[This transcript is unedited]
Hubert H. Humphrey Building
Room 705A
200 Independence Avenue, S.W.
Washington, D.C. 20201
Agenda Item: Call to Order, Welcome and Introductions, Review of Agenda - Dr. Cohn
DR. COHN: Well good morning everyone, I want to call this meeting to order, this is the first day of two days of meeting of the National Committee on Vital and Health Statistics, the national committee is the public advisory committee to the U.S. Department of Health and Human Services on national health information policy. I'm Simon Cohn, I'm an associate executive director for health information policy for Kaiser Permanente and chair of the committee. I want to welcome fellow committee members, HHS staff, and others here in person and of course also welcome those listening in on the internet. And as always I want to remind everyone to speak clearly and into the microphone because we know the acoustics in this room.
Let's now have introductions around the table and then around the room. For those on the national committee I would ask if you have any conflicts of interest related to any issues coming before us today would you so publicly indicate during your introduction. I want to begin by observing that I have no conflicts of interest for any of the items today. Jim?
MR. SCANLON: Thank you, Simon, good morning everyone, I'm Jim Scanlon, I'm with the HHS Office of Planning and Evaluation and I'm the executive staff director for the full committee.
MR. ROTHSTEIN: Mark Rothstein from the University of Louisville School of Medicine, member of the committee, and I have no conflicts.
MR. BLAIR: Jeff Blair, Medical Records Institute, and I'm not aware of any conflicts.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the full committee.
DR. HUFF: Stan Huff with Intermountain Health Care and University of Utah in Salt Lake City, member of the committee and not aware of any conflicts for today's discussion.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to the full committee.
MR. HUNGATE: Bob Hungate, Physician Patient Partnerships for Health, member of the committee.
DR. CARR: Justine Carr, Beth Israel Deaconess Medical Center, member of the committee, no conflicts.
MS. MCCALL: Carol McCall, Humana, member of the full committee, no conflicts.
MS. MCANDREW: Sue McAndrew, Office for Civil Rights, liaison to the Privacy and Confidentiality Subcommittee.
MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services, liaison to the full committee.
MR. LOCALIO: Russell Localio, University of Pennsylvania School of Medicine, I'm a member of the committee, I have no conflicts.
DR. VIGILANTE: Kevin Vigilante, Booz-Allen & Hamilton, no conflicts.
DR. TANG: Paul Tang, Palo Alto Medical Foundation, member of the committee, no conflicts.
MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield North Carolina, member of the committee, no conflicts.
MR. HOUSTON: John Houston, University of Pittsburgh Medical Center, member of the committee and no conflicts.
DR. WARREN: Judith Warren, University of Kansas School of Nursing, member of the committee, no conflicts.
MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC, and executive secretary to the committee.
MS. SQUIRE: Marietta Squire, NCHS, staff to the committee.
MS. SIDNEY(?): Cynthia Sidney, NCHS, staff to the committee.
DR. BICKFORD: Carol Bickford, American Nurses Association.
MS. KANAAN: Susan Kanaan, writer for the committee.
MR. ALFANO(?): Bill Alfano, Blue Cross and Blue Shield Association.
MS. BOYD: Lynn Boyd, College of America Pathologists.
MR. BRUCKLE(?): Mark Bruckle, Academy of Managed Care Pharmacy.
MS. GOVAN-JENKINS: Wanda Govan-Jenkins, NCHS, CDC.
MS. JACKSON: Debbie Jackson, National Center for Health Statistics, CDC, staff to the committee.
MS. PICKETT: Donna Pickett, NCHS, CDC, and staff to the Standards and Security Subcommittee.
MS. FRIEDMAN: Maria Friedman, CMS, lead staff to the Subcommittee on Standards and Security.
MR. DICKMAN(?): Barry Dickman, Department of Veteran Affairs, HIPAA Program Management Office.
DR. KILE: Frank Kile, American Dental Association.
MS. WILLIAMSON: Michelle Williamson, CDC, NCHS.
DR. COHN: Well welcome everyone and I guess we're getting close to happy holidays because we're moving to mid-November though I'm obviously delighted at least for this moment the weather in Washington seems to be very pleasant and almost balmy, though I hear by the time we leave this afternoon we may notice a slightly different weather pattern coming through. Now I guess I have to remind everyone please put your cell phones on mute or stun or however that works best for you.
Now before we do agenda review I do want to make a couple of comments and sort of help set the stage for the discussions for today and tomorrow. I think for all of us this continues to be an interesting and exciting time and certainly the pace of events in our area, national health information policy, continues to accelerate. Indeed I am describing this sort of publicly is what I describe as living in an accelerated environment and all the things that we've talked about over the last couple of years are suddenly really beginning to come to pass. In a little over the two months since our last meeting of the full committee I think much has happened and I'll just sort of run through them and probably talk about them for a second knowing some of them we will be talking about more during the deliberations of the day.
First of course is Secretary Leavitt's 500 day plan which includes as all of you know as a centerpiece the next phase of the HHS/HIT strategy. This is continuing to unfold, obviously what we're talking about here is an acceleration of activities and efforts to move health care into the information age and transform the health care system. This is the vision we foresaw when we wrote our document information for health in 2001 which we laid out a strategic vision and having reviewed that recently it's very interesting that while things aren't happening exactly as we suggested most of the elements are actually coming into play so I think we can congratulate ourselves on some of our vision as well as obviously congratulate the department on moving forward in this very important area.
The executive subcommittee, Jim and Marjorie, has been working with me on how we can best support and assist the secretary and the department going forward in this accelerated environment. And as I've commented before obviously because of our content expertise and experience we do have a lot to contribute going forward. In addition of course we have a reputation for a strategic focus and also being practical, which is something I think that is well appreciated by the department. We have had ongoing discussions with HHS leadership on how we can best make a contributions and these conversations continue. I did however one to share with you a statement made by Secretary Leavitt at the first meeting of America's Health Information Community on October 7th, I know Jim shared this with some of the subcommittees but let me just quote a couple of sentences from his introductory comments, and I quote from Secretary Leavitt, we will use the depth, expertise, reach, and experience of other people and organizations that are critical to our success. The National Committee on Vital and Health Statistics has significant expertise and more then 50 years experience as a public advisory body. I am pleased to say the NCVHS chair has expressed to me NCVHS's support and engagement, we will invite NCVHS to be actively engaged in our work. So we obviously we appreciate the comments from Secretary Leavitt and obviously we step forward to be actively engaged in helping anyway we can.
I believe it is safe to say that we will be playing an important role in helping to assure the success of the Secretary's new HIT strategy and initiatives. And certainly this will be a topic as we hear from Dr. Brailer later on today about ONCHIT and all the new initiatives and contracts that they've awarded over the last couple of months. So that's item one out of a number of items. Item two is e-prescribing and the final rule. Now I know Karen Trudel is going to be discussing this but I obviously wanted to first of all congratulate CMS on having completed the final rule and published it, so congratulations. We also wanted to thank HHS and CMS for including so many of the NCVHS recommendations in that final rule and being a prolific reader of final rules these days, all 165 pages of that one, I did want to point out that the NCVHS is being asked to provide ongoing advice and guidance to HHS related to versioning and maintenance updates of this suite of standards and it sounds like much the same sort of pattern as we've done with HIPAA. So I obviously want to thank the government, the federal government, for their faith in us.
Item three is the claims attachment standard, we'll be talking about that, that's a Notice of Proposed Rule but we get another thing that's out now that we have to deal with.
Finally is the Commission on Systemic Interoperability that released its report and its recommendations three weeks ago. This federal commission was charged with taking a fresh look about how to accelerated progress towards an interoperable future. I was honored to have been a member of that though not with my being the chair of NCVHS but a representative from a private entity. We were pleased that CSI in their recommendations specifically named the NCVHS, in particular those recommendations related to data standards and it did request that NCVHS collaborate with AHIC to ensure acceptance and use of a set of interoperable non-overlapping data standards.
While I will not be reviewing these recommendations in any detail with the committee today, I think we've had a presentation with Scott Wallace previously, I know Marjorie had sent around the website for this. I will however knowing how busy we all are make sure that we package the executive summary and the recommendations and we'll send them out as an email so you can all review. I think it's important probably that subcommittees and workgroups review these only because some of them may impact or provide you additional thoughts for what your 2006 work plan potentially should involve, and so we'll sort of do that after the meeting for at least your review and thoughts.
All in all as I commented there's a lot going on related to national health information policy. This is an exciting and fast moving time and I want to acknowledge all of you for your hard work and vision in helping make all of this a reality so thank you.
Now let me shift gears. Obviously while this is going to be somewhat old news because we've publicly announced this in September, sent this person a letter, mentioned it on executive subcommittee calls, we haven't seen him since all of this happened. So since we're actually seeing him today I wanted to take a moment and congratulate Jim Scanlon, our director, for his well deserved promotion at HHS. He was previously acting deputy assistant secretary for science and data policy in ASPE and he's now the deputy assistant, got rid of the acting, deputy assistant secretary for science and data policy. We're obviously delighted about the promotion and Jim since we're seeing you here in person congratulations.
[Applause.]
MR. SCANLON: I think I set a record for longevity in that acting position and I hear that I've been nominated for thespian --
DR. COHN: Congratulations. I also want to thank the full committee for all of your comments and suggestions at the end of our last full committee meeting in terms of meeting planning. I think many of those suggestions were taken to heart by myself and by the executive committee as we planned out the meeting today. We will obviously continue to fine tune this and this will be sort of an ongoing conversations likely at the end of each of our meetings about how we can make the meetings more useful and helpful. But I'm hoping that all of you will feel that we will at this meeting have considerably more time for discussion and reaction about the topics and issues that are coming before us.
Now the other thing that sort of came out of that meeting was I think a discussion about what I described as strategic planning. Based on your input we are at least discussing the possibility of a full committee strategic planning session attached to one of our full committee meetings in 2006. I'm not formally announcing it at this point but I think it will be an ongoing part of conversation about how we can do this in a way that is useful and successful.
Well with all of that background let's talk about the agenda for a minute. This morning we begin with an update from the department, we start with Jim Scanlon, our executive director, followed by Karen Trudel, thank you for joining us, and Susan McAndrew from the Office of Civil Rights. After the break we'll be talking about the health claims Notice of Proposed Rule Making, as this is an open comment period we'll be reviewing a draft letter that the Subcommittee on Standards and Security is bringing forward in relationship to that. Late this morning we are pleased to have David Brailer join us for an update on the many new initiatives and contracts underway, sort of once again an exciting time.
After lunch we'll be beginning to discuss a couple of issues, we start off with Mark Rothstein, we'll be discussing the status of work underway by the Subcommittee on Privacy and Confidentiality relating to privacy and the National Health Information Network. This will be followed by once again a presentation and discussion being led by Stan Huff relating to hearings being undertaken by the Subcommittee on Standards and Security on secondary uses of clinical data.
Now from there we will break up into subcommittees and workgroups for the remainder of the afternoon and we'll talk about that potentially in the afternoon about where we'll be going, what the various meetings are as well as the starting time tomorrow which is actually at least to my knowledge unchanged from your current schedule for a change of pace here.
Oh, I did want to before I finish here mention at 6:30 there's a dinner for the full committee and staff and I guess we'll be identifying people, getting a number after lunch.
Well with that, Jim about if I turn it over to you and thank you.
Agenda Item: Update from the Department - Mr. Scanlon
MR. SCANLON: Thanks very much, Simon, and good morning everyone. As Simon indicated a number of developments have taken place, progress continues to be made on health information technology and policy here at HHS and I think it's fair to say that we're now seeing the fruit of many of the collaborative relationship between NCVHS and the department over a number of years, many of the ideas that you now see manifested in contracts and in structures and in directions you'll remember had their nucleus in many cases in the discussions here at NCVHS and I hope the collaboration will continue forward as well.
As Simon indicated the AHIC, the American Health Information Community, had its inaugural meeting on October 7th, I think we'll get a report from David later today. The focus there was pretty much as an initial meeting always is on kind of getting organized, but then they began to turn their attention to what are possibilities for fairly quick progress use cases and applications. And I think they have another meeting scheduled late in November, the 29th I believe it is, and I think hopefully some progress will be made in those areas where what is the committees, what the community's desire in terms of moving forward. There's no meeting I think scheduled in December and then I think there's working on a meeting in mid-January.
Aside from that there are a number of activities that Karen and Susan and David will describe later today. Again not only e-prescribing and some of the HIPAA progress but also on the FDA side you'll remember a number of initiatives at FDA aimed at, and many of them again coming out of the committee's recommendations, aimed at bringing the benefits of interoperable health information technology to that world as well. You remember seeing the bar coding, the proposal for bar coding that would incorporate standards. There are some other initiatives that will be coming forward again from FDA that will support Rx-Norm and Daily Med and it's kind of bringing all of these various strands of health information technology potential together across a lot of department's programs. Mike?
DR. FITZMAURICE: Jim I wonder if I could add to what you reported, I'm going to be leaving today about 11:00, 11:30, to go to a celebration at FDA, they have just had the first structured product label come in from a manufacturer, be approved by FDA, and then put up on NLMs Daily Med website.
[Applause.]
DR. FITZMAURICE: This is the start of the pipeline for getting all of those little package inserts up on a website where people can read them, it's also a place where knowledge vendors can go and form a common base with all the other knowledge vendors and add their value to it and resell it to electronic health record systems and others. This is quite a momentous achievement, could not have been done without the expertise of NLM and FDA and many others, and the financial support of AHRQ, that came from NCVHS, it came from recommendations by the Institute of Medicine, and many policy committees within HHS and our partners at VA and DOD. It's truly as Jim said a collaborative effort spearheaded around NCVHS's recommendations that the department do something and AHRQ working in collaboration with ASPE and Jim were able to make it happen. A lot of kudos for NCVHS. Thank you for your support.
MR. SCANLON: Let's see, let me turn to just for some contextual information the budget world. As you know we're, this is sort of what supports all of our activities, we're now in fiscal year '06, HHS like many other federal agencies is still operating on a continuing resolution, I think it's taking us through December and it more or less sets spending at the level of last year, a little bit, so we hope to have a regular budget sometime later. HHS is quite accustomed to this situation, we often have a later appropriation, but again we're hoping that some of the HIT initiatives, the standards efforts and others that we, and some other population statistics efforts that we worked for and got into the President's budget will find their way in the actual appropriate that's enacted by Congress as well.
Let me say a little bit now about the population statistics area, within our Data Council we have been working on data improvement and enhancement initiatives in five areas and again these are for the most part budget neutral, they are meant to try to find ways of improving and enhancing the data, collection of data analysis and the data availability in several areas that are of particular interest to the policy community, let me just briefly run through those areas. The first is in prescription drug utilization and expenditure data, this is both for program purposes and for policy utility as well. We have a number of enhancements underway, now that we'll have the Part D Medicare Benefit beginning in January much of this will support that. All of you who are eligible for Medicare I hope you've gone to the CMS website to look at your options for Medicare Part D as of yesterday.
The second area is health insurance data, we've had a lot of interest, actually it's more health and insurance seems to be the interest. As you know from our statistical systems we have estimates of the number of uninsured population in the United States, this of course is the other side of the coin of the population that does have insurance and what the nature of the coverage is. And our surveys tend to produce somewhat differing estimates of the size of the, and the relative size of the uninsured population so the Data Council and ASPE working with several of our agencies is trying to shed some light on why do they differ, what are the assumptions, are there artifacts that produce this difference. Interestingly the two surveys within HHS are reasonably close but the Census Bureau surveys, there are two of them, they're quite different at two extremes. So Census Bureau, the population, the current population survey, tends to produce the highest estimate of the number of uninsured. At any rate we're trying to work on why is that so, what are the correlates, what is this related to and so on.
A third area is really the state and to some extent the sub-state area and there are some efforts here looking at state data on health care access, utilization, health insurance coverage, so policy related data at the state and the sub-state level.
A fourth area deals with improving income information and associated information in our major statistical surveys. Again, the interest here is not pure data but data for policy purposes and we have a couple of activities there, in fact we're looking at, we held a workshop, federal workshop, about a month and a half ago where we pulled in all of the agencies that produce, that collect this kind of information on their surveys and as well as some of the policy community folks and tried to look at how we're measuring this, why are we differing. And we'll probably be doing an evaluation in the year ahead that looks at this more systematically and some ways of improving.
And finally but certainly not least we have again within the context of budget neutrality we have a race and ethnicity data improvement initiative underway under the Data Council's auspices. The Council is looking at ways that we can get better use out of our current resources, how we can draw more attention to getting the data analyzed and organizing the data a bit better on race ethnicity related to health and human services. And we're looking at some web based approaches, we're also looking at possibly some workshops in the year ahead where we can bring together the major HHS data producing agencies with the analysts and see if there are ways we could increase their interest and their ability to analyze the data. We can't really do it all here as you know in HHS.
We've also started a study that kind of combines the data standards area with our statistical systems area. We've initiated a study of data standards, again these are more content standards, not message format standards, code sets, data item standards and so on in our major HHS statistical systems. And we've identified sort of three phases I think the committee could help us here as well, the first stage will be just to pull together in one place the various code sets, standards, content oriented standards in the health area that are existing. And this would be looking at CHI standards, HIPAA standards, there are a number of statistical policy standards, for example the race ethnicity standardized data item measurement is a statistical standard. There are standards for classifying industries and occupations and so on, so we're going to be looking at what are the extent standards currently in some formal or informal a set of adoption, what are people working on, that's the first compilation --
MR. BLAIR: Does that so include identifier standards like NPI?
MR. SCANLON: Well these are statistical systems so I'm not sure, we'll probably to look at to what extent they would be applicable but in the statistical systems to be honest there's virtually no interest in individual identity other then for the initial data collection and then for matching --
MS. MCCALL: I'm sorry, I missed the question, can you repeat the question?
MR. BLAIR: My question was whether the evaluation included identifiers, for example the National Provider Identifier.
MR. SCANLON: That's probably not going to be in initially but I think we would at least include those in the focus. I could see down the road where the National Provider system for example, the data system itself, could be very applicable to our surveys, particularly our provider based surveys. But the initial focus will be on content code set standards, ICD, CPT, you know the alphabet as well as I do, that will be the first look. But the second look --
MS. MCCALL: The question that I would have is in addition to code set standards will there also be work on standard, I guess we'll call it classification of taxonomy systems, so how to group them so that you get the same answer.
MR. SCANLON: Well yeah, the whole idea of statistical classification systems is, and there's a long history actually on the statistical side as you know to help do this, on the economic side, and yes, those will be parts. We actually have, they're not all that well known but within the federal statistical community there are a number of statistical policy standards, they are classifications just like that and theoretically agencies are supposed to be using them when they collect that kind of data, so those clearly will be there. We're also, we have a contractor to help us here and we've asked them not only to look at the formally adopted standards but are there almost best practices, conventions, that people say well yeah, if you're going to do that then this is the way you should do it.
MS. MCCALL: Will those be published as well?
MR. SCANLON: I think so, yeah, we'll put together a compilation with all the references and source documents, but secondly, that's the first stage, the second stage would be to look at maybe our major statistical workhorse kinds of systems possibly up to two dozen, this would include the family of health care provider surveys, emergency departments, doctor's offices, hospital discharge data. It will include the Health Interview Survey, the MEPS(?), the Medicare current beneficiary survey, the mental health and substance abuse surveys, so we'll be looking at those in terms of what standards are they employing now, I certainly hope they're using the race ethnicity standards, that's already been adopted as policy, but to what extent are they employing some of the other standards as well. And then based on that to look at some directions for future work, this would be sort of benefits cost potential, what are the benefits, what are the limitations, what's the applicability, and there's always cost as you know associated with these things and to kind of give us some ideas for moving along.
So I think we'd like to, I've asked the Data Council to kind of serve as our internal brain trust on this issue and I would like to bring this to the NCVHS when we move a little further along to get some feedback as well.
And then finally on the privacy side and again combining privacy and statistics we've employed a consultant to begin to pull together kind of in a monograph form the current authorities in policies and practices for statistical confidentiality in our research and data systems. So this would include the statutory authorities of the National Center for Health Statistics for AHRQ, for SAMSA has some as well, and then other practices and policies related to data sharing as well, so that we hope to begin. Much of this information as you know is known but it's not really been pulled together in kind of one overall monograph as a reference and I think we're asking, we're going to have that project as well.
So let me stop there and see if there are any questions.
DR. COHN: I think there's probably a variety of questions. John Paul and Jeff.
MR. HOUSTON: The last comment that Jim made, when you were talking about confidentiality were you also looking at standards to ensure that as data is aggregated that information couldn't ultimately in the aggregate be such that it can be --
MR. SCANLON: Disclosure avoidance standards.
MR. HOUSTON: I wasn't sure whether that's what you were referring to. And that will be published as to what those standards are going to be in?
MR. SCANLON: Whatever the authority for it and the practice and the policy, we will describe those, yeah. So we'll go from, I mean in many cases NCHS and AHRQ they actually have statutory protection of information, identifiable information, comparable to the Census Bureau which is always sort of held up as a gold standard. So taking that authority out of the agencies, employ that, what are the policies and practices they use to kind of cover that through the entire effort. And disclosure avoidance would be one of those areas.
MR. BLAIR: Thank you, Jim, I think that it sounds like the way you've describe it that this is an inventory which certainly is needed. One of the things that I tend to think of because of the work on NCVHS since we've been working in this area for so long, or at least I tend to think of these not just as line items with the number of folks that are using these for statistical purposes, we tend to think of this, or at least I tend to think of it as something that is dynamic, that is evolving to provide additional capabilities where some of the clinically specific standards will be very enabling. And of course the National Library of Medicine has been doing mapping among many of those code sets. So my question is will this research paper, I don't know what to actually call it because I don't think you refer to it as an inventory, will it identify the code sets or terminologies which are mapped by NLM and will it identify the purposes for which each of these code sets will be used?
MR. SCANLON: You're referring to the data standards project, right?
MR. BLAIR: Yes.
MR. SCANLON: It's not meant to be an inventory at all, it's meant to be an evaluation of the extent to which and the potential of to what extent the existing sets of code sets and content standards and statistical policy standards are being employed and if they're not sort of what are the barriers and what's the utility. It may be that standards that are quite applicable for clinical description or reimbursement make no sense in a research or statistical program in the sense of you're starting there with it, it depends, I think you could argue for the standardization as well as for the, when you're trying, you're usually trying to pick the best measure when you're doing research or statistical work.
So I think we're keeping an open mind but it's not meant to be an inventory, it's meant to be these are the standards that have already had some measure of adoption or use and it will include the content standards that NLM is looking at. And you're familiar with them, it's everything from ICD to, and ICD is used in some, it's used in our mortality classification system, it's used in, I think it used to be used in the Health Interview Survey, I'm not sure it is now, I think in some of our provider surveys.
But it's much more then inventory, it wouldn't really be worth our time to do just an inventory, we want to see to what extent they're being used. Again there may be reasons why they're not being used, we'll have to see what exactly that is. There's always the balance in a survey or in a research project that has specific objectives, you have to find the measurement of the variables as you all know as well as I that best suits the question and that's always, that's sort of where you start, if a standard is the best way to do that and it often is certainly for continuing statistical system then there's almost no reason why the standard implementation and cost shouldn't be used. I think for example in the hospital discharge data I think that already employs some of our standards, ICD and so on.
But we'll see, I think we're just starting and I think we'll have to see where it takes us.
DR. COHN: I know Russ has a question and then I have a question and clarification and then hopefully we'll wrap this area up. Russ?
DR. LOCALIO: This is Russ Localio. Jim on your last comment about the consultant, I'm not going to ask who but when will it be finished and how will it be released and will there be a period of comment?
MR. SCANLON: We're just starting on it, we just awarded the contract, I won't mention who it is but he is well known to you and no one would argue that he's not probably one of the best experts on this area. But I'm guessing it's a sixth month study and I would be happy to come back, there's nothing confidential about it, these are well known, these are public laws and so on so I'd be happy to bring it back.
DR. COHN: Well I think Russ actually was asking some of the questions I was which is I think we all think that this is a fascinating investigation and we'd love to have some updates about it as you move forward, I don't know if it's a presentation for February or a presentation for June but potentially we need to sort of figure that one out. I think from my view, I mean given that, this is an area where obviously standards are critical and there's obviously a tension here though because beyond standards there's the issues of there's sort of the pros and cons of linkages because the standards actually do provide some ability to be able to use the data for more then one would be able to use for otherwise, also reduce redundancy of repeated data collection which I know is something that I think is populations is thinking about as one of their issues for next year but there's also privacy issues, so I think there's going to be an interesting tension and a conversation we'll need to have.
MR. ROTHSTEIN: Simon, maybe we can invite the contractor when he's finished to give a presentation to the full NCVHS on some of the findings.
DR. COHN: Well I was actually thinking that maybe even during the process we might get an update in the middle and the answer may be both. But absolutely --
MR. SCANLON: But again, this information, these are public laws and regs and so on, it's just that they haven't been pulled together, some of you are familiar with these, those of you who do business with our research and statistics agencies but again this would be a place of pulling it together and when you're pulling things together you do find comparisons and contrasts and interpretation.
I guess one other thing, Simon, if I have the time, we were planning to have the NCVHS brief the Data Council on the race ethnicity data recommendations, I think they're formally transmitted now and we have them within HHS and perhaps at a, we'll work something out but I think we'd like to have a briefing to the Data Council and I think it fits in well with our internal initiative on race ethnicity data.
DR. COHN: I think our chair of Populations would be more then pleased.
-- [Laughter.] --
DR. COHN: Well Jim thank you for a very interesting update, and Michael, congratulations. Actually before we move on I do want to suggest that potentially given the work that's happening I think an important event around package labeling that maybe the committee would like to prepare a letter congratulating the, I'm not sure what the term is, the department, I think we'll have to get some help from Mike about exactly who to send this to.
DR. FITZMAURICE: I would say it's an NLM, FDA and AHRQ, and the department for recognizing the importance of this.
DR. COHN: Is everyone okay with us preparing such a letter? Okay, great.
Okay, Karen you're on next.
Agenda Item: Update from the Department - Ms. Trudel
MS. TRUDEL: Thank you, I'll start with an update on some HIPAA issues and then move on to some general health IT/e-prescribing things that are underway.
As I think everyone is aware CMS Medicare fee for service has ended its contingency plan for inbound claims so we are receiving now only compliant 837s and the statistics show that as of last week we only rejected 5,000 claims and that's a drop in the bucket for Medicare fee for service for being non-compliant. The 835 remittance advice, we are up to 92 percent of the receivers in production so we're pushing forward towards that goal. And the 837 coordination of benefits transaction is somewhat behind that because we've been phasing in a COB contractor, so the statistics for that are about 31 percent of the submitters are in production at this point.
Very interesting to report though that in the summer we did phase in the electronic 270/271 and all of the 270/271 data is being held at a central data mart so that at this point people don't need to query the particular contractor that may be holding data. We started very slow and the volume has just skyrocketed, for this quarter so far which is just October and half of November we've received 2.8 million 270s and have been able to turn them around in just a few seconds.
We have 20 submitters in production, they're primarily clearinghouses and providers with very, very heavy volumes, they're having to do this over regular phone lines. And there are about 50 more submitters who are somewhere in the process of establishing connectivity, testing, and moving into production --
DR. STEINWACHS: Karen, for those of us less knowledgeable, 270s are --
MS. TRUDEL: I'm sorry, that's an eligibility query and response, I mean to say that right up front, eligibility query and response.
DR. STEINWACHS: Thank you, we were talking about a highway leaving town --
-- [Multiple speakers and laughter.] --
MS. TRUDEL: I apologize for throwing around numbers and acronyms.
The internet version of this will be available in approximately the April timeframe and that's intended for smaller providers who don't have the kinds of volume that would necessitate their actually establishing connectivity, going through AT&T or whatever. So I think we're doing very well with that and the fact that we've had 2.8 million queries coming in just tells you that people really are taking up on these other transactions that are coming along behind the claim as we always suspected that they would.
The attachments proposed rule I'll talk about a little bit more later, the comment period will end on November 22nd and I'll talk a little bit later about the fact that we've been receiving some industry push back on extending that so that people can make a really careful analysis of the technical documents that go along with the proposed rule.
The HIPAA transaction and code set and security complaints, I don't really have very much to report, we still are getting very small volumes as compared to OCR and for the most part we're having excellent good luck on achieving voluntary compliance and we have about six corrective action plans that are in process that are being monitored at this time.
The NPI, the National Provider Identifier, we continue to enumerate providers to issue IDs through the web based system and two of the other aspects to NPI implementation, the data dissemination process and policy and the procedures for enumeration not on a one on one basis but in terms of large files, which we call bulk enumeration, the procedures for that will not be available until sometime in 2006 but we do continue to work for those.
Let me turn to e-prescribing a little bit, as Simon did mention the final rule was published on November 7th, we were all very relieved about that, and have gotten some questions but mostly a lot of good feedback and relief that it happened. We now turn our attention to the pilot that was required in the legislation and our friends at AHRQ have agreed to help us with that process, they already have a process in place that's excellent for reviewing scientific type studies, and we're taking advantage of their expertise.
We received 16 proposals and 14 of them met the basic criteria that were in the RFA, so they moved forward into the study section process. The review panel will met on December 1st and 2nd I believe and the panel is composed of a number of distinguished experts in the area of e-prescribing including Mr. Blair. So we're looking forward to, the ones we've looked at so far look really wonderful, there's a good mix of collaborators and partners and geographic areas and there's some, there's really some potential to find out some really great information from those.
Let me talk now a little bit about what we're doing inside CMS to try to cope with the, all of the initiatives and spotlights that are focusing on health IT these days. One is the office that I am in, the Office of eHealth Standards and Services, is the group that is coordinating all of the e-health activities within CMS. We have just established an eHealth Steering Committee, had its first meeting last week, and it's composed of the senior executives in the agency who have interest in the e-health area and they will give us guidance on strategic directions and priorities and things that we need to work on, not just projects like public health, personal health records, but also some underpinning types of initiatives like making sure that we have an integrated data strategy in the area, in the agency, that will support not only what we're trying to do today with e-health, what we might need to do five years down the road, and also to support some of the department's initiatives that have to do with drug data, etc., so that's a very, very exciting area that we're embarking on.
Our second goal is to coordinate with HHS, especially the Office of the National Coordinator, AHIC, etc., and so we have also initiated some discussions and ongoing dialogues with the Office of the National Coordinator to make sure that whatever initiatives CMS undertakes are consistent with a direction that he and the Secretary are planning to go in. So I think that's probably a good thing.
On the personal health record front we did publish a request for information in July asking people in the industry what they thought CMS's role should be in the area of personal health records. We received over 50 responses and they were very robust, we are in the final stages of developing a summary of those responses, it will not include any action plan or policy on the part of either CMS or the department, it's strictly going to be a report of what was given to us so that's our first deliverable in the PHR area. I'm estimating that that will be published within the next month or so.
Our next step will be an action plan which we will be rolling out in the early part of 2006 that will say okay this is what the industry told us and we've digested it, we've thought about it in context of what the Office of the National Coordinator is planning to do, the RFPs, the contracts that are in place there, and this is how we think CMS should be positioned in the area of personal health records.
Just a couple things to report from what we did here in the responses, most of the respondents said that CMS should not be in the business of providing personal health records to Medicare beneficiaries. They felt that that was the wrong thing for us to do, that we should concentrate on educating on the benefits of personal health records, that we should concentrate on facilitating the exchange of data if the beneficiary authorizes it with the personal health record vendor that they have selected. We also received comments that I thought were rather interesting that we need to make sure that we are the ones, we CMS, pursue especially vigorously personal health records that are directed towards specific chronic disease management and similar areas where the market as a whole may not be going and where Medicare beneficiaries may have a particular need. So that was rather interesting.
I think that's all I have to report on and I'll take any questions.
DR. WARREN: Judy Warren. Go back and talk about, because I didn't quite understand, you said that one of the responses you got about the PHR was people thought CMS should not be doing that and yet they also thought that in some areas that PHRs may not show up in CMS may cover that void, is that right?
MS. TRUDEL: I think in some cases the comments didn't exactly gel with each other so that's part of the analysis process. I think the sense that I got from the comments taken as a whole were that we should not be in the process of actually standing up PHR products but that we should be working with the industry who develops PHR products and to try to partner with them or collaborate in such a way that the products that they stand up will meet the needs of our beneficiary population.
DR. WARREN: I guess I'm just concerned by some of the responses that you did share that if we have PHRs for individual chronic conditions, etc., that what we're doing is kind of supporting fragmentation of personal health data, which concerns me, that we would be making choices on partial data, I just want to be sure I understood what you were saying, the responses.
MS. TRUDEL: I don't think the suggestion was that there should be a personal health record product that strictly addressed diabetic management or COPD management but that the products that are available would be robust enough that they might have a component that would have tools in it that could help someone with that condition.
DR. COHN: Karen, before I open it up are you done?
MS. TRUDEL: Yes.
DR. COHN: Okay, I wasn't sure whether people had jumped on this one. Okay, Harry I think you're next and then Paul.
MR. REYNOLDS: Thanks, Karen. Two questions, you mentioned the 270 which is the eligibility, I don't think you mentioned the 276/277 which is the claims status.
MS. TRUDEL: No I didn't and I didn't for a reason, the 276/277 because it is the claims status can only be handled by the specific carrier or intermediary because they're the ones that have the information about the claims status as it is at the moment. And so all of the carriers and FIs have implemented 276/277 functionality and from what I'm hearing they're not receiving very many of them. I think that one of the reasons why the 270/271, the eligibility, has become so popular is that we do have the data mart where all the queries go to one place and the clearinghouses especially find that very, very convenient.
MR. REYNOLDS: Second question, out on the HHS website it was noted that claims attachment rule is now schedule sometime around 2008. Is that a position or is that --
MS. TRUDEL: The claims attachment final rule? It's very difficult, the regulation agendas that are published because they go so far out into the future very often are developed on the basis of well it will take six months to do this and 12 months to do that and three months to do that, so you really need to look at those as a guide post as opposed to a cut and dried date.
MR. REYNOLDS: Since the committee is about to send a letter forward I just wanted to make sure whether that was just kind of somebody putting a boilerplate answer down versus a position.
MS. TRUDEL: Pretty much, yeah, I mean we try to beat the dates to the extent that we can.
MR. REYNOLDS: That's fine, thank you.
DR. TANG: I have a couple questions please. The first is do you consider facilitation of online care including its reimbursement part of the health steering committee's jurisdiction or things to discuss?
MS. TRUDEL: I'm sorry, could you repeat that?
DR. TANG: So you said there's an establishment of the eHealth Steering Committee and you talk about some of the projects like PHRs, is one of the topic areas to be considered facilitation of online care including its reimbursement?
MS. TRUDEL: Actually we've had to make some fairly tough decisions about what is in the purview of this committee, which is e-health and health IT oriented, and what is in the purview of our quality council which is another executive level organization. And they tend to look, if you look at it it's kind of quality slices this way and health IT slices this way and the decision is that the quality related items stay with the Quality Council, so they're the ones who are interested in tele-health and electronic health record adoption issues, vista, things like that.
DR. TANG: And electronic visits, or electronic encounters would be in that, the quality area?
MS. TRUDEL: I think if that's something, if anybody in CMS is thinking about it that would be the group that is.
DR. TANG: And the second is, relates to, and this may be premature to ask this but you talked about some of the feedback saying that CMS should not be in the business of offering a PHR, do you interpret that as saying that the kinds of experiments you're doing in Indiana with the beneficiary health data accessibility over the web as not, do you interpret those comments to say that that's not something CMS should do?
MS. TRUDEL: No actual I don't because the beneficiary portal was never really intended to be a personal health record per se, it has some of the qualities of a personal health record but it doesn't have an awful lot of the qualities that people seem to think that a personal health record should have. So I think that what we're doing there is a tool that has some personal health record like functionalities to it and I didn't get the sense from any of the comments that we should step back from that.
DR. COHN: I'm just reminded by our letter that we passed in September about the ambiguities around exactly what a personal health record is and isn't and is it a portal, is it a, I mean is it a what, and I think that may be some of the reflection we're seeing here. Thank you, Karen. Michael.
DR. FITZMAURICE: I think Paul probably asked one of my questions which was the personal health record, I think what CMS is doing to make information available from the claims data to the beneficiary, I think it's outstanding and would hope that those comments wouldn't be construed to say gee we shouldn't do it, and I think your answer was no, you think it's a good thing and you'll keep pursuing it.
So my only remaining question is at the very beginning you gave some numbers and statistics about the claims, 31 percent of submitters are in production, but there were some at the very beginning, I'm not sure if you mentioned the 837 or what others, you mentioned the 835 remittance advice, I wonder if you could just briefly review those.
MS. TRUDEL: Right, for the incoming claim which is the 837 we're rejecting any transactions that aren't compliant.
DR. FITZMAURICE: And what percentage or what number of those have been rejected? In the past month or whatever you have.
MS. TRUDEL: I mean we're taking 99.9 something of claims are compliant at this point and they have been for some time. The number of rejects last week were just a little over 5,000 Medicare wide.
DR. FITZMAURICE: And after that was the 837 --
MS. TRUDEL: The 835, the remittance advice going back out to the provider and that's at 92 percent of receivers in production.
DR. FITZMAURICE: Very good, CMS is to be congratulated on this.
MS. TRUDEL: Thank you.
MR. BLAIR: The eligibility of the 270, what percentage is that now?
MS. TRUDEL: You can't do percentages on eligibility because you have to be signed up in order to conduct the transaction, so essentially 100 percent of the people who've qualified are conducting the transactions but we did 2.8 million transactions in the last month and a half. And that's with only 20 submitters.
MR. REYNOLDS: Which some of those in the past, Karen, probably would have been phone calls.
MS. TRUDEL: Many of them would have been phone calls, yes.
DR. COHN: Probably millions.
MR. REYNOLDS: I was serving it up for you so you could get --
-- [Laughter.] --
DR. COHN: I actually had a question for you and once again I think I was referencing that one of my joys in life is to actually read final regulations from CMS and certainly there's enough there to keep everyone busy for probably decades if not longer. But I was particularly fascinated in the e-prescribing rule and I will apologize, you can certainly say no comment to the question that I'm asking, but the committee has gone on record as have many others about this concept of streamlining the processes relating to both HIPAA and other regulations in this area and we've talked about that in relationship to claims attachment, we obviously had talked about that in relationship to e-prescribing and we've also talked about it in relationship to HIPAA.
Now I was very gratified to see that there was a discussion about potential ways that things may be streamlined for e-prescribing and for those of you who didn't read it there's a concept at least in the discussion part of the, it's 150 page discussion, the five page law, but that describes how CMS is I think considering strongly the approach of backward compatibility and if things seem to work and the public and NCVHS and everyone else thinks that a new standard or revision to a standard is really backward compatible and it's of value to the country there may be a way to allow that to occur without having to go through full rulemaking process, or at least the Secretary might have some discretion in relationship to this.
I'm actually wondering, first of all I want to congratulate you, it looks like a very good move forward in terms of lessening administrative burdens and regulatory burdens for each sort of minor change, but is this something that would be at all applicable to the actual HIPAA regulations also? Or is it, do we need to see how e-prescribing goes with this first?
MS. TRUDEL: As it happens we are also working on another HIPAA modification rule which we hope will address some of the streamlining issues and we do, we have already scheduled a discussion to take a look back at what we've thought about HIPAA from the perspective of e-prescribing, so not sure how that's going to come out but we definitely are thinking along the same lines as you are.
DR. COHN: And I presume this will be an internal discussion about regs that need to come forward. Great, well congratulations. Other questions before we move on to, Jeff anything before we move on?
MR. BLAIR: It turned out that the final rule for e-prescribing was I think November 7th and the pilot test announcement for the RFAs, the requests for applications, was I believe late September, middle September, so in an effort to try to do everything that was possible one of the things that apparently was not possible was for them to be sequenced a little differently and as a result during that pilot test piece it indicated that, I think, I'm trying to remember whether it was the medication standard or medical history, was indicated as a initial standard as opposed to a foundation standard, and when I saw the final rule it wasn't exactly in sync. This may not make any practical difference because it's going to have to be tested either way but I was wondering if you had any clarification for us on that.
MS. TRUDEL: Actually when we published the RFA because we knew it was coming early we didn't distinguish between whether something was a foundation standard or not and we simply said that all of the standards including whatever turns out to be a foundation standard needs to be tested together, so that as far as I can tell from my read we pretty much kept our options open in the RFA and that whether the medication history and the formulary benefit management which were pretty much the two standards that were a little bit kind of on the cusp, whichever way that went we provided neutral language so I think we're fine.
DR. COHN: Well Karen, thank you very much, and congratulations on the various work going forward including e-prescribing and it sounds like your new work on e-health. So thank you.
Susan McAndrew from Office of Civil Rights, thank you very much for joining us.
Agenda Item: Update from the Department - Ms. McAndrew
MS. MCANDREW: Thank you. With regard to privacy rule compliance, as of the end of October we had received over 16,000 privacy rule complaints and we have closed 68 percent of those complaints. We are continuing to receive a fair number of non-jurisdictional complaints but the percentage of closers are also increasingly including complaints that are resolved through voluntary compliance on the part of the entity.
There has not been much movement in terms of the types of issues that are raised most frequently in those complaints, it continues to be headed by impermissible uses and disclosures as the primary reason that people are concerned. We also continue to get a lot of complaints raising the adequacy of the safeguards with regard to that, that plays along usually if you have an impermissible disclosure you have a safeguard that has broken down somewhere.
We continue to get a fair number of complaints that are concerned about denial of access to their health records, we also have begun to get more complaints concerning the amount of fees that are being charged with respect to those access of records and whether those fees are reasonable.
Minimum necessary is also frequently raised in our complaints as well as whether or not a disclosure required an authorization and none was provided in the record.
The types of entities also has not changed much, the most frequent entity type complaint against are private health care practices followed closely by general hospitals. In addition a variety of outpatient facilities get a lot of complaints as well as pharmacies and following somewhat behind would be a variety of health plans led by group health plans as the type of entity that is complained against. And we also continue to refer cases to the Department of Justice and we have to date referred approximately 256 cases.
I will say with respect to these numbers that we were finally able in conjunction with this meeting, Linda Sanchez and I were able to sit down with John Houston to discuss the potential for our own type of data mining and we had a very productive discussion about what the capabilities of our current complaint database is and what the current reports look like and we will have a continuing discussion with John and I believe tomorrow morning with the Privacy Subcommittee as a whole to identify additional data areas that would be of interest that are also feasible to extract from our database. So hopefully we will be able to produce, I'm not, I'm hopeful that this may integrate into the monthly statistics for the use of all but at least we may also, it may be that for the time being it may just be periodically more robust reports if we can't generate some of this data on a monthly basis, but we are very happy to be moving forward on that effort.
On some other fronts there was released just last week a new survey done by the California Health Care Foundation using, I'm forgetting their consultant, but they did, they had done a privacy survey largely focused on privacy and electronic systems back in 1999 and the 1999 survey predated HIPAA, the regulations, it was surveyed even before the NPRM was issued, so they wanted to do an update of that survey based on experience with HIPAA implementation as well as all of the new activity in electronic health records and other HIT movement in the health industry. I think we had met with them following their announcements of their privacy results, I think we're still looking at some of those results.
They had some very strong recommendations in terms of the additional need for public education which I think echoes many of the concerns that the committee has expressed and they also had made some comments about enforcement and we did question then on that because as I was looking at the survey results there really were no questions or data points collected in that survey that would cause them to, that would support their recommendation on attitudes toward the enforcement under HIPAA. So we were a little concerned about that being a headline item based on the survey results.
In other fronts, on the regulatory front we are in conjunction with our General Counsel's office and CMS coming to closure on the final enforcement rule and it's hopeful that perhaps by the next NCVHS committee we'll be able to have a report on a final enforcement rule. This is setting up, trying to make uniform the procedures across HIPAA in terms of how complaints are handled and investigated and how CNPs will be imposed and what the hearing rights will be with respect to any imposition of civil monetary penalties.
In addition we are participating with the other components of HHS in a new, becoming sort of an annual event, a regulatory reform task force has been formed up I believe, ASPE is in the lead on that together with OMB to take an overarching look at department wide regulation that may be imposing undue burdens on the health industry, and so they have launched a series, they have asked for public comment on regulations, department regulations in the health area that they impose undue cost. And in addition to those public comments they are starting a series of four public hearings across the country, the first one was held last month, earlier this month, I can't remember, in Washington, D.C. and there are four others that will be held between now and February in Chicago, Oklahoma City and San Francisco.
The other initiative that we are beginning discussions with AHRQ on concerns the recently enacted Public Safety and Quality Improvement Act which sets up patient safety organizations and participating providers who will be working on patient safety activities and producing patient safety work products which will have confidentiality and privilege conditions attached and there is also a scheme for, an enforcement scheme that relies on civil monetary penalties for violations of the confidentiality protections and there's also a private remedy which attaches to reporters of information on quality and safety who may have experienced an adverse employment action as a result of their reporting. And so we are talking with AHRQ in terms of handling the enforcement aspects of the patient safety civil monetary penalty.
And that's it.
DR. COHN: Okay, Susan, thank you very much. Paul Tang and then Mark.
DR. TANG: Two questions, one you reported 256 cases were referred over to the Department of Justice, what happens? Do we have any outcomes to report?
MS. MCANDREW: When we refer them to the Department of Justice the department has, will make a decision as to whether or not they will initiate a criminal investigation based on that referral. If they do not the case may come back to us and we would pursue that case just as part of our normal caseload if there are civil aspects to that complaint. Some contain only criminal allegations and so those cases we would close with the referral to DOJ.
DR. TANG: So have there been any prosecutions?
MS. MCANDREW: Actually there have to date been no prosecutions based on any of the referrals to my knowledge.
DR. TANG: What about the case in Seattle?
MS. MCANDREW: The Seattle case was not based on a complaint referral because we did not receive a complaint from that individual about that incident, but we did refer to the Department of Justice the press reports related to that incident. There's also a new indictment that has been brought in Texas for which I have very little information at this point, and that also as far as I know was not based on a complaint that we had referred. So they do, they have their own investigatory means as well.
DR. TANG: And the second question relates to a high profile case that was apparently brought to your office in terms of the JCAHO, is there something that you can share with us on the details of that complaint?
MS. MCANDREW: That is not really, that's not a complaint issue, we met last week with the American Hospital Association and actually will be meeting this afternoon with JCAHO and the American Hospital Association representatives to talk through their issues. The American Hospital Association had asked us for guidance on the scope of business associate activities under their contracts with JCAHO and so we're trying to, at this point we're still in the process of trying to identify what the issue is and whether or not there's any meaningful guidance that OCR can provide. I do understand there was some announcement recently by JCAHO, I think they were having their own board meetings yesterday and today perhaps and there was some article in the press this morning concerning that one of the recommendations is that JCAHO would no longer do the kind of data mining activity that results in the sale of information to Blue Cross and Blue Shield.
DR. TANG: The reason for asking that is because later on today we're going to be talking about secondary uses of data so I just want to thank you for sharing some of that.
DR. COHN: Mark Rothstein and then Carol McCall.
MR. ROTHSTEIN: Sue, we both know that John Houston has great plans for mining your complaint data but I have a question that may be not exactly flowing from John's use and that is to what extent has OCR used the complaint data to help guide its enforcement assistance activities? In other words it seems to me that having a sort of a feedback loop from the complaints could help decide in what areas you need more guidance, in what areas you want to emphasize in our outreach programs because you have lots of complaints in a certain area, people are obviously not getting it. Is there some system in place or have you thought about a system for having the complaints in some sort of aggregate form feed into your other activities?
MS. MCANDREW: We have from time to time used that, I think we haven't gotten to the point of doing that on a systematic basis and so it's of interest to us as well to in conjunction with John's needs and the committee's needs for this data is to raise the profile within OCR in terms of getting some more management substantive programmatic reports out of the system. Right now, it was really designed largely as a management monitoring tool so most of the reports that are imbedded in the system now go to workflow and monitoring progress and various administrative steps. Which are very helpful in terms of seeing how productively the regions are working, tells me very little about how the program is working. So we are interested in making a more programmatic use of that information and making that more systemic.
DR. COHN: Okay, Carol, I think we'll let you ask the last question and then we'll wrap this up.
MS. MCCALL: It's actually very related to Mark's comments and it has to do with some of the uses of the database, before the question just an observation that in a microcosm what you're experiencing is essentially, if you design the ebb to help the workflow but don't think about how you can use it to report, that's what we're going to experience if we don't understand how a lot of EMRs and EHRs are going to be used to actually drive quality, so keep that in mind, a taxonomy I'm sure is something that maybe Jim Scanlon's team could put together for you.
The specific question though, you mentioned volumes, that they come from private practices and hospitals, and which is not to be unexpected I would think because the volume of activity in those places, utilization tends to follow that curve, it's a lot more active in physician office visits then perhaps admissions and things like that. Will you be doing things that try to create a denominator for that so that you could say relative to the amount of care being delivered in physician practices versus hospitals in terms of just visits or admissions we get a relatively higher percent, so those types of things as well as others as you go about the data mining would be valuable. But do you have any insight into which has a relatively higher proportion?
MS. MCANDREW: I think other then just common sense and logic would say that the private practices and the general hospitals not only have many more interactions with the public and so therefore that's where the rubber meets the road for many individuals and I think also the individual, that kind of face to face interaction tends to heighten the individual's interest and expectations in privacy and how that data is being handled.
One of the things we were talking to John about that may go somewhat to your point is to try to correlate or get some profiles in terms of the size of the entities within the private practices, large group practices versus small groups, hospitals, number of beds, and that kind of thing. The database right now does not capture size.
DR. COHN: You'll notice that John Paul has not asked one question during this particular session, this may be the first time. However, John Paul did ask to make a final comment before the break.
MR. HOUSTON: Just a real quick comment, I mean the dialogue was really good with Susan and Linda and I just wanted to sort of expand on Susan's last point which is that we looked at some strategies yesterday to try to, since they only capture information by hospital, it's not hospitals over various sizes, you don't really get a sense on where some of the problems that big hospitals, that are small hospitals, that are rural hospitals, one of the things that we're thinking of trying to do, as we talked about is whether we can capture like bed counts, something out of an AHA guide or zip code to try to get a sense of where these hospitals are to try to get better statistics about where the problems lie. So again, I think there's a lot of opportunities here and trying to be practical about how to mine this data and get this type of information.
DR. COHN: Well we're looking for the Subcommittee on Privacy and Confidentiality to assist us with this in an ongoing fashion. Now I do want to break, I know we can continue on with the conversation but we do need to be back at 10:45 for our last session of the morning, so we're going to break for about it looks like 13 minutes. Thank you all.
[Brief break.]
DR. COHN: Okay, we are going to get started for our next session. What we are going to do for the next little bit, for our next session we're going to start out with a discussion about claims attachments, there's a brief presentation that Karen Trudel I think will be providing and then we'll be talking some about the letter that the Subcommittee on Standards and Security has developed. I do want to sort of explain to everybody about the timing of this next period. We obviously have time for the discussion about the attachments, we'll have I think hopefully to get at least some briefing about the letter that's been prepared. David Brailer needs to be leaving here exactly at 12:00 and I think we'll expect to see him at about exactly 11:30 knowing how he runs. So just recognize that we will do is to wherever we are with this letter we will put a hard stop to the letter at that point and then if we need to we can sort of talk about it in the afternoon either before or after our break to go to the subcommittees, but I think that will be the plan of action on this one.
Now I think Karen is in the process of getting the presentation so Karen I will turn it over to you for at least the background discussion about the claims attachment NPRM and then we can let Harry and Jeff discuss the letter.
Agenda Item: Briefing on Health Claims Attachments NPRM - Ms. Trudel
MS. TRUDEL: Okay, thank you very much, I would beg your indulgence on this, I'm pinch hitting for this at the last minute, it's not my presentation and I apologize in advance that it has some somewhat distracting animation in it. Luckily people will not notice on the internet.
One thing I'm going to say before I start is that while I mentioned earlier that the claims attachment NPRM comment period date closes on November 22nd we did receive a very large number of requests from various industry representatives saying that because of all the technical documents, the booklets and different things that go along with the rule people really felt that they needed more time to review and provide comments and people asked for extensions of anywhere from 30 to 60 days. We are very sympathetic to that, we would rather have good complete comments before we go into the final rule period so that we don't have to deal with an issue like the HIPAA modifications when we had to go to the 4010A.
So we are working on putting forward a proposal to extend the comment period for an additional 60 days, it would be a Federal Register notice and it is not completely approved but it is in the review process so I'll just mention that. However until that comes out the official date for comments still is November 22nd just so you understand that.
Again I'll just start from scratch very quickly for members that weren't around back in the stone ages. The claims attachment standard is one that is required by the original HIPAA legislation and it is a health care claims attachment so it is an attachment for a health care claim, not for a referral or remittance advice or for other uses, so we're only talking about developing a standard for this purpose. And it is the additional clinical or administrative information needed from a provider to allow the health care plan payer to adjudicate a claim, so this does not have to do with, again we're excluding requests for information that come post adjudication for purposes of medical review cross periods of time, this is a request for a specific piece of information required to adjudicate a particular claim.
And I would say that, venture to say that in the administrative part of the health care industry the claims attachment process is the most manual, the most time consuming, expensive, and inefficient. It is something that is just plain not automated at all at this point in time.
So the proposed rule clearly affects all covered entities under HIPAA, we all know that. The health plans will be required to be able to accept or send the transactions, the providers as always have the option of using the transaction or continuing to conduct their business on paper. And clearinghouses if they are in the communication loop will be required to use the standard transaction. We're proposing six types of attachment standards, only six, and again everything else that's outside that scope is something that is not being regulated at all so there are no constraints on what people can continue to do outside the scope of these.
The standards that we're proposing, and I will attempt to stay out of acronym land now, there is a request for information, it is a HIPAA transaction, an X-12 transaction called the 277, so that is the request that comes from the health plan and goes to the provider. The response that comes from the provider back to the plan would be the X-12-N 275. The codes that will be used in that request and also in the response are LOINC codes which are a CHI standard and they are the list of codes that identify the specific information that is being requested, so it's a codified way of saying this is exactly what I want you to give me, totally, unequivocal.
The additional information specifications are the basically the content format and what the LOINC codes are that associate with each type of attachment transaction because their subject matter is different, the content is different, the specific LOINC codes that associate with, for instance an ambulance claim is different then for a therapy claim attachment. And the clinical document architecture, the HL7 CDA, is the XML based document markup standard that would include the clinical content, the payload if you will that goes back to the health plan in response.
The proposed attachments are for ambulance, emergency department, rehabilitation, and there are nine different categories of that including cardiac, rehab, PT, OT, psych, substance abuse, laboratory results, medications, including current and discharge meds, and clinical reports which could be almost anything in text form, op reports, discharge notes, etc. And again it's important to note that these attachment types don't actually correlate to a specific claim type always, in other words an ambulance attachment probably will correlate with an ambulance claim, however a laboratory result request for an attachment may correlate back to an ESRD claim where for some reason the service that was built for dialysis there's a requirement for laboratory results before the plan can determine whether or not they're going to adjudicate the claim. Same with medication, same with clinical reports.
There are other attachments under development, we're not recommending them at this time, they're not really relevant to the discussion, but there are HL7 groups working on home health care, DME, periodontal, and children's preventive health service attachments, and they may come up for adoption or consideration at a future time.
When we begin to talk about claims attachment data, electronic data, and how it affects business processes it became very clear that there really are two different variations. One is what we call the human decision variant which means that the information that is coming in maybe electronic but it can't be utilized but a computer so you may have a scanned image or a text or an image of a health record, it can come in electronically but a computer can't work with it. The computer decision variant is one similar to what is being used for the structured product label where the values allow for automatic processing on receipt.
We're allowing for both in this environment, we think it's asking a little bit too much to expect that health care providers will immediately jump to a computer variant process because it requires a significant reengineering of their business processes, and the same with health plans. So we allow for both, the attachment can be submitted on paper if the provider wants to, the attachment information can be coded into data and sent electronically, it can be sent electronically but the plan may convert it back into text, it really doesn't matter to us, that's all okay. But both variants basically encourage participation in some level of electronic attachments.
I will only take a moment on this because this is the flow of the attachment request and response, it starts when the service is delivered, the provider submits a claim. If the health plan decides there's a need for more information they request it using the 277, the provider sends it back, and I think we've just looked at that enough.
We've already talked about the comment period extension, again judging rule of thumb NPRM to final rule a year or more, and from the date of the final rule to implementation is two years, so that gives you an idea of the actual time in the future that we're talking about to implement.
Of course the attachment standards can be used voluntarily prior to that date, there's no stopping anyone from using them even today. And we have already conducted a CMS pilot to look at the proposed standards and came up with a number of changes that we believe need to be made. We are encouraging industry to investigate other opportunities for pilots and the more pilots we do the more we find out the little hidden problems or potential improvements with the transactions.
I think I survived.
DR. COHN: Karen, thank you very much. I actually want to say that I think some of us have received this presentation via conference call and the conference call does not do the presentation justice. I also I think would further say that every year we sort of reflect on maybe the single presentation that had the most interesting aspects to it. We may want to consider this one to really be the presentation of the year as far as, and unfortunately for those on the internet, I mean the number of, the amount of animation was really wonderful.
Anyway, Karen, thank you. Any particular questions about the presentation before we move into the letter? Paul.
DR. TANG: With the flexibility in the proposed rule meaning basically all kinds of variance in the ways it can get to you is this rule viewed as sort of an encouragement rule to get people to start getting closer to computers? Because it doesn't sound like it's moving a great towards standards, at least enforcing standards. Am I interpreting that incorrectly?
MS. TRUDEL: Well I think even the basic level of standards use is a significant advantage because it does allow for the plan to ask for exactly what it needs and it provides structure to the provider in that the provider can know by looking at the LOINC code exactly what the plan needs. Very often what happens now is that the plan asks for something, the provider is not exactly sure what the plan wants, and they send the whole medical record, or the whole record of the encounter, they could possibly send one lab value and they send the information that relates to a full hospital stay. So I think that's a significant advantage.
You have the ability to send these things via EDI where even if it's just a scanned image it is being sent electronically so you're not faxing. It's a lot easier for the plan to associate the information back with the claim which they've suspended and is hanging out there in their system. And so I think there really are a lot of advantages.
The other thing is that, and we don't go into this in the presentation, but we specify you ask for what you need once, you don't keep coming back if you're a plan. So if you need information ask for it all one time and I think providers will find that to be advantageous because you don't get into this tennis match kind of process where you provide data but it wasn't the right data so they ask you for it again and you provide it again. So I think that's going to be considered another advantage.
DR. TANG: So I can see that the value in moving along the path, is there a roadmap to a completely standard of more streamlined way of sending information and getting it adjudicated in an automated fashion on your end? I mean so I see all the advantages of where you're taking in your first step, are there future steps to follow?
MS. TRUDEL: I would say that the steps that should be taken in the future probably should not be taken in the HIPAA arena because keep in mind that HIPAA is a requirement, there are penalties, there are enforcement aspects to HIPAA, we're stating what the standard looks like, we're setting the stage, and now I think we let the industries, health IT and EHR adoption processes to feed along with that.
Another thing that's not mentioned in the presentation that's important to remember is that this standard is the first one where the HIPAA administrative transaction world meets up with the CHI clinical standard world and it's the first time we're using X-12 standards which are administrative primarily, with HL7 which are primarily clinical, with LOINC, and all of them together form the bridge to get from administrative to electronic health records. And if you don't build that bridge and people aren't thinking about it, if EHR vendors aren't thinking about how could I take my content in my EHR and turn it into something that I can pass to a practice management system so that it can create a claim you're again going to have two silos.
DR. COHN: Steve and then Justine.
DR. STEINDEL: I'd just like to introduce some clarifying words in terms of terminology because in the last few months the CHI standards have taken on a broader perspective then when they were originally introduced and Karen you used the words LOINC and you said it was a CHI standard, specifically the laboratory names portion of LOINC is a CHI standard and not all of LOINC --
MS. TRUDEL: I stand corrected.
DR. STEINDEL: And the actual attachment standard points to three parts of LOINC, the clinical LOINC, the laboratory part, and the attachment part of LOINC. The attachment part of LOINC if this is approved will by default become a CHI standard because it will be a HIPAA standard but the other parts would have to be looked at.
DR. COHN: Okay, Justine?
DR. CARR: This is really helpful and clarifying, I appreciate it, and maybe this is a naïve question. When you say the proposed attachments, there are six types and four others proposed, is this the current state or is this derived from current state of what would be able to be transmitted? Just some clarification on how these, why these six --
MS. TRUDEL: That's an excellent question. When we started looking at this it was pretty clear that no one was exchanging any attachments electronically and the group that was doing the groundwork for this essentially did some surveying and found that there were literally hundreds of potential different kinds of attachments, some extremely specialized. And so they tried to do some kind of 80/20 analysis to figure out if we only adopted a certain number of them where would we get the biggest volume and the six that we're proposing are the ones that if those were automated those are the ones that the industry would be most likely to adopt and the ones where the types of data that's most often requested in a claims attachment.
DR. COHN: Other questions? Bob Hungate.
MR. HUNGATE: As I looked at the flow chart the presumption is that the claim when it originally goes in says nothing about claims attachments, that the claims attachment process is triggered by someone asking questions. Now I can visualize a data mining methodology where a hospital might mine its data and find that this vendor always asks these questions about this kind of claim. Is there provision in the claim information to say this claim will have these attachments? Is there a way to link the information from the claim to the required attachments based on a specific vendor?
MS. TRUDEL: That's an excellent point and that's something that is debated in the proposed rule. What we found in some of our initial discussions was that providers said oh for heaven's sake, I know every time I send an ambulance claim this plan is going to ask me for this piece of information, why can't I just send it all at one time and that's more advantageous to my processing and my cash flow. What the plans said was yes that's true but if you send me attachment information that I don't expect I don't know what to do with it and it seriously affects my business process because then I'm sitting here with this piece of data with no claim to associate with it and I don't know what to do with it, all I can do is store it and hope that the claim will come in.
We've tried to split this down the middle and our proposal was that for the most part an attachment would be based on the plan asking for information from the provider. However in situations where a plan is willing to tell its providers in advance this is how I ask for information then the provider could send it in at the time of the claim and we request comment on this because it's really a very tricky issue for business processes on both sides.
MR. HUNGATE: That's good, glad to hear that.
DR. COHN: Carol McCall?
MS. MCCALL: You talked about bridges and I think that they're going to be absolutely critical. The question that I have here around the standards and the taxonomies that are being used, do you know the extent to which these are being integrated in some of the AHIC work and the RFPs and the certification essentially of EHRs?
MS. TRUDEL: Steve is going to answer that for me.
DR. STEINDEL: Yeah, I can give a comment on that, Carol. In terms of the clinical information that's going to be transferred in the claims attachments the RFPs call for the people who were awarded the RFPs and for AHIC to consider the CHI standards in any discussions that they have about what standards to recommend in an area, and that's the standard government approach for this. So I would imagine that we would be seeing a congruence between what's coming out in the claims attachment and what's coming out in the electronic health record world. And at this point in time certification has not pointed to particular standards because that's a private sector activity and we haven't had any clear direction on that but they're planning to.
DR. FITZMAURICE: I would also add that the AHIC probably at the end of this month will be deciding on the use cases to be used throughout the standards activities and that will be the opportunity to see where the attachments and the clinical information within fits in with the use cases.
DR. COHN: Any other questions? Okay, well now, let's now turn to the letter.
DR. COHN: Let me tell you we obviously have a number of options with this letter, I mean this is a letter being proposed by Standards and Security, excuse me, Subcommittee on Standards and Security. Obviously we'll go through it sort of basically paragraph by paragraph, we may make it through it in the next 15 minutes, I mean we have to at least go through it once today. If everybody thinks it's great we can obviously pass it, we can provide comment, take it back to the subcommittee, bring it back tomorrow. We could even decide that given that there's more time we could even decide that we need an additional letter. On the other hand if we do that we would have to convene a conference call of the full committee probably over the holiday season to deal with that --
MR. HOUSTON: Mr. Chair, are you threatening us?
DR. COHN: No, I'm just giving you your options. So I mean I think we can keep that in mind or if indeed there's a 60 day period we can do a follow-up letter with a conversation. The point I'm making is is that even if there is a 60 day extension we do not have a face to face meeting occurring until middle of February which is long after that window closes so if there are additional comments that really do require an additional letter we need to come up with another process to deal with that. So that's just sort of setting expectations.
MR. BLAIR: One thing Simon also, NUCC, NUBC has also written a letter which covers a number of topics which I think Steve or you might be able to point out that a number of issues are covered in that letter and we chose to not be redundant and cover them in ours. Did you want to make a comment about that?
DR. COHN: Well actually the comment I would make is that a wide swath of the industry, including many health plans, providers, organizations both public and private are obviously in the process of reviewing this and providing comments and I think that it's very appropriate, there are probably many people around the table whose organizations are providing comments to the Secretary as well as many of you are members of other organizations which are providing comments also. Jeff that's not quite the comment that you wanted me to make but I mean I think we're all aware of that and obviously these are meant to be NCVHS comments.
Okay, everybody okay with this so far? Okay, well Harry do you want to start off with this?
MR. REYNOLDS: Do you want me to actually read the letter or just go by paragraph by paragraph talking about the highlights?
DR. COHN: I actually would like you to read the letter given that it, yes I would like you to read the letter and then ask for comments or clarification paragraph by paragraph.
MR. REYNOLDS: And it's also great to follow Cecil B. DeMille(?) and read a letter. And we're going to actually put those highlights in the letter when we send it.
Paragraph one. As part of its responsibilities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) the National Committee on Vital and Health Statistics, NCVHS, is responsible for studying, selecting and recommending standards for electronic health claims attachments. We are pleased therefore to comment on the new claims attachment Notice of Proposed Rule Making, NPRM, which was published on September 23, 2005.
Any comments?
Second paragraph. NCVHS's interest in the topic of claims attachments spans several years including numerous hearings. Our recommendations most recently were provided in our letter on claims attachments dated March 5, 2004. We further evaluated the need for streamlined updating of transactions and code sets to keep pace with industry requirements and new use cases. This issue was addressed in the context of our recommendations on HIPAA related topics and included in the recommendation number two in our letter on electronic prescribing dated September 2, 2004.
Comments?
Paragraph three. We appreciate the efforts undertaken by the Centers for Medicare and Medicaid Services, CMS, in developing this claims attachment NPRM. We believe that the use of electronic claims attachments will help decrease the administrative overhead associated with clarification and adjudication of approximately a quarter of the health care claims submitted in the nation today and help advance initiatives related to the development and adoption of electronic health records.
John?
MR. HOUSTON: This language, a quarter, I would say one quarter.
MR. REYNOLDS: Okay, next paragraph. NCVHS supports the proposed standards for electronic transmission of attachment information for the six types of services as set forth in the NPRM but having only a limited time to review the standards offers no specific technical comments. We do recommend flexibility for adopting new claims attachments transmission and messaging standards in additional types of attachments. In particular the NCVHS recommends a streamlined process for adding new standards and attachment types and for modifying existing standards. The committee urges the department to investigate other ways that adoption of new versions could be accomplished without the need for the lengthy and cumbersome rule making process.
MR. BLAIR: Question on that? I notice that some of the recent bills in Congress seem to be continuing the process of having Congress specify a new version of, I think it was CPT codes and going from ICD, well, is that correct?
DR. COHN: Jeff, I think that's ICD codes you're referring to.
MR. BLAIR: And also there was an NCPDP code that they specified in the House bill that I saw for a different version. And so my question is whether it is sufficient for us to direct that recommendation to the Secretary or whether it's beyond the Secretary's ability to be able to make that modification without the support of Congress to modify the law, I don't know. Is there any guidance on that?
DR. COHN: Harry do you want to comment or should I try to comment?
MR. REYNOLDS: No, you go ahead. I have your wing.
DR. COHN: There are obviously a variety, in any year there are a variety of pieces of legislation that come before Congress and obviously without them passing one it's hard to comment specifically on pending pieces of legislation however obviously there is significant Congressional in both the issue about moving forward with ICD code sets and I of course would remind the committee that we have previously had hearings, had a RAND report that we sponsored in relationship to the issue of moving from ICD-9 up to ICD-10 which is part of, which we have gone, we are previously on record as supporting the move from ICD-9 to 10 in a measured and careful fashion.
It also turns out that there is a, to move to that one needs to have new ANSI X-12 standards just because the current standards cannot accommodate ICD-10 and so I think there is Congressional interest and discussion around all of this, the recognition that these two pieces are interrelated. And I think the recognition probably that something as important as moving from ICD-9 to ICD-10 really is of interest to a wide variety of people across the country may fall into legislation as well as regulation.
MR. BLAIR: The ICD-9 to ICD-10 I know that definitely is but it was like going from one version of NCPDP Script --
DR. COHN: It's actually ANSI X-12 I believe unless I'm mistaken, and you may be referencing another bill potentially. Was there something else? Karen, do you have a comment
MS. TRUDEL: Yeah, I just have a general procedural comment and Marjorie may want to correct me if I'm not quite right on this, but the NCVHS as an advisory committee to the Secretary should feel free to make whatever recommendations it feels are appropriate to the Secretary, the Secretary then makes the decision or the assessment as to whether he has the authority under his current legal authority to take that kind of action or if not then he may wish to pursue legislative change.
DR. COHN: And we can continue this conversation, I suspect that this issue you're bringing up Jeff may be a little beyond the scope of this letter but it is something that should be talked about by the Standards and Security Subcommittee only because I think you're bringing up obviously a much bigger issue which may be the purpose or point of another letter. Mike Fitzmaurice?
DR. FITZMAURICE: On the last paragraph in the sentence next to the last it reads in particular the NCVHS recommends a streamlined process for adding new standards and attachment types and for modifying existing standards. Well then my mind naturally asks what streamlined process are we recommending, so I would suggest a change in the sentence to in particular the NCVHS recommends that a streamlined process for adding new standards and attachment types and for modifying existing standards be found, or be developed.
MR. REYNOLDS: Everybody in agreement? I've got a question, were you going to respond to Jeff and Simon? Okay.
DR. TANG: Actually I'm piggybacking on Michael because I was talking about the last sentence, and Karen's response to the question I asked about is there a roadmap you're planning and her response was no, we'd prefer this to happen outside of the HIPAA process. Would that satisfy what you're requesting in the letter?
DR. COHN: Are you recommending some changes here or --
DR. TANG: Well I'm trying to make sure I understand what the letter is requesting, so when I asked Karen is, this is a rule, it is not a complete standard, set of standards, it is a direction and she explained how the incremental benefits would accrue. And she also added that in order, this is my interpretation, to make sure this is done in a streamlined and expeditious way their thought is that further development of the next steps and roadmap would occur outside of the HIPAA process. Did I misunderstand that Karen?
MS. TRUDEL: No, I don't think you misunderstood it but I need to clarify what I said a little bit. My point was that there's some leeway in terms of how prescriptive we want to be inside a standard and we chose not to be particularly prescriptive within this standard. If for some reason the industry decides that there's a need to go to another version of the claims attachment that has to be done by regulation and that's what the issue of the modification process addresses. So the current version of the standard provides a fair amount of flexibility but if at some point in the future there's a decision that we want to step further or we want to adopt new standards for new attachment types we're back in the HIPAA realm again and there is a specific modification process that the committee is already on record as saying needs to be more flexible.
MR. REYNOLDS: And I would say as a committee we tried to step, this is not, we prefaced in paragraph two carefully that we mentioned in e-prescribing we had the same issue, the same recommendation, that as the industry, as NCPDP or anybody else starts rolling out version, if every version has to be dealt with through a large legislative process how will people move forward, we used the term backward compatible as one of our terminologies that we used so that you could allow people to move forward but you're not penalizing everybody behind.
On the other hand we didn't want to be too prescriptive because how this actually works with all the HIPAA regs and all the other things that are going on as to how things get approved, we were not trying to be prescriptive in stating exactly what should happen, instead we were recommending that as you look at more and more versions coming out, for example the attachments came out on, mentions 4050 which is not actually an approved version yet, also people are already working on 5010 so you find yourself in a situation that you got lots of things in place.
So we were just trying to make a point, a clear point that the whole process needs to be considered because there's a difference between adding a significant thing like an 837 versus possibly just changing some data elements.
John had a question first.
MR. HOUSTON: Just real briefly in the first sentence, the last part of it, but having only a limited time to review the standards offers no specific technical comments, I'm not sure whether that's meaningful, I mean because you're talking about having a streamlined process later in that paragraph so when I read it it sort of seems like it's sort of whining a little bit.
MR. REYNOLDS: Comment on that Marjorie.
MS. GREENBERG: My concern on that is that does this raise the expectation that if the comment period is extended, which there's a strong possibility, then you'll be coming back with specific technical comments, and do you have any intention of doing so.
MR. REYNOLDS: No, I'm not sure the committee ever had the intention of diving into this at a significant technical level and anybody else on the committee can jump in --
MS. MCCALL: Then it's not because of lack of time. I would recommend then that we drop it because it does set the expectation that we would come back.
First some of this is relatively new to me and I guess the whole concept of taking this out of the realm of legislative activity and out of HIPAA. Is that going to be well embraced? Or is that something that we need to make sure not to bury the lead if that's one of the key themes here. We did it this way the first time but by God let's not ever do it this way again because it will never be nimble enough to adapt. Is that going to be easy to accomplish or is it going to be hard?
MR. REYNOLDS: I would say until, the whole reason we have stayed out of prescriptive is the way this all works, and if you make, if you allow the adoption of new versions then how do you get everybody to move towards it because there's one school of thought that says if it's not mandated it's not going to happen, there's another school of thought that says let free enterprise move as long as things are approved. And so I think it is an issue, in other words in a lot of other situations I know from our committee we have been a little more prescriptive in what we may or may not have said, this one opens a whole new process, a whole new situation and a whole new structure as to how it all plays together and whether it's Karen looking at it from CMS, whether it's Congress looking at it, whether it's the department looking at it, whether it's the industry looking at it, it's going to take some vetting and it's going to take some issues. But the point is continuing to have everything have to go through a three, four year cycle is not where we want to be so that's kind of the initial message that we're sending out.
Please, anybody on the committee agree or disagree.
DR. COHN: I'm just trying to think of how we're referencing here it, I think we're referencing it by reference to other documents that we've sent about all of this stuff and I don't know that we really necessarily need to go extensively into this document rehashing other pieces though I do think we may need a sentence at the very end where we talk about, I mean we're sort of saying department go off and come up with something streamlined and maybe we need to say something along the lines for our part we will continue to work with you to help identify and refine that streamlined process, and that's sort of the thing. Obviously the government itself it sort of, I mean there's pieces called legislation, there's pieces called regulation, but then there's also pieces called streamlining the regulatory approach, and I think what we were talking about primarily and have referenced previously has been trying to streamline the regulatory approach on this.
MR. REYNOLDS: Before we get too many subjects on the floor at once does everybody recommend in that next to the last paragraph that we strike the limited time and whether or not we would come back with --
DR. STEINDEL: I have a comment on that. Actually in the various drafts I was the one suggesting adding that wording and the reason why I added that wording is without it it says we support the proposed standards. There are numerous aspects of the proposed standard that if we had, and other groups are asking for more time to review and we would never have the time as Harry points out, that I think we would find we wanted to comment on. So I did not want the word that NCVHS supports the proposed standard to be interpreted that we were fully behind all aspects of it because we haven't had enough time to review all aspects of it from a technical detail.
MR. BLAIR: What if we took the entire sentence out so it doesn't have the statement that we support, just the entire sentence goes?
DR. STEINDEL: Or we compliment CMS on introducing, something like that.
MR. BLAIR: I think his idea of compliments, Steve is saying we compliment CMS because this is making progress, this is moving the ball forward, and we don't have to say anything more.
MR. REYNOLDS: What I'd recommend is that the committee take this and bring it back, this sentence back tomorrow for consideration.
DR. COHN: Karen, did you have a comment on this?
MS. TRUDEL: I just have one suggestion for pursuing additional language and rather then saying that there's an agreement in every aspect, what are the aspects that the committee does agree with, does the committee agree that the first six are good, that it's good to take a phased approach, that it's good to use established standards like X-12 and HL7, I mean I think there are some things that the committee could weigh in on and say that they're good without giving the impression that we buy in down to the lowest possible level of technical detail.
DR. TANG: In my mind there's a critical question of scope of this particular piece of, particular provision of HIPAA, because an attachment can be as expensive as basically the EHR and clearly that's not, that may be what we need but that's not what we're expecting I think of CMS. And that bears on the whole process of what's included and what's excluded from this regulatory process and modification. So I don't know what the answer to that scope question is because I think that will bear on what we want to comment on with respect to the process. Do you have a clear definition for what standards is within the scope of this regulatory process on claims attachment?
DR. COHN: There are a number of standards referenced, things like HL7, LOINC, there's obviously X-12, this is a CDA document and I think they're asking for comments about that. I think there's I mean a whole set of issues about all of this stuff but I think as Karen has comment this is meant to be something that sort of links the clinical and the administrative side. Now I don't know whether you're asking about the issues about whether or not, how much information you could ask for which of course is governed by minimum necessary, but are you talking about the --
DR. TANG: It's more they could get into data content standards for example and is that the intent and so if that were true would that be, have to follow the regulatory process and notification process, so that's my real question is how expansive is standards regarding claims attachment because that can be key.
DR. STEINDEL: Paul is getting into some of the nitty gritty things. May I recommend that we defer it until the subcommittee discussion? Because you're bringing up some of the technical issues.
MR. REYNOLDS: Are we continuing then?
DR. COHN: I think we should continue, I'm sort of looking around --
MR. REYNOLDS: No, when David walks in I'll stop. We were interested to see that the development of the NPRM, this is the last paragraph, we were interested to see that the development of the NPRM was informed by a small scale pilot project with Empire Medicare Services which focused on the human decision variant for sending text or converting data to text. We believe a pilot, we believe pilot testing is critical for both the human decision variant and the computer decision variant in which data can be used in an automated fashion and read and understood by the computer. Because clearinghouses and vendors may not have the experience with LOINC code sets we believe that pilots should include testing of the full range of LOINC codes required by the clinical and laboratory attachments along with any other untested claim attachment types.
NCVHS therefore recommends that pilot studies should be funded and conducted using both the computer and human variants for the full suite of claims attachments and attachment types that are proposed for adoption in this NPRM as well as the other attachments that are under developing including home health care, durable medical equipment, periodontal, and children's preventive health services. The committee expects that the department will be able to leverage partnership opportunities with the private sector that should be stimulated by rulemaking in the areas of claims attachments.
John?
MR. HOUSTON: I have two comments, one is a real nitpicking thing which is as you talk about a pilot project in one place and a pilot study in another, make it consistent. The other one is I don't understand what that last sentence means and I guess I'm not sure what it is, what it adds to the paragraph, or whether it just needs to be clarified.
MR. REYNOLDS: I guess our comment is that obviously the private sector is very interested in this and focusing on it and it's not like you're having to possibly look real hard to find people that would be willing to pilot some of these things. I think that's where we were heading.
MR. HOUSTON: I think we should probably just clarify it, say it more clearly.
MR. REYNOLDS: Simon, I'll turn it back to the chair.
DR. COHN: Harry, thank you for your good work on this one, we'll finish off the remainder of this probably some point in the afternoon.
Well with that I'm pleased to welcome Dr. David Brailer, David thank you and whenever we see you we usually congratulate on your good work and I think never more so then now, so please.
DR. BRAILER: Thank you, that's a very kind way to start the meeting, I appreciate you all taking time to hear the update about what we're doing in the Office of the National Coordinator. That is our new acronym, ONC, we have stopped the acronym ONCHIT for fear of constant abuse of the name.
-- [Laughter.] --
DR. BRAILER: I'd like to just give you all a quick update on two things that we have underway, first is a very quick briefing on the contracts that we've signed since I last met with you which constitute a very large share of the infrastructure that we will be laying out and playing from over the course of the next year, and then also on the activities of the American Health Information Community which is one of your peer advisory committees and we'll be working very closely with you to advance the health information technology agenda. And I'll be very brief and I'm passing out a copy of both the major initiatives that are going on through the contracts as well as the breakthroughs that are detailed for the American Health Information Community. So I'm going to just very briefly comment on six contracts, one policy change, and then I'll turn to the community, and it's largely following this major initiative sheet.
So I think you all know that we awarded a contract to ANSI, the American National Standards Institute, a couple of months ago to create a new group which is the Health Information Technology Standards Panel, and that panel will be our harmonizing agent for standards in the United States. The purpose of this group is to not change or intervene directly into the affairs of the SDOs, to let the SDOs continue their entrepreneurial spirit and to be part of whatever global alliances they may be part of, but to create a coherent single set of standards for the U.S.
And our challenges are three fold, first to make sure that the standards are non-duplicative, non-overlapping, non-ambiguous. Two, to make sure that they are complete, I'll come back to that. And thirdly, to make sure they are specific in detail. And I think standards in the U.S. generally speaking fail on one or more of those nearly every time. They're often duplicating or ambiguous standards, standards exist but they are not complete enough to be used to solve certain problems, and they often because of the consensus process stop at the level of detail needed for two different software engineers or coding teams to implement them in a way that allow them to be interchangeable.
And standards harmonization will focus its efforts on those three challenges and we've asked them to be not data driven but business driven and what we mean by that is don't say what can we do to standardize lab data but say what can we do to solve the problem of lab data arriving in an emergency room, so to work from business cases, to help focus this and ultimately link the pain of standardization, and let's be honest, standardization of data is painful, it's costly, requires changes of systems, of business process, the only way we think this will diffuse the U.S. is if we link that pain to a benefit and the benefit comes from solving someone's problem.
So we do want the standards community to directly integrate itself into the problems that doctors, patients, and hospitals live with every day and to see themselves as an ingredient of their success, and if they don't see if that I think we will not achieve the level of standardization that you've called for since I was a child, which wasn't that long ago.
Secondly, compliance certification, I think you've heard a lot about this, we had the privilege of contracting with a group that has already distinguished itself for the quality and detail of its work and the very, very well developed public process and that's the Certification Commission for Health IT. It's really a remarkable group of people who came together with a passion, its what the private sector has done best I think in health IT recently, and we have now contracted with them to develop first criteria for what constitutes ambulatory electronic health record.
And to make it as simple as possible what they will do by developing those criteria is change our language about health IT. We will no longer get into debates about what's the difference between an electronic health record and electronic medical record, a computerized patient record and other things, we will talk about functions and whether or not functions constitute those tools and I think we need to get that level of specificity.
They have a very short deadline for delivering to us ambulatory PHR certification criteria in a draft state, i.e., next month, and to finalize those by no later then mid-2006. And expect to see prototype certification results done by July of 2006 such that a system could ask to be certified such that it gets a Good Housekeeping Seal of Approval as certified or not. We think this is a benefit to physicians and hospitals that are trying to sort out their options and are feeling confused and overwhelmed with all the different choices they have and they want to kind of know what's going on with products, it will be the investment community put their capital against tools that help the American public become more healthy, and it will help policy makers have specific policies that can be enforced and operationalized in a way, and I'll come to the primary example of that that's underway now which is the physician self referral and anti-kickback safe harbor that we've proposed.
We will then follow compliance certification into inpatient electronic health records, and then into national network architectures. But the Certification Commission is required to lay out a roadmap for a variety of different technologies that it can look at over the next three years.
Third is privacy and security solutions and we have contracted with RTI to launch a new organization called the Health Information Security and Privacy Collaboration. And this organization is novel in that it will be an organization of states and state leaders to come together to begin understanding what we need to do to move the paradigm for privacy and security from the paper age to the digital age. It's our sense that a lot of debates occur about what's right or wrong with current policies but the issue in the middle of these is the irreconcilable challenges that paper introduces. We have a debate about enforcement, that enforcement means cost and it means significant barriers in a paper world. That debate changes dramatically in electronic world, it is also is the same with disclosure accounting.
So if you look at many of the issues we're facing we believe that they're imposed in part by our dependence on paper and so what this group is going to start doing is looking at what should the policies and procedures and practices look like at the state, federal, and business levels in a world that is digital, what are the policies we should begin expecting and who is it that should do things about these, what are federally driven, what are state driven, and what are business policy driven. Because we want to make sure that our paradigm for privacy and security keeps up with the technical innovation that's occurring today.
Now I need not say that to you as a group who is already well along in this work but we have to be able to get this to live and breath at the level where these laws are largely made which is at the state level. And so we want to be able to get focused quickly on each state that wants to engage on this having their own health information security and privacy collaboration that rolls up into a federal effort to begin creating a living breathing effort. In many ways I view this as the first cousin of compliance certification in that it is an organization process we're trying to create that gives us a platform to begin addressing this problem over the course of time.
We announced last week four awards for prototypes of the Nationwide Health Information Network. This was a very tough choice because we had more then 80 excellent proposals from well developed teams and consortia of providers with very good health markets. But given the current status of our range of '06 appropriations we awarded four contracts, those were to Accensure(?) and colleagues, CSC and Colleagues, IBM and colleagues, and Northrop Grumman and colleagues all working with three distinct health market areas. And these market areas will work with these consortia to develop architectural requirements for nationwide connectivity, they will submit those for review across all four of them, and they will prototype those in the actual markets.
The output of this group will become inputs into the Certification Commission in its dialogue about how do we certify architectures and our thinking is that this is not unlike the electronic health record except we don't have a large share of providers offering the service today. In the end the best analogy I can give you is that our vision for the Nationwide Health Information Network is not unlike cellular telephony where the electronic health record is like the handheld device, you have many choices, some that have a lot of features, some that don't, but all of them can connect to a cellular network and you can have complete interoperability of sharing calls back and forth and passing them off to any network.
So there will be a set of competing network operators who compete on the price, the quality, and the data completeness of their service to doctors such that they can connect to electronic health records and delivery them, the labs, the pharmacy data, the other doctor's notes, the other components that are now done in one up specialized and highly cumbersome and costly direct integration and interfaces. This project will take some time to play out, it's an 18 month project to start, and we expect to see this evolve significantly over the course in time.
We just finished the report on an effort on health information technology and health care fraud asking questions about what do we believe the impact of health IT will be on the rate, incidence and prosecution of fraud, what do we expect it to do with respect to fraud losses, and on the flip side what is it that the both private enforcement and federal, state law enforcement authorities should do to begin preparing for the world of cyber fraud. This looked at legal regulatory issues, it looked at business practice questions and it looked at economic models.
And the findings of the economic models would not be surprising to you that with partial interoperability, with information silos, the exposure to fraud, could go up, but more important the cost of policing fraud could go up dramatically. But in an interoperable world where we're able to get more complete data and move information tools towards the point of care that can help providers know while they're seeing a patient and coding them whether or not fraud could be being perpetrated, we can begin to move into a world not of prosecuting fraud but of prosecuting fraud as preventing it at the source of care which is much cheaper for everyone. And so there's great potential, we'll be following this on with a much more specific demonstration project to begin understanding what that means sometime in 2006.
We also awarded a contract to George Washington University, to Sarah Rosenbaum and to David Blumenthal at Massachusetts General Hospital to pull together an annual report on health IT adoption. Now there are many, many surveys that exist about the level of health IT adoption and some of you know that I wrote a paper on the level of health IT adoption, in fact I think Paul Tang asked me to do that for his Patient Safety Data Standards Committee, and what I ended up doing was writing a paper on how bad all of the statistics were. And then of course like any good scientist I drew conclusions from it anyway.
But our sense was that we clearly have an obligation to report to the President and to the American people about whether our policies are working and what's happening with adoption, in particular not just to focus on broad levels of adoption but specific drill downs on adoption gap issues in urban versus rural, large versus small, safety net versus general care environments, etc. And the way to do that was to not just fund another survey that supplements the ones in CDC and CMS and the private sector, but was to put together an expert panel whose job it was to create a meta analysis framework for all of the standards, or all of the surveys, and to be able to compile them into an aggregate view of what's happening.
The best analogy I can give you is the Council of Economic Advisors who pulls together many, many data points, forecasts, models, leading indicators of economic function and tells America what's happening with the economy in an objective quasi scientific way. And I say quasi because it is a meta derivative product. And so this group will do this but hopefully over the course of that not just tell us what the statistics say but through their meta standards allow all of the data collectors to begin adopting common questions and common survey techniques in working together. And we have given them authority to do specific surveys if they need to drill down on a specific area or if they can't resolve a finding based on the data that happens to be made available. So this group is goin