[This Transcript is Unedited]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Subcommittee on Standards And Security

September 25, 2002

Quality Hotel
1200 North Courthouse Road
Arlington, VA 22201

Proceedings By:
CASET Associates, Ltd.
10201 Lee Highway, 160
Fairfax, VA 22030
(703) 352-0091

P R O C E E D I N G S [1:58 p.m.]

Agenda Item: Welcome and Call to Order - Dr. Cohn

DR. COHN: Good afternoon everyone. I want to call this meeting to order. This is a three hour break-out session of the Subcommittee on Standards and Security of the National Committee of Vital and Health Statistics. I think as you all know, the committee is the main public advisory committee to HHS on health information policy.

I think we've done introductions this morning so I don't think we need repeat them. Obviously I want to welcome the fellow subcommittee members and also remind those that are here that we are still on the internet so make sure to speak slowly and into the microphone so people on the internet can hear you and we can also have a transcript of the proceedings today.

Let me just take a minute to review the agenda and talk about a couple of issues and then we will get into the agenda as well as identifying if there's other issues that need to be addressed during the session today.

Currently we have a couple of issues that we were going to talk about, first has to do with the Administration Simplification Compliance Act, little more than update as well as beginning to talk about next steps for the subcommittee, and I'll apologize to Brady Augustine on this one since I sort of asked him to begin to think about this one, he had requested some conference calls to further delineate this but I think it's an opportunity to at least talk for a couple of minutes about how we might move into this issue of identification of best practices as well as learnings from the compliance extension forms which I guess are coming in now, thousands a day, and likely will become at a greater level between now and then.

The next issue after that is the ICD-10-CM and PCS letter. I'm actually going to suggest that we not focus on -- in the letter at this point but I do think we need to reflect on what the full committee wanted to see happen and how we're going to do this as well as perhaps what we see as sort of the critical issues that they need to be further informed about. Then we can spend a couple of minutes talking through that and figuring out how we're going to create all this stuff as well as what a single or multiple panel sessions might look like in November to sort of deal with all of that.

Well on your agenda is a note about the HCPCS panel report. My understanding is that they were not available for this session today. We will likely be hearing from them coming up there in October, at our November break-out or in December with a variety of responses to issues that we've brought forward to them. In addition, though not on the agenda, Jeff wanted to update everyone on the next PMRI hearing and get input as we begin to fashion that agenda, and of course we'll also be talking about additional dates and all of this.

I will note that there are obviously a number of other issues we are tracking. We are obviously going to talk about alternative health care on the agenda day, we were obviously asked about that this morning and I think maybe I'll ask Kepa to review, perhaps before the ASCA update just the -- what our views of our next steps are or, how would you like to handle that Kepa?

DR. ZUBELDIA: The ASCA update?

DR. COHN: No, the alternative health care.

DR. ZUBELDIA: Any way you want.

DR. COHN: Ok, we will do that after we go through the agenda and all of this. There are still outstanding communications related to dentistry and CDT. I understand there's actually a letter that we've received at the NCHVS that I've not seen in any way at this point, I don't know if there's any additional information there but it is an outstanding issue. We've obviously heard from the DSM and the American Psychiatry Association at our last meeting and the question is what sort of updates relate to that.

I do briefly want to comment that I've had a conversation with Maria Ward who did the DSMO's and their yearly update. I think at this point their preference would be to come in December to present to us an update and that's mostly for your information. In addition I do want to announce that we are going to be polling the committee for hearing dates for the first six months of the year, and the dates that we've identified, and this will be coming out to you by e-mail very shortly, that we're looking for the first hearing for two days, somewhere in the period January 20th to 22nd, or 28th through 31st. These are date ranges that we are going to be querying the committee on. A first hearing in January, looking for two days out of the period either January 20th to 22nd or 28th through 31st. And then we're looking in March, looking for two days again, 18th through 21st or 25th through 28th. Then the third hearing in May, hopefully sometime during the week of May 19th through 23rd. You'll just be getting an e-mail hopefully in the next week to ten days looking at your availability for those period.

Are there any questions or do we have any other agenda items that we need to be discussing at this point? Clem?

DR. MCDONALD: Actually I'm almost afraid to bring this up and I don't know whether it's really an agenda item, but in terms of all these coding systems, it would be nice to know really what economic impact some of the decisions make for the providers, I don't understand the economics of these codes. I'm not talking about what they cost to buy them, but what's the value of having a code system be part of HCPCS. Does that mean you can bill for that thing automatically or is there another decision made for that part and who is decides the pricing?

It would be helpful to understand what the forces are that make people feel so strongly about coding systems, which when you think back about, privacy ok, but we do kind of get all fired up about coding systems and I think there's that dimension that sort of beneath the level that if there'd ever be any time that we could get CMS people to say if you get to this, when does it you get to be paid. Because the other part of that there may be some sort of intrinsic push back from CMS, not deliberately, but the more new procedures we can chart, set new billing fees for, the worse the budget gets, the Medicare payments costs get. Just to understand the big picture at one time might make it easier to sort out what the arguments are about.

DR. COHN: I can address a piece of that though I think maybe having Tom Gustovson(?) come back from CMS might also be very useful. This is just sort my knowledge of procedures codes, which is really what I think you're talking about. Typically the existence of a procedure code is typically sort of a relative gaping factor. It's lucky you can't bill without out it because all code systems have unlisted codes for individual pieces, those are obviously procedures that typically are reviewed by a case by case basis. If you have a code then the question gets to be does somebody pay for it. There is certainly not in HCPCS or CBT or anything else is there a one-to-one correlation to the existence of a code and the willingness of CMS or any other payer to necessarily pay for that.

So for example, when you look at a HCPCS book to be sold by a third party, they will often color-code sets of codes as being some of them are paid, some of them might be, for example for Medicare, at carrier discretion, others are not paid, some of them are paid by third parties, and it gets to be sort of quite a dance of colors as you look through that.

But I do think it would be useful to hear from Tom a little more about the relationship of --.

DR. MCDONALD: Doesn't someone decide what the rates are for each of those codes too? Isn't that HCPCS or CMS?

MR. AUGUSTINE: Medicare pays it's own rates but each payer sets it's own rates typically based upon Medicare but it's up to their discretion.

DR. MCDONALD: You don't get to argue about the rate unless you get a code in.

DR. COHN: Well, it becomes the difference of systematic discussion versus an individual discussion because if it's unlisted I think it's usually a negotiated one-on-one what the rate ought to be.

MR. AUGUSTINE: In the past what typically occurred was they had those local codes that they used. In the -- setting we do that in a lot of occasions, the use of local codes because the payer may require that we use a certain code even though it's not really applicable to the service we provided. So there are a lot of different issues.

DR. ZUBELDIA: Another topic for the agenda for today if we can, I'd like to get an update for where we are with the DSMO addenda process for the addenda to transactions sets and where that it and where it's going.

DR. COHN: Karen would you like to at all start with a, I guess the question is would we like an update or any further updates or questions from Karen was talking about, either ASCA or any other issues we are likely to be talking about today. Any comments or questions?

MS. TRUDEL: No.

Agenda Item: Alternative Health Care Code Sets - Dr. Zubeldia

DR. COHN: In that case, maybe what we should do just sort of as I commented, it probably may make sense before we get to the ASCA discussion, since we were asked about Alternative Link and what we think our next steps, not so much about Alternative Link, but the issue of alternative health care coding. Kepa do you want to talk a little bit about sort of what we see as the steps and process involved?

DR. ZUBELDIA: Well, I'll give you some ideas then we can use those to start the discussion. We heard from Alternative Link which is the code developer. I think we need to hear from other constituents of industry, code users, not just the code developer, and talk about what are they using today, how is that working or not working for them, and we need to explore what the actions are. I think with Alternative Link we have explored some of the issues and some of the options. I'm not sure that the process has worked as well as it could have worked. I think there has been a lot of problems with the relationships and everything, but I think we need to explore where we are. Under HIPAA the secretary adopts voluntary standards. In the past the standards have been standards, -- code set standards that were in use by the industry. Now we have a code set that is relatively new to the industry.

I'm not happy that I have heard that there is extensive use of this code set and we need to explore further what are the options for Alternative Link or for these alternative medicine users, what options they have. What concerns that I have and then I'm just going to dig deep into --, technically, even if there's a new code set, say the DSM codes adopted for psychiatry diagnosis coding. If we were to adopt the DSM today, before the DSM can be used with the transactions, it would have to be put into the implementation guides and for that to happen it has to go through the -- process, the -- process, the Notice for Proposed Rulemaking and a new standard that replaces the existing standards. That's going to take anywhere between three and four and five years for that to happen so I'm not sure that that is the best process to adopt a new code set. It may be the secretary under the Act has the authority to grant some sort of a pilot project or an exception process to test the new standard before its adoption. And maybe the secretary, not the secretary, maybe the alternative medicine people should ask for that kind of process to test this code set and see if it's worth adopting as a standard as not. I'm just throwing out some ideas.

DR. COHN: My understanding is that there's a report coming up from the HCPCS panel. Where does that fit into your thoughts?

DR. ZUBELDIA: My recollection is that six months ago when we heard from alternative medicine, one of the things that I pointed out was that this process with introducing a new code sets and the implementation guides has to go through X-12, through implementation guides, and NPRM, and this process will take three to five years. And at that time I told them that if there is a need for the codes, as an immediate need for the codes, perhaps the CBT or HCPCS codes could accommodate the immediate need while the process of adopting a separate code set as a standard happens. So they could have some of this, at least the immediate need resolve. And if the immediate need is resolved then there's not that much pressure and then the process can wait, the due process of adopting a new standard. But under HIPAA to adopt a new standard, essentially you have to go through that test period before it can be adopted as a new standard, once HIPAA is in place. I think that's where the HCPCS fits. HCPCS, CPT, whatever it fits. I'm not sure what it fits, but if there are a few codes that they need, some codes for chiropractic because they only have two or they need some codes for nurse midwives because maybe they don't have any, whatever codes they need can be put into one of the existing code sets so they can be used today while there is a process to adopt a new code set from scratch. To adopt a new code set from scratch may take a lot of more study. I don't think we've heard enough.

MR. BLAIR: I'm not an expert in this area so I really don't know very much more than what I read in the media but my thinking is that just hearing from the discussion that we've had here and in NCVHS that for the most part we're representatives of a traditional medical industry and when it comes to alternative medicine, in many cases there are practitioners that are not either traditionally part of the medical industry or folks that are doing complementary medicine, where they might have a medical degree plus they may have a degree in either oriental medicine or some other form of complementary medicine.

So I think it would be helpful if because some of the comments that I've been hearing is, is it really needed, I think that it may be helpful if we hear from some of the representatives of these alternative fields about the need and I have a sense, just like many other areas, they feel that there's an urgency for the availability of these codes from the standpoint that one of the frustrations that I'm sensing in the alternative medicine field is that it's been very very difficult to get support for clinical trials from the National Institute of Health and other areas because of the fact that the code sets are not there, so they are in a chicken and egg situation, if they don't have the code sets then there are delays in being able to get the clinical trials to prove whether or not a particular approach, a therapy, a method is effective or not.

So in short, I guess I'm kind of thinking of a different balance in what you're saying Kepa. I think the emphasis should be more on educating us to understand this new area of health care and why what they do and why they need these codes sets, I think that if we put the emphasis on use out there today that the use probably isn't there because they don't have a mandated code set whereas CPT codes, for example, is mandated, everybody has to use them so I'd hate to see us using broad market acceptance as a criteria because I sort of feel like that may not be fair. That's my thoughts on that.

MR. AUGUSTINE: It goes both ways. There definitely is a need because there are payers, for instance Oxford Health Plan pays for some alternative services, to have some codes for them to use. I don't know the specifics by the code set, but Kepa what you mentioned seems like a good interim solution, to include the more urgent of them into some other code set while we work on the process going forward.

DR. ZUBELDIA: Those payers are paying for the services are using some codes today. I don't know what they are using, probably local codes of some sort. If that can be addressed right away while the new code set goes through the process that will give it more wide-spread test environment, if you want, --.

DR. MCDONALD: A comment and sort of maybe a question on one. The issue of these various different codes and I'd like to pick on DSM a little bit because I don't know it as well, I know a little bit about it but not enough. The nice thing about HCPCS is that it's sort of a federation of codes in some way. You've got what are effectively doctor codes are CPT for plus or minus, I may be wrong on the --, there are the dental codes, you've got another string in there you use for going for drugs and there's sort of like designated categories. What would be troubling is if I didn't know which one to use or had to use both in some circumstances, so I guess in the case of DSM was it proposed that that be used for all psychiatric diagnosis so I gotta learn? I'm having enough trouble with the 13 or 14 ICD-9 codes which say this is a depressed person who is depressed frequently and often and not too much at night or, they have a lot of break downs that are funny.

Or would it just be used for psychiatry coding? Because if you have a nice subcategory of who has to use them I think it's easier to say that's what they want to use why not let them use them versus, so I'd just like to know the game a little bit better here. Are we talking about areas and the same as with alternative medicine, would that be for alternative medicine practitioners would use those codes and no one else would have to worry them because otherwise you get into the problem of the same thing instead different ways in both codes and there's a challenge in sorting them out. I guess I would focus on DMS just --.

DR. ZUBELDIA: You are touching a little bit on one of the problems, again, a technical problem that could be resolved. Whereas the CPT codes are five digit numeric, there can be 99,999 of those. The HCPCS codes have one letter and four digit numeric and there can be 260,000 of those. The Alternative Link codes are five positions of a numeric. There can be billions, I don't know many millions, but there can be lots of them. And essentially they cover the entire spectrum and one thing that I requested from Alternative Link last time and I think they got it is make sure that you don't have codes that conflict with existing CPT or HICPIC codes. And once that Alternative Link code set is adopted as a code set it has the potential to collide with all other code sets that have five positions.

DR. MCDONALD: Just as a position?

DR. ZUBELDIA: Just because it's five digits, five positions alpha numeric.

DR. MCDONALD: But you can fix that with a code identifier, that's tough for the industry, but I'd still like to know conceptually, are these mostly carve out codes like the DMS, is that being proposed to replace that chunk of CPT codes that are doing what psychiatric is doing --.

DR. ZUBELDIA: Just carve out and the codes are the same, the codes used by DMS and the codes used by ICD-9 are the same code, it's the description that is different. But the code is identical.

DR. COHN: Is that clarification Jeff?

MR. BLAIR: Yes, because you mentioned collide if they have the same five characters, my thought is wouldn't that mean that they could work in a manner that is compatible?

Not if they have different meanings.

DR. MCDONALD: Could you clarify, are there conceptual collisions or conceptual overlaps as well?

DR. COHN: Between what and what?

DR. ZUBELDAI: From what I've seen in the very brief ten second look at the book I just opened to one page at the last NCVHS meeting, I just happened to go into lab codes, and out of the lab codes I saw on that page most of them were already CPT codes. That's the only chance I've had to look at the codes was that ten seconds.

MS. GREENBERG: Well, I was going to say something about the process related to the alternative medicine codes just since Dr. McDonald brought up this other issue, that certainly in the case of diagnosis there has been a long-standing tradition not to differentiate, the same condition, not to differentiate the code based on who is diagnosing it. So a cardiologist might actually diagnose at a more detailed level so they might you a finer level of detail. If you don't have different codes for heart conditions for cardiologists versus for internists etc., and I think even in procedure codes it's been a effort away from distinguishing, to really focus, from a patient centered point of view, either what is the condition or what is the service, and not distinguishing all sort of different codes based on who the person who is providing it or diagnosing it, but anyway that's for another day.

Related to the alternative medicine codes I think what we've got a situation as Kepa began to lay out where immediate needs are going to have to be met probably through existing code sets given the length of time that it take in order to adopt and implement through the whole rulemaking process a new code set as we've been discussion with replacement for 9-CM, obviously this is not something that can be done very quickly. Then there's the longer term issue of whether an entirely different code set is the only way to rally meet the full needs of the patients and providers and plans, and basically all the people who are interested parties with the services. So I think the first thing we have to do is hear back from the HCPCS panel, that's kind of where we left it and I think, it's my understand that they are doing kind of analysis of overlaps with existing codes and gaps, is that correct? I think what we need to find out first is, because we did talk right before the lunch break about a time line, so let's say the first step is to find out when we can hear back from the HCPCS panel because if there are sufficient gaps then that will to future work by the subcommittee which will probably be as discussed, hearings in which you hear from providers of alternative medicine services and payers and potential payers which is probably going to be needed. Karen can you give us an idea when we think we can get a report from the HCPCS panel?

MS. TRUDEL: I'm afraid I didn't talk to them before I came, so I'm really hesitant to speak for the staff that are doing the paper. I know we had talk about the possibility of having it in October and I don't want to promise if on their behalf. And I have not seen the draft yet.

MS. GREENBERG: So would December seem to be reasonable? So it would seem from a step wise point of view to get that report back from the HCPCS panel at the December and then, from what you described, we're looking at meetings in January, February and March.

DR. COHN: January, March and May, let's not make it any worse than it is -- January, March and May, assuming the availability --.

MS. GREENBERG: There was nothing in February?

DR. COHN: There's a full committee meeting.

MS. GREENBERG: So then I would think based on what comes back from the HCPCS panel, something could be hearings, getting testimony from the industry could be potentially for January or at the latest the March meeting. Does that seem reasonable?

DR. COHN: I'm obviously -- sitting back here. I apologize, your back is to me so I can't see you standing up there and they want to speak.

MS. MALINA: Cynthia Malina, CEO of Alternative Link. I'm not sure exactly where to begin on this so I'll just start by addressing Clem's question earlier about what the role of codes are, how codes function, and I think ultimately where I'm going is I think it would be more beneficial for the subcommittee to develop a set of criteria and a timeline for evaluating the code sets then the way this comes across from the perspective is getting sort of incremental assignments that don't necessarily relate to the big picture and not having a clear sense of what's been decided or by whom or on what timeframe against what criteria.

So I think ultimately where I'm going with my comments, it would be beneficial to have criteria established on the basis of which the subcommittee makes a decision about whether a new code set is needed or not needed and then systematically assess the ABC codes against those criteria with well identified decision makers, with a well identified process, in a timeframe, in a stated timeframe, so we can actually get a result that would be helpful to the marketplace. I know that the subcommittee is doing the best it can and this is a new area, it's not something the industry has been faced with before and I do think we need to just take one step back and try to think through the big issues here, get them on the table and then move forward instead sort of opportunistically moving ahead as we are.

In terms of Clem's question, in other industries, and I'm thinking in particular of the grocery industry, because I think they do a particularly good job in coding, codes are established by a uniform code council. It's a very unbiased, broadly represented group of individuals. When a new product is developed, this council assigns a code, there is no technology assessment or evaluation made of the quality of the product, it's merely coded, a bar code is assigned to it, the manufacturer has the bar code, and that bar code can be used through sort of universal technologies that are placed strategically throughout the supply chain in the grocery industry from the manufacturers all the way to the grocery store shelves.

DR. MCDONALD: Just to clarify, are you talking about UPC codes?

MS. MALINA: Yes, sir. Now there is a fundamental difference and, in my view, a challenge between the way codes are developed in that industry and in most industries, frankly, and the way they are developed in the health care industry. The purpose of codes is to support research, supply chain management and electronic transactions, those are the three basic areas of function for codes. Research, supply chain and electronic transactions. So the only way to have pure research about who is buying what and what works and what’s cost effective and what's not is to get unbiased assignment of codes to the products and services that are delivered.

The analogy that I think is very helpful is to think about if in the grocery industry, there was an American Food Association that controlled the issuance of coding, if it wanted to ensure that only American foods were on the shelves of grocery stores, all it would need to do is either slow down or miscode or in any way manipulate the coding of international foods, Mexican food, Asian food, Chinese food, French food, Italian food. So we have in the health industry, unfortunately, the potential for that kind of bias in code assignment and the fact is, that whoever controls coding, controls the health information infrastructure in the country and controls what the data that can be collected in support or opposition to different interventions.

Right now the codes that are developed by the American Medical Association, they evolved in a very rational way, I don't think there was any malicious intent on the part of the AMA, there was a need for coding and at the same time there was a need for pure scientific coding there was a need for a technology assessment function to make sure that products and services that were coded were safe and effective, that they were not going to harm the public. Since that time, there have evolved in most insurance organizations and most integrated delivery networks and other places technology assessment functions that are freestanding so there's no longer a need for an organization like the American Medical Association to be issuing codes with a technology assessment function. In my view what the country needs right now is coding that represents all alternatives, conventional, complementary, alternative, nursing interventions, so that there can be scientific data compiling, and data warehousing and data evaluation to determine what is truly cost effective medically necessary health promoting, etc.

The reason I bring this up is I don't hear this sort of criteria or these issues being addressed as directly as I think would benefit public health in this circumstance. I think there are several sort of gate-keeping questions and one of the first questions is, is the way coding is done in health care the most appropriate in support of public health? And my answer to that question would be no, it's not, because codes are assigned with a bias.

The second question would be are there tools available today to rectify that situation and are those the ideal tools? And the answer is the tools are available and they are not the ideal tools because they are not as well integrated as they should be.

And the third question would be, how best can we get to the ideal circumstance which would be an integrated code set? And in my view, those are the real gate-keeping questions that we ought to be evaluating when we're looking at the alternative medicine codes.

Our organization has been repeatedly approached by major health plans and payers of union organizations, there's increasing demand for complementary and alternative medicine among unions, particularly in the aerospace and airline industries. We've been approached by an academic consortia that represents the 12 leading medical schools with complementary and alternative medicine programs. We have pilot programs that have been in place for years, the University of California San Francisco uses the codes, the codes are used in a pilot program in New Mexico that spans the entire supply chain. There are Medicare patients involved in that supply chain and it's elsewhere as well. I feel like we're not having the opportunity to present systematically what's going on with these codes.

We have three books which I'm holding in my hand that have been published for years now. One of them is a complete CAAM(?) in Nursing Manual, it has over 4,000 interventions that are not adequately coded today. Another is a State Legal Guide to CAAM in Nursing, the laws around alternative medicine are different from the laws around conventional medicine, so code set functionality has to be different to support that particular legal difference. And we have Relative Values for CAMM in Nursing. Now in my view it is just unjustifiable --

MR. BLAIR: CAAM being complementary and alternative medicine. When you say CAAM?

MS. MALINA: Yes, complementary and alternative medicine and actually there are many many nursing codes in here as well, nursing has not been adequately coded either. In my view it's tragic that there would be resources, these measurement tools around for years, literally years, and blocked from use because we don't have a systematic way of evaluating their relevance. I think the first step for this subcommittee is to really think about how we're going to evaluate the relevance of these codes. If that is beyond the scope of the subcommittee then that's something that can be taken up on the Hill or elsewhere and that's, it's not a challenge, it's just something I think we haven't taken full responsibility for coming to terms with.

Now we did go back and do a cross walk between the codes, the ABC codes and the HCPCS level one and two codes, and I have the results here. They suggest there are 4,222 codes that are the in books, 1992 are herbs and botanicals and 2230 are service and procedure codes. We focused only on the service and procedures codes. I should mention that the ability to track botanicals and herbals is going to make a significant difference to public health because there is currently no way to track that and it's a problem that has been noted by other areas of health and human services.

But among the codes that were reviewed, 94 had terms and meanings that were essentially the same as terms and meanings for the same procedure in CPT or HCPCS level two. That's 4.22 percent. 201 are similar to CPT and the meaning is pretty much the same and that's 9.01 percent. 338, the terms in the ABC codes are similar to CPT or HCPCS, but the action is different and therefore the meaning is different, that's 15.16 percent. 754, the terms are similar but the context is not the same and therefore the meaning is different, 33.81 percent. 510, the closest CPT or HCPCS level two cross walk is to an unlisted procedure, 22.87 percent and then 333 codes, no valid cross walk exists, 14.93 percent.

So the vast majority of the codes that have been identified have value in scientific evaluation of the economic and health outcomes of care that can not be captured in existing code systems.

We have a challenge in my view, the key challenge, I had a mentor who used to break up issues into one of three basic categories. He'd say it's either an economic issue, it's a political issue or it's a moral issue. If it's a moral issue the answer is do the right thing. If it's an economic decision, the answer is do the thing that saves the most money or makes the most money, and if it's a political decision, make the decision that makes the person in power or the greatest people in power, greatest number of people happy. So we have on our hands the opportunity to evaluate this circumstance and say is this an economic issue, is it a moral issue, or is it a political issue. And I think we have to make that decision moving forward.

In my view this is a moral issue. We have a whole area of health care, approximately 629 million visits to CAAM practitioners versus 386 million to primary care practitioners in 1999, so many more visits than to primary care practitioners that are completely unstudied because of the lack of coding. We've visited a major -- and we found that when they're trying to evaluate what's effective and not effective for their populations they're looking at the very last conventional medicine intervention that was delivered and they are assuming that if the patient did not go back into the system after that last intervention then that was the one that worked. But CAAM is often an intervention of last resort so there may be much lower cost interventions that are being delivered that are working for individuals throughout the country that we have no data on whatsoever. We could be paying tremendously more.

Now I'll stop my comments there. I know the subcommittee has been very indulgent with me and I appreciate that indulgence. I'm just pleading with you to please look at the entire picture and approach this in a systematic way with defined criteria with a defined process with defined decision makers and established timeframes and please give this the legitimate scientific appropriate review that it deserves. Thank you.

DR. COHN: Thank you. Anybody have a question or comment?

MR. AUGUSTINE: Maybe I missed something, but I thought that we were kind of on that same track. We believe in the value of the codes, being a researcher myself you kind of have to separate out what's good for a data perspective and what's good for reimbursement. We need to gather information on these services, that's true, and just kind of set aside that whole reimbursement issue, and I think what Kepa described is an acceptance of the fact that we know that we're going to need to reflect a lot of these and what is the best solution we --. I don't think there's anything more we can do than what Kepa described.

DR. MCDONALD: Well, there's an awful lot of information there and I appreciate that. I think we still don't understand as much about this as we should and if I could be really, I guess I'll just be blunt because I often am, I think there's some concern is that, in my head, the nursing thing I can understand, but how is in there and how much is it are things that we, the snake oil, I'm not accusing anything, I'm not asking for an answer, I think we should probably -- that summary was really nice and if we could get sort of some details and that's sort of a concern, you use scientific in a way that I don't, I just want to clarify that and also to that there's no requirement to have a ICD-9 code or a CPT code or any kind of code to do an NIH study. Never has been, never will be. All drug studies are done without CPT codes, so that the experimental part, there's a whole NIH institute now that's dedicated to alternative medicine so I think that's not the kind of research that we're talking about, the clinical trials, the comparison, we're talking about post hoc analysis which is horrible and hard to figure out in all circumstances, it's really hard to tell because of the selection biases just by seeing who went where what came out well.

It's a great area of research to figure out how to do that, but I don't think anybody's confident you get a really high likelihood out of that. And I think the NIH Institute will be very helpful in clarifying some of these things and I'm sure we're going to discover things that are very helpful. We're always surprised by the simple things that work so well.

The third thing was the UPC code, we have in medicine just like it, identical NDC code, exactly the same principle, the manufacturer gets a code and he gets to make up anything he wants in the tail of that, which is good for identifying supplies and inventory but it's bad for making comparisons across supplies because I can't tell what's a toothbrush across ten manufacturers. So just to make that clarification.

And that I think is the biggest issue I think in terms of the conceptual spaces, how do we make it so that when we do look at the whole set of whatever these codes end up being, and HCPCS is much bigger than AMA, when we look at this how do we know that we're looking at two different toothbrushes, so the challenge of integration is high and so to say whatever the code system is, ABC or it's someone else's code system, and say you now have free rights to make up codes for this space, who worries about the overlap and the collisions and I think that's kind of what -- so I don't have an answer to that but I think we'd love to see more details and really understand what these are and I think we probably have wrong ideas about what they are, what's the subject matter of these codes. Actually having one of those books would probably be good but they're pretty heavy.

DR. COHN: I'm sure she'd probably be happy to give you one.

DR. MCDONALD: I'd like one. Actually one more thing, in terms of the nursing space, we may do more good for quality in health care if we got the economics of nursing improved than anything else we could do. These are kind of techniques that sometimes may help that too.

MR. AUGUSTINE: I personally think there's a lot of parts of health care we're just now becoming to understand, the continuity of care issue like behavioral health in the primary care setting. Patients are 30 percent more likely to see their PCP if they are depressed if not, so they are really pushing in -- and JACO(?) and others of getting those integrated. I think you may see some of the same issues with alternative and complementary medicine in the sense that a lot of elderly that I see, living in South Florida I see a lot of the elderly, I believe that if they have like some type of basic alternative therapy like a massage or something once a month and it was paid for, you'd actually see them less in the physicians office. Things like that we may be able to understand better from a utilization perspective, there wouldn't be a clinical trial, but things like that we need to start looking into, so that services are over utilized or inappropriate services are utilized.

MR. BLAIR: One piece, I don't know if you could help me with this question or not Malina, Cythina, Malina Gianini(?) represented Alternative Link for a while so I key on that same name. I think because ABC has alternative billing codes I was originally thinking of these as part of reimbursement code sets which would fall into the HIPAA financial transaction standards code sets. When we had testimony August 28th, I guess it was Susan Bochan(?) who included alternative billing codes, Alternative Link billing codes, as one of those she recommended that we consider as a candidate under the PRMI terminology's. Maybe they have to be considered in both areas. Do you have any suggestions for us or thoughts as to whether they should be in both domains or one domain or the other?

MS. MALINA: My impression is that they should be in both domains. I think a pure code set if it's properly designed from the ground up will serve that entire realm from research to supply chain management to electronic transaction support, so a code should have functionality in all three areas if properly designed. Other industries have been able to achieve that, there's no reason why health care couldn't.

DR. COHN: Cynthia, thank you very much. Let me try to put this together a little bit. I am certainly reminded as we are talking that at least to my knowledge there's actually a National Institute of Health that's devoted to research and other things related to complementary and alternative medicine. So certainly if we have issues around research we would, with whatever hearing we do, we would like to hear from them. I'm sure it's -- and I'm just trying to put this together that obviously we need more information, obviously waiting to hear from HCPCS national panel, certainly our view of the world may be a little different than that of groceries or other aspects in manufacturing, just in the sense that we, for whatever reason, the history of coding and health care has tended to focus more on certain higher level classifications and code sets that have to do with payment or other things like this, that are involved in electronic transactions and then more clinical codes which I think is what Jeff was alluding to in where does this fit. I personally don't have enough knowledge at this point to say and I think that's part of the evaluation and I think we need to be hearing from providers of the service as well as potential payers of the service and additionally people who are trying to do research on the service to get a better idea of really where this all fits and what the opinions of the committee might be. I think the first step is still to hear from the national panel but is this the sort of hearing that people might be talking about for later on? Brady and then Jeff.

MR. AUGUSTINE: I just want to make a quick comment. Adding to what you said I think one of the reason we had these issues is because our code sets typically have been the treatment of illness and conditions as opposed to the treatment for health which is something that we're looking at into the future, but there's a transition there that we're, that's what we're going through.

DR. COHN: And certainly the codes exist as for treatments that don't have anything to do with the disease, more prevention than disease. Jeff did you have a comment?

MR. BLAIR: I support the list that you just listed. I just wanted to add one additional group among the providers is those folks in the complementary medicine scope, those medical doctors that are also certified in alternative medicine as well and are using both. I think that may be as helpful to us as those that are exclusively alternative.

MS. MALINA: I have a very quick request which is that the subcommittee consider Kepa's point about granting an exception for a demonstration project for this area so that we can bring people to the table.

DR. ZUBELDIA: The subcommittee doesn't grant an exception.

MS. MALINA: Recommendation, I apologize.

DR. ZUBELDIA: Based on a request for an exception so any code set can be tested, based on that request the subcommittee will make a recommendation to the secretary. We can't say we recommend an exception be granted without having the request and without all the information that we would need to make that kind of a decision.

DR. COHN: I think this process we're talking about will lead us to some place at the end. So anyway maybe we can move onto the next item. Clem is there something really important that you have to say here?

DR. MCDONALD: You're asking? I guess not.

[Laughter.]

DR. COHN: I think we needed to talk about next steps and I think we've clarified them at this point.

DR. MCDONALD: I can't help this, this is not the thing I was going to do. But I think what would be helpful with the Alternative Link group is to understand what's the request. Is the request a carte blanche to just have this be added in or is it to deal with the issue of integration?

DC. COHN: Clem, I would actually suggest we go a step before that which is let's understand what the community needs first. If we're dealing with this issue we really need to understand what the various users, providers, payers in this whole domain need and then we can begin to sort of ask that question.

DR. MCDONALD: I don't want to talk any more about it.

DR. COHN: Thank you. Karen thank you for being a time keeper on this one. So, should we talk about ASCA for a couple of minutes?

Agenda Item - ASCA - Ms. Trudel

MS. TRUDEL: As I mentioned this morning we are getting many many more compliance plans in and we're fast approaching the mid-October timeframe. We need to really start to solidify some thoughts about what kinds of analysis you'd like us to begin to do and what kind of results you're looking for and without some kind of specifics that you want me to begin to look at it would be just a matter of kind of going through a lot of correlation analysis to see if this affects this or if it appears to. I'd just like to kind of start to talk about that a little bit.

DR. COHN: That's a good idea. I think there are two pieces. Once is analyzing the data and two is obviously our other part of the responsibility is to identify and begin to recommend best practices as we identify what the issues are.

MR. AUGUSTINE: Just understand where we're at, what are best practices, how we bridge the gap for everyone. We need to have a talk, well what we have talked about previously is maybe we can sketch out some ideas, share them and maybe have a call and kind of flesh it out a little bit better.

DR. COHN: It appears to me there are sort of two pieces and one is certainly we can take a look at how we might go about analyzing that, but the other question is how, and maybe it's premature for us to figure out what we need to have in terms of best practices until we've seen the data. I'm already sort of thinking ahead to who do we need to begin to talk to around these best practices.

MR. AUGUSTINE: These actually parallel, you could do both at the same time.

DR. COHN: So it might be, for example, appropriate in October, we have obviously not seen maybe SNIP for a while, there are very involved overall in the implementation, the question might be as we begin to have a discussion with them and others to see how we sort of begin to link up around best practices and what sort of best practices do they feel comfortable recommending that we ought to be linking or pointing people to or whatever.

MR. AUGUSTINE: Is this paper to be published by NCVHS or CMS or what is the direction?

DR. COHN: You mean best practices?

MR. AUGUSTINE: What was in the statute.

MS. TRUDEL: What the statute says is that the NCVHS would, I'm not sure which they used, publish, disseminate or recommend, best practices. We, in talking about it initially sort of concluded that that could mean almost anything and that it very particularly could include white papers on the NCVHS web-site, which I think is, if that's done then I'm sure the WETE-SNIP(?) organization would link to it or whatever. There would be others who would pick up any recommendations that the committee made.

DR. COHN: Comments Marjorie?

MS. GREENBERG: Now that there really are coming in and I guess to two things. First, from the point of view of analysis it would seem the most critical information would be what people are reporting are their reasons for requesting the delay. So what their problems are. And see if there is some way, a place that they could indicate if they are going to have problems even making the June deadline or only why they aren't able to make the current deadline.

MS. TRUDEL: Why they aren't able to make the current deadline.

MR. AUGUSTINE: Another question is not included, whether or not they're going to be able to make the later deadline.

MS. TRUDEL: My guess would be that Congress assumed that having given everyone an additional year they would all make the deadline.

MS. GREENBERG: There is a question, I think they do have to lay out a schedule or something, will they be testing by certain dates, I guess a few of those would need to be analyzed to see where then you want to focus the best practices. From what you reported about six percent of them I guess at this point are paper? 13,000 out of 200,000? Is that what you said?

MS. TRUDEL: Actually it's less than that. At that point I had statistics that were a few days old. We now have more than 200,000 electronic plus the 13,000 paper, so it's maybe five percent.

MS. GREENBERG: So I guess I'd ask Brady what his thinking is as needs to be done with those because the ones that are electronic you can to some cross tabs or analysis or whatever would be easier.

MR. AUGUSTINE: We need to update the sampling plan for the paper so if you can this week send me the most recent information on submissions so far, paper versus electronic, I will update that and we'll use that as our guide for sampling.

DR. COHN: Kepa you had a comment?

DR. ZUBELDIA: It was just a remark, it seems like either on electronic submissions of claims to Medicare you get around 94 percent electronic and six percent paper where ASCA filings you get 94 percent electronic and six percent paper.

DR. MCDONALD: I just wonder, looking at what you've seen, is there any sense that there is anything more than perfunctory content? I would guess that people are going to go, I'm just going to whatever, the simplest way to get it done I'm going to do it, so the question I have is whether there is any real content in there except they are saying what they had to say to get that year.

MS. TRUDEL: We haven't done any really in-depth analysis to see if people just made up dates. If the dates don't flow.

DR. MCDONALD: I didn't mean that. When you look at it, are they all looking like the same guy wrote it? That's what I would guess, they have to get it done, they want the extra year no matter what --.

DR. COHN: Most of it is check boxes, so --.

MS. TRUDEL: It's all going to look very similar, check boxes and dates, it's really hard to tell.

MR. AUGUSTINE: What are the thoughts about teaming with WETE-SNIP on like a white paper, something of that nature, that includes all of this information?

DR. COHN: A single white paper with all the best practices?

MR. AUGUSTINE: No, no, no, just some best practices, some examples of what people have done that have worked, what kind of process did they use and what not and also maybe some analysis in looking at how to bridge the gap, or what people did to bridge the gap.

DR. ZUBELDIA: I think that would be very possible because within the WETE-SNIP group you have people that have gone through implementation and they have real hands on experience with what's happened, and there's payers, providers, vendors, there's everything there.

DR. COHN: So Brady, just to restate what you're saying is that we should ask WETE-SNIP to come and sort of share with us if they have any white papers that were linked to, that are compilations of the best practices, case studies, of successful practices in all of this. These may be things that we need to review and if appropriate we can then sort of send out points to whatever.

DR. ZUBELDIA: Some of the original SNIP and affiliate groups have identified specific problems that they are addressing in their region and that may be also very useful feedback for us.

DR. COHN: Is there anyone else other than WETE-SNIP that we should be talking to about this?

DR. ZUBELDIA: There's two more surveys that are done periodically, one by the Governor Group, they took a control group at the very beginning of this process and they have periodically surveyed the same population and then there is a survey done by Phoenix Health that is a random group, not even random, they just post a web-page and say, come here and check this out and answer these questions, but they do get a lot of traffic. Of course the people that go to that survey are mostly people that are very involved with HIPAA so they are aware of the Phoenix Health web-site and so on.

MS. GREENBERG: This might just naturally happen anyway, but in communicating with WETE-SNIP I think it's very important to think also to reach out and get input from the regional groups that, I don't know, have actually that are associated with regional groups, but I know in Massachusetts, the Massachusetts Health Data Consortium has been very active and we heard about them in both the relationship to privacy and transactions and there are groups in different parts of the country, we want to get, they are the most likely ones to actually identify best practices and have worked with groups because they are more on the ground.

MS. BEBEE: I had mentioned this before, at X-12 they have an implementation group that meets through the guidance and leadership of Jan Root(?) where different states, providers, whether they are large providers, small providers, talk about the implementation of HIPAA and that might be a place to pull from.

DR. ZUBELDIA: They are not going to meet in Miami this time.

DR. COHN: They are or they are not?

DR. ZUBELDIA: They are not. Jan sent us an e-mail last week saying that she hasn't had time to prepare it and they will not meet in Miami.

MS. GREENBERG: I would think to be most helpful we would want to get this information out soon.

DR. COHN: As well as identify -- you know what I'm going to suggest and I'm sort of listening here, the second day of our October hearings, it may make sense to sort of try to do two things, I'm not quite -- but sort of overlapping, I think it's been a couple of months now and probably longer than that since we've talked to people about the status of implementation and I know everybody has been focused on just getting the compliance delays, all that did was give you another year, you still have to be dealing with implementation and it might make sense to hear from people that have a broad view of where we are with implementation and that may be the -- Group might be one group in all of this as well the issues that they are seeing as the implementation goes forward. It may be time to ask them if they can come in and update us and with that, it might be useful perhaps as another panel to talk to people about sort of best practices for problems that are both, we've got multiple sources to identify issues related to implementation, it isn't only that, the compliance forms that should guide us, so if we find out from them a little more about what they see is going on and what issues they see as problems that the industry is having it will allow us to have a more informed conversation with WETE-SNIP and others about what sort of best practice documents they are looking at, maybe it's a first panel and a second panel on the same day. Does that, Karen is that something that you can help us with, put together, does this sort of make sense to everybody as a second day discussion in October? It feels like it's about time. We'll have some off-line discussion about that.

DR. ZUBELDIA: Are we going to have DSMO talking about that, too, or you want clearing houses and actual implementers talking about it?

DR. COHN: I don't this is so much a DSMO discussion. I think they will come in December and if we're hearing about issues related to more the bedrock issues --.

DR. ZUBELDIA: One of the issues that is coming up constantly with implementation is the flexibility of implementation. Where there is multiple ways to interpret the requirements of the implementation guides. DSMO is addressing some of that, X-12 is addressing some of it, but that's probably one of the things that is in everybody's mind.

DR. COHN: Why don't we hear that in October and when we talk to the DSMO's in December we can ask more about it, fact-finding in preparation, that's the perfect one-two punch. Why don't we take a short break, like a five minutes break, and then we'll let Jeff lead off and then we’ll get into ICD-10 next steps.

[Brief recess.]

Agenda Item: ICD-10 - Dr. Cohn

DR. COHN: Ok, during the break out staff actually asked us if we would deal with the ICD-10 first before talking about the October hearing just because of time issues and all of that. The good news is is that I don't really want to have a discussion with everyone around the issues again. I think what we want to do is to make sure we are all agreed around a process for meeting the needs of the full committee, and probably as a by-product of having us all get a lot clearer about all of the issues that we've been arguing back and forth and about what those are and the pros and cons on each. I think what the committee asked was actually very reasonable.

I think rather than spend time having us wordsmith the document any further what they want us to do is go through and identify the contentious issues and pull them out and create some background as well as pros and cons around those issues. Is that what everyone else heard too? And hopefully something short, this was not meant to be the 80-page document, because we know what the full committee will do on that one, we are talking about a bulleted, concise, really identifying the key issues in all of that. What I was proposing to do was to ask one of our staff to sort of help us with a very first draft. I had actually already asked Donna Pickett so she's not surprised by all of this stuff, but to begin to put something together for us that we could begin to review via e-mail to identify that indeed we had pulled out all of what we thought were the contentious issues. And the reality is there aren't that many but there are probably five or ten. Yes?

MS. GREENBERG: I think they need a little background also which I think Donna has been working on but before we get to the contentious issues I think, I don't think we should assume anything at this point. We need a little background as to what these classifications are, what they are used for, what the current status is, maybe pull a little bit out of the letters to what we've heard and then you can get into the issues. I think they need that --.

DR. COHN: That's true, but I think we're also planning during the meeting to also give them some background, too, you're right, whatever it is, I'm actually just sort of thinking we need to do and you're absolutely right, Donna if you have some background material we can all agree to that would be great.

MS. TRUDEL: I seem to recall at the very first hearing there was a really good presentation by 3M that did a factual, this is what 9 looks like this is what 10 look like, this is how long it is, this is how it's constructed --.

DR. COHN: About PCS?

MS. TRUDEL: Right, no I think they did both. My only point was whoever did it that we have a couple of really good basic presentations that we could just put in a book.

MS. GREENBERG: A little summary from them might be helpful to.

DR. COHN: Ok, so we've moved up to background and then contentious issues, a little background on the issues and the pros and cons.

DR. MCDONALD: I have an important question. I heard what they said slightly differently. I heard that number one is they didn't say we shouldn't do a letter, they just said they didn't want to discuss it at that point in time and I think we should at some time finish just a couple things we could argue about and we could get a letter done. The second thing is I heard them say have two members of the committee present as a pro and a con.

DR. COHN: No, that's not what I heard. What I heard was is that they wanted members of the committee to reflect on the pros and cons of the particularly contentious issues.

MR. AUGUSTINE: They had originally talked about getting a panel with two people pro, two people con and then we talked about it a little bit and decided that the subcommittee members would present the pros and cons.

DR. MCDONALD: That's what I heard but I heard the subcommittee, I thought I still heard two subcommittee members and the pros and the cons and I assigned that in my mind, one committee member pro, one con, well, I would volunteer to do it a con --.

MS. GREENBERG: On both diagnoses and procedures?

DR. COHN: I think we need to do a little more distillation here before we --.

DR. MCDONALD: I'm not fiercely con I just want to clarify that, but just to clarify the issues and try to dig out these issues about where we're really going.

MR. BLAIR: Clem, I'm always I guess a mediator here in a sense. What if they go forward with developing the background and the issues, review it with you, and if they don't have the cons clearly reflected in the issues, then you can get up in the meeting and wind up indicating that there's one other thing, or two other things that need to be considered that aren't reflected in the issue.

DR. ZUBELDIA: I think we need to do all of the above. We need to have a document for people to read before the next meeting and we need to have a presentation with Power Point for Clem and somebody else to present with a presentation of essentially the same sort of material but it gives you a lot more freedom to speak about it then just presenting it in writing.

MR. AUGUSTINE: Do you think it's valuable for them to get the letters that have been submitted to the subcommittee and maybe the GAO report? That would be kind of for their reference if they want to read.

DR. MCDONALD: The letters aren't that long, the GAO report is.

MS. PICKETT: If you go back to the hearings in April and May and August, then it starts to get to be quite a lot of documents.

DR. COHN: Let's take a look at the letters and see if we should put them all in or whether we take out some essential developments.

DR. ZUBELDIA: I think that's what they're asking us to do, to distill information from the letters and the testimony, rather than giving --.

MR. BLAIR: Could I suggest that if we go forward with the background, if we go forward with the issues, that we really make an extra effort to make sure that Clem is satisfied that the pros and cons are properly reflected in the issues. I think that that would simplify things for them to digest because I don't think they want an in-depth immersion in this, they just want a comfort level and then I think would be satisfied in deferring to the subcommittee with our decision. Clem, do you feel like that's ok or not?

DR. MCDONALD: I could do it in five minutes. The thing is, the issue isn't whether we should take this action or not, the issue is I think they need to understand the big space. I'd like to understand the big space, I still don't quite understand it in terms of what are these forces pulling all these different ways? I think it's important because the main thing is -- this is what I'm going to say -- we got this set of codes that's used for professional billing now and it's the same set of codes but we do it twice in the hospital and the one set is really crummy and so we're going to replace them instead of just throwing them away, that's really my question.

DR. COHN: I think that that's a --.

DR. MCDONALD: It's a lot easier to throw them away, now there's another issues, and I don't know what those all are, we've got to expose them that maybe make it a reason why we don't because maybe the other code is really crummy too and we really want a new one. One last thing is if there is someone in CMS could get me those other documents about the studies I never got I might be a little more comfortable.

MS. PICKETT: Clem in the background materials that I've been preparing I've actually included some of that information about the other studies that they've done but if you'd like to see the actual reports I have copies that we could distribute to the full committee. But in terms of the background documents, I am including the number of records used in each phase of the testing of PCS. The background document also includes a lot of historical information about dating backing to 1986 when the discussions regarding single procedure coding systems first began --.

DR. MCDONALD: I just want to make sure I know everything that is really there so that I'm not saying something out of ignorance.

MS. PICKETT: The background document contains a lot of that information now, it's still needs to be expanded upon but we do go back pretty far in the historical events so that everyone has a better understanding of how we got to sort of where we are now and the fact that certain things were developed based on criteria developed by NCVHS back in 1993, so that information is included in the background document and that Vol. 3 and CPT were considered by the national committee to be structurally problematic for use as a single procedure coding system and that was kind of reaffirmed in 1986, 1990, 1993 and in 1995, so the committee has been on record regarding the historical problems of Vol. 3 and CPT as a single procedure coding system for a very long time.

Again, I've included all of that information in the background document and would share drafts with everyone before finalizing it to make sure that whatever outstanding questions you may have, perhaps I need to add a little more detail to the document, but I'm trying to keep it bullet points and by year so there is a logical progression.

DR. COHN: I was going to say I do agree with those who think that the GAO document, even though others may not read it, is a very interesting slice on all this and I certainly, I was concerned when I didn't see a recent document by the Government Accounting Office in the packet that was referencing what we were talking about and I'd certainly like to see it on, I'm not sure I agree with all aspects of it, but I did think it was a very interesting slice on things. We can decide at some point if we need to have anybody from them giving us information depending on how long this extends, this continues on.

Now I guess my thought on all this was, we're not sending Donna or Simon or Kepa or anyone off into the wilderness to do this and show up in November. What I was trying to do was to get some agreement that these are sort of the essential pieces of documentation that we needed to create with the idea being that we would review them at our October meeting which you know is not that far away from now.

Knowing that it's not going to be perfect, hopefully we'll be able to see them in e-mail and I would ask all of you to when I type something important across the top please review it and get back to us so that maybe we can have done one revision by the time we get together. I think this is going to be helpful for us, too, because we've spent hours arguing about things but then a day later we sort of change our minds and go back again. Seeing them as the issues and getting some clarity about them might help us all work on a letter and do it, rather than trying to work on the letter on the side, let's get clarity on the issues first. Now is everybody ok with that? Marjorie is there anything else?

MS. GREENBERG: Well, I just want to mention a few things from the point of view of timing. Until a few days ago, actually neither Donna nor I expected to be at the October meeting. It turns out now we will be at the October meeting. We'll be out of the country the two weeks prior to the October meeting, we're leaving in less than two weeks for this annual WHO meeting, it may be difficult for Donna to have a lot prepared in time for that October meeting since we get back on like Sunday and the meeting is on Tuesday. You've already made a fair amount of progress.

DR. COHN: We've agonized over them for so long they are pretty obvious.

MS. GREENBERG: She's not in a position to spend the full next month on it.

DR. COHN: I think that's understandable.

MS. GREENBERG: The other thing is that one concern that I have is that we not, you might say what's two months, you just lose two months completely, but I would rather that not be the case that we end up at that November meeting, which I guess is about two months away, with people saying oh, well it sounds like we really need this cost benefit study or really need to look at whether CPT can be used in the in-patient environment, those seem to be two big issues that at least external people have brought forward, it may be that those, the way the committee has recommended, started to recommend, in this letter is reinforced by everything that's been presented, but I'm just putting on the table, is there anything that we should be doing in the next two months other than what we've just described?

DR. COHN: Well sure if you want to look at the cost benefit analysis, that would be great. If you want to do the first step and that way we can decide whether what needs to happen next.

MS. GREENBERG: Well, one question is, the department could start its work to the extent that resources are available, but is there anything that the subcommittee might want to commission or get started that, analysis of any of these issues by a consultant or --?

DR. ZUBELDIA: Referring to what Jim mentioned that the subcommittee or the committee could have the possibility of -- cost benefit analysis without the NPRM just say work product of the committee or consultants or --?

MS. GREENBERG: Well, in order to have let's say a cost benefit analysis that gets full input after it's laid out, you get input putting it together but then after it's laid out to get input back from all stakeholders, it has to be an NPRM. The subcommittee wouldn't substitute for that process. The subcommittee could contribute to the cost benefit impact analysis that the department would develop for an NPRM by commissioning some work. It's a possibility.

DR. ZUBELDIA: Is it possible to contract with somebody?

DR. COHN: I think this would have to be a consultant.

DR. ZUBELDIA: To have that cost benefit analysis prepared by a consultant published in our web-site as some sort of NCVHS document and people will be free to comment on it if they want to comment on it?

MS. GREENBERG: Well, I'll ask Karen whether she thinks any of this would be helpful or whether she will just let this wait and see what comes out of the November meeting. It's just that I know if we were going to do anything like this it does take some time to find someone, to define the scope of what you want done, find someone to do it, get the process underway to engage them to do it, etc., and my preference is not to lose two months if that's what we end up deciding to do, of course, hindsight is always better than foresight. I'm just putting that on the table.

MS. TRUDEL: I think at least the fact finding or a survey design or some kind of structure around what an analysis would look like and who would need to be involved in it, who would need to be contacted, that would be helpful, and that could take almost the whole two months.

MS. GREENBERG: So it might be helpful to have a consultant, and also looking at, because we talked about how do you really, how would you try to quantify or at least explicate the benefits, the risks of not, the costs of not making changes versus the cost, maybe even getting some additional information of what the costs were to other countries that have implemented, that have replaced their versions of ICD-9, there are a lot of different things which could be productively done maybe towards that end. Maybe we could find someone who could do it.

MS. TRUDEL: Could I clarify, are we talking about CM, PCS, or both?

MS. GREENBERG: I guess both I was thinking.

DR. ZUBELDIA: I would like to address both separate, but address both.

MS. TRUDEL: Both separately together?

DR. ZUBELDIA: Yes, there you go.

MS. GREENBERG: I think you have to be clear which one you are talking about but probably either one does have costs and benefits.

MR. AUGUSTINE: I think we haven't made that distinction of it sometimes in the past because I don't want CM to get dragged down by PCS because there's really no contention on CM except on time and when it should be implemented by, and cost.

DR. COHN: I'm sort of looking around at everybody and my mouth is a little bit open here only because I've been trying to reflect and recommend a cost benefit study as opposed to us undertaking it ourselves, but certainly if, it's certainly not impossible unless we have good consulting and support to do all of this stuff, listen, you guys are all going to live and move to Washington for the next couple of months?

DR. MCDONALD: We don't do it, someone else does it.

DR. COHN: You don't send somebody off and then hear from then again in six months. We have to be pretty much overseeing both the study design and really all the many aspects of all this.

DR. MCDONALD: I assumed that someone who had to do all that, is that wrong? They do it for NPRM's --.

DR. COHN: The reason I'm asking, I've done and been involved in enough cost benefit studies and you pretty much gotta have your hand in, you don't do it, but you pretty much have got to agree about what it is these people are going to do because at the end of the day, for example, Dr. McDonald, I would not want to have a report come out and they say but they didn't ask or evaluate these four things, and so it's that sort of issue, and I don't really, I'm being facetious when I'm talking about moving to Washington while this is happening, but it is an additional time commitment --.

DR. MCDONALD: Fall is nice in Washington.

MS. GREENBERG: What I might suggest is that the staff look at whether, given the expectation that at some point they are going to have to do a cost benefit impact analysis for an NPRM, maybe in our lifetime, that we look at whether in fact it would benefit from some external resources to support this and what that would entail and if they feel that it would, they can take it back to the subcommittee if the subcommittee wanted to help sponsor this that we'd have some resources. If the subcommittee doesn't really want to have anything to do with it then the department would just find other resources.

DR. MCDONALD: I'd say go forward and see what you come up with it. That's what I think I'm hearing everybody saying. I had another slightly different question about ICD-10-CM and I just realized I really don't know what that is either and I wondered if someone could here, I mean I know what it is but I don't know how it's different in what substandard or systematic --.

MS. GREENBERG: We've had presentations, lots of them.

DR. COHN: I think without trying to answer that question that hopefully the documentation, and I'm expecting at a minimum in November that there will be sort of an update of where we are with ICD-10-CM, PCS, others, you can't have a conversation unless everybody's sort of aware of that. That was sort of my reference about mapping and all this stuff, recognizing not, I find myself a little unclear about where the whole mapping project was.

DR. MCDONALD: Kind of what I understood was a whole bunch more emergency codes than there are trauma codes and that kind of thing, e-codes are now -- formally and otherwise it wasn't radically different, just all different codes. Is that fair?

MS. GREENBERG: I'll send you a Power Point presentation, ok?

DR. COHN: Ok, so I'm hearing a couple of things just to move forward. Obviously we're going to do this document, some background as well as identifying the issues and some pro and con. We are talking about doing some work to sort of see what it might take to do a cost benefit study and whether that's something that we should tell the secretary that we're doing rather than just have the secretary do it, but that's something I think we can mull over as well as the staff can think about a little bit and come back to us and talk to us in October about that just so we understand how much this would involve.

Now obviously we talked about potentially doing, having a sort of a session with the full committee in November and hopefully that will work and part of it I think is sort of a quick background, not everybody will have read every piece of the whole document but probably starts with what are the problems with the current coding systems, what is ICD, what are diagnoses codes, what are procedure codes, what are the problems with the current coding systems, what are potential alternatives, and then gets into looking at the document. I think the things we were sort of mulling about and probably, depending what we're beginning to see on that, we may decide that we need some expertise or some speakers to come in if there are particular areas that we feel need to be a little more fleshed out or we think it would benefit the full committee to hear a little bit more. I agree, I think I was hearing that they didn't necessarily want a whole bunch of outside speakers to come in and replicate what we've been having testimony on for the last eight months.

MR. AUGUSTINE: They wanted us to kind of summarize that for them but I think all of us and I kind of got the feeling from them that any more testimony is not desired.

DR. COHN: Certainly some of us, my own view is, I think we've heard a tremendous amount and it's really more a question of reflecting that as opposed to getting new testimony and we can probably say it more succinctly than many of the testifiers may be able to. We will reflect on that in October and based on how many issues we have we may wind up dividing up some of the work in terms of leading the discussions.

MS. GREENBERG: Actually we have done a paper for the WHO meeting on the hearings that were held on replacement of ICD-9-CM and Vols. 1, 2, and 3, we've summarized everything up through I believe, well pretty much up through the August meeting, we might have to add a little bit to that and then we've got those additional letters, I don't know if they have anything new beyond what was already heard, but it's just about five pages, so since our international colleagues are interested and quite fascinated why the United States doesn’t seem to be able to even set a date for moving to at least 10 --.

MR. BLAIR: We're waiting for a UN resolution before we move forward.

MS. GREENBERG: I thought we wanted to be the first on the block, not the last, but I guess it depends on the subject. Anyway, so that would I think be helpful, particularly to the members of the committee who are not part of the subcommittee --.

DR. COHN: It would be helpful to members of the committee.

MS. GREENBERG: We'll make that available to you and we can update it to --.

DR. ZUBELDIA: Should we explore the possibility of the industry coming up with their own cost benefit analysis and presenting it to us in November? What if somebody from the outside does their work and comes to us in November and says here's this document?

MS. GREENBERG: It would be nicer I think if it could be done collaboratively.

MR. AUGUSTINE: We also can side step the bias issue, make sure there's no bias.

DR. MCDONALD: We're going to get biases no matter what we do. The question is if you couldn't get it that fast any other way, that's I think the advantage, we could still do our own.

DR. ZUBELDIA: We could still do our own but issue that challenge to those that are saying this is going to cost a ton of money and say how much? Tell us in November.

DR. COHN: Well, Kepa, I certainly, if people want to come forward in October when we have our next subcommittee meeting, not with us and the answer but the fact that they are 80 percent done, or whatever they have really sufficient information, that would be very useful to know. I would reflect all that in all of our letters and all the information we had was I think one that nobody understood how much this was going to cost or what it was going to take and everybody was asking for the NCVHS or HHS to lead that effort. I didn't hear any, and my memory may be poor on this one, but I didn't hear anybody from the private sector coming forward and saying we're going to do this and we're going to get the answer for you in two months, but certainly, do you want to say this clearly in the microphone so that if anybody wants to come forward they can?

DR. ZUBELDIA: If it does happen, I don't know if it will or not, but if somebody from a private sector starts working on it, I certainly would be glad to hear from them in November.

DR. COHN: Yes, I would, if anybody on the internet or otherwise wants to send us an e-mail and we'll certainly make time for you in October to have a session.

MS. LEON-CHISEN: Nellie Leon-Chisen, American Hospital Association. I think that private sector would be interested in producing cost benefit studies, but just like you mentioned earlier, it's very difficult unless you have a set of questions that you really want answered, because to just say cost benefit, what specifically are you looking for and what's the universe that we're looking at?

DR. COHN: Ok, also in October we can make sure we have all the right questions. Clearly the areas of contention in our letter really reflect on the questions that need to be answered. This is going to be exciting. Anything else on this one or can we, it seems like we've sort of laid out at least conceptually many of our next steps. Karen do you have any issues? No? I just want to thank both Donna and Marjorie for being available at our next meeting. Shall we move on to talk about the October PMRI?

Agenda Item - PRMI - Mr. Blair

MR. BLAIR: I think a number of you are familiar with the fact that we've gone through the process all the way since mid-August of trying to find an individual that could help us as a consultant with the process of evaluating, selecting and recommending PRMI terminology standards. The first candidate that we had turned out to not be available in the August timeframe and we went ahead and kind of got a list of candidates and kind of went through them. You can tell that I'm avoiding mentioning the name of the individual although last week we distributed the name of that individual to all of the subcommittee members and all the staff already was familiar with the name of the individual because they were part of the process of coming up with that individual name. We're trusting that that individual will be with us October 22nd and contract negotiations began already with Michael Fitzmaurice but Michael's father, as you know, just passed away and Susie, are you here? Susie is either stepping in to take over for Michael or just for the interim, I'm not sure which.

MS. BEBEE: Probably for the interim.

MR. BLAIR: So, is there anyone on the subcommittee that didn't recall the document that I sent a week ago because I brought extra copies for you if you'd like.

DR. COHN: I think people would like extra copies. Is this the agenda for the hearings?

MR. BLAIR: Well, I was thinking of the criteria of the selecting the consultant, the timeframe, and --.

DR. COHN: No, Jeff move on to the agenda please.

MR. BLAIR: Move onto the agenda. Susie would you mind distributing copies of that? Let me mention something kind of as a preface to the agenda. The testimony that we received on August 28th was very very rich. There were a lot of, when you wind up having testimony on subjects like that, we had clearly defined questions, and what came out of that is that there wasn't a consensus on a number of things, there wasn't a consensus on the philosophy with which we approached the scope, and I should tell you that Susie Bebee and I have gone through the process so far of pulling together the matrix, we've gone through ten of the 14 different testifiers, so I'm able to go back over the testimony and I have a fresh perspective of that so let me give you a feeling for what I'm coming up with. There's at least two if not three different approaches to how we might approach the scope and then once that scope is determined then that winds up leading us towards which particular terminology's we then include as defined within the scope. And then lastly, whether we're going to have to prioritize because some of the issues, depending on which philosophy or alternative the subcommittee decides to embrace we may have a broader or narrower scope. And we may decide to go on a narrow forward path, or a broad one, I don't know, and if we do go on a narrow one we might decide what will be our priorities.

So I think that there's going to be a lot of discussion and Susie and Steve Steindel and myself are working to try to frame this for you in as helpful a way so you can see what, we'll give you the matrix on October 11th along with the issues for each of these things we've defined, the alternatives we've defined and a way to try to help with our decision-making process on October 22nd. From what I could see there's going to be a lot of decisions, I don't know if it's a full ICD-10 type magnitude of decisions but it may be, it may be. So you'll see that there's quite a block of time that we've put there for discussing just simply the philosophy and approach of the scope and then assuming we can wind up coming up with some agreement on that then the other issues there.

In terms of the criteria, the criteria then also winds up being somewhat dependent on what we decide on that philosophy and approach for the scope because we may wind up coming up with a set of criteria for a core or convergent or interlocking terminology but if we decide to not go down that path then we may have a different set of criteria or we may have multiple criteria, one for a core and other ones for the others so there's a lot of different ways that this could play itself out.

And then that takes us through the afternoon and lastly on the agenda would be given that we go through all of those issues we may wind up modifying our work plan and I'm just going to go ahead -- I brought ten copies of the document so all of the people on the subcommittee and staff already have seen this because it was distributed last week, but if there's someone else here that hasn't seen it, this is the criteria for selecting the consultant, and the responsibilities of the consultant, but basically -- I sent it out to everyone during this last week or so.

DR. COHN: This is the job description of the consultant?

MR. BLAIR: The only reason that I brought this is that it has the timeframe in the responsibilities, it breaks it down into gathering information from the SDO's, gathering information from vendors and users, other experts, and so in a sense it's preliminary to a work plan that we developed at the end of the day.

DR. COHN: Thank you for the clarification.

MR. BLAIR: I really did, I'm sure I distributed it to everybody during these last two weeks. Nevertheless, just in case, it's here. So anyway, that was what I would suggest as an agenda and if anybody feels like we should approach it in a different way, please speak now.

DR. MCDONALD: I don't have an alternative but it's really, I just want to bring up some of the complications that have occurred lately that might make it harder than, it might make it different that what we thought because basically we we're kind of hoping back a year ago that by the time we got to this, certain negotiations would have been satisfactorily concluded and that would have made certain decisions easy. What's more complicated as I understand the picture and this is not inside scoop or anything and there are still some contingencies that could make a big difference, is that there's likely to be in the next six months a RFA for broad kinds of approaches to vocabulary. In which case that same candidate would maybe have a real high change of winning, but there will be other probably contenders, so the question really is how do we avoid changing the motivation of the various players in terms of how hard they compete?

MR. BLAIR: If we pre-judge something we may change the dynamic of the competition in a way that wouldn't be as good as if we didn't. I guess I'm really clear in all this.

DR. COHN: Now are you talking about the criteria issue? Or when you actually start the --?

DR. MCDONALD: I guess if we get to the point where we should say we should use X or Y, or even if we set up criteria that don't comport with the RFA which might be looking at price and long-term openness and things like that, but I guess I really worry, I think that some of the candidate vocabulary's are in a position to decide to do exactly what might be really good for the country in terms of -- they may not decide if they think they're going to get it anyway because of how we would specify, so I think we just have to be careful. It may weaken the negotiating hand or the bidding process hand is all.

MR. BLAIR: My thinking is that if we're lucky it will be June before we are able to make our recommendations and so the, but I think the points that you are raising are absolutely appropriate and I think that that's one of the reasons why we need as much time on that agenda on that first item to decide how we're going to deal with those issues. What do you think Clem?

DR. MCDONALD: I don't have answers. I just have the questions.

MR. BLAIR: I guess I feel like this could go in a lot of different directions and the other alternative that we have is to wait and I'm not sure that that's a good approach either. Is that something we can address on the 22nd?

DR. COHN: Let's see what others have comments. Steve and Bill Yasnoff.

DR. YASNOFF: I might suggest that as part of the agenda for the October meeting that we, after introductions, start off with an update on this acquisition process, whatever, and find out what's going on and then depending on what's going on we can make a decision at that time how we should proceed so as not to interfere with that process.

DR. STEINDELL: First comment with regard to what Bill said is I'm not sure if we will actually have an update to the RFA process in the October timeframe because there's some recent developments. I hope we do, I wish we would today and I'll be pushing for one but I don't know if we will.

The second thing is, Jeff, I would like you to address the comment for if we should not, if we don't, if you aren't to address it now I think it should appear on the October agenda as to exploring in more detail the question of the possibility of waiting. What is forcing the decision today? We're in a very delicate time in terminology discussion. This committee, subcommittee deliberating on it right now can introduce as Clem pointed out some very vast -- that might not help the issue, it might confuse the issues whereas waiting might be a very good strategy in this case.

DR. MCDONALD: You said wonderfully what I was trying to inarticulately get out.

DR. YASNOFF: I don't disagree with Steve, I think my interpretation of what you're saying is there may not be anything substantive that can be said over but there certainly can be an update as to what is going on and also recommendations to the committee as to what the committee should do so as to be most helpful wherever the process is and whatever the process is. The alternative is to seek that information between now and October and plan the agenda accordingly, and I don't see, I don't have any objection to that either, but I think this is an important issue that needs to be considered.

DR. STEINDEL: Just to clarify my semi-cryptic remark which I don't think is really private information. As everybody is aware, sometime in the beginning of the summer a letter was sent to NOM to SNOMED saying that we didn't feel the negotiations could go forward. At the SNOMED editorial board meeting in the UK last week John Neff(?) announced to the board that the College of American Pathologist's Washington office had received communication from the NOM that they were willing to reopen the negotiations for a limited period of time. Now since I'm involved with the negotiations I hadn't heard anything, I was wondering what was going on. I did get clarification at the end of the week from Betsey on that and Vivian I notice is sitting there and she can probably say the exact date, but I believe the exact communication was they agreed to meet one day with the College and the date is right around the time of this meeting. I'm not sure exactly which date it is. October 22. The day of the meeting. So consequently, I think you can see where my cryptic remark is coming about. There's going to be a meeting that might involve changes that are going to occur with regard to either the negotiations or the RFA process right when we are meeting.

MR. BLAIR: Ok, I'm not sure what to do.

DR. YASNOFF: I think in view of that I would suggest that we do something else for the October meeting and then wait to hear what the result of this is and then consider what we should do until there.

MR. BLAIR: What I would do is, I'm accepting both of your recommendations and Clem's, let's go ahead and defer the agenda, the PRMI activities, at least a good part of them for October. I think what I probably will do is continue working with Susie and Steve in pulling together the summary of the testimony that we received for August 28th so that when we do reconvene we at least have that well documented.

DR. STEINDEL: I think I would like to see not totally curtailing discussion on the PRMI on October 22nd but we might want to limit it to about a half a day to revise the results of what came out of the testimony and produce it in the form of a summary document because regardless of what occurs, the results of that testimony will be very very useful to the people who are moving forward in the RFA process or negotiation process. So I would encourage us to keep that on the agenda and formally develop a formal report on it.

DR. MCDONALD: To make use of the time, I think this is exciting however you think of it for vocabulary's and there is an activity underway and I never have the right name for it anymore --

DR. COHN: RXNORM(?)?

DR. MCDONALD: Yes, thank you, and I'm wondering whether we could get some testimony about that because no matter what comes to pass that's likely to be of interest.

DR. COHN: Thank you for going there because that's exactly, I was even going to ask that before that I felt we needed an update on that, and there's another piece to it and I want to say it's like RTF, I forget, these are acronyms I'm sort of losing right now, there's some looking in drug terminology's that we should be --.

DR. MCDONALD: There's actually a whole bunch of activities all which I'm not sure I'm supposed to know about but sometimes --.

DR. COHN: I think that would be useful. I think the other piece that would be very useful is potentially to get an update on where LOINC in relationship to, knowing that that's sort of a quasi clinical terminology may show up at some point --.

DR. MCDONALD: I can't be a part of any of that, I'd have to recuse myself.

DR COHN: We'd have to find somebody to talk.

MR. BLAIR: My thought would be that rather than an update on LOINC, which has been out there, and it's not so controversial, let me put it that way. It's pretty straightforward I think, that's not an issue where there's a lot of educational concern about. But if it would be possible to get some education on the Open Source Health Terminology at that time, I don't know if they are going to be ready on that. I'm hearing some no's.

DR. STEINDEL: Clem said I don’t know but Simon and I both said no.

MR. BLAIR: Let's just leave it with the RXNORM and a half a day.

DR. COHN: We're talking about a half a day then for --

MR. BLAIR: A half a day plus the RXNORM.

DR. COHN: Ok, that will give us a little more time to work around looking at status of implementation and other issues related to that.

MS. GREENBERG: Who would present the RXNORM?

DR. MCDONALD: I think I would suggest that we talk a little broad on RXNORM because I think there's some parallel but separate processes. And I think that parties that would know who should talk about it are Steve Brown from Memphis at the VA and somebody from Randy Levin's office. There's even some discussion of a mild change in NDC which could be very helpful.

DR. COHN: This would be very useful. We'll have a session on drug terminology updates.

MR. BLAIR: Maybe two or three different activities.

DR. COHN: I would also probably just talk to Betsey Humphries, I'm sure she knows the work of the players. If you leave it to Jeff and I we will sort of reconnect agendas and make all of this happen. Jeff do you have any other comments on the October agenda?

MR. BLAIR: No, it's, this is a significant change but I don't think it's any surprise and all I can say is I hope that some of these, I hope that they'll be clear answers, there never are I guess, out of that meeting, so that we're not in a situation where we're waiting here for the next nine months to 12 months.

DR. MCDONALD: I would guess we won't be only because either it will be like white smoke or no smoke or something like that. I guess that could be hanging. The sentiment I have is that they made, the goal is to do it the other way, now that it hasn't worked for so long the first way. My guess would be there would have to be a completely different kind of proposal before it would get reversed. In which case it would go forward. I think it's highly likely to be a yes or go forward with the alternatives that have been discussed.

DR. COHN: Let's not get in the way of this process at this point.

MS. GREENBERG: Given the goals and the commitments of the CHI I don't think we, we can't look, the department isn't going to, that initiative isn't going to let this sort of hang for nine months even if, and I would hope that what the committee does could be contributory to the CHI effort, just says what the committee did on message format standards.

DR. MCDONALD: Does CHI have a deadline or a timeframe when they'll publish something?

MS. GREENBERG: I think there's like 12 to 18 months or something.

DR. STEINDEL: It's about 18 months left on the running two year clock. But what I'm looking at is the matrix type document would prove very useful in helping to put together an RFI or an RFA.

DR. MCDONALD: Do they have any intermediate publication plans? I couldn't get clarity this morning.

DR. STEINDEL: Clem, it was actually mentioned this morning. There are two draft recommendations that are being reviewed by the agencies for federal adoption and they are not surprising. One is a conditional recommendation on laboratory LOINC and that's the document that you saw. And the other is on the approval of the messaging standards with modification as came out of the NCVHS letter and the modifications for those are relatively trivial, instead of 2.2 as a base the recommendation of 2.3 as the base. The NCVHS letter was for PRMI standards --.

DR. MCDONALD: PRMI message formats.

DR. STEINDEL: Right. And the CHI is just involved in interagency communication so there are conditional recommendations for IEEE and Diecom because those are more designed for intra communication, which are very appropriate for PRMI messaging standards but not for the CHI mission. We're hoping those documents will be approved for posting and distribution hopefully within the next month or so as was mentioned this morning since this is the first time the agencies are seeing them. And the agencies have to approve internal processes for signing off on those because it does commit the government to those standards.

MR. BLAIR: Will you be here tomorrow where we could talk either at breakfast or lunch?

DR. STEINDEL: At breakfast. I've got to catch a plane about 11.

DR. COHN: We can talk about these sort of things off-line. I guess the question is I think we're sort of at the end of the agenda that I have. Are there any other issues that we need to be talking about at this point? Are we getting clearer about the October hearings? And obviously we will spend more time talking probably about implementation status, ASCA, best practices and all of that, shifting time away from PRMI and if there's issues related to, any white papers or HCPCS issues that come forward we can deal with them at that point. Obviously we know what's happening in November, December we have the report from the DSMO's and probably a look at what's working with the HIPAA process and what isn't at this point. Then probably at this point in January we would start out depending on what happens with the discussions with the national panel and Alternative Link to start looking at alternative health care codes and needs of the industry. Is that sort of what everybody, the broad expanse out there? Some of these may shift around a little bit as we go forward. Yes?

DR. YASHOFF: Did we set dates already for meetings next year?

DR. COHN: No I just announced that we were going to be coming, I announced some dates in January that we were going to be querying everybody about, dates in March and then dates in May, these are most cases at least ten day periods where we need two days out and hopefully in the next couple of days we'll send out a query to all of you.

MS. MALINA: Cynthia Malina, CEO, Alternative Link. I just am concerned that on the HIPAA transaction and code set implementation date those who didn't apply for an extension would essentially be blocked from using the ABC codes and we do have current users so it would be beneficial if we could address the alternative medicine issues sooner rather than later. We can certainly reach out to constituents and have people available for hearings immediately and we also have the results of those studies, so in my view there's not a lot of value in the delay. The information to take this to the next step is available now for discussion.

DR. COHN: Thank you, I think we had talked, wanted to do was to hear the report from the HCPCS panel as I understood from our previous conversation, I'm just looking to make sure I understood our previous conversation, and we were looking towards December or January, I think it's more likely January, I can't -- shift back and forth, yes, to hear back form the industry, and I think at that point what we will do is sort of figure out a work plan -- get some sort of potential consulting help to get a better sense of what the industry needs are and then go from there. As I said I'm not guaranteeing it's January, I expect it will be either December or January depending on how everything sort of fits together at this point.

DR. ZUBELDIA: Cynthia if the concern is that they need to file for the ASCA extension, then I would recommend that they do, file for the ASCA extension.

DR. COHN; Yes, I think the general recommendation we made months ago was that probably everybody ought to file for the ASCA extension.

DR. ZUBELDIA: To be brutally blunt, the implementation guides without the addenda are not very practical, the reason for the addenda was changes that are required for implementation. Without the addenda, some of these things are, really have problems with them. If they are doing any of the HIPAA transactions without the addenda they're going to encounter lots of problems. They need to file for the extension.

DR. COHN: Final questions, comments? In that case we are adjourned. Thank you all very much.

[Whereupon at 4:23 p.m. the meeting was adjourned.]