[This Transcript is Unedited]
Silver Spring Hilton
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Agenda Item: Call to Order - Dr. Cohn
DR. COHN: Would everyone please be seated? We'll get started momentarily. Okay, good morning, I want to call this meeting to order, this is the second day of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The committee is the main public advisory committee to the U.S. Department of Health and Human Services on national health information policy. I am Simon Cohn, chairman of the subcommittee, and the national director for health information policy for Kaiser Permanente. I want to welcome fellow subcommittee members, HHS staff and others here in person. I also want to welcome those, and I think I should comment that we're I believe not quite on the internet yet, as I understand there's nobody in the internet office yet this morning, so we'll notify everyone when the internet connection is established, but for most of the day we will be on the internet and I do want to remind everyone to speak clear and into the microphone so that when we get connected they can hear our discussions.
This morning we continue our discussion in testimony regarding ICD-10. We'll be having testimony discussion, we intend to be having some open periods for public comment and testimony as the morning continues. In the afternoon we'll be discussing possible next steps and possible letters or other actions we may be recommending to the full committee.
Tomorrow we'll focus on reviewing and updating as necessary the PMRI terminology letter that we've been working on for the last several sessions and hope to bring to the full committee next week.
I guess finally I would comment, obviously for those in attendance, I do want to emphasize that this is an open session. Those in attendance are welcome to make brief remarks on the issues coming before us today as long as it obviously has relevance to our discussion. As I commented we also will have time at the end of the session for anyone who feels that they need to make additional comments on the issues. Obviously for those on the internet, and we'll say this when the internet is established, we do welcome letters via either paper or via email on any of the issues coming before us today.
With that, let's have introductions around the table and then around the room. For those on the national committee if there are any issues coming before us today for which you need to publicly recuse yourself please so state in your introduction. Jeff, would you like to introduce yourself?
MR. BLAIR: I'm Jeff Blair, Medical Records Institute, vice chair of the subcommittee, member of AMIA, ASTM, HL7, HIMSIS, there's nothing that I'm aware that I need to recuse myself from.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the subcommittee and liaison to the full committee.
DR. HUFF: Stan Huff with Intermountain Health Care and University of Utah in Salt Lake. I would need to recuse myself if we vote on HL7, LOINC, or ICD-10-PCS.
DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation, member of the committee and subcommittee.
MS. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC, and executive secretary to the committee.
MS. AULD: Vivian Auld, National Library of Medicine, staff to the subcommittee.
MR. GRISSOM: Tom Grissom from the Center for Medicare Management and I'm appearing here as a witness before the subcommittee.
MR. SMITH: I'm Merritt Smith from the Robert E. Nolan Company and I'm here as a witness.
MS. DOYLE: Theresa Doyle with Blue Cross/Blue Shield Association, I'm also a witness before the committee.
MS. GRAHAM: Gail Graham, Department of Veterans Affairs for Dr. Claudner(?), staff to the subcommittee.
MS. FRIEDMAN: Maria Friedman, CMS, staff to the subcommittee.
MS. SQUIRE: Marietta Squire, CDC, NCHS, and staff to the subcommittee.
MR. GUSTAFSON: Tom Gustafson from the Centers for Medicare and Medicaid Management, excuse me, Services.
MR. RODEY(?): Dan Rodey from the American Health Information Management Association.
MS. PROPHET-BOWMAN: Sue Prophet-Bowman also from the American Health Information Management Association.
DR. BICKFORD: Carol Bickford, American Nurses Association.
MS. SMITH: Louise Smith, McKesson Corporation.
MR. ALFANO(?): Bill Alfano, Blue Cross/Blue Shield Association.
MR. SPIEGEL: Jeremy Spiegel, reporter from the Gray Sheet Medical Device Journal.
MR. ABLE(?): Richard Able from 3M.
MS. BROOKS: Pat Brooks, CMS.
MS. ECKERT: Karen Eckert from MediSpan.
MS. HARPER: Danine(?) Harper, the American Hospital Association.
MR. ARGUS: George Argus, the American Hospital Association.
MS. WALWORTH: Shelly Walworth, Unicorn Medical.
MS. LUNDBERG: Michael Lundberg, National Association of Health Data Organizations.
MR. EMORY: Jack Emory with the American Medical Association.
MS. FRASIER: Chris Frasier, American Academy of Professional Coders.
MS. MIDHANY(?): Sheila Midhany, American College of OB-GYN.
MS. LESH: Kathy Lesh, the Kevar Company.
MS. THOMPSON: Maureen Thompson, the American Speech Language Hearing Association.
MR. KYLE: Frank Kyle, American Dental Association.
MS. FISHER: Pat Fisher, National Center for Health Statistics, CDC.
MR. WILDER: Tom Wilder, AAHP/HIAA.
DR. COHN: Good morning. I presume we're still off the internet? Okay. Now this morning we're hearing testimony from Tom Grissom and from Merritt Smith and Theresa Doyle, both from Blue Cross/Blue Shield Association. Tom obviously we're very pleased to have you here and we know that your time is limited. What we wanted to do is to let you just give us your testimony and then we'll obviously as we've talked allow time for questions and discussions before moving to the Blue Cross testimony, and obviously we understand that you have to move on to your next engagement later on this morning. Tom, would you like to start off?
Agenda Item: ICD-10: Next Steps: Discussion Panel - Mr. Grissom
MR. GRISSOM: Thank you Mr. Chairman and thank you members of the subcommittee for this opportunity, for CMM, which is a unit within the Center for Medicare and Medicaid Services, to offer comments and testimony as you try to formulate a decision or recommendation on the coding issues facing American health care. The agency for which I work, which used to be known as the Health Care Finance Administration, is essentially structured into three centers, one for Medicaid, one for Medicare Plus Choice, and one for the traditional Medicare fee for service program and my responsibilities are director of the latter of those three units, the Center for Medicare Management is responsible for the fee for service program.
We are still, even after yesterday's announced merger, we still are the largest payer of health care in America, I don't know who we can merge with to withstand the competition, but in any case we have 40 million beneficiaries, which includes both disabled as well as Americans 65 and older, and we provide over $100 billion dollars worth of health care on an inpatient side and more then $50 billion dollars in payments to physicians and clinical professionals each year. Our objective this morning, or my objective this morning, is to not sit here and read the testimony, which I believe has been provided to the committee, I hope is in your binders, but to do a real quick walk through about the large issues and try to clarify some of our concerns when we look at the issues facing our program knowing that this committee serves as an advisory committee to the Secretary of the Department, and your recommendation to him is one that we may well have a part in implementing, and so I don't mean to speak for the Secretary but as part of the Department of Health and Human Services that will have to live with whatever decision we make here and the Secretary carries out, I want to bring to you just information about our experience and about our preferences and our beliefs.
There is a long history, it's at least a decade old, the issue being in front of this subcommittee and the committee at large with respect to the use of ICD-9 and the belief or the articulation that it was fast, I think the language at that time, the wording was fast becoming outmoded, and what I would like to do in part this morning is to tell you what has happened, I don't know that it was fast becoming outmoded but we are ten, 11 years post that commentary and I'm going to try to give you concrete examples of where ICD-9 is reaching its limits and then talk about ways in which we believe that ICD-10 would lead to more accurate payments, more appropriate payments, and we believe improved quality in health care, which at the end of the day is the objective of the Secretary and the Department, and as I reminded myself coming over here this morning you are a subcommittee of a committee that is concerned with vital health statistics, and if I can keep you focused on vital and health this morning I will have reached my own objectives.
I am not a clinician and I certainly am new to service in the government but I have studied this issue because of my exposure to health care, my participation as a provider and running a hospital and coming up through companies that provided both long term care and acute care, and perhaps its useful as an outsider, or perhaps as an outsider I can offer you a perspective that perhaps is a little different. And so I'm going to do a real quick comparison of nine and ten just to make sure that we're on the same page. One of the difficulties is that ICD-9 does not have a PCS, go off to a PCS and a CM, instead those functions are collapsed into three volumes, volumes one and two, and three. Three are the procedure codes, volumes one and two are conditions, symptoms, and diagnosis, and I want to focus, encourage you to focus not just on the D in ICD and the diagnosis but to recall that in volumes one and two we're also talking about conditions and symptoms of the patient. Volumes one and two of nine is a five digit numeric, volume three, the procedure code in ICD-9 has about 4,000 codes.
When we look at ICD-10 it is split, not into volumes, but into CM, clinical modification, which I believe is under the maintenance of CDC, another sister agency, and ICD-10-PCS, which could be, if it's the committee's decision would be under the maintenance of a committee sitting in CMS. ICD-10-CM is a seven digit alphanumeric system that has 120,000 codes, ICD-10-PCS is a seven digit alphanumeric with about 200,000 codes. The P in CPT and the P in ICD-10-PCS both stand for procedure, but they're not interchangeable, so far as I can tell in looking at this issue and all the literature is they were never meant to be interchangeable, and no one has spent a dollar of resources or an hour of time focusing on proving that they are interchangeable. The D, in DRGs, which is a payment grouping on the inpatient side, is also mirrored with the D in ICD-9 and 10, both stand for diagnosis, but the terms again are not interchangeable in their uses nor are they intended to be.
ICD-9, as well as 10 if it is adopted, serve payment categories, DRG is a payment category, CPT codes are payment categories, APCs, which are the way we pay the facilities on the outpatient or ambulatory basis are payment classifications. And there has been and continues to be concern that we not make inappropriate use of ICD-10-PCS in setting for which it is not intended, and just because it and typically I think people are concerned that we use it for and make use of it in settings other then the current use of ICD-9, which is the Volume 3 or ambulatory payment category. The fact that there are people concerned about that sometimes means that they don't also tell us what they are for or what they could support, and what I would like to point out to you is the value of ICD-10, not PCS, but CM, because that's where the clinical condition codes, symptoms and diagnosis are contained. And they're corollary, they're parallel in the current ICD-9, are used in physician billing, the accompany the CPT-code, CPT-4 codes, the HICPICs codes, and they tell us about the conditions and symptoms that are presented to the physician. Silence on the appropriateness of ICD-10-CM as a replacement for Volumes 1 and 2 in ICD-9 should not be interpreted as opposition, and in fact it is my opinion that in fact the increased specificity and breadth of the provisions found in ICD-10-CM will enhance health care and improve not just payment but also quality of our health care system.
In the years since ICD-9 has been in place and in the years since this committee expressed reservations about its lack of capacity we have been beset by many changes, new technologies, new procedures, new drugs in health care, and I want to give you just a few examples of what is occurring. Both systems are hierarchical systems that will lead a person or lead an individual who's trying to decode the codes through a path from the body system to more specific problems with the body system and what is done, and there are chapters in ICD-9 and what is happening is that we are running out of appropriate chapters to place procedures because of the limitations, and the limitations all have to do with the number of digits and fields into which you place things. Examples, LVADs, left ventricular assist devices, have been approved for specific conditions and we increasingly as technology develops make coverage decisions and payment decisions based on the condition of the patient, the symptoms presented, and the diagnosis. And if there is not a loop between the service back to the conditions inappropriate payment can result, or inappropriate care can result, and what is now happening is that the conditions for which the device or a drug are approved increasingly cannot be mirrored in the CM portion of ICD-9, and that's why the increased breadth and specificity of 10 is important and attractive to us.
Defibrillators that are increasingly in use should appear in chapter 36, which is where cardiovascular systems appear. There is no room in 36 for cardiovascular defibrillators of the new kind, and so they're put in a 00 chapter which has kind of become a miscellaneous place. It's like a broom closet and increasingly you put things in that closet. The difficulty may not be all that important, in other words I don't think we should design our health care system so that we can have an elegant perfect payment system and people who code know exactly what to do. And I don't want you to think that all we're focused on in Baltimore is the payment, I really want to focus on the health.
If you have a parent in a nursing home who has a decubitus ulcer today, there's one code in ICD-9-CM for describing that. In the ICD-10 system, CM, there are 60 codes. We cannot know anything more about your loved ones ulcer then that they have one, we don't know its location, we don't know its depth, we don't know its width, and over time the change in the depth and the width and the location and the increase in number of decubiti is extraordinarily important for care. That's the CM part, not PCS part, not the Volume 3 part, and the importance of CM and the patient's conditions and symptoms in 10 gives us so much more capacity for understanding the progress of treatment, the appropriateness of care, and the outcomes.
The fee for service program is easily ridiculed and easily held up I think for criticism because there is no feedback loop between service and fee, and there is no understanding of once you get past medical necessity, which is not done because of coding, because of compliance with certain policies, there is no feedback between service and fee. Improved payment systems, accurate appropriate payment, is important and I don't mean to underestimate that. However, payment should represent value, and value has to relate to care and health and outcomes and benefits. The public now demands its health care system and the Secretary demands of us increased attention to quality and increased attention to outcomes, not how many dollars you paid, now how many services you provided, but did the patient get better, was the protocol for care, was there one and was it followed correctly. We believe that 10 gives us the ability to develop metrics and to measure and to follow patients to do disease management, to develop protocols in ways that 9 does not.
One issue that everybody is concerned about is cost and benefit. At the last meeting of the larger committee, CMS was asked to provide a cost/benefit analysis and you have paid the RAND Corporation a considerable amount for a contract in which they were to give you a cost/benefit analysis, I believe Merritt is going to do that also. I think that we will be able to deliver an estimate from the Medicare and Medicaid programs before the full committee's meeting next month. But let me tell you that based on the numbers that I have seen there is no way that I can anticipate some catastrophic cost or risk that outweighs what we believe to be the potential benefits. And whether you take the range of the RAND Corporation that they have given you, whether you take the lowest end or their highest end, and they do have some pretty broad ranges, I think that they came down on the side that benefits outweigh risks.
Our agency will have to do a fair amount of work to crosswalk DRGs away from 9s and use 10s and move them in, they'll be some moving around of the diagnostic related groupings, there will probably be the creation of those, we believe that they would, could be done in our normal course of business on normal appropriation in terms of research contracts. But I do want to point out to you that without a doubt we believe that the number of claims that would be processed and accepted the first time and processed electronically would increase. 98 percent of our claims in the inpatient side come through electronically and pass through the first time. 95 percent of our claims on the part B side, carrier side, the physician side, pass through the first time. Most of the rejections are suspensions in payments, not denials, they're suspensions, because there's insufficient documentation. If you begin to count the numbers of dollars that are involved in rework or incorrect payment and we will be, we as an agency are trying to drive down our so-called error rate and announcements about the error rate will be forthcoming next month, if the benefit dollar or the dollar value of the benefit, and the dollar value of returned claims and reworked claims is considered as part of the benefit and cost analysis I feel confident, we feel confident, that the benefits outweigh the costs. A one percent reduction in those two categories I just gave you is a small reduction but it's one percent of a billion claims and it's one percent of nearly $200 billion dollars, and so we can talk about small percents but we are talking about such huge volumes that even in the absence of our report, which we'll give to the committee, I did want to say to you that our feeling is is that without doubt it will result in improved benefits.
That is not, and I don't know how we measure this, that is not to measure what we believe is the potential in improved care and outcomes, and that's why I want to get back to back to not PCS, but CM, conditions, symptoms, and diagnosis. The opportunity to understand what works, what the proper treatment protocols should be, how someone progresses over time, how the progression of an illness or a disease or the control of that occurs over time is essential to understanding what we do in the health care system. So for all of those reasons I appreciate the opportunity to explain myself and gladly pass on the responsibility for this decision to you and make myself available to answer any questions. Thank you very much Chairman.
DR. COHN: Tom, thank you very much. I think you all have heard that we're on the internet at this point. Questions or comments from the subcommittee? Well, Tom, I guess I'll start out with just a question and a comment.
First of all thank you for your comments about cost/benefit, obviously we're sorry that you haven't, that CMS hasn't completed it, but on the other hand I think it's important for us to know that there's nothing that you're seeing in any of the data that changes your conviction about an interest in moving to ICD-10. Code sets, at least from my view, and obviously I'm a practicing clinician but I still stalk about business, and I tend to think of code sets as business enablers, and really one of the things that we've been sort of listening for in this subcommittee and really the full committee is people in the world of health care, health care industry, willing to take advantage of the new functionality and capabilities of both ICD-10-CM as well as PCS and figure that they can do something with it to make either their work better or make them more successful, make the health care of America better, help you with fair and accurate payments, I guess maybe I'm paraphrasing but I think I'm hearing you stepping forward and saying that you feel that it would make a difference in terms of Medicare's ability to care for its population. Is that a correct statement?
MR. GRISSOM: I do, I believe that, and I believe that it will give us an opportunity to look at incomes, if we choose to, manage disease, and if it's, if it is possible or I know that it's possible, you make the choice, to develop best practices and what I call treatment protocols because the specificity of 10-CD will show us precisely how someone's condition has changed over the course of treatment. And I believe that that's what the public expects of its health care system and that we ought not to just focus on statistics having to do with the numbers of providers and the dollars paid and the services delivered, but in fact on the outcomes. And so I do believe that 10 gives us the potential to do that. What use we make of the increased functionality is a much different question and a long term question.
DR. ZUBELDIA: Tom, thank you for what has been probably one of the most cohesive testimonies we've heard on this topic, it's been excellent. I want you to for a moment on 10-PCS, rather then 10-CS, how will 10-PCS, is that the only solution to the ICD-9 Volume 3 dilemma? If I understand it correctly Volume 3 is also controlled by a committee that is under CMS and one of the options that we discussed yesterday was if a coding structure, coding hierarchy runs out of space in certain parts of the hierarchy, the hierarchy could perhaps be converted into just an identifier, flatten it out and remove the meaning of the branches of the hierarchy so instead of being in the 36 branch that won't have any meaning, it would just be an identifier for the procedures. Is that a possibility for ICD-9 Volume 3, or how would you compare that with the benefits or the costs of moving to 10-PCS?
MR. GRISSOM: I really should just say I'm not competent to answer that questions, because you are asking me to comment on the possibility or the practicality of a fix on what we have now that would not entail a total transformation or transition to another system. I can tell you that in a lot of places in the fee for service program we do a little tweaking and we create temporary codes that never die, they just continue, and we put modifiers and identifiers and what I would say is that instead of simplifying is really, it creates entropy and the system becomes more complicated and not more transparent, more simple, and its explanatory power is not increased, it's, in anticipation of a question like that I was going to say it's like a Band-Aid approach, then I realized this morning that I was speaking to a group of physicians so I wouldn't talk about Band-Aid's, there might be somebody from Johnson & Johnson here, but you get, I hope you get my analogy. I don't really think I'm competent, I've tried to focus on what I thought were the alternatives in front of the committee and the history of the development of coding systems in health care, not only here but around the world, so modifications of what we have or fixes on the current system probably you ought to ask someone else.
DR. ZUBELDIA: Thank you.
DR. COHN: Any questions and comments? Any questions from the audience? Tom, I think you've let you off easily this morning.
DR. GRISSOM: Out of courtesy I'm going to stay as long as I can.
DR. COHN: Well, okay, thank you. Thank you so much for joining us, I know you have a very busy schedule. Theresa, do you want to start off, Merritt, okay.
Agenda Item: ICD-10: Next Steps: Discussion Panel - Mr. Smith
MR. SMITH: Thank you for having me come again to talk about the costs and some of the implication challenges of migrating to ICD-10-CM and PCS. When I talked last time after that I asked for some feedback from the group about the presentation and what they told me, kind of the consensus view was I needed to talk louder, faster, and smarter. Two out of three probably isn't bad.
I'm Merritt Smith from the Nolan Company and we're a management consulting firm that works with health plans and provider organizations on operational problems, and we've been asked to look at the issue of cost and migration by the Blue Cross Association as part of their ongoing program of understanding health care costs. And the approach that we took to this was a combination of secondary research and primary research interviews, and from that data gathering we developed cost models and then took that back to knowledgeable people in different kinds of organizations and built out a range of costs. And we compared that against learnings from other changes in, large scale changes in data systems and looked at specifically the international experience of other countries that have made similar kinds of changes.
Those methods generate a range of costs that are conservatively stated to implement CM and PCS in the range of $3 billion to $14 billion. That assumes that that implementation is done in about a two to three year period. If you do it more quickly, if you do it in a more compressed time period, we think that the cost would increase slightly because you begin to get contention for scarce expert resources in making the conversion. We think if you lengthen that time period that you may increase the cost because you end up having to do somewhat more testing and verification because of other things that may be changing.
In developing those costs, it was harder to do then you would think that it should be and the reason for that was that a lot of the people that we needed to talk to develop the initial numbers flat weren't aware of the topic, it was a blank suit to them, and they hadn't really thought about it, they hadn't thought about the implications to their organization. So in some cases we excluded entire categories of provider organizations, provider entities, and payer type entities from the cost estimate. Now we're conservative when we make estimates anyhow, but by excluding those we made that range, the $3 to $14 even more conservative because we excluded things such as third party administrators, clearinghouses, traditional individual health insurers, DME vendors, physical therapists, and other kinds of entities where we couldn't get good initial cost figures. So again, that adds some conservatism to it.
The details, numbers and calculations of that are being posted in the detailed report on a website, it will also be distributed to you electronically and in hard copy today. So we have is a conservative $3 to $14 billion dollar implementation cost for hospitals, physician groups, and health plans.
What I'd like to do now is shift to another implementation kind of concept or topic, and that's unanticipated consequences of implementation. And there's a couple of things here that we think are of interest. We think that without extraordinary care in implementing the proposed change there will be delays and backlogs in coding that result in delays in data and dollars flowing. This was the experience in Australia, seems to be the experience in Canada, and recently you've heard of the experiment by AHIMA and the American Hospital Association with the help of Ohio State. In that simulation or experiment that they conducted showed a substantial reduction in productivity of coding, which parallel quite closely what we found in the literature in Australia and in Canada. Now that problem of productivity with coders and the resulting delays is not a reason not to make the change, but it is a reason to be very careful about how it's implemented, and that care translates into additional staffing, additional training, additional testing, and over time during the transition period, and that's one reason that that cost range is so high.
The second area in unanticipated consequences is an area that became known in our work as data fog. Data fog is the condition where you have different data then you're used and you're not yet entirely comfortable with having it and using it. So even if there is a 100 percent success in mapping from this schema to that schema, and that's most unlikely, but assume a perfect crosswalk, users of the data will be very uncomfortable with the newly displayed data. We know that they will need to test, to retest, and to test yet again. They tell us that in the interviews, we see that same behavior going on with HIPAA implementation. So much of the expense that we're showing in that $3 to $14 billion dollar conservative range is involved with testing and confirming and being comfortable with the data and that's really around that data fog issue.
Now some of that testing is driven by the conservative nature of the people using that data. Some of it is driven by the importance of the use of the data for clinical and financial uses. And some of it now is we think going to be driven by new federal regulations that require very detailed assurance of the quality of data used in creating financial statements. All of that together results and we think it will be some time before data users can return to kind of normal conditions of use.
In some cases that data is going to be sufficiently different that it will change how we think about trends and it may be a long time before we really know if the new data provides us a better picture of reality or if it is just a different view of what we knew previously. So in some ways reformatting the data changes our access to medical knowledge that we've already had. A cautionary tale in this regard is AIDS mortality in Florida, almost everyone is aware of that but we discuss it in the document, and it just talks about that problem of the data fog and the time turn.
The last item I'd like to talk about really isn't in the report but it's an item that came out of the study and is in kind of the context of what this group is doing and what the larger committee is doing. And that's the context that you're making a decision against a backdrop of all kinds of other initiatives and alternatives. We can make a good defensible conservative estimate that it's going to cost between $3 and $14 billion dollars for facilities and physician organizations and HMO's to make the conversion if you decide to make it. But we don't know if that is the best use of that $3 to $14 billion dollars. There may be other alternatives that you have in front of you, there may be other items that would give you more benefit then this one, so it's really judged I think best in the context of what the other alternatives are. So I think that we would encourage you to take the time to sort out that priority and the sequencing between those alternatives. That's really probably a tremendous service that you could provide for both payer and provider organizations in getting that sequencing right. We think if that sequencing and prioritization is done correctly that gives the lowest cost implementation, the fastest path to implementation, and the biggest increment of improvement in care in service to people in any part of the system.
I think it's hard to argue that we're running out of codes when less then 15 percent of the code space is used. I don't think it's that we're running out of codes, you have maybe more time then you realize. It's not that we're running out of codes, it's that they're in the wrong, sitting in the wrong place, they're kind of, I don't have enough here and I've got a lot more over here, so maybe what I do is I kind of do something like this rather then something like that. And that probably doesn't go out over the internet but it's kind of a reallocation of code space rather then, it's a good hand gesture but it's not a good internet technique I guess. But again the problem isn't that we don't have the codes, it's that we don't seem to have them in the right place, so maybe we have to turn the page.
It seems to me that the current coding systems could be, have their life extended in such a way that gives you time to safely sort out that prioritization and to let this group really establish the framework for health care data going forward for the next ten, 15, 20 years. And that concludes my remarks.
Agenda Item: ICD-10: Next Steps: Discussion Panel - Ms. Doyle
MS. DOYLE: Mr. Chairman and members of the committee my name is Theresa Doyle and I'm director of legislative policy for Blue Cross/Blue Shield Association. I appreciate the opportunity to present our comments today regarding the Nolan Cost/Benefit Analysis of ICD-10-CM and ICD-10-PCS. BCBSA represents 41 independent Blue Cross and Blue Shield plans across the country that together provide health coverage to almost 89 million people, one in three Americans. We commissioned Nolan to analyze the costs and benefits of the migration to ICD-10-CM and ICD-10-PCS, and to assist Nolan developing the initial scope and to provide guidance feedback during the initial research we had assembled a small industry advisory panel composed of several provider organizations and national accreditation organizations, representative from the National Association of Medicaid Directors, and we wanted to ensure that all the viewpoints were considered and that we had important industry input and we believe that it gave us a final better product.
The following are sort of just brief comments that we would like you to consider about the report before you make your recommendations to the Secretary. The first is that the industry cost burden of migration to ICD-10-CM and ICD-10-PCS on the heels of Y2K and HIPAA, and I know that Merritt continued to say $3 to $14 billion but it's actually $5.5 to $14 billion, I think that the cost estimate, he kept saying $3 but it's actually on the higher end if I'm not mistaken, I just want to correct that because if you look at your report I think he's, anyway. Nolan projects a cost for a subset of providers and payers and that's very important, it's a subset, as well as Medicare and Medicaid between $6 and $14 billion over a two to three year implementation period. And it's very important to note that these are conservative numbers and that they exclude a significant number of providers and payers because those entities frankly we could not estimate their cost. And therefore it may be more important to look at the per entity cost, for example, the Nolan projects that the cost for large hospitals between $1.5 and $5 million dollars, and the cost for a large multi-regional or multi-regional health plans at $10 to $20 million, and then large plans are a little less then that and so on and so forth, so I think when people look at what is the cost they really do care about what the cost is to them.
And many of the benefits we discuss oftentimes are not, do not accrue to them, but this is very important because while these numbers are very significant it could be particularly burdensome to the industry on the heels of Y2K and HIPAA transactions and code sets and privacy. And we agree with this point in the study. The cost of HIPAA transactions and code sets was greatly underestimated when the rule was adopted, the industry struggling to implement the regulations and many payers are now running dual systems, both their current legacy, existing legacy systems and a HIPAA compliant system to minimize disruptions to claims processing because of lack of provider readiness. This is exacerbating the implementation costs of HIPAA, and in addition HHS is expected to adopt additional HIPAA mandated standards within the next year, which will demand extensive industry resources. And under these conditions I guess at this particular point we sort of question the wisdom of recommending adoption of a wholesale change to the diagnosis and procedure codes like ICD-10 at this time.
The lack of quantifiable benefits is sort of disturbing in the Nolan report. We've heard many proponents of ICD-10-CM and ICD-10-PCS argue that the cost of implementation outweigh the benefits. However, the Nolan report concludes that the benefits are speculative and may not be achieved by migration to ICD-10. And a particular concern is the potential impact of ICD-10 on medical research and data trends. According to the report during a three to five year period existing medical knowledge would be degraded significantly. And further, the report states while cross walks have been or are being attempted between ICD-9-CM, ICD-10-CM and PCS, it's important to understand that to date they cannot address all the comparability issues and thus do not solve the problem of data continuity, and consequently we urge the committee to ensure that these issues are addressed before recommendation is forwarded to the Secretary.
Third, appropriate cost effective sequencing of standards to enable certain benefits. Again, the Nolan Cost/Benefit Analysis raised the question as to the appropriate sequence of standards adoption. Now the authors argue that in order for any benefits from ICD-10-PCS to be achieved, particularly outcomes, improvement in outcomes measures, standardization of a clinical vocabulary is a prerequisite. Now while this needs to be validated and the impact of a national standard for clinical vocabulary, analyzed and the impact on the industry if it was adopted universally, it does seem to call into question our national strategy or lack thereof for information health care technology. And we think that there is an urgent need for a national information technology strategy that establishes an industry roadmap to guide policy makers, standards development, and technology investments.
Over the past few years there have been a proliferation of information technology initiatives promoted by Congress, the Administration, and the industry, and there are many benefits that can be achieved through these proposals, reducing medical errors, improving quality, lowering health care costs, and improving public health. But these, including ICD-10 perhaps, these proposals including ICD-10 are being pursued in addition to the numerous HIPAA financial and administrative standards the industry is currently implementing, and the three pending HIPAA regulations that HHS is expected to release within the next two years. ICD-10-CM and PCS cannot be considered in isolation of these other health care technology initiatives and I would ask where does it fit.
The current piecemeal approach to national health information standards is like building a house room by room without an overall blueprint. The health care industry needs a blueprint to know where it is headed with a prioritization and a timeline to provide order and predictability to stakeholders and importantly to ensure that the standards are implemented in a cost effective and efficient manner. BCBSA has recommended the creation of a high level stakeholder commission to create a consensus on the goals and objectives of the national health care information infrastructure and to develop a comprehensive strategy for the adoption and implementation of voluntary standards. With so many demands on the industry, health care premiums rising at double digit rates, and with over 40 million uninsured Americans it is critical that we spend our resources wisely. And I want to emphasize that given limited resources and the demand for information technology is ICD-10 next? Based on the information I guess that I've seen and the reports I've read, I don't see, and we certainly are open to understanding this issue better, the tremendous urgency to move forward with this at this time. And so we think that we have time to develop a long term roadmap, prioritize the standards development and their implementation, and reach consensus among the stakeholders on how we really move forward.
Thank you.
DR. COHN: Okay, Theresa and Merritt, thank you very much. Questions or comments from the subcommittee? Stan, I think you're first and then Jeff.
DR. HUFF: Questions for both of you. Change is hard and it costs money but it's not a surprise. But I mean what I didn't hear from you is really any specific solution proposed to the problems that other testifiers have pointed out. You basically said well we could sort of allocate codes here or there and do something, sort of a non-specific well, and so, and even in sort of in the vague way that you indicated, I mean what evidence is there that reallocation of codes wouldn't cause just as much cost and just as much change and just as disruption and just as much data fog as the proposed change? I mean we're aware that it's going to cost money and it may cost more then we estimate and we know it's hard to estimate in fact as well, but what I didn't hear, I mean you either don't believe that there is a problem or that you have a specific solution to the problem that other testifiers have posed.
MR. SMITH: I guess what we were charged to do was kind of sort out the costs and I think we've done that in a credible way and a conservative way. We were asked to look at the benefits and develop a cost/benefits but as we did that what we found was that there weren't strongly quantifiable, clearly quantifiable arguments made by the proponents of the change in a way that you could develop a traditional cost/benefit analysis that you'd use in a business organization. So we concluded that those were speculative and that doesn't necessarily stop you from going ahead, wanting to go ahead and do it, I mean think of Tom and the bedsore example, our problem analytically was it's very hard to go from having, being able to describe this differently to reducing ultimately the cost of bedsores. Finding that path from having data to having medical knowledge to changing practice patterns to actually effecting care and costs is a very long and tenuous path that frankly we couldn't weigh out in a way that we could compare against the cost. So we concluded that those benefits, although they may very well be there and we all would want them to be there, it's darn near impossible to weigh them up squarely against the cost in a traditional way. So that's that part of it.
In our work we found what I think is a model that suggests a type of solution that you might want to consider, and that is a model of clinical terming, coding, and grouping, and I think Tom used the word, that would course one of the grouping of payment categories, yeah, payment categories. And essentially we've got, I'll use hand gestures again, in that sequence of events I have clinical terminology and vocabulary, it's non-standardized, then that drops into a problematic coding scheme and it flows into a whole series of groupers that further use that data. I would suspect that you might get more benefit from working first on the upstream part of that sequence of events of standardizing clinical terminology and vocabularies, which is one of the initiatives I believe under consideration, and maybe allocate the time and effort to that first before coding. So work on the upstream part of the process before the middle of the process.
DR. HUFF: Have you made any estimates of the cost of doing that?
MR. SMITH: No, I think it, we would expect it to be higher, but it gets you farther along and what it prevents you from doing, that in and of itself may be greater then doing the coding but doing coding and then terminology may be greater yet. So that's why I think the sequence and the prioritization and sorting that out helps reduce overall implementation costs across all of the initiative being considered and gets you through the implementation of them probably faster then doing one and then having to redo. Does that help?
DR. HUFF: Sure. I guess the challenge we've been faced with from the start is that in fact estimating the benefit has greater uncertainty then estimating the costs, and what we haven't, I mean what would be very useful is for someone to come up with an idea of how that could be done better, if there were an experiment that would do it and we haven't come up with any idea that would get us beyond essentially best expert opinion and all of the best expert opinions say while I'd have to agree it's speculative has said there is benefit there. I mean the professional coders, all of the other folks, say there's benefit there and while it's speculative and it's hard to turn that into hard dollars, it's the best opinion we have and we don't know any other way to quantitate it. I mean have you got better ideas about experiments that are undone that would allow us to quantitate that in a harder better way?
MR. SMITH: Well, you may, now I'm going to go kind of off in a different path for you. You may look at international experience and see what benefits have been received by doing it in other settings. You may find a free standing experiment there that you can gain some insight from. If you look at the literature that we've read and we've been able to find I don't see a lot of mention and discussion of how they've made that transition on the bedsores. I think one path to gain this understanding is look at what's been done in other places and try and gain that. Another approach could be to find a relatively isolated disconnected setting and experiment, just like, it's kind of like the Ross Perot approach, let's try it first in one place, where that one place is I don't know, it could be isolated geographically, it could be by a payer, you could contract with an integrated health system that's relatively isolated to do that, where you have a teaching hospital, a network of clinics around that, and a health plan and just run, convert them and run an experiment. They would take a lot of risk doing that, but I think you would learn a lot from doing that.
DR. HUFF: I know I'm hogging time but a couple more questions, so this is directed to Theresa. One of your comments was this coming directly on HIPAA and analogies to HIPAA and I guess one thought that came to my mind is if we decide today this is something that's actually going to happen three years from now or two years from now, we don't have an exact timeline, so we decide today it's not really following directly on HIPAA, it's following two or three years after HIPAA.
MS. DOYLE: Actually HIPAA is an ongoing process obviously and we're still waiting for some important rules that have yet to be promulgated but probably will over the next year or two, so then there will be a 24 month implementation period for those rules, so actually, HIPAA won't be, the initial standards of HIPAA are going to probably be taking place over the next five years I would judge because of the time in which we're going to get the rule promulgated and then the 24 month implementation period and then going into compliance, so they'll be a lot of systems changes.
But where I come from is actually somewhat unique because of what I do with Blue Cross/Blue Shield is I look at not only what is happening within HHS but also what's happening on Capitol Hill. And when you see a lot of the initiatives that are pending in various bills, whether it's the Medicare Reform Bill, with the e-prescribing requirements, or it's the Patient Safety Bills for the interoperability of health care information systems and requirements of HSS to develop those standards, data and messaging standards and so on, and if you really laid out all of these, and I would say that both those bills are not just standing there alone, one of them is pending Senate approval, the Patient Safety Bill has been approved by the House and in the Senate the Patient Safety Bill has passed the committee and is now pending full Senate consideration. And then you look at the Medicare Reform Bill, which is currently in conference, I mean there is a possibility that these move forward, so they're all being looked at we believe in sort of piecemeal isolation. Nobody's really laid out a game plan and when you look at those implementation dates they too say within the next two years HHS must report back these standards. If they pass and you laid out a timeline of when they are directing HHS to produce standards and then you have your ICD-10 recommendations, whenever that is, and then you lay out the HIPAA, you start realizing there's a lot of demands on the industry on HHS to develop the standards that frankly are not feasible, I mean what we really need to do and I think for many plans, I can say we really do have some information technology initiatives that are not just government mandated ones, and so I think what we need to do is to sit back and say where do we want to be in 15 years from now and how do we get there. I know the Secretary is very interested in electronic medical records, that's pretty consistent with the National Health Information Infrastructure that this committee has worked on, and again, how does it all come together. I know there's a lot of initiatives that are being proposed by the industry, whether it's the e-health initiative or it's some of the other groups, and again, there's no real consensus and we don't share an understanding of where we're all going. So I think that you need to develop that shared understanding and then say we have a limited amount of resources, where do we spend it, what do we need to do. And I think that while we're not saying we embrace the idea yet that we need the standard clinical terminology certainly does raise some question as to the sequencing, and maybe that needs to be looked at because I know that that is something that may be needed for the electronic medical record anyway. So I'm just saying where does it all fit and how do we get there is sort of important to us because we need to have that predictability to move forward.
DR. COHN: Stan, are you done for the moment or do you want --
DR. HUFF: One more comment. There are a lot of analogies and comparisons in your statements to Y2K and HIPAA and that this is on the same order of magnitude, and I guess my gestalt of that is that it's actually dramatically different. With HIPAA we're developing new transactions and the fact they cause business changes, that is the flow of information is entirely different. In this case what we're doing is saying we've got databases that have a certain column that may need to change direction but nothing changes about the process, I mean we're assigning a different code where we used to sign another code, the same transactions flow but with a different code in that slot. And I see many more differences then I see similarities in those processes and to compare it to Y2K again is dramatically different, because of the number of applications that every application uses dates. In our institution this change is reflected in two or three systems in a system of hundreds of systems, and so the order of, I mean to compare the two seems to me just not to be really credible in terms of the changes.
MR. SMITH: What we found when we talked to people about this was that they naturally fell in conversational pattern of explaining it in the range of between Y2K and HIPAA, and I think that's because those are big events in recent memory and current memory, but they fell in that. And then, you'll see this in the detailed report, there was some documentation about expenditures on those that were, that are in that are in that order of magnitude, they're in that range. So that's where that comes from.
The changes that have to be made are more then just one column or one attribute in a database, they are interfaces, they're screen changes, they're report changes, they're programming and logic changes, in this system and in that system, and it goes on and on, and subsidiary systems that are fed in data warehouses, and it just goes on and on, and that's the, it seems, it's one of those things that seem so deceptively simple but it does add up. And because it's so pervasive that's why there's the need to do the very detailed comprehensive testing, run a parallel, test it again kind of thing that runs the cost up.
MS. DOYLE: If I could just comment about that because I think that when we approached transactions and code sets initially I think most people thought it was an IT exercise and that that too was not going to impact the rest of our business processes. I think we learned the hard way it absolutely did effect a lot of our business processes, and the diagnosis codes I think are the underpinning really of the health care system and I don't begin to estimate really the number of systems it is going to touch and the number of reports that may have to be re-looked at and considered.
One point I'd like to make because I think it fits into this is this sort of the DRGs and their change. As we know that the DRGs were developed in about 1970 under the diagnosis procedure codes from ICD-8 and as I understand from '78 when the U.S. switched to ICD-9 there were so many code changes that it was necessary to kind of repeat the entire pricing study using the new codes and new cost information. And at that time the hospital reimbursement system was not dependent upon the DRGs and the calibration effort did not disrupt sort of the health care industry. But right now we're talking about a tremendous change and when I've talked to some experts that had actually worked on some of those DRG changes at that time and certainly I know some are probably here, the difference between 9, ICD-9-CM and ICD-10-CM are so much greater then they were in '78 and so building DRG values are going to be absolutely necessary. And really as I've talked with these experts they've said to ensure fairness to both the providers and the payers and really the solvency of the health care system, the rebuilding of this has to be done off-line and that they have, it has to be done in parallel with payments using the current DRGs, and then only have really thorough testing can you make that change. So I think that there's, I think there's a lot we're going to learn but I wanted to emphasize that I don't think the DRGs are as simple to just say oh, well now it's changed, I think that there is a tremendous process that has to go and I understand from having made that transition previously a lot of this is needed to be done off-line in a parallel system, so it's a tremendous effort.
DR. COHN: Jeff and then Mike.
MR. BLAIR: Merritt and Theresa, I want to thank you both for your testimony, there's a lot of things you've said that I agree with and there's a number of things that I may not agree with, and I'm going to kind of make my comments in three portions. I'm going to tell you what I agree with, the other areas where I'm not sure whether your argument is compelling or not, and then the third is I'm going to try to use that as a basis for the question I'm going to ask.
The first is Theresa I think you're very correct about the fact that we need a national cohesive strategy for a National Health Information Infrastructure, the NCVHS of course put forth a proposal, we not only need leadership and coordination we need an architecture and I absolutely totally agree with your suggestion that that is necessary and that a lot of the things that we're doing really should fall within an overall national strategy, so I agree with that.
Number two is Merritt, you pointed out that your estimation of the costs varied, I think you said from $4, or $3 billion to $14 billion, is that correct?
MR. SMITH: Yes.
MR. BLAIR: Yes, I don't know if those numbers are correct but I wouldn't argue with them and I think the fact that they're higher then the RAND Corporation, I think that's estimates, I think that's just fine, so wouldn't argue with the fact that the cost may be high. I want to support Stan's observation that just because we're not in a position today to quantify the benefits doesn't mean that the benefits don't exist and there was one item in the RAND Corporation that pointed out that those benefits may be very substantial and it's difficult to quantify and put a cost figure on improving quality and improving patient safety. They do, however, typically, now that we're in the information age, as you improve quality and you improve patient safety there is and can be a tremendous cost saving. But your testimony also suggested to me that we needed to add a new area to maybe the things we've considered so far in what our recommendation should be, because I think there's quantifying the cost, and I'm thinking if we go forward into an NPRM what do we want that NPRM to sort out, doing a better job of quantifying the costs and I think the limitation that everybody has been frustrated with is that the costs at this stage are based on very short periods of people estimating the transition. I mean weeks or days rather then months or a year, and the costs may change dramatically if we have a longer period as people get accommodated to it, so it could be the costs are exaggerated because we're estimating it based on just a few days or an initial look at it, that's one piece.
The other is we need to do a much better job of quantifying the benefits. But the third thing that I think has been missing and that Tom's testimony I think highlighted, is no one has made an attempt to identify or try to quantify the cost of not acting. What if Tom's observations have merit and if we are impairing the health of the nation by allowing ICD-9 to go on for many years, what is the cost to health care by failing to act? So that I think needs to be a third dimension that hasn't been considered so far.
Now that I've said those observations comes the question. I think the major issue that the NCVHS is considering right now is we've heard testimony from a lot of folks and it is clear that there is not a consensus on whether we should go forward and how we should go forward. And as Stan observed if we begin an NPRM process, a Notice of Proposed Rule Making process, the regulatory process, part of that process is additional discovery, additional learning, okay? And that NPRM probably couldn't be released before a year and it probably is going to be maybe two years before we're going to wind up seeing a final rule if things move forward quickly and that's questionable, and then there would be two years for compliance and we're looking at four years away, maybe five or six years away, before there's the possibility of any kind of a mandate that we move, make that move. If we don't begin that process now, if we don't begin that process now then the missing piece that I mentioned, what is the cost of not acting, that cost could be high and if we do decide to make the transition later rather then sooner the cost may be higher to make the conversion six, seven, eight years from now then it is to make it four, five or six years from now. That needs to be considered. So my question to you is given the nature of the regulatory process with a Notice of Proposed Rule Making, which is going to wind up soliciting additional industry comment, and hopefully learning more then we know now, what opposition do you have to us, NCVHS, making the recommendation that we go forward recommending that the regulatory process begin?
MS. DOYLE: I guess I'm sort of, I still go back that I think there were some serious questions raised as to what is the appropriate sequencing of moving forward. And I guess I understand the concerns here, I'm not really sure at least whether I'm at least very satisfied that we have really explored some of the alternatives, but going back, the importance is where does it fit into the overall strategy and you're right --
MR. BLAIR: If the NPRM process included trying to address that issue would you feel okay with it?
MS. DOYLE: Well, if I was to look at ICD-10 in isolation of everything else that's pending, whether it's in Congress or they're initiatives within HHS, that might be one thing. We're not really convinced that ICD-10 at this point is going to produce all the benefits that people have touted. Perhaps it's not the ICD-10 that produces the benefits, perhaps it's this clinical terminology that produces the benefit, I don't feel that that really has been fleshed out well enough.
MR. BLAIR: Would you recommend for example that that be an issue that also be considered as an alternative within the NPRM?
MS. DOYLE: I don't know that it's necessarily in looking at an alternative, I think again it's, I'm sort of looking through and saying what are all the demands on resources, what are the, what is the logical steps in which we get from where we are today to where we need to be, and we have a consensus on how we do that. And there are some standards that will benefit other initiatives that may be important to this Administration or to the Congress or to the industry but we have to reach a consensus on how we do that and the consensus really needs to be not among the IT community but I think among a very high level stakeholder, the end users, because as we have found with HIPAA implementation I think there was a lot of misinformation about what was actually required and the amount of money it took to be HIPAA compliant. We need to have a commitment from the industry as to how we're moving forward, the complete understanding that this is the way we're heading and a commitment to the resources that they will spend to get there. And so I think that, I understand what you're saying that it's going to take five years, but we're still not convinced that this is really the right move, because we're not sure yet of the benefits are really valid but with everything else that's pending we would rather see a strategy laid out and that this fits within that strategy and then we have a consensus among the industry.
MR. BLAIR: So if I hear you correctly, see if I'm saying this correctly, you feel that we should not begin an NPRM process until the industry has at least come close to reaching consensus, is that your --
MS. DOYLE: If we had, the Blue Cross/Blue Shield Association is supporting creating a commission, it would be a high level commission that would report back within 18 months. We think in that period of time they would develop an agreed upon strategy over the next ten to 15 years on how we move forward on information technology standards. We would see this as one of those considerations in how it fits in. In that time period certainly we could continue to do some more studies as to the appropriateness of ICD-10 and whether it really solves these issues, but more importantly we would say that if we're going to spend time, the Department's time, on developing the standards, the industry's time, what have you, that it should be part of an overall strategy.
MR. BLAIR: Is it possible, would it not work that that information could also be provided within an NPRM process? So that we don't have further delays, because we've been struggling for years to try to find consensus and for years there hasn't been a consensus, and the lack of data has frustrated us from being able to reach consensus, so my thought is if you feel like more data will be available that's fine but do we need to hold up the NPRM process before, in order to try to get more, because maybe the additional still won't give us consensus.
MS. DOYLE: I think our sense is is that it's premature to go forward at this time, that we do not have a sufficient even crosswalks to have answered a lot of the problems that we think are out there, we really need I think to dot our I's and cross our t's on some of this before we move forward. We're not convinced that an NPRM process really gives us a lot of the information that we need, we saw that again in HIPAA where we went forward with an NPRM and actually put out a final rule only to find out that it was unworkable and we had to go back and develop a modification and I would argue that that modification, the delay of that critical modification probably held a lot of this industry up from being compliant on the October 16th extension deadline. So I just say, I'm not really sure that it's ready for prime time.
MR. SMITH: The idea of studying the cost of non-action I think is a good idea, that's your third dimension, I think that seems to be a good idea. But I go back to the bedsore, I have that in my mind, how that information is coded really doesn't in a very direct way impact the quality of care because the physician, how that's coded doesn't change what the physician does, the coding occurs after clinical services are delivered. So being able to observe that data from an administrative system in a way doesn't have, today, doesn't have really very much impact on what the physician or the provider is doing to effect care. And I think that's likely to continue for a long time so I think it may be, while it's a good idea to study the cost of non-action I think it's going to be difficult to do that for that reason.
DR. COHN: Well, thank you very much, that's interesting interaction. Mike, I think you have a question?
DR. FITZMAURICE: I guess it's hard to, when Jeff has said so many good things there are a lot of things that I wish I had said, it's hard to follow on that. I, too, would like to thank Merritt and Theresa for coming and giving us your study and your views, that's how we get a lot of input from people and society who come take the time and the expense to come in and give us their best wisdom on this. With regard to the cost I see a cost estimate of $6 to $14 billion dollars, I don't see any estimate of benefits, and this is after a heroic effort on costs that seem to be, I don't want to use the words giving up on benefits, but there's no quantification of benefits and no comparison with RAND, no saying well I think RAND was ten times too high and so I would put the benefits at one tenth of that, so you kind of didn't make that comparison that's in front of our mind. I grant you there's a lot of imprecision in the benefits and the costs and I'm not raising any fault, just saying it makes our decisions harder when we have two different bases for comparison that don't relate. There's not too much guidance for solving national problems in the report but that wasn't your charge and it would be unfair of me to make that a criticism. You did offer standard clinical vocabulary, in fact that's on my wish list too, but I think it's too soon, too expensive, and maybe we need to prove the benefits before we get to it, like you're saying about ICD-10. But ICD-10 is maybe the next first step.
Theresa notes a need for a national health information strategy and an industry roadmap that follows that strategy to guide policy makers, standard developing organizations, and technology investments, right on target, that certainly is needed. Whether that is the responsibility of NCVHS or others to give it, I think we're taking on a good part of that responsibility with the National Health Information Infrastructure, and if you see the vision a lot of what we're doing here in the subcommittee follows from that vision, that is we're trying to encourage the development of tools that give us the benefits of having a National Health Information Infrastructure. But Theresa would say if you want better information make sure that the benefits will ultimately be greater then the costs, a fair comment.
What I see is that we need more precision in measuring health care inputs and what those inputs do. We need more precision in patient conditions. We need more precision in disease categories, that's the classification part of it. NCVHS has a responsibility for understanding the health care systems, to look at the benefits to consumers and patients primarily, but also to those who serve patients and consumers. We have heard a lot of testimony that there's a need to address problems to improve public health, I don't think there's any question about that, even with the infusion from bioterrorism funding. But we need to improve the quality of care and patient safety. There's a need to improve resource use and incentives for the wise purchasing use of health care. Even heard some discussion this morning about we'd have DRGs that become more complex if we shifted to ICD-10, but maybe it's time to examine their efficiency for payment based upon more precise diagnostic and more precise cost data. But we're looking for solutions to the nation's problems and moving to ICD-10, there's a cost estimate, there's a benefit estimate, I think that's the next best step but I would be very open for the committee hearing what the next steps should be other then let's study the problem for another 18 months to five to 15 years.
There's some things that we can do to get better information, it does come with a cost, and we spend a lot of time looking at the benefits and the costs. Do you have any suggestions for next best steps to solve the public health, the quality and patient safety, the research use issues that are driving a lot of our interest in this?
MS. DOYLE: Well, I mean obviously, there's a huge difference between the benefits analysis done by the RAND Corporation and those done by Nolan, there's a huge difference between what RAND projects as the benefits and the savings I guess associated with those and what Nolan has done and obviously I think there needs to be some critical analysis of that, of the benefits, I think we've all talked about that. I think we would like to see some discussion, I think Merritt's raised it, about whether patient safety comes because of the coding or because of some other behavioral change within the physician community or information, I'm not really sure how it all gets linked to the code, the code, everything is sort of hung, I'll tell you that there's a lot of proposals out there and every one of them improves patient safety and outcomes and things like that but what we really need to do is figure out the true benefits, do you really derive that benefit from the coding or is it from something else and we would just like a further examination of that.
I'd like to emphasize one point you made earlier that NCVHS is moving forward on an information, on a technology strategy, and I certainly have watched and participated to a certain extent in the audience with that but I think we feel strongly that really we need a consensus, not just among us here at NCVHS but the Hill has to share, Capitol Hill needs to share that consensus as well and the only way we're going to really get there is that we have high level key stakeholders that also share that vision I guess if where we're going because they're the decision makers within their organizations and this is going to take a great deal of financial resources to make this happen. And I think there may be some consideration for Congress into how maybe through tax incentives or something to help facilitate some of that. And I'm not, I don't want to get ahead of myself but I think there's certainly a need to take it, not just NCVHS but rather we need an industry wide very high level understanding of what the goals and the roadmap is.
DR. FITZMAURICE: Thank you for your comments.
MR. SMITH: Can I inject a couple of comments? If you look at the literature from the UK where this has been in place for some time you don't see citations of improvement in patient safety and its related to improvement in the quality of data. If you look at the literature for patient safety going back say maybe the past ten years there really wasn't much talk of the importance of data, if you go back, I think it was the Institute of Medicine study, maybe some of you were involved in that, it wasn't mentioned, it wasn't one of the basic recommendations or even one of the subsidiary recommendations in making this change. I don't quite understand what's happened but sometime in the past several years now that's become a patient safety issue but the people doing the original work didn't consider it. So I combine that kind of with the UK and then I'm maybe a little skeptical there.
An earlier question was how could you isolate a system a setting and create an experiment almost to see if you could find benefits. You may be able to do that without doing an entire system, you could do it in a specialty within a defined area and see if improved does really does, more fine grained data really does lead to improvement in patient safety and care. You don't have to make it all the way across the board.
DR. FITZMAURICE: I'd like to respond to that. There's a very recent study out from AHRQ that looks at ICD-9 codes and hospital discharges and the complications that arise, and the costs of complications in terms of additional days of care and additional funding. The study would be even more precise if we had a more precise diagnostic system, so I see a benefit for at least giving research findings to having a more precise diagnostic system. UK has things like the REED(?) codes that get pretty specific and get into more vocabulary, and so perhaps they already have a lot of what we should be striving for.
DR. COHN: Kepa?
DR. ZUBELDIA: This is a question for both of you. If the subcommittee recommends the adoption of ICD-10 today under HIPAA what would be your suggestions to minimize the disruption and to minimize the cost? Obviously there's a big range between $6 and $14 billion dollars, and what would be your suggestions to get closer to the lower cost estimates?
MR. SMITH: I think the main thing that could be done to help in that regard is to reduce the uncertainty about the implementation schedule, I think that helps all of the organizations and the entities pull it off and be successful with it. In our study we lay out kind of a similarity between what a facility has to do for HIPAA and what it has to do for ICD-10 implementation. And kind of the task sequence is very, very similar, almost change the nouns, the verbs are the same and the sequence of events is very similar. So these organizations have experience in many of those things but there's a lot preparatory period of training people and testing and the more time that's allowed for that and the more certain that that time is actually going to be available and it's not going to change really makes it easier for organizations to be successful doing it.
I think anything that could be done that would increase confidence in the technical capability of the crosswalks for it to use your term in some of your discussions, fidelity of the crosswalk, I think would really help those organizations also because it could lead them to maybe use that rather then get into thinks like expensive time consuming testing and retesting, they're still going to do that but if they're more confident in that they maybe able to shorten implementation. I think those are some practical --
MS. DOYLE: Actually if I could comment about that, I think that there are tremendous lessons to learn from the initial HIPAA, particularly transactions and code sets and I would suggest that we really need to look at some of those lessons learned before we move forward on a national implementation of any additional standards, which would be very important obviously, we've always advocated a credible cost benefit analysis would be very important but in addition to that I think we need to pilot test programs before we implement them on a national level, and to the extent possible we would like to see any issues sort of ironed out before it's sort of imposed on an entire country.
We also think that we need, we really do need to focus on the importance of education and a very large scale education process. So many people with the transactions and code sets, important stakeholders did not know really what it meant. I remember three years ago coming to these meetings and having important sectors of the industry saying that they were ready and I think when you get into the details you're not, just because you're doing something let's say electronically doesn't mean that you're necessarily doing it in a national uniform standardized way and there was a big difference between just transactions, electronic transactions and HIPAA compliant electronic transactions. I think that these are the types of things that we need a very strong aggressive educational program.
And I think that the other thing that has probably created problem is that, and certainly the modification held this up, but the vendor community did not have the products available and so there were a lot of, it's kind of tough to start implementing something when you don't have the software to begin to do that and so there has to be some sort of consideration of what are the logical steps so that the time for the covered entity to implementation, let's say the hospital or the physicians office or the payer, is not eaten away by the amount of time it's taking really for the vendor, those that are depending upon vendor products. That sort of created a whole set of difficulties I think as well, so I think there's a lot of lessons to learn and I think we need to take those into consideration before we move forward on an implementation program of any standard in the future.
DR. COHN: Please introduce yourself.
MS. FRASIER: I'm Chris Frasier from the American Academy of Professional Coders and I have to backpedal here but we have been mentioning, but I'm compelled to talk about this one detail about it doesn't seem that you see the importance of additional codes or that it would not have an impact on quality health care, and I'm compelled to say that I disagree with that point. I believe greater specificity provides more information about the encounter and that quantification of the information is valuable to the entire health care community especially in consideration of performance measurements. I don't think as in comparison that one code can take the place of 60, I think we need that specificity. I don't think health care happens in isolation and I think ICD-10, we need an advanced system and I don't think reallocating codes in our current system is sufficient. I think we need a greater specificity for greater understanding of conditions, symptoms, and diagnosis, it's kind of the loop that Mr. Grissom was talking about, tying procedures to diagnosis. And I'm sorry but I just had to make that point. Thank you
DR. COHN: Thank you. Any other final comments? I think maybe we'll be obviously finishing up here in just a second but I do obviously want to thank you both for some very good testimony. I'm actually, first I do appreciate your desire for a national strategy, that's actually something I was going to bring up to the full committee at some point later on, I think really the work of the subcommittee and full committee is to identify whether or not this work is such an obvious part of whatever long term strategy needs to come forward that it needs to come forward regardless of this, I mean having, I'm sure you've been involved in many strategic planning exercises as have I and I think we've all learned the lesson that you don't stop everything while you go off into a room and spend whatever period of time you want to on your next strategy, and I really think that that's really part of our discussions and deliberations. But I really do think you're bringing up a good idea. Now I think I see one other comment from the floor here and then we'll take a break.
MR. RODEY: Just a comment and a question. Dan Rodey, American Health Information Management Association, and we, too, agree with Blue Cross about the need to look for strategy and plan our future in the United States.
A question for Mr. Smith, the range of cost $3 billion to $14 billion you have termed several times as conservative. You've also mentioned that there were a number of entities that were not accessible to you as you put the data together. Do I assume when you say your data is conservative that you have then taken a conservative view of what those missing entities may have in the form of costs?
MR. SMITH: We've excluded them from the cost estimate.
MR. RODEY: So the $14 billion would not include all the entities that you excluded?
MR. SMITH: That's right.
MR. RODEY: So therefore what you're saying is the $14 billion would be a minimal cost --
MR. SMITH: Well, you can take, I would think it's more that if you added those entities in the actual number at the end of the day would be closer to the $14 then the lower end.
MR. RODEY: Okay, I wanted to clarify that. If I recall a number that Medicare put out some years ago there are approximately 2.1 million providers in the United States, there are additionally TPAs, insurance companies, clearinghouses and so forth, so if I divide it just by the two million I come up with about $7,000 per entity and I agree with Theresa's comment that some are going to pay more and some certainly less, it would seem to me that in addition that the sooner we make a change such as this as Stan pointed out the sooner we impact less systems.
We're going through a national process of moving to an electronic health record and the more we are putting these records in place and the more we put all of the other systems in place that are going to be required of us for safety and whatever other reasons we have to meet the more systems we're going to have to change when we finally get to the point of implementing these new structures, including something like a terminal classification system, aggregate classification system. So if those are the costs then I would say that we need to look at how do we implement in such a way as to minimize the classes Kepa brought up and how do we look at this system in light of maybe not stopping the whole thing as Simon just pointed out but looking at it and saying gee, if I do it today, and today as it's already been pointed out is probably at least three years away, if I do it today the costs are going to be much lower then if I wait five or six years and I have a much larger electronic health system in place that's going to have much larger costs available, which becomes part of that what's it cost to do nothing. Thank you.
DR. COHN: Thank you.
MR. ARGUS: George Argus with the American Hospital Association. Just a couple observations, I wanted to at least point out an important point that Tom Grissom made and that was the costs associated with the volume of claims that have to be resubmitted because they have unspecified diagnosis and the like. And I'm not quite sure if that was factored into the costs that the Nolan group had looked at --
MR. SMITH: Yes, it's in the detail of this.
MR. ARGUS: Okay, and I just wanted to be sure that those costs were factored into that process. But what I see here is this effort to basically try and find a perfect time and I get back to the idea that trying to find perfect could be the enemy of the good, I think you've looked at ICD-10 for over ten years, you know this is something that has to be done. It is an intrical part of the National Health Information Infrastructure. This reminds me about the debate around health care reform, all of us agreed that things needed to be done but no one wanted to do a comprehensive effort on reform. Instead we went incrementally and I think this is an incremental part of that process and I think I would urge the committee to move forward again with the draft on the NPRM.
MR. SMITH: My sense is that, what I'm seeking is not a perfect timing, it's rather to avoid kind of a perfect storm of all these things hitting at one time, I think that's really the risk to the system.
DR. COHN: Tom Wilder, our final commentor and then we'll break.
MR. WILDER: Thank you, my name is Tom Wilder and I'm with AAHP/HIAA, I do appreciate the opportunity to make a few comments. We did provide you with a letter on behalf of our association and laid out some comments.
As I've expressed in the past to all of you I am not a coding expert, I am not an expert in statistical analysis, and so I have approached these issues as a policy maker and as an attorney. I think there are in your discussions some things that we do know and some things that we don't know. It's very obvious from the discussions that there are problems with ICD-9 and that there are some concerns that need to be corrected. I think it's very obvious that ICD-10 is a more complex structure. From one standpoint that gives some benefits in terms of research and in terms of look at quality outcomes. But from a practical administrative process the fact that you're going to have an increased number of codes and an increased complexity in that coding structure are going to cause some problems and I think you really need to think about those and address those as you make your recommendations to the Secretary.
We have learned a number of lessons from HIPAA, again, to get to Stan's comment, I don't think that we're saying that ICD-10 is just like HIPAA, but I think what we are saying after expending considerable amounts of money and time over the past three years to find as of the implementation date, we're getting probably 25 percent or fewer of the claims coming in the door HIPAA compliant, you'll have to pardon the payer side if we're less then enthusiastic about another massive change to our systems. We've learned from HIPAA that it takes a whole lot longer and costs a whole lore more then you think it is and so that's why there's some caution from our standpoint about going forward.
I know the question that we've been asked several times is do you support or oppose ICD-10, and to be very honest with you and we've talked to our members and we've talked to them repeatedly about this issue, we get kind of a blank stare because they are so focused on implementing the transactions and code sets requirements and implementing privacy and looking at what they need to do for security and looking down the road to claims attachments, to be honest with you they've not focused on whether or not ICD-10 is a good or bad thing. What they've done is they've asked questions and they've said these are the questions that we think need to be answered when you look at this issue and we've laid those out in our letter, we've laid those out in prior testimony, we think these are the legitimate issues that need to be addressed when you look at this issue, when the Secretary looks at the issue, what is the anticipated impact, what is the cost, how do the benefits match up with the cost, what's the anticipated impact on existing data that's been collected, is there going to be this impact on ongoing studies, and are there alternative fixes or systems available.
And finally just to respond to Jeff's question about whether or not well, should this be settled through the NPRM, a Notice of Proposed Rule Making is really a process by which the government says we're going to do this, it's not a process by which the government says what should we do. An NPRM is a way for a regulatory agency to say we're going to buy these chairs, what do you think about them, they may ask you about the color but they basically say this is what we're going to do, it's not where they say we're thinking about buying chairs, should we, should they have three legs or two legs, should they be tall chairs or short chairs, so if you say to the Secretary I want an NPRM you're basically telling the Secretary we want you to issue an NPRM with the adoption of ICD-10.
The other point I would make is about timing on the NPRM, again going back to HIPAA, it's true I think that if you way to the Secretary we need to have an NPRM that process is going to take some time before it's put together and issued and they'll be a comment period and then they'll be a final rule. People really don't focus on what the requirements are until the final rule comes out. Until that point it's really speculative so if you want the industry, if you want the provider community, if you want payers to focus on implementing ICD-10, they're not going to really think about it until a final rule comes out and from that point under HIPAA they have two years to get their ducks in a row. Small health plans get an extra year but basically the date that that's published in the Federal Register is really when people think okay, it's real now, what do I really have to do.
And the other message that we've heard from our members is that two years is not enough time, and again, we've seen this with HIPAA. People had a lot of advance warning, they had the two years, Congress gave us an extra year, and we're finding that that's not enough. So I can't tell you going forward if on behalf of our members ICD-10 is a bad thing, I can tell you that there's a lot of very serious questions that you're going to need to think through as you make your recommendation and as the Secretary takes an action. And I'd be glad to answer questions if there are any.
DR. COHN: Tom, thank you very much. I do want to remind everyone that we will be taking a break, we will have one more testimony and then we have sort of open time for people to testify or make comments. Anyway we will break for 15 minutes and reconvene at 11:00.
[Brief break.]
DR. COHN: Please be seated, we're going to get started here momentarily. Everyone please be seated. We have our testifier of the morning, Michael Lundberg, and I'll actually let you introduce yourself because I didn't quite get your title or affiliation correct. I also want to remind people, those in the audience, that after, as the discussion progress you're obviously free to ask questions and we're obviously also hoping to have some time to sort of have open testimony from the floor and comments. So just to remind everyone that that will be a feature after we're done with this particular discussion. Michael, please.
Agenda Item: ICD-10 Next Steps: Testimony and Public Comment - Mr. Lundberg
MR. LUNDBERG: Good morning, Mr. Chair, members of the committee. My name is Michael Lundberg and I'm the vice chair of the board of director of the National Association of Health Data Organizations. I'm also the executive director of Virginia Health Information, a non-profit organization in Virginia. I want to thank you on behalf of both NAHDO and VHI for the opportunity to offer testimony about the adoption and implementation of the ICD-10 as a coding system for the health care industry in the United States.
The National Association of Health Data Organizations is a non-profit membership and educational organization established in 1987 to promote the public availability of health care data and improved state-wide health care surveillance systems. VHI is an independent, non-profit organization collecting health care data for the Commonwealth of Virginia on costs, quality, and access for use by Virginia business, consumers, health care providers, policy makers, and public health officials and for use by Virginia citizens also.
We believe the health care industry in the United States is at a very important crossroads in its adoption and use of national coding standards. NAHDO feels that the ICD-9-CM has outlived its usefulness and support replacing it with the ICD-10-CM for the identification and coding of diagnoses and conditions. NAHDO also recommends initially a dual approach to procedure coding with ICD-10-PCS for hospital inpatient services and CPT for outpatient services while an index and cross reference system is developed for all patient services in the years to come. NAHDO recommends NCVHS immediately announce a two year voluntary transition process from ICD-9-CM to ICD-10-CM and establish a defined date for the adoption of ICD-10-CM as a new code standard under HIPAA.
My testimony will focus on three major areas, first the overall perspective on ICD-9 and ICD-10. Secondly, examples of benefits that can be achieved with a transition to ICD-10. And lastly NAHDO recommendations to NCVHS.
Regarding overall perspectives on the ICD-9 and the new ICD-10 coding and classification system, we believe the ICD-9 is no longer sufficient for today's purposes and it's not consistent with the direction that the rest of the world is going. The current HIPAA regulations require the use of ICD-9-CM Volumes 1 and 2 for the reporting of inpatient conditions, and the ICD-9-CM Volume 3 for the reporting of hospital inpatient procedures. For all outpatient procedures, including hospital outpatient procedures, the regulations require the use of HICPICs codes. In the 90's our members have noticed the following flaws with the ICD-9-CM classification system, and that's just become more exacerbated as the time has moved on.
The ICD-9-CM classification system is outdated and inconsistent with current health practice. The ICD-9 process is reaching the point where it cannot be adequately updated and cannot keep pace with the changes in health care. Now I certainly can't overemphasize that and speakers prior to mine have made that known numerous occasions. Frequently manual review of health records are required to meet the information needs of researchers and to fulfill other data mining functions. In addition to its role in payment for health care service the ICD-9 classification system is currently being used in our view for the following purposes, measuring the quality, safety, and efficiency of health care services. Conducting research, epidemiological studies, in clinical trial. Improving clinical, financial, and administrative outcomes performance. Now in order to perform the listed purposes the 24 year old I-9 system needs to expand distinctions for ambulatory and managed care encounters. Expand to include emerging diseases and more recent medical knowledge. Develop consistent and current use of standard terminology. And capture procedures being performing using new technologies.
The two new classification systems, I-10-CM for diagnosis and ICD-10-PCS for procedures will capture greater specificity and clinical detail and new technological procedures. The significant improvements will result in improving the ability of providers, payers, government agencies and others to measure the quality, safety, and efficiency of health care services. Reduce the need for manual review of health records to perform research and data mining. Enhance public health decision making. Improve the ability to forecast the health care needs.
While data will be more robust under I-10-CM we must be mindful of the costs. The first cost has to do with data collection costs. The average learning curve according to AHIMA for other countries was four to six months and they reported that they did not find ICD-10 anymore or less difficult to learn then ICD-10. The changes to data systems, groupers, and software will incur a one time cost similar to costs that were incurred in HIPAA changes, maybe not in their scope, but in the depth for other standards. Information technology and vendor costs. The move to ICD-10 system will increase the workload for the information system personnel, similar to the HIPAA and Y2K standardization. The software needs to accommodate the seven digit diagnosis codes and seven digit procedure codes alphanumeric data type, edit logic changes, and expansion of files containing I-9 codes, I-10 codes. The changes will impact the data retrieval between the old ICD-9 and the new ICD-10 which will necessitate the use of crosswalks and refinement thereof, those developed by CMS and NCHS.
Vendors and IT staff will also need to modify existing audit and edit systems, both respectively and retrospectively for the analysis of past records. Then there are analytic costs. The specificity of ICD-10 codes will require a much more robust review of small cell sizes to further prevent patient identification. It will also be important to consider the needs to develop methods for bridging trend data pre and post-adoption of ICD-10.
The next section is people costs. Now this is obviously one of the most significant costs, the need to prepare, train and educate coding personnel across the health care industry. The increased specificity of ICD-10 classification systems will make documentation more important. Health information managers and coding professionals will need to help radiologists, pathologists, and other physicians and clinicians become more aware of documentation requirements for accuracy and completeness about the patients' health care. With these challenges in mind the possible uses of ICD-10 provide greater provider return in improving health care needs for all people. The aging ICD-9-CM system will hinder the health care progress as it does not provide data specificity when associated with other current data information such as rising health care costs, health care performances, and other outcomes factors.
I'd like to share with you some of the examples within my paper about the benefits that could be achieved although I will not go over all of them. For outcomes studies on acute myocardial infarctions there are codes that can lend more specific information about the cardiac arrest. ICD-9-CM describes cardiac arrest with no further information on cause. ICD-10-CM describes cardiac arrest as due to underlying cardiac condition, due to other underlying condition, or cause unspecified. For trending conditions in cerebral vascular disease there are codes that can provide more information about the specific cerebral artery causing the subarachnoid hemorrhage. ICD-9-CM describes subarachnoid hemorrhage or cerebral aneurysm 430 with no further information as to which cerebral artery is effected. On the other hand, ICD-10-CM renamed the condition, it's non-traumatic subarachnoid hemorrhage, and describes it further as which of the nine specific cerebral arteries the hemorrhage is coming from. This will obviously provide more clinical details for identifying, tracking, and managing disease processes.
For studies on procedures we know that the ICD-9-CM Volume 3 lacks specificity and has an insufficient numeric structure to capture new technology. You're aware that in 1994 the DHHS Office of Inspector General issued a report describing vulnerabilities in maintenance, use and the management of CPT. The report identified several flaws in CPT-4 codes, guidelines, and index that can lead to improper codes. The ICD-10-PCS will provide a marriage of dual procedure systems, with structure to capture new technology, greater specificity and detail and new medical services and technologies. A number of approaches and techniques used for procedures, such as laser, scopes, and minimally invasive techniques can be readily captured by the ICD-10-PCS. This will provide insight as to the improvement of the patient health outcomes with these new procedures.
The ICD classification system will be more consistent and uniform with HIPAA standards. There is already in place a federal committee, ICD-9-CM Coordination and Maintenance Committee, who will ensure continuity and efficient updating to this medical code set standard over time. From what we've seen in the preview of the ICD-10 classification systems it has greater flexibility to adapt easily to changes in health care infrastructure. Most notably the development of these two classification systems was accomplished with the expert advice from physician groups in neurology, orthopedics, pediatrics, obstetrics and gynecology, psychiatry, dermatology, and surgeons of various specialties, professional organizations, and other ICD-9-CM users, including federal agencies, workers comp, epidemiologists, and researchers. Since other countries and vital statistics in the U.S. have been using ICD-10 diagnoses the use of ICD-10-CM by the health care industry within the U.S. would provide comparability with international data and state and national mortality data.
I'd like to move on to conclusions and recommendations. NAHDO feels that the ICD-9-CM has outlived its usefulness and support replacing it with the ICD-10-CM for the identification and coding of diagnoses and conditions. Furthermore, NAHDO recommends NCVHS immediately announce a two year voluntary transition process, through the NPRM, from the ICD-9-CM to ICD-10-CM and establish a defined date for the adoption of ICD-10-CM as a new code standard under HIPAA. At the end of this two year transition period the new regulations would be adopted with ICD-10-CM as the new standard code set, because the HIPAA rulemaking processing this gives the industry an additional 180 days for compliance after the final rules are adopted. NAHDO believes that issues with the adoption of the coding standard could be worked out during the two year transition period. Costs would be expected to be distributed throughout the transition period.
With regards to a single procedure classification system for all services we know that the ICD-9-CM Volume 3 lacks specificity and has an insufficient numeric structure to capture new technology and that CPT-4 has a number of vulnerabilities in its maintenance, use, and management referred to prior. The ICD-10-PCS provides a marriage of dual procedure systems with a structure to capture new technology, greater specificity in detail and new medical service and technologies. Nevertheless, the ICD-10-PCS would financially impact the outpatient health industry, it would essentially impose a completely new medical terminology, assigning new name and conventions to current procedures. There would need to be a well developed index and cross reference system, therefore we would sort a dual approach to procedure coding with ICD-10-PCS for hospital inpatient procedures and CPT for all outpatient procedures as it is today. Perhaps over time the ICD-10-PCS can be phased in over time for all services and thus satisfy the HIPAA requirement to eliminate duplicative efforts of dual procedural classifications. This we believe does require more study.
It is very important that the changes in ICD-10-CM be coordinated with HIPAA data standards. If the new coding system increases the average number of codes per patient then the requirements for the number of codes included in the administrative data sets, such as the health care claim, need to be expanded. It's our understanding that the ANSI X-12-N standards are being updated to support ICD-10-CM and ICD-10-PCS. It seems that the way the maintenance was done will support, allow an ICD-9-CM coding along with ICD-10-CM and ICD-10-PCS. That support should be specifically identified and included in the next iteration of HIPAA regulations.
We also understand that the National Uniform Billing Committee is in the process of approving the next version of the paper billing form, the UB02, and believe that new forms should also support ICD-10-CM and ICD-10-PCS coding. In summary, we believe the efforts undertaken by the committee to look into the need to transition to a new coding system and to find the best approach for achieving this goal are commendable. The opportunity to continue to offer comments along the way and in particular as final recommendations are drafted will be critical to success and acceptability of any transition plans. NAHDO will stand ready to continue to work with the committee and other industry improves to ensure that.
I thank you again for the opportunity to provide this testimony.
DR. COHN: Michael, thank you very much. Questions from the subcommittee? Yes, Steve.
DR. STEINDEL: Thank you for your nice presentation, I have a question concerning estimated cost. NAHDO has a good feel for what it costs to collect data on a sate level on hospital discharge information, etc., do you have any feel of what it might take to convert the present system, which is running on ICD-9, to a system that runs on ICD-10?
MR. LUNDBERG: I guess what I'd have to do is try to talk about the different perspective, my business is actually to receive information from 800,000 discharges a year in the state of Virginia and process those. It costs us less then 13 cents per record to process those now but that is our cost. To convert to a new grouper, to convert to add the additional fields would be more in the thousands of dollars to receive that. That doesn't come close to accounting for the costs that would be at the hospital level or the other level so it's hard for me to address that, but for us it's minimal.
DR. STEINDEL: Thank you.
DR. COHN: Michael, let me ask a question. Obviously I think one of the concerns we have, and I know that you're obviously a holder of databases, you're concerned about longitudinal review of data, do you see any issues as a transition might occur or post transition in terms of the comparability or value of your data?
MR. LUNDBERG: It's a little known secret that every time CMS makes significant changes to the DRG system there's trending issues, what meant this, does it mean that, and it takes vigilance, it takes efforts to associate with that. I think all of us could guess that a transition to the ICD-10-CM and the resulting grouper would be much more significant, but I also believe that with the efforts of others to map those and to study those and work on those that it can be overcome. We actually use two grouper systems, we use a proprietary system that changes every three to five years for severity, in those cases we go back and convert all our history. It is something that we as part of doing business, it's important, but the net gain to us is much greater for outcomes measurement and others.
DR. ZUBELDIA: Michael, you're talking about a voluntary transition, voluntary two year transition. What would compel the industry to do something voluntarily?
MR. LUNDBERG: I actually ultimately, I'm not really saying that we're going for voluntary transition, I'm saying that it should be announced that we need to move forward on this. I believe that, NPRM would not be a voluntary transition, is that correct, if it goes through there?
DR. COHN: The ICD-9 is now a HIPAA reg so I don't think that, I think any regulation would obviously have to go through the normal regulatory channels and I don't think there's, voluntary is part of --
DR. ZUBELDIA: Your recommendation is to have a voluntary transition even before the NPRM, even before the final rule.
MR. LUNDBERG: I came in here unprepared for the fact that you were having an NPRM, I believe that NAHDO members support the idea of moving to be mandatory. I will tell you from my own experience with state mandates in which Virginia has some on health care data collection that mandatory systems actually give health care providers a breather because they know they have to do it and that by having everyone follow the same rules then you have comparability and that it's just something that they have to do it, they're unburdened with that decision is what they tell us when they do that. I'm sure that will generate conversations later but a mandate does allow and I think it does ensure compliance ultimately. Reasonableness and then having a reasonable transition period and listening to those in the industry about the issues and addressing those is also critical.
DR. COHN: Michael, you have any thoughts during whatever period might be between now and some possible migration to ICD-10, what might be able to be done in that period to ease the transition for the industry? Help mitigate costs or processes, I mean you've obviously been dealing with the hospitals and others as you've gone through all sorts of various changes. Any thoughts? Obviously you mentioned voluntary transitions, but other ideas?
MR. LUNDBERG: I think that this committee has already benefited today from the very heartfelt feelings of the payer industry and others about some of the issues that would arise. I think they need to be taken very seriously and worked to the extent possible within your, if it should be your desire to move to ICD-10 to try to address those in a proactive fashion. Too often we aren't aware of what the problems are until the shoe has dropped, so that by working with those folks now to identify those issues and try to mitigate those makes perfect sense. I was struck by the point that was made earlier that the vendors, while payers might have been ready to implement changes associated with HIPAA the software wasn't there. What are the reasons the software wasn't there? Was it because they didn't move fast it? Or is it because they were waiting on rules from the federal government that didn't allow them the cover to move? Frankly I'd do a post mortem on those types of things to try to identify and minimize those, those clearly would reduce costs. If a vendor is developing a new grouper system or a new ability to handle edits associated with codes, they cannot move until they have enough direction from the federal government or from those adopting ICD-10 on exactly what it is and what it will look, smell, and taste like. So those types of things that are really in the trenches that are people who are waiting to press the button but it won't boot. Those are the things that are very real issues to these people and I think that to the extent those can be projected, because there's very fine people out there, and dealt with, I think we could make a great deal of reduced costs and make the process a lot more smooth.
DR. COHN: Thank you. Other questions or comments? Kepa?
DR. ZUBELDIA: Michael I want to pick your brain a little bit. Where are the landmines in a transition like this? One of the lessons that we learned in HIPAA is that there were a lot of hidden surprises in the implementation guide and we keep still finding surprises in those implementation guides every week. Where are the surprises in a transition from ICD-9 to ICD-10, what are the things that, I mean I'm sure you've looked into what would happen during the transition, what should people be looking for?
MR. LUNDBERG: If I knew the answer to that I'd probably be one of the consultants that submitted comments earlier. There's a number of issues, I think so much of it has to do with the different layers. If you look at hospitals they have multiple layers of vendors and it's a real challenge for hospitals to work with those, they have vendors associated with the administration portion of the data collection, they have vendors associated with the payment portion, they have vendors associated with the submission and the retrieval of those, and it's the reliance that health systems have on multiple things that is very expensive for them and the interaction, I mean that's a landmine for them. I think a similar thing exists for payers but it's even more complex when they're dealing with hundreds of different providers and others. I guess there's really nothing new I'm adding to that. For you folks I think you're feeling the landmines when you're hearing again the very well thought out comments and concerns that people have about this. Again, our view is to keep our eye on the prize and the prize is better health information to allow people to act on it to improve the quality of care.
DR. FITZMAURICE: Mike, a quick question. You and others have mentioned the fact that it doesn't seem like vendors stepped up to the plate with regard to HIPAA and I don't see any factual basis to dispute that. Does that carry over into ICD-9, ICD-10 coding, that is are there vendors there who make software that lets you look at something and come up with a code pretty quickly, and if there are do you think they would be quick to react to meet the needs for ICD-10 coding? Or do you think they won't?
MR. LUNDBERG: I don't have any personal experience to know that the vendors did not step up, what I was doing was repeating some of the comments that I heard earlier and have heard other times. I believe that the vendors will step up to the plate and move quickly and I am pretty sure since ICD-10-CM has been put out internationally for a number of years that there are already some applications that are there. Whether or not they're appropriate to the United States unique needs I can't answer that question, but I think that is a type of exploratory thing that could be probably done fairly quickly to understand.
DR. COHN: Other comments or questions from the subcommittee? I guess I would ask the audience are there questions, comments, statements that anyone would like to make at this point? It's hard for me to believe that we've left everyone speechless.
DR. FITZMAURICE: I would just like to ask you to expand just a little bit on, you said the reliance that the health system has on multiple vendors is a pitfall or a source of potential cost increases. Could you explain that? You rapidly said, when you collect data, when you store it and you pull it out, can you just maybe expand on that a little bit so that we can understand this pitfall.
MR. LUNDBERG: I'm basing this on conversations I've had over the years with Virginia's 80 or so hospitals who submit data to our organization. They have multiple systems that have been developed for specific purposes that in order to meet health care data submission requirements to us and to others those systems have needed to talk to each other. They would have an administrative system that would set up primarily just to gather information associated with where the patient was coming from to schedule the admission. They would have another system that actually goes through and does some pricing and it takes information on a revenue center codes, runs associated with that, it's to go into the different billing and those are then specific to different payer requirements associated with those. They would then have another system that in some cases would then submit the bill. Now us, we're a downstream user that just takes extracts of that information so in that case there would be another company who would extract just those elements that we receive and go through there. So hospitals have indicated that whenever they make a change, when we periodically have changed the information that we have required it was important to the hospitals that it be a mandate because their contracts required to these different vendors that they would meet state requirements. Now it's not a fault of hospitals that they have multiple vendors, they've been responding to a changing health care environment over the year that started essentially in the ‘60's and has gone up to today.
DR. FITZMAURICE: Is the solution to have some consolidation into say a compliance data vendor that says alright, spill out your data into a warehouse or a clinical repository and I will mine that and supply all these requesters of your data with the data in the formats they want based upon what you give, so you don't have to deal with multiple vendors. Do you think there's some efficiencies in that?
MR. LUNDBERG: I think there would be a great deal of challenges associated with that, I think conceptually it sounds like it would be great because if you could just have someone take care of it, but I think there's, because the data are being collected for a number of different needs I'm not sure, quite honestly I think the hospital industry would be able to provide a lot more insights on that then I could.
DR. FITZMAURICE: The reason I'm asking that is to look at the value of standards. A lot of what we're doing here is trying to make things uniform so that judgments can be made on more uniform data and more of it, and so that was the reason for my questions about all the different data collections and different systems, and then about the potential for integration. I know it's difficult to integrate the clinical data needed to take care of a patient in a hospital, each department has the best possible system you can possibly buy but often it's not to their advantage to speak to each other, but it's to someone's advantage that they speak to each other, certainly to the patient's advantage and I hope to the hospital's advantage, and I hope to the payer's advantage. A lot of the National Health Information Infrastructure is built around getting that information to where people can make a good decision from it.
MR. LUNDBERG: I think most people would favor some sort of within hospitals some way to simplify this because again, it's grown, it's been tacked on top of others, how they could get there I don't know.
DR. COHN: Okay, Carol Bickford.
DR. BICKFORD: Carol Bickford from the American Nurses Association. I'm
interested in understanding why your organization or you or whoever is making
the statement supports the 10-PCS as well as CPT-4. It would seem to me that as
we're looking at our evolving health care practices that the distinction
between ambulatory and acute care is becoming very blurred, so in essence we're
having duplicate coding systems because I would have to code the procedure that
used to be only hospital based is now in ambulatory setting and is in office
practice and a CPT code. Could you speak to that, please, about why you're
looking at two coding systems for the procedure component rather then
advocating for one?
MR. LUNDBERG: At the moment there are two coding systems for procedures, one is
ICD-9-PCS and the other one is CPT-4. We believe that requiring adoption of
ICD-10-PCS for physician components where payments are completely separate and
different is more of a burden then it is worth at this point with lack of
available of that information, the incredibly huge cost that very small
providers in many cases would have to bear for conversion, that we don't
believe that is something that should adopted at this time. We do think that
over time looking at crosswalks might lead to that but we think that that would
be too much of a step at this point.
DR. COHN: Other comments or questions from the audience? Dan Rodey.
MR. RODEY: Dan Rodey, American Health Information Management Association. I presume this is the time for public comment and I certainly welcome NAHDO's comments as well as others that have been made this morning. We've been at this now for 13 years, we've had a lot of input, we've lost and increased a lot of costs because we didn't make a decision in the ‘90's and we can all find reasons that we didn't do that. But as Tom Grissom said this morning as a committee on vital and health statistics I think we have to look at the directions we have available to us and in taking in part Blue Cross's comments about also a need in a larger timeframe to look at a strategic plan to move forward with an NHII and most of you are also on the NHII panel, so we have a crossover there.
I think we're at a point where we've got essentially four or five questions. The first question is do we recommend and adopt ICD-10-CM? If we accept the National Center for Health Statistics and many other pieces of testimony that ICD-9-CM is broken and that we've got problems with the exchange of data and the collection of data and the lack of detail that's been expressed several times, then we need to move forward. If we don't believe we need the detail and that we can live with today's issues, that we can live with the need to exchange vast amounts of paper data and medical records and attachments and what have you, whether they're scanned or copies, then maybe we stay where we are, but then I think you have to take into consideration the comment that it's time to look at how are we going to handle all the uses of data, we speak a lot of reimbursement but we also have data for public health, for research, for clinical care, for managed care and so forth.
We have a second decision on PCS, I can't be as eloquent about talking about PCS on the basis of inpatient facilities, but coming from a university health care career, 30 years, I can tell you that the ability of tertiary care in educational organizations that I've worked with desperately need the detail that comes out of PCS not only for the internal purposes that we heard talked about yesterday but also for the external purposes of being able to report to Medicare and to finally bring ourselves together with a PCS, ICD-10-CM system that will allow to adjust severity outcomes and other things that we've been trying to do for years. We have good sense from the testing done in the ‘90's that we've got some capabilities that we can now use and as Tom Grissom said time we met if after collecting these data for a couple years we look at the med-par file, think of what we're capable of doing.
The third decision, which is do we do PCS and ICD-10-CM together, and I think we've heard no testimony suggesting that we do them apart. The combination of them together is significant.
We have a fourth decision that I'm going to suggest maybe is not yours, and that is the decision about this question of costs, whether it's $14 billion or $425 million, there is going to be a cost. The cost is going to trickle down as they say to the public, it's going to be borne in increased money that's necessary, either through a tax fund or premium. How much trickles down will depend on how much the industry can absorb and it's been expressed several times here today how efficient we are in implementation, but the cost will be borne and if we wait as Blue Cross pointed out, there will be further costs. One way or another there will be further costs.
There are several associations in this room and elsewhere working together now with Congress, separate from the Medicare program, to look at the funding that would be needed to rebuild our infrastructure and our systems and we are certainly active and invite others to be active as well to look at that, we recognize there's a cost, we believe that one of the recommendations this committee can make is to recommend to the Secretary and to the Congress that we look at the purpose of cost and how we might invest in the future. And I think one of the things that was pointed out in RAND, it's certainly pointed out in the testimony you've just heard, is our investment in the future of the health care of this nation. How long do we put it off? How long do we ignore the detail that we can collect? And so as a committee of vital and health statistics, a committee that has to look at our use of data in this country, the use of that data in statistics that come from it, the exchange with other countries, we desperately think that we need to make a decision to move forward because the alternatives when it comes to a clinical terminology system, excuse me, an aggregate terminology system that ICD-10-CM and PCS present to us, there are no other alternatives currently on the table and will not be without significant development over the years. Your ability to move forward with PMRI, and the ability of us all to build electronic health record system, is greatly going to depend on how we can address this issue. If we don't address it then some of those other things are going to come to a halt or we're going to have this situation where vendors will wait because there's no red light, there is a red light showing, there's no green light, no way to proceed.
We have a lot of work ahead of us, implementation is certainly an issue in this case and it's probably the key part of any NPRM because we're upgrading code systems, we're not asking people to come in and change the code systems in NPRM, we're asking people how do we implement an ICD-10 upgrade, how do we get from where we are today to the future. We've got a lot of experience, we've got a lot of great minds in the industry, I'm sure we can work with CMS and CDC to do that, but I certainly encourage us to move on because we've got a lot of work to do and right now it's really hard sitting here at the traffic light waiting for it to turn green. Thank you.
DR. COHN: Dan, thank you very much. Other comments? Okay, well, it's actually lunch time and I think we are scheduled to adjourn to 1:00 p.m., so we will reconvene at that point. Thank you.
[Whereupon at 11:45 p.m. the meeting was recessed, to reconvene at 1:05 p.m., the same afternoon, Wednesday, October 29, 2003.]
Agenda Item: Discussion of Issues and Draft Recommendation Letter - Subcommittee
DR. COHN: Okay, we're going to get started with the afternoon session here. I guess I should ask you, this afternoon is really meant to be A, a discussion of the issues, and B, a discussion of a potential letter that we may send to the full committee. Before we start in talking about letters do people have anything that they need or want to say just at the beginning of the session? I know it's after lunch. Okay, well I think what I'm going to then propose is that we at least start talking our way through a possible letter. I think as you all are aware you have actually two copies of letters in front of you, one of which has lots of options and another one which has been marked up with things that have been sort of, is a further version and I'm going to suggest that we deal with the version which has been, Maria how shall we describe this one?
MS. FRIEDMAN: Actually it has a messed up date, so it actually redline date should be 10/28, 10-218, but it should be 10/28.
DR. COHN: So that should be 10/28.
DR. ZUBELDIA: So what have they done with the other seven drafts?
DR. COHN: This is a further modification of the last draft. You will see the optionalities and the comments that many of you have made through earlier versions but this one is making, doing a little bit of additional wordsmithing as well as making some choices in some of those areas where there are seven or eight options. And once again, I'm not suggesting that this is the final letter but I thought it was a good jumping off point and I think we're just going to need to talk through it paragraph by paragraph if that's okay. As I said you all have access to comments, suggestions, possibilities of inserts, possibilities of various changes in sense of the letter as we go along so none of that has been hidden in this particular version.
Now my preference is is rather then us starting to put up something on the computer and up on the screen is that we actually go through the letter since it's in front of us and only if we get into significant wordsmithing will we start putting up on the screen and showing you what those modifications look like. Now is that okay with everyone? Okay, well let me start reading and we'll just go through sort of paragraph by paragraph, hopefully the first couple of paragraphs will not be too contentious and then we obviously move into the main part of the letter. This letter once again dated, this particular version is 10/28, supposed to be 10/28, to Secretary Thompson.
As part of its responsibilities under the Health Insurance Portability and Accountability Act of 1996, HIPAA, the National Committee on Vital and Health Statistics monitors the continued effectiveness of the health data standards adopted pursuant to the requirements of HIPAA's administrative simplification provisions. Comments? Everybody okay with that one?
Okay, next paragraph. During the past several years NCVHS' Subcommittee on Standards and Security has focused considerable attention on the feasibility and desirability of replacing the current diagnosis and institutional procedure classification system, ICD-9-CM, with a newer and expanded version, ICD-10-CM and ICD-10-PCS. At issue are the moves from ICD-9-CM Volumes 1 and 2 to ICD-10-CM for diagnosis codes, and from ICD-9-CM Volume 3 to ICD-10-PCS as the replacement code set for institutional procedures. I'm further recommending, unfortunately I don't have the wording in front of me, the following that we would actually do is to quote the HIPAA reg part that refers to the usage of ICD-10-CM Volumes 1 and 2 and 3 in terms of their current usage.
MS. GREENBERG: 9-CM you mean?
DR. COHN: I'm sorry, yes, 9-CM, thank you, 9-CM, recognizing I think that there's, should be a succinct definition within the industry --
PARTICIPANT: -- specifies that it's for inpatient procedure --
DR. COHN: Exactly, exactly, and I think we need to come up with the right wording here, but as I said I thought just really quoting the HIPAA reg, or the applicable portion of the HIPAA reg, would further clarify what it is we're talking about. Now let me ask people about this paragraph, and I know that it feels like we could wordsmith it better, Michael?
DR. FITZMAURICE: Clement made a statement before he left yesterday that he thought a useful addition might be, and I think he made it to everybody, sent it to everybody not just to me, that having at the end of the paragraph something like the coding system for professional procedures done out of institutions would remain as CPT-4, or words to those effect, remain unchanged.
DR. COHN: Yes he did means what?
PARTICIPANT: Michael reflected accurately, that's what he wanted.
DR. COHN: Okay, as opposed to yes, you're putting it in. What does the committee, or subcommittee, feel about that addition?
MR. BLAIR: Fine.
MS. GREENBERG: Statement of fact.
DR. COHN: Okay, then that's fine, I just want to as we start building on these things we want to make sure that everybody is sort of following along here.
MS. GRAHAM: We could use the same annotation from the HIPAA regulations regarding that to clarify just so, you clarify what your proposing for ICD-10 but then you go on to clarify what the existing regulation is.
DR. COHN: I think that's probably, my memory of that area is that that gets to be very long because I think it goes through and talks about all the various levels of HICPICs and all of that, I mean we could wind up with a page and half quote, but there may be some pertinent part there that we can pull in.
MS. GRAHAM: We kind of struggled a little bit with institutional versus inpatient.
DR. ZUBELDIA: And where do you put the dental procedures?
DR. COHN: I don't think we're talking about dental procedures.
DR. ZUBELDIA: I know we're not, but if you're going to start clarifying non-institutional procedures you also need to talk about dental procedures and HICPICs and perhaps even NDC.
DR. FITZMAURICE: The coding procedures for all other procedures would remain unchanged? Incorporate it by reference as opposed to listing each one individually?
MR. BLAIR: Or in a footnote. One thing, I tend to think chronologically and to wind up after the sentences that you read Simon to then go back and wind up saying that HIPAA included the ICD-9 codes is like taking a step back, is it possible for us to include that sentence prior to the fact that we're recommending ICD-10 or discussing ICD-10?
DR. COHN: Actually you're saying that maybe we do put that quote in before we start, there's a sentence at the end of this paragraph that says at issue are the moves from ICD-9-CM Volumes 1 and 2 to ICD-10-CM for diagnoses, and put those quotes first, that would actually be very nice wordsmithing. Okay, are we comfortable with that so far? Because I clearly agree with everyone that we want to make sure everybody understands what we're talking about and I think this is, and I think we've also said that institutional isn't the right word, it probably is inpatient, but we need to make sure that it's consistent with whatever's in the HIPAA reg.
DR. ZUBELDIA: The inpatient/outpatient issue is an issue that needs to be resolved but I think, I would not want to perpetuate that issue in this letter.
DR. COHN: Kepa, I don't understand what you're saying.
DR. ZUBELDIA: Okay, the use of the ICD-9 procedure code for outpatient institutional billing today for principle procedure is something that is not contemplated in the reg as it stands today. We talked about it yesterday and that's how it's happening today and that's the contingency plan that has been implemented by essentially all the hospitals and all the payers, everybody is using that, not everybody, most everybody is using ICD-9 Volume 3 for outpatient principle procedure coding at the claim level, outpatient, so I would like to leave that inpatient/outpatient distinction out of this letter because it's a separate issue that needs to be addressed and resolved and I would like to not --
DR. COHN: Well, Kepa I agree with you, but how do we, I mean that was why we were using the word inpatient, so I'm not --
DR. FITZMAURICE: This letter does not propose any changes to other coding systems?
DR. ZUBELDIA: Well, we're saying institutional procedure codes, it could include both depending on the final resolution of this other issue.
DR. FITZMAURICE: This letter does not propose any changes to outpatient coding systems.
DR. ZUBELDIA: What I'm saying is by not specifying inpatient or outpatient and leaving it as institutional we're kind of binding this to whatever the resolution is for the other one.
DR. COHN: Kepa, I'm suggesting that we use whatever terminology is in the HIPAA reg, and that says inpatient and I think we should leave it at that. And I agree with you, we should not go into the issue as you described only because I think, if it isn't resolved we will actually need to hold hearings on that because it's not really all clear to me what the industry, I mean my understanding of industry practices appears to be somewhat at variance with your understanding of industry practices, and I think that we want to actually ask the industry what their practices are specifically on that. So I agree with you, this should not be an issue for this letter.
DR. ZUBELDIA: Knowing that once we resolve that other issue we discussed yesterday, once that's resolved that would also impact, the same impact would be on this letter as it has on today's regulation. Right? If the resolution is that the ICD-9 Volume 3 or ICD-10-PCS is usable for outpatient institutional procedures for the principle procedure it would impact both the existing reg and this letter.
MR. BLAIR: Do we want to put that in the letter?
DR. COHN: No, I don't think we want to go there, Kepa.
DR. ZUBELDIA: That's what I'm saying, we ought to stay away from that in the letter --
MS. GRAHAM: Because I think there are dissenting views on that so I think additional discussions would be beneficial.
DR. COHN: Yes, Steve.
DR. STEINDEL: Simon, we're not proposing any change in use of ICD-10 versus ICD-9 and maybe we can use some language that just says something like the current uses of ICD-9, wordsmith it that way to avoid specifics and getting into the type of quandary that has been discussed.
MR. BLAIR: If you have it in the sentence, and I'm kind of building on what you're saying, and I think you have the sentence there indicating we're proposing ICD-9, excuse me, ICD-10-CM and ICD-10-PCS as replacements for, then you go to the ICD-9 ones, the word replacements I think could help us avoid getting into the other discussions.
DR. ZUBELDIA: And replacement for the same use.
MR. BLAIR: Yes.
DR. COHN: Okay, so maybe that last sentence as basically replacement code sets, period. But maybe the --
DR. ZUBELDIA: And then you're going to add an insert from the final rule that explains what is the use of the ICD-9 today, so it will be a replacement for that same use.
DR. COHN: Exactly. Maria, are you okay with this?
MS. GREENBERG: Right now the word replacement only seems to be associated with procedures not diagnoses, it's really a replacement for both.
DR. COHN: For both, exactly.
DR. ZUBELDIA: So as a replacement code sets.
DR. COHN: Yeah, how the sentence will look now, okay. And actually it was almost sort of like at issue was the replacement of ICD-9-CM Volumes 1 and 2 and 3 with ICD-10-CM and PCS for current uses, or something on that level.
MR. BLAIR: Is this analogous to playing Chopin?
PARTICIPANT: It's in very hard keys.
DR. COHN: Okay, are we okay with that paragraph with the addition of quotes from HIPAA regs and with relying more on the concept of replacement?
MS. GREENBERG: What was the conclusion in regard to mentioning that this did not impact on other HIPAA code sets?
DR. COHN: Well, I think that's probably a sentence that needs to be there.
MS. GREENBERG: Some kind of general statement like that because I think Kepa is right, that if you name one then what about the others.
DR. FITZMAURICE: Something like this letter does not recommend changes in the other code sets adopted under HIPAA.
MS. GREENBERG: Well, the other, are they called medical code sets?
MR. BLAIR: Does not effect the usage of other code sets.
DR. COHN: Of other medical code sets recommended under HIPAA. Okay?
DR. HUFF: I'm not sure that meets what Clem wanted because it's true that the other dental coding systems and other things fall into the same category theoretically but they were never an issue and never discussed, and with the change now it's not, again, I think Clem's goal was to make it clear that we were not recommending the change to that one particular thing, and now it's probably more obscure then it was to start with.
MR. BLAIR: Stan, what if we did this then, what is we had a sentence that wound up saying this does not effect the usage of any other medical code sets recommended under HIPAA such as CPT code, ACT codes, etc.
DR. STAN: I think that would be great.
DR. COHN: Okay, Maria are you catching this? Okay, good. Steve?
DR. STEINDEL: I'd like to see the paragraph, I think it's become overly long and overly convoluted. I just think we should deal with a simple statement that it's a one to one replacement, I think we can say that in a few words, and then when we start qualifying is when it gets complicated.
DR. COHN: I guess we'll have to wait and see.
DR. HUFF: This paragraph isn't even our recommendation --
DR. COHN: This is what we're talking about. Let me think about how we're going to help everybody with this one, Maria, we haven't talked about process and all of this stuff and I'm not at this point that we wanted to make you have to start wordsmithing on the screen, but is this something that --
MS. FRIEDMAN: I can, whatever the committee desires.
DR. COHN: Would people like to start seeing some of these things up on the screen?
PARTICIPANT: Why don't we take one run through it first, take one run through the whole letter first so we don't bog down.
DR. COHN: Okay --
DR. HUFF: I think before we're done I think we do need to see that --
DR. COHN: And one option might be actually for us to move onto other business while Maria works and then take a look at it at the end of the afternoon might be another option also rather then trying to oversee her wordsmithing. I mean I've been very impressed with her ability to put things together.
Anyway, next paragraph. ICD-9-CM was developed in the 1970's. Despite an annual update process ICD-9-CM has structure and space limitations, and actually I think, how about this, despite an annual update process ICD-9-CM Volumes 1, 2, and 3 have structure and space limitations that increasingly curtail its ability to accommodate advances in medical knowledge and technology.
MR. BLAIR: Curtail says stop, constrain, I think constrain is a better word then curtail.
DR. COHN: Constrain, thank you. ICD-10-CM is recognized as a logical successor code for ICD-9 Volume 1 and 2 diagnoses, ICD-9-CM Volume 1 and 2 diagnoses, that sound, in fact ICD-10 already has been used for mortality classification in the United States since 1999 and has been implemented for that purpose throughout much of the rest of the world since the mid 1990's. Many of these countries also have adopted ICD-10 or a clinical modification of it for diagnosis reporting. Now we also need to say something here about somehow similarly ICD-10-PCS --
MS. GREENBERG: It's not an international code set so you can't say --
DR. COHN: That's true, we need to say something about procedures here.
MS. GREENBERG: Countries that had used ICD-9-CM Volume 3 or other procedure classifications have moved to newer, many of them have moved to newer procedure classifications, but they're all over the map so I wouldn't get into that here.
DR. COHN: Well the problem is though is that we start off by talking about issues that are generally relating to Volumes 1, 2, and 3 and then we move off to talk about diagnoses and we don't say anything about procedures. There needs to be something that says, I mean I think we're talking about the fact that there's constraining the ability to incorporate things which applies to all of them so we need a sentence or something that relates to procedures. Yes?
MS. GREENBERG: You have a sentence that says despite an annual update process ICD-9-CM has these limitations and that of course refers to both. Then you have these statements about ICD-10-CM --
DR. COHN: About diagnosis.
MS. GREENBERG: 10-CM, which is for diagnosis, and then you could just also say ICD-10-PCS has been developed by CMS as the successor for Volume 3.
DR. ZUBELDIA: To address the same sort of structural limitations found in ICD-9 Volume 3.
MS. GREENBERG: Although you don't say for 10-CM that it's to address those, it's just logical I think that it is.
MR. BLAIR: Kepa, we've already kind of said that.
MS. GREENBERG: Said they have problems, so 10-CM is the logical successor code and then you put that, for diagnosis, and then you put that in the context of its broader uses and then I would just say that ICD-10-PCS has been developed by CMS as a successor for Volume 3.
DR. COHN: For Volume 3 of ICD-9. Okay, good. Other suggestions for that paragraph or are we okay? Okay, next paragraph, more then eight hearings have been held by NCVHS since 1997 and oral and written testimonies have been provided by more then 80 public and private sector groups. A complete listing of the groups that have testified and a synopsis of their testimonies are attached.
MS. GREENBERG: Now is that going to be the timeline? Yesterday you weren't sure whether we really wanted to provide that matrix.
DR. COHN: I guess my view was is that given the problems we were having with that one particular appendix I thought what we wanted to do is to with the timeline, footnote, especially as we go through with letters, footnote the signatories of the letters, and probably include the letters as part of that timeline only, because sometimes the letters are a little more complex then to put into a sentence or two. Does that make sense?
MS. GREENBERG: You mean attach the letters? I don't think I would do that.
DR. COHN: Okay, maybe no, okay maybe --
MS. PICKETT: Let me make a suggestion. As part of the timeline in many instances for the letters I had actually summarized what was in the letter so we could go ahead and add additional summaries into the timeline and then the table, which we won't use, I'll strip it and just have the complete listing of all of the testimonies and organizations that have provided information to the committee. So we would lose the portion of the table that contained support/do not support/undeclared but the listing of those organizations and the number of times that they have provided comment to the committee would remain.
MS. FRIEDMAN: I think that's useful, it's alphabetical by an organization so you can see at a glance if there's any particular group you're interested in to see where they are.
MS. GRAHAM: I just want to note that I didn't think it went back that far but VA among others testified in 1997 and were not listed on there, so federal agencies are kind of admitted --
MS. PICKETT: We could add that, the table as presented yesterday basically summarized the last 12 to 13 months, but we could certainly go ahead and go back to 1997 when the initial hearings regarding the adoption of the initial code sets under HIPAA were involved because I have that complete listing.
DR. ZUBELDIA: Which brings up the count of hearings, when I read more then eight, I think what, is that nine? If it's nine just say nine, otherwise you say multiple hearings.
MS. FRIEDMAN: We can get the count right or we can say multiple, whatever.
DR. ZUBELDIA: If we can't get the count right --
MS. PICKETT: Perhaps it might be useful to give an exact number, multiple I think you kind of lose what you're trying to say in terms of how many times the committee and the subcommittees have actually heard testimony on this, multiple you kind of lose that so we can provide an actual count.
DR. COHN: And we probably want to say this is more then X days of hearings, because I don't, I mean it seems like we've had much more then just eight days of hearings on this topic, but maybe it just seems that way.
MR. BLAIR: I support that.
DR. ZUBELDIA: I would go for a count of the days, count of the days, count of the hearings, something, but an exact count, don't say more then 143 --
DR. COHN: And I actually think that we probably should include times where this issue has been brought to the full committee.
MS. PICKETT: Because the 1997, that was the full committee.
MS. GREENBERG: I think we've got to come up with a number, part of the problem is sometimes it was mentioned but it wasn't a formal hearing and you had a few speakers --
DR. COHN: And I'll give you latitude in how you count them. Steve?
DR. STEINDEL: Simon, I have a little bit of a problem of counting the 55 signees of that one mass mailing in the table as individual organizations, listing them all. It seems to inflate that table, mass mailings are a problem.
DR. COHN: What table are you talking about? There's going to be footnotes with people --
DR. STEINDEL: There's the AMA letter that the AMA signed and then there was a repeat of the AMA letter that was signed by 55 associated professional organizations as a mass mailing.
DR. COHN: I think if I were a professional society I might be offended by your comment.
DR. STEINDEL: That's why I'm raising it. If it's the consensus of the group that we count them individually that's fine, I just, I know when we looked at letters like that we bring that into account.
DR. COHN: Maria, do you have a comment?
MS. FRIEDMAN: I do, I think that's the reason that they signed the letter is that they all wanted to weigh in and I think they wanted to be counted for the same weight as anybody else, it's just a more efficient way of doing it. But my vote for what it's worth would be to list them all.
MS. GREENBERG: Have we agreed that the matrix is or isn't going to be attached?
MS. PICKETT: Marjorie what I was suggesting is doing away with the matrix portion of it but leaving intact the listing of the organizations and other stakeholders and the dates that they had provided information, either in testimony or in letter.
MS. GREENBERG: But not saying what their testimony was?
MS. PICKETT: It will be summarized in the timeline.
DR. COHN: And I guess one question I was wondering is are we relating the statements to those who signed the letters in some way? And there's some footnoting or something that's going to indicate that right?
MS. PICKETT: I don't have the timeline in front of me but I do recall that in one particular instance I summarized the content of the letter and then mentioned that either 46 or 55 specialty organizations were signees to that letter, so you'll understand what the focus was and also how many organizations signed it.
DR. STEINDEL: It's handled I think very well in the timeline.
MS. GREENBERG: With the separate signatories, listing of the signatories.
DR. COHN: Right, that's what I meant, okay, great. So I think we're fine on that?
Next paragraph, the issues surrounding the migration in the United States to a replacement diagnosis and inpatient procedure classification system are complex. For example, there are many in the health care community who believe that ICD-9-CM is an antiquated system that cannot meet the current and emerging needs of payers and providers in today's fast paced highly specialized and technically sophisticated environment. There also are concerns that ICD-9-CM is increasingly unable to support the need for accurate data for billing, quality assurance, public health reporting, and health services research. This has been well documented in the testimony given to the subcommittee over the past several years. Stop for a second? Okay so far?
MR. BLAIR: I may come back to that sentence, I've been a little nervous about having a sentence winding up starting the beginning of a paragraph before we got to our recommendations saying this is complex, I was very concerned that the Secretary, or the staff to the Secretary, would wind up saying hmmm, this doesn't sound like this is going to lead to something useful. But let's go on because you may wind up further on in the letter leading to something clearer. I had suggested some wording, but let's just go on and we'll see if --
DR. COHN: Well, certainly wording is helpful as long as it doesn't disguise the complexity. I'm giving you a hard time, Jeff.
MR. BLAIR: Let's go on --
DR. COHN: At the same time the subcommittee has heard significant concerns from the industry about costs, benefits, actually it should be probably from the health care industry, we'll have to think about, industry may not be the right word there but we'll figure it out --
DR. FITZMAURICE: Health care community?
DR. COHN: Yeah, maybe from others in the health care community.
MS. GREENBERG: I would actually say the committee, I think it's always in a better in a letter refer to the committee, I mean it's okay to say that the work has been done primarily by the subcommittee which you did on the first page, here I would say the committee because they've heard it also.
DR. COHN: Okay, so basically at the same time the committee has heard significant concerns from others in the health care community about the costs, potential benefits, and implementation issues associated with transitioning to ICD-10-CM and ICD-10-PCS. Given the use of these codes by all payers and providers there are widespread potential costs in terms of hardware and software changes, loss of productivity and training among others. Probably the word is not widespread, it probably ought to be significant. It's always good to read these things out loud, you sort of pick up things you don't when you're reading them.
The size of the benefits --
DR. ZUBELDIA: Hold on for a second. Where it says all payers and providers, can we change that to most payers and providers? Saying by all providers gives the wrong impression.
MS. GREENBERG: That all providers use the code sets?
DR. COHN: By most payers and providers.
DR. ZUBELDIA: It's institutional providers. I mean if you want to say all institutional providers that's fine --
MS. GREENBERG: Except all providers use the diagnosis codes.
DR. ZUBELDIA: Except the dentists.
DR. COHN: How about this instead, how about given the widespread use of these code sets there are numerous potential, there are significant potential costs in terms, is that okay?
MS. GREENBERG: Should this be qualified, the loss of productivity, I mean presumably it's a temporary loss of productivity, I don't think we're saying it's a permanent loss of productivity.
DR. COHN: Well, I think it's described as potential --
PARTICIPANT: That infers that the productivity of a coder would be effected indefinitely --
PARTICIPANT: Until the learning curve goes up.
PARTICIPANT: Well I mean this implies that it will be forever.
DR. FITZMAURICE: Temporary loss of productivity.
DR. COHN: Betweening(?) is only a one time event, too, and software changes are only a one time event, I don't know that, we suddenly start temporarily qualifying these things where it's going to --
DR. FITZMAURICE: Simon's right.
DR. ZUBELDIA: Can we say there are significant potential implementation costs? Because all you're talking about here is implementation costs.
DR. COHN: Okay, that's even better, okay.
PARTICIPANT: Implementation costs is fine, it's just to get to the term initial start-up or implementation costs.
DR. COHN: Okay, great. Let me read this one, this is going to need a little fixing here. The size of the benefits is much harder to quantify but appear to exceed the costs, we'll come back to that one. The benefits are harder to quantify? That still doesn't quite make sense, the benefits are harder to quantify but appear to exceed the costs?
DR. FITZMAURICE: That'll work
DR. COHN: These benefits include more accurate reimbursement rates for emerging technologies to assure those services are available to patients, improvements to the quality of care and patient safety, and improved information for disease management. These costs and benefits and related issues have been substantially documented in testimony before the subcommittee as well as in a specially commissioned cost/benefit study by the RAND Corporation. A copy of the RAND study is attached. I guess I would sort of comment, this is sort of a long paragraph first of all --
MS. GREENBERG: Is it two paragraphs?
DR. COHN: Yeah, maybe it is two paragraphs, no, actually it's, yes it is two paragraphs, thank you.
MS. GREENBERG: At the same time starts another new paragraph.
DR. COHN: I think what I'm concerned about is the sentence where the benefits are harder to quantify but appear to exceed the costs, and then these benefits include and there's a couple things that it includes. And these benefits that are being mentioned here I think were the qualitative benefits that were mentioned in the RAND study if I'm not mistaken, the benefits that we have here are really the qualitative benefits --
MS. GREENBERG: Some of them were quantified.
DR. COHN: Well, not in any of these, none of these.
MR. BLAIR: Could I suggest that since it's, when you get to the benefits it's a mixture of what the RAND Corporation was able to quantify, plus it alluded to substantial benefits that it couldn't qualify. So maybe if instead of saying that, I think you said appear to exceed or something like that as if you're still dealing with just costs, is that right? Is that the words? What if we say but appear to outweigh instead appear to exceed? Because if you start using a word like outweigh then that could indicate that the subject is benefits, or the non-quantifiable benefits are something that we're considering in the back of our mind but we don't have a dollar figure for them.
MS. GREENBERG: I don't know that we need to make that distinction but the ones that were quantified in the RAND study are more accurate payment for new procedures, which is listed here, fewer rejected claims, fewer fraudulent claims, better understanding of new procedures and improved disease management. I think they didn't quantify improvements to the quality of care and patient safety --
MR. BLAIR: But at least in my mind I take a look at historically what's happened in other industries and when you improve quality there's indirectly a derivative which sometimes is very substantial in lowering costs.
DR. COHN: Marjorie, there was one that you mentioned in the quantifiable benefits and I believe that that had to do with, help me with this one again, the quantifiable ones in the RAND study included, say this again because there was one or two missed on list, fewer rejected claims, more accurate payments, this improvement, for emerging technologies to assure these services are available to patients seemed to be sort of an odd --
MS. GREENBERG: That was actually in their report.
DR. COHN: Steve.
DR. STEINDEL: Well, two points, one is a very quick one, I think we need to make a mention in this paragraph about ongoing costs, RAND did address them and we're just talking about one cost, the implementation cost, people who read this letter are going to ask are there any ongoing costs because of the change and I think that needs, that thought needs to be added if for no other reason to say that they've been identified as being low or something like that. That's something I think needs to be added and I have a problem with, I like Jeff's statement about outweigh or something a little bit more subjective because even where the RAND report did put numbers on things there were assumptions that were used to calculate those numbers and I think those assumptions are open to question.
DR. COHN: Okay, let's take a listen to that one again then. Can you restate it?
DR. STEINDEL: I like using Jeff's way of wording things --
DR. COHN: Well, I need to have them say it again.
DR. STEINDEL: Which was instead of appear to exceed the costs, to change that from a quantitative to a more subjective word like outweigh, which is the way Jeff worded it, which is more subjective, and the reason why I say that is because in the RAND report, which we cite as a basis for this, RAND used a series of assumptions which they documented very well in calculating the way they came up with those benefits and they make the point in many cases that these are assumptions and they're open to question. So I have a problem with being very specific about costs, about benefits. But I think it's very clear from everybody that they do outweigh the costs, it's just how much is the question.
DR. COHN: Well, and how much we want to reference them in the document. I mean we can either leave it at a very high level where we don't say anything about the benefits, we can, I'm trying to think of where to go with these couple of sentences, I don't have any objection to I think Jeff's statement but it doesn't solve the problem of what these benefits include --
DR. STEINDEL: I think we've heard from multiple people that these benefits include what's listed, not just from the RAND report, just looking at this very quickly and not pulling out the testimony this morning from Tom Grissom I think he mentioned all of these in his testimony without putting numbers on them. And I think we've heard similar things from many other people.
DR. COHN: So these benefits include more accurate reimbursement rates comma, or is it more accurate reimbursement rates for emerging technologies to assure those services are available to patients?
DR. STEINDEL: I think actually he mentioned both.
MS. GREENBERG: If you're sticking with the RAND --
DR. STEINDEL: RAND was just emergency.
MS. GREENBERG: -- more accurate payment for new procedures.
DR. STEINDEL: RAND was specific for emerging technologies, what we've heard is more accurate reimbursement rates in general and also more accurate reimbursement rates for emerging technology. We've heard both in testimony.
MS. GREENBERG: We could say more accurate reimbursement rates comma, including for emerging technologies comma --
DR. COHN: Thank you, that sounds good.
MS. GREENBERG: And you could leave off this to assure those services are available.
DR. STEINDEL: And actually RAND made a discussion about whether that's more of an assumption.
DR. COHN: And then I think we had talked about the issue of fewer rejected claims, improvements to quality of care and patient safety, I think the others are probably fine then. Are you okay with this so far Maria, can you read over what we just decided then, do you have that, or am I putting you on the spot here?
MS. FRIEDMAN: Okay, given the widespread use of these code sets by, there are significant potential implementation costs in terms of hardware and software changes, temporary loss of productivity --
MS. GREENBERG: You don't need temporary there then I guess if we said implementation.
MS. FRIEDMAN: Okay, temporary loss of activities and other. Benefits are harder to quantify but appear to outweigh costs. These benefits include more accurate reimbursement rates, including for emerging technologies; few rejected claims; improvements to the quality of care and patient safety; and improved information for disease management.
MR. BLAIR: I don't know, let me offer my sense of those and I don't know whether you all will agree with this or not. I would order them differently, that first one is more accurate and that seems to me to be something where that could fall either way and it's not clear when you start to read that sentence that that is going to be something that is significant, I would have that at the end of the list, not at the beginning. The other thing --
DR. COHN: Quality of care and patient safety?
MR. BLAIR: I would move quality of care and patient safety unabashedly to the front of the list and it is not quantifiable at this point, at this time, but I think that we were using the outweigh and I think that that should be first and then we wind up showing the things that can be quantifiable and then we have that accuracy item at the end. Just a thought.
DR. COHN: I was agreeing with you and then I wasn't quite sure what you said about quantifiable. I mean were you saying that we should order, I wouldn't make the distinction at this point.
MR. BLAIR: I don't think we want to make the distinction --
DR. COHN: That's what I was hoping --
MR. BLAIR: Conceptually.
DR. COHN: Okay, so we're okay at this point. Okay next --
DR. FITZMAURICE: One minor thing, I would strike the semicolons and put commas.
MS. GREENBERG: Except that we had that parenthetical phrase which led us to a semicolon.
DR. FITZMAURICE: Do we still have it?
DR. COHN: Yeah.
DR. FITZMAURICE: Okay.
DR. COHN: Are we fine so far? Comments?
DR. STEINDEL: I'm actually indifferent to the reordering.
DR. COHN: We'll have a chance to see a revised version.
MS. FRIEDMAN: It may look different once you see it on the screen.
DR. COHN: Okay, next paragraph. In addition many in the public, are you okay Steve? In addition many in the public and private sectors are concerned about the additional administrative and resource burdens that would be imposed by such a, the printed word is pervasive change that would follow on the heels of HIPAA's mandated requirements. Along with testimony about the timing and cost concerns the subcommittee also received considerable input about the timeframes needed to effectuate a successful transition to ICD-10-CM and ICD-10-PCS.
MS. GREENBERG: How are timing and timeframes different?
MS. FRIEDMAN: Timing is when it takes place, timeframes are how long it takes.
MS. GREENBERG: Oh, okay, when it happens and then how long.
DR. COHN: Are we comfortable with the word pervasive?
MS. GREENBERG: It's better then massive.
DR. FITZMAURICE: One suggestion on that first sentence, would read in addition many in the public and private sectors are concerned about the additional administrative and resource burdens since they would follow on the heels of HIPAA's mandated requirements, so that would strike out the pervasive change. The concern is because they would follow on the heels of HIPAA's mandated requirements.
DR. COHN: I think that's, everybody okay with that?
DR. FITZMAURICE: Links the cause and effect.
DR. COHN: Next paragraph --
DR. STEINDEL: Simon, I think one thing that we've heard from several people is that it's not just following on the heels of HIPAA's mandated requirements, but the continuing HIPAA requirements that they expect to see over the next few years as well. The HIPAA requirements didn't stop on October 16th.
DR. FITZMAURICE: It doesn't say that they stop.
DR. STEINDEL: Follow on the heels --
MS. GREENBERG: Current and proposed or current and future or --
DR. HUFF: I think that's true but in another sense we were changing our financial transactions before HIPAA and we'll continue changing them after, I don't know that our rate of change is any greater, after the big bolus I don't know that our rate of change is any faster then it was before the change.
DR. STEINDEL: Stan, you bring up a very good point because I think one thing that concerns me about this letter and a lot of what we have heard is, and we've actually heard this statement from several people, is there are coding changes that go on in effect on a day to day basis in industry, each year the codes tend to change, there's costs associated with that, and it's not really borne out that we're introducing a total set of new costs into this system.
MS. GRAHAM: I would say we're not actually not, because every year for instance we have to change our reports, we have to change our encounter --
DR. STEINDEL: That's what we've heard from several people.
MR. BLAIR: Maybe you could solve the problem by just removing the phrase following on the heels, there's an image portrayed by on the heels as if it's immediately after, and just simply say following the changes from HIPAA then I think you get a different image.
DR. HUFF: I think we're trying to describe here what was testified to, is not necessarily what we think is true, and I think, I mean I think the sense of the testimony was that that's what they feel like is that it's right on the heels and that's --
DR. STEINDEL: We heard from Blue Cross/Blue Shield this morning and I think we've heard from some people in the past that it's not just the present changes --
DR. HUFF: That's a separate issue, my argument was against removing follows on the heels because I think that's, they intended that part and they intend, they probably intend the other part you're saying.
DR. COHN: I'm certainly sensitive to knowing that there's a day doesn't go by where there isn't some sort of a new compliance requirement and it isn't just, I mean we only are hearing about a couple of them, I mean there are laws every day that impact some sort of information technology activity. I don't know how though to recognize, I mean one day it might be e-prescribing, another day it might be fraud and abuse requirements coming from CMS, how do we, I think HIPAA was the one that people pointed out as really the timing issue and if had been a couple years ago they be talking about Y2K --
DR. STEINDEL: Well I think RAND points out in theirs, the AHIMA study on coding pointed it out, and I believe the coders pointed it out also, that the code changes occur every year and people undergo training, new training for this and implement changes in doing codes, and that it's difficult to apply an ongoing cost to this system in light of the fact that these changes already occur.
DR. COHN: Yeah, but it's like, yes, changes occurred before HIPAA but HIPAA was a lot bigger then most in the way that every year you make changes to your system, that Y2K was a little bigger then most. I guess I'm, Marie maybe you have a solution to this --
MS. FRIEDMAN: I don't have a solution but when I wrote it that way I was sensitive to what we've heard about people who just say one more mandate and HIPAA was so big and they're so close together, you could add Y2K into that litany, too, but it's a timing issue for a lot of people in addition --
MR. BLAIR: In the overall letter I really don't think this thing makes that much difference, I think this is background information and it doesn't have to be that precise, what we need to do is make sure that are statements of fact are precise as well, and our recommendations are on target.
MS. GREENBERG: I would say, I mean if you're going on the heel of HIPAA's other mandated requirements, because this would be part of the suite of HIPAA, it's not like it's outside of HIPAA mandates.
DR. COHN: So other mandated, great, we've got security coming --
DR. STEINDEL: -- comes in the future, yes, I like that wording change.
DR. COHN: Thank you. You solved our problem. Next paragraph. Despite the input over the past several years from the health care industry the federal and state governments, the public health and research communities, insurers, and providers, there is, it's either no consensus, not unanimous agreement, I think it's way beyond not unanimous agreement, I think there is no consensus unless you come up with a better word, on either the reasonable vehicles to move forward or the timing of such a move. Actually maybe it's not agreement is really what we're talking about here, rather then consensus or, maybe it's just not agreement, there's no agreement. At the same time there's a considerable constituency among providers and payers who believe that ICD-9-CM certainly cannot be used forever, or in fact much longer, because of structural, content and space limitations. Comments? Are we okay so far?
Now from there a whole bunch of choices in relationship to the next transition sentence. I sort of like the one that isn't marked out but you can all, and this is once again we're getting to areas where everybody had their own view about exactly what we transition to and what we say in here, but let me at least just pose this one, which is basically taking into account the diversity of opinion, the majority of the members of the NCVHS conclude that it is in the best interest of the country as a whole that ICD-10-CM and ICD-10-PCS be adopted as replacements for ICD-9-CM Volumes 1, 2, and 3. Marjorie?
MS. GREENBERG: I would just say this language would be appropriate if we know for sure that there are members of the committee who do not think it is in the best interest of the country. I mean this is to me a fall back position, you start by saying the NCVHS concludes it is in the best interest of the country as a whole that ICD be adopted. If there are people who say no, or if we've already, I'm not exactly clear because Clem isn't here, he said he wasn't going to speak against the letter but I don't know what version of the letter he supported. But I mean, since it is very unusual for the committee to come forward with a recommendation that says the majority of the members believe this, I'd say 99 percent of the committee's recommendations the NCVHS recommends. Now if in fact, and there have been times, a few times, where mainly around privacy issues I believe but in the last number of years where there was a recommendation and then a minority opinion, I wouldn't be, I'm not advocating for a minority opinion at this point, let's not go there, but it's just a question of whether you want to take to the committee a letter that says a majority of the members since that is rather unusual for the committee.
DR. COHN: Let's hold that for just a second, I just want to make sure everybody is okay with the other parts of doing that. Is there anybody --
MS. GREENBERG: What other parts?
DR. COHN: The rest of the sentence, and then let's talk about the majority versus, that was the part that got you, was there anything else, I guess the question is, I mean we can either, I mean to me this as you described is sort of an issue that we could decide now or recommend now or have, even leave it as an insert as a decision for the full committee to make about how we want to do this one, but this does deal with a variety of possible sins and otherwise, my observation on this one is the tighter we try to make this the more likely people may be uncomfortable about it, say it nicely, and this does provide a little wiggle for people to support. I'm happy to bring it forward in any way, shape or form, this was not my wording as you know.
DR. HUFF: I'd just say I like the approach that Marjorie has explained, I think we should state it as if it's the opinion of the committee and then let people object and if they're not persuaded by the arguments then we fall back to this.
DR. COHN: Well certainly having this might prevent minority opinions, so I guess, I mean what is the wish of the committee? I would not suggest we completely remove it at the moment but we might bracket it as a discretion for the full committee.
MS. GREENBERG: The committee does not require unanimity in order to make recommendations, that's not part of its ground rules, they usually try to reach consensus obviously but, so I'm just saying that this an irregular way for the committee to express itself but I understand this is a difficult complicated area.
DR. COHN: No argument that this is difficult.
DR. HUFF: Well, in support of that I think that if there's one dissenting vote, even if it's Clem, it overstates the importance of that, I think this makes it sound like it barely scraped by and if there's really just one dissenting opinion about this then stating it this way overstates sort of the diversity that exists.
MS. GREENBERG: A majority could be nine to eight.
DR. FITZMAURICE: That's a good point.
MR. BLAIR: I'd like to state my opinion first and then I'm going to defer to Simon and I'll say exactly why I'm saying that. Under normal circumstances I would totally agree with Marjorie and Stan and I think that it helps, it would help, when we vote if there's a majority then we wind up saying that that issue has been carried and it's the NCVHS position, so normally I think that would be the case. The reason that I'm stating, and I would normally support that, okay? And I'm stepping back from asserting that as a position other then stating how I feel in the sense that I think that Simon has worked very, very carefully to build a consensus and if Simon is aware of areas of sensitivity that he doesn't need to express I would leave it to Simon that if he feels it's important and helpful to leave the wording the way it is I would defer.
DR. COHN: And without making any comments I'll ask Kepa what his thoughts are.
DR. ZUBELDIA: I think that the committee needs to make a recommendation along the lines of what's stricken out on the on the previous sentence, therefore it's the committee's belief that ICD-10 should be adopted by the Department. And a sentence like that, I think that we need to have a clear black and white recommendation from the committee to the Secretary. Now there may be some additional recommendations on how to implement the NPRM or what kind of questions should be in the NPRM and everything else that is in the rest of the letter, but I think that the recommendation to adopt ICD-10 should be black and white and it should be the committee's position and belief that we recommend that ICD-10 be adopted.
DR. COHN: So your response to that is you don't even like this at all, you actually like the stricken area.
DR. ZUBELDIA: I like the first part of the stricken area. It is the committee's belief that ICD-10 should be adopted by the Department.
DR. FITZMAURICE: Except this isn't a -- standard, the Department would be adopting it for the country as part of HIPAA, as opposed to adopting it for the Department such as we did under PMRI.
DR. ZUBELDIA: Okay, so adopted by the Department as part of HIPAA for national implementation as a standard.
DR. HUFF: I think you can't say the therefore because --
DR. ZUBELDIA: No, no therefore.
DR. HUFF: You've got to say something else, you still need --
DR. ZUBELDIA: We may need a transition phrase.
DR. HUFF: Diversity of opinion, we adopt --
DR. ZUBELDIA: Taking into account all the testimony we have received --
DR. COHN: And maybe the term is while taking into account the diversity of opinion, I think we're referencing the sentence above so I don't know what, I would defer to you in terms of that wordsmithing. I actually sort of, I think maybe that that would solve some of your problems, I think the only question to my view is, I guess the majority of the members of the is something that I think that we should, I mean we may not necessarily bring forward as our main recommendation but I would hate to lose that wording and have to invent it on the fly next week in case we need it.
DR. ZUBELDIA: You can put it in parenthesis as an option.
DR. COHN: That's what I meant, I wanted to leave it as an option for the full committee to decide on their temperament on this one, I mean I know, I have a pretty good sense of what the subcommittee feels, I have a lot less certainly about how the full committee feels. Marjorie obviously has many more years with this committee then I do, in my experience with this committee I can't think other then for privacy that there was a time where we didn't have a full consensus on something coming forward, and in that one case we actually wound up with I think at least one and maybe more then one opposing opinions that were affixed to the letter. And I guess my preference would be to have some flexibility around so that we can accommodate some range of opinions in case it becomes necessary because I think this is more desirable wording then affixing an additional letter from X number of committee members.
MS. GREENBERG: Those were the two choices --
DR. COHN: You would agree with that, so are we okay then putting that piece into parentheses?
MS. FRIEDMAN: Okay, let me make sure I understand. So we're going, we need some kind of a transitional something and take the first part of stricken out portion from above, however we would --
DR. COHN: No, no, actually what we're doing is we have that underlined sentences above, and then we say while taking into account the diversity of opinion, the NCVHS, I mean the parentheses or whatever, the NCVHS concludes it is in the best interest of the country as a whole, is that okay?
DR. ZUBELDIA: Can I try to refine it a little more? I would say after taking into account the diverse input, and then in parentheses a majority of the members of, perhaps to be taken out later, the committee believes, and then, or concludes, concludes it is in the best interest of the country.
DR. COHN: You didn't like diversity of opinion? So do you want to read that one over as it came out? I'm sorry, I'm not sure that I like what Kepa's final words were.
MS. FRIEDMAN: While taking into account the diversity of input --
DR. ZUBELDIA: Diverse input.
MS. FRIEDMAN: The diverse input, okay, the NCVHS concludes, bracketed, the majority of members of, basically the sentence that we have there is just a majority, or a majority of members of, in a bracket.
DR. COHN: In a bracket, exactly. Okay? Then the next sentence, and I'm on page four now, as a result the committee believes it is prudent at this time for the Department of Health and Human Services to initiate the regulatory process for adoption of ICD-10-CM and ICD-10-PCS. By issuing a Notice of Proposed Rule Making the Department would provide a structured environment in which these critical issues around this adoption may be addressed.
DR. ZUBELDIA: Simon?
DR. COHN: Yes?
DR. ZUBELDIA: There is something missing here.
DR. COHN: Okay.
DR. ZUBELDIA: We conclude that it's in the best interest of the country that ICD-10-CM and ICD-10-PCS be adopted. And then we believe it's prudent for the Department to initiate, where do we say explicitly that we recommend that ICD-10 be adopted as a HIPAA standard for national implementation.
DR. STEINDEL: I was thinking the same thing, Kepa.
DR. COHN: Maybe it's --
MS. GREENBERG: You could say it at the end of that sentence.
DR. COHN: That other sentence, be adopted as a HIPAA standard for national implementation. Good, okay. So we're back together again?
DR. ZUBELDIA: So going back to that sentence that Maria captured, it's in the best interest of the country as a whole that ICD-10-CM and ICD-10-PCS be adopted --
DR. COHN: I mean basically ICD-10 and ICD-10-PCS, okay as a HIPAA standards to replace --
DR. ZUBELDIA: -- replacing ICD-9 --
DR. COHN: Volumes 1, 2, and 3.
DR. ZUBELDIA: Volumes 1 and 2.
DR. COHN: And 3.
DR. ZUBELDIA: As a HIPAA standard for national implementation replacing Volumes 1, 2, and 3 of ICD-9.
DR. COHN: Okay, so are we okay at this moment? Now I'd read another sentence or two, are we okay so far or do you want me to read those again? So basically as a result the committee believes it is prudent at this time for the Department of Health and Human Services to initiate the regulatory process for adoption of ICD-10-CM and ICD-10-PCS by issuing, yes? Jeff?
MR. BLAIR: What is the value of having the word prudent? Why don't we say appropriate, timely, or whatever. Is there a reason why the word prudent is in there that I am failing to see?
MS. GREENBERG: We could say recommend that the Department initiate the regulatory process.
DR. ZUBELDIA: As a result the committee recommends for the Department to initiate the regulatory process.
DR. COHN: So what does it read now?
MS. FRIEDMAN: As a result the committee recommends for the Department of Health and Human Services to initiate the regulatory process, etc., etc.
DR. COHN: Recommends that the Department.
DR. ZUBELDIA: Well recommends that the Department initiate --
DR. COHN: That the Department of Health and Human Service initiate the regulatory process. Okay? By issuing a Notice of Proposed Rule Making the Department would --
DR. ZUBELDIA: I would strike that sentence out.
DR. COHN: Let me see if I can read the sentence first. By issuing a Notice of Proposed Rule Making the Department would provide a structured environment in which critical issues around this adoption may be addressed.
MS. GREENBERG: Why do you want to strike that?
DR. FITZMAURICE: It doesn't say anything extra.
MS. GREENBERG: It's redundant.
MR. BLAIR: And actually it's part of the concern that I was having, it is true that we're looking at this process as being one to address a number of issues and we're going to delineate them further on in the letter, but I just don't want to be so tentative and so cautious that the Secretary feels as if there's not a clear statement that we should go forward and I think --
DR. HUFF: No, I think the purpose I saw in this sentence was not to equivocate on our recommendation but to say this is a good way to make sure that the implementation is done in the best way possible.
MR. BLAIR: That's better.
DR. HUFF: So I would add in implementation word in here, so I would say would provide a structured environment in which the critical implementation issues around this adoption may be addressed.
DR. COHN: Okay? So we're okay leaving the sentence in with that change? Great. Additionally the NPRM could specifically invite, oh sorry, all interested stakeholders would have the opportunity to comment and provide additional input. Additionally the NPRM could specifically invite structured comment on the key issues presented in testimony before the committee: okay so far?
DR. STEINDEL: The sentence all interested stakeholders, I have no problem with leaving it in but that's an obvious part of the rule making process.
DR. FITZMAURICE: It could be stricken with no loss.
MS. GREENBERG: I think that sentence could go.
DR. STEINDEL: It could be stricken or left in.
DR. COHN: So get rid of that sentence and maybe the word additionally get rid of also?
DR. STEINDEL: Then you would --
DR. COHN: So basically the NPRM could specifically invite structured comment on the key issues presented in testimony before the committee.
MS. FRIEDMAN: Do we need structured? Because we had structured in the sentence before --
DR. COHN: Thank you.
MS. TRUDEL: I would suggest that you might want to say we further recommend that the NPRM invite, because that was something that Clem was really clear on, that was the part of the recommendation, is that being included as part of the reg.
DR. COHN: Okay, great, thank you.
MS. FRIEDMAN: So that will say we further recommend that the NPRM specifically invite comment on the issue presented in testimony.
MS. GREENBERG: Not just that it could be we recommend it should.
MR. RODEY: Dan Rodey, AHIMA. Since the testimony seemed to apply that there should be a simultaneous adoption and implementation I wondered if you needed in that previous paragraph to say simultaneous as opposed to adoption of the two code sets.
MR. BLAIR: Does concurrent get to the same idea?
MR. RODEY: I think so.
MR. BLAIR: Simultaneous is so exact but concurrent could be --
MR. RODEY: Well, if they're both going to be on October 1st I guess that's simultaneous or concurrent, which ever way you want to do it. But to imply that both go in together, which was essentially what we heard throughout this process.
DR. COHN: Gosh, this is not an area where I felt that there was an issue about meaning but do others have an opinion or feeling of how you want to handle it?
DR. ZUBELDIA: I think it's a clarification that yes, we are recommending concurrent adoption, because that has been brought up in the testimony.
DR. STEINDEL: It's one of the things we specifically asked RAND to investigate.
DR. HUFF: If you're going to say something here you almost feel obligated to say something earlier --
DR. STEINDEL: Earlier, I was thinking the same thing.
DR. HUFF: You can't just say it sort of out of out of the blue here or it doesn't --
DR. STEINDEL: We could mention in the paragraph where we're talking about what we asked RAND to do, that was one of the things that we did ask RAND to do.
MS. FRIEDMAN: There's that paragraph previously that talks about, about three full paragraphs before that, many in the public and private sectors are concerned about additional administrative resource burdens, blah, blah, blah, along with testimony about the timing and cost concerns the subcommittee also received considerable input about the timeframes that would be needed to effectuate a successful, we could say concurrent transition --
MR. BLAIR: At that point in the letter you're trying to describe the complexity, now you're winding up saying our conclusions, so I think it is appropriate for us to introduce it now for the first time, that our conclusion is that it should be concurrent.
DR. ZUBELDIA: In fact there's something else that we heard, I don't know if it was a year ago or two years ago, that the transition date should be on October 1st, no matter what year, but on October 1st, to not disrupt existing systems and make for an easier transition. We heard that very loud and clear and perhaps that should be one of the recommendations.
DR. COHN: I think there's a point where we are an advisory committee and I'm not sure where micro management gains us a lot, the question would be whether or not somewhere down here in these bullets that we could slip that in or whatever, I mean that would be I guess my question. Maybe the timeframes be adequate for implementation, maybe there's another final sentence there, the committee further heard strong recommendations that it be on October 1st to ease, would that work for you later on? Marjorie?
MS. GREENBERG: I think you can say it here, that they be adopted concurrently, but I think we had said as a HIPAA standard, you really have to say as HIPAA standards, they're two different code sets. But I think it's okay to put the word concurrently here, particularly since we've mentioned above that timing and all that was an issue.
DR. STEINDEL: I was going to add that, we've mentioned that and we've also said that a synopsis of the testimonies are attached and that's addressed in the synopsis as well.
DR. COHN: Okay, are we okay so far? So the bullets that we wanted to make sure that the Secretary was getting additional input on include what could be done to minimize the costs of transition to ICD-10-CM and ICD-10-PCS. What could be done to maximize the benefits of implementing ICD-10-CM and ICD-10-PCS. What are potential unintended consequences of such a migration, and how could they be mitigated. What timeframes would be adequate for implementation, and I actually would return the comments that go after that, which is the NCVHS heard in testimony that the industry would need a minimum of two years for implementation, however such time horizons could be further clarified and refined to the regulatory process. And maybe this one needs, maybe NCVHS heard in testimony that the industry would need a minimum of two years for implementation and that an initial implementation date of October 1st was strongly preferred. And then we say however, such time horizons could be further clarified, time horizons and dates could be further clarified and refined through the regulatory process.
DR. HUFF: I think that's more detail then we need to say in here.
DR. COHN: Well, I think my initial comment to Kepa, but on the other hand I do sort of agree that if we're, I mean I think we do need to say two years, I don't think that's too much detail and if we're throwing in that we probably, I mean unless the Secretary thinks that this should happen in six months --
DR. HUFF: No, you could just say something as simple as is the timeframe of two years adequate for implementation.
MS. GREENBERG: I didn't hear what Stan said.
DR. COHN: Stan was saying he wanted to rephrase the timeframe question about is a two year implementation timeframe adequate.
DR. HUFF: From the time you ask the question when from when the final rule --
MR. BLAIR: I think that's a little different then what Kepa was suggesting, Kepa was suggesting he wanted to make sure the letter included advice from testifiers and the way it's written now it would wind up acknowledging that that's what we heard and that's what we're passing on. I'm frustrated because I tend to have the same sympathy that you do that I would rather keep it simple but I think it would be overriding what Kepa is advocating here.
DR. COHN: Karen has a comment, maybe she has a solution for us.
MS. TRUDEL: I think there are two different issues on the table here, one is what the committee actually wants to recommend to the Secretary, and what the committee might want to bring to the Secretary's attention. And I think you have to remember in terms of bringing things to the Secretary's attention there are one, two, three, four, five, six, seven people sitting around this table who would be working on this regulation and who many of us have been sitting around the table during all these deliberations, so I'm not sure that you need to include everything in here that you want to make sure that we think about. I would just include the things that you feel strongly enough about that you want to actually recommend them.
DR. COHN: Okay.
MR. BLAIR: Let's go back to Kepa and see if Kepa would --
DR. ZUBELDIA: I withdraw my motion, I think it's in everybody's mind and attention already so --
MS. FRIEDMAN: So are we leaving this the way, what timeframes would be adequate for implementation?
DR. COHN: Well, no, I think we're actually adding the two years, but we're not adding October 1st is what I thought.
DR. ZUBELDIA: No, it's in everybody's mind --
DR. COHN: Okay, then I guess I'm objecting to it because I think that we, I mean the Secretary, depending on how they read the reg, could conceivably implement a change to a code set in six months. This is not, I mean what we're making sure is is that everybody is well aware about the two years.
MS. GREENBERG: It's find to keep that sentence.
DR. COHN: The sentence that's been marked up, I thought Kepa was saying we should get rid of it.
MS. GREENBERG: Just the October 1st.
DR. COHN: Okay, that's fine, Steve.
DR. STEINDEL: I'm recalling now Maria bringing up two points that we discussed in a sentence I think but much earlier in the letter and there are two issues, one is the time of the implementation and the timeframe of the implementation. And should we put that in the recommendation that he investigate the time of implementation and the timeframe for implementation?
MS. FRIEDMAN: When it happens and how long does it take.
DR. STEINDEL: The timeframe is how long it takes, because we heard testimony from the industry previously that they are not prepared to do this before October 1st, and I think it was 2005 or 2007, and they want a two year timeframe to do it. There's some point in the testimony where we heard evidence on that and it's noted in the synopsis. And so one of the questions we might want to address is the way Maria phrased it, when is this going to happen and how long should it take to happen after that date, and that would get towards Kepa's question.
DR. COHN: I think Kepa had retracted his question as I understood.
MS. GREENBERG: My understanding when Marie said that is that the timing issue was when should the committee make a recommendation, so should it wait until there's been a cost/benefit study, ta da ta da ta da ta da, and now, so that was the timing issue. The timeframe would be when should it actually be implemented. I mean I personally think it's adequate for you to bring back in the sentence that the industry felt it would need a minimum of two years because as you said as a code change one could potentially do it in a shorter period of time, although we've always had a commitment, the Department has never, or those who have testified on behalf of the Department has never recommended a shorter timeframe, although some people have. So I think you're fine if you just leave that sentence, not get into further detail.
DR. COHN: So we're going to leave it the way it is without the mark-outs. I'm sorry Steve, I sort of cut you off on that comment but I think the other question then was is that do we need something about the early timing, I mean Karen obviously had commented that there's certain people around the table that are already well aware of that issue, do we need to somehow reference that, is that something that they need specifically in an NPRM get further comment about.
MS. FRIEDMAN: The NPRM process in and of itself takes care of that in a way.
MS. GREENBERG: You're talking about the October thing? And the other thing is, I mean if you say this is a replacement for 9-CM, the changes to 9-CM are always on October 1st of each year, so as a replacement it's kind of logical, you'd have to have a reason to do something different.
DR. ZUBELDIA: But still, that needs to be accommodated in the final rule.
MS. GREENBERG: It would have to be.
DR. COHN: Steve?
DR. STEINDEL: One thing I'm thinking about of asking about the time is if we get a series of people or some type of consensus opinion that the time should be some date certain we might be able to expedite the rule making process, I mean we all know how the rulemaking process drags on and that's one of the comments and complaints we've gotten about the HIPAA process, that this can be tied up in the Department for years. And if we ask the people do you have a date that you would like the process to start by and they all come in and say like October 1st, 2007, and the rulemaking process is starting to slow, maybe the Department can go to the Secretary and say but this is what the people wanted.
DR. ZUBELDIA: Steve, if there was a way to nail that date down it would be tremendously beneficial to the industry.
DR. STEINDEL: And that's what we heard from industry.
DR. ZUBELDIA: I don't think there's any way to nail that date down.
DR. STEINDEL: I don't know either, it's just a way to --
MS. GREENBERG: I think earlier in the letter you said that there was a sense of many that it can't be used forever, 9-CM, or much longer, so that gives an indication that it shouldn't be 2012.
DR. COHN: I think we're comfortable with where we are right now but --
DR. ZUBELDIA: It would be tremendously beneficial to the vendors to know that this is going to happen on October 1st 2005 and to know that today, but nobody will believe it.
DR. COHN: I think that's the purpose of the final rules I understand, to identify the time. Anyway, I think we're sort of, we can bring this one back up when we see the next version of this letter but why don't we leave things as they are here. I think our last bullet was what additional steps would be required ensure a realistic and smooth migration.
MS. FRIEDMAN: Clem had suggested one more about alternatives, for alternatives --
DR. HUFF: Is there exact wording?
MS. FRIEDMAN: Not really, I can come up with a suggestion.
DR. HUFF: It sounds like we made the recommendation and now we're just asking, but do you really want to do it.
MS. FRIEDMAN: That was his suggestion since he's not here, I thought I'd bring it up.
DR. HUFF: No, it was appropriate to bring it up. I would need more convincing.
MR. BLAIR: I'm offering this in the assumption that we've now gone through the list, if not then I'm waiting for the end of the list.
DR. COHN: You've got two more sentence and then we're done with the letter, so we're done with the list.
MR. BLAIR: What is the sense of the subcommittee, do you feel that it would be helpful for us to incorporate an additional item in there reflecting the testimony we heard from Theresa today, that this activity be considered within the context of a strategy to move towards a National Health Information Infrastructure? Is that useful?
DR. COHN: Maybe I'll start with a comment. I think that many of the things that Theresa said earlier today are very useful, I however don't think that they are particularly germane to this letter, and I thought that was a really, some very good ideas that needed to find a different path both within discussion of the NCVHS and potentially to the Secretary. But I don't think that somehow trying to weave this or tie it to NHII or somehow overall strategies for national health information necessarily helps anybody deal with an NPRM. I mean that's my own personal feeling and yet I do think that there's definitely a need for some work being done to really give the industry and the health care community some sort of a blueprint about what the future might look like. Now I've heard that from enough people that I'm, I think that's sort of just a general view if we see things coming at up. But once again I don't necessarily think it's part of this letter or part of these recommendations. Do others have comments, Stan?
DR. HUFF: I agree, I wouldn't, again, I wholeheartedly support the idea of the infrastructure, etc., but I don't think those longer term goals should be tied to what I think is something that we just kind of do independently and expeditiously as possible.
DR. COHN: Kepa?
DR. ZUBELDIA: I agree with that, I would not put it in this letter and in that same vein this next sentence that we're going to look out, I would take that out, too.
DR. COHN: Well, we'll get to that next sentence in just a second. I'm just, and this is neither good nor bad but one of the comments I had made to Theresa was this issue having been involved in enough strategy projects that you don't hold up things that are obviously things that need to happen for the development of whatever strategy, and that's just been a learning because what's obvious in the near term is obvious.
DR. HUFF: -- the fact that you're contemplating buying a new car shouldn't prevent you from changing the oil and buying new tires.
DR. COHN: Stan, thank you very much --
Are you comfortable with our comments so far?
MR. BLAIR: It was given fair consideration.
DR. COHN: Now the next sentence is the NCVHS intends to conduct a post implementation review of HIPAA and the lessons we learned may also help inform the Department's deliberations on these critical issues. And the final sentence is NCVHS wishes to thank you for the opportunity to submit these recommendations. I think Kepa was just suggesting that we remove the sentence related to the post implementation HIPAA review --
MR. BLAIR: I agree.
DR. COHN: They are so removed. Now I would ask everyone, are we comfortable with this letter, are there things that were obviously missing that we just haven't thought up that need to be in a letter like this?
MR. BLAIR: I don't know if anybody else reacts the same way I do, but it's going back, in the past when there is a letter to an executive and a paragraph begins with the phrase now this is going to be complex, it really tends to put people off and I just felt that there's different words that we could use, I'm not deleting the message, just trying to take that and essentially say, and I don't know if the suggestion that I made with the words and Maria whether you still have them or whether they're still appropriate, things have changed since them, if you do, what did I suggest?
MS. FRIEDMAN: I'm sorry Jeff, I don't have those with me.
DR. STEINDEL: Is it possible to see another version of this letter, to take a break and have another version --
DR. COHN: Let me describe to you the process, what I was thinking of was that we could have Maria work on this and what we could do is either take a break or probably more likely begin to move to the PMRI letter after a break and then when we think we have it together maybe the copies, we could then go through with copies in our hands that time. But I do want to get the complex issue handled before we start doing this.
MR. BLAIR: Well maybe nobody else feels that that's a problem, and maybe we could just settle and not even waste time in rewording it.
DR. HUFF: I like it the way it is.
DR. COHN: I like it, yeah --
MR. BLAIR: Okay, then let's let it be.
DR. COHN: Are we comfortable then for the moment, anything else that we're missing? I guess what I'm going to suggest is let's take a ten minute break, 15 minute break? Let's take a 15 minute break, when we get back together we'll begin to work on the PMRI letter, and then when we are in a position where Maria is comfortable with the wordsmithing changes and hopefully copies have been made of it then we can go through, a last review of that letter.
DR. ZUBELDIA: You want to email it to Clem as soon as we have the letter, too.
DR. COHN: I'm sorry --
DR. ZUBELDIA: For Clem's review, maybe he can review it today.
MR. BLAIR: He's going to be on a call with us tomorrow.
DR. COHN: He'll be on a call with us tomorrow morning.
MR. BLAIR: So if we email it today he can read it tonight.
DR. ZUBELDIA: It would be nice to have his accord before the meeting tomorrow.
DR. COHN: That would be fine, and then what we can do is to review it, if we think it's in pretty good shape we can ask Clem for whatever comments he may have and then do a, make a disposition at that point. Okay, so why don't we then give ourselves 15 minutes, we'll get back together at 3:00.
[Brief break.]
Agenda Item: PMRI - Subcommittee
DR. COHN: Obviously we're starting the last session of the day, I think the intent here knowing that there's still work going on on the ICD-10-CM and PCS letter is to use the time to look at the PMRI letter. I think the intent, I think you all have draft copies of it in your packet, it should be in your blue, now I think as you'll remember what we did was we got at our last session on this up to page six, which is the drug terminologies. And I thought that, what Jeff would like us to do is to sort of start on page six and what we'll do is start reading it and sort of see how comfortable people are with the wording, if there are obviously issues that come up we will note them, and it's my understanding that Betsy Humphries will be with us tomorrow morning, we can clarify them with her, there are other issues that may come up. Steve?
DR. STEINDEL: Simon, there's a few of the federal people that if there are issues would like to be present for the discussion and they're obviously not here today, they were planning to be here in the morning. So what I would like to suggest is maybe a read through of the section and just ask about the comfort level, and if there is a lack of any comfort level, any discomfort, that we postpone the discussion until the morning, and go on to the other sections.
DR. COHN: Shall we start with the section? This is actually, I think it's called federal drug terminologies is the current --
MR. BLAIR: Maybe Simon, if I could just take a moment, when we went through the previous draft of the letter in August there was I think a background section, I don't remember exactly, but a background section that we went through and then we started on the recommendation section and we did get through on the recommendation section the wording for both SNOMED and LOINC and where we began to have some difficulties was when we got to the recommendations related to drugs, so when we're referring now to the section on drugs to be consistent with the fact that the subheadings under recommendations were SNOMED, then LOINC, so this subheading is federal e-drugs, federal e-drug terminologies.
DR. COHN: Well maybe I need to start out with just a question, why are we calling them e-drug terminologies as opposed to federal drug terminologies? The last time I thought about this one I thought we were talking about federal drug terminology, actually PMRI core drug terminologies, not core e-drug terminologies --
DR. FITZMAURICE: -- over the internet.
DR. COHN: Is that right?
MS. GRAHAM: I would hate for anyone to get that perception.
DR. STEINDEL: Let me preface this with the statement that the federal people that crafted this section were given a list of potential titles to the section that I made up and I'm very bad on making up titles and I asked them to pick one, and the only person outside of myself who picked one suggested e-drugs, so I don't think it's cast in stone, but one concept is cast in stone I think with the group is they wanted to convey the impression that this was not, in the title, that this is not a single terminology but a set of terminologies that are interrelated to each other and need to be accepted as an interrelated set of terminologies. And I think we're more then happy taking the e off, or finding something that's more catchy, that's catchier.
DR. COHN: Okay, so for the moment we'll just call it federal drug terminologies. Let me read through this section which start I think talking about our initial 2000 report and then goes to other recommendations, and I'll just read through what we have on this and then we'll go back and talk about paragraph by paragraph if that's okay to get input. And as I said this is about three pages long.
So federal drug terminologies.
In our July 2000 report, Uniform Data Standards for Patient Medical Record Information, we recommended improvement of drug, data capture and use through 1) requiring the FDA to make publicly available in easily accessible format its NDC database registry information; 2) requiring the FDA to develop a drug classification system based on active ingredients so that all drugs that fall into a given category can be identified by the name of that category; 3) encouraging the FDA to participate in private sector development and ongoing maintenance of a reference terminology for drugs and biologics that promotes the ability to share clinically specific information for patient care services, excuse me, patient care purposes.
We note to date that HHS has made great strides in --
MR. BLAIR: Are we taking like a paragraph and then we can make a suggestion for --
DR. FITZMAURICE: Because we'll forget otherwise.
DR. COHN: Okay, that's fine, why don't I stop now then and I'll --
MR. BLAIR: The only suggestion that I have is right at the very start we use the word we instead of NCVHS and it takes me a moment to figure out, shortly I'll figure out that it is NCVHS but I think it would be easier to replace the word we with NCVHS.
DR. COHN: And actually Steve, you're the holder of the pen on these?
DR. STEINDEL: I have the pen.
MS. GREENBERG: Then you might have to say in its July 2000 report.
DR. COHN: Okay, Michael?
DR. FITZMAURICE: On the first one it talks about requiring the Food and Drug Administration to make publicly available in easy format the NDC database registry. In the next one it requires FDA to develop a system, but it doesn't say anything about making it publicly available.
DR. STEINDEL: This is the direct quote from the July 2000 report, so we can't change it.
DR. FITZMAURICE: Never mind.
DR. COHN: Okay, any other comments before we go on?
MR. BLAIR: Is it in quotes? Does it actually show --
DR. STEINDEL: It is in quotes.
DR. COHN: Next paragraph. We note today that HHS has made great strides in implementing these recommendations --
MR. BLAIR: And again, I'd say the NCVHS notes.
DR. COHN: Okay, through cross agency partnerships that can serve as an example for future efforts. Because the FDA has regulatory responsibility for approving safe and effective drug products in the U.S., and has engaged in efforts to harmonize drug related terminologies nationally and internationally, it serves as the basic source for terminology and information about drug products. Since our July 2000 recommendations the FDA has been working in partnership with NLM and the VA in open collaboration within the HL7 Standards Development Organization to address the substance of the above recommendations by 1) NLM creation of Rx-Norm, a non-proprietary vocabulary that represents drugs at the level they are prescribing in clinical practice, something wrong there, at the level --
PARTICIPANT: How about at the prescribing level?
DR. ZUBELDIA: That represents drugs as they are prescribed in clinical practice.
DR. COHN: Okay, maybe it's that, that they are prescribed in clinical practice, okay.
MR. BLAIR: Steve, are you correcting this as we go along?
DR. STEINDEL: That represent drugs --
DR. COHN: At the level in which they are prescribed.
DR. ZUBELDIA: That represents drugs as they are prescribed --
DR. STEINDEL: Represents as they, just, instead of at the level, as they are --
DR. FITZMAURICE: What does level mean?
DR. COHN: Yeah, exactly, so represents drugs as they are prescribed in clinical practice.
DR. HUFF: It was intended to mean granularity.
DR. COHN: I think we've gotten rid at the level, so NLM creation of Rx-Norm, a non-proprietary vocabulary that represents drugs as they are prescribed in clinical practice.
DR. FITZMAURICE: So that means a doctor would prescribe something using an Rx-Norm vocabulary, it would transmit right into the name and the dosage?
PARTICIPANT: What's that?
DR. FITZMAURICE: Does this mean that doctors could use Rx-Norm to prescribe as well as using the name and dosage amount of a drug? That those would be equivalent?
MR. BLAIR: I think we ought to go, Stan was I think getting to it, and maybe we ought to say at the level of granularity necessary to support --
DR. COHN: Clinical practice.
DR. FITZMAURICE: So what's the intention, doctors could use Rx-Norm for prescribing?
PARTICIPANT: Yes.
DR. COHN: So what do we want to do with that first one, at the level of granularity --
MR. BLAIR: Necessary to support --
DR. COHN: To support clinical practice, is that? As long as it's true. So we're okay with that? Steve, you got that?
DR. STEINDEL: No, I haven't. I'm in sync.
DR. COHN: So one is NLM creation of Rx-Norm, a non-proprietary vocabulary that represents drugs at the level of granularity to support clinical practice --
DR. FITZMAURICE: You know that's pretty clear just the way you said it.
DR. COHN: Needed to support clinical practice.
DR. FITZMAURICE: It's pretty clear just the way you said it, as they are prescribed in clinical practice.
DR. COHN: I think we agree with what Stan's comment was.
DR. STEINDEL: Needed to support what?
DR. COHN: Clinical practice. Do you want to read over what you have?
DR. STEINDEL: NLM creation of Rx-Norm, a non-proprietary vocabulary that represents drugs at the level of granularity needed to support clinical practice.
MR. BLAIR: Do you need a moment to go back and capture the other two suggestions?
DR. STEINDEL: I got the others.
DR. COHN: Okay. 2) VA creation of NDF-RT, a non-proprietary terminology that includes representations of the mechanism of action and physiologic classification of drugs. And we probably should at some point spell out NDF-RT, just make a note of that. Linking the above --
DR. ZUBELDIA: Wait a minute, what does physiologic classification of drugs mean?
DR. HUFF: You make names for classes of drugs that have the same physiologic effect, so things like beta blockers --
DR. ZUBELDIA: Okay, an immunologic effect.
MS. GRAHAM: It's what we voted on yesterday in the CHI recommendations.
DR. ZUBELDIA: What is the physiologic effect --
MR. BLAIR: So how would you alter the sentence to get the word effect in there?
DR. HUFF: You could say classifications based on physiologic --
MS. GRAHAM: That's how it's worded, it was mechanism of action and physiologic effect, that's how it was worded in the CHI --
DR. ZUBELDIA: Physiologic effect.
MS. GREENBERG: Where does this classification of drugs come in? It says a non-proprietary terminology that includes representations of the mechanism of action and physiologic effect.
MS. GRAHAM: The way it was worded in the final recommendation for CHI was NDF-RT classification schemes for mechanism of action and physiologic effect --
DR. STEINDEL: We should track what CHI is saying, if it came across as classification it's just an error in translation.
DR. HUFF: [Comment off microphone.]
DR. ZUBELDIA: A non-proprietary immunology that classifies drugs by mechanism of action and physiologic effect.
DR. COHN: Steve, did you hear that?
DR. ZUBELDIA: That classifies drugs by mechanisms of action and physiologic effect.
DR. COHN: Okay, Steve, do you have that? Okay. 3) Linking the above to FDA drug terminologies that represent other levels of medication information required for regulation, formulation, linkage to commercial drug information services, and other special instances of clinical practice, is it other levels of or is it just represent medication information?
DR. HUFF: What they're referring to is, you guys haven't sat through enough presentations yet, there's this whole hierarchy of ingredients that get built into components, get built into, what's the right, and then there's the finished dosage forms that become products that become packaged products, and that's the levels he's referring to.
DR. STEINDEL: I think for the purpose of this letter probably from a clarification point of view that represent medication information, just take out other levels would probably suffice.
DR. COHN: Okay, so we're getting rid of other levels of, okay, good. Now there's a footnote here where it says about the FDA drug terminologies where it ways FDA, I presume it's supports terminologies, excuse me, FDA support terminologies, maybe it's FDA drug terminology, what is this, I'll just read it and maybe we'll make sense of it as we go here. FDA support terminologies include present terminology for medication active ingredients, ingredient name, UNII, external publication required, the NDC and the manufactured dosage form and package name code from the FDA Cedar(?) Data Standards Manual. Also included is the developing terminology for the electronic product label, the FDA terminology set is required by the CHI Initiative for federal agency exchange of drug information and when appropriate may be used as PMRI terminology. That's something really weird about that --
MS. AULD: It should be FDA supported --
DR. COHN: So FDA supported terminology, okay, thank you, FDA supported terminologies include, what is present terminology for medication active ingredient --
DR. STEINDEL: The word present is in there to state that the ones that we're listing in this sentence exist today and because the next sentence mentions the developing terminology for the label codes.
DR. ZUBELDIA: So it's present terminologies?
DR. COHN: Currently available terminologies? Except it isn't currently available existing terminologies --
DR. STEINDEL: Existing is fine.
DR. COHN: Thank you, existing terminologies for medication active ingredients, probably should be a hyphen between medication and active --
DR. ZUBELDIA: For active ingredients.
DR. COHN: That's probably better, get rid of medication period.
DR. STEINDEL: I would hesitate to make that change because the FDA terminology may actually be medication active ingredients, it has regulatory connotations.
DR. COHN: Okay, is that something you can check, I mean this is wordsmithing right there.
DR. STEINDEL: This is one reason why I would be more comfortable if the other people were around.
DR. ZUBELDIA: What's this external publication required?
DR. STEINDEL: We brought that up yesterday about UNII codes when we were talking about the CHI recommendations is presently the UNII codes exist internally within FDA and they are slowly published them and one of the recommendations we made in the CHI letter is that we provide, that HHS provide funding to more expeditiously produce that publication. So we're making the comment in this letter for people who think they can go to the FDA site and get the UNII codes today, they probably can't.
DR. FITZMAURICE: Maybe it would be easier to say instead of external publication required, not available on the FDA site.
MR. BLAIR: Not yet?
DR. STEINDEL: Or not yet available.
DR. ZUBELDIA: Not yet published.
DR. COHN: Not yet published.
DR. ZUBELDIA: But I would put that in the beginning of the parentheses.
DR. STEINDEL: Not yet published ingredient names.
DR. COHN: Or actually, was it not yet publicly available or, except some of it is publicly available, no I guess it isn't publicly available yet is it?
DR. STEINDEL: No, it's not publicly available.
DR. COHN: Okay. And basically the, probably just by, this would probably be helped by the use of some additional punctuation such as a colon after the word terminology and semicolons where appropriate in the sentence just because it gets a little hard to figure out what we're talking about as we move through it.
Also included is the developing terminology for the electronic product label, developing terminology, is a terminology under development for the electronic product label, is that what we're talking about?
MR. BLAIR: No, we know what the electronic product label is because we've had a presentation and been briefed on it but in this letter I don't think there's any other prior reference to it, does it help at all to say the FDA's electronic product label? Or program?
MS. AULD: The whole paragraph is talking about FDA products.
DR. COHN: You know what I'm going to suggest is, and this is something we don't need to do here but needs to be handled between the end of the meeting tomorrow and the next week is I think this footnote needs to be understandable. And what we might do is, one option would be is to put a colon and put bullets and for each one of them indicate whether it's available or not or whether it's under development or what the status is as opposed to trying to handle it quite this direction. I mean whatever it is it just doesn't, I think we're having trouble understanding what's available, what's not and all of these other things and I think that's what the point of this footnote is, is there's a variety of terminologies, some of them are currently available, some of them are not yet externally published, some of them are being developed, and then the final sentence which is fine which is the FDA terminology set is required by the CHI Initiative and that --
DR. HUFF: I guess the question that comes to my mind is all of those things are true, does it really serve a purpose in this particular letter to say it all?
DR. STEINDEL: There has been extensive discussion around that point and the feeling is very strongly that the FDA terminology needs to be specifically enumerated. Without it, and this is why I would prefer that the FDA, the FDA people and some of the VA people be here for the discussion, but --
DR. HUFF: If it needs to be there then I agree with Simon, I would even make, actually just make it bullet points so you can see the parts but a numbered list --
DR. STEINDEL: I'm actually working on that change right now because --
DR. COHN: I mean there's nothing wrong with the information it's just badly worded.
DR. HUFF: The other thing that I would say, so this goes back sort of, this whole set of things I think, it says that the FDA has been working on them in partnership, it seems to me that what they really had done, I mean some of these things they've done and some of them they've orchestrated, because I mean it's not like they produced all these things themselves. I mean they didn't produce Rx-Norm --
DR. COHN: Well why don't we hold that question for Betsy, because I'm not sure if Betsy is willing to have this described this way, I don't think I would start getting to micro on that one. Mike, I'm sorry.
DR. FITZMAURICE: Stan raised one of two points that I want to raise and that is the FDA has been working on something to do something, and I would start each one of these with a verb, you can say by collaborating with NLM on the creation of, by collaborating with VA on the creation of --
MR. BLAIR: That's good.
DR. FITZMAURICE: And then the second point I wanted to raise was that the sentence down in the footnote, the FDA terminology set is required by the CHI Initiative for federal exchange of drug information, and where appropriate may be used as PMRI terminology, Steve, I don't know, is required the right word? Maybe it's being analyzed? Only the Secretary can require.
DR. STEINDEL: I would prefer to move on to another section, for this level of detail I would just feel more comfortable if Betsy was present and if Steve Brown and somebody from the FDA was present instead of acting as a messenger.
DR. COHN: Well said. Let me do this then, what I will do is to read through the remaining part of this section but we won't take comment on it at this point and then we'll move on to the remainder of the sections where we actually can do some work. Is that okay? Okay.
So 4) is taking steps to improve the quality in electronic dissemination of all linked federally supported drug terminologies, that's just a word, wordsmithing, Rx-Norm and the representation, I'm sorry I'm just having trouble figuring out, 5) is Rx-Norm and the representation of the mechanism of action in physiologic classification of drugs from NDF-RT is sufficiently developed to be recommended as part of the core set of PMRI terminologies. These portions of NDF-RT complement rather then compete with the capabilities of drug knowledge bases that have been developed within the private sector. That is not, that shouldn't be a 5) I don't think --
DR. HUFF: That looks like it should be the next paragraph, unless you changed it so say, because you need to make it into, I mean this needs to be, this is a list of projects or activities right? And this is like a statement of fact about it, so unless you make it say they had an activity that you made it --
DR. COHN: I bet that this is meant to be part of, it's supposed to be a paragraph and somehow got into an item 5), so I presume you would agree with that Steve?
DR. STEINDEL: It was originally a paragraph.
DR. COHN: It was originally a paragraph, okay, good --
DR. STEINDEL: It was originally a paragraph and somebody suggested making it 5) and I will say I did not agree with that change.
DR. COHN: Okay, well you were right Steve.
DR. ZUBELDIA: Can you add the word effect after physiologic?
DR. STEINDEL: Yeah.
MR. BLAIR: Steve, there's another thought I have which I don't would necessarily effect any of the other folks we're waiting on, but that paragraph begins a very important sentence and a very important departure from everything else that we read so far and if that sentence could clearly start with the sentence that the NCVHS recommends, because that's, that's where the recommendations start for the drugs. Would that be acceptable?
DR. COHN: I think that actually that sentence is in the wrong place is what I think is going on. Let me read the next paragraph and Jeff see what you think because it looks to me like it may be after this next paragraph potentially. It says versions of Rx-Norm have been available quarterly for several years through the NLM's UMLS. It is our understanding that full documentation for Rx-Norm will be available before the end of the year. NDF-RT currently used in the VA and now available directly from them will be released in the UMLS in April 2004. Rx-Norm also facilitates the clinical use of associated drug product information in electronic form from the FDA. Rx-Norm, NDF-RT, and the linked FDA terminologies have also been proposed as target U.S. government standards by CHI. And so the question is is, what?
DR. ZUBELDIA: Where is the recommendation?
MR. BLAIR: It was in that sentence but the thing is that it was at the end of the sentence instead of the beginning, so the sentence started with Rx-Norm and the associated piece, that's the key sentence.
DR. ZUBELDIA: But it says they are sufficiently developed to be recommended --
DR. BLAIR: Well it seems to me that the recommendation is Rx-Norm and the representations of the mechanism of action and physiologic classifications of drug from NDF-RT are sufficiently developed to be recommended as part of the core set of PMRI terminologies. These portions of NDF-RT complement rather then compete with the capabilities of drug knowledge bases that have been developed within the private sector, I think that's the first recommendation.
MR. BLAIR: It is and I'm simply suggesting that since you don't realize that when you start to read the sentence that we simply move that portion alluding to recommendation to the very beginning of the sentence, so the sentence starts with NCVHS recommend that, do you see what I'm saying? Steve, is that a problem?
DR. STEINDEL: No.
DR. ZUBELDIA: I would put a sentence maybe in the middle, maybe at the end, I don't know where, but clearly say in addition to everything that is here NCVHS recommends that Rx-Norm and NDF-RT be adopted as core set of PMRI terminologies. You have to make it very explicit, this says that they're sufficiently developed to be recommended --
MR. BLAIR: That's what I'm taking out, I'm taking out the word sufficiently recommended, sufficiently developed to be recommended, and I'm replacing that by right at the start saying NCVHS recommends that da da da da da da be adopted as part of the core set of PMRI terminologies, so that's, it's clear and it begins the paragraph because the rest of the paragraph supports it.
MS. GRAHAM: Then are you going to move that to be above the thing that starts with further recommendations?
DR. COHN: Shouldn't it be after that paragraph where you're setting things up rather then before?
MR. BLAIR: My thought was, well, it might be but my thought was that it was intended that that was where the recommendations should be and that all the rest of the paragraph that follows it supports the recommendation. Is that correct Steve or not true?
DR. STEINDEL: The paragraph now reads NCVHS recommends that Rx-Norm and the representations of the mechanism of action and physiologic effect of drugs from NDF-RT be part of the core set --
MR. BLAIR: Right, of PMRI terminologies.
DR. STEINDEL: And then the next sentence of the paragraph is these portions of NDF-RT complement rather then compete with the capabilities of drug knowledge bases that have been developed within the private sector.
DR. COHN: You know this would be helped if this were separated from the previous by a new title, or I mean a new sort of subject area, something like drug terminology core recommendations or something like that because it really doesn't have anything to do with the previous couple of bullets the best I can tell.
DR. STEINDEL: What I'm looking at suggesting is we have NCVHS recommends that Rx-Norm, which is the recommendation paragraph, and I think you suggested this time and move that to the end of the paragraph, the end of the section, and then we have as the paragraph after the numbered list versions of Rx-Norm have been available quarterly blah, blah, blah, and then the last paragraph being NCVHS recommends.
DR. COHN: That sounds fine, and with just a new header that somehow indicates that this is a different topic then federal e-drug terminologies. Are we okay?
MR. BLAIR: I just, the only thing I'm not sure about is if somebody start to read that, if that sentence isn't there and somebody starts to read that paragraph the paragraph does, it's sort of like where is this paragraph going, it doesn't wind up, you don't know where the paragraph is taking you --
DR. STEINDEL: Which paragraph?
MR. BLAIR: The paragraph where we, I thought you were saying we would be moving the sentence that says NCVHS recommends --
DR. STEINDEL: I'm saying we moved that paragraph to be the last paragraph in this section.
MR. BLAIR: Oh, okay then, then maybe if you just read back to me how the two paragraphs go so I can get a feeling.
DR. STEINDEL: Okay, we have the bulleted list and then after the bulleted list it says versions of Rx-Norm have been available quarterly for several years through the NLM's UMLS. It is our understanding that full documentation for Rx-Norm will be available before the end of the year. NDF-RT, currently used in the VA and now available directly from them, will be released in the UMLS in April 2004. Rx-Norm also facilitates the clinical use of associated drug product information in electronic form from the FDA. Rx-Norm, NDF-RT, and the linked FDA terminologies have also been proposed as target U.S. government standards by the Consolidated Health Informatics Initiative.
New paragraph. NCVHS recommends that Rx-Norm and the representations of the mechanism of action and physiological effects of drugs from NDF-RT be part of the core set of PMRI terminologies. These portions of NDF-RT complement rather then compete with the capabilities of drug knowledge bases that have been developed within the private sector.
DR. HUFF: I would just say, including the transaction, say based on these developments recommend, the NCVHS recommends --
MR. BLAIR: That's fine, based on these developments, NCVHS recommends --
DR. STEINDEL: Now Simon, based on your comment, should we label that section PMRI, that paragraph PMRI core drug terminology?
DR. COHN: Recommendations.
DR. STEINDEL: Recommendations.
DR. COHN: That would be helpful.
DR. STEINDEL: So it stands out. Now we should review this with Betsy and the others tomorrow to make sure that everyone is in agreement with the changes and also get their input on the changes in the footnote that we were discussing.
DR. COHN: So should I read this last further recommendation now or has that been, okay, the further recommendation is the NCVHS recommends that the federal government increase funding to the Rx-Norm project to accelerate the population of current terminology, to increase links to the NDC HIPAA standard, and to improve the distribution mechanism to accommodate frequent updates. The NCVHS also recommends increased funding for the FDA's effort to improve the timelines and efficiency with which it collects and distributes drug product information. The success of these efforts will streamline the maintenance of Rx-Norm and NDF-RT and hence their value as national standards for coding medications, facilitate patient safety activities, and improve dissemination to private sector drug terminology suppliers. Probably once again this is just wordsmithing stuff, probably isn't the Rx-Norm project approved as the NLM? What's the, I guess increased funding to the Rx-Norm project, isn't it to the NLM?
PARTICIPANT: Would it be for the Rx-Norm?
DR. COHN: Yeah, I think we're talking about increased funding to the NLM to support, to accelerate the population of, I'm not sure what current terminology is, but to accelerate I don't know, something related to Rx-Norm.
DR. ZUBELDIA: The population of current terminologies sounds weird, I would say to accelerate the development of the terminologies.
DR. COHN: And we actually have a comment, did you, were you making a comment? Come to the microphone and introduce yourself, I'm sorry. We get so involved in the wordsmithing here that we sort of lose track.
MS. ECKERT: Karen Eckert with MediSpan. Just trying to clarifying, so the recommendation is for Rx-Norm and the mechanism of action and the physiological effects of NDF-RT is what the committee is recommending. So I'm trying to understand in the description of what is the purpose of pulling out the FDA's available vocabulary because as you read through it it was very confusing to say here's three or four things out there, well we're only going to recommend two and just wondering what, it's eventually setting itself up for. And just from having heard the letter --
DR. STEINDEL: I would prefer you defer that question until tomorrow.
MS. ECKERT: Okay, it was just from your reading the letter is very confusing I guess was my main point.
DR. COHN: And then basically, and obviously we, that's fine, so beyond that are we okay with that sentence knowing that we'll be going over it again?
DR. ZUBELDIA: Steve, did you capture that, accelerate the population of current terminology, to accelerate the development of the terminology?
DR. HUFF: Or you could say accelerate the development of terminology content.
DR. STEINDEL: I would prefer that.
DR. COHN: I think the rest of this is probably, it says to increase links to the NDC HIPAA standard, which probably, I'm not sure the rest of this needs to be referenced, and to improve the distribution mechanism to accommodate frequent updates. I think we wanted to accelerate the, Kepa, you had what now, accelerate the --
DR. ZUBELDIA: Development of the terminology --
DR. COHN: That's right, and enable frequent updates is I think what we're talking about. Isn't that really, seems to me the rest of this is sort of unnecessary. Mike?
DR. FITZMAURICE: In missing HIPAA down there, I was looking back up to number four at the top of the page, taking steps to improve the quality, and since it emphasizes low cost distribution of things I would insert low cost in front of electronic dissemination.
DR. STEINDEL: Where are you?
DR. COHN: Where are you?
DR. HUFF: Number four in the bullets.
DR. FITZMAURICE: At the top of the page. Because if we're improving the distribution mechanism down under further recommendations we might want to have a mental link back up to taking steps to improve the quality and initiate the low cost electronic dissemination of all the linked federal supporting drug terminologies since HIPAA does emphasize low cost distribution in the original law.
DR. STEINDEL: Can your hold your thought on that one because we've added some wording in another section about distribution mechanism of all the PMRI terminologies and we may want to introduce your wording at that point and perhaps even take out the fourth bullet here.
DR. COHN: So in this area I was actually suggesting that we get rid of the linkages to NDC HIPAA standards and the distribution mechanism with really with the issue being frequent updates. I guess we can talk to Betsy about that tomorrow.
DR. STEINDEL: I think you're going to have to talk to Betsy because this wording is from her and she is fairly specific that funding would be required for that.
DR. COHN: Okay, let's move on to the next section.
PARTICIPANT: And they're interrelated so --
DR. COHN: Well, but it's got to make sense. Let's move on to page 9, mapping among core set of PMRI standard terminologies, and obviously we're going to be trying to balance this discussion but then going back to the other ICD-10 letter, which you now have on your desk, so we're going to try to move through this relatively rapidly.
Mapping among core set of PMRI standard terminologies. To form a cohesive internally consistent terminology resource the core set of PMRI terminologies must be integrated. This integration should consist of mappings between equivalent or hierarchically related concepts across the core terminologies such that these relationships are explicitly represented. The mapping relationship should be part of the content of the PMRI terminology standards and maintained in concert with changes to the constituent terminologies. Okay?
DR. HUFF: Is that what we really want? What I mean by that, let me say what I thought we were doing and then see if this says what --
DR. COHN: We're doing, please.
DR. HUFF: I mean what we would want for instance is that the pieces for instance that make up LOINC codes would be mapped to concepts that are in the other reference terminologies, so for instance the names of drugs that are in LOINC, LOINC drug measurements, we would want to map to the concepts that are drugs in Rx-Norm and in the FDA's drug terminologies, etc. And I guess the part that I wonder about, I really don't want mappings to equivalent concepts, I only want one concept, and the work that's going forward is really to try and say what's the boundary between SNOMED and LOINC so that we don't have redundancy between LOINC and SNOMED. And so I don't really want equivalent, I don't want a SNOMED and a LOINC concept in there, I want one concept and I want it attached at the right place in the SNOMED hierarchy or in the --
MS. AULD: The UMLS already provides the equivalent mapping that this references, and what needs to be developed is the explicit mapping for specific business cases, which is what Stan's talking about.
DR. STEINDEL: I think this is another issue where we need Betsy to help us with this. I think what we were just talking about is deleting that sentence because it already exists, that sentence is redundant, the insertion of the core terminologies which we talk about later into the UMLS as part of that insertion process would create a list of equivalent terms under one CUI(?).
MS. AULD: Automatically.
DR. STEINDEL: Not automatically.
MS. AULD: Automatically as part of the process.
DR. COHN: Okay, so the recommendation might be there to get rid of the second sentence? Well, that certainly would solve our problem.
DR. STEINDEL: I think the last sentence is still appropriate.
DR. COHN: I'm all in favor of simplifying things by removing things if it helps. Okay, so the next paragraph, mapping to important related terminologies. NCVHS also recommends that the federal government recognize an additional group of terminologies as important related terminologies and that the government promote the creation, I'm sorry, and maintenance and mappings between these terminologies and the core set of PMRI terminologies specified above. Although these terminologies did not meet the NCVHS criteria for inclusion in the core PMRI terminology standards their use in important administrative and clinical processes will likely continue and should be compatible with the recommended PMRI standards. The NCVHS asserts that compatibility of the core set of PMRI terminologies with these important related terminologies specifically in the form of mappings will enhance the value and accelerate the adoption of the PMRI terminology standards. Okay?
The NCVHS recommends that the mapping to the important related terminologies --
DR. STEINDEL: Simon?
DR. COHN: Yes?
DR. STEINDEL: Where we have their use in important administrative and clinical processes will likely continue, can we remove the qualifier likely?
DR. COHN: Will continue?
DR. STEINDEL: Will continue.
DR. COHN: That sounds fine. NCVHS recommends that the mappings to the important related terminologies be prioritized as follows. Priority one, terminologies previously designated as standard terminologies for communicating, it says clinical data under the HIPAA administrative simplification regulations, it's actually I think it's, I'm sure it's clinical, but anyway --
DR. ZUBELDIA: Medical data sets.
DR. COHN: That's what I was thinking, communicating medical data or health care data, probably it's health care data.
DR. ZUBELDIA: Actually I think the regs called them medical data sets.
DR. STEINDEL: Why don't we just use those words, for medical data sets, designated as standard as medical data sets under --
DR. COHN: Maybe rather then communicating clinical data, maybe it's terminologies previously designated as HIPAA medical code sets. There we go, then CPT, CBT, HICPICs, ICD-9-CM, and NDC.
Priority two, terminologies in common use as enables of important health care functions, these terminologies include but are not necessarily limited to DSM-4, the FirstDataBank NDDF+, ISBT128, Medcin, Medra, MediSpan, Multum, nursing terminologies not otherwise included in SNOMED CT.
DR. ZUBELDIA: I'm wondering if in priority one we should split ICD-9 into Volumes 1 and 2 and Volume 3 so when they get replaced with ICD-10 it's clearly the replacement and it's not just one terminology.
DR. COHN: So one line for Volumes 1 and 2 and the next line for Volume 3?
DR. ZUBELDIA: Yeah, I don't know, what do you think?
DR. COHN: Well, or do we just want to specify Volumes 1, 2, and 3?
DR. ZUBELDIA: Well, because they're being replaced with ICD-9-CM and ICD-9-PCS, which is two different things? They'll be replaced with ICD-10, I'm sorry.
DR. COHN: I don't feel strong, I'm not sure in this context it matters a whole lot, I think we would want to mention Volumes 1, 2, and 3, but whether we split them out 1 and 2 and 3 is I think a whole, I would defer to the rest of the committee on that, I don't have a strong feeling.
DR. ZUBELDIA: We have split CPT-4 out of HICPICs, which I think in the transactions final rule is all together.
DR. COHN: Yeah, that's actually, I think the differentiation here which I didn't get into is probably level one versus level two, is what I think that that means.
MR. BLAIR: In the context of this letter I think it's referencing ICD-9 generically, I think it's adequate.
DR. COHN: But Kepa, you're right, we're going to need, we are going to need to come up with a way of differentiating the intent of HICPICs here, which is the alphanumeric HICPICs, and is that what we call it, alphanumeric or level two --
DR. ZUBELDIA: Level two.
MS. TRUDEL: Level two.
DR. COHN: It's level two, okay, so it should be level two HICPICs. Okay, a central coordinating body. The NCVHS recommends that you designate the NLM as a central coordinating body for the PMRI terminology standards. As such the NLM should serve as 1) an official repository and distribution center for the core set of PMRI terminologies; 2) the organization responsible for integrating the core set of PMRI terminologies into a cohesive internally consistent whole; 3) the provider of a mechanism for extraction of the individual PMRI terminologies from the code set, which I agree with but it needs to be reworded, and 4) the organization responsible for funding, coordinating, and/or performing mapping between the core set of PMRI terminologies and the important related terminologies. I think three needs some wordsmithing but --
DR. STEINDEL: Yeah, it was put in there to kind of track the wording of the others and it was difficult to do and I'm open to any suggestions there.
MR. BLAIR: It's grammatically correct but it is awkward.
DR. STEINDEL: It is awkward, no, I agree with that.
DR. HUFF: Because I think you want three to say something like and provide a tool, provide a mechanism for extraction, so if you go back, what it means is that, you could say and as such the NLM will and then put serve as into one and serve as into two, and then let three just be provide, I like will or shall better then should.
DR. ZUBELDIA: That's it, that's a HIPAA lesson, you should never use the word should.
DR. COHN: Actually this area if Mike could help at all, so rather then serve as change that to be.
DR. HUFF: That's good.
DR. COHN: That would also help.
DR. HUFF: So it would read now something like as such the NLM will, one, be the official repository and distribution center, two, be the organization responsible for integrating the core set, three, provide the mechanism.
DR. FITZMAURICE: In keeping with the tense shouldn't the should be instead would rather then will because you're presuming a conclusion?
DR. HUFF: I want to presume a conclusion.
DR. FITZMAURICE: But NCVHS recommends this, as such if you follow the recommendation then NLM would, so it's presuming that the recommendation will be followed rather then saying here are the consequences of the recommendation.
DR. STEINDEL: Instead of will, would.
DR. COHN: Let's move on to the next area and allow the tense masters to --
DR. ZUBELDIA: Would and should go in the same bucket.
DR. FITZMAURICE: I don't know, should is a statement that this must happen, would says if you follow our recommendation then the NLM would do this.
DR. STEINDEL: Now, to get to your point earlier that I asked to be deferred, Mike, should we say official repository and low cost distribution center?
DR. FITZMAURICE: That would be okay, but I would put it under, also under that four above.
DR. STEINDEL: And then the question is can we remove four above.
DR. FITZMAURICE: Because it says, well, it says the FDA is doing this, FDA is taking steps to improve the quality on low cost dissemination, that's what this one, two, three, four are. And assume that FDA is doing that as well as the NLM will be doing this. I want them both doing it.
DR. COHN: Okay, let's move on to the next section. I want to give about another five or six minutes to this and then we move back to the ICD-10 letter, this is obviously sort of hard going at this point.
Next area is relationship between PMRI message format standards and PMRI terminology standards. In previous recommendations to you the NCVHS identified a set of PMRI message format standards that included HL7 version 2.2+, HL7 version 3, DIECOM, NCPDP Script, and IEEE-1073. Each of these message format standards includes its own code sets which are used to represent clinical and non-clinical information needed for standard message exchanges. These code sets, while not part of the PMRI terminology recommendations presented herein, remain essential elements of the message format standards, are in no way supplanted by the core set of PMRI terminologies described above. To the degree that there may be overlap in meaning between certain elements of these code sets, and the elements of the PMRI terminology standards, efforts should be made to achieve consistency. These efforts may include, maybe should include, 1) constraining the use of codes from PMRI terminology standards within PMRI message format standards where appropriate. For example HL7 messages may require the use of codes from the PMRI terminology standards for certain agreed upon coded element fields.
DR. FITZMAURICE: I'm not sure who does the constraining, it's hard for me to picture that right now.
DR. HUFF: I'm not sure what this means, either, HHS actually has no authority to constrain HL7 to use anything.
MR. BLAIR: I think it's the other way around, I thought it was that HL7 would be constraining the use of SNOMED or LOINC within its messages, did I misread it?
DR. HUFF: It already has the ability to do that so why, does anybody here know what the intent of this paragraph was?
MR. BLAIR: I'd be, well, at least that phrase anyway, I'd let it go.
DR. COHN: I would actually think the term is more encouraging the use of codes from PMRI terminology standards within PMRI message format standards where appropriate, which I think would make a lot of sense.
DR. STEINDEL: Simon, since you actually wanted to cut this short in five minutes may I suggest that we cut it short now? Because this wording is from Walter and he'll be here tomorrow, too.
DR. COHN: Well, I just wanted to make sure that we read, so let me just read through the rest of it here and we won't make --
DR. ZUBELDIA: If you were to remove the constraining the, this effort may include use of codes from PMRI terminologies within PMRI.
DR. COHN: That's probably even better, getting rid of those first two words, the use of codes in mapping of codes, from the message format standards to codes from the terminology standards, more the message standards and the terminology standards both encode the same concepts. For example, mappings between specified HL7 and SNOMED CT codes for gender and units of measure and mappings may be specified between, so 11073 in SNOMED CT codes for systolic and diastolic blood pressure, etc. Okay, we'll keep going here. Specification of the required constraints in mappings will require additional work and the cooperation on the part of the Standards Development Organizations and the terminology developers responsible for the various individual standards that comprise the PMRI standard suite.
Additional research, NCVHS recommends additional research to address outstanding content issues related to core sets of PMRI terminology standards. First is dental content and medical device content, standard terminology for dentistry and medical devices is an important element of the core set of PMRI terminology standards, however, the NCVHS must resolve a number of outstanding content issues before it can put forth recommendations in these specific areas. The NCVHS is in the process of investigating and resolving these issues and plans to make additional recommendations upon completion of this work.
Clinical LOINC, the NCVHS recommends further research into the need for and value of incorporating the clinical subset of LOINC into the PMRI terminology standards. This research should focus on the degree of overlap between clinical LOINC and SNOMED CT and the general applicability of concepts from clinical LOINC to the PMRI terminology standards.
And then content from other terminologies, NCVHS recommends exploring incorporation of content from terminologies other then those selected from the core set of PMRI terminologies, for example ICF, which was highlighted in a previous NCVHS recommendation to you, may be a valuable source of concepts for encoding functional status although the terminology as a whole lacked certain features required for the core set of terminologies. Similarly codes from terminologies specific to complementary and alternative medicine may also constitute useful additions. Augmenting the core set of PMRI terminologies in this way may accelerate any needed enhancements to the terminology standards.
Then NCVHS wishes to thank you for the opportunity to submit these recommendations within the framework of the HIPAA administrative simplification provisions of HIPAA, I don't know what this, okay, I'm a little concerned at this point that we'll make it through these recommendations tomorrow but it will become clearer.
DR. STEINDEL: Simon, since we had a specific hearing on devices I would like a specific statement in this letter concerning devices.
DR. COHN: As opposed to it being additional research?
DR. STEINDEL: It can be in the additional research section or something like this, just something from the worded that we, someplace in this letter, and I can craft some wording tonight for it, that we heard testimony from device terminology suppliers and we note that there is a move to coordinate this and we recommend that we shall review the situation when that happens, just something like that because we did hear from these people and I think --
DR. COHN: I think that's fine, is that additional research then or is that a paragraph we stick under medical devices?
MR. BLAIR: I would feel it's additional research.
DR. STEINDEL: I would just put it under additional research.
DR. COHN: That's fine then.
DR. STEINDEL: I just want to make sure that the device people don't feel like they were left out from this letter, we did hear what they said and we're going --
DR. FITZMAURICE: Two issues that probably don't require any additional comment, on the last paragraph you read that started off the NCVHS recommends the incorporation of content, it doesn't say into what, but when you get down to the last sentence it appears the intent is to augment the content of the core set of PMRI terminologies, so linking the last sentence with the first sentence could make it a lot clearer that it is meant to augment the core set with terms from other terminologies.
The second issue is on page 11, the sentence to the degree that there may be overlap in meaning between certain elements of these code sets and elements of the PMRI terminology standards efforts should be made to achieve consistency. I'm assuming there that what's meant by overlap would be similarities in meaning and that if something is called X in one terminology and Y in the other that you replace Y with X or X with Y, but if they don't overlap exactly you've got a problem, so it's not as easy as all that. This is the question before the constraint of codes, just a further explanation of that sentence would be needed to know when you can take action and when you can't take action, because we're trying to provide guidance here for constraining the use of codes and it's not clear.
DR. HUFF: Another comments or --
DR. COHN: I'd actually like to move to the ICD-10 letter, what?
MS. GREENBERG: Does anyone have the previous letter?
DR. COHN: Probably Steve has, you're looking to see what the previous recommendations were?
MS. GREENBERG: The letter that we looked at in --
DR. STEINDEL: The letter that we looked at at the last session, there was some minor word changes circulated by Jeff that appear mostly in the section that we haven't gone over, the beginning section, and there was a substitution of the drug section with the new drug section but the remainder of the letter was the same as it was before.
MS. GREENBERG: This additional research area, is that the same?
DR. STEINDEL: Yeah, it's the same.
DR. COHN: Carol Bickford?
DR. BICKFORD: Carol Bickford, American Nurses Association. Not being able to review the document help me understand what this document does in relation to your letter that you were just crafting with ICD-10. Is that relationship identified at the front of the letter so there's understanding of what am I supposed to do with these two letters?
DR. COHN: I think they're completely different topics. I guess we should all, just having, it's been a while since I've looked at the PMRI letter and I know we all, we all just have to think about this one and what direction to take with it. I mean somehow it, there are parts of it that I think, I mean this letter needs to come out, the question is is does it need, given all the work that's gone on with CHI do some of the parts still need to stand as they are or can we, I mean I'm looking at the relationship between the standards organizations and code sets and I'm sort of going geez, is that even necessary for example, is that a value added entire section. I mean I think that there is key pieces here that we want to move forward but we just sort of need to, maybe people want to read it tonight and make sure that it's, all aspects of it are still timely.
MR. BLAIR: Is it possible where Steve you could maybe print it out either tonight or first thing in the morning and copies be made of this latest draft of the PMRI letter so that all the folks in attendance, because they'll probably be folks that are coming specifically tomorrow because maybe they have some questions or comments or concern about these issues, so that they have the latest copy?
DR. STEINDEL: That should be no problem Jeff, assuming I can find a way to print it out. I don't think that's going to be a problem.
DR. COHN: Okay, great, let's move back to the ICD-10 letter and sort of see where we are with this.
Agenda Item: Discussion of Issues and Draft Recommendation Letter Continued - Subcommittee
MS. FRIEDMAN: Can I add two disclaimers before we start? In the second, I think I got everything but the second paragraph, which we'll be going over in a minute I did not get all the reg text that I needed, so there's a bunch of stuff in there, I kind of put it in brackets just for flow purposes, it's reg text but I set it off a little bit just so you'll see. And I also left off a sentence at the end of that paragraph about this would not effect the usage of other code sets under HIPAA such as CPT and NDC. I think I got everything else.
DR. COHN: Okay, that's good. Okay, let me just read through this and we'll see where we are, hopefully it will, we'll be comfortable with it.
Dear Secretary Thompson:
As part of its responsibilities under HIPAA the NCVHS monitors the continued effectiveness of the health data standards adopted pursuant to the requirement of the HIPAA administrative simplification provisions. During the past several years NCVHS' Subcommittee on Standards and Security has focused considerable attention on the feasibility and desirability of replacing the current diagnosis and procedure classification system, ICD-9-CM Volumes 1, 2, see, this still doesn't, with a newer and expanded version, ICD-10-CM and ICD-10-PCS. ICD-10-CM is the official HIPAA code set for, and then there's, we don't actually anything for --
MR. BLAIR: You just read ICD-10-CM is the official --
DR. COHN: ICD-9-CM, I'm sorry, is the official HIPAA code set for, and I think what we wanted was one thing that said Volumes 1 and 2 and then another thing that says Volume 3, what we do is we have verbiage here related to the procedure, which sort of says for the following procedures, gosh --
MS. FRIEDMAN: I just put this text down to just put it down.
DR. COHN: Yeah, and actually the interesting thing here just to note is that the way you describe it is basically, the following procedures or actions taken for diseases, injuries, or impairments on hospital inpatients reported by hospitals, which is probably a good way of describing this since we've talked about inpatient when really what we mean are inpatient procedures reported by hospitals, I think is what we're describing here. And obviously it looks to me like we still need to at the beginning where we talk about ICD-9-CM in the first sentence --
MS. FRIEDMAN: Do you still want Volumes 1, 2, and 3 in there?
DR. COHN: Well, that, yeah. And we need to say something about procedure classification, when you say inpatient procedure classification or something just to clarify that part.
MS. FRIEDMAN: I think I got it right at that last sentence at the end. Do we want to repeat that twice or move that up?
MS. TRUDEL: I'd suggest moving it up.
DR. COHN: So we don't want to say desirably replacing the current diagnosis and inpatient procedure classification, ICD-9-CM period, and then we say at issue, does that work for everybody? Are you catching what I'm saying here?
MS. FRIEDMAN: I know, there's all that reg test in there that doesn't quite fit.
MS. TRUDEL: I sort of revised it if I could read what I wrote?
DR. COHN: Please, thank you, sure.
MS. TRUDEL: And this is just the whole paragraph. During the past several years NCVHS' Subcommittee on Standards and Security has focused considerable attention on the feasibility and desirability of replacing the current diagnosis inpatient procedure classification system, ICD-9-CM, with a newer and expanded version, ICD-10-CM and ICD-10-PCS. ICD-9-CM Volumes 1 and 2 was adopted as the HIPAA standard for diagnosis in all settings, and ICD-9-CM Volume 3 is the standard for hospital inpatient procedures --
DR. COHN: Reported by hospitals.
MS. TRUDEL: Reported by hospitals --
MR. BLAIR: Well, it says hospital inpatient procedures doesn't it?
MS. TRUDEL: Then, at issue are the one to one replacement as HIPAA code sets of ICD-9-CM Volumes 1 and 2 by ICD-10-CM for diagnoses in all settings, and ICD-9-CM Volume 3 for inpatient procedures reported by hospitals by ICD-10-PCS. The subcommittee did not contemplate expansion of ICD-10-CM beyond current ICD-9-CM uses, for example, for professional services.
MR. BLAIR: If we say hospital inpatient procedures then why do we have to tack on at the end for use --
DR. COHN: I think Clem was requesting --
MS. TRUDEL: That's what Clem wanted, he wanted us to say what we weren't considering it for in addition to what we were considering it for.
MR. BLAIR: Oh, well then, let's add the word exclusively or only reported by hospitals or something to that effect. Because it sounded redundant --
MS. TRUDEL: Well I have my alternative last sentence, which is this would not effect the usage of other code sets under HIPAA such as CPT and NDC.
MS. GREENBERG: I think that's better.
DR. COHN: Okay, so are we, Michael?
DR. FITZMAURICE: I have a suggestion, to keep a parallel structure of the last sentence I would take the phrase for inpatient procedures reported by hospitals, put that at the very end, so that you have, we have this one code set replaced by another one for the following purpose, another code set replaced by this one for the following purpose, just to add a little structure.
MS. TRUDEL: So what's in the last sentence now?
DR. FITZMAURICE: It would put for inpatient procedures reported by hospitals, move that phrase to just before the period at the end of the sentence.
DR. ZUBELDIA: Wasn't that replaced with what Karen read?
MS. TRUDEL: And ICD-9-CM Volume 3 by ICD-10-PCS.
DR. COHN: By hospitals, taken out at the end there.
MS. FRIEDMAN: Oh, I see, gotcha.
DR. COHN: It's not a big change. Okay, so does Maria have your --
MS. TRUDEL: She's got it.
DR. COHN: Okay, so we'll go back and take a look at that after Maria gets it up on the screen, that paragraph. Let me keep going.
ICD-9-CM was developed in the 1970's. Despite an annual, Kepa?
DR. ZUBELDIA: The ICD-9-CM was developed in the 1970's --
DR. COHN: What?
DR. ZUBELDIA: The ICD-9-CM, I don't know.
DR. COHN: ICD-9-CM was developed in the 1970's. Despite an annual update process ICD-9-CM Volumes 1, 2, and 3 have structure and space limitations that increasingly constrain their ability to accommodate advances in medical knowledge and technology. ICD-10-CM is recognized as the logical successor for ICD-9-CM for diagnoses. In fact, ICD-10-CM has already been used for mortality classification --
MS. GREENBERG: No, ICD-10 --
DR. COHN: I know, I saw, Maria that's actually just ICD-10 for mortality classification, in the United States since 1999 and has been implemented for that purpose throughout much of the world since the mid 1990's. Many of these countries have also adopted ICD-10 or a clinical modification of it for, I think it's morbidity reporting, isn't that correct? ICD-10-PCS was developed by the Centers for Medicare and Medicaid Services as a successor to ICD-9-CM Volume 3.
Yes, Michael.
DR. FITZMAURICE: I would put a hyphen between mid and 1990's, say mid-1990's.
DR. COHN: Thank you, okay. More then XXX days of hearings have been held by NCVHS since 1997 and oral and written testimonies have been provided by more then 80 public and private sector groups --
MS. PICKETT: Excuse me Simon? A question, where referencing oral and written testimony should we also refer to the many letters that also came in on this subject matter?
MR. BLAIR: Well if you say both --
DR. ZUBELDIA: That's written.
MS. PICKETT: Well, it's not written testimony, though but they were letters, some sent to --
DR. FITZMAURICE: Testimonies and letters.
DR. COHN: Okay. Are we okay with that? A timeline for the development of ICD-10-CM and ICD-10-PCS, which includes a synopsis of testimonies, is attached along with a complete listing of groups that have testified. And actually it's testimonies and letters. Okay. The issues surrounding the migration, oh Michael, I'm sorry.
DR. FITZMAURICE: On the previous paragraph the statement a timeline for the development of ICD-10-CM and ICD-10-PCS, which includes something, is attached, I would suggest a timeline report on the development, because this says like we're setting up a timeline for the development of it, in fact it's a timeline report on the development.
PARTICIPANT: Why don't we call it a chronology?
DR. COHN: That's even better. We okay? Maria are you okay? The issues surrounding the migration to a replacement diagnoses and inpatient procedure classification system in the United States are complex. For example, there are many in the health care community who believe that ICD-9-CM is an antiquated system that cannot meet the current and emerging needs of payers and providers in today's fast paced highly specialized and technologically sophisticated environment. There also are concerns that ICD-9-CM is increasingly unable to support the need for accurate data for health care billing, quality assurance, public health reporting, and health services research. This has been well documented in the testimony given to the committee over the past several years.
DR. HUFF: Would it be better to say in that first sentence at the end instead of saying complex say controversial?
DR. COHN: No, let's leave it complex. And I think rather then support the need, it's address the need, so get rid of support and change to address. Yes, Michael.
DR. FITZMAURICE: -- some parallel structure, in the second sentence it says for example there are many in the health care community who believe ICD-9-CM is an antiquated system. And then in the next sentence, there are also concerns that ICD-9-CM is increasingly unable, I would say instead of for example there are many, I would say for example there are concerns in the health care community that ICD-9 is an antiquated system, which is parallel to there are also concerns that ICD-9-CM is increasingly unable. So we're talking about not number of people and then number of concerns, but concerns and concerns.
DR. COHN: Okay, you capturing all of this? Okay, good.
MS. TRUDEL: We're going to revise the second sentence in the paragraph to say for example there are concerns within the health care community that ICD-9-CM is an antiquated system, and then there are also concerns that CM is increasingly unable to address the need for accurate data for blah, blah, blah.
DR. COHN: At the same time the committee has heard significant concerns from the health care community about the costs, potential benefits, and implementation issues associated with transition to ICD-10-CM and ICD-10-PCS. Given the widespread use of these code sets there are significant potential implementation costs in terms of hardware and software changes, lost productivity, and training among others.
MS. GREENBERG: In the paragraph above we removed that there are many, we just said there are concerns, and now suddenly on the other side with the costs there's significant concerns, are those concerns more significant then the concerns above? I don't think we should say one play there are concerns and another place that there are significant concerns, unless you're trying to say they're more significant then the other concerns.
DR. FITZMAURICE: You also use significant twice in the same paragraph, maybe we'll take out the first one.
MS. GREENBERG: I'd take out the first one.
DR. COHN: Okay, what do other members think about that? Stan? Jeff? Okay, so leave one significant in the paragraph and get rid of the other one.
MS. TRUDEL: This is really picky, I'm sorry, but the second sentence is given the widespread use of these code sets, and in the previous sentence we were talking about 10-CM and PCS, which are not in widespread use, so I think what we're saying is given the widespread or the broad implications of this transition --
DR. STEINDEL: Or the widespread use of diagnostic and procedure code sets.
DR. COHN: Say what you're saying again.
DR. ZUBELDIA: Widespread use of the ICD-9-CM.
MS. TRUDEL: Yes.
MS. GREENBERG: How about given the widespread use for these code sets?
MS. TRUDEL: No, because these code sets still refer back to 10.
DR. COHN: I think given the widespread use of ICD-9-CM, much cleaner. Okay.
DR. HUFF: Does potential add anything in that sentence, in the last sentence, there's significant implementation costs.
DR. FITZMAURICE: Only that it hasn't happened yet.
DR. HUFF: That's the point is that I don't think there's any question that there will be costs.
DR. FITZMAURICE: I'll grant you that.
DR. COHN: Should we get rid of the word potential?
MS. GREENBERG: Well, with lost productivity you don't know how much that will be.
MS. TRUDEL: Well, there's been debate on what's significant.
DR. HUFF: I'm happy to throw out significant, too, but I don't think the potential.
DR. STEINDEL: There could be significant implementation costs.
MS. TRUDEL: If you take out potential and you don't put in something else it kind of softens it, it gives the appearance that we are absolutely sure what those costs are and I think that's still open to a lot of debate.
DR. COHN: And maybe we say there could be significant potential --
MS. TRUDEL: Could be significant implementation costs.
DR. COHN: Okay with that?
MS. GREENBERG: How did you change it?
MS. TRUDEL: Given the widespread use of ICD-9-CM there could be significant implementation costs in terms of, is that okay?
DR. COHN: The next paragraph. Benefits are harder to quantify but appear to outweigh the costs. They include improvements to the quality of care and patient safety, fewer rejected claims, improved information for disease management, and more accurate reimbursement rates for emerging technologies. These costs and benefits and related issues also have been substantially documented in testimony before the subcommittee as well as in a specially commissioned cost/benefit study by the RAND Corporation. A copy of the RAND study is attached. Michael.
DR. FITZMAURICE: We have fewer rejected claims, improved information for disease management, I would put a comma there before the and because that's parallel to what we did two paragraphs above, in a statement of three we use a, b, and c.
DR. COHN: Okay, anything else?
DR. ZUBELDIA: Instead of specially commissioned cost/benefit study I would say in an NCVHS commissioned cost/benefit study.
DR. COHN: Okay. In addition many in the public and private sectors are concerned about the additional administrative and resource burdens posed by this migration since they would follow on the heels of HIPAA's other mandated requirements. Along with testimony about the timing and cost concerns the subcommittee also received considerable input about the timeframes that would be needed to effect a successful transition to ICD-10-CM and ICD-10-PCS. Michael, please.
DR. FITZMAURICE: I would suggest instead of migration, maybe putting in implementation, and I've got a reason for wanting to do that because there's a beautiful structure in these three paragraphs, as we look two paragraphs above it says at the same time the committee has heard significant concerns from the health care community about the cost, potential benefits, and implementation issues. Then the next sentence talks about costs, the next paragraph talks about the benefits, and if we change migration to implementation then that paragraph talks about implementation.
DR. COHN: Makes sense, thank you.
DR. FITZMAURICE: While I'm on a roll I would take away the also after subcommittee because we along with testimony, so we've already made reference to what we've heard before.
DR. COHN: Okay. Anything else?
DR. FITZMAURICE: I wish I could have seen that in college, but I didn't.
DR. COHN: I wish I could teach that to my high school daughter. Despite the input over the past several years from the health care industry the federal governments, federal and state governments, the public health and research communities, insurers and providers, there is no consensus, it should be there is not consensus, on either the reasonable vehicles to move forward or the timing of such a move. At the same time there is a considerable constituency among providers and payers who believe that ICD-10-CM certainly cannot be used forever or in fact much longer because of structural, content, and space limitations.
MR. BLAIR: You just said ICD-10 again?
DR. COHN: I'm sorry, ICD-9, I'll say X from now on. ICD-9-CM.
DR. ZUBELDIA: I thought we had talked about replacing that word consensus with agreement, there is no agreement.
DR. COHN: Yes. Thank you.
MS. TRUDEL: Can I ask, what do we mean by reasonable vehicles to move forward?
DR. FITZMAURICE: That's my question.
MS. TRUDEL: It's my turn, new paragraph.
DR. FITZMAURICE: Because I think we have the vehicle.
MS. TRUDEL: The initial vehicle is HIPAA via regulation. Maybe we mean an implementation plan --
DR. COHN: Yeah, but this is deeper then that I think, the intent here is not to say that the arguments are just about timing of implementation, I think we were hearing things that were much deeper then that about whether implementation should happen at all. And so maybe we need to come up with different words around all this stuff but I certainly wouldn't want the Secretary to think that all that we'd heard over the last three years just had to do with whether it was two or three years out. I share with you that maybe vehicle is not the right word but is the right, reasonable approach --
MS. TRUDEL: It sounds like you're saying whether to pursue --
MR. BLAIR: Could you read the sentence as a whole?
DR. COHN: Sure. Despite the input over the past several years from the health care industry, the federal and state governments, the public health and research communities, insurers, and providers, there is no agreement on either the reasonable vehicles to move forward or the timing of such a move. That actually gets getting better, each time I read it it sounds better.
MR. BLAIR: The thought I would have on that is that if there's no agreement then how can we make our recommendation? I would rather wind up saying there's no consensus rather then no agreement and therefore that gives us room to wind up saying alright, there's not a consensus out there, however the NCVHS feels, you see what I'm saying?
DR. COHN: Well we can go back to consensus certainly --
DR. ZUBELDIA: We said all of this, why don't we just take this entire paragraph out?
MS. TRUDEL: I was just going to say the same thing, I think it's restating the things we say in the first full paragraph on the page.
MR. BLAIR: Yes, I agree, I don't think we need it.
DR. COHN: Let me, let's see if indeed everything is, well, you may be right.
MS. TRUDEL: I don't think it adds anything.
DR. FITZMAURICE: It is a restatement of everything.
DR. COHN: Okay, I think the only thing I would ask is if maybe Maria is looking at this over, I guess, I'm just looking to see if there's anything here at all that's being missed.
MS. TRUDEL: The only thing that's really new there is the litany of the groups, it's the first time we've really stated kind of the full complement of groups but aside from that it's a restatement.
MS. PICKETT: And that will already be in the attachment.
MS. FRIEDMAN: It's just that sometimes they never get to the attachment, so sometimes it's worth saying in the letter.
MS. TRUDEL: Could I suggest, Maria is right, that's the only thing that's new here, what if we take the statement about the participant list and move it to the paragraph on page one that talks about the days of hearings and more then 80 public and private sector groups, and then say representing federal and state governments, public health and research communities, insurers, and providers.
MR. BLAIR: Is that even necessary? You wind up saying the private and public groups, is it really necessary to go ahead and expand that further?
DR. COHN: Yeah, I think it is.
MS. FRIEDMAN: I think it's worth saying for the people who haven't been involved in this process for so long and who might be coming to it new.
DR. FITZMAURICE: I'd also keep the sentence the way Karen had phrased it before, I'd mention those groups, it's useful.
DR. COHN: The reason I'm sitting here mulling about this one is I'm trying to think if there's any other place that we really say, I mean we sort of go on the edges of a lot of all of this in the previous paragraphs, about the fact that, I mean as Jeff commented there's no consensus in the industry, I guess I'm trying to think in my own mind whether --
DR. FITZMAURICE: Simon, there's another way to say this and that is despite the input over the past several years from the health care industry, the federal and state governments, public health and research communities, insurers and providers, there's not full consensus on moving forward or the timing of such a move. So I said full consensus or full agreement, that seems to be the --
DR. COHN: I think I'd rather it off then what you just said. Why don't you move it down to the bottom of the page and we'll look at it tomorrow when we look at it a final time to see if there's anything there that needs to be added back in.
MS. FRIEDMAN: Alright, I did move the list the way Karen suggested it.
DR. ZUBELDIA: You moved the list? Then I would say just take the whole thing out. If you preserve that list of constituents, there's nothing else new here.
DR. COHN: I mean you're probably right, I'll keep a copy here and as I look at it if I think I need to have it back in I'll deal with it. Yes, please.
MR. DECORNEY(?): Frank Decorney, American Dental Association. I was going to offer another spot for the list if you care to, I was going to suggest that the list of the federal and state governments, etc., another possible location might be in the second full paragraph on page two, the one that says at the same time the committee heard significant concerns from the health care community, at that point after the word community, the list could be inserted there as a possibility.
MS. TRUDEL: I think I'd prefer to put it up at the front because that implies that those same people didn't say that it was an antiquated system, that can't meet current emerging needs.
MS. FRIEDMAN: It also makes that sentence overly long if you put it where he just suggested it, it flows better putting where we moved it on page one.
DR. COHN: I can keep a look at it, I was actually wondering about, why don't we think about removing that paragraph, let's read the next sentence and I wonder if maybe there needs to be something a little more there. It says while taking into account the diversity of input the NCVHS concludes it is in the best interest of the country as a whole that ICD-10-CM and ICD-10-PCS be adopted as HIPAA standards for national implementation in place of ICD-9 Volumes 1, 2, and 3. As a result the committee recommends that the Department of Health and Human Services initiate the regulatory process for the concurrent adoption of ICD-10-CM and ICD-10-PCS. By issuing a Notice of Proposed Rule Making the Department would provide a structure environment in which critical implementation issues might be addressed. We further recommend that the NPRM specifically invite, that the NPRM specifically invites comment, that's actually invite comment on key issues presented in testimony before the committee and then I'll go through those in a second.
I guess I'm wondering, if we're going to take that paragraph out which may be fine the question is is the diversity of input, does that really state what we were saying in the paragraph above, or do we say while taking into the diversity of input and lack of industry wide consensus?
DR. HUFF: I think it still works because when that paragraph was there then it clearly sort of applied to that one paragraph, with that paragraph gone then it sort of applies to, that's what the diversity is described by the three paragraphs prior to that.
DR. COHN: So are you saying that we should that other piece in or leave it out?
DR. HUFF: I think it works with the paragraph gone, to still say while taking into --
DR. COHN: I'm sorry, we took out the lack of consensus --
DR. ZUBELDIA: Diversity of input, the lack of industry consensus.
MS. TRUDEL: I think that's absolutely clear in the previous paragraphs, I mean we're saying, they told us this then they told us that, so I mean that to me is a lack of consensus. I mean the concept is there.
DR. HUFF: So you just wanted to add after input, take into account the diversity of input and the lack of consensus --
DR. COHN: Of industry wide consensus. Is that okay? With that I'd be happy to get rid of that paragraph, that was really the thought, okay? We're at the bullet list, I think we're running everybody down including myself here.
MS. FRIEDMAN: The bullet list is the same and the one paragraph is gone so that just leaves the one list.
DR. COHN: It's good to get short letter, you know you're doing the right thing when the letters get short. Anyway, the first bullet is what can be done to minimize the costs of transition to ICD-10-CM and ICD-10-PCS and to get the number right there. Second is what could be done to maximize the benefits of implementing ICD-10-CM and ICD-10-PCS. Third is what are the potential unintended consequences of such a migration and how could they be mitigated. And it's probably not what are but what could be the potential consequences. Then what timeframes would be adequate for implementation. The NCVHS heard in testimony that the industry would need a minimum of two years for implementation, however such timeframes could be further clarified and refined through the regulatory process. And then finally what additional steps would be required to ensure the realistic and smooth migration. And then finally NCVHS wishes to thank you for the opportunity to submit these recommendations, John Lumpkin.
Now Michael you had your hand up and if you didn't I'd have called on you anyway.
DR. FITZMAURICE: Going back to the paragraph on the bottom of page two I would strike the word the in front of NCVHS, so while taking into account the diversity and the lack of industry wide consensus NCVHS concludes. And it's in the best interest of the country as a whole that ICD-10-CM and ICD-10-PCS be adopted as HIPAA standards for national implementation, etc. I'm not sure that they're HIPAA standards, maybe adopted as HIPAA code sets?
DR. COHN: Clinical code sets?
DR. FITZMAURICE: Yes. Or HIPAA standard medical code sets.
DR. ZUBELDIA: They are HIPAA standards.
DR. FITZMAURICE: Okay then.
DR. COHN: We'll leave them as HIPAA standards, at this level that's probably fine.
DR. FITZMAURICE: I've got one more suggestion and that is, the fourth bullet down, what timeframes would be adequate for implementation, and then the NCVHS heard, I would put that in parentheses because you might not be suggesting to the Secretary that he use that part of the bullet as laying out the NPRM, but you'd want to explain to him why you're suggesting this.
DR. COHN: I've lost where you were here.
DR. FITZMAURICE: On the fourth bullet put parentheses around the NCVHS heard in testimony that the industry --
DR. COHN: Okay, that sounds great.
DR. ZUBELDIA: And then the word horizons seems weird.
DR. FITZMAURICE: Such timing.
PARTICIPANT: [Comment off microphone.]
DR. COHN: Let me ask everybody, are we generally comfortable with where we are at this point? I mean we'll see another version tomorrow morning. Now I'm trying to think about how to ask this one but I'm just concerned because we're running, there's four out of six and if tomorrow something happens and there's only three of us we won't have a quorum to move this morning. I know that Clem will be on the phone also. I guess I want to, I'm trying to think, I don't need, Marjorie help me with this one. What I'd like to do is to get some sort of a provisional note on this particular draft version that just in case as I said somebody doesn't make it tomorrow that we have the sense of the committee that we can move forward taking this to the full committee with other such modifications as may occur.
MR. BLAIR: Won't we be in the same position with the PMRI letter as well?
DR. COHN: Let's do this letter first and then we'll deal with the PMRI letter after that.
DR. HUFF: I won't leave tomorrow before we're done if that makes a difference to you.
DR. COHN: I guess I'm sort of --
DR. ZUBELDIA: -- done by 11:00?
DR. HUFF: No, if I miss the ballgame I miss the ballgame.
DR. COHN: Can I ask somebody to move for a provisional recommendation on this one, recognizing that we will continue to wordsmith it --
DR. HUFF: I make a provisional --
DR. COHN: Okay, second?
DR. FITZMAURICE: Second.
DR. COHN: Okay, all in favor?
SUBCOMMITTEE: Aye.
DR. COHN: Now Jeff, did you want to do something about the PMRI letter, do you feel it's in sufficient shape that we can make a similar recommendation?
MR. BLAIR: Well, do we expect to not have a consensus tomorrow? Not a consensus but a quorum? Because if we are then that's a real problem, there's almost no point in going through tomorrow if we can't vote on that.
DR. ZUBELDIA: We'll have five tomorrow.
DR. COHN: Well, Clem will be calling in tomorrow.
MR. BLAIR: Clem will be calling in, Kepa you'll be here and Stan you'll be here? Okay, then that's four, a minimum of four even without Clem.
DR. COHN: Okay, I may be being overly paranoid on that one. Is there anything else coming before the subcommittee today? First of all I want to thank you all for your help, it's been a tough but I think productive day. You'll all being seeing I think cleaned up versions of the ICD-10 letter and I guess also the PMRI letter tomorrow morning first thing. And just to remind you we are starting again tomorrow morning at 8:30, and it will clearly be an abbreviated session tomorrow it being day three. So with that thank you all very much and see you in the morning.
[Whereupon the meeting was recessed at 5:05 p.m. to reconvene the following day, Thursday, October 30, 2003, at 8:30 a.m.]