
MS. WARD: Maria Ward with Price Waterhouse Coopers here today representing HL7.
MS. GILBERTSON: Lynne Gilbertson, National Council for Prescription Drug Programs.
MS. WEIKER: Margaret Weiker with EDS representing NCPDP.
MS. GOVAN-JENKINS: Wanda Govan-Jenkins, National Center for Health Statistics, staff to Standards and Security Subcommittee.
MS. GREENBERG: I'm Marjorie Greenberg from the National Center for Health Statistics, CDC, and executive secretary to the committee and just truth in advertising, I'm also a member of the Disability Workgroup for CHI.
DR. COHN: I'm Simon Cohn, I'm associate executive director for Kaiser Permanente, chair of the committee and a member of the subcommittee, I have no conflicts of interest.
MS. TRUDEL: Karen Trudel from the Centers for Medicare and Medicaid Services sitting in for Denise Buenning as chief staff to the subcommittee.
DR. FERRER: Jorge Ferrer, VA, staff to the subcommittee.
MS. SQUIRE: Marietta Squire, CDC, NCHS, and staff to the subcommittee.
DR. FERGUSON: I'm Jamie Ferguson from Kaiser Permanente. I'm here today in my capacity as vice chair of WEDI.
DR. WHICKER: Jim Whicker, Intermountain Health Care, I'm here also chair-elect of WEDI.
MR. SHUPING: Jim Shuping, chief staff executive for WEDI.
MS. KOCHER: Gail Kocher from Highmark, Inc. co-chair NPIOI for WEDI.
MS. SPECTER: Nancy Specter from the American Medical Association.
MS. FRIEDMAN: Maria Friedman, Health Strategies LLC.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC, committee staff.
DR. BICKFORD: Carol Bickford, American Nurses Association.
MR. ALFANO: Bill Alfano, Blue Cross and Blue Shield Association.
MR. FRENCH: Jonathan French, HIMSS.
MR. SHEATH(?): Tony Sheath, Point of Care Partners and NCVHS groupie.
MS. FREDERICK: Anne Frederick, Rx Benefits Coalition.
MR. REYNOLDS: Okay, if we want to get started, it's good to see some of our old friends back to talk to us again. So first agenda item is the SDO recommendations on streamlined standards revisions and procedures. Do you want to go in order on our agenda or do you already have a prescribed order? And would that be you starting first, Lynne? This would be the same order that usually happens, I should have known that. Okay, you have the floor.
Agenda Item: SDO Recommendations - Streamlined Standards Revisions Procedures - Ms. Gilbertson
MS. GILBERTSON: It is wonderful to be back. Mr. Chairman and members of the Subcommittee on Standards and Security, the Accredited Standards Committee, ASC, X12, Health Level 7, HL7, and the National Council for Prescription Drug Programs thank you for the opportunity to testify today on the subject of the Standards Development Organization, the SDO process, and how it works within the regulatory environment. My name is Lynne Gilbertson and I am speaking today on behalf of the joint SDO initiative to improve the standards adoption process under HIPAA.
The testimony delivered today on behalf of ASC X12, HL7 and NCPDP is a continuation of the December 2005 testimony that each individual SDO provided on this topic. At the conclusion of the December hearings the subcommittee requested that we, the SDOs, collaborate to present one unified testimony on this subject.
Our formal remarks to you today are a summary of our comprehensive proposal document. The recommendations provided to you in the document entitled Proposal for the Modification of the HIPAA Transaction Standards Adoption Process represent the SDO unified approach to streamlining the HIPAA standards adoption process. This joint SDO prepared document examines the current process for adopting transaction standards, summarizes findings, and proposes ways to improve the adoption process that will result in increased efficiency. The joint SDO proposal has been approved by all three SDOs and the approaches we recommend can and will be implemented by us should HHS elect to adopt this streamlined approach.
In order to maximize the time for us to engage in a more productive discussion with the subcommittee on this topic we've elected to keep our verbal testimony brief to allow more time to fully explore your questions to the identified problems and the proposed solutions that we prepared for your review, input and support today. In anticipation of this approach we delivered the document to the subcommittee for your review prior to this session.
To try to understand the process we used Microsoft Project to lay out the steps, the timeline, the dependencies, the interdependencies, and took that into a high level version which are shown as the charts that are in this proposal to understand the current process.
It has become abundantly clear that the Health Insurance Portability and Accountability Act, HIPAA, has a profound and burdensome impact on health care transaction implementation specification development and deployment. Several years of researching the problems resulted in white paper drafts as well as recommendations to HHS and to NCVHS but it became clear that the Administrative Procedures Act, or the APA, constrained the process since it has a direct impact on the federal government's ability to timely adopt modifications to HIPAA implementation specifications. The current process for adoption of transactions adopted under HIPAA is problematic.
Operating in the regulatory environment, the ability of the Standards Development Organizations to be responsive to industry need is greatly impaired resulting in stakeholders waiting a minimum of five years to be able to implement new specifications adopted under HIPAA. Please refer to Section Four, Problems with the Existing HIPAA Transaction Implementation Specifications Adoptions Process for further information.
Most concerning are the underlying industry assumptions, and they are assumptions. One, to wait until the NPRM to review and provide input on the implementation specifications. Two, based on public comments received through the NPRM process the approved, published version of the implementation specification may be opened and updated and republished in order to accommodate changes requested by the NPRM comments.
Due to the time lag in the APA process these changes may be requested years after the approved implementation specification has been published and brought forward. Changes made in this manner either require a new SDO ballot or approval process to take place, and consequently a new version released, or cause the SDO to proceed in a manner contrary to their American National Standards Institute based policies. Refer to Section 4.3, Modifications Being Made to Approved Implementation Specifications for additional information.
An additional dynamic exists for X12 related to their underlying base standard. The X12 base standard is used by many industries for EDI exchanges. X12's implementation specifications are built from a specific version of this base standard. A requested change to an X12 imp guide may correlate to a base standard change. This base standard change needs to be fully vetted through the consensus based process to prevent a negative impact on other industries.
Therefore the regulatory process is not predictable when it begins or ends, is potentially very lengthy and compromises the ability of the SDO to be responsive to industry business requirements.
Now the proposed solution. This proposal retains many of the existing processes. It also offers a more efficient approach to several of the key areas where current problems exist. Opportunities for input and participation are not eliminated. Rather efficiency is achieved by consolidating public participation and input at the appropriate times. Additionally we propose adding steps that are critical to the process, such as the development of a benefit analysis report, requested by the Office of e-Health Standards and Services, OESS. Finally, this proposal incorporates recommendations that have been made in House Resolution 4157.
The streamlined process highlights, and this is just a highlight list, the more detail is in the document. The first is the notification of work. The Federal Register, the HHS listserves, and the SDO processes alerts the industry to the development of an implementation specification. The industry is made aware development is beginning and encouraged to participate. Refer to Section Five, Changing HIPAA Transaction Implementation Specifications Adoption Process, the Outline Narrative.
Industry involvement in these steps is critical to the successful development of consensus based standards that represent the widest most diverse collection of industry stakeholders. The most effective use of the industry volunteer input and time is during the development of an implementation specification, during the development. Individuals not wishing to participate in the development can participating during the public comment or ballot timeframe. Valuable input occurs during this timeframe, this involvement results in the collection of all technical public comments at one time while the implementation specification is being developed and approved thus eliminating the need to reopen an already published implementation specification years later. The collection of comments at one time improves the timeline for adoption, the industry knows that their comments are discussed during the development cycle and during the ballot or approval process.
Then there's the notification of the ballot or approval timeframe. The Federal Register, the HHS listserves, and the SDO processes alert the industry to the ballot or approval process steps and the critical dates and timelines. Once again the industry is made aware and encouraged to participate.
Then there's the DSMO process that continues to go on, while this process is underway an industry benefit analysis survey is conducted by WEDI. This is another opportunity for the industry to be alerted of activity and to provide valuable feedback. This resulting benefit survey analysis reported is provided to the SDO, the DSMO Steering Committee, and to NCVHS for their review.
Another step, NCVHS, which now currently receives public testimony, which would include a recommendation on the change request from the DSMO, as it does now, a report of the survey findings from WEDI, and the public testimony. Then the final rule is published in the Federal Register based on recommendations from the SDO, the DSMO Steering Committee, and the NCVHS, which has been collecting it. The notice provides the adoption and the implementation timeframe for the industry.
With these process improvements important benefits are reached. The timeliness and length of time for adoption are optimized. The volunteer industry participation is at the beginning of the process yielding more efficient use of limited volunteer resources. The stakeholders have input during both the development and the approval of the implementation specifications and they are notified of the timeline.
Beyond the increased quality perspective timeframe estimates prepared for both the current and the proposed process indicate potential time savings of up to three years and we eliminate the possibility of having an endless loop of NPRM change requests that never move to a final rule. Please refer to Section 5.2, Proposed Improved Process Timeline.
ASC X12, HL7, and NCPDP thank you for the opportunity to offer these collaborative recommendations on improving this important process. We have spent considerable time understanding the process, assessing the impacts and building recommendations. We firmly believe that action needs to be taken at the federal or Congressional level for changes to occur that will allow us to be responsive and supportive of industry business needs in a predictable and timely manner. We look forward to further discussing our recommendations with the NCVHS and OESS to affect change on this important issue.
Thank you for the opportunity to testify today and we welcome any questions.
MR. REYNOLDS: Thank you. I would commend you for again getting the industry together to take a look at this across the board. I'll open it up to the other members of the committee and staff and then I've got a few of my own questions. Michael, go ahead.
DR. FITZMAURICE: Once again the industry seems to have stepped forward with something positive and something fairly complete and I applaud all of the SDOs for participating in this and coming to a conclusion.
DR. HUFF: Harry, this is Stan, I can't hardly hear you at all.
DR. FITZMAURICE: I will continue with the praise for the SDOs who've come to an agreement and have put forward a proposal, sometimes it's difficult and time consuming in the government to come up with a proposal particularly that flies in the face of some of the things that we're used to. So my immediate impression was gee, I wonder if this is legal, because the APA, American Procedures Act, requires a certain due process to be followed. And then I wondered well, this would be helpful to get all the public comments in and if it were part of the process, I don't know if it's part of the APA process, A, you could change the APA to Congressional action, that's cumbersome but the industry can move mountains, its shown in the past that it can.
Secondly, I wondered well, it's possible that if the Secretary is convinced that the industry is headed say that all the materially affected parties have weighed in and there appears to be a consensus it may be possible that the Secretary could move to a final rule with comment as opposed to going through the NPRM process.
And then as I listened to Lynne's testimony reflecting all of your concerns and solutions I'm wondering, there's some time in there that isn't laid out, that's the time that the government has to do things, for example the comments have to be collected, are they collected at the SDO or are they collected within the federal government, or are they collected at the SDO and shared with the federal government in such a way we know that 100 percent of the comments are accounted for as we have to do in due process.
And then secondly as you write a say proposed final rule it has to go through inside the agency that writes it, then it has to go to all of the federal agencies within HHS who weigh in on it and if that's not enough, and it isn't enough, it has to go to OMB for OMB comments and OMB decides whether it goes to other federal departments or not, then it comes back to the Secretary with requested changes, back to the agencies for their comment on what we hope would be the final rule.
So the question is does this short circuit some of the time? I think it has potential to do that, I think it could shorten the time, it does show industry consensus on what's proposed, particularly changes in the HIPAA standards dealing with transactions, I think it's positive. I don't know what the legalities are and so I would have to defer to the Office of General Counsel, I would even defer to Karen who knows much more about the regulatory process then I think I do to say what is possible and what is not possible.
But I would like this to be a positive experience with industry stepping up to the plate and I want us to throw strikes at the industry and let them hit them out of the park. We all want a faster more efficient process that improves as technology improves, that improves as agreement improves, and it's difficult to move from EDI to object oriented, HL7 Version 3 if we're talking about clinical information which we're not really except for claims attachments here. It's hard to have the progress that technology brings without also an efficient process within the government.
And so I look upon this as a call for the government to weigh in with will this work and if it needs to be tweaked how can it be tweaked to make it better and how can the government process dovetail with the industry to reflect what the industry and consumers want, more efficient claims process handling.
So I'll conclude by saying I really applaud the industry, you've done it again, you did it before with a short circuited first year changes in the transaction standards and you've done it many times in the DSMO, you're doing it again. Thank you.
MR. REYNOLDS: One comment, before you answer that, Stan, would you please introduce yourself since you are a member of the committee and are on the phone now?
DR. HUFF: Yes, Stan Huff, Intermountain Health Care and the University of Utah, member of the committee and a member of the subcommittee. I don't think I have any conflict with things that we're discussing but I have potential conflict if we talk about HL7 specifically and if we talked about LOINC specifically at some point.
MR. REYNOLDS: Okay. Responses? I'm not sure if that was testimony or a question.
MS. WEIKER: Well, Mike, in regard to the collection of the comments, because I believe that was one of your items, where the SDOs would collect the comments and obviously those comments would be shared with OESS or NCVHS or whomever, in fact I know in NCPDP when we receive comments on a ballot, I mean they're known throughout, anybody can get that ballot and can see the comments made by anybody as well as the resolution that we came up with in regard to that comment.
DR. FITZMAURICE: Margaret, let me just respond to that, we make all the comments available publicly and I would ask that if you're considering that process you might consider doing the same as well so that it dovetails with our process.
MS. WEIKER: Right, and we could look into using probably maybe some of the resources you all have, or at least the website maybe to post them, or we could post them on ours or something. I mean those kind of little details, those can be worked out, that's not a problem.
And in regard to timeframe, we do have some of the steps in here, we probably have cut the time probably too much, we had 90 days for some of the items to write the final rule and it probably will take more than 90 days to do that based on history.
MS. GILBERTSON: What we used in the proposed timeline which appears on page 20 was the guidance that's given in H.R. 4157, the 30 day, 90 day, whatever, those timeframes, just to see how it would plot out in a new process. So we didn't make up these numbers ourselves, they were part of that proposal.
MS. GOSS: In regards to the public comments and building on Margaret's remarks from an NCPDP perspective, from an X12, there's a full reconciliation of all the comments so if comment A gets submitted there's a response back to comment A. And one of the things that I think would be achieved out of this proposal is a better viewing by the industry of all the comments made and the resolution of those compared to the consolidation process that now happens in the NPRM to the final rule preamble. So I think that we actually can elevate the level of industry awareness and of what's been commented on and how its been resolved by the Standards Development Organizations.
DR. FITZMAURICE: Alex, I think you make a very good point and it's the industry finding solutions to those comments as opposed to having a longer time for give and take with the government, I think that could reduce the time.
MS. GOSS: I think it also produces a quality byproduct in that what you have is everybody working through the issues at one time and everybody can put their voice into one place, whatever SDO it is, so that you can actually get a better level of consensus before you develop a final work product that would then be recommended for adoption.
DR. FITZMAURICE: I think it could add to the process whereby the Secretary considers all the relevant facts before he or she makes the decisions for making this change in HIPAA, that could be an improvement.
MS. GOSS: Also in regards to the legal dynamics that you reference, that is a major hurdle and we do need legal resolution to the policies that are in place right now.
MR. REYNOLDS: I've got three or four questions myself. The first, and again since not everybody in the room had this ahead of time, the committee did but as we all, we try to adjudicate this, what do you actually define HIPAA to be? In other words you've got things like NPI out there now, you've got other things, what is the exact definition of what you're talking about streamlining right now?
MS. WEIKER: The transactions.
MR. REYNOLDS: Okay, fine, that's good. The second, as you look at the summary that Lynne you testified, you come all the way through and you've had the SDOs and everybody look at it and you get to NCVHS and you discuss public testimony. And our process has always been after we hear public testimony we make recommendations and those recommendations as we did when we looked at e-prescribing and other things were for other people to go back and look at it. But it looks like it moves directly from there into the final rule so it almost looks perfunctory based on the testimony rather than, I don't see a loop back process that says if the public testimony were to be such that the SDOs or others would need to look at it again, I don't see the loop back in here. It kind of says hey we've done all this stuff, we're going to bring it in, but how you would adjudicate that if that public testimony we heard might be different than what you had heard or what your process had been, how do we get that back to you and then come back again? So just if you could comment on that.
MR. BECHTEL: I think it was always our intention that if NCVHS had considerable concerns that prevented you from making a recommendation to the Secretary to adopt that those concerns would be brought back to the SDOs and the SDOs would try to reconcile those. So I don't think we intended to preempt that process at all and if we didn't explicitly say so I do believe it was intended to be there.
MR. REYNOLDS: Again, I wasn't alluding that you did, just for completeness of your recommendation it would have been good to see it and then we would have had a process that said when it comes to us it's not a rubberstamp, it's that if we have comments then you take it back and bring it back at the next meeting or something would happen that would show a little more of a process rather than when we get it it's kind of that's it.
MS. GOSS: And this is our optimistic process.
MR. REYNOLDS: The other question I have, and this is going to be the same question that I'm going to have in a later session. So we talk about implementation timeframe so we have an industry right now that continues every time we come up with an implementation timeframe it looks like it's going to slip. So now we're going to go faster setting standards, what have all of you looked at as SDOs to address the idea that once we say go how we get everybody to go, and once we say stop how do we get everybody to be done. So there's this idea right now it takes a long time but even if it takes a long time people still aren't getting it done and we'll talk about that a lot when we get to some of the other things on the agenda. So I would love to at least hear your comments, not necessarily in your structure but how do you see that because if we're doing things faster how do we, so for example I would think 5010 would fall under this, would be a big change again for the industry, so anything that you can do as far as that concern that would be good, so any comments you have.
MR. BECHTEL: I guess I'll speak first, I'm sure others will have more to say. With regard to 5010 this is going to be a much larger change if we adopt it because its been so long since we had 4010 issued. I think the goal of this process is to make the standards come out more rapidly so that we have smaller changes and the changes can be more easily adopted by the industry and not have to be such a struggle to get completed. So I do agree that 5010 will be harder to implement but the goal is to improve the process so that we get faster shorter easier to implement changes.
MS. WARD: In our discussions the group here as we were preparing this recommendation, one of the decisions we made was that in terms of what is the appropriate timeframe, is it 18 months, is it two years, how often should we be turning around new versions of standards, we really think that the SDOs should not dictate that but the industry, and that's a very generic term, but wherever that wider more diverse public industry conversation takes place, we think that should be driven by that sector of the industry not by the standards development organizations, we want the standards to be there, to be ready, to be implementable, but we don't want the standards organizations to dictate the timeframes for implementation.
MS. WEIKER: Well, from an NCPDP perspective the changes from version 5.1 to what we're calling version D0, they will be a big change much like the X12 4010 to 5010 changes. However with the industry input we have all sectors of the industry participate within NCPDP that are impacted by our standards so they are there, they're requesting the changes, they're aware of the changes. Our industry so to speak has met the deadlines, we've had Medicare Part D come up with specific deadlines that we have met, we've been very creative in, and I use that word very loosely, in order to maintain the HIPAA version 5.1 in the Medicare Part D, we've done that. So I think one of the things is by having the industry participate up front and through the process, one, there are no surprises so when I open a D0 or I open up an X12 guide or I open up a claim attachment I'm not going to be surprised by the content, I'll know what's there, I already can start planning, geez, if this goes through like this this is going to take me six months to make the changes, test it and roll it out. So I think by having the industry participate sooner versus wait until the end that will help as well.
MS. GOSS: Margaret makes an excellent point which I want to add one item too which is not only do we get people more educated as the process of development is happening so they can forecast the changes they need to make but we also as SDOs have instituted a number of educational guidance processes through our 4010 experience to help people with understanding what is really in those implementation specifications and then also work with our sister organizations that are not necessarily SDOs but such as WEDI, and we've worked with OESS when they had an Ask HIPAA hotline to give that infrastructure knowledge that would help the industry move along and adopt the standards more quickly and more efficiently.
MR. REYNOLDS: Okay, Jeff and then Karen.
MR. BLAIR: First of all let me do full disclosure and indicate that I'm biased because I strongly support the efforts that you have to try to streamline the process, I strongly support it. So the questions I have are for clarification and to try to go back to some of the areas, what was it, December of last year when you testified to us on this issue? And the last prefaced remark I want to say is thank you to Marjorie Greenberg for distributing the document to us so that the committee members could read it over the weekend before we came so I have read it and it's very thorough, very comprehensive, obviously a great deal of thought has gone into this.
As I was going through this and as my reader was reading it to me there were some times when I felt as if this was targeted towards standards that had already been approved through the HIPAA process but only involved a new version or a revision, but there were other times when I just wasn't sure whether it was broader than that, so can you clarify that.
MS. GOSS: It is specifically focused on existing adopted standards because we believe that if a new standard would be proposed that that needs a more, that has policy implications around it which are not within the existing processes to cover, that really is a federal process to manage.
MR. BLAIR: Okay, then I would make a small suggestion and that is that if this document is to be updated slightly that there be either a definition of a version or a reference, maybe it was in there and I missed it, but something where I could understand what are the boundaries for a new version or a revision, the scope that this covers, because if it was there then maybe make it a little bit more prominent, that's one piece.
The other pieces that I recall was I remember back in December that we felt that we could come up with a process to streamline things but as Michael mentioned some of the HHS legal guidance was winding up saying they couldn't change this without Congress agreeing to that. Have you had a chance to explore a little bit what it would take to either get Congressional or HHS legal approval for this process, that would help me a little bit because I sort of don't know how bit a mountain we're facing and if you've already started to look into that could you share that with us.
MR. BECHTEL: Yes, I've been very much involved in trying to get Congressional, I've been working with a number of Congressional areas on this issue and in particular the House Bill 4157 is largely the result of work that I've done in cooperation with all these fine people at the table with me. We have talked to legislative attorneys within the Department, well not the Department, within the House Ways and Means Committee and within Energy and Commerce and their opinion was these kinds of changes could be made and obviously they felt that way because they put forward a bill that was proposing those kind of changes.
Everything that's outlined in this paper really is representative of what we put forward in 4157 but you're absolutely correct, I do not believe this can happen without some sort of Congressional action. And what they were perceiving is that we're kind of moving the comment period that normally occurs from the NPRM process into the SDO, almost the delegation if you will, of that process to the SDOs to conduct and they were constantly looking for well how do you manage comments, where are the comments placed, exactly the questions Michael was asking us, and we went through that process with them, what we do as SDOs, and they were reasonably comfortable that what we were proposing was a solution that could work.
Now obviously there are different opinions on the Hill with any kind of legislation and I'm not sure everyone agrees but the ones we were working with do.
MS. WARD: I have another thing to offer I guess, based on our December testimony when individually as SDOs we talked about our respective processes and how we might be able to streamline that, the committee asked us to kind of put our heads together and come up with the one so we focused, in this group on this task we focused very much on our processes and how HL7, X12 and NCPDP could all agree to one process as it relates to standards in a regulatory environment. But I have no idea the extent to which any part of what I'm about to say may be true but after the December testimony --
-- [Laughter.] --
MS. WARD: I think this is worth putting on the table because after our December testimony there was one member of the committee, the subcommittee, that I had subsequent conversations with and then a couple of other folks who their background in all of this certainly is substantial enough that their opinion might actually be something we could pursue and that was that it is an opinion of OGC on how the APA is applied that is restrictive for us in that indeed the APA might actually be interpreted differently by different organizations or individuals. So this isn't so much about the Congressional approach but more about interpretation of the Administration Procedures Act. And again I'm not the one to have that debate but I wonder if that can't also be something that our friends within the government could possibly explore.
MR. BLAIR: Okay, thank you for that. Is there anybody else that has any insights on either the legislative issues or what it would take to get legal approval? If there's not then I have a few more questions. Is that all right Harry?
MR. BECHTEL: I realize as you said your question I should clarify something and I'm not responding to your immediate question but going back to my last response when I was talking about House Bill 4157, I want to point out that there's only one section in that bill that pertains to what we're discussing today which is Section 201, not the entire bill, so I don't want to leave the opinion that all of 4157 is addressing this. I apologize for the miscommunication.
MR. BLAIR: I like the way you laid things out and this additional comment is a little bit of an echo of what Harry has already raised and that is that when presentations for revision or update for a standard is brought before the NCVHS in a lot of cases when we're briefed earlier that it's coming and we have our homework done and we're not hearing the testimony for the first time, just like in this case where we've had a chance to read through the documents, that usually enables us to kind of come to a conclusion at the end of the testimony period, however there's a lot of times when that is raised here and it triggers responses from other sectors of the industry who want to get heard which means that we're into a mode where we're receiving testimony either from other private sector organizations and/or federal agencies before we are in a position to make a recommendation, so maybe if that modification could be noted in your process, that's very much consistent with Harry's, I just phrased it somewhat differently.
This is my third and last question, one of the things that I remember hearing as an issue back in December, at least I thought it was in that session, maybe it was afterwards, was that all of us are kind of part of this public/private standards development community and we look at what we do, we understand its impact, and for those folks that attend the SDO sessions they understand it, and it's almost as if once it gets here either at an NCVHS forum or through the NPRM process there's other aspects of the health care community that all of a sudden wake up and start to pay attention, and sometimes they become indicated as a rule by HHS, folks don't start to react until the deadline is approaching at which point they wind up objecting and saying oh we need more time even though its been years while this has been discussed and preparations could be made. And specifically it was said that well, these other elements, CEOs, COOs, other executives within the health care community don't attend SDO meetings and don't know what's going on but that delays us kind of at the last minute after we think we've heard from everybody and then all of a sudden these objections come in.
What thought had you had or discussions have you had to be able to somehow educate, include, get awareness during the process that you've involved so that that doesn't come in after this process is over where we're thrown right back into the fact that somebody is demanding an NPRM process at the end?
MS. GOSS: This is Alex, I'm going to take the first stab that because I suspect that my compatriots will also have remarks on this because its been a very interesting part of our discussions. Yes, we did testify in December and we've been working on this paper since then so nine months worth of effort. We really feel that people do need to be educated and that by using the vehicle of the federal register to get notification out to the industry to say hey folks, there's a development going on on a standard that is going to impact you, please come play here, is going to be the key vehicle for us to make the industry aware that they need to pay attention at the ballot or public comment period of the standards development organizations.
There's always going to be an issue with reaching, getting everyone to pay attention, we have a little bit of the ostrich syndrome at times, and I think that our education, if we get a change actually put into play regarding not having an NPRM for reviewing and proposing adoption of a new HIPAA standard, or an upgraded HIPAA standard let me say, that there will need to be a series of educational efforts taken once we get a new process put into place and that's something that the SDOs would undertake along with WEDI and I would certainly hope that our federal friends would also assist with that effort and would look to OESS to be a leader in that arena.
MR. BLAIR: But essentially the main vehicle for this publicity is the Federal Register.
MS. GOSS: For the development review period, yes.
MR. BECHTEL: Just to add on to that, my vision of what the Federal Register announcement might indicate is when a public comment period is taking place that it be clearly stated in that notice that this is your only opportunity, there will be no NPRM hopefully and that this is the time to comment so not to delay. It's kind of maybe the last moment process just moved up but I think the Federal Register has to make it clear what the process is.
MS. WARD: Jeff, this is Maria, as Alex pointed out this was a discussion that really carried on with our group for a long, long time as we prepared this paper. And I just want to echo what Don said, the Federal Register notice of the development can't just say it's happening, it has to say this is your opportunity just the way an NPRM says this is your opportunity, you have 60 days. The weight of the message from the federal government really needs to be conveyed in that Federal Register notice for people to understand the importance of it. I mean I think we as the SDOs can educate and do awareness campaigns for years and years and years and it does not get the attention that a message from the federal government gets.
MR. BLAIR: May I suggest something else for possible consideration? And that is that if this change does take place there needs to be a major announcement that the process has changed and that the NPRM process won't be there anymore for folks to wait for and that they now need to get involved in SDOs and if they do get involved in SDOs it may change the complexion of the SDO process if there's more business folks and executives and financial folks now part of that process, the profile of the participants might become altered a little bit.
MS. GOSS: Jeff, this is Alex, building on your comment, we would expect to see an increased level of participation in SDO activities although we don't believe that our workgroups will suddenly balloon 15 times their current size but we do expect our public review or ballot periods to balloon in tremendous size, and being ANSI accredited organizations we have a very transparent process and a reconciliation as a part of our due process that enables people to participate in that review and commenting process that really enables the people that would have paid attention at NPRM to actually have a better level of participation because they get more intimately involved in the entire process through the SDOs step by step.
MR. BLAIR: Thank you, I really applaud your efforts.
MR. REYNOLDS: Karen.
MS. TRUDEL: My question has been answered, thank you.
MR. REYNOLDS: Okay, Simon.
DR. COHN: First of all thank you very much for coming and joining us today, like the other members obviously this is I think an important topic that we all discuss. I think you know that in HIPAA reports and letters to the Secretary within the last year as well as in testimony of the House Ways and Means Committee we've obviously been very strongly supportive of a more nimble process for the HIPAA regulations and modifications to the HIPAA rule so you know you come to a group that has great understanding I think of the issues you're dealing with. Now having said that obviously much of, we're all aware in much of what we're seeing here in the testimony is actually at this point on Capitol Hill and none of us know how that's all going to work out. Congress still will likely start again after the elections, I think none of us know before the end of the Congress this session exactly what is going to happen. Obviously one option is is that a bill is passed at which point we have substantive conversations with you all about exactly how we work in this new world.
Now the other question and I almost hate to bring it up because it probably isn't as happy a world is you've done a lot of very good working and thinking over the last several months, are there parts of what we're seeing here that could be implemented, that could help streamline even absent Congressional activity?
MS. WARD: I think that we were trying to take a two pronged approach here, we know that there's activity and potential with bills that are being considered right now by Congress but we were trying also to say, as you point out, if that doesn't result in the kind of changes that we would like to see could we actually have a regulatory change that supports our approach, so not just the legislative path but also can we go down a regulatory path. And that I think leads into my earlier comment about is there wiggle room, is what we're dealing with now an interpretation of the APA where possibly there could be other interpretations of how the APA is applied. So I think we want to, we are supporting and we think that our recommendations are fully in sync with what's proposed in 4157 as it relates to standards but we also coming before you are trying to take it down the other path which is do we have other options. So it's almost like we're asking the same question of our friends at the federal level, are there different interpretations that can be offered of the APA.
DR. COHN: Thank you and as you know I think we've had attorneys come and testify to us for, not being an attorney sometimes you can only get so far by asking questions but have you received any legal opinions from, once again there are many ways to get legal opinions, one is formal from the government, another is through people that you've retained as a private organization that may suggest that there's more flexibility than the government's current interpretation of this.
MS. WARD: We as the joint SDOs have not sort of collaborated to engage any sort of, I'm not talking about the Congressional part, I'm talking about this document that's going before the NCVHS in terms of the APA interpretation, the SDOs as three organizations have not collaborated and engaged attorneys. AFACT(?) might have supported that and Siemens and private organizations but at least HL7 has not been involved in engaging an attorney, I know that the discussions have taken place and they've been more related to 4157 and other organizations, I don't think X12 paid an attorney did they to have an interpretation on this?
MR. BECHTEL: I don't want to get in a dialogue between the people at the table here but I will disagree with you just a little, we did hire an outside attorney, the attorney was paid for by AFACT as an organization but the conversation with the attorney was shared with this group and this group commented back extensively on what the attorney was providing including HL7, Chuck provided enormous editorial to some of the work. And this was all surrounding the APA discussion and I think the attorney that we were working with would confer that what we're trying to do could not be done without some sort of Congressional action to permit the Secretary to delegate this process. I think that's what we were trying to do in 4157, so I think probably a better thing for us to ask of this committee is if you agree with the changes we're proposing, any support on that issue would be helpful that you can provide. And I don't know what liberties you have in doing that, I know you have some constraints too, but anything that would support this would be helpful.
MS. GOSS: Much of our work over the last four years in looking at this issue has been done in concert with OESS and getting, trying to slice this issue every way to Sunday and what you're seeing in this 20 some document, the full testimony, is really the result of we have no more options at this point, the APA interpretation and the current status that we're trying to get changed through Congressional action is the only path that we can take.
MR. REYNOLDS: Okay, I've got a couple other questions, and Michael after me. As you look at the little guys getting involved, little people get involved in this, when you have a government process they get in free, when you have an SDO process it's voted by the members and there is a cost to be a member of an SDO. How do you envision making the people that would, if you move it from a government process to a private sector process that has a cost, even though you have a public hearing it is still voted on by members who have paid dues and represent a lot bigger players than the standard people, so how do you see that working so that for example, again looking at the process, they don't show up, they might not show up where it costs but obviously some of the other things that you have in here were free for people to come in and make comment to. So trying to be inclusive along the way how do you see that playing versus what the government does? Maria?
MS. WARD: On the ballot for HL7, at least on the ballot side when it comes to there has been a recommendation and it's going to be balloted you don't have to be a member of HL7 to participate in a ballot, there's a nominal fee currently, last I inquired, and this is going back probably to the December testimony, it was $25 dollars. Now I think we would be perfectly willing to engage in a conversation if this could be brought forward to reassess that, I haven't had that conversation with HL7 but you certainly don't have to join the SDO in order to participate in a ballot, and you don't have to join the SDO in order to participate in the discussions, the conference calls, sort of development type things that lead up to the ballot, we in fact encourage domain expertise and we solicit that to come in and help us as we develop our standards even if those individuals are not formal members of the organization. So I don't see that as a barrier in terms of the development or in terms of the ultimate balloting.
MS. WEIKER: In regard to NCPDP, in regard to our ballots, you do not have to be a member in order to vote, we do not charge any type of fee in order to have a non-member vote on a ballot, the materials would be provided to them, either electronically or via paper if they don't have an electronic means, the adjudication of the comments would be posted. In regard to the development of the standards most of the detailed work is done at a task group level via a lot of conference calls, you do not have to be a member in order to participate in a task group, voting there is just, it's by consensus, so we don't believe we have barriers in regard to having anybody come and participate.
MS. GOSS: From an X12 perspective our public comment period is open to anyone and everyone, it is done electronically as well as a part of it is in person, but all comments are posted to a publicly available site and all answers to those public comments are also posted 15 days before we have an in person face to face recap of the comment and resolution process. Currently our ballot is limited to members only however we are currently at X12 taking a stab at how we can modify that process, we're trying to balance the needs of the industry to participate at a reasonable cost with the overhead associated with individuals either attending a face to face meeting where there would be voting that would happen, and the process with supporting people who are coming into an organization that is basically staffed by volunteers.
MR. BECHTEL: Let me just add on to everyone's comments here, the part we're removing that you're saying is open to the small person, the NPRM process, is not a vote, it's only a comment, and so our comments at X12 as Alex has just suggested is free and open to everyone and is responded to everyone. So we haven't eliminated a process that they have, we've simply moved that process. And the balloting part, true, we do have that issue at X12 which --
MR. REYNOLDS: The purpose of the question obviously as we try to look at this very independently is everybody also has the ability to go up on Capitol Hill and lobby and everything else so if we're going to set up a good process that's going to work let's have it work other then the others ways which are always available, but if you can get more people involved in the beginning and more people that stay involved and say they're involved and don't have barriers to be involved then that's the only reason I'm asking the question.
MS. GOSS: And Harry, I would ask you then for guidance and suggestions on how we can get the attention of those people, the small guys, who are focused on their clinical practices and providing the safe care for patients. You asked us about, earlier about the education that has to go on and getting people to implement these transactions, we still have people that are struggling along way after our potential train wreck date, we struggle with how to get people to pay attention and to come play at the table when that's not their primary focus.
MR. REYNOLDS: That's a fact and we sure don't have that answer either yet, but that is absolutely a fact. Michael?
DR. FITZMAURICE: I'm wondering, since I'm not an expert in the administration practices, Administrative Procedures Act, I would bow to people who are experts in them and that's probably an OGC if not filtered down from OGC to the agencies. But I wonder if the Secretary has more discretion than we understand, to get that we could invite OGC to testify or we could make a recommendation that the Secretary ask for OGC to consider alternative ways to speed up the processes in ways that fall under the Secretary's discretion. That is we don't need to leave this as a closed end, it can be an open end, recognizing that the final choices remain with the Secretary.
MR. REYNOLDS: Jeff, is it a follow-up to that? Karen has another question.
MS. TRUDEL: This definitely does follow-up on that, I would make a recommendation to the subcommittee, and I have done this on issues in the past with respect to e-prescribing that the subcommittee make recommendations to the Secretary that aren't constrained by what may ultimately be a departmental interpretation of procedure. I would suggest that if the subcommittee feels that this particular proposal has merit recommend it to the Secretary, it's always easier to get an opinion when you have a specific product for someone to review, and if there is any external legal opinions that you'd like to pass along to us that we could share with our counsel's office we again have precedent for doing that in some of the e-prescribing discussions on state preemption where we did assess and consider other perspective from external attorneys.
With respect to the pending legislation Marjorie may contradict me if I'm not correct but this is an advisory committee to the Secretary and we don't have the ability to provide Congressional recommendations.
MS. GREENBERG: They do not, I would agree with that though, of course the committee does provide an annual report to Congress on HIPAA and certainly I would think this would be part of the content of that report that I think we're working on as we speak, or it's going to be brought to the November meeting for approval so the process for the transactions and some of the issues you've raised actually have probably given us some good content to consider, so in that sense the committee has specifically been asked by Congress to provide an annual report on the implementation of HIPAA.
MS. TRUDEL: No, I meant specifically with respect to H.R. 4157 and those deliberations.
MS. GREENBERG: Right, the committee does not provide lobby for legislation obviously, although its been known such as in the privacy recommendations indicate where additional legislation might be needed to address gaps or problems. And I know Karen realizes this but just for the record the subcommittee will make recommendations to the full committee and then the full committee will make recommendations to the Secretary.
MR. REYNOLDS: Okay, Jeff?
MR. BLAIR: As we are going through our discussion this morning and we try to think of how we can streamline or accelerate this process, because we know that there are a lot of, there's a lot of benefit that gets delayed because of this whole standards development and implementation process which can be shortened. When I think of the types of issues that seem to come up when we go through the NPRM process and even after the NPRM process when there's promulgation of the rule they tend to not be the technical pieces, the technical pieces usually are pretty well accommodated by the SDO process and the implementation pieces are also fairly well thought through. They tend to be business issues but not the same type of business issues that are used to identify the requirements for a standard. They tend to be the kind of business issues of industry, health care industry saying oh my goodness you have wound up, you being the federal government with an NPRM, saying that this is going to be implemented in such and such a timeframe and very often the argument is not with the value of the standards or the technical attributes of the standards, it's with the timing and it's because there's other relative things going on in the industry which industry is trying to work through and there's a conflict.
I think that this, I think it would be maybe helpful if there's some thought for us to try to include industry review of the timing of these things so that that could be included in the process because if it's not included in the process then it simply turns out to be a delay where industry goes back to Congress and says set it back a year, 18 months or two years. And if there's some way we could start to build that into the process I think that could help us.
MS. WEIKER: Jeff, this is Margaret, and WEDI is doing a benefit analysis survey as part of this process and what we have a vision for them also asking was about timeframes in their survey because WEDI tends to hit at a more CXO type of level in a lot of organizations versus the analyst type of people further down. So we anticipated at least asking WEDI to ask that question as part of their survey.
MR. BLAIR: And that would be good and if that could be done in parallel, if there could be some business analysis done in parallel with the technical standards development so that it's not serial where we get to the end of this entire process and then the business community starts to look at it and say I need two or three years. If it could be done in parallel I think that would be very helpful.
MS. GOSS: Jeff, this is Alex, the development process, what we're hoping to achieve is to have the review of a near final work product done by the industry which would include a DSMO review and the DSMO bodies provide not only the SDO voice but also a data content voice. So there's a way to get input from that process and typically I know having participated extensively with NUBC and NUCC as I sit on both of those committees they do talk about these timeline in business issues and so that comes then into the discussion at the DSMO level and DSMO and WEDI are working very closely on the benefit analysis report and that information would then kind of come to a point here at NCVHS for overall review and also we would expect an opportunity for other industry participants to testify to you on that topic.
We think that the timing issue is one of concern but we hope by getting people involved earlier in looking at the technical changes being proposed that they then will be able to think about what does this mean to me in my current budgetary environment and systems infrastructure so that as they're responding to the WEDI survey or participating here or within the SDOs that that information is all starting to come together by the time it gets to this point so that you're really looking at the big picture at NCVHS to make those recommendations that go to the Secretary that says okay, we recommend adopting this new standard and here's the timing to do it based upon educated information.
MR. REYNOLDS: Stan, I've been remiss not to check and see if you had any questions.
DR. HUFF: I don't think I have anything to add, as others have expressed I thought that this is a very well thought out presentation of how we might change the process or how the process might be changed, and I don't, but I don't have any additional insights on how we can get there faster or better or whether we're going to be successful through a regulatory process or is this a legislative process. Thanks.
MR. REYNOLDS: Last question.
DR. FITZMAURICE: Margaret mentioned that WEDI is doing a benefit analysis report of these changes, would this be part of the process that is each time you had a set of changes there would be a benefit analysis report and do you see that dovetailing into an economic impact analysis requirement that OMB has for all regulations that have more than $100 million dollar impact so it helps streamline the process and that it shortens the development of that impact analysis.
MS. WARD: I think the inclusion of the benefit analysis report was something originally that was stemmed from conversations with our friends in HHS and OESS that that was an important part of moving forward with new standards. So I suspect that the intent was that they would indeed take the information on the federal side from that and do whatever they needed to do in terms of an economic impact section of a final rule.
DR. FITZMAURICE: On the federal side it certainly would help us with how to frame it in terms of a model and to look at the assumptions about the different parameters, we might disagree and put different parameters in an economic impact analysis, but to start with the model and to be able to discuss the parameters would be very helpful to us.
MR. REYNOLDS: Okay, that concludes our discussion, Jeff jumped out early and said he was biased, the rest of us recognized good work, so don't take any of the questions or any of the things to be any more than adding to what we thought was an excellent set of work, an excellent paper, a process that's needed. I would hope at some point it would even be considered that as all these things having to do with some of these issues relate that after the first time maybe it falls into this process for other things also but we should start small and do the right thing for something that's already grouped up in that way.
So thank you very much to all of you, appreciate it, another good job from those of you we've seen over there numerous times and thank you very much and we'll get back together at 10:35.
Thank you.
-- [Brief break.] --
MR. REYNOLDS: Before we get started are there any other members of NCVHS on the phone other than Stan? Okay, let's go ahead and start our next group which is the Disability Workgroup recommendations and like we said last time we welcome our friends from CHI who are here on a regular basis to see us also, so Beth, are you going to lead the discussion and if maybe each person would introduce themselves, and aren't you going to have some people on the phone?
MS. HALLEY: Yes, there should be some people on the phone.
MR. REYNOLDS: Okay, so why don't you go ahead and take care of introductions so we know who's who and then please continue with your testimony.
Agenda Item: Disability Workgroup Recommendations - Ms. Halley
MS. HALLEY: Thank you, Chairman Reynolds and Chairman Blair for this opportunity to present the CHI Disability Standard. My name is Beth Halley, I am with Mitre, and have been the CHI facilitator. I do believe we have several folks on the phone but if we can take a minute and introduce the people in person and then we could go to the phone and we can start with Jennie Harvell.
MA. HARVELL: Hello, I'm Jennie Harvell. I work in the Department of Health and Human Services in the Office of the Assistant Secretary for Planning and Evaluation.
MR. SHIPLEY: My name is Sam Shipley, I'm also in ASPE.
MR. STRESON(?): My name is Manny Streson, I'm a medical officer with the Department of State in the Office of Medical Services in the State Department.
MS. HERRING(?): Hello, my name is Irma(?) Herring, I'm also with the U.S. Department of State, Office of Medical Services.
DR. HUFF: Good morning, I'm John Huff, I'm from the National Center for Health Statistics in the Classification Section.
MS. HALLEY: If there are any members of the Disability Workgroup that are on the phone could you please identify yourselves?
DR. DESI: Dr. Desi, Social Security.
MR. CONLEY: Hi, this is Bob Conley, the Centers for Medicare and Medicaid Services, Office of Clinical Standards and Quality.
MS. CAMPBELL: Hi, this is Kim Campbell with the Office of E-Health Standards and Services also with CMS.
MS. PRATT: Mary Pratt at CMS.
MR. BOGNER(?): This is John Bogner from the United States Rotary Town Board in Chicago.
MR. LANG(?): This is Derrick Lang from Social Security Administration.
MR. DANIELSON: Mike Danielson with Indian Health Service.
MS. HALLEY: Thank you and I believe that's everyone and I think I interrupted, that was Cheryl Ford who I interrupted. Thank you everyone that is on the phone, that you were able to join us today.
The purpose of today's meeting is to give you an update on CHI Standards Workgroup specifically the work of the Disability Workgroup and they have presented to you in writing the recommendation. Many of you who have been around for a while know that the Disability Workgroup, this is phase two of their work, they did present a report to you during phase one back in 2004, they have worked to address several of the recommendations that you recommended. So the work that we are bringing forward today has been about a year and a half worth of work on top of the original work that the workgroup has done.
The workgroup has asked that I present an overview and a summary of their work and the recommendation, and then we could open it up to any questions or comments from you if that would work. Thank you.
The overview that I'm going to present today is to discuss a little bit about who our participants are, the scope of our work, a little bit of the background of the recommendation, the process that we've been through and the dates, the target dates that we've been working to get the endorsement to you from CHI. We'll talk specifically about what the recommendation is, the actual standards, and then we'll talk about some of the conditions that are associated with the recommendations, some of the benefits that the workgroup has seen and also some of the considerations of the recommendation that's in front of you.
In terms of the participants, Dr. Desi who is on the line from the Social Security Administration and Jennie Harvell from ASPE have led this particular portion of the effort. We have also had approximately 30 members of our workgroup and they include ASPE, CMS, the National Library of Medicine, CDC, Indian Health Service, as I mentioned Social Security Administration, the Railroad Retirement Board, both the VHA and the VBA, the Department of Defense, the Department of Labor, and the Department of State.
And I would like to just mention one of our members happened to bring to my attention that not only has many of the people been working on this but for one particular member has been their entire career with the government, they started and their very first project was to work on the Disability Workgroup. So that gives you a perspective, for some this has been their entire career effort.
The scope of the workgroup, the scope obviously is disability and functioning content but based on the recommendations of the first recommendation that came to you the scope has really expanded a bit to include disability related assessment forms. And the reason for that was that there was a distinct need within the content area to look for ways to standardize disability and functioning content and in that need there was not only the content but how is the content used. And so as you'll see as we go through the recommendation process today that we will expand looking outside of just the content areas to LOINC which was looked at to actually codify the kinds of questions that are asked in the disability domain as well as the vocabularies that support the kinds of answers and the kinds of content that is needed within the domain. So that is one slight different that you'll see from the workgroup initially.
When the workgroup presented during phase one there was not endorsement because the group really focused on two areas and one had been in the clinical domain and the other was within the benefits and administrative domains. And within those two domains none of the standards that were available really incorporated all of the needs so at that point they were looking at SNOMED in the clinical areas and ICF in the benefits and administrative kinds of statistical areas.
Because of this inability to come to consensus on what was really the appropriate standards you all had recommended taking a look at, maybe looking at the use cases that were involved with this and potentially LOINC-ifying, looking at LOINC as I mentioned, LOINC-ifying, the kinds of content questions that are asked and to look at the semantic terminology that would support that approach. So in the last couple of years the workgroup has in fact moved forward with your recommendations and have leveraged and done a lot of analysis with four different activities.
One is related to an ASPE project that was funded by ASPE and CMS to look at a specific type of assessment report called the minimum dataset, or the MDS, which is used for long term care reimbursement and quality measures, nursing facilities essentially submit these kinds of assessment forms. In addition to that the Social Security Administration under the direction really of Dr. Desi and his staff took a look at the RFC form which is the residual functional capacity form and that is a report that SSA uses to determine benefits for disability and functioning areas.
And to give you a sense of the scope and why disability is so important, SSA is looking at about three million applicants or claimants for disability every year and we heard a presentation by SSA last week who said if they could save just, they put in hours and hours of trying to collect information from hospitals and providers and insurance companies, if they could save just a half hour in that process by automating some of this that would be 1.5 million man hours a year on a very conservative basis, so I think that gives you a sense of why this is, in one area why this is an important area to consider for standardization.
In addition to LOINC-ifying the RFC which I believe Dr. Huff is on the phone the Clinical LOINC Committee presented, or actually volunteered to pilot looking at LOINC-ifying the RFC and we'll talk a little bit about that and that was in one of the appendix of the report.
In addition to that Dr. Desi also led an analysis of what are all the concepts across the federal government relating to disability. All of the participants who you just heard from submitted a survey result and Dr. Desi and his folks compiled that work and you will see in one of the appendices across the federal government what are the concepts that are used within disability between the SSA and the RRB and the Indian Health Service and how are they similar and how are they different. And then in that process they took that data and then mapped it to IFC, which is the international classification of functioning, and then took and mapped it from IFC to SNOMED, and the results of that work is in the report and we'll go over that a little bit but they are the four main pieces of work that compiled the background to the report that has been presented to you.
In terms of the process, again this work has been done, this phase of the work in those four areas since about July 2005. The CHI Workgroup as you know, this report gets vetted and that's the federal agencies vet this report. We got a unanimous endorsement of this report at last month's, or excuse me, last month we presented it in September and last week we received full endorsement of this report to bring it to NCVHS, and here we are today.
The actual recommendation, what the workgroup is recommending is that LOINC be considered for the questions and answer format within the assessment forms, and CHI endorsed vocabulary be endorsed for the exact or usefully related content of those answers as related to disability, and then we'll take you and show you some information for a broader look at how CHI endorsed vocabulary support LOINC-ification, the answers of those kinds of questions.
In addition to CHI endorsed vocabularies this workgroup is recommending that you endorse, and they have endorsed, adding ICF to the UMLS and to develop mappings between the ICF and SNOMED. And we'll talk about this a little bit more but there was a distinct, in the work that this workgroup has done there was a distinct identification that by adding ICF to the disability domain it adds a coverage that was not there before so it broadens the ability to identify standards for the disability and functioning domain and that was a very strong indication with the analysis that was done by this workgroup.
In addition to the content the workgroup is recommending that HL7 be considered for the exchange of this information. I know this is similar to how we presented allergy where we didn't look at just the terminologies but looked at really the whole process, and we'll show you some of the HL7 exchange recommendations that this workgroup is bringing forward. Another important item that we want to bring to your attention that all of these recommendations we are bringing forth as conditional and we will discuss the conditions that the workgroup has identified associated with these recommendations.
I'm just really at summary level going to take you through these three pieces of the recommendation to give you an idea of what does this mean, what does this LOINC-ification of assessment forms mean, what does attaching CHI endorsed vocabularies for content mean, and what does the HL7 exchange mean.
As I mentioned ASPE and CMS co-funded a study to see the viability of LOINC-ifying these questions, all of the results, very extensive study, is available at this HHS/ASPE site noted here and also was noted in the report. But to date the LOINC-ification of these assessment forms has been done with our workgroup looking at the MDS, the RFC, and then there are several others that LOINC is working on including the Oasis form, the IRPI(?) assessment form, these are all very CMS oriented assessment type forms but the two that our workgroup really looked at was the MDS and the residual functional capacity.
And essentially what LOINC does, and Dr. Huff, I don't mean to take any pride to know more than the clinical workgroup so I will just at a very high level what they do is they take a look at the manual assessment form, and there's lots of questions including demographic information, information to identify the patient, as well as the disability concept. And they codify these into LOINC codes so the form has a code and the elements of the form also have a code. So if we take a look at, here's a PDF copy of the MDS, this is the manual form and I know it's probably hard for you to see here, this is several pages long, but this is just one of the pages that shows you the patient information, some of the other types of information they're going to collect.
And this is what the LOINC form looks like of the MDS, you can see that there's a LOINC code that identifies, that 45981-8 identifies this as a specific form. And then it goes through and it has characteristics of the form and as you get down into the panel you can see how the codes are assigned to the patient's name and as you get further and further into the report LOINC assigns these codes for all the different kinds of questions that are asked within this form.
Another example of a manual form that we looked at as we mentioned is the residential functional capacity form, and the example here shows exertional limitations and it shows things like occasionally can lift and carry, frequently lifts and carries, and then there's qualifiers or scalers associated to them, can lift ten pounds, less then ten pounds, ten pounds, 20 pounds, etc. So what the clinical LOINC committee does or did in this example and what LOINC does is it codifies those kinds of concepts. So here we have exertional limitations and then you have a code associated to occasionally lift, and then you have essentially the answers and the physical as we said here it's pounds, less than ten pounds, more than ten pounds, etc. So this is the process that LOINC goes through, it looks at the manual form, looks at the information, and assigns the LOINC codes to them.
Now that's the LOINC piece. Then the committee is recommending that we take a look at CHI endorsed vocabularies to answer those questions. So what the workgroup, when they took a look at SNOMED, ICF, and several other vocabularies but for the disability of it what they found in their analysis was that SNOMED was very good at a very granular level, was able to capture concepts at a very granular level, was very good at the clinical concepts, but there were gaps within the disability domain. When they looked at ICF what they found was that there were numerous higher level concepts within the domains that supported the needs of people or forms and agencies like SSA that is required by Congress to categorize their disabilities a certain way and ICF met that need. So where there were gaps within SNOMED ICF seemed to fill those gaps.
And we also noticed that there were overlaps within these vocabularies as well, so even though there were still gaps by looking at ICF and SNOMED gave a much better coverage of the disability domain.
And I think I've already talked a little bit about some of the work that was behind these analyses, in Appendix D of your report was SSA's survey to all the federal government agencies that participated and a synopsis of the summary of those results. And then John Huff who is here did an exceptional job in creating the mappings between the residual functional capacity concepts, ICF, and SNOMED. And because of the outcome and the analysis of this this is one of the really strengths behind this concept of recommending ICF to be included in the UMLS and to be considered as a CHI endorsed vocabulary, as well as considering the mappings between ICF and SNOMED.
Here is just one page of hundreds of pages I think of John's work but it just gives you an idea, again if you look at that exertional limitations category of lifting what the ICF code was here, and you can see it's a d430, what the explanations within ICF about lifting and carrying, what the concepts were essentially, and then what the SNOMED code that would be associated with that. And this is just an example where you can see one ICF code maps to numerous SNOMED codes and that again is in line with the idea that ICF is kind of a broader category and SNOMED is a more granular. But I think that within the report that John and Dr. Desi also participated in and the workgroup reviewed it was obvious that ICF really did identify a gap in the terminologies that were needed, that there's one to one mapping in cases, there's one to multiple mappings, and that there are still some gaps within these terminologies.
This is a review of the other CHI endorsed vocabularies as I mentioned, these expand beyond disability, you'll see how lab and SNOMED and HL7 for demographics, these are the other pieces of the CHI endorsed vocabularies that could answer those questions that LOINC is LOINC-ifying on our results. So there you see LOINC, here is how the CHI endorsed vocabularies support the answering of those questions, and then the HL7 is the third piece of our recommendation in terms of messaging.
And what we found, and a lot of this information comes from the ASPE and CMS report but it also was brought up in our workgroup that HL7 has the OBR and OBX transactions which are for observations and they do support transmitting both LOINC and SNOMED codes, or CHI endorsed codes, and it was also brought up within the workgroup, specifically VA and SSA where they would like to start to transmit this information in a human readable form, even that as a first step would be a benefit. And that as things become codified through LOINC and CHI if this recommendation moves forward that there becomes a machine readable version of the HL7 CDA.
And just to go over those again at a summary level, here's an example of the OBR and the OBX transactions and how information is set. Here we see this is a minimum dataset example, you see the questions, the ability to make decisions is the question, and then you see impaired and a SNOMED code as an answer. Again, just an example, an illustration of how HL7 supports this domain.
Here is an HL7 CDA XML coded version of what the MDS would look like, and again it just shows you how the XML coding and the coding system and the value codes support both the LOINC as well as the CHI endorsed standards.
As I mentioned, and that's a summary of the actual recommendations but as I mentioned earlier all of these recommendations are bringing forth as conditional. And one of the reasons the workgroup is bringing these forward as conditional is a lot of this work has been done in a study environment and there was a sense that there were three main needs to really bring this recommendation out and fully endorsed. They include the federal government creating a web based collaboration tool where these usefully related concepts from CHI endorsed vocabularies be accessible so that if an agency is creating an assessment form there would be a place to go to find where these usefully related matches can be found and that works in conjunction with a knowledge base that this workgroup is recommending within the UMLS and this would be essentially a database or a knowledge base of all the LOINC-ified questions. So again, if you're creating or if a systems person is needing to automate an assessment tool they could go to the UMLS, to this knowledge base, and find what LOINC-ified codes have already been assigned and hopefully create an environment where there is truly standards used across these assessment tools.
The third condition, and this is a condition that we are looking for NCVHS to support this recommendation, and that would be that the NLM and the World Health Organization complete their negotiations on bringing the ICF to be incorporated into the UMLS. We also recognize that since most of the work has been done in a pilot and a project environment that pilot testing of these assessment forms would be necessary. We have this listed as both a recognized need and you'll also see it in one of our future considerations.
So some of the benefits that the workgroup has noticed, that by looking at including ICF in the UMLS and mapping into SNOMED for needed codes that it really does enhance the coverage of the disability and functioning domain. This use of blended standards also between LOINC and CHI endorsed standards, and using HL7 enhances this ability to exchange this information so this workgroup, similar to allergy but different than some of the other CHI, really took a look at the whole process so that need of having the exchange messaging standard be incorporated into our recommendation.
And in addition I think it's very important this idea of looking at LOINC as the potential to address assessment questions as well as the content standards that would be needed to answer, this would be a real benefit in interoperability, I think the potential to create an interoperable environment across federal and hopefully private institutions where this information would be interoperable is one of the goals of this workgroup. And again it enables the needed analysis of this that would not only address disability but eventually could expand into other areas of assessments and surveys across the health domains.
Future considerations, these are also listed in your report and as I mentioned pilot testing of the implementation programs will be needed for the assessments and this ability to link them with content standards, so the workgroup recognizes that this is kind of in the forefront of this process, that no one really has implemented this, so we are recognizing that pilot testing will be needed.
There has also been a request that the federal government continue participation in the clinical LOINC committee, this is obviously an extensive amount of work, they've been extremely generous with our workgroup in looking and piloting some of the work that is included in the report but there is recognition of the need to continue participation.
We recognize that federal software will need to be modified to support these standardizations.
And lastly and perhaps from our workgroup standpoint a more imminent need is to conduct outreach and to educate people on what the recommendation is here for disability and functioning domain as well as the assessment form process, or automating the assessment form process. So the workgroup would also like your endorsement is to take a use case forward to AHIC and to HITSP and recognize this as a priority area as HITSP moves forward with its work.
And that's it from a summary standpoint anyway and we have all of our subject matter experts here or on the phone and I think would be willing to answer any questions you may have.
MR. REYNOLDS: Okay, before I look around the room, Stan, since you've been LOINC-ified probably for a lot longer than anybody sitting in this room I'm going to let you be the first one to ask any questions that you might have.
DR. HUFF: I participated in this process and because of my involvement in both HL7 and LOINC I think I need to recuse myself especially if there's a vote on this. Just allow me to say that I'm very supportive of this process, I thought there was a very good information exchange and I think this has been a great presentation of that work. And so I would just say that I'm very supportive but officially I would have to abstain from a vote both because of my involvement with HL7 and LOINC as potential conflicts of interest.
MR. REYNOLDS: And I've been amazed with the amount of collaboration and breadth of work that CHI continues, you all continue to bring to us, it's pretty amazing, it's pretty special actually what you're doing and how you're trying to drive this forward. Simon?
DR. COHN: And Stan, maybe you can help answer some of these questions, we'll put you in an expert role for the moment though potentially Elizabeth and Jennie and others can assist with this one.
Now first of all I'm very impressed, I mean what I'm seeing is, I mean having been, when you came here originally which was disabilities domain and we're not exactly sure what it is or how to approach it, being sort of moving much into the world and recognizing that there's a reason that there are questions and forms and all of this in terms of trying to deal with these areas. So what I'm seeing is obviously a process where you're taking forms, identifying the questions on the forms, deconstructing them into various codes and codification, and then basically reconstructing them as CDA documents via HL7 that then could be sent out so people can yet fill out more forms or produce more forms or whatever, so it's sort of the form circle.
Now I guess some of us had hoped that maybe there'd be less forms in the future of health care but you may be proving me wrong on that one, but I've made other projections in the future that haven't worked out either.
Now Stan, maybe you can help me about this one because some of it relates to exactly how clinical LOINC works and all of this stuff and what we're going to get out of all of this. What I've seen is sort of rigorous analysis as well as identification of elements and codification of all of those elements so we will now have lots and lots of lines on the database of all sorts of questions with LOINC codes related to forms.
Now the one thing I wasn't sure about is knowing that, having at times been someone who's actually had to fill out forms, is that there's tremendous redundancy in the questionnaires typically, typically questions that are almost alike but not quite alike except for just the small little word here or small little word there or that the answers are instead of I can only carry ten pounds it's 12.5 pounds, or 15 pounds and all of that. And obviously at the end of the day we would like to see simplification, administrative simplification, maybe not administrative, maybe clinical simplification.
I guess I'm trying to figure out how this effort moves us in that direction or doesn't, I mean you certainly are classifying, you're computerizing, you're codifying, I'm not sure that I'm hearing the simplification part.
DR. HUFF: It's an excellent question, Simon. LOINC committee has the same goal as you described, what we're trying to do is only have one question --
DR. COHN: Stan, I think we lost you with others making comments on the phone, say it again.
DR. HUFF: We have the same goal in the sense of getting to a single question, the tricky part really is getting the people who use the questions to look and see that when they're making a new questionnaire in fact if there's a question that's already they could reuse. We're in a bit of a Catch-22, you have forms that are already in use and either by regulation or by policy can't really be changed immediately and so we want to meet the need by creating LOINC codes that correspond to what's currently in use. But what we want to have happen over time is an examination by the various agencies and by the user groups, or the groups of people who are using these codes, examine it and say could we in fact use the same question and isn't it more important, could we consolidate to a single set of answers that could be used. And so I think this as an excellent first step in sort of making a category of things and being able, having a consistent set of codes sort of allows that next level of discussion, are there some of these that we should now deprecate, are there some of these that we could consolidate, and I think that's the next step in the process.
MS. HARVELL: Can I add an additional comment? In addition to an additional important first step working towards hopefully consolidation of similar questions emerging over time as form developers go forward and trying to ask the questions they need to ask and being able to review questions that have already been encoded and captures in for example a LOINC repository. I think another important first step here is this would hopefully enable analyses of questions and answers that have been coded in LOINC and are captured in a LOINC hierarchy. And the UMLS database that's being developed would also support analyses of codable content, both exact batches and usefully related matches that haven't been identified for the questions and the answers in these coded assessment forms. And being able to analyze the terms that have been, the coded terms that have been related to the questions and answers would support analyses of and perhaps including analyses of the similarities of questions and answers that could lead towards increasing comparability of questions and answers on these assessment forms over time.
DR. COHN: Thank you for mentioning the word hierarchy because you actually are bringing up an issue, and Stan I guess I need a little clarification on this one. Does clinical LOINC have a hierarchy or is that another add-on that needs to be done after the development of the codes?
DR. HUFF: LOINC does have hierarchies and it has hierarchies now and it has an improving, we're working on even more sophisticated representation of hierarchies. So there are at least kinds of hierarchies that are supported now, one is basically just the containment hierarchy so that for instance when you're creating forms you can represent basically the complete form then show sections and then questions within sections so it's just containment that you would normally have structurally within the form. But then the other kind of hierarchy that's supported and actually this came from Steve Steindel and work in microbiology, there are hierarchies that allow you to collect elements and know for instance that all of these codes pertain to depression scales or all these codes pertain to, in the case of what Steve Steindel was doing is that these are codes that pertain to a particular organism as a causative agent. The more sophisticated kind of hierarchies we're working on are ones that would allow specific use of the hierarchy for a clinical purpose, so for instance if you wanted to say these set of codes for our purposes all roll up into or could be used as evidence of existence of a given disease those are hierarchies that actually are supported now too in the newest version of LOINC.
DR. COHN: Okay, thank you for that clarification.
MR. REYNOLDS: Marjorie, you had some comments, you'd sent some comments out to the committee on this and some other things, both Jeff and I would love to hear some comments and statements from you since you also I think enriched, at least enriched our understanding of this through the emails.
MS. GREENBERG: Thank you. First I really do want to recognize Beth and Jennie and Dr. Desi and the whole membership of the Disability Workgroup. Although this has not occupied my entire career it feels like it has but when I introduced myself and most of you from the Disability Workgroup weren't here at that time but when we went around as we do in the morning and introduced ourselves the members all say whether they have any conflicts of interest and as Stan said and we're really pleased that he can put on his expert hat for this because its invaluable, it's incredible the amount of collaboration which I think you've recognized that went on in all these CHI groups and this one was certainly no exception, a lot of volunteer hours.
But when I introduced myself as executive secretary I said just for truth in advertising I am a member of the Disability Workgroup and have been from its inception as have Jennie and Sam and Dr. Desi and many others actually, we got some new people as we went into this phase two but it has been an amazing process. And I think that in many ways obviously our phase two was very much enriched by the presentation that was made here on phase one with the recommendation about LOINC-ification which I still think is an incredible word but it seems to describe what happens when you take a survey and put it into LOINC codes. I have that little LOINC pig that Clem gave me and I really should have brought it to this meeting, either that or give it to my grandson, I'm not quite sure the best use of it, but it says it all.
But I think I've been very proud to be part of this, I think in the first phase John Huff wasn't yet on my staff, he filled the position that Paul Playcheck(?) held for many years as the ICF expert and when Paul retired John joined us and so he's been a critical member of phase two and particularly with the mapping that he's done with the ICF and the SNOMED. I might also mention that obviously the national committee has been looking at ICF before the CHI process with the report that came out of the subcommittee under Lisa Iezzoni on populations so I think in many ways these recommendations were very responsive to and the whole process was very responsive to work that's been done by the national committee so I want to thank the national committee for your support in this realm of functioning and disability which I agree with Beth is extremely important and under recognized I think in our clinical and administrative standards process.
The communication that I had with you all came after we sent the report, we had several conference calls preparing ourselves for this presentation. I think what Beth did not mention is that this is actually the last domain to come forward under the CHI process, I mean it's sort of amazing. It was one of the more difficult ones, I think all the ones in phase two, the multimedia, the allergies, and now this disability were very complex domains and involved tremendous collaboration. I really want to recognize Beth whose just been an incredible facilitator because when you have that kind of collaboration you need kind of a neutral party to do that, we didn't have that in phase one as much, one dedicated, everyone was dedicated but one person, I think its just been amazing that all of these have come to a fruitful conclusion.
We were talking about the conditions and particularly how you all, if you are supportive of this report, which we hope you are, how you might help us address these conditions so that we can move from conditional to full acceptance. And one of them I think has to do with the use case, the encouragement of a use case. Right now there is not an AHIC or HITSP use case that addresses the functioning and disability domains. As you know although the use cases sound broad like EHR, consumer empowerment, and biosurveillance, sounds like the whole ball of wax. Then within those topics though there are very limited, well, limited but critical exchange of information. So even diagnoses frankly have not been a significant component of those particular use cases, exchanging information on health conditions, problem lists, etc., but functioning and disability hasn't even been on the radar screen or assessment instruments.
So one thing that we feel would be very useful if this committee through the recommendations of the subcommittee recommended really the department going forward with a use case related to this domain, or these domains, disability, functioning and assessment instruments. And we are in the process right now within HITSP and AHIC of identifying new domains and new use cases so it's an ideal time to put this one, give this one some visibility. And this would of course then encourage the pilot testing and all that that we've recommended.
The other, of course I'm unabashedly pleased that the recommendations included recognizing the international classification of functioning, disability of health as a CHI endorsed vocabulary but that as you'll see the condition for that is to include the ICF in SNOMED, in the UMLS, and then to do the mappings with SNOMED CT. And I think Vivian probably also feels like she's been working on this her whole career because she has been a critical person in these, she and Betsy Humphries of course, in these negotiations with WHO. We've made a lot of progress recently in those negotiations but, this is one of my passions but as you know when we included SNOMED CT in the UMLS, which really opened up then the opportunity for its use and we included it as a category four which means that people in the U.S. can access it from the UMLS at no licensing fee and no cost, that was really to enable the whole use of SNOMED pilot testing, development of SNOMED and coded electronic health records, all of that. And it required a substantial financial commitment by the department as it needed to because the people who maintain SNOMED CT needed to be supported.
On a much smaller scale this is also true for the ICF, CAP(?) holds the copyright currently for SNOMED CT, the WHO holds the copyright for ICD and ICF. We have an agreement on the use of the U.S. use of ICD and there's no licensing fee for the use of ICD-10 for U.S. government purposes or U.S. purposes, we have not yet negotiated such an agreement on ICF and that's what we're trying to do to include ICF in the UMLS as a category four which means it would be freely available to everybody who would want to use it and then the maps between SNOMED CT and ICF would also be available and that does require a much more modest licensing agreement between NLM and the WHO, what's being discussed is $50,000 dollars per year.
So we need to raise those funds and that was one of my emails that if you support the recognition of ICF as a CHI endorsed vocabulary and its inclusion in the UMLS and its mapping with SNOMED, etc., as part of this whole process that you also encourage the department to identify funding for NLM to complete its negotiations with WHO. And we feel that, as I speak as the head of the WHO Collaborating Center for the Family of International Classification which includes responsibility for ICD and ICF, that was a mouthful, but anyway I'm pursuing possible avenues for raising those funds but I think that the support of this committee would be very helpful in that regard.
Is there anything else, my colleagues, that we've discussed that we particularly wanted the committee to endorse? Does that cover it?
MR. REYNOLDS: Thank you, Marjorie. Jeff, you had a question?
MR. BLAIR: Let me add to the fact that this is very impressive, obviously very complex, had to integrate a number of different standards to be able to come up with a useful and meaningful approach. I'm assuming that you probably have dealt with these two questions but I'd just like to have a better understanding of it. Number one, I suspect that a lot of patients that come in that have, that would benefit by this classification have multiple disabilities, not just one, so question number one is how do you handle multiple disabilities, and question number two is kind of related to it although it sounds like it's a different one is what about conditional situations with a disability, does that disability get better or worse during the day, does it get better or worse related to exposure to allergens, does it get better or worse due to other related conditions, so the second one is conditional although I think that there may be a relationship between the conditional situation and the fact that there are multiple disabilities. So could you help me understand that better.
MS. HALLEY: Thank you, Jeff, I'm actually going to suggest that some of our experts respond to that, we do have several clinical folks here as well as Jennie Harvell whose worked very closely with some of that content. So Jennie, would you like to start and Manny, if you had any thoughts from a clinical perspective or any of the folks on the phone.
MS. HARVELL: If I'm understanding your question, in terms --
MR. BLAIR: There's two, multiple disabilities, the second one is how does it deal with variations in the disability due to different conditions.
MS. HARVELL: So in terms of these recommendations we're recommending LOINC-ifying questions and answers, identifying usefully related and exact semantic matches, that's part of the recommendations here so in terms of your question I think in terms of identifying multiple disabilities you'd have to articulate the question, does the person have a seizure disorder, does the patient have cerebral palsy, so you would articulate the series of questions that the user wants to have the disabilities, the disabilities of interest to the user of the assessment information. And perhaps you'd have some scales regarding the types of seizures, for example, the response, the answer list would reflect the types of seizures in this particular example that you would be, as the user, would be interested in understanding. And you'd represent the questions and answers in LOINC so your questions would be coded in LOINC and you'd associate your response set to each of those questions that have been coded in LOINC. You would identify if there are any exact and usefully related semantic matches for each of the questions about the disability status of the patient and the exact and usefully related matches that correspond with the answer set.
So that's how I think in terms of our recommendation we'd identify multiple disability conditions for particular patients. In terms of conditions that might affect a patient's disability status I think that is one of the benefits that could accrue from this type of standardization because I think this type of standardization would allow analyses across questions and answers in your assessment form. So if for a particular disability you wanted to know the impact of time of day or allergens or affective medications you would need to be able to analyze the patient's response, across populations perhaps, to understand the relationship of the environmental or other influences on a particular disability status.
And so to me the concept of identifying usefully related semantic matches that are associated with the question and answers that are being asked is one of the significant value added components of our recommendation. That's a long winded answer, I hope it goes towards answering your question at least in part.
MS. GREENBERG: Harry, I have a follow-up and I also wanted to mention, see I'm trying to closer here, one of the advantages of my having a Blackberry is that people who are trying to listen in on the internet will sometimes email me and I just heard that, I mean that could be a negative, they'll email me with relevant information, I also get irrelevant information, and what I have heard here from one of our listeners is that some speakers come in loud and clear and others are very faint or not audible. My mic is apparently rather low and the current discussions, this was sent a few minutes again, is inaudible. So I don't know that that was you, Jennie, but in any event let's all, we all need to really try to speak very loudly and distinctly into these microphones and I'm also alerting our audio specialist there, if you heard me back there.
In relationship to your excellent questions, Jeff, I think, I agree with everything that Jennie said and I wanted to make two other comments. One is that one of the reasons that this functioning domain is so important to get into the standardization process is that in fact a person can have, of course they can have a number of functional limitations, but they can have a number of health conditions diagnoses, but they may or may not have functional limitations. And actually they may have the same functional limitation across several diagnoses and you don't know that when you only have the diagnosis. And so that's why it's so important to be able to also collect information on functioning which is often what takes a person to the health care environment or setting is their functional problems rather than whatever their diagnosis or even their classified disability is.
MR. BLAIR: So when you identify the functional disability that could lead to a menu of multiple possible diagnoses.
MS. GREENBERG: Absolutely --
MR. BLAIR: Thank you, that's really what I was, thank you very much.
MS. GREENBERG: And one diagnosis can lead to all sorts of levels of functioning, higher or lower depending upon various factors and in addition to co-morbidities one of the big factors as you pointed out is environmental factors and that is one of the real strengths of the ICF which actually includes in its classification structure a classification of environmental factors which is one of the reasons we really want to get it included in the UMLS because if I'm correct that's an under covered area right now in the UMLS. So we didn't pay you to ask those questions but they were excellent ones.
DR. DESI: This is Dr. Desi, given an example I guess in a use case which was where my orientation tends to be in Social Security and also in the private sector as well insurance companies need to know what someone is capable of doing, you may have seen the forms that say is claim able to do his work or any other work, and that's a question that needs to be answered and private insurers don't have good ways of collecting that data and being able to analyze it other then by asking a physician to fill out the form.
If we look at someone who say has arthritis and a heart condition and neither one of those diagnoses can limit that person's ambulation to stay 100 feet it really doesn't matter from the standpoint of assessing capability what the diagnosis behind it is other than to substantiate the necessity for the further restriction because if that condition restricts someone to 100 feet of walking and his arthritis in his knees does the same thing it's still 100 feet. At the same time you're saying that you having a relationship that can be one to many or many to one, that's kind of the clinical sense that you can have, when you asked about multiple impairment, multiple impairment may mean one or no restrictions or multiple restrictions, or more impairment may have multiple restrictions, that goes back and forth.
In terms of conditions, things varying throughout the day or something like that, for work or employability use case we generally look at the lowest common denominator, taking into account that somebody's asthma condition may wax and wane over time, if we could put the restriction in not to expose them to certain trigger, environmental triggers, but still recognizing that some parts of the day may be better than others, any medical conditions that have this diurnal variation, like I said from an employability standpoint we're looking at the lowest common denominator, what can this person do throughout that eight hour day, 40 hour week, even if for 20 hours they can function at a higher level we need to know what the lowest level of function is going to be. Does that kind of broaden that area of the question for you?
MR. REYNOLDS: Okay, Jeff is shaking his head, thank you. Mike, you had a question, then Jeff's got one and then I've got a process question.
DR. FITZMAURICE: Yes, Harry, I too want to compliment Beth and Jennie, Dr. Desi, and the whole workgroup for pulling together a lot of information and then deciding more is needed and defining what more is needed truly is an interoperability specification of standards and standards to be I would guess. When I ask myself who would be the users Dr. Desi came up with some users as well as Beth's presentation, Social Security Administration, Medicare and Medicaid, I would think workman's compensation, health plans and many others. Given the variety of uses I wonder if this is possible to go to AHIC rather than to HITSP, that might address some concerns over is there government staff availability to develop a use case, maybe more formal than as presented in this document, and vet the same standards, is there a willingness to do that.
Is there funding for HITSP to manage this use case? I know that HITSP is considering, or AHIC is considering giving at least two more use cases to ANSI, I wonder if there is funding for ANSI to manage yet another use case like this and I would hope there would be. Is there a matter of timing between the user need, the Social Security and Medicare and Medicaid and so forth, the user need and the interoperability specification process, is this good enough to go, but is it bound too much by the narrowness of users who are basically federal partners and not private users, is there a more urgent need of the federal players for having some designation for this set of standards. So I guess does it, what makes sense, sending it to AHIC, sending it to HITSP, what would get it vetted and able to be used by the federal agencies more, does the workgroup have a sense of that?
And I'll have a second question but it will be shorter.
MS. HARVELL: I think those are really good questions and I think in this, at least from my perspective this AHIC and HITSP process and the addition of additional use cases through that process is one that I'm still learning and trying to understand. And it was my understanding, perhaps incorrectly, that use cases are advanced via AHIC to HITSP, that's the only path that I know of, maybe additional paths will emerge but that's the only path that I've seen to date.
In terms of the funding question, I think that's a very good question and I don't know the answer to that.
In terms of private users I have a couple of answers about that. Certainly these recommendations were developed with the federal government, the public sector's use cases in mind. But in addition to that, for example on many of the federally required patient assessment instruments work has been done to identify that the, because these forms have evolved over many, many years and predated this big push, oftentimes predated this big push towards health IT standardizations most of these assessments presently are not standardized. And in many sectors of the health care industry the IT solutions that have emerged in the private sector have emerged in response to these federally required assessment forms. So if the federal government moves forward in standardizing, deploying more standardized patient assessment instruments I think we'll have a positive impact on private sector vendor solutions in that they will become more standardized.
I also think that this database that hopefully will emerge through the good work of the National Library of Medicine to represent LOINC coded assessment questions and answers and the usefully related and exact semantic matches would be publicly available and could be used not only by the federal government but also by the private sector as they hopefully go forward in deploying additional IT applications that could link with these standardized assessment forms.
DR. FITZMAURICE: I guess my question was really as what would you have NCVHS do, would you have them recommend to the Secretary that the Secretary adopt the standards? Would you have them recommend that it go to AHIC for an AHIC judgment about whether the federal government should use them, pilot test them, and/or a recommendation that AHIC consider this as a use case. I'm trying to see how not to let all this good work lie dormant for a while while we get the resources to say yes we can have another use case to be considered through the process that we have now. One way is to say let's go and let's start and indeed one could go and start without a Secretary's adoption of these as a CHI standard but yet there's a lot of advantage in having a formal blessing, a blessing from NCVHS, a blessing from the Secretary, a blessing from AHIC, even a blessing from HITSP.
And it's the stage at which these are that some of these really do need to be pilot tested that it might be a different category than say well we need a use case and then specify the standards, it may be we have a federal set of use cases and we need to pilot test them to see if this is a really good workable solution. That's something that AHIC could say is that we recommend these be pilot tested for federal use. As we're learning more and more about the process and indeed probably giving a recommendation for how this might work, this might lend itself to something a little bit different then we currently have.
I'm just not sure and I guess what you're saying is that there are a lot of different avenues that could be approach to further expand the applicability of these standards and develop standards.
A second question, who would support the maintenance of LOINC codes as new questions arise? And would these be category four codes that you could go to the National Library of Medicine and say I want the disability codes that have been LOINC-ified and the NLM would make them freely available if you sign a license for use, or is it envisioned that you go to the LOINC incorporated and get the LOINC codes directly from LOINC? Where do you go to get them?
Now I would like to see NLM be kind of the, not only the research arm that looks at these but also the production arm that says if they're useful, if they're adopted, then we make them available to everybody as long as the resources exist to cover the cost of doing so. Any thoughts about that last avenue?
MS. AULD: Once they're LOINC-ified they go into LOINC and they are automatically available at no charge either from the Regenstrief Institute or through the UMLS, so there's no copyright, no royalty charges associated with that.
DR. FITZMAURICE: Fantastic, thank you, Vivian.
MR. REYNOLDS: Okay, Jeff and then I've got one process question.
MR. BLAIR: This another twofer and the central theme is overlapped with other standards and standards processes. Could you help me understand a little bit whether anybody has discussed the use of this, I don't think of it as a standard, I think of this as a set of capabilities to help define disabilities and functional limitations. And as such is there an overlap with signs and symptoms like the standards for signs and symptoms because I tend to think of either depending on the functional limitations, does that start to flow over into that area and was there discussion on that.
And the other piece of it which is also kind of related is the way Marjorie was discussing it where you identify a functional limitation or disability and then that can be traced back to one or more probable diagnoses, was there any discussion of how this could enhance and strengthen the use of problem knowledge couplers being used by DOD, I think that uses Medcin(?) for part of that. So those areas of overlap, could you help me understand those a little bit.
MS. HALLEY: Is Nancy Orvis on the line? She's from DOD and she's had some input, she was hoping to attend but I know she's had another --
MS. ORVIS: No, I'm here.
MS. HALLEY: Great, Nancy, any thoughts on Jeff's comments?
MS. ORVIS: Repeat your comment, Jeff, sorry.
MR. BLAIR: Okay, the portion was it appears to me as if this whole structure, this framework for functions and disabilities might be something that might complement or fit in with the problem knowledge couplers being used by DOD, did you see that or not?
MS. ORVIS: What we can do is I can make sure that that vendor who provides the problem knowledge couplers to us, and I would agree that those, because there's some decision support trees, that this is what you would come up with I think is what you're kind of, yes, I think that's a very good point and I think that's useful for many of the agencies looking at this, that this is really good work done by everyone in detail and this should certainly help a lot of vendors or people in decision support figure out how they could use this information as soon as it gets mature in UMLS and SNOMED CT and the other places we need to have that work done for this standard.
MR. BLAIR: Thank you. And the other piece was overlap with standards for signs and symptoms.
MS. ORVIS: Well the signs and symptoms right now are in, we don't have symptoms on the CHI list I don't believe, we have --
MS. HALLEY: Problem lists and diagnosis through SNOMED.
MS. ORVIS: We have SNOMED CT. Now certainly for DOD we use an internal product that we could talk some about to say that you all do your cross linking of your whole way internally for your signs and symptoms, we're using the data capture technology of Medcin to do a lot of signs and symptoms right now and yes, this would be an interesting link, I guess we could talk with them about, but I think that you're making a good point, this is useful for a lot of us whose software vendors are saying that what CHI and these kind of workgroups are proposing is kind of a little, if you want to talk easily across a lot of venues you can translate it to this stuff and you can use your own proprietary application in a way, you continue to use your application and map, right now many have mapped to ICD-9-CM or ICD-10 or anything else like that. But if you want to talk across a larger higher and travel further if we can develop this thing for disability, documentation, that will be much more useful in the long run and saying that your application has to be in all these locations which we know the market is not going to say that there's one application everywhere. So I think this is useful.
MR. REYNOLDS: Okay. The question I have is your recommendations are clear, your conditions are clear, when I look at future considerations some of them look like something you might want us to recommend, others look like the second bullet says participate in a clinical LOINC committee, I'm not sure if that's a statement or I'm not sure if that's a request for us to join or somebody, I guess what I'd like to hear before I ask for an adjudication of this matter is which of these do you think are actually part of your recommendation or part of what you want us to maybe move forward with versus just kind of this is where you're going to go.
MS. HALLEY: Thank you, Harry, that's a good question. We tried to in the conditional recommendations list the very specific activities that would move the recommendation from conditional to full. In the future considerations, I appreciate you bringing that up because as a workgroup and I'd like to hear from the members but I'll summarize some of the discussions we had. Certainly recommending the ICF to move forward with the negotiations with WHO moving into the UMLS is an important piece and I believe that's maybe in the future considerations.
But the other piece of future considerations, as far as the endorsement goes, the recognition of this standard being endorsed by the Secretary and moving to AHIC I think is one of the pieces we would like to see endorsement or recommendation from you and that I do recognize is in the future considerations and not in the conditional, so we would very much like that. I think the three conditions we recognize and then the endorsement of this by the Secretary as a CHI endorsed standard and then having AHIC identify it as a potential prioritized area for the next use case, they would be the pieces that I think the workgroup has hoped that you would endorse.
MR. REYNOLDS: Jorge, you had a question?
DR. FERRER: Beth, I also want to comment, it was a tremendous amount of work that was done here. As you know AHIC and the workgroups and the Secretary, he's very time driven and likes very quick wins, he reminds the workgroup every time that he's got so much time to do. Let's say that you did become an AHIC use case, what would you deliver in a year or in a shorter period of time? Because it seems that you have a lot of tremendous amount of work that still needs to happen but you also have to frame that in the political timeframe. So what would you do?
MS. HALLEY: Well we actually did discuss this and we recognize particularly a lot of the assessment pieces, there are steps that need to be taken, including pilot testing, and whether or not that could happen in a HITSP environment or in a federal project environment is a question. However, one of the communications that came out from HITSP just this week was asking the members to identify areas of prioritization to take to AHIC and we recognize that as part, one of the things is a problem list as well as any expansions to the current breakthroughs like the EHR, so we would like to see disability and functioning content be included as a prioritized part of potentially a problem list or an expansion of the EHR breakthroughs.
So in a short term I think that is doable and in perhaps in a longer term timeframe, and I know HITSP because we participate in HITSP, may not be in the next year breakthrough but its certainly with these conditions being met certainly a lot of advantage of putting that piece, the assessment piece, the LOINC-ification piece out so that it is broader than just the federal government, that it is considered at the national level a real opportunity to interoperate from the three million SSA claimants to the hundreds of thousands of long term care reimbursements, etc., it's just a wide area. But in the short term and I'll open up to any other comments we would certainly like to see disability content be included in either the problem list area or an expansion of the EHR use case.
MR. REYNOLDS: Before anybody else comments what I'd like to do, we've run over quite a bit and I think it was good to do that because obviously this is the first time you've come in with the breadth, kind of some new stuff for us I think. But I guess to the committee, we've got, Stan has recused himself, we have a quorum with Jeff you and I and Simon, and whether or not we want to take a vote now or what we want to do and then if we were to recommend that we go forward with this then the possibility of Marjorie and Stan working with Beth to put together maybe a draft letter for us because I think this is going, the reason for my question was a lot of stuff here and exactly which piece you take forward and exactly what it says. I know personally I would want Stan and Marjorie to be involved in making sure what that was because obviously the subcommittee would see it again before we'd take it to the full committee but I think this is going to take a little bit of crafting, we just can't, in the past we'd take your presentation and kind of go on, this one is going to take a little crafting because there's a wide breadth of lots of things and now you're bringing in AHIC and we're bringing in some other things so this is a little different game then we've tended to. So Simon --
DR. COHN: I was actually going to agree with you, I mean we certainly support all this in principle and I think that's, I think your next steps are absolutely right --
MR. BLAIR: Did you need a motion? I'd like to move that we go forward with the preparation of a letter of concurrence.
DR. COHN: Second.
MR. REYNOLDS: Okay, all those in favor? That's unanimous, thank you, we appreciate it, we'll expect a draft from --
DR. HUFF: I abstain but I'm in favor.
MR. REYNOLDS: Yes, we had that point earlier. Okay with that we will adjourn until 1:00, thank you to all of you that presented, thanks for your good work and we'll move forward.
[Whereupon at 12:00 p.m. the meeting was recessed, to reconvene at 1:05 p.m., the same afternoon, October 11, 2006.]
MR. REYNOLDS: Okay, our next item is an item near and dear to our heart, the NPI implementation. So we have Jim Whicker and Gail Kocher, we appreciate you joining us and look forward to your testimony so please begin.
Agenda Item: NPI Implementation - Issues and Concerns Update - Dr. Whicker
DR. WHICKER: All right, thank you. Mr. Chairman and members of the subcommittee I'm Jim Whicker, chair-elect of the Workgroup for Electronic Data Interchange. Thank you for the opportunity to speak with you today on behalf WEDI regarding the National Provider Identifier. By way of information I also serve as EDI Liaison for AAHAM, an organization of provider patient financial services professionals and am currently employed as director of EDI with Intermountain Healthcare in Salt Lake City.
Following my comments, Gail Kocher, who is also here representing WEDI, will be providing information regarding the results of the WEDI readiness survey and the NPI forum WEDI conducted in August.
WEDI presented a comprehensive report on NIP at the July NCVHS subcommittee meeting. We will not attempt to cover all that information again today and have attached a copy for your review and reference. Today we would like to focus our comments on a few significant issues related to NPI.
On September 6th 2006 WEDI met with several individuals from CMS including representatives from OESS. The agenda for the meeting was focused on the NPI. Discussion was based on feedback received by WEDI during the NIP hearing. Topics included the overall industry readiness, the NPI dissemination notice, challenges with the current deadline and dual usage, and coordination of outreach activities. It was a productive meeting and all topics covered in that meeting are addressed in detail in the following discussion.
During the CMS meeting WEDI suggested that there be an industry summit for health plans to discuss the options surrounding adoption and use of the NPI and gauge from that sector of the industry as to what the state of the industry is. CMS supported the concept and we will be proceeding with scheduling this summit as soon as is feasible.
The following are issued WEDI would like to address as key topics to consider in order to have a successful implement of NPI.
First, there appears to be a lack of understanding of basic NPI tenets. There is a need to expand NPI outreach to both the payer and provider community. The frequency and the urgency of messages is critical. WEDI is committed to providing education to the industry. The support and presence of CMS payer and regulatory staff provides the draw needed to get those who need the information to the table. The messages that needs to be sent include, first, NPI 101, there's a need for basic information about NPI. For example, frequent questions heard are can one NPI cross two tax ID numbers, or can a physician have more than one number. We need to have the ability to push that information closer to the provider. A CMS conference call was held on September 26th. Thousands of attendees dialed in and many more were unable to participate as the number of phone lines available was exhausted. This shows the huge need for that information. This type of format, with that many participants, cannot deliver the messages that the individual provider office or hospital appears to need.
What goes out must come in. This message needs to be delivered to help payers and providers understand the relationship of the billing provider, and under the 4010 transaction the pay to provider as well, and its relationship to the payee on the 835. This ensures that the right provider NPI gets the right payment for the right amount. There are Medicare crossover and coordination of benefit implications when receivers are not capable of using the identifier, whether legacy or NPI, that is crossed. The implementation guides were written long before the NPI rule was written. The guide authors tried to anticipate the needs and additional education about the intent of the transactions is needed to head off problems down the road.
Many providers do not fully understand the usage or meaning of health care provider taxonomy codes. With the recent mandate by Medicare to use them on institutional claims there is a need for answers to questions about usage of taxonomy and its relationship to NPI. Providers need to know how payers, mainly Medicare, will use it to apply payment methodologies to help them determine their enumeration strategy and other payers need to understand it for crossover purposes.
It's critical that more information be presented and supported from CMS in its role as regulator. Information from CMS as a payer is received as such and many in the industry question how or if that information can or should be applied to other segments of the industry. One of the most common requests for information centers around unresolved issues and questions around subparts. Medicare has shared a significant amount of information about their data needs but providers still do not understand the subpart issues well. Information to help them make intelligent enumeration decisions is needed.
Number two, lack of NPI or NPPES dissemination. As a result of the NPI hearing WEDI recommended that CMS issue the NPI dissemination notice and have in operation a dissemination system by June 15, 2006. This date was agreed upon by the participants in the hearing as the latest date dissemination should be made available so as to not impact the successful implementation of NPI. As of today we do not have a dissemination notice.
Access to NPPES data is part of the overall NPI dissemination process needed to successfully achieve industry compliance. Generally speaking data can be obtained from two main sources, the providers themselves and in the future from the NPPES system.
The following are some of the most significant needs for accessing the NPPES data.
Payers and clearinghouses need the NPI now in order to perform NPI verification, confirming that an NPI they already received from a provider is indeed the right NPI that belongs to and identifies that provider. For population their large internal provider database. To build, establish and test their internal crosswalks. To begin using the NPI in outgoing claim payment transactions. And to begin using the NPPI in coordination of benefits with other payers.
Among other things a health care provider needs the NPI of other providers now in order to perform NPI validation of other providers such as rendering, referring, ordering, and so on. To populate their internal databases of external provider NPIs. To test the use of these external provider NPIs in electronic transactions with payers.
Billing services and others need the NPI of providers to support their clients' needs for appropriately billing payers with those NPIs.
All will need to obtain data from NPPES frequently to make sure new NPI data is obtained particularly in the coming months when the database will ramp-up significantly with new applications coming in at a rate of several thousand a week.
All parties need access to NPPES data to identify which of their trading partner providers have NPIs and which do not so they can effectively target their outreach efforts, sharing the NPIs for those who have them, applying for NPIs for those who do not.
It is critical that the NPI dissemination policy be released immediately. WEDI urges NCVHS to work with CMS to release the policy as quickly as possible. Many organizations are considering data use agreements. We are hopeful that meeting the needs of these requests does not detract from the issuance of the dissemination policy.
Number three, delays in provider enumeration, both individual providers as well as organization providers, are of great concern. Statistics from the NPPES enumeration process show great strides in enrollment of providers. However the real issue is not the number of providers enrolled but the number who have shared that NPI with their payers and the payers who have implemented those numbers into their systems. Gail Kocher will speak on this topic in more detail.
Anecdotal information indicates that a statistically insignificant number of transactions between trading partners have actually used NPI. Those transactions sent with NPI are mostly claims. Few if any payment status or eligibility transactions have been tested between payer and provider to validate the implementation of NPI correctly. The critical issue is not who has an NPI, it is how those that have them are using them.
Concerns have also been expressed about the downtime selected for maintenance of the NPPES system. Downtimes have usually been during standard business hours and often for a significant period of time such as entire business days. In addition industry reports indicate paper applications take four to six weeks and sometimes as long as nine weeks to process. As we move closer to the critical May date this will become a much larger issue that may impede provider enrollment.
NPI testing, successful testing of NPI transactions is at risk for many reasons. Providers have experienced a significant amount of delay, mostly due to their lack of understanding of the Type II concept and their being able to make strategic decisions in how they wanted to enumerate for Type II NPIs.
Providers are still reporting that in many cases vendor supplied billing systems still need to be modified to handle the NPI.
The industry is still waiting for a dissemination rule in order to finalize the processes they intend to put into place to collect, validate, create crosswalks, and so on.
Provider and payer IT resources are involved in other projects such as changing to the new 1500 claim form and the UB04 claim form.
Payers are requesting proprietary methods of communicating NPI data for crosswalk building rather than use the recommended methods suggested by WEDI white papers. These documents had the intent to standardize the sharing of NPI information from provider to payer until the NPPES system was operational. The lack of usage of these recommended information exchange processes and the lack of a functioning dissemination process is creating an administration burden on both payers and providers. WEDI recommends that CMS, as NPI regulator, assist in providing education and encouragement to utilize those tools and to expedite the release of the dissemination policy.
These delays, as well as the number of trading partners that are just not ready to test, brings the industry to a very short timeframe now to move transactions back and forth to ensure smooth migration from legacy only transactions to dual use NPI and legacy transactions and finally to full NPI usage.
CMS as a large payer organization has had access to the NPPES data via a data use agreement and seems to be ahead of the industry in its preparation. They are also able to gather NPIs through enrollment forms providers are required to complete. Another example is access that Medicare contractors have to electronic file interchange or EFI organizations and information about NPIs assigned through that process. These sources of information are not available to other covered entities. Access to this information has provided an advantage to CMS that others in the industry who desperately need the information do not have.
It is important to note however that we have heard the concerns expressed that Medicare does not have the kinds worked out of their NPI crosswalk. As such providers face rejections of claims, even though both the NPI and the legacy number on the claim would be correct.
Concerning covered entity readiness, data and anecdotal information that we have access to tell us that not all payers and providers will be ready on May 23, 2007. Payers and providers need to consider what plans they need put in place should a trading partner or vendor fail to be ready in time to test and validate prior to or after May 23, 2007. They need to consider what post implementation strategy is needed should they find out that claims and payments are not being processed as expected. Gail will review the results of the readiness survey and discuss some statistics that we believe represent actual usage of NPI in transactions.
The WEDI hearing and subsequent WEDI letter to Secretary Leavitt recommended the following.
Recommendation, that CMS allows the dual reporting of NPIs and legacy IDs after the deadline of May 23, 2007, for a minimum of six months. The need for more than six months should be determined through a status check of the industry readiness in November 2006. Failure to allow such an extension would exacerbate and prolong the period of non-compliance.
This recommended six months periods is a transitional period where NPI is required in all transactions but legacy IDs are allow concurrently as secondary IDs. This should not be perceived by the industry as a delay in the NPI implementation by May 23, 2007. Providers must still have completed their NPI enumeration by the deadline. Systems remediation must have also been completed. Health plans must still be capable of processing NPI transactions. Extending the dual use period is only intended to allow trading partners to address NPI crosswalk, mapping and reimbursement issues.
As of this date the WEDI position on this recommended six month dual usage transitional period extension has not changed. WEDI is in the process of conducting a status check of the industry for November to determine if there is a need to recommend an extension beyond six months. We believe that the signs in the industry are showing us that many entities have a significant amount of work to complete to ensure claims and payments continuing flowing electronically after May 23, 2007. Many state Medicare operations have already informed providers that they will not make the May 2007 deadline. Any provider that submits claims to those organizations will need to have the dual capability long after the May 2007 deadline in order to keep claims and payments flowing.
I would now like to turn the time over to Gail Kocher. This will conclude my prepared remarks.
Agenda Item: NPI Implementation - Issues and Concerns Update - Ms. Kocher
MS. KOCHER: Thank you, Jim. Mr. Chairman and Members of the subcommittee, I am Gail Kocher testifying on behalf of WEDI. I am a co-chair of WEDI's National Provider Identifier Outreach Initiative, NPIOI, and the NPI subject matter expert liaison from ASC X12 to WEDI. For information purposes I am also a technical business analyst in the HIPAA Knowledge Center for Highmark, Inc. I would like to thank you for the opportunity to present testimony regarding the National Provider Identifier, or NPI.
Industry readiness survey conducted May 2006. WEDI NPIOI conducted an industry readiness survey in May 2006. I will address the highlights of the results many of which identified the need for additional data collection this year.
This survey asked whether respondents had established an overall NPI project plan. Only a small percentage of providers had established or were in the process of establishing a plan, nine percent, 80 percent of payers had or were in the process and 58 percent of providers indicated they had no plan in place. WEDI NPIOI continues to pursue education and outreach, often in conjunction with CMS, in an effort to bring full awareness of NPI to the provider community as well as to other stakeholders.
Survey participants were also asked where they were in their project. At approximately one year prior to the mandate date a very small percentage of the industry had implemented. Many providers and payers were still in early phases of the project process or could not even provide a response to the question. The state Medicaids met in late September and information coming out of that meeting indicated that approximately one third of the Medicaids will absolutely not be ready on May 23, 2007 for NPI only. Another third are planning to be ready but reports are that many of those will not meet the deadline either. If the industry reaches a point where some have implemented to NPI only and others cannot do business without a legacy ID additional impacts will result especially in the coordination of benefits transaction environment. If secondary payers receive only NPI on crossover claim files and they cannot process NPI only the claims process will fail. Providers' account receivables will likely suffer. At that point providers are faced with either sending secondary claims on their own, often resulting in additional costs when using clearinghouses, or they will bill patients and expect the health care consumer to pursue reimbursement from the other payer.
The ability to conduct NPI only claims is a significant measure of industry readiness. Only one quarter of payers and providers will be ready for NPI only claims prior to the first quarter of 2007. Many of the payers that can receive NPI only claims late in 2006 are requesting that providers continue to send legacy IDs even when they are NPI only ready. Both of these occurrences limit the testing time available to all stakeholders. The available time to react to any issues identified when entities actually move to NPI only becomes very limited.
Survey participants were also questioned on the guidance CMS and WEDI have made available to date. We found that this guidance is not meeting the expectations of the industry. There are still many unanswered questions in the minds of the industry. Continued education and outreach needs to be provided jointly by CMS and WEDI. Key topics that are missing continue to be subparts and dissemination.
Let me now discuss some questions that are specific to the provider community. Providers were asked whether they will subpart their organization and whether they are sending NPIs on claims transactions as of May 2006. The results clearly show that the industry is still waiting for additional clarification and information. Many have not decided or do not understand enough to determine their enumeration schema, which undoubtedly impacts when they will begin using their NPIs in the transactions. The use of NPIs in transactions is also a factor of providers having information available from all their payers as to their payer's timelines so they can incorporate this information in their own planning and implementations.
Let me now discuss questions that are specific to payers and clearinghouses, who are the primary receivers of the HIPAA transactions in which the NPI will be mandated. Some in the industry are taking a crosswalk approach that can be attributed to many factors such as atypical providers will not be issued NPIs or a national ID so legacy enumerations will still need to be in place. The costs associated with converting legacy systems to NPI only were significant, estimates were heard of approximately $20 million for large health plans, due to the complexity and logic behind health plan legacy enumeration identifying things such as contracting and pricing arrangements.
Many are still working out data collection strategies, especially since the data dissemination notice is as yet unpublished. The low percentage for NPPES as a collection method we believe is due to lack of dissemination information which has forced many to forge ahead and prepare alternatives. Lack of data dissemination likely plays a role as well with respect to provider enrollment requirements. Payers and clearinghouses are still undetermined as to the best approach of obtaining provider NPIs.
Again, the uncertainty of whether entities will be able to access NPPES to collect NPIs and/or conduct primary source verification has delayed decision making on the approach to what validation or verification is needed in an operational environment.
At the time of the survey neither of the paper claims forms that undergo OMB approval had been approved and we believe that the industry was waiting for confirmation that the forms would be available with the time allowance that is required to implement the paper forms with NPI. While OMB approval is not required for any other payer than Medicare many payers in the industry follow Medicare's lead in terms of implementation so as to limit the differences in requirements placed on the provider community.
Vendors are integral to NPI implementation and there were some questions specific to vendors. There is still the possibility of over half of the direct billers having to pay to obtain the needed upgrades for NPI. Payment requirements may impact when clients obtain their upgrades due to availability of funds, especially if they did not plan for a cost to their upgrade. Such costs may cause delays that impact testing by creasing the available time. Providers that are required to use NPIs on paper claims by a payer may be impacted if their practice management system is not upgraded by the vendor, or they do not know until late in the timeframe before May 23, 2007, whether it will be upgraded or not.
There are several transaction issues that continue to cause concern to the industry, one of which is the 835 claim payment transaction. Providers need to understand what they can expect to receive in order to coordinate with their vendors and clearinghouses when applicable but 61 percent of payers did not respond to whether or not they will return NPIs or legacy IDs on the 835.
There has been much discussion recently on the 835 and how it is to be implemented. ASC X12 is currently processing some HIPAA interpretations through their portal that address this issue. As outlined during a session at the recent X12 trimester meeting the intent is to return the billing provider NPI in the payee segment where the tax identification number is returned today. The TIN then moves to the payee additional identification segment with in the payee loop and the legacy ID can still be sent in a second iteration of the REF segment through May 23, 2007. Claims may be bulked to a mutually agreed upon provider entity NPI but the NPIs submitted on the claims must still be returned in the 835 in the provider summary information segment.
Adding to the confusion is the Medicare implementation plan as identified in Change Request 5081 which states that as of October 2, 2006, Medicare will start sending NPIs on the 835. The NPI will not be sent at the payee level, however, it will be sent only at the claim or service level which is intended to identify the rendering provider.
Providers need to understand what to expect due to the many impacts they face. Medicare's approach leaves providers and vendors with no ability to test prior to May 23, 2007, for the claim payment transaction they will receive from Medicare. For applications that look to the provider ID in the payee segment for posting or reporting there is not ability to test that the returned 835 can be matched up to their claims data since the NPI is being returned in a different location than will occur after the mandated date. Providers depend on remittance data for claim resolution and/or payment. There are many concerns over how the data will be returned and bundled. These concerns stem from the availability of data elements used on an inbound 837 to crosswalk which are not available on the 835. Provider account receivables changing drastically due to unexpected claim payment data or last minute changes without testing capabilities is of significant concern to the industry. The high percentage of no responses to this question highlights that this is an issue that needs to be addressed from an educational perspective quickly so that payers will be able to implement with their trading partners as soon as possible rather than waiting until May 23, 2007.
Finally let me offer some general summary conclusions and observations. The survey included strong provider participation with 69 percent of the total respondents, there were 635. Payers were the next contingent at 21 percent with clearinghouses and vendors making up the remaining ten percent. The respondents did not answer many of the questions leading to the conclusion that a lot of organizations were not far enough along in their processes to even provide an answer. There were, however, enough responses within each question to conduct an analysis. Additional surveys are needed to gauge industry readiness going forward and WEDI NPIOI released a second survey the first week of October. The survey questions were streamlined for ease of response. Additional content questions and clarification of content in some existing questions were undertaken as well.
Now I'll talk about the WEDI NPIOI August 2006 forum. We held our 4th industry forum in August of this year. Given the attendance of 185 stakeholders it was evident that NPI is still a very significant issue for the industry. The open forum style sessions brought together providers, payers, clearinghouses/billing services, and practice management vendors to discuss a variety of NPI related topics, for example case studies of enumeration including electronic file interchange or EFI, NPI cross-walking, and the use of taxonomy codes for subparts. We observed that the industry's transition is occurring at a disparate rate. Earlier forums had audience bases that were on a more equal knowledge level. This forum found some in the audience brand new to NPI and others at end-stage implementation points. This points to the continued need for education at the 101 level while also working with those farther along to educate based on lessons learned.
WEDI NPIOI is continuing to work to educate the diverse audience by developing a NPI 101 audiocast in advance of the November fall conference, we're also working on developing a 101 toolkit. We are also conducting a series of early adopters audiocasts from various stakeholder perspectives to make available their lessons learned for others a step or two behind in their implementations.
There's also some mismatches between the NPPES enumeration statistics to actual provider reporting and transactional usage with payers. As of October 4, 2006, a total of 1,234,910 NPIs were issues. The statistics only break down Type I individual versus Type II organizational. Health plans often track providers by provider type and specialty so the high level breakout of data is difficult to compare to health plan data to get a true picture of where the industry is with respect to enumeration. Industry planning, transition and implementation would be better served with weekly reports of the number of NPIs issues. Reports that break out the numbers by NPI type, I and II, and provider type, for example MD, DO, DMD, and provider taxonomy would facilitate stakeholder analysis of their status of NPI information exchange and data collection versus NPIs issued.
CMS estimates were that approximately 2.5 million providers would need NPIs but there is concern that the estimate did not account for subpart enumeration or ancillary and allied health care provider types. For example the following are NPIs issues to Pennsylvania providers, Type I, there was a little over 50,000 and Type II were over 14,000, for a total of 64,737. In contrast as of October 2, 2006, based on providers on record the following numbers of NPIs were actually reported to Highmark. For Type I we only had 38 percent reported and Type II 12 percent for a total of 26 percent of our provider universe on record. For information Highmark is the largest health insurer in Pennsylvania based on membership and one of the largest health insurers in the United States.
The actual usage of NPIs in transaction is significantly less than the number issued. From August 29, 2006 through September 29, 2006, we received a little over five million claims electronically, 837 institutional and professional only, of which 114,000 claims had an NPI in at least one of the provider loops.
Only two percent, a little over two percent of the NPI claims had NPIs on them on average. Did have to make note that the graphs did have to be adjusted to double axes because otherwise the NPIs, claims with NPI numbers would have been a negligible line across the bottom of the graph.
Providers are still uncertain as to what they need to do with their NPIs once they have obtained them. Many believe that their health plans will have access to NPPES as was available for UPINs. Concern over requests to provide copies of NPPES notification as audit trail documentation that an NPI was issued by NPPES exist today. Mixed messages from payers about whether or not to report across the industry is also confusing to providers. Providers are hearing that carriers and FIs do not need them to report as they have access to NPPES. Providers extrapolate FI/Carrier NPPES access to their other payers as well. Other payers continue to request NPIs from providers in a variety of formats and documentation requirements.
Finally there is an 837 inbound claim transaction concern. As of October 2, 2006, claims are being rejected by Medicare when submitted with NPI only, or NPI and Medicare legacy ID where the NPI is not found on the Medicare provider identifier crosswalk. This applies to billing, pay-to, and rendering providers and secondary provider IDs when a Medicare legacy provider ID is sent. Some other payers have taken the same approach and other payers have taken the approach to attempt to translate the NPI to legacy ID but if it does not match the legacy ID submitted on the claim continue processing with the legacy ID. These dual strategy differences ultimately impact how and when providers implement based upon their own system capabilities.
This concludes my prepared remarks. I would like to thank the subcommittee for the opportunity to present this testimony. Jim and I would be pleased to respond to any questions or points of clarification that you might have.
MR. REYNOLDS: Thank you very much, very thoughtful industry wide approach so we're anxious to ask you some questions. Members of the committee? Nobody's hand is up yet, I'll start.
Tell me a little more about the dissemination rule, you mentioned it a number of times and what exactly is that, you say it needs to be out, what exactly is it and what is it going to do to change these numbers that you've already listed here?
DR. WHICKER: From my perspective speaking purely as a provider I see today, there's a requirement for example with Medicare B that any time I send in a professional claim to Medicare I have to identify the referring provider. I have to identify who it is that sent that patient to our office for services. Today we have access to the UPIN registry where we can log in, put in the physician name, city, state, some identifying information and get the UPIN number so at least I have an identifier to submit on the claim. If I don't have access to something like that to get the NPI number the only other option that I have is their federal tax ID number or their Social Security number, but if I can't get an NPI from a physician I'm not going to get their Social Security or their tax ID, if I get the NPI and have it. So that's the big concern from a provider perspective is being able to obtain those NPI numbers from a source that I can use to submit my claims, otherwise I can't send a claim in.
MR. REYNOLDS: So this is not just an implementation issue, it's an ongoing issue, to have that capability available.
DR. WHICKER: Correct.
MS. KOCHER: And I would add to that that as a payer I want to be able to verify with the primary source that issued an identifier that that is an indeed a number that was issued first of all, and it was issued to the person that's telling me that it belongs to them, just the same as I would verify DEA numbers, I would verify a state license, because anyone could create a number that meets the check digit verification so they could get in through my base validation but I want to be able to know that NPPES actually issued that number and to whom it was issued.
MS. TRUDEL: If I could add to that from the HHS perspective, the final NPI rule in the discussion about data dissemination which is what data are we going to share out of the NPPES database and how and under what circumstances the final rule so that that would be addressed in a data dissemination notice to be published later in the federal register. So what this data dissemination notice is is the first indicator that both providers, plans, clearinghouses, all covered entities will have as to how much data we propose to share, under what circumstances and by what mechanisms. And plans obviously are concerned about it from the perspective of building their crosswalks, providers are concerned about it as Jim mentioned from the perspective of being able to identify NPIs from other providers that they need to submit claims. So the question really is how much data are people going to get, have access to, and how will they have access to it over time. The data dissemination notice hasn't been published, it's still in the review process, and believe me we understand how critical it is to have it out there, we're moving as quickly as we can to get it published. And I think that pretty much covers it.
MR. REYNOLDS: My next question, on page six of your testimony you talk about the recommendation about the six month extension. I was a little surprised in the first paragraph of that where it says that the decision would be in November of 2006.
DR. WHICKER: When we held the WEDI hearing I believe it was in May of last year, it was April of this year, let me get my dates correct here, at that point we felt like the dissemination notice needed to be out for the purposes that we discussed so that health plans and clearinghouses and providers could build methodologies to access that data based on how it was going to be disseminated and so on and that at that point considering where the industry was at that point we recommended from the WEDI board that there be at that time a six month extension to the dual use, and the November date that I'm referring to here is a status check that we agreed to do to say let's look in November as we are further down the line and say where have we gotten to, have we moved further than we thought, are we closer to implementation, are things moving quicker than we had anticipated, or is it worse than we thought, are we a lot further away from being able to have a fully functioning full NPI system in the industry.
So Gail mentioned a survey that went out the first week of October, it's actually out in the industry right now receiving comment, is to find out, do that gauge right now to say do we need to recommend from at least a WEDI perspective that we extend beyond that six month recommendation period.
MR. REYNOLDS: So basically in November, right now if left as it is in November the decision would be made that it would take 13 more months past November to be done, six months past May but if you start in November when you're making the decision it's still going to take another 13 months for everybody to implement.
DR. WHICKER: What we're looking at doing is in November getting the results back and making a decision as a WEDI board whether we would want to recommend that we extend beyond six months for the dual use period --
MR. REYNOLDS: Yeah, but what I'm saying is that's even longer than 13 months, so deciding in November of '06, you're supposed to be done in May of '07, it's extended to January of '08 and it may go further, that's another 13 months. It's six months above the schedule or more, I'm just, again, everybody has been at this.
My next question is you have an underlined, you say the NPI is required in the next paragraph and then you underline some things. So providers must still have completed their NPI enumeration by the deadline, so what is the governance of that, what is your recommendation on that, what is, does somebody hurt at that point or what do we do?
DR. WHICKER: If I were to put in my words what I would interpret that recommendation is that what we're saying is that we don't want anyone to think they cannot get their NPI and have it ready and up and running by May 23rd of 2007, that in no way are we recommending that we delay getting your NPI and having it in production on May 23rd. What we're recommending is, for example I'm hearing reports that if depending on who the payer is that I'm working with and the status of their crosswalk capability if my NPI and my legacy number are not in their crosswalk database even though both may be valid the transaction could reject and my claim could come back. Or I could have the NPI in there but the payer may not have all of their back end systems for applying contractual arrangements, they may not be applying the appropriate contract payment of that claim and so on May 24th I start getting payments in under NPI that may not be correct. Or the claim will hit the payer system and because they don't recognize the NPI but they're going to have to pend the claim and start doing some manual processing and working of the claim.
So our recommendation is to say let's go six months beyond May 23rd and allow the provider to continue sending both legacy and NPI so that if a payer has an issue with processing the claim they've at least got that legacy number as a fallback to go back and look at their crosswalk and make sure that they're processing the claim appropriately so the provider is not hurt by having a claim reject or pend and not be able to be processed.
MR. REYNOLDS: Okay, but looking at your words in May, I agree with what you just said, but in May if the NPI is not, if somebody hasn't gotten an NPI what would you expect to happen?
DR. WHICKER: Right now what WEDI's position has been if they don't have their NPI May 23rd the claim should be rejected because it's a requirement by law that have an NPI on their claim on May 23rd.
MR. REYNOLDS: Rejected and turned to paper? Which is what would happen.
DR. WHICKER: That's potentially --
MR. REYNOLDS: I'm asking, is that WEDI's recommendation that it be rejected and turned to paper?
DR. WHICKER: I wouldn't say that that's the recommendation that we've made, the recommendation is that the provider has to have an NPI and an electronic transaction on May 23rd.
MR. REYNOLDS: And you would expect who to enforce that?
DR. WHICKER: I would believe that follows OESS to enforce.
MR. REYNOLDS: Again, I'm trying to completely understand your recommendation.
DR. WHICKER: What we're really trying to do, I mean to be honest with you we're trying not to have provides default to paper and trying to get the word out, get your NPI, get it in your transaction, and if you're concerned that your trading partner isn't ready to go they'll at least have the same number that they were able to process claims on the 22nd.
MR. REYNOLDS: Now you mentioned providers, what parameters do you put on payers and vendors, May is May and so all the providers in the world can be ready, if a vendor is not ready, if a payer is not ready, you got the same situation but you don't mention anything in here on any kind of a jurisdiction over any of them.
DR. WHICKER: I don't think that we necessarily addressed, those are separate entities. What we were saying is that for the industry there's a May 23rd deadline to have NPI and that payers, providers and clearinghouses have to be ready to have the NPI and it would be required to be in their transactions on May 23rd, 2007, and that all three entities, providers, clearinghouses and payers, based on the recommendation would be allowed to continue sending the dual use strategy types of transactions for six months beyond that May 23rd date so that I mean as we discussed in our last paragraph I mentioned there's already several state Medicaids who have told me as a provider sorry, we're not going to meet the May 23rd date so I've got to be able to send those and my clearinghouse is going to have to be able to process those without rejecting my claims or I will be forced to paper.
MS. KOCHER: Can I just add to that, to your question, the way the final rule is structured right now the providers have until May 22nd to get their NPI and everybody has until May 22nd to implement NPI only and so both of those things, if a provider waits until May 22nd they have no ability to do any dual testing. We can educate and educate and educate and encourage them but there are going to be those that don't do that until May 22nd and so if they would have the ability to do dual for a little longer timeframe we feel that will be a better implementation and transition for the industry. So there's no intent to hold anything else up, just allow dual capability.
MR. REYNOLDS: The reason we had asked this question earlier this morning a little bit on the SDOs as far as us speeding it up, you get to an end date and then we say everybody has to be at a certain point and what kind of jurisdictions over that and you look at 5010 we'll be talking the same thing and then ICD-10 we'll be talking the same thing, so trying to get a sense as you as obviously a significant entity in grouping people up for these kinds of things, that's why I was pushing on this a little harder to really get a sense of what does that mean May 23rd and if somebody says I'm not is that really a big deal.
DR. WHICKER: I'm not sure if this will answer your question per se but one of the things that as a provider that I'm concerned as I am testing with my NPI and working through this whole process is it takes me back to the 2001/2002 timeframe when we were in the middle of remediating our systems and developing the X12 transactions and starting to send 837s and receive 835s and the testing that had to happen at that period of time. And in some ways that was easier for me because I was validating a new format of claim that had the same data content from a billing data content point of view, maybe it was a little different format and a few qualifiers were different and so on.
But today with the NPI change it's actually going to potentially affect my reimbursement, that if there's an issue with the provider number that the payer is going to be looking at and reimbursing me as a provider and it's incorrect the consequences are substantially greater. Whereas under the original implementation of these transactions I wasn't changing provider numbers, Medicare knew me as who I was and Blue Cross knew me with the same numbers and now I'm doing a wholesale change of all those identifiers that for years and years and years every payer has been able to use to identify me.
One of the fundamental issues about the NPI if I understand it correctly it's a national provider identifier so that anyone who looks at data that's passing through the health care industry they will know who the provider was that performed that service and traditionally provider numbers have been payer specific, payer based identifiers that do identify the provider but also identify the provider in the contract. And so one of my facilities could have multiple different provider numbers with a payer depending on the type of service that provider was billing. And one thing that hasn't I think filtered down to a lot of people is to understand that this NPI is not a contract number, it doesn't identify the contract that the provider has with the payer, it identifies the provider, and that's where some of the rub that I'm seeing, some of the testing and the delay in how providers and payers are trying to work through these issues.
MR. REYNOLDS: Michael?
DR. FITZMAURICE: Thank you for the testimony, we haven't heard it laid out this precisely and with what the specific issues are so I really appreciate you coming on board and letting us know.
I think you just answered my first question which was in the past health plans have used the provider number to denote which payment schedule to use for the provider for payment, the hospital ED or physician's office, other clinic, here's the provider number that ties them on the contract and here's a payment schedule. So I would ask you has that problem been solved but I think you just told me it hasn't been solved and they don't seem to be aware that they're going to have to make that change, that is very scary.
And also you're talking about one third of the Medicaid programs aren't going to be ready, I think they use it as much as anybody to denote how much to pay, that's double scary, and it's not yet Halloween. What's the way out of it, more education? Scare everybody so that they realize this is a read deadline? And any leeway that might been provided hasn't been decided upon yet, there's going to be a horrendous cash shortage on the providers, they may get the float but the providers are going to be very unhappy.
DR. WHICKER: I would agree with that and I'm not sure exactly what's going to wake everyone up, I think it's going to be May 24th, 2007, when providers start to see claims that haven't taken the time to do their testing, to work with their payers and communicate.
Just speaking from personal experience within Intermountain Healthcare it took us quite a while to sit back and determine what our enumeration strategy was going to be and we took information that we received at some of the WEDI conference where Pat Payton for example did a presentation last May and she was very clear and I wished every payer and provider in the country could see it but it basically said payers need to look at more than just the NPI on the claim to determine their payment methodologies, there's other data out there that they're going to need to look at to figure out how to pay and process the claim.
And so as we've sat back and met with payers sometimes we have some ah ha's on our and the payers are having the same ah ha's where they're figuring out wait a minute, I'm not going to get the data that I thought I was going to get in the past and I'm going to have to remediate my system to be able to process and pay claims for this provider.
DR. FITZMAURICE: Let me ask another question that based upon the experience that we've had with the HIPAA claims transactions and the getting everybody on board, my question really was can you tell me now who is further along, providers or payers or clearinghouses or vendors? Everybody has to be there in order for the system to work but in the past the health plans were ready and the providers, providers were ready and the health plans seemed to be ready, we heard both sides of that. This may be a little bit early to give any judgments but can you give us a shadow of who needs to be prodded maybe a little bit more and are the vendors serving the providers and the payers well in this?
MS. KOCHER: I think from the data that we received back in the May readiness survey the payers were farthest, were overall farthest along in their plan and their project phases and actually vendors were sort of, vendors were farther along, providers were split, there were a significant number of providers that 35 percent just couldn't even answer the question. I talked to vendors, I deal directly with some of the vendors, I also deal with providers, and it really gets down to how in tune they are, how important they think it is to their system. There's so many smaller vendors out there that I think to some extent that is an impediment because they're all doing it on their own and it's the vendors that are participating and following the national education and trying to work collectively in some of the organizations like AFACT and others and HIMSS that I think they're the ones that are farther along, it's those mom and pop shops that ultimately are impacting the single or like office providers, rural community providers. And they're the ones that we're struggling to figure out how can we get to them because they are the ones that may not have internet connection or don't get the notice until a week after the presentation was given. And I think that's where the target audience needs to be is those individual vendors, providers, who aren't getting the message, or aren't acting.
DR. WHICKER: And I would probably echo that as well. I've done presentations and spoke about NPI to several provider groups over the last few months and every time I ask how many of you have actually sent a transaction with an NPI on it and I think I probably had in the hundreds of people that I've spoken with maybe three or four that have actually raised their hand and said yes, we've sent a claim transaction with an NPI. But if I ask them how many have their NPI almost every hand in the room goes up. So they've got their NPIs, they haven't sent them, and so I say why have you not submitted them, they generally blame it on their vendors.
Now in the defense of the vendors, I had a provider approach me at a meeting a couple of weeks ago who said our vendor is not able to handle the NPI yet and they haven't released it. And I said who's your vendor and without mentioning who they are it's someone that I'm quite familiar with because we happen to use them as well and I know they're ready because we're actually starting to create our transactions and be ready to test. So there's even been vendor and provider there's some miscommunications in some instances so I don't know how pervasive that is.
But I would agree with Gail payers tend to be more ready, I think the larger providers and larger health care organizations that have the resources to have someone who's keeping on top of NPI, who's attending the WEDI and the X12 meetings, they know what's going on, they know what questions, it's the one who are dialing in, and I don't in any way mean that the conference call that we had with CMS the other day was not of any value but just the sheer number of providers who are getting on and asking questions that, they're looking for somebody to validate the decisions that they're making and it's just hard to do that in a one and a half hour conference call when there's several thousand people wanting to ask their own question.
DR. FITZMAURICE: One last question, a short question, that is clearinghouses perform the function of translating stuff that comes in into the right standards and sending it out, sometimes billing services do that too. If the provider already has his or her provider number, national provider number, is this a function of the clearinghouse is to verify that number when a claim comes through and that's why the NPPES, one of the reason why the NPPES is so important is that you need to get access to a master inventory to let the electronics flow as fast as possible?
DR. WHICKER: You're correct and without having access to the NPPES all you can do is validate that the number matches the structure with the check digit at the end of the ID. When we started our testing we didn't have our NPIs and so we were creating dummy numbers and we found out that the software, the company that we used to validate our claims and transactions recognizes a good NPI, doesn't tell it's the right NPI for that person but it does validate it. I think in the ideal world you would want a clearinghouse that could not only check the validation of the number but also ensure that it's a number that has been assigned and that it belongs to Hospital XYZ or Dr. Jones.
DR. FITZMAURICE: Thank you for great testimony.
MR. REYNOLDS: Simon?
DR. COHN: I think this is sort of a brief question, I somehow feel I asked it the last time you were all here. The recommendation I see from you is certainly well thought out and I'm certainly very sympathetic to it but I'm having a little disconnect between this solution and the problem you're laying out. And maybe I'm misreading all of your graphs and material but I'm hearing yeah there's a problem with everybody mapping and letting everybody else know their number but there's seemingly a very big problem that not all the providers may have their numbers by May 23rd, at least that's, and maybe I'm missing something here but I didn't, you mention in every room you go in all the providers are raising their hands and they have their NPIs, that appears to be you're in different rooms than the survey was. And so I'm obviously sitting here going geez, we could recommend a proposal such as you have, it seems to solve part of the problem but as one who doesn't like to send out multiple letters suggesting different tactics on a three month level what about the other problem, about getting, what happens to the providers who aren't going to have it on the due date?
DR. WHICKER: I guess the way that I would answer that is as you're correct, it only talks to the one problem of the mapping, the crosswalk, creating the reimbursement issues and so on. What that does is it doesn't penalize the provider who has got his NPI, who has done his testing and is ready to send transactions. By not delaying the May 23rd date for the providers who haven't enrolled it basically puts the carrot out there, maybe the stick that's going to beat them, that if they don't enroll then they're the ones that are going to be panelized. And I'll guarantee you as a provider who has a different reimbursement window with Medicare if I don't have my, well, A, I can't submit a paper claim so I have no choice, I would just stop processing claims to Medicare and I would probably be unemployed with my employer if our system stopped sending Medicare claims on May 24th, 2007. And so I think there's a significant incentive on the provider side to get their NPI and have their system up and running to send it. My concern though still is that as I have that number now I've got to test with every payer that I'm under contract with, those are the ones that I'm most concerned about because those are the ones that generally have the more complex payment arrangements with me and that's what scares me and that's why I would like to be able to have that little extension.
DR. COHN: Sure, and I don't mean to give the answer, I'm just sort of trying to think of whether there's, thinking of this in a comprehensive fashion, and I don't know what to do about that other piece either but Gail, maybe you have a thought.
MS. KOCHER: Well I think that since the final rule didn't stagger the enumeration to the transition to the implementation by proposing that the enumeration stay solid but that dual transition and the final implementation date moves out that gives us a staggered approach that on the hindsight may have facilitated the industry, gotten providers to move faster. If we would consider moving everything we would be at the same point whether it's six months, whether it's May or it's December, because the providers that would say oh, now I have another six months, so I think the intent was to let's get one piece of the puzzle done and now we give ourselves time to work on the next piece and that transition because that's the piece that impacts the provider's payment.
MS. TRUDEL: I'd just like to provide just a little bit of background in terms of some of the things that CMS is looking at and I think they dovetail very nicely with some of what Jim talked about. Obviously one of the main things that we need to do and we realize this is to publish the data dissemination notice as soon as we can.
Another thing that we need to do is as we did for the initial implementation we do need to continue to do assessments and we're doing our own assessments based on the NPPES data that we have available to us, Medicare data, and also working with WEDI and other industry organizations to gather some of that information.
Outreach clearly is a crucial thing and Jim mentioned that we actually did have a HIPAA roundtable a few weeks ago devoted strictly to the NPI where we maxed out on 5,000 phone lines. So it's very clear that people are starving for this kind of information and we need to make sure that we continue to give it to them.
The other thing that we need to do and that we've talked to WEDI about in the context of this plan summit is to make sure that the plans are all sending messages to providers that are similar. And we have already started to say to providers don't just get your NPI, start to use it as soon as you can, so it's get it, share it, use it. And the more we can target those messages to make sure that providers understand how much lead time they really need in order to be safe I think that message is very critical too.
Not to say that these are going to solve all the problems and we're all going to be fine but these are some of the things that we're looking at to try to make sure for instance that the very basic idea of the providers at least having their NPIs in time is addressed.
MR. REYNOLDS: Any other questions? We had some discussions earlier, if we have a hearing in December we may want to definitely have you back because as you mentioned your timeframe here, that's why I was pushing on that to see because obviously the full committee meets in November and then we meet in February again so anything we would want to produce to support anything you're doing is key, our timing, as Marjorie mentioned in the earlier segment you can meet with the subcommittee all we want, we got to get it through the full committee before we have this group really pushing something.
So I think it's key that we stay closely aligned with you as to what's going on because this is a big issue and this happens to be part of my day job and we've put on 20 seminars in North Carolina for all the providers, we're at 19 percent enumeration, and we're ready to receive them. So this is a 50 state look at the reality of the world and our RHIO is pushing it too, so it's a different game out there on the street for everybody that's on the street and for the next session I think we'll want to hear a little more from CMS on the may 23rd because the reason I think that's key is, and I won't make Gail shake her head but I promise you Highmark is not going to drop claims to paper and not going to stop processing claims because Jim back to your point in the end if the claim gets held up it's the individual J.Q. Public who ends up with an accounts receivable sitting out there with somebody that did a service for them.
So I think in the end we can talk here as industry people, in the end there's a real person with a real bill for a real service and we got to be careful we don't play ping pong with it and leave them out of center --
DR. FITZMAURICE: Harry, could I ask a quick question? You're not testifying but you've mentioned that 19 percent of the providers in North Carolina had been enumerated, you mean that 19 percent had gotten their NPIs and the others didn't report that they had, or 19 percent had gotten their NPIs and given them to their health plan?
MR. REYNOLDS: I'll say it this way, a lot more than 19 percent have their number, with 20 seminars we've only gotten 19 percent to turn them over to us, and a lot of the people that do have numbers are not necessarily providers that submit claims, we're finding that out also. So be careful, the numbers are a little skewed, a lot of people who don't actually do claims but are, they have their numbers so good, you can get real excited about the numbers, let's talk about the people that are doing business. So that's the big issue that as it gets parsed that's a big issue, so the numbers to me are a little fluffy --
DR. FITZMAURICE: 19 percent of the people that you pay have given you their numbers.
MR. REYNOLDS: Have given us the number to work on the crosswalks, even though we're ready to do it, and those are real numbers and those are as of yesterday. We need to change the message that's for darn sure because we've been out there and talked to a whole lot of people and it isn't getting through.
Any other comments from anyone? Okay, thanks everybody, really appreciate it.
Okay, is there anyone on the phone? Are any of the other NCVHS members on the phone please? Okay, good.
All right, the next session is hearing about the pilots on e-prescribing which is a subject near and dear to our hearts, so John please proceed.
Agenda Item: AHRQ - Update on E-Prescribing Pilots - Dr. White
DR. WHITE: Thank you very much. All I'm going to say is I know how to clear out a room apparently since about half the folks here have left.
Hello, my name is Jon White as the nametag says, I work with the excellent Dr. Fitzmaurice at the Agency for Healthcare Research and Quality, and for about the last year and a half I've been kept pleasantly busy working on the e-prescribing pilot projects as mandated by the Medicare Modernization Act. I want to say that I'm really grateful to be able to come here today, all of this work rests on the work that NCVHS did prior to the initiation of these projects and I've taken the time to read everybody that you've written so I'm really grateful for the amount of work that you all went through to get here to this point and I'm hoping we can do you proud by the time we're done with this.
So I'll start with just a brief reminder, like you all need it, about the Medicare Modernization Act, and that specifically among the many things that MMA requested, directed, was that it directed the Secretary of HHS to conduct a pilot project to test the initial standards in order to provide for efficient implementation of the information requirements for an electronic prescription drug program set out in section 1860D-4(e)(2) as you all know, specifically information on the drug being prescribed, possible interactions and warning with respect to other drugs and patient medication history, as well as information on eligibility and benefits such as drugs included in a formulary or tiered formulary structure.
So that's the direction, you all may remember these, these are the foundation standards as adopted by CMS through regulation again after significant work on the part of NCVHS, NCPDP SCRIPT Version 5.0, NCPDP Telecom and ASC X12N 270/271.
Now I have a list of the initial standards here as we put them in the RFA, I will back up a little bit, there's a little history, we were contacted in May 2005 by CMS who was directed by the Secretary to undertake this work, CMS engaged with us at the agency knowing that we have a health IT program and we have wonderful people like Mike Fitzmaurice who work with us and so we do a lot of work in this area and we think about these subjects a bit. And after a phone call and a half the folks at CMS said so why don't we send you the money and let you do this work and our then director Scott Young said that sounds great, looked at me and said Jon, this will be you, so here I am. My background is a family physician and I do the work that I do because I'm really interested in the ability of information technology to improve care that we deliver and although at first blush doing standards work on electronic prescribing may not seem like that fits that need it really does and we'll talk about that as we get a little bit further into it.
After review of the Medicare Modernization Act HHS determined that these could not be contracts, these could not be contracted, these had to be cooperative agreements, couldn't be grants, couldn't be contracts, had to be cooperative agreements. AHRQ has in place a fairly robust peer review process not until that of NIH so for a lot of reasons it was felt that AHRQ was a good place for these projects to go through.
So we developed a request for applications, which was released I think in, I want to say October, it was October, and we had a fairly quick turnaround time, we gave folks about five weeks to put together applications to respond to this request for applications. So my hat is off to the e-prescribing industry, came together in a very nice way, we had a review panel, Jeff Blair was part of that review panel and we're really grateful for his participation, which I am really grateful to say really understood the issues and did a fantastic job of reviewing the applications that came in and were able to give us really sound advice about which projects to select.
So from a release date in August, October, I can't remember, it all blends together, in late 2005 we made awards before December 31st, 2005, which any of you who have been involved in the grant making process can probably appreciate that was a fairly rapid turnaround time but again because there were a lot of folks who understood this work well and were prepared for it to come we have really consequently had a number of excellent projects that have been running and I'm going to talk a little bit about those today and kind of tell you where we are and then lay out for you the path forward.
The reason why for all that exposition is to understand that since these are not contracts these are grants, they're cooperative agreements which means the government has some influence but the important thing to know is that the ultimate about what comes out of the project lies on the grantee as long as they adhere to the original application, as long as they address the issues in the RFA. The point of that is that what's in the RFA is really, really, really important so I'm going to go real explicitly through some of the stuff that was in the RFA because that's what you're going to get out of the pilot projects, there's a reason for me to kind of belabor this, which I will.
So in the RFA we specified initial standards. Many of those standards were existing, some of those were not at the time that we released the RFA, always a challenge to ask people to test things which don't exist yet, it's okay, DARPA does it, why can't we do it. But here's a list of them, specifically we asked folks to look at formulary and benefit information, NCPDP was developing a standard which was on its way out and has been out using the RxHub protocols and pilots should determine if it should be adopted as a standard.
Exchange of medication history, determine the readiness of NCPDP's standard medication history message.
NCPCP SCRIPT, fill status notification function, the pilots need to assess the business value and clinical utility of this.
NCPDP SCRIPT cancellation and change functions.
The structured and codified sig, we said, and again this is all language from the RFA, pilots should test structured and codified SIGs, patient instructions, developed through standards development organization efforts, nice nebulous language.
Clinical drug terminology, specifically pilots should determine whether RxNorm terminology translates to NDC for new prescriptions, renewals and changes.
And prior authorization messages, the pilot should determine functionality of new version of the ASC X12N 278 and evaluate the economic impact of automation and impact on quality of care, and to support standards development organizations development of work flow scenarios.
So those are the initial standard, not foundation standards, that we asked folks to take a look at.
We laid out research objectives in the RFA as most of our RFAs do. We said that folks should determine whether vocabularies and code sets are unequivocal and can communicate needed information.
To determine how initial standards to be tested interoperate with the foundation standards.
Consider how the information is transported.
Consider the suitability and the impact of particular e-prescribing standards with respect to the workflow of the participants, in other words, and this is Dr. Fitzmaurice verbatim, are the right data being sent the right way and are they usable and useful to recipients, please translate into English, thank you, Mike.
Also public/private partnerships that will result, we looked for public/private partnerships that will result in interoperable standards based data sharing across multiple care sites and lead to measurable, generalizable and sustainable improvements in patient and quality of care.
Again, standards are important but they're important for a reason and that's what we hope they lead to.
The core evaluation questions we asked all the grantees to answer:
Are the right data being sent?
Are the data usable and accurate?
Are the data well understood at all points of the transactions?
Are all of the above listed initial e-prescribing data communication standards included in the pilot working? For example, can they effectively and unequivocally communicate the necessary information from sender to receiver to support the electronic prescribing functions? Are the data for the patient an the prescription transmitted accurately among all participants in the transaction, such as the pharmacy, pharmacy benefits manager, router, plan and prescriber?
Do the initial standards work well together and with the foundation standards? If not, why, and what workarounds were used?
And unspoken there is the next part, how can the initial standards be improved to address workarounds?
How long does it take to conduct each transaction using the initial standards?
Can all appropriate drugs and other therapies be ordered via electronic prescribing?
So a good chunk of questions that we expect them to answer, that they're going to bring back to us.
Beyond just the standards we also asked the pilots to look at outcomes and specifically things that would be, in health care that would be impacted if we brought these standards into existence and kind of pushed electronic prescribing as we're supposed to in the Medicare Modernization Act.
Specifically we wanted them to report on use of on-formulary medications and generics.
Changes in the rate of potential inappropriate prescribing, for example the Beers criteria.
Change in the rate of hospital and emergency department use overall.
Report on medication errors.
Adverse drug events.
Rates of hospitalizations and emergency department visits associated with adverse drug events, for example bleeding while anti-coagulated, ACE inhibitor caused acute renal failure, anaphylaxis, rash, etc.
Workflow changes in prescriber offices, whether this means fewer interactions with pharmacies, freeing up support staff time for other functions, more time available for patient interaction.
Workflow changes relating to verbal orders.
Prescriber uptake and dropout rates.
Changes in prescription renewal rates.
Changes in new prescription rates.
Changes in fill status rates.
Patient satisfaction.
All things that people probably want to know about when they say so am I going to pick up a PDA, a Tablet, whatever, and electronically prescribe.
So we went through the process and I fondly call our collaborators in this project my piloteers, it gives it the feel of the Mickey Mouse Club, and there's a reason for the separation here. The top four are grantees, CMS ponied up $6 million dollars for this and $6 million dollars went to the four grantees that you see listed there, the grantee institutions are Achieve Healthcare, Brigham and Women's Hospital in collaboration with MA-SHARE, RAND in collaboration with Blue Cross Blue Shield of New Jersey, and SureScripts in collaboration with Brown University. Just below that is a contract that CMS elected to execute and put in with the pilot projects, they are held to the same constraints as the pilot projects but they are a contract. They also got started a couple months later because of the contracting process but basically CMS brought forward an extra million dollars and took a look across the work that the grantees proposed to do felt like each one of the different characteristics that these projects brought was important enough to look at that they managed to find an extra one million dollars.
The standards that these folks are looking at are listed here, NCPDP formulary benefit 1.0, SCRIPT 8.1, prescription history request and prescription history response, prescription fill, cancellation requests and cancellation response, prescription change request and response, and refill request and response, as well as NCPDP structured and codified SIG, RXNORM, which is clinical drug terminology, both the ASC 12N 278 health care services review standard which is the prior authorization request and response as well as the ASC 12N 275 claims attachment standard for prior authorization request and response and those are both initial standards.
Beyond those standards each one of the projects takes a unique look at an aspect or a characteristic of electronic prescribing. I'm going to flip back one slide for a second and talk about the piloteers. I put them in this order because it's alphabetical order, not because I have a favor for any one over the other. I love all my children differently.
Achieve Healthcare is a health care technology company based in Dallas but they are working in Minnesota and specifically they're working in four long term care institutions in Minnesota. Two of them are controls and two of them are receiving electronic prescribing. This is the only project which is looking at the long term care setting and one can probably appreciate that as this will impact CMS and the regulations they felt that long term care was an important setting to look at.
The Brigham and Women's Hospital and MA-SHARE is a unique environment, Brigham and Women's has a long history of excellent research in adverse drug events as you all probably appreciate. They bring that experience which is largely based in their hospital setting and they're extending it to their ambulatory setting so in addition to testing the standards they are really robustly looking at adverse drug events and how that can be impact by electronic prescribing. In addition they are connecting with MA-SHARE which is a fairly good sized project connecting many of the health care providers in Massachusetts and CSE(?) is a tight partner with Brigham and Women's and has been running a lot of the gear head work I'll affectionately say, I mean that in a good sense, at testing the standards and implementing the electronic prescribing utility in their care settings.
Also worth mentioning that the application through which this is being done in Brigham and Women's is called the electronic gateway is going to be made available at the finish of the project as in an open source application, it will be made available to folks who want to pick it up and use it which is attractive.
RAND and Blue Cross Blue Shield of New Jersey, Tony Sheath is here in the room with us today, and I'm grateful for his presence as with many of the other folks here because I'm hoping that when my memory fails they can contribute. RAND is doing really in the estimation of the reviewers did the best job of any of the applications purely at looking at the standards and the process through which they were going to evaluate the standards and how well they worked and specifically probably gave the most robust look of anyone at RxNorm. They are working fairly extensively in New Jersey with a number of provider sites and in addition I know Tony's special project is prior authorization which Tony led for NCPDP, the workgroup that created the prior authorization standard, so I'm really looking forward to good things from them on that.
SureScripts you're all familiar with, the scope of this project is quite significant, six states, all these other folks are located in a particular state. This project crosses six states, I think they were looking at about 270 providers was the last I had heard which again, you're not talking about thousands and thousands of prescribers but you are talking about a number of different regulatory settings which is really critical both for SureScripts as a business but also for us in our regulatory process and how we estimate success or failure of these projects.
I have been delighted with the work that Kate Lapan(?) who is from Brown University and the rest of the project has contributed to the academic rigor that they have brought to this, this has been a really, all of these represent a really heartwarming, if I can say that, collaboration between industry and academia and the public sector, SureScripts is a great example of that and I've been really pleased to have that.
NEO, Ohio KePRO is the QIO in Ohio and this was the contracting mechanism that CMS elected to go through. The strength that this project particularly brings is that they look at a number of small offices and the workflow that happens in these small offices, which is everybody is looking at workflow to one extent or another but again the reviewers felt like this particular project, that was a real strength of this.
So you can probably appreciate that in addition to the standards work there's some significant variation across the projects as far as the settings that they're looking at, the types of resources and experience that they bring to the table.
So having said that I will also reflect to you that as you look across these standards that the projects are looking at not all of them are looking at them in the same way, many of these settings, many of these standards are being tested live in doctor's offices with patients and with computer in hand. A number of these are not being tested in that way, either they're being tested in a laboratory setting, a non-live setting but still a fairly robust laboratory setting, or they are not being directly tested with prescriptions but instead folks are looking at them with regard to their business utility or their clinical value and evaluating them in that respect.
I will harken back again to the fact that these are grants and these are contracts, we cannot hammer these square pegs into round holes. These folks all made excellent proposals and applications but as a consequence they had to stick to what they proposed which is again why that information in the RFA was so important to have laid out as clearly as we could but also will reflect that what you get out on the back end is going to be what I consider, and the folks who are taking a look at this to consider, a robust look at these standards but do not expect the same data from each individual grantee, this is not going to be a meta analysis kind of in that respect. So I just wanted to kind of flog that dead horse for a little bit and just point that out to everybody.
In addition to a quarterly report, well hang on, let me back up for a little bit. So in January we awarded these and the grantees have been furiously working, I think that is probably fair to say, these folks have been working harder than just about any other grantee or contractor I've had the pleasure to work with, with the possible exception of our evaluation contractor who I will get to shortly. There was a lot of infrastructure to spin up here in a very short period of time, we've all had the pleasure of working with health care providers and know how grouchy they can be, so getting systems in provider offices, operational, in a fairly short period of time and then kind of robustly gathering data and pulling this out, they are coming near to completion with this phase of the project with kind of gathering their data. There are a few folks who will need a little bit of extra time towards the end which not for some of the core work, for some of the standards work, but I'll get to that in a minute.
But by and large all these folks are getting this work done in one years period of time, MMA is very clear that the stop date for this work is December 31, 2006, so within one years period of time there has been a lot of work that has gone into this and they have been working, I was tickled, we had a conference call, we have monthly conference calls and we had a conference call the other day and Drew Morgan from CMS was going through some information, I was going through some information, and it was just silence on the other end and I said are you guys still there, yes, yes, we're still here, why aren't you asking questions, they said we're all doing four different things at the same time, we're here for you but we are really going with our hair on fire so they really have been working fairly furiously.
In addition to submitting us quarterly reports telling us how they've been doing there is specified in both the RFA and in their notice of grant awards a final report and I want to go very clearly again through with you what has to be in all the final reports.
There has to be discussion, so there's a standards and an impact side to the final report, for the standards side discussion of implementation by standard.
Answer the question do all of the standards, initial standards included in the pilot work?
Do the standards work well together?
How can the initial standards be improved? Again reflecting of what you heard from the research objectives.
How do you the initial standards work with the foundation standards?
Are the right data being sent?
Are the data usable?
What is missing?
What should be changed to improve functionality?
Barriers to the adoption of initial standards.
Critical success factors for adoption of initial standards.
List of techniques for making the standards work.
And other suggestions for improvement of standards in the future pilots.
Now there's a couple things there that I want to call out. The top half is fairly self explanatory, what should be changed to improve functionality is going to be different from pilot to pilot depending on the environment in which they put this in as you can probably appreciate so that is going to have to be pulled together on our end.
Barriers to the adoption of initial standards, this is going to be probably some of the more interesting work for me because you do have so many folks from the electronic prescribing industry involved with these projects. Their assessment of barriers and success factors and next steps to take are really going to be interesting to me because they both have to be practical about what we put in and how we put it in or what the recommendations are about that as well as guardedly optimistic cheerleaders about moving this forward. So I'm very curious to see what will come out of this as probably we all are.
MR. REYNOLDS: Jon, before you change slides, in the second sentence what word is missing?
DR. WHITE: Do all of the initial standards included in the pilot work?
MR. REYNOLDS: Do they work, thank you, it's fine.
DR. WHITE: Again reflecting the homespun wisdom of Mike Fitzmaurice because I think those are your words as well. That's the standards side.
The impact side read something like this.
Effect on functionality, integration with practice management and electronic health record and decision support systems. Again, variable from pilot to pilot, some of them will be a lot more robust than others.
Standards effect on quality and patient safety, maybe a little hard to tease out but I'm from AHRQ, I had to put it in there.
Does the use of initial standards increase efficiency of prescribing? Very interesting question, may not have been the right question upon further reflection but it's the question and we can talk about that later.
How the use of an electronic prescribing system improved care from prescriber perspective.
Effect on adverse drug events, changes to medication error rates.
Participants by type by month for the duration of the pilot, and these were who's using the system, did they drop in, did they drop out, why did they drop out.
Reasons for changes, plus/minus participation and retention rates.
Patient experience with health care, as an example, not to push our AHRQ horn but the CAHPS instrument.
Impact on beneficiaries.
And the ubiquitous other information as specified by the project officer, whatever else I ask for.
And that's what we're expecting to come out from the final report. Again, a number of these projects are looking at things other than this or things in much more depth and detail than we're requesting here so you will see additional information coming out but these were the things that we really asked them to focus on and report out to us in addition to the other work that they're doing.
All right, so I've given you an initial appreciation for the timeline up until now, let me give you an appreciation for the timeline from here on out. You thought we had our hair on fire, I have very little hair left but what hair I have left will be on fire and perhaps incendiary. The evaluation contractor work was awarded to AHRQ's National Resource Center for Health IT which is primarily led, the primary contractor is the National Research Center at the University of Chicago. These folks are the primaries but they have brought in a number of folks from the world of electronic prescribing and the pharmacy world to assist us with looking at these projects.
The next quarterly report was due yesterday, I have a template that I haven't sent to them yet so they have a week to get that done and that's mea culpa.
The pilot work ends on December 31st, 2006, the report to Congress is due April 1st, 2007, four months later, no, three months later, I want to say four months later, three months later. Secretary to adopt standards by April 2008 and standard in effect by 2009, this is the MMA timeline. So let me back up and talk to you about some of this.
These folks have in the past several months put in infrastructure, set up research teams, have been generating data, have been gathering data and are reporting to us on this. The evaluation group is getting up to speed, have been and are pretty much well up to speed on where all the projects are. Their final report is due to us two months before the report is due to Congress as such we have pleased with projects and they have graciously assented to really work collaboratively with us over the next several months to get as much of this done ahead of time, meaning now, as is possible.
You can imagine that the report to Congress is going to encompass a number of elements, CMS needs information for an impact analysis for a draft regulation that will come out of these projects, we will be quite busy. The evaluation contractor and actually a lot of folks from CMS too will be actually visiting a number of the pilot sites over the next couple months to kind of, nothing like going there and touching it, as well as having frequent phone calls, we've already had a number of phone calls with them, we are having weekly meetings to kind of keep everybody up to speed on where we're going with these projects. And we are really hoping to get something done and into clearance relatively quickly after these projects end.
And you all can appreciate that that's a really tight timeline, I'm not without a little bit of anxiety about it as Karen knows, I've sent her late night emails, but we will get there and we will get there because they really are excellent projects and excellent people working on this.
So that's a summary of where we are and I am really looking forward to talking with you, answering questions and getting feedback and things like that, thank you for having me come talk to you.
MR. REYNOLDS: Okay, Jon, well done, and after your compliments to Mike and Jeff you've tainted your conversation quite a bit --
DR. WHITE: The first part of any good political speech is bond with the audience --
MR. REYNOLDS: Well done and this is a subject we really care about so that's great. Mike, you have a comment?
DR. FITZMAURICE: I hate to be asking questions of myself --
-- [Laughter.] --
DR. FITZMAURICE: One question and that is what methods will these grantees and contractor be using to determine how well the standards work? I can think of before and after, I can see looking over time and are things going up or are they going down, I can see comparing those that have them with those that don't, and you said that each one is kind of different, can you give us a flavor for what methods they're going to be using to determine how well the standards work.
DR. WHITE: Sure, the first thing to appreciate is that it's going to vary a little bit by standard, there are some standards that when we asked for applications were out there and were, although there wasn't extensive industry experience with them was enough experience that it was out there and they could actually make concrete plans at the time of the application around what they were going to do with that standard. A number of those have been in production, being used for transactions in provider offices, and for those standards you will see back, and these are things like NCPDP SCRIPT 8.1, a number of the elements contained under that, you will see data on the standard was used for this many transactions.
On a very basic level they'll initially look at did the right data go to the right place for the right purpose and that information will be reflected back. On a next higher level and on a less specific level the projects will look at because this information was available this effect was present on safety or perhaps because this standard did not work as anticipated this information was not available at the point of care and we saw this range of adverse drug events during this time that could potentially have been impacted by having that information available in the same place and the same time. That's for the production level.
The next level of testing that you're going to see kind of generically across the pilots is lab testing, which is where they've set up a virtual environment, there is not live doctors with live patients but they have an application, Brigham and Women's for an example has what they call a harness which is a test EMR that has patient data, fake patient data in it. They've taken a set of actual prescriptions which contain elements which they have recognized as important to verifying that certain things work and they're looking at certain standards within that lab environment. So they will be able to reflect back to you when standard X was put through its paces in the lab environment, all the data went to the right place as anticipated or it did not go to the right place and here's where it actually went.
The third level is evaluation of the elements of a standard and looking at things like the business utility, the safety utility, the clinical utility. One important one to call out I think is probably the structured and codified SIG standard which became available in I think April of 2006, all of the pilots are looking at that in a lab setting, they are not looking in a live setting, because from the end of April to December 31st is just not enough time to actually get that out there.
So I will also say that there is a little bit of variation between pilot projects as far as the way that they're looking at some of these standards. Some folks may be looking at prior authorization for example in a non-live setting whereas others are looking at it in a live setting, and the challenge is going to be to bring that data together in a useful and meaningful way.
Does that answer your own question?
DR. FITZMAURICE: Except for telling us what the final report is going to say which you can't, that was good, thank you, Jon.
MR. REYNOLDS: Jeff?
MR. BLAIR: Of course our real interest is in the final report, I will refrain from asking you for a preview, I'll just have to wait. But since we can't ask about the meat at the end what about feedback to NCVHS, what could we have done better that could have helped the process?
DR. WHITE: That's a very thoughtful question. I'll answer and then I may actually ask other folks around the table to feedback, other folks who have been also involved in the projects who may be able to answer that better.
I think NCVHS did an excellent job of sifting through the landscape of what was out there and what, both what was out there and what you thought needed to be looked at in order to have electronic prescribing be useful and workable. As we can all appreciate it seems like a very simple thing to whip out a prescription pad and write Lisinopril 10, POBID, PTAW, no refills, that simple act belies a very complex set of circumstances leading up to and stemming out from the act of prescribing.
The only way to have been more helpful which I'm not really sure how you would have done this would have been to have given us a little more structure at the outset as far as specific things that were in existence that needed to be tested. And here's why I say that, because at the time that we wrote, and again, all this is on a fairly compressed timeframe, you know what you could have done, you could have talked to Congress and given us a better timeframe for MMA, that's what you could have done. But you will wind up seeing variability about what comes out of the pilots because we weren't able to be specific enough when we asked for folks to send us applications and I think that's just a function of temporality, I don't think there's anything that necessarily could have been done other than to see these standards exist now, test these, these standards either are on their way very shortly or not so shortly but at least take a look at those, and then here are things that don't exist, nobody has got plans to but really do need to be in place in order to have a quality prescribing process.
So that's my two cents worth, do other folks around the table want to say anything about that? Let me dangle, okay.
MR. REYNOLDS: Jon, you made a comment earlier about the clinical and business value, tell me a little more about that.
DR. WHITE: Sure. Although we may not appreciate it as providers medicine is a business, health care is a business. What we also don't appreciate about the health care, well, that's not true, we are increasingly appreciating this, is that we do have such a fractured health care system to the point where we really do have to look at clinical and business value separately.
I wind up spending a lot of time thinking about health IT and the whole reason I do my job is not because I was really looking for a job in the federal government, two and a half years ago I was delivering babies, but the reason I'm here is because I really believe that in order to deliver quality health care as a clinician I need better information about my patients and my patients need better information about my patients and the care that I deliver, which is why I do what I do.
That conversation is divorced largely right now from how much it costs to install an electronic medical record or an electronic prescribing system, or how much does it cost to order a lab test or to write a drug, I can't tell you how many times patients called me back and say remember that drug you wrote me for, I couldn't get it because it's not on the formulary, or did you know that it cost me $160 dollars to get this, and I go no, that was just the best drug for you as far as I knew.
Those conversations need to come together, I am not going to talk on the bully pulpit, what I will say to you is that because these projects do really reflect a great collaboration of industry and academia and the public sector is that you will get a robust discussion, if somewhat separate, about clinical and business utility of a lot of these things, it probably won't be quite to the extent that any of us want it to be but both of those things are really important to look at because even though it may be really great for me as a clinician to have the medication history every time I write a prescription for a patient if it takes me twice as long to write a prescription and you add that up over a 100 prescriptions over a day that's not insignificant to my business although I may know it's the right thing to do for my patient. Both critical, not clear how they come together yet but both being looked at by the pilots.
Is that what you were asking? That may not be --
MR. REYNOLDS: That's good, yeah. One other comment I'd like to make is, maybe offline, talk to you and Michael, out of these same standards, we just rolled this out in North Carolina, I made a presentation at one of Marjorie's seminars, we started in March, have 544 doctors using it already, will have 1,000 by the end of the year, our tracking these clinical and business results like 33 percent of the time we give them a drug/drug interaction message they change the drug, what percent are generic substitutes, average time to deploy, so these are real prescriptions, 109,000 prescriptions so far. So if there's any way you would want to look at any of that data and add it to your report or what you're considering, and better yet talk to the actual doctors and/or vendors and/or others that are rolling it out, to add to your statistics be more than happy to offer that, not because of the company because of the fact that it's real people doing the exact same standards rolled out everybody that was in this room that agreed to do it.
DR. WHITE: I will say back to that both Karen and myself would, and the evaluation team, many of whom are here today, would actually really value any data you or anybody else can provide to us. Part of the report is going to be a background review of not just the current environment but what's out there.
I would reflect back to you also the recent Institute of Medicine report Preventing Medication Errors, yesterday I was at a CERTs steering committee meeting at AHRQ, CERTs are the Centers for Excellence in Research and Therapeutics. And we had one of the folks who was on the IOM's panel get up and it struck me there are two recommendations, two sets of recommendations, and the first one says everybody should be electronically prescribing by 2010 and everybody should have plans in place to electronic prescribe by 2008, which is a noble sentiment. And then about two or three recommendations later it says we don't know a whole lot about using health information technology to prevent medication errors, we do some but we need to do more work on things like work flow and other things.
And I called that out to him, I said on the one hand you're aggressively pushing electronic prescribing as a tool, and on the other hand you're saying we really don't know whether this works or not. And he said well, the handwriting thing is important, even if we just get to keeping people from having bad handwriting that's important.
We talked about a little bit more and there's more to it than that but it's a fact that there's not as much data out there as we need to really be convincing so the more data we can garner the better. And again, we'll do what we can in the period of time that we've got.
MR. REYNOLDS: Any other questions from anybody on the committee? As we were talking at lunch about formulating a December subcommittee meeting, and we'll have that discussion again this afternoon or tomorrow morning, we may --
DR. WHITE: I may be back, the pleasure of my company --
MR. BLAIR: I guess I refrained from a whole bunch of questions because I have the idea that it would be difficult for you to comment on the things that have worked well, the things that there may be difficulty, areas where you're getting, you expect to get a good deal of data and areas where it may be thin or areas where mapping of terminology is going well or it's not, so is that true that you'd really like to refrain from commenting on those at this point?
DR. WHITE: Yes is the short answer. The longer answer is all of those things are there and all of those things have been in our heads as we've gone along but the final chapter is not yet writ is what I would say and until it is writ I'd just be shooting myself in the foot, which I'm very good at doing but will decline the opportunity for right now. But I'm happy to come back and tell you more specifics when they're available.
MR. BLAIR: Is there some arrangement that we could make so that shortly after you provide the report to Congress April 1st that we might be able to get a copy shortly after that?
DR. WHITE: I would actually hope and expect that that report will be disseminated widely and in particular I am happy probably through Karen to expedite that, yes, the short answer is yes, happy to.
DR. FITZMAURICE: What I want to say is in kind of summary of what Jon has done and what Karen has done and the partnership of CMS and AHRQ, it's virtually an impossible task to evaluate what a standard or maybe even a set of standards can do for a given process because when you put it in the system changes and you've got something different. And if you haven't looked at it for a while before and looked at it for a while after you can't do it. If you haven't measured these things and tell me anybody who knows all the errors in a particular facility over even a short period of time, nobody does. And yet this is the state of the art that couldn't be done without full industry cooperation, without the standards development organization cooperation, everybody wants to have the health care more efficient, not just for their own businesses and their own incomes and their own profits, but for their own selves, their parents and their kids.
And you're seeing the partnership result in what the state of the art is in evaluating something that has probably never been evaluated before and its been guided and led by the National Committee on Vital and Health Statistics, by experts who advised us before we wrote the RFA, by people who evaluated what came in, it's a widespread partnership that doesn't stop in this room. And I think the NCVHS recognizes that in a lot of different things that we do, it's never more focused than right here because we're looking at something that is very, very difficult to do and it will be done and we'll have the best report that we can in April.
MR. REYNOLDS: Anything else? Jon, thank you, we look forward to seeing you again and again and again. Okay, we're running a little bit ahead of schedule, we'll take our break now and if you come back at 3:25, we'll give everybody 20 minutes this time so see you at 3:25.
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MR. REYNOLDS: Okay, the next portion of our agenda is Karen Trudel going to cover our electronic prescribing of controlled substances, another subject that we remain very interested in. Karen?
Agenda Item: Electronic Prescribing of Controlled Substances - Ms. Trudel
MS. TRUDEL: Well to an extent I think this presentation is going to share some characteristics of the last one in that the things you probably most want to know are probably things that I can't tell you. So I'm going to make up for that by providing some background in case people have forgotten when we had the last installment of this story.
The Controlled Substances Act which is administered by DEA does currently require pen and ink signatures and paper prescriptions for controlled substances. By law pharmacists are required to be responsible for assessing the legitimacy of prescriptions including both the signature and possible alterations prior to their dispensing medications for controlled substances. And the DEA has additional concerns in terms of how pharmacists can continue to do this in an e-prescribing environment, how the DEA can audit compliance and investigate and prosecute diversion which is criminal violation in an e-prescribing environment.
The DEA over a year ago put into place an ordering system, electronic ordering system for controlled substances, this is on the supply side, not on the dispensing side, and they rolled that out with a PKI solution. At the time that the original e-prescribing hearings were going on the DEA had been considering a similar PKI solution for the dispensing side.
The concerns that were raised in the NCVHS hearings and that HHS also adheres to are that having two different solutions for controlled and non-controlled substances would cause potential slow down in e-prescribing adoption since there would be two different solutions and that current e-prescribing even though it is not widespread the applications do not currently use PKI.
At the time that the hearings took place there was only one e-prescribing pilot that was testing PKI for controlled substances, that was at a VA hospital which as we know is a closed environment, and while it was working well there were some concerns about how that could be scaled.
A meeting was held in July, a public meeting, to allow both DEA and HHS to understand each other's requirements and issues and to understand the current e-prescribing environment and hear industry input on a potential future direction for e-prescribing of controlled substances.
Generally the industry testifiers took two quite different positions. One suggested that we should move immediately to the ultimate solution, we should look for a very robust technology with PKI, potentially smart cards, and essentially build this infrastructure up from the ground. Another group suggested that we use existing framework, the existing e-prescribing framework that's in place and fill whatever gaps are needed to provide the kinds of assurances that DEA requires for controlled substances.
Some of the discussions were that e-prescribing could provide better monitoring of scheduled drugs. There were concerns that we not have a solution that was so robust that the cost involved would hamper adoption. And as I said there was some consensus that at least in the beginning a solution should be based on existing standards and fill in gaps.
There was a thought that we should incorporate existing technologies, change should be incremental, that there were already HIPAA standards on the books for covered entities with respect to authentication. And with respect to PKI there were concerns about a lack of extensive health care experience, the costs involved in supporting PKI, and the potential for scalability to a level that would be required for e-prescribing industry wide.
Some of the discussions resulted in identification of alternative safeguards that could be used by DEA in place of actually having the paper and pen prescription for controlled substances that's available now. The fact that there are electronic audit trails built into many of these software products that are in use. That there is already authentication in use throughout the e-prescribing chain starting from the provider going through the clearinghouse or aggregator to the pharmacy. That there was data integrity throughout that chain. That there were already HIPAA security rules in places that addresses many of the authentication requirements. And people also mentioned the fact that the fill status notification which is one of the transactions in the NCPDP SCRIPT suite that is being tested in the pilots because it provides the real time input back to the prescribing physician that a prescription has been filled that this provides an additional business closing of the loop with respect to controlled substances because this gives the physician a notice that something has been filled and if he didn't prescribe it that obviously provides a little bit of a safeguard where the prescriber, the alleged prescriber can begin to look into what actually happened there.
After the conference DEA and HHS have assessed the testimony, both agencies have been reviewing it in great detail. We have had coordination meetings subsequent and DEA because they are the lead agency is in the process of assessing a number of legal and technical issues. Currently as I said the regulations and requirements on the books have a requirement for paper and pen and ink signature for controlled substances, to make a change regulations would be required. DEA as the lead agency would be, is in charge of determining what changes they may want to make and we are going to be discussing issues in that respect with them collegially.
We will be having ongoing discussions and I can't say again because we're in a pre-decisional period what decision will occur, don't know what a specific timetable is, do know that both agencies are committed to completing an analysis and trying to arrive at a solution and that both agencies found the public meeting to be extraordinarily useful and provided a really wide range of information that was very helpful in our helping to both understand our somewhat different sets of requirements and perspectives and to get a sense of what is out there in the industry today that we could bring to bear to solve some of these problems.
Any questions?
MR. REYNOLDS: Questions from the group?
MR. BLAIR: All my questions you're not allowed to answer.
MS. TRUDEL: I'm glad I made that point clear at the beginning.
MR. REYNOLDS: Michael?
DR. FITZMAURICE: Hypothetically speaking if DEA found merit and HHS found merit in an electronic prescribing method that could also include controlled substances would the action taken be to write regulations to permit this on DEA's end and is there any action that HHS would take of a corresponding regulatory nature? It would seem to me that DEA would have to write regulations --
MS. TRUDEL: I'm speculating here but yeah, the point I was trying to make was that DEA is the agency that's responsible for administering the Controlled Substances Act and the DEA regulations that are on the books today don't facilitate electronic prescribing so in order to move in that direction regulations would be required, they would definitely be required from DEA based on the Controlled Substances Act. Whether HHS would need to publish regulations to make sure that we are consistent with that I think would probably be something that we'd have to look at in terms of is anything we're doing now contrary to what a new regulation would require.
DR. FITZMAURICE: I'm not sure that prescribing is a HIPAA transaction, paying the claim for a drug is a HIPAA transaction, so we may not need to have a HIPAA transaction on there.
A second question, hypothetically would DEA be interested in giving temporary relief to a region or an area of the country that wanted to participate in a pilot whereby they put cost controls and you look at controlled substances prescribed electronically and see if there is more or less egregious behavior under electronic prescribing than they might find in some other place. Is that the kind of a pilot kind of a research project that DEA would find merit in?
MS. TRUDEL: I really can't answer that question, I don't know the answer. To go back to your original question since I actually can answer that one, I'll cling to it, the prescription itself is not a HIPAA transaction and my off the top of my head analysis would be that if the solution were consistent with HIPAA and the solution could wrap itself around the existing e-prescribing transactions, it would seem that everything would be pretty seamless without HHS doing any more regulation.
MR. BLAIR: Karen, is there any desire on the part of the two entities, HHS and DEA, to attempt to come to some kind of a understanding on how controlled substances could be included within e-prescribing for the report to Congress which is due by April the 1st?
MS. TRUDEL: I don't think the timing is good for that.
MR. REYNOLDS: I have a comment and a question. I don't think that the payment under e-prescribing is a HIPAA transaction either because most of them go from the pharmacy benefit manager to the pharmacy --
MS. TRUDEL: It's a retail pharmacy drug claim, that is a HIPAA transaction, the prescription is not --
MR. REYNOLDS: Is it paid by an 835?
MS. TRUDEL: No, it's by NCPDP --
MR. REYNOLDS: That's fine, okay. The pharmacies take care of that, we take care of other people. So if HHS and DEA agreed on whatever they agree on and decided to move forward with something, are there any state laws relating to these controlled substances that would then have to also be dealt with in any way so to make it a multi-step process or is it the DEA owns the deal and once they make the decision then the decision is done?
MS. TRUDEL: There are state laws particularly with as I understand it, and we're reaching the ends of my knowledge here, particularly with the controlled substances in Schedules III through V. But again the state regulatory agencies do tend to take a lot of their direction from the Controlled Substances Act and the DEA regulations. So I think there would be some state law that would have to be harmonized.
DR. FITZMAURICE: If I could follow up on that, if I could remember what I was going to follow up on, oh, I wonder if the Controlled Substance Act has anything in there that would allow DEA regulations to supercede state law, that might be one way to assist the states in making a quick change.
MS. TRUDEL: I know there are already state regulations in place so the best I can do is to say that the next time we have a discussion with DEA we'll be sure to bring that up and have that be a topic for discussion.
MR. REYNOLDS: Any other questions on this or issues with this? Well, Karen, thanks for keeping the ball going and it's obviously a subject that makes related to this more robust if we can make it happen. Okay, with that that ends the prepared comments, what I can take since we're running a little bit ahead of time is whether anybody in the audience has any public comments or anything they want to make based on anything they've heard today, and if not then we'll move into our committee discussion. I see some people moving but nobody heading towards the mics, heading out.
Agenda Item: Subcommittee Discussion
MR. REYNOLDS: A couple things have come up today I guess that we need to talk about, the first, I heard it mentioned today and Marjorie you're still here, I heard it mentioned today that the HIPAA report is coming out in November, I know that the department is working on it but will we, will this subcommittee, the full committee or somebody see it?
MS. GREENBERG: Definitely. I'm not sure what the status of the first draft is, I think Simon may be able to report on that but it would, after it's drafted it would got to the subcommittee for review and then only after the subcommittee, and probably to the Privacy and Confidentiality Subcommittee, it would go to at least those two and then after the subcommittee commented then it would go to the Executive Subcommittee and eventually to the full committee, but I think you're concerned about the timeframe --
MR. REYNOLDS: Well again, the next subject will be our next hearings and discussions and so I'm just trying to decide if --
DR. COHN: Let's talk about this one for a second because first of all, Harry, like Karen just to keep things going here, I can't tell you anything, I can't answer of your questions --
-- [Multiple speakers.] --
DR. COHN: What we are doing is creating a first draft of a report, this will include obviously a review of what's happened this year and probably for a couple months before on HIPAA. I think I've also asked the work to take particular pains to include for example references to the work that the subcommittee did earlier about the HIPAA lessons learned and things like that so hopefully that will be a slightly more thoughtful framing of the discussion a little bit.
I think that certainly we need to get a draft that will certainly include this, that relates at least to the transactions for the subcommittee to review and certainly anything related to privacy and security also needs to be handled by them, and clearly, I mean you're right, it would be nice if we had it today to discuss, as it is I'm sure we're going to have to have a conference call to sort of review it and provide additional input.
MR. REYNOLDS: When do we want to send it, when is the desire to send it to Congress?
DR. COHN: I think our plan was to have it, I mean and once again we'll obviously make sure, we'll see how this plays out but I think we waned to take it to the full committee which is at the end of November, so we have a little while, I mean this isn't like you have to have it written up tomorrow but also observe that this is the last full meeting of the Standards and Security Subcommittee before that next committee meeting.
MR. REYNOLDS: That's why I was bring it up, I was bringing it up as process more than anything else --
DR. COHN: Exactly, so clearly that will have to be a conference call at the very least to discuss that but I think you already identified that there were things that we needed to have a conference call on.
MS. GREENBERG: Well the committee is meeting at the very end of November, the 28th and the 29th, but it should go to the full committee, the version that you're taking approval should go to the full committee certainly a week before, before Thanksgiving obviously, early that week of Thanksgiving at the latest I would think, which means it has to go to the Executive Subcommittee before that so we're already getting into, sort of backing up here to about a month from now that it needs to go to the Executive Subcommittee.
MR. REYNOLDS: That's fine, I'm just making sure as we set our plans.
As we look at, we have a tentative subcommittee meeting in December, we heard from WEDI today that they talked about that in November they will make their next look at whether or not they will want to continue to look at this extension, I think also CMS continues to look at this and obviously any recommendation coming from WEDI that's gone to the Secretary or gone anywhere else and been discussed with us obviously we would want to know what CMS is doing so that as we would write anything coming out of that December hearing to the Secretary we would at least have good input. Because then if we did it in December it would have to be February before it went to the full committee which would be where we would take a stance, I'm trying to remember, I don't think we've set any committee meetings for next year --
DR. COHN: No, I was going to bring that issue up.
MR. REYNOLDS: So that's another thought as to whether, there's a February meeting of the full committee which is the next time, if anything we did letter wise other than maybe CHI is going to be, that's when it's going to be heard because we're not going to do anything else, I don't see anything else we can pull off between now and November that makes any sense especially if we're going to be focused on the HIPAA report so I think that kind of, I'm just trying to look at our collateral that we're trying to put together to move forward.
And then obviously as I think we heard today e-prescribing we had talked about, Karen has got, excuse me, CMS is going to put out, start working on the final NPRM or whatever is going to come out of it in January so whether or not a hearing from us in December to look at that to hear any issues related to that is again timing again because that would mean that if we had a hearing and put some input then I think you have to have it, well, you're talking about trying to have it out in April, Karen, what were you saying on the NPRM possible?
MS. TRUDEL: Yeah.
MR. REYNOLDS: So again, looking at our timeframe anything we would want to say we got to say early enough so that it gets into their process and it can be considered. But then tying it these pilots we heard today as to whether anything that would come out of there would be helpful and we can't hear anything out of there until after the end of the year so I'm trying to balance all this and at least have a discussion, we've got something to say on all these but the timing of how we do it and the timing of where it is and the timing of what it means is really probably one of the more critical. Simon?
DR. COHN: I actually also look at Karen but I think we're probably talking about a subcommittee meeting either in December which is what's currently scheduled or very early in January and I think that it really is a question of figuring out how we can best help HHS and CMS with the work that they're doing which I think becomes the deciding factor on that.
MR. REYNOLDS: On both NPI and e-prescribing, the two things that are kind of sitting out there right now.
DR. COHN: Exactly. And I suspect that NPI may be a little more flexible in terms of timeframe, actually both of them are pretty, I take back what I said, both of them are tight on timeframes.
MR. REYNOLDS: Yeah, because I think if anything is going, I mean obviously any kind of a, if we were to adopt WEDI's recommendation and pass that one that's a big deal to a lot of people.
DR. COHN: I guess I would sort of comment that I know we've heard now from WEDI twice and I think the world of WEDI, I've previously been on their board, but I do think if we're going to get to the point of actually writing a letter on NPI it would also be good to hear from those also in the community and potentially hold a slightly wider set of hearings to get wider input to see if there really is an issue there or not. But once again I know they're doing work, they're asking people also but I think we need to also make a bit of an assessment on that.
MR. REYNOLDS: Okay, other comments around the table on agenda items? On the timing of these? That's what we have this time for to try to get ourselves together on what we want to do next. Marjorie?
MS. GREENBERG: So at this point it's not clear whether you need to have that or will have that meeting in December? Might want to have it in January?
MR. REYNOLDS: In other words I want to continue the conversation on the timing of when these key things would align and whether or not anybody has got something else that needs to be considered and then I think that tells us which one it will be. Do you have any input as to which one would be better or worse from your standpoint at least as a piece of input, not necessarily --
MS. GREENBERG: I think you're right, either one would allow if you wanted to have some letter of recommendation that would allow you to get it done for the February meeting but you'd have to do it, have the meeting, if it were January it would probably be relatively early in January because the February meeting is mid-February. So I think if you're thinking, right now people have that date in December locked in to the extent that they do and so certainly if you're thinking about changing it to January we would need right after this meeting to poll the members very quickly because January is not that far away.
MR. REYNOLDS: I totally agree. Karen, why don't you give us a little input on especially e-prescribing, what the schedule you see based on, we heard from Michael's group a little bit ago, we heard some others, kind of what the flow is for you so that will help us and what would it be that you would think would be most helpful from us, and that would also then start formulating what our hearing might look like.
MS. TRUDEL: Obviously the longer we wait into December or early January the more information we'll have from the evaluation contractor but that said as John indicated we have no choice but to multitask on the evaluation so the question in my mind is how much information could we draw off the evaluation at a point in time to come in and present it in the December meeting. That is unfortunately a question that I have not thought to ask Jon while he was still in the room so I can take that back as a quick turnaround action item to find out at the point in time when the December meeting will occur how much meaningful data would we have from the evaluator and would it make sense to wait a few more weeks into early January and try to have that discussion then.
MR. REYNOLDS: Do you have any comment on that Michael?
DR. FITZMAURICE: How soon would we need to know something in order to make some recommendations, I'm not sure what recommendations we would make for the electronic prescribing that wouldn't be in the report but yet I'd want us all to be fully aware of what's happening, it would be nice if we could provide input on a draft and maybe I will talk with Karen and Jon to see if that's possible, I know that we've done that before on some things like the National Quality Report, National Disparities Report, might be useful to have some comment like that. But as far as electronic prescribing I don't see what additional recommendations we would make other than in the report but maybe we need to wait until December or January to decide that ourselves.
MR. REYNOLDS: Karen, what would you want from us that would be helpful? Back to Simon's earlier point, what would be helpful from us as far as e-prescribing right prior to you doing an NPRM?
MS. TRUDEL: I think the notion was to, because a lot of these recommendations came from the NCVHS in the first place in that some of these were things that NCVHS recommended be pilot tested, that this was our opportunity to close the loop and that because we're drafting documents in a very quick turnaround mode we are developing, will be developing document shelves and starting to populate recommendations before a lot of this work is finished. So we thought it would be helpful to provide an opportunity for input from NCVHS fairly early in the process whereas if we wait until February for a report to Congress that's due on April 1st and that report has to go through an internal clearance process we then run into some problems of how could we actually implement your comments.
DR. FITZMAURICE: I see that as being an impossible job, NCVHS to say we said test these standards and we see from your tests that we don't have the results yet but we think they're going to be good and so we, we can't make a recommendation like that, it's kind of an impossible job for us to make a recommendation based upon what we recommended before to say yes, the test was successful without having the report, or without having at least the data that goes into the report.
MS. GREENBERG: Well yes but I guess if the report, the report from the evaluator is due the end of December, right?
DR. FITZMAURICE: January 15th.
MS. GREENBERG: What was due the end of December?
MS. TRUDEL: The pilots end --
MS. GREENBERG: The pilots end the end of December so it's January 15th. So if the subcommittee met in December, and this is something that Karen says she obviously has to talk with Jon about, and they were able to provide the outline for the report, some content, etc., etc., that would give the subcommittee an opportunity not to make recommendations about the standards or e-prescribing but maybe just say well if you could include A, B, or C, or X and Y also in the report it might make it more useful or that type of thing. Obviously in January then the report is essentially written or submitted.
If that were to be helpful to have the committee or subcommittee kind of provide some input into what the final, what would be good content for the final report beyond what's being planned then that would have to be in December, there would be no value to that in January, December might even be too late, I don't know, it may be that, I mean you now have the slides from the presentation that Jon made and you might want to look those over and have a conference call and say is there anything here that concerns us, is there anything that we would like to kind of flag that the evaluators should be looking at based on the concerns that we've had and the recommendations we've made, the sooner you could do that the better probably. It just depends on where you think you might have input. I would think as for actually making recommendations about, related to these standards, etc., you really couldn't do that until after the April 1st report was completed probably but I don't know.
MR. REYNOLDS: Michael, were you going to make a comment?
DR. FITZMAURICE: It's not on this exactly but what we're looking at is do we have a December meeting or a January meeting and what can we do about each one of the issues, we've got electronic prescribing, we've got the HIPAA standards streamlining, do we want to make recommendations on that. We have the national provider issues and I heard that, I think it was Simon say that he thought we would like broader input into those issues and are they still real after several months and I'm sure they will be real but to what extent are people getting interested in it, Blue Cross, American Medical Association, might be called upon to testify. Time is short for making recommendations if we're going to get them out in June or even before June in case of the National Provider Identifier. I guess I always like to have it sooner rather than later, give us more time, put the time pressure on maybe the testifiers and give us an extra couple of weeks to write up recommendations. That would argue for December although I've got so much leave I'm going to be taking some of it in December but these things are important so maybe I'll not take that much leave.
MR. REYNOLDS: Jeff, you had a comment?
MR. BLAIR: The MMA directed NCVHS to evaluate, select, and recommend e-prescribing standards and we executed that responsibility. It then indicated that there would be pilot tests and it then indicated there would be a report to Congress. And when I looked at that it didn't say that the pilot tests would then come back to NCVHS and that NCVHS would report to Congress and I think that unless CMS and AHRQ ask us to be part of the process between December and April that we could be more disruptive than helpful. And the other piece is the limitation of our timeframe here because for us to be helpful if they were to ask us we would probably have to have all of those members that conducted the pilot tests, that actually were the five entities, testify to us for us to get enough information to be helpful to contribute to that report in a meaningful way. So it just doesn't seem like we could make it fit in a way where we really could be constructive and that's not that I'm not interested in e-prescribing, I'm very much interested in e-prescribing, it's just doesn't seem like we could contribute without being disruptive in that timeframe.
I do think in terms of the NPI that we might be constructive but I think we would have to have hearings probably in December from other groups, other than WEDI, I kind of am echoing Simon's comments that I have tremendous respect for WEDI and I think it probably gives us a pretty good picture of the industry but we need more diverse input to be able to come up with meaningful conclusions. And in reality if we did that it would be the full committee meeting in February before we could wind up passing NPI recommendations and I almost wonder whether that's too late, I'm not sure.
And then on the other piece which is the streamlining, I'm sort of back to, I'm certainly supportive of the streamlining, I think all of us are, but I almost feel as if that's either going directly to Congress as an idea or it would go into an area where maybe we would have to hear from a panel of Congressional and HHS attorneys to wind up saying what is the best process to recommend to Congress. That's something we might consider doing although I don't know if that goes beyond the jurisdiction of NCVHS for us to get into that kind of policy assessment area.
MR. REYNOLDS: Okay, one other thing, let me throw it on the table while we're trying to figure out where we're going next. Simon, is there any reason that the December hearing dates, since you have incorporated almost all the Standards and Security group into NHIN, that there are any agenda items on NHIN that could go along with that at the same time?
DR. COHN: You're asking a very good question, I think my intent had been actually to, I mean if indeed the work of the NHIN Ad Hoc Workgroup is complete with the delivery of the report then we dissolve the workgroup and at this point the question will be is whether there's follow-on work that needs to occur so I think it'd be a little waffling on that one but that would certainly be a key piece.
I hear everybody sort of struggling about exactly how to, I mean sort of what to do when in the next several months and I don't think that, I mean it may not be something we can resolve in open session --
MR. REYNOLDS: And we have some time again tomorrow morning.
DR. COHN: Exactly, so we can sort of reflect on it a little bit. Certainly if there are urgencies to letters, as we've discovered later on this month there's ways to deal with urgencies to letters if indeed there is an urgency to a letter we better brief everybody real well in November at the full committee meeting about the reason for the urgency.
Now having said that of course that a lot of times the act of holding a hearing on an issue like NPI and getting to the point where you're actually making committee recommendations, subcommittee recommendations, does a lot to help inform and move the federal government and its associated agencies in an appropriate direction because it isn't just our recommendations, it's the actual process of all that we hear and the conclusions we all reach together. So there are many ways we could deal with that if mid-February is too late for a letter on NPI or not, there are things that we can do to handle that so I don't think that that's an impossible situation.
But I do think we need to think about it, I mean I think the other issue which we're obviously, we've all been wrapped up in the NHIN work but I do think that there's something called with committee meeting and coming up with its agenda for 2007 and it probably needs to be more than just finishing up a lot of other pieces that have been sort of dragging on, I'm really looking for more of a proactive agenda dealing with sort of the next issues.
MR. REYNOLDS: I plan to pull that, we had that chart that we were using for a long time and then we got pulled into hand to hand combat, a whole lot of things that were --
DR. COHN: But what I'm saying is between now and then or at that meeting would be an occasion for that sort of discussion also.
MR. REYNOLDS: Let me just summarize then. We know that this committee has to work on the HIPAA report, doesn't have to be a hearing but we've got to work on the HIPAA report. We commissioned the CHI letter out of today's discussions so we have two pieces of collateral that obviously will need to be dealt with over the next full committee meeting, we got that.
The NPI obviously is an outstanding national issue that I would think we will probably weigh into one way or the other because any time you start talking about a transition period or delaying something that was agreed on, and we've heard enough testimony we probably should have something to say on it, one way or the other, otherwise back to the idea of people are talking to us about being part of the process that would streamline something and then we take something that's this big affecting the whole industry and don't engage, and engage all the way to the Secretary, then I think we're probably almost disenfranchising ourselves from a key process.
Others may disagree but that's the way I see, I mean you got some big games going on, those are not the ones to turn our heads on and be afraid to engage in. But on the other hand I don't want, the December meeting was initially put on there as a tentative session, we had done the business that we had actually executed for '06 so I'm not interested in just spending money to come up here and say we did what we did, so that's why I'm trying to adjudicate this a little more aggressively than I would on our normal process.
So if everybody agrees with what I'm said and I'm going to let you make your comments on, we have tomorrow to talk about it and we have other times to talk about it but I'd just like to make sure that we make sure we keep our portfolio clear. And then we need to set up '07 and I think we'll bring the chart back whenever we meet next and really get into what we're doing and work that with others because I think that's going to be key.
DR. COHN: I'm actually going to make a comment just to follow-up with Jeff's statements about e-prescribing and once again this sort of goes along with my general view of us being proactive and involved. Obviously I think it would be very useful to hear more from CMS about the results of their evaluation but we may just want to take some time and hear from the actual people that have been involved in the projects to just get a sense of was it successful, did the standards work, I mean standards are a key piece here but it's also, I mean the standards are really supporting an important business process and clinical process that is providing increased quality, safety, value to society, and really I think what we're interested in at the end of the day is making sure that that expands more widely --
MR. REYNOLDS: Adoption being a key point.
DR. COHN: Adopting being a key piece and so talking with them to sort of see how this went, the goods and the bads and whatever, supplement whatever evaluation information we'll get from CMS I think would help obviously, it would help certainly round out whatever advice we might want to give to HHS on next steps.
MR. REYNOLDS: Because I think when you use adoption it probably goes beyond your studies but that was one of the charges that we continue to keep an eye on was how does it really work in the individual office, not just is the standard okay and does that look like it's going to be okay. Marjorie?
MS. GREENBERG: I agree with Simon, I was thinking of the, it's somewhat different but the analogy of actually bringing in the contractors on the NHIN and hearing from them and that I think was certainly valuable to the committee, I think there would be real benefit. So if you say that then I mean probably the middle of December is not a great time for them since they're finishing up, their reports are due the end of December, but I did just want to, but I think I would still just say we'll keep that December date until you hear otherwise because I do recall when we have tried to hold meetings early in January it really is difficult because a lot of people are on leave, certainly you have the whole use or lose with the government as Mike alluded to but a lot of people are on leave at not only the last two weeks in December but even the first week in January, it's a hard time to contact people, it's a hard time to reach people, you don't have your full complement of staff to do the work. So if it's got to be done we'll figure out a way to do it but it is not an ideal time to meet.
MR. REYNOLDS: And if we had an NPI hearing, I just mention North Carolina, we're using three national vendors to roll this out to 1,000 doctors in ten months, so having them come in and testify as well as these other people that are doing this other study talks about those, they're on the ground, they're doing it, forget what state it is, forget what the situation, they put it in a 1,000 doctor's hands in ten months. So when you talk about adoption that's a pretty significant focus, it doesn't matter where they did it, and obviously that's the kind of input that gets back to the adoption because it's small docs, it's larger docs, it's all kind of docs as we try to make it happen.
We got some time tomorrow to just touch base for a few more minutes but I wanted to make sure we at least got all these things on the table today so we could kind of paint a picture of who we are, what we are and what we're going to try to do between now and the end of the year and then how does that match up to the full committee and how does that match up with what we're trying to help with and so on.
Are there any other items anybody wanted to discuss this afternoon? Okay, with that the meeting is adjourned.
[Whereupon at 4:16 p.m. the meeting was adjourned.]