[This Transcript is Unedited]
The Wyndham City Center Hotel
1143 New Hampshire Avenue, NW
Washington, D.C.
Introduction - Dr. Cohn
Develop draft letter to Secretary on transaction modification; NPRMs
Review draft letter to Secretary on Adoption of ICD-10 Codes
Discuss assessment process for ASCA compliance extension plans
Review Subcommittee issues for 2002
DR. COHN: I want to call this meeting to order. This is the subcommittee on standards and security. I would like to welcome the subcommittee members who are here and obviously Brady, who is on a conference call and obviously I will remind everyone to speak clearly, so that our stenographer and reporter and capture all the information.
We are obviously already running an hour late. I want to inform everybody about that. Recognizing that, I think we can get through most of what needs to be done.
I am changing the agenda around a little bit. Assuming that my computer does come up, I wanted to start off by talking about something simple, at least I hope it is simple, which is reviewing the draft letter on the NPRMs as the first item, just because I think that is quickly handle-able and doable, assuming the computer comes on.
Then we will decide on the letter about ICD-10 and decide about next steps. Then after that, Brady, you are on to talk about ASCA and I think some very important statistical proposals in terms of how we handle paper as well as electronic form.
Then we will talk a little bit about what our plans are for the next three hearings after this meeting, which are August, October and in December.
I think we have some ideas and I have the sort of issues list that we keep. With that, maybe we should do introductions around the room very quickly and buy a little bit of time on the computer. I am Simon Cohn, chair of the committee.
MR. BLAIR: Jeff Blair, vice chair of the subcommittee.
MR. ZUBELDIA: Kepa Zubeldia, member of the subcommittee.
MR. MC DONALD: I am Clem McDonald, from Indiana University, Regenstrief Institute, member of the subcommittee.
MS. BURKE-BEBEE: Susie Bebee, NCHS, CDC, staff to the subcommittee.
MR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Research and Quality, staff to the subcommittee.
MR. DENEHER: John Deneher, member, NCVHS.
MR. TRUDELL: Karen Trudel, Centers for Medicare and Medicaid Services, staff to the subcommittee.
MR. D'AGOSTINE: Brady D'Agostine, corporate director of special projects, Gambra Health Care, member of the committee, member of the subcommittee.
MR. EMERY: Jack Emery with the American Medical Association.
MS. GRADY: Debbie Grady, graduate student.
MS BARTLETT: Melissa Bartlett, AAHB.
MR. RODIE: Dan Rodie, AHIMA.
MS. KLAUS: Linda Klaus, AHIMA.
MS. WIERS: Chris Wiers(?), Healthlink.
MS. STERN: Catherine Stern(?), Association of American Physicians and Surgeons.
MR. STEINDELL: Steve Steindell, Centers for Disease Control and Prevention.
MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics, CDC.
MS. PICKETT: Donna Pickett, NCHS, CDC, staff to the subcommittee.
MS. PROFFITT: Sue Proffitt, AHIMA.
MS. TRUSANA: Natalie Trusana(?), National Hospital Association.
MS. KNOLL: Vivian Knoll(?), National Library of Medicine.
MS. OSWALD: Pat Oswald, National Blue Cross Blue Shield Association.
MR. COHN: Is the computer ready? Almost. I am going to ask Karen, as sort of a first step here, to read the draft document.
MR. FITZMAURICE: Is this the same letter that Kepa was talking about?
MR. COHN: No, this is the letter on the NPRM.
MS. TRUDELL: No, we just drafted it. You don't have copies of it at all. It is a very short letter. It is comments on the two notices of proposed rule making, and I will proceed to read it.
MS. TRUDELL: Dear Secretary Thompson. As part of its responsibilities under HIPAA, the National Committee on Vital and Health Statistics has reviewed the notices of proposed rule making, proposing modifications to the original HIPAA transaction and code set standards.
We offer the following comments. One, NCVHS supports the modifications to the electronic transactions final rule and the addenda, as identified in CMS 0005, as valuable and necessary changes to the standards that should mitigate identified issues and improve the HIPAA implementation.
Two. NCVHS supports the modifications to the electronic transactions final rule, as identified in CMS 0003, as valuable and necessary changes to the standards that should mitigate identified issues and improve the HIPAA implementation.
In addition, we would recommend that a replacement standard code set for NDC, for reporting drugs and biologics, in non-retail pharmacy standard transactions, not be named.
We believe this will give the industry time to fully evaluate its current practices and identify preferred alternatives. We are also hopeful that there will shortly be a new drug coding system available for evaluation and testing that may better meet the needs of the industry. We would recommend delaying a code set standard until this new drug coding system has been evaluated and tested.
We further recommend that HHS publish these modifications in final form as soon as possible, so that covered entities have as much time as possible to implement the changes prior to the April 2003 dates specified for testing transactions in the Administrative Simplification Compliance Act. NCVHS wishes to thank you for the opportunity to submit these recommendations within the framework of the administrative simplification provisions of HIPAA. Sincerely, John Lumpkin.
MR. FITZMAURICE: Could I ask a question? We are asking that a replacement drug code set for drugs not be named.
MR. BLAIR: At this time.
MR. FITZMAURICE: Does it actually name a code set? Does it say it has to be HCPCS?
MR. TRUDELL: No.
MR. COHN: There is actually a question asked in the NPRM about this.
MR. ZUBELDIA: The reality of it is that because the implementation guides only have a few qualifiers about them, if you don't use the NDC codes, you have to use the HCPCS codes. There is no other choice. If it is not named by this -- there is no other choice.
MR. FITZMAURICE: So, somebody would be able to choose between the two as opposed to being forced to one or the other at this time.
MR. ZUBELDIA: You would be forced to use HCPCS.
MR. MC DONALD: That is where there is no other choice.
MR. FITZMAURICE: You mean in reality or because of the law?
MR. ZUBELDIA: In reality, the guide has been changed with the addenda to remove NDC as an option, and the only option here is HCPCS.
MR. FITZMAURICE: So, it forces everybody to HCPCS.
MR. MC DONALD: In the hospitals.
MR. COHN: For institutional and professional claims.
MR. ZUBELDIA: For institutional, you could use either ICD-9 version 3, or HCPCS. For professional, all you can do is HCPCS. That is it.
MR. FITZMAURICE: So, those who anticipated and built their systems or modified their systems around NDC will have to go back and use HCPCS.
MR. BLAIR: They are having problems doing that.
MR. ZUBELDIA: You have to use HCPCS at the procedural code. Then you can use, in addition to the HCPCS code, which is required, if you need to send the drug, you can use another loop that is introduced in the addenda, where you can send the NDC in that additional loop, in addition to HCPCS.
MR. FITZMAURICE: So, those who are using the NDC code will still be able to use the NDC code.
MR. ZUBELDIA: Yes, and they have to use a generic HCPCS code as a place holder and then use the NDC code to convey whatever information. The risk in not adopting formally HCPCS as a standard is that it opens up to the use of local codes, where a specific payer would say, since there is not a HCPCS standard for drugs, you are going to use this code that I have created as a local HCPCS code.
Because the qualifier has to be HCPCS, it has to be a local HCPCS code. So, it opens up that door and that is, I think, a problem.
MR. FITZMAURICE: I don't understand that completely yet.
MR. ZUBELDIA: Because there is not a standard, they could create one.
MR. FITZMAURICE: Whereas, if they adopted both HCPCS or NDC, just given those two choices and no other choices, then the pathway would be clearer. You do whatever you have and wait for the further adoption of the drug code. It seems to me that it makes more sense to recommend that you adopt either HCPCS or NDC but nothing else.
MR. MC DONALD: I think there are problems whatever we give them. The solution, I think, is the one that is really basically the way it is now.
MR. ZUBELDIA: Right now, it is HCPCS and local codes.
MR. MC DONALD: Medicare only pays very specific drugs with very specific codes, and if you don't have the code, you don't get paid. So, that is not going to be a problem. Are there other categories? There is not a lot of drug billing coming out of hospitals. It is really office practice oncologists.
MR. ZUBELDIA: Home infusion.
MR. COHN: I did some rough drafting of this and I think Karen has done a good job of cleaning up many of the concepts.
I am positive that our interest was, over the longer term that if, indeed, a new drug terminology to better meet the industries than it does now, that we want to be moving to that, and that, to me, was the critical issue.
Now, in the near term, it seemed to me that the best way to do that was to leave the situation beg for the moment. This is meant to be a draft that we would chew over. Clearly, we have the option to either be vague for the moment or we can sort of say, NDC or HCPCS, but that we want to see people move as quickly as possible to the new drug code terminology, if it works well after being evaluated.
MR. ZUBELDIA: I would prefer to narrow it to either NDC or HCPCS, number one and number two, and close the door on local codes. There are some drug codes in the J section and some in the S section and some in the Q section of HCPCS.
MR. BLAIR: The other piece that may also be helpful to clarify, and I don't know if you are still noting Kepa's piece -- I will wait until you are finished -- which I certainly agree with, the other piece of clarification might be that when you refer to the NDC codes in the letter, you may want to point out that the NDC codes were a new requirement for acute care institutions in HIPAA.
It is not what most people have been using up until now, and so we are removing that as a new requirement. We are not asking them to stop something that they have already been doing. I think that clarification might help us understand.
MR. FITZMAURICE: Picking up what Kepa say, though, I think what I heard Kepa say was, keep that as a new requirement, but also use HCPCS as a requirement, so they can have their choice.
MR. BLAIR: The testimony we received was to not put NDC as a new requirement.
MR. ZUBELDIA: To allow what is being used today --
MR. BLAIR: To continue.
MR. ZUBELDIA: Such as home infusion, to continue to allow NDC codes and to allow to continue HCPCS codes. I think that is what Mike was saying.
MR. MC DONALD: I really don't understand quite well enough, because I had the impression that there was a lot of fussing because this new requirement in, and then it is all interactive because they send them on to someone else. I don't know how we can mix the two together.
MR. FITZMAURICE: Some people may have already geared up to NDC.
MR. BLAIR: No, we nipped it in the bud.
MR. TRUDELL: Not based on the HIPAA standards, no.
MR. COHN: I guess I should ask, since you know the NPRM better than anyone, I would imagine, are there any unforeseen consequences to the direction being the current recommendation?
MR. TRUDELL: I think you are saying what the recommendation says.
MR. ZUBELDIA: This withdraws the standard so there is no standard. The recommendation also asked a question about the advantage of -- that is on page 48 --
MR. BLAIR: What I thought it says is that it withdraws NDC as mandatory.
MR. ZUBELDIA: Yes, it withdraws that requirement. By not adopting a standard of any kind, it opens the door to the payers creating their own codes, because there is no standard.
So, each payer could create their own codes, and each Medicaid could create their own codes and call them local HCPCS codes, still with the HCPCS qualifier, same structure, but create a local code.
MR. MC DONALD: Should we specify J codes?
MR. ZUBELDIA: I wouldn't specify J codes because there are J, Q and S codes. I would say HCPCS levels one and two.
MR. MC DONALD: Let me just read this over. They said, we recommend adoption of the NDC as the standard medical code for reporting drugs and biologics in the retail pharmacy transactions.
We also amend section blah blah to reflect the adoption of the HCPCS coding system as the standard medical data code set for reporting drugs and biologics for non-retail pharmacy transactions.
MR. ZUBELDIA: Actually, then when you go to the regulation itself, it is not there.
MR. COHN: That is because this is an alternative.
MR. ZUBELDIA: The alternative narrows the choice to only HCPCS. That will not work for home infusion. Home infusion needs to have NDC codes also. They do have HCPCS codes for some things, and they need NDC codes for other things in both sets.
MR. COHN: I guess the question I would have, I am a little bit more concerned, at this point, just mulling about, how many local codes are there currently to deal with this recommendation?
MR. ZUBELDIA: For drugs? Lots of them, and they are issued by a single payer and the payer contacts the home infusion company and says, this is what I want you to use when you bill me.
MS. WILLIAMSON: Karen, could you clarify for me, is the final rule that we are recommending the implementation of local codes? A payer is precluded from creating their own codes.
MR. COHN: Maybe the answer here is to leave it without a standard, but we strongly recommend that local codes not be allowed.
MR. BLAIR: Kepa's wording, I think, is very directive and helpful.
MR. ZUBELDIA: The regulation removes local codes for specific things. For drugs and biologics, there will be NDC codes.
In adopting HCPCS codes, the recommendation doesn't specifically remove drugs and biologics. Maybe it does, but I don't see that.
MS. WILLIAMSON: Somehow I recall the language that we will remove local codes across the board, that it was not drug specific or any other entity specific. Local codes were being eliminated across the board.
MR. ZUBELDIA: Maybe all we need is a reinforcement of that, saying leave it with a standard that, for all practical purposes says, you have to use HCPCS because there is no other, and then reinforcing that local codes have already been removed, or reduced by this mechanism.
MS. WILLIAMSON: A local code, a real HCPCS local code, has to be approved by the HCPCS panel, and they are not going to do it.
The HCPCS panel is not entertaining level three coding requests any more. So, what you are really talking about, it is a misnomer to call it a HCPCS local code. It is just a made up code of any kind.
MR. ZUBELDIA: Those local codes that NAMI has been calling local codes, because they were never approved by the HCPCS local panel, there were 30,000 of them that were made up local codes.
What I am saying, by not making this a standard, there could be new made up codes that are not disallowed by HIPAA.
MS. WILLIAMSON: But the only things that can be used in the transactions are HCPCS and we don't have level three. So, I think we just talked ourselves around in a circle.
MR. ZUBELDIA: There are no level three codes today.
MS. WILLIAMSON: And there won't be any.
MR. ZUBELDIA: So, what people are using today are made up codes.
MS. WILLIAMSON: Right, and the 837 does not allow a category for made up codes, the last time I checked.
MR. ZUBELDIA: Those made up codes are called HCPCS level three today.
MR. MC DONALD: They are either allowed or not allowed. I am hearing conflicting stories.
MS. TRUDELL: Is there a need to -- how do I quantify this in a sentence.
MR. MC DONALD: The feds have made a decision already and we are just kind of supporting it? I would say the least, then, so we get in the least trouble.
MR. FITZMAURICE: You are asking the Secretary to investigate the need for the use of NDC codes, particularly with regard to home infusion, to support what the NPRM already says.
MR. COHN: That is a different issue.
MR. ZUBELDIA: If we are not comfortable with recommending the use of HCPCS level one and level two and NDC codes, then the alternative would be to just take it as it is without a standard and somehow, in the preamble, emphasizing again that, even though it is without a standard, people cannot make up their own, and that the transactions limit the choice to either real HCPCS or NDC codes.
MR. COHN: I think that is fine. Obviously, the issue you are bringing up is the issue of local codes and made up codes or whatever we want to call them. Do you want us to hold off until you have word smithed?
MS. TRUDELL: Yes.
MR. COHN: Is there anything else?
MR. ZUBELDIA: There is something else.
MR. BLAIR: The only thing I didn't understand about the way you framed it, is that you framed it in a manner that they won't have any choice except to use HCPCS level one or level two or NDC.
Why did you not choose to simply say, they should use HCPCS level one and two in an acute care setting and NDC for home infusion. Why didn't you just be more directive? I didn't understand.
MR. ZUBELDIA: Because there may be other settings in which they also choose to use NDC, not just home infusion, but maybe there are other situations.
MR. COHN: I think we are trying to stay out of that.
MR. ZUBELDIA: Let industry to find it.
MR. COHN: I think the only thing we are saying is that we don't want them to use local codes.
MR. MC DONALD: Are we contradicting the idea that NDC is still used in pharmacy settings?
MR. ZUBELDIA: No, we are not touching that.
MR. BLAIR: The only other piece that I would say, just to edit slightly your wording, is to -- essentially you say they have a choice, HCPCS level one, HCPCS level two and NDC codes as appropriate; is that correct?
MR. ZUBELDIA: Yes.
MR. BLAIR: Why would you not say those words, that the users will have a choice to use dah, dah, dah as appropriate. I think it just comes out more positively.
MR. COHN: We have just been talking about that.
MR. ZUBELDIA: That was my first option.
MR. BLAIR: As opposed to saying they don't have a choice. Why don't we put it in the positive by saying they do have a choice of this, this and this.
MR. MC DONALD: The implication is that they can all use HCPCS and you can have a second choice of NDC.
MR. BLAIR: It always sounds coercive if you say, well, you don't have a choice.
MR. MC DONALD: But they don't.
MR. BLAIR: I understand, but you simply phrase it in the positive, they have a choice between this, this and this.
MR. COHN: Kepa, at the risk of making Karen crazy, but is there a whole other issue or was it on this same point?
MR. ZUBELDIA: It is a whole new related issue.
MR. COHN: Why don't you begin the discussion?
MR. ZUBELDIA: That is the pharmacies. Pharmacies are complaining that, by the implementation guide requiring essentially HCPCS for drugs and biologics, and in addition you can have an NDC code, then the pharmacist would not be able to bill for pharmaceutical supplies that are billed with the NCPDP standards.
So, when the diabetic buys insulin and a syringe, then the syringe that is covered by the drug plan is billed with an NDC code by the pharmacy, using the NCPDP standards.
Their fear is that they may have to start billing those supplies to the pharmacy prescriptions benefits manager using J codes.
In removing the standard for drugs and biologics for non-retail pharmacy, it could create a problem for retail pharmacies.
I don't know if that is something that we need to address or not. This is something that NCPDP is addressing.
MR. COHN: Professional pharmacies is also an issue?
MR. MC DONALD: You hurt one side or you hurt the other side.
MS. TRUDELL: Yes, especially with the professional services, there are two completely different schools of thought on that.
MR. ZUBELDIA: On the pharmacy side, what they want to do is, they want to say that everything that is billed as an NCPDP transaction should have the choice of being billed with an NDC code, and that option should not be taken away from them.
MR. MC DONALD: Is there an NDC code for syringes?
MR. ZUBELDIA: Yes, many codes, and that is why they want to continue billing it that way, because that is the way they are doing it now.
MR. MC DONALD: That is kind of inventory control.
MR. ZUBELDIA: Yes.
MR. COHN: I thought that there were also some other supply codes that they wanted to have that were beyond NDC and I thought that was part of the conversation. We have received letters from NCPDP about this.
I guess the question is, do we deal with it now in the context of this letter? Do we hold the discussion until we get input from the DSMOs, which I understood were considering this issue.
Recognize that I have, for example, received a variety of letters, as probably have all of you, on both sides of all of these issues.
I actually didn't think it was really part of this particular NPRM. Now, it is up to you on how you want to go.
I sort of thought we were going to do this, hear from the DSMOs, hear their recommendations, and do that.
MR. ZUBELDIA: We don't need to comment on that. NCPDP and pharmacists are commenting on it and we may want to invite them to explain what the issue is in one of our meetings.
I don't think we can comment about that. I think there are a couple of other issues, that we probably ought to skip, not comment on.
MS. TRUDELL: Do you want me to read what I have got?
MR. COHN: Why don't you read what you have got.
MS. TRUDELL: This goes after the sentence that says that the committee supports the modifications as valuable and necessary.
However, we wish to raise a concern that the absence of any standard code for non-retail pharmacy claims should not lead to a proliferation of payer developed local codes similar to HCPCS level three codes.
Use of such codes which might be developed as an alternative to HCPCS and NDC should be precluded in the standard transactions. Is that what you said?
DR. COHN: Prohibited, not precluded.
MS. TRUDELL: Prohibited, okay.
MR. COHN: Are we okay with that? It is said differently but it gets to the same point, I think.
MR. BLAIR: I think there is going to be a problem if we don't say what they should do. We said what they shouldn't do.
MR. FITZMAURICE: It doesn't say anything about using the NDC codes.
MR. BLAIR: I think we need to tell them what they should do.
MS. TRUDELL: Well, the regulation tells them what they should do.
MR. BLAIR: I think that Kepa just wound up saying, like in that one sentence where he said, they will have a choice between HCPCS level one, level two and NDC as appropriate.
MR. MC DONALD: That is going to get confusing even saying that, because it is really one, they have got no choice, but you have got your choice by using the second loop. So, I think the less we say, the better off we are.
MS. TRUDELL: The people who are reviewing the comments will understand this letter. I think what Jeff is saying is that it is going to be important to make this point as we develop outreach materials and FAQs, so that people understand what they are supposed to do.
MR. ZUBELDIA: The advantage is that, in the future, this won't have to change if there is a new code set that is implemented.
Just by changing the implementation guides and allowing for the quantifier for the new code set allows you to use the new codes without a new regulation.
If there is no standard for drugs and biologics -- none -- like there is now, then you can use whatever the implementation guide allows you to use.
MS. TRUDELL: I think it conveys the concerns so that the reviewers can get it.
MS. WILLIAMSON: I thought for any new code sets, we still had to go through the notice of proposed rule making with a comment period and a final rule.
MS. TRUDELL: Yes.
MS. WILLIAMSON: I don't think we can just rely on what it in the implementation guide. It still has to go through the rule making process, doesn't it?
MR. ZUBELDIA: If there is a standard.
MS. WILLIAMSON: To make a new standard, you still have to go through an NPRM. You can't just start using it.
MR. ZUBELDIA: What we are talking about here is not having a standard so that the industry can use whatever the implementation guide allows them to use.
MR. FITZMAURICE: That is the question, is can we put a new code set into the implementation guide without adopting it.
MS. TRUDELL: The code set trumps the implementation guide, but if there isn't a code set standard, then there is nothing to trump, I think.
MR. MC DONALD: These are Solomonesque questions that have no end to the depth of the detail.
MR. COHN: I thought this was the easy part of the meeting today.
MR. FITZMAURICE: Can the Secretary adopt a new implementation guide without adopting a new version of the standard and does that require a new regulation?
MR. MC DONALD: We are not doing that now anyway. This was the easy one, remember?
MR. BLAIR: Would it be helpful to reference that the implementation guide sets forth the guidance?
MR. MC DONALD: Mr. Chairman, I think we should move on.
MR. COHN: Are we comfortable with the letter? Do we need to vote?
MR. MC DONALD: I think that is a good idea.
MR. ZUBELDIA: The other two issues, we are going to skip in the letter, so we should make sure we are okay with skipping them.
MR. COHN: I apologize that I did not see these other two issues. What were the other two?
MR. ZUBELDIA: Professional services pharmacy.
MR. COHN: What page is that on?
MS. TRUDELL: It is not in here.
MR. ZUBELDIA: With the standard adopted for health care claims or encounter information, the Secretary adopts a standard for retail pharmacy drug claims.
For retail pharmacy drug claims is the NCPDP portion 5-1. By not adopting a standard for retail pharmacy claims, and being specific to retail pharmacy drug claims, the professional services are excluded from the NCPDP 5-1, because they are all drugs.
MR. COHN: Kepa, let me ask you these questions. I mean, we can go into these things. The question is, do we have knowledge of the right answer on this one, or do we need to hold hearings, get input from the DSMOs.
I would kind of say the latter, recognizing that these things are, once again, relatively contentious issues.
MR. ZUBELDIA: That is what I am saying. That is an issue.
MR. COHN: It wasn't something where comments are being solicited, I guess is what I am commenting on.
MR. ZUBELDIA: Comments are coming.
MS. TRUDELL: The comments are saying that there is something that we left out that we should have done that we didn't do. That is the context of the comments.
MR. MC DONALD: There is a process underway that they are being digested.
MR. COHEN: I think the question is, is there anything else that we, as the NCVHS have the expertise and the agreement to comment on at the moment.
MR. MC DONALD: So, what is the next issue?
MR. ZUBELDIA: The answer to that question is no. There is another issue that will be coming in that I want to let you know but I don't think we have the expertise to address and therefore it is my recommendation to leave it out of the letter.
MR. COHN: Are you proposing that we accept the letter as is?
MR. MC DONALD: Yes.
MR. COHN: In favor, say aye?
[Voices heard in agreement.]
MR. COHN: Okay, that was the easy one.
MS. GREENBERG: I don't know, because I had to step out, but I do have one small issue before you adjourn. I want to get it on the agenda.
MR. COHN: Oh, an additional item. What is the additional item?
MS. GREENBERG: That regards, I would say, a current misunderstanding that currently exists with Alternative Link as to what the next interaction with the committee is and whether they are going to be on the agenda in the August meeting.
I have had several phone calls to this effect and I have now obtained and read the relevant part of the transcript.
That is the way I left it with them. I said, well, there is a misunderstanding and I will see what the transcript says.
MR. COHN: Why don't we handle that after we handle the letter on ICD-10 and actually after we consider the ASCA compliance extension plan. We will consider that in review subcommittee issues and plans for the meeting.
MR. MC DONALD: Isn't that an executive committee decision? I guess not.
MS. GREENBERG: It has to do with the next meeting. So, that is where it belongs. I just wanted to alert you.
MR. COHN: Kepa, would you like to lead the discussion, once again recognizing, as I said, that obviously I am going to have to recuse myself from discussions of CPT and other procedures for systems.
MR. ZUBELDIA: I would invite Clem to educate us on what the issues are.
MR. MC DONALD: I don't claim to be the world's expert on this, but we have looked at it and studied it a bit about a year ago.
The problem with PCS, from my perspective, and I think other people's is that it is very large. So, it is very granular, but there is a cost of that in the code.
It is bigger, so it is not going to fit in any of the fields that people have now.
I heard complaints that they didn't have certain centers, so that maybe by constructing all these parts, you can construct many kinds of constructions, which is an attraction to it.
All expressions may not be in it. I am not sure that is still true. It may not have a piece for everything.
I guess in terms of disruption -- and I think we will have a decision about CPT no matter what, because why do you want to have people from code systems, when they are coding the same feature in the same operating room, the surgeon puts it in and then typically I think the CPT generates the ICD-9 in our setting.
It couldn't. I have tables all over the place. They record in the surgery log, or what the surgeon records in the surgery log is a CPT code. I thought that is largely how they code that.
Now, you may have three codes or two codes. I have seen tables that go back and forth. If someone knows more about this, I would like to hear it.
I half understood -- I don't know this clearly -- that basically they take one code and then they figure out what it translates into.
They have to make them match up because they get in trouble when they don't match up.
MS. GREENBERG: We have some expertise here.
MS. TRUSANA: It is not as simple as it sounds. There are cross walks but they still require someone who can understand both coding systems to review the code descriptor, look at what the surgeon actually wrote and then pick to make sure that it matches. It is not a one to one match.
MR. MC DONALD: It is not one to one, I know that, because one code in CPT might be hysterectomy or ovariectomy and in ICD-9 it is two separate ones. I think ICD-9 now is rather skimpy.
Still the big alternatives would be to -- I just read this letter from Blue Cross Blue Shield Association -- is to do nothing. That is what they are suggesting because it is going to be very disruptive to decide to go to ICD-10-ECS and we have choices on the procedure code.
One choice would be to go to CPT for the intake. That would probably be easier.
MR. COHN: I am sorry, you lost me.
MR. MC DONALD: I think it would be easier for a lot of places to just go to CPT for their procedure code. They are in the surgery systems. They are sitting in there. Every hospital, they have got a surgery log, and there is a CPT code.
MS. TRUSANA: Not every hospital keeps them like that, and not every hospital takes the CPT coding from the surgery log.
MR. MC DONALD: I am not saying they do.
MS. TRUSANA: For surgeries, the medical records review them and assign a code. So, they might have some of the CPT codes already built into their charts for smaller procedures like x-rays and EKGs and things like that, but not for surgical procedures.
MR. MC DONALD: If we are looking for efficiency, why are we screwing around with totally independent systems? I still would say, you go with one code. You go with CPT and make it easier on everybody.
MS. WILLIAMSON: Just by way of historical background, some of it shows in the letter, but the 1993 NCVHS report on a single procedure coding system stated that the existing system volume III notes CPT core as being inadequate for use as a single procedure coding system. So, that is on record from the full committee from a study done previously.
Also, to address the issue about CPT-IV, what I think the subcommittee heard at the hearings was that volume III is just so broken that we have to move to something else, and we can't wait for a resolution of the debate, the very long-standing debate which, by the way, goes back to 1986, about single procedure coding systems.
MR. MC DONALD: Can you be very specific about what is broken? Are hospitals going broke? Are people dying? What is broken. Who wants it? Who wants more? I don't hear anyone saying, you have got to give me more codes.
MS. TRUSANA: With all due respect, Dr. McDonald, I think if you go back and review the testimony that was presented --
MR. MC DONALD: I am asking a very specific question. Exactly what is broken and to whom?
MS. TRUSANA: That is what I was getting at. In the testimony that was presented during the hearings on 10-PCS, a lot of that information came out.
MR. MC DONALD: I was at the MPCS hearings a year ago or whenever it was.
MS. TRUSANA: There was one this year.
MR. MC DONALD: If it is badly broken, can you give me one example?
MS. TRUSANA: For example, there is the procedure code 9925, where it just says infusion or injection of therapeutic substance, and that is being used for a lot of different procedures. It is being used for -- I don't remember the details, but if you go in there, there is a list of about 10 different procedures.
MR. MC DONALD: Why is that a problem? We are always going to have some lumping. Who is that a problem to?
MS. PROFFITT: There have been numerous requests to the core maintenance committee to have additional expansion of codes that have been unable to be accommodated simply because there is no place in the system.
MR. BLAIR: I wish my memory was clearer. Please correct me if it is faulty. I thought that I heard testimony from Michael Levy of AMA on this question that you are raising, Clem, that the editorial board of CPT -- and feel free to make any contributions on this also -- that they really are not ready to assume that responsibility right away. It would take time for them to develop the additional codes to replace ICD-9 PCS, and that therefore there would be a delay. Do I remember correctly or not?
MR. EMERY: I think that is accurate. However, I think Michael did express a willingness for the CPT panel to undertake that. It certainly is part of the evolution from CPT-IV to CPT-V. That is certainly something that could be done by the editorial panel.
MR. MC DONALD: I just want to press hard on this question because I have a feeling, when we look at the big picture of health care today, that this is not our problem right now.
If I want to do research on infusions, I am not going to go to any of those codes. I am going to go to the drug records, and we have good records in the drug file. That is number one.
Number two, what it mostly is coming from I think is people who want to split up their billing to make more money and the money is going to get squooshed anyway. So, we are just fighting with each other.
MS. WILLIAMSON: It is not a billing issue.
MR. MC DONALD: Who is asking for them? Who is asking for these codes if they are not billers? The people who are asking for codes are billers. It is the people who want to get paid. It is the people who want to discriminate between their procedure and some other one to get the right payment.
MR. FITZMAURICE: The development of quality measures is limited by what the existing codes are.
MR. MC DONALD: That, I think, is the worst way to think about it. We are not going to be able to stick the whole elephant in a coding system. We have got lab tests and drug usage and we have got to be looking at a richer content than medical record. We can't stuff it all in the code.
MR. FITZMAURICE: If anyone who wants to identify patients who have particular procedures, particular ways of doing it and look at quality of care, you can't pull it out with some of the existing codes.
MR. COHN: I am really not going to comment on what procedure system ought to be moved forward or whatever. I am going to reflect on, when we started this set of hearings, I think our thought was that we would basically deal with diagnoses and other procedures separately. I think that had been our initial thought, which I think you were commenting on earlier.
We also heard some strong concern and requests from the hospital community and the coder community that, if you are going to move from one system to another, you should try to move them both, from the vendor community also.
You have a couple of options. Clem, you said you had other options about what to do with all of this stuff. One is -- obviously, we have the option to accept the letter completely, we have the option to abandon the letter completely, we have the option to divide the question. We have the option to get more input, at which point, if we are going to get more input, I would say let's have the whole committee participate in that discussion so that everybody can be informed.
Clem, it sounds like you had some other options?
MR. MC DONALD: I don't know all the details on this. The easiest thing, from my view of the information systems world, which is mostly in a hospital and clinics, and running systems and doing searches and doing research on the computer data is that it would be easier -- I don't know whether it would be feasible -- ICD-9, I think, is much skimpier than CPT. That is my understanding, there really is much less detail in it in general.
Whatever you did, if you could enrich one, you could evolve and make your choice about what everyone wants. You are basically deciding now to go to ICD-9 PCS for all of them, because it doesn't make sense to have these two silly systems, when the hospitals are going broke and there is just all this work and all this overhead and all this regulation. That makes no sense at all to me.
MS. TRUDELL: Let me reiterate a point that Marjorie made earlier, that this recommendation grew out of a number of very exhaustive hearings where we did listen to a lot of testimony.
The point that was made that started this letter was, we can have hearings until the cows come home, we can never get enough people in the room.
The idea behind this was to address and to give a lot of people an opportunity to weigh in as opposed to just whatever five or six people we could manage to squeeze in at a table for 45 minutes.
I know that Blue Cross Blue Shield Association has a raised an issue, there was a concern that the cost aspects of this hadn't been appropriately thought through with respect to both the hospitals and the impact on the payers.
The very process of developing a proposed rule and preparing an impact analysis gives us a chance to do that. This burden is basically going to fall on CMS. We are going to wind up having to do a certain amount of it.
That is okay, if you think it shouldn't be a proposed rule, that it should be the step before that, which is the notice of intent. You know, we can think about that.
I don't know how to get enough people in the room to get a complete discussion of this issue.
MR. MC DONALD: My other thought was we would actually propose two different things, as is often done in NPRMs and ask for comments. One would be to switch to ICD-10 CPS and the other one would be CPT.
MS. TRUDELL: CPT can't do that right now?
MR. MC DONALD: Not right now, in 2005.
MR. BLAIR: I would feel like that was okay if -- you know, you never know, when you have a day full of testimony and I wasn't part of picking and choosing folks that testified to us -- but I believe we had a bank of providers, a bank of vendors, a bank of payers.
MR. ZUBELDIA: We didn't have any payers.
MS. TRUDELL: Yes, we did.
MR. ZUBELDIA: We didn't have any payers. We had associations. They are not the same thing.
MR. BLAIR: I accept the correction. If it didn't go a whole day, it certainly went the better part of the day with testimony which was from a dozen different folks.
At least, from what I recall -- again, it may not have been entirely representative of all those sectors, so maybe it should be revisited.
It seemed as if it was all in favor of we need to go forward and there is not a perfect solution. I think the issue that you raised has come up from time to time as, gee, it really would be nice if we could wind up having PCS cover everything, except that it didn't seem to be ready for us to do so as an option.
The choice seemed to be, from everyone, let's go forward with ICD-10 PCS and throw it into -- not throw it into, put it into -- an NPRM. Let's see if there is reaction to it, but at least let's go forward.
Here is my thought, and you tell me whether you feel okay with this. There was so much testimony, Clem, it is hard to summarize.
Would it be possible or reasonable that you could go through the transcripts of the testimony, so that at least we are all singing from the same hymnal.
MR. COHN: Clem was at the procedure code meeting.
MR. BLAIR: Was he? I don't think he was.
MR. COHN: You were at the first one.
MS. TRUDELL: He was at the February hearing, where we had the code set developers. He was at the first one in February.
MR. BLAIR: But not the one on April 9-10; right? That was the PCS ones. Here is what I am about to suggest, is that if you go through those and then, if you still have the same feelings that you have --
MR. MC DONALD: I have some long-term feelings about this. I think it is a little crazy to try to stick the whole damned record into one code field.
MR. BLAIR: Right now it kind of splits, because a lot of us have heard one thing and you haven't heard that. If at least you go through that transcript and then you wind up saying, Simon, I still feel as strongly as I did --
MR. MC DONALD: The other question I have is, is the other alternative viable. I guess it is to suggest two possibilities.
I understand that this is what is true. The current code set is extremely shrunken, and I have known that. The ICD-9 procedures codes is very, very skimpy and doesn't say very much.
Is it true that the CPT-IV or V would be better at the present time or in the 2001 time, than that, and we still make a choice about final code sets.
We are prejudicing that decision by doing this. We are making that decision now.
MR. ZUBELDIA: I think the testimony was that we move away from CPT-IV and I think go with ICD-9. That is what they are doing in Maryland now. They are putting everything in ICD-9.
MR. MC DONALD: I would be happy to read it.
MR. BLAIR: Then if you wind up saying you feel just as strongly, then Simon could go ahead and schedule --
MS. GREENBERG: I don't feel that testimony that the committee has heard, et cetera, would allow it to recommend offering the choice that Dr. McDonald is proposing.
We got a summary of all the testimony that came before the CMM committee on moving to 10 PCS. With the exception of the AMA, which strongly objected to it, everybody else who provided testimony -- and that was an open meeting and anyone could provide testimony that wanted to, and it was well publicized -- supported moving to 10 PCS.
We have a long history as a committee of recommending criteria for a single procedure classification system.
CPT does not meet a number of those criteria. 10 PCS was actually developed in response to that report and meets those criteria.
That doesn't mean that it is perfect and I do think that this is a different situation, recommending an NPRM, than just saying do it.
As Karen said, the department is going to have to come up with an impact statement on the implementation plan, et cetera.
I think CPT has enough strength in the physician community that saying that this is just good-bye to CPT is just not the case.
There was a lot of concern in the original transaction and code set proposed rule about having a proprietary system. Now you are talking about proposing the proprietary system be the only system for coding procedures for all health statistics.
We are not able to use CPT. We have not been able to use CPT for health statistics, we use 9 CM, for DRGs, et cetera.
I would say that, before you are prepared to make that recommendation, you are going to have extensive additional hearings, and I think that that will then -- it is going to delay this for at least another year.
So, I think you have to recognize that. I personally just have to say that I don't think the committee can make that kind of recommendation to offer that option at this point.
MR. MC DONALD: The costing is an issue. I think we should have a net cost to user mechanism.
MS. GREENBERG: I can say, for 10 CM, we did hear from a lot of people who said they wanted it, lots of physician groups, a lot of people coming forward saying, we need this, 9 CM is archaic, it uses old language, it doesn't represent what we are doing. It would be easier for us to be using 10 CM because it reflects medical practice.
I don't know if you were saying who needs it on both of them or on just 10 PCS, but on 10 CM, we did hear that.
MR. ZUBELDIA: You raised the issue of 10 PCS having some of the classification areas without room for expansion.
MR. MC DONALD: Yes.
MR. ZUBELDIA: That is interesting. That hasn't been brought up in anyone's testimony.
MR. MC DONALD: I think most of the people in the community aren't deeply familiar with the code structures. I guess what I would then argue for is that we should throw out the original plan, we are not going to make decisions about procedure codes until we can resolve it.
This is a cop out. We may end up with the CPT forever, but I don't think that is the right way for the system to be ending up. I think we should end up with not doing all this work twice.
It might be good for certain professionals who do coding, but it is not good for the system. We should make the world simpler, so the system isn't more expensive.
MS. BURKE-BEBEE: There are two code systems now. What are they going to do anyway with a broken one, which we heard testimony that it is broken, badly broken.
MR. MC DONALD: I made my offer and that was rejected.
MS. BURKE-BEBEE: Which was to go forward with CPT. We heard testimony that didn't support it. It is not that we didn't hear it. It is was that it didn't support it.
MR. MC DONALD: Was it raised?
MS. GREENBERG: Yes.
MR. FITZMAURICE: I raised it in a question and the answer was that AMA felt that CPT could be made into a coding system to cover both inpatient and outpatient.
MS. BURKE-BEBEE: When we talked about this going forward --
MR. MC DONALD: The truth is, we have a radiology department. I don't know how they code, but it all goes out in CPT.
MR. BLAIR: Can I get back to this piece here? Frankly, you know, your view Clem, you know a tremendous amount about these coding systems and, frankly, I feel uncomfortable going forward if there are things that maybe we didn't have a representative to listen to.
It was clear that they really led us pretty much in uniformity to the decision that is in the letter now. If yo could simply review that testimony and if you still feel that we are making a mistake or the information was not representative, then I don't have a problem doing that.
MR. COHN: I think it is reasonable to ask Clem to review all the testimony from the day he wasn't there.
MR. MC DONALD: Is there anybody else who has any doubts about this decision?
MR. ZUBELDIA: I have a concern about the cost, about the cost versus the benefit. I have a concern about that. I don't think we have heard enough about that. I don't think we have heard from payers themselves. We have heard from associations. They are not always the same thing, as we have seen in the past.
I would feel a lot more comfortable hearing from some small payers and some hospitals, the actual users at both ends, and take a look at the cost.
I also know that the arguments for having both CM and PCS coming out at the same time, that is an argument of convenience and cost, and people were saying, we need to make this change and let's do it once instead of twice. I think that is where the cost part, I think we need to know more about it.
I would not object to separating the two issues, diagnosis and procedure codes, but I think cost is an issue.
MR. COHN: I guess going back, we heard from the physicians, as is, what we have now two in favor of voting on it as is, one against and one abstaining. That is hardly an overwhelming thing to bring to the full committee.
The question is, do we want to circulate this letter around, get some additional public comments, get additional people to come in and talk to us, on a day when Clem can actually be there as well as everybody else, and maybe include the rest of the committee.
I think these things are big decisions. I don't think that this is a security and standards subcommittee decision, at the end of the day.
I am just saying that this is one option. You guys have other options.
MR. ZUBELDIA: I think the it takes several months to put together an NPRM. I think that we can circulate the letter as is, while we continue investigating this issue.
If we need to send an additional letter saying, an additional investigation has resulted in us making this change, we can do that later. I think that we need to get going on this.
MS. GREENBERG: Nothing will get started until there is agreement.
MR. BLAIR: I would like to get back to this. It seems to me as if there is a gating factor here. Clem, if you read through the testimony and you say, okay, there is a lot of stuff I didn't realize, it has been addressed and I say go ahead with the letter, then in the next few weeks or a month from now, we can go forward with the letter.
MS. GREENBERG: No, it has to go by the full committee, has to approve it.
MR. BLAIR: If the rest of us are just simply --
MS. GREENBERG: You have to hold it until at least the September meeting.
MR. FITZMAURICE: I would like to pick on something that Simon said when we first started off on this, and that is that this is a letter that recommends an NPRM. It doesn't recommend the standards. It recommends an NPRM taking the following positions.
That letter just making those recommendations gives everybody more information on making a decision.
MR. MC DONALD: Can you put a minority view in the letter, or does that defeat it?
MR. FITZMAURICE: I think that is something for the full committee to decide.
MR. ZUBELDIA: Clem, if you want to add in the letter that the NPRM should contain an option, because of the reality of using CPT --
MS. GREENBERG: You yourself just said there was no testimony that -- there was no basis for saying that.
MR. MC DONALD: We are a committee. One of the things that I have always been told is that we sometimes believe that all we do is show up at meetings to hear what people say.
I didn't think that was our total job. I thought we were supposed to think about what we heard.
The truth is, we are going from 10,000 codes to two million codes. That seems like an awful lot of burden to put on hospitals.
MR. ZUBELDIA: There are not two million codes.
MR. BLAIR: There is room for that many.
MR. MC DONALD: How many are there?
MS. WILLIAMSON: It was in the presentation. It was 200,000.
MR. ZUBELDIA: There are 200,000 codes?
MS. WILLIAMSON: We can go back and look at the information that 3M provided, because it was covered in their presentation.
MR. MC DONALD: I think there was more than 200,000.
MR. FITZMAURICE: Why don't we go through what we agree upon and what we don't agree upon, and then we can present the issues to the full committee.
MR. COHN: Kepa, I need you to lead on this.
MR. ZUBELDIA: I think that is a good approach. What we agree on is ICD-9 levels one and two are broken and need to be replaced with ICD-10 CM. We agree on that.
We agree that that needs to happen as soon as possible and no later than October 2005.
We have agreed that ICD-9 volume III is out of room and needs to be replaced with something.
We agreed that the replacement should happen also as soon as possible.
MR. MC DONALD: The replacement of what?
MR. ZUBELDIA: The replacement of ICD-9, volume III.
MR. MC DONALD: I don't agree with that. My alternative position is, let's settle what the heck the final code system is going to be, like we said we were going to do a year ago.
MR. ZUBELDIA: The subcommittee avoided that issue. We discussed that and we said, let's avoid that issue now, because it would postpone that decision until we have resolved that issue. That may take another five years and, in the meantime, ICD-9 and ICD-10 are broken.
So, the discussion was that it was better to avoid that issue but continue with the work that we have now, and fix at least one of the tracks.
Then, when we are ready to resolve the issue, maybe we can address the issue at that point.
MR. MC DONALD: When I am looking at the health care system, that is not where I look at the biggest problem right now, is we don't have enough codes.
MR. FITZMAURICE: But it is the one in front of us right now. It is the issue in front of us.
MR. MC DONALD: If we just keep layering stuff on top of the system, it is going to crash. It won't work.
MR. ZUBELDIA: So, what is the resolution to this? Is there --
MR. MC DONALD: You can vote and I am not voting, and this is America, you know. You can say it was two to one and that is what the vote was and tell that to the committee. There is nothing wrong with that. I won't be offended or anything.
MS. GREENBERG: As the institutional memory here, there is precedent for the committee going forward with the recommendation with a minority opinion.
I think it weakens the committee's recommendation, obviously, but there is precedent to that. So, you asked is that possible and I think, you know, the committee could decide to do that.
MR. ZUBELDIA: We don't have to have unanimous consent.
MR. MC DONALD: What I would like to express is the fact that we don't know the cause of our problem, that somehow we have to get a unified system that no one really knows deeply what this ICD-10 PCS is and how it is going to work.
I think there are some advantages to that, but I would like to know the scope of it, what it really is. If it was 50,000, I wouldn't worry so much, but I think it is more than 200,000.
MR. COHN: We can find that out. So, are we recommending we go forward with a minority report? The committee doesn't have to approve the content of the minority report, does it?
MR. FITZMAURICE: It might influence their voting.
MR. BLAIR: Doesn't it undercut the sense of urgency that we are trying to go forward with if we do that?
MR. ZUBELDIA: I think the sense of urgency to go forward is very high. I think the reason that we are looking to move forward now is because of this urgency.
MR. BLAIR: I would like to express my personal view in terms of how I might vote, which is that, you know, up until Clem made his comments, I was heavily influenced by all the testimony, and it seemed to be weighted on the side of going forward, and reflected in the letter.
Clem's experience and perspective is something that I hold as very important and there is a missing piece here, and I really would like to know, if Clem has the information that we had, whether he would either alter his view or whether he would wind up saying that either we didn't have representative folks there to testify and we need additional testimony, or if there are additional issues, to ask questions that we failed to ask. I could change my vote based on what he says.
MS. GREENBERG: I don't know if I want to propose this or not. Obviously, I think we have heard several possibilities here. We could defer the whole thing, but we realize that could go on indefinitely, decouple them.
I mean, one possibility is to put forward a letter that makes a recommendation on 10 CM, because there seems to be total agreement on that.
I can say -- I mean, I have to be honest. My staff is responsible for 10 CM. So, I acknowledge that, but nothing can really go forward on this without a decision by the committee.
So, to delay the 10 CM part, you know, when there is consensus, has its cost. One possibility is to say in the letter, make the recommendation on 10 CM, say that you heard from the industry -- and also present the finding that 9 CM volume III also has to be replaced.
I don't think there is -- you said you don't think it is a big priority to you, but I really think that if you heard the testimony you would agree that nobody thinks that --
MR. MC DONALD: If we look at the testimony, you are going to have a large amount of testimony -- I am interested in looking at what was being presented and who the presenters were.
MR. GREENBERG: I think IMA was one presenter. That was it. AHA or AMA. In any event -- anyway, let me finish what I was saying.
That you also include in the letter the finding that 9 CM needs to be replaced, that we shouldn't continue with this, probably shouldn't even be continuing with it now, but in any event, indefinitely.
That we heard a lot of testimony about moving to 10 PCS, but there is testimony expressing concern about that as well and some outstanding issues, and that this committee is going to -- and the advantages of having a single procedure classification, which the committee recommended in the past, dah, dah, dah, dah, dah, and that the committee does see an advantage of doing both of these together, but that you are going to hold some more hearings on the subject.
I don't like that, but given that probably the NPRM isn't going to be written in a few weeks, that might buy you a little time, but Steve is really shaking his head.
MR. STEINDELL: I am looking at the letter from Blue Cross Blue Shield on 10 CM. If we use the argument that you just made, why don't we delay 10 CM also in both of our hearings. I don't agree with that statement. I am just taking the argument to its conclusion.
MS. GREENBERG: There is no alternative to -- nobody came forward with an alternative to 10 CM, other than staying with 9 CM, which nobody felt was an alternative.
MR. STEINDELL: Blue Cross Blue Shield is saying there are valid reasons, blah, blah, blah, which I don't necessarily agree with.
I think the approach that we should be taking is the approach that is recommended in the letter and get the comments coming in from everybody on why 10 CM PCS should or should not be used.
We need a broader base for the comments. The way to get that broader base is to go to the rule making process. Once HCFA goes through and does the cost estimates, et cetera, we are addressing some of Blue Cross Blue Shield's comments, because that is what they are talking about.
At least we have the government's idea of what this would cost and industry could comment back on that. You are right or you are not right. They do that all the time.
In the other areas, they will also comment back. We know they are not shy. Just because we publish an NPRM, that doesn't necessarily mean we will go to rule making the next week, and it also doesn't mean that the rule that we finally put out will take the shape of the NPRM. It can be totally different.
Our big problem, from what I gather, is that we have not gotten the depth of comments that we need from all the players.
I can assure you, once we publish an NPRM, we will get the depth of comments we need.
MS. GREENBERG: I agree with you, Steve.
MR. STEINDELL: I am in favor of doing it from a tactical point of view. I am also in favor of doing it from a practical point of view, but I think tactically it is the only approach that we can take.
We heard very clearly from industry what is out there is broke and needs to be replaced as fast as possible. If we start looking at things, we will be holding hearings, as was said earlier, from now until the cows come home. We will not get consensus from the hearings. We will have to go to the rule making process to get the information anyway, except it will be two or three years later.
MS. GREENBERG: I agree.
MR. STEINDELL: I think just from the tactical point of view, we need to get the comments coming in today.
MR. ZUBELDIA: We do have a precedent with the privacy subcommittee, of sending comments to the Secretary or recommendations to the Secretary in two or three phases, in separate letters on different topics.
We could do that and give Clem some more time to both review the testimony and, if we need to get more testimony from more people, and have a recommendation now, and then a second phase for CM PCS in September.
We can set our own deadline and say we will have a second letter for the Secretary in September. Would that work?
MR. COHN: What additional information would it take for you to have something in September?
MS. GREENBERG: It was, again, what Steve just said.
MR. MC DONALD: There are a couple of issues. I am sorry to be the sort of sticking point on this, but I feel there is this sort of framing issue.
If you said, we want 10 PCS, it has 300,000 codes versus the 10,000 codes, and you put it all in that frame, it makes a totally different response to MPRM than just to say we have 10 PCS and everyone assumes that is okay because we are the experts and we know all about that, so we are going to be okay.
That is our worry. No one knows about it. No one has looked at the damned thing. I am talking about us.
MS. WILLIAMSON: Just as a point of clarification, the ICD 10 PCS has been posted on the CMS web site for almost a year and a half at minimum.
There have been a number of organizations that have actually looked at it, they have actually tried working with it.
Comments have been provided back to CMS on modifications that would enhance the clarification at the level of detail in the classification. I don't think we can totally say that no one has looked at it.
MR. MC DONALD: The voting people on this committee.
MR. RODIE: A point of clarification. Wouldn't it have to be included in the NPRM? When you describe a system you are going to adopt in an NPRM, you have to put the system in that you are referring to.
MS. GREENBERG: Just like the implementation guides.
MS. WILLIAMSON: With the NPRM for the initial standards, we referred to appropriate web sites for all the code sets that were considered as candidates. So, there is some history in terms of how we send people to our potential candidate.
MS. TRUDELL: I think I am starting to get an inkling of a possible compromise solution here. We basically have written a two-and-a-half page letter where all but one paragraph of it talks about recommending ICD-10 CM and PCS, and all the reasons why the testimony said we should do it and all the reasons why it is a good idea.
Then we have one little paragraph at the end that says, this would be a good way to get information from people.
Maybe what we need to do to address this concern is to make it a lot clearer about the intent of doing this, and that our recommendation, the committee's recommendation, is a tactical one, and that it is one that the recommendation is not just to recommend publishing a proposed rule for ICD 10, but publishing a proposed rule that would recommend ICD 10 as a trial balloon, and that it would ask a lot of questions.
The letter could specify the kinds of questions and concerns that need to be addressed in the regulation. That is what we would have done anyway.
MR. MC DONALD: And that there is some concern about the expansion of the number of codes and put the real numbers in.
MR. ZUBELDIA: Part of the NPRM process is to gather that sort of feedback.
MS. TRUDELL: Exactly, so that it specifies that the purpose is not just to throw something over the wall. The purpose is to use this to get information that we can't get by just one panel at a time.
MR. MC DONALD: If that included some pros and cons.
MR. SCANLON: The NPRM is not the only way to get information. That is a fairly serious step along the way to rule making.
We will be interested in what the assessment and general reaction is. There are some preliminary activities that could be considered process-wise.
If you really don't know the direction to go, if you are genuinely not sure, you could back up to things like notices of intent, where you publish the idea that you have to consider, you are considering this or that, and you would like to get some basic information prior to the rule making process about directions.
It is a formal process but, on the other hand, it is not quite as serious a commitment as an NPRM.
MS. TRUDELL: You could leave that to the Secretary's discretion and simply say the committee is recommending the use of the rule making process, you know, to gather this kind of intelligence.
MR. MC DONALD: Put the pros and cons in it, to get people to think about both sides.
MR. BLAIR: Karen, could you add that to the letter with just another sentence or two, so that we could at least vote on that as a committee?
MR. COHN: I think this is a rewrite.
MR. ZUBELDIA: The concern that I have with that is that a notice of intent is going to delay the whole process by one or two years.
MS. TRUDELL: I understand, but if you leave it open to the Secretary's discretion as to how we use the rule making process, then we can work this out through our general counsel and figure out the best way to do it.
I think that we have got a statement in there that there is a time issue here, that there are things that need to be done.
There are options about developing, adopting CM and PCS at the same time or not at the same time, and again, I think that is something we just put on the table in this process and come out with a result.
MR. ZUBELDIA: Can we resolve 10 PCS in three months, between now and September? If we can resolve that, we are now in September.
MS. TRUDELL: Do you think so, resolve it?
MS. GREENBERG: We will not move to a single classification system, we will not resolve that.
MR. ZUBELDIA: If we can resolve that between now and September, it is worth waiting three months.
MS. WILLIAMSON: I just have a question, again reflecting on the history of the NCVHS and looking at code sets. Based on what I have heard and I think, Jack, you agree that right now CPT IV isn't ready. So, what is it that we would be resolving in three months?
Again, AMA says that CPT IV isn't ready. If it is not ready, then I don't think you could do it in three months.
MS. TRUDELL: The idea is that, if there can be one additional round of review and the subcommittee members feel a lot more comfortable about recommending both CM and PCS, then that is time well spent, and we delay and go forward at that point.
MS. WILLIAMSON: Just one point of clarification. What is it that the committee or the subcommittee would be reacting to?
If you are trying to evaluate something for its usefulness in a particular environment, but you don't have something available to review -- I am the one that is writing this letter, so I am looking for as much clarification here as I possibly can.
MR. MC DONALD: I would like to know how many codes there are so we can make those comparisons are up front. I want to know what the real incentives are to have more of these codes. Is it because hospitals are trying to get better billing?
MS. WILLIAMSON: It has nothing to do with billing.
MR. MC DONALD: I would still like to know. You keep telling me what it is not. I don't know what it is. I live in a hospital and I work in administration and I work in a computer room, and these aren't things that are burning up in our place.
MS. WILLIAMSON: It is the researchers --
MR. MC DONALD: I am a researcher.
MS. WILLIAMSON: Some of your other colleagues have a different opinion about the amount of data that they need.
MR. MC DONALD: The public health is not an important part of the hospital operation. It is an important part of the world, but it is not --
MR. ZUBELDIA: That is very concerning, what you are saying, that this has nothing to do with billing because from my point of view --
MS. GREENBERG: Of course it relates to billing.
MS. WILLIAMSON: It is an aspect of it but, again, it is not the only thing.
MR. ZUBELDIA: Let's make that clear because we are proposing the code for billing purposes.
MR. BLAIR: I am almost coming around full circle to our original idea, of moving forward, using the NPRM as an opportunity to get some additional comment.
Either this motion will fail, in which case we will have to look at other alternatives, but based on that and Steve Steindell's comments, I would like to make a motion that we approve the letter as is and bring it to the full committee. Let's see if there is enough to carry it. If there is not, then we have to look at alternatives.
MR. ZUBELDIA: Is there a second? Brady, do you second that motion?
MR. D'AGOSTINE: I am still trying to gather my thoughts on this conversation.
MR. COHN: That is understandable. I don't mean to sound stupid, and I am trying very hard to hold my words, but Karen did make a proposal.
MR. BLAIR: That is a complete rewrite and that is a delay.
MR. DENEHER: Only members of the subcommittee can second it; right? I am not officially a member, but I would second it.
MS. GREENBERG: It turns out that all the rules apply to the full committee. You don't need a quorum at the subcommittee. This is sort of new, but everything applies to the full committee, all the rules, all the FACA rules, et cetera, apply to the full committee.
We try to operate our subcommittees according to the same rules, with a quorum and all of that, of course open meetings and all of that.
MR. ZUBELDIA: Now the motion has been seconded. Is there any discussion?
MR. MC DONALD: Who seconded it?
MR. COHN: Even though I am recusing myself from the content here or trying to, do we have precedent for committee members coming in to second the work of the subcommittees? I am sorry, this is all new to me.
MS. GREENBERG: We could get John Lumpkin in here to second it.
MR. D'AGOSTINE: Let me second it, just so we can bring it to a vote.
MR. ZUBELDIA: So, the motion is to approve the letter as is and let it go through the NPRM process. Discussion.
MR. MC DONALD: I have already said all the things I have to say about it.
MS. TRUDELL: Could I just say one suggestion that might make things a little bit easier? We talked about a minority opinion, and if Marjorie could sit in for the rest of this discussion for me and take down any action items or anything, I will just sit here and develop that, and you can take a look at it, that brings up a lot of these concerns and issues.
MR. MC DONALD: The minority opinion?
MR. BLAIR: The minority opinion might go away after Clem has had a chance to review the testimony.
MS. TRUDELL: Right, but it will be separate.
MS. GREENBERG: Whose minority opinion is this going to be?
MR. ZUBELDIA: Karen, after you send the letter with a minority opinion, can Clem withdraw his opinion?
MS. TRUDELL: Sure.
MS. GREENBERG: That, I think, is a little bit bizarre.
MS. TRUDELL: The full committee has done this before.
MR. DENEHER: I was on the dissenting end of some of the privacy end. I thought what we did was frankly, when they did encompass two of the recommendations to the Secretary with a minority opinion, then it went forth with the full endorsement of the committee, given that my views were represented in that.
MS. GREENBERG: That would be an alternative, to put something in the letter to say that there is some concern about the following things, but the consensus of the committee is that these can be adequately addressed through the comment period of the rule making process.
MR. MC DONALD: I guess I would like a chance to both understand some of these dimensions better, and to say and get something in the letter that will stir the NPRM to raise these kinds of issues, to make sure that people who are commenting understood what they are getting into.
I feel a little bit like we are being railroaded. You know, there is this emergency condition, but I can't actually put my finger on it. I can't actually get a name for it. I can't find patterns that make full sense to me. So, what is the big rush on this.
MS. GREENBERG: Just picking up on what Karen said and this is obviously the thinking evolving here with what the group said, maybe better than doing a minority opinion would be to put a paragraph in the letter that says these concerns, you know, have been raised in regard to making these recommendations to you, but we feel that probably the best vehicle for really addressing them is through the comment period in the rule making process, and we do feel that these issues should be raised in the NPRM. Would that satisfy you?
MR. MC DONALD: Has this got to be done tonight?
MS. GREENBERG: Karen is prepared to do it right now.
MR. ZUBELDIA: Clem, could you work with Karen and redo the paragraph after the bullets or recommendations? That is probably the only thing that needs to be changed.
MR. MC DONALD: I would actually like a chance to talk to these folks who are the cheerleaders, to try to understand what is going on.
MS. KLAUS: We have heard testimony from the HIMA and we have consistently testified in favor of the same old system, because of the burden, the work and cost.
I think there might be the possibility of taking a couple of sentences here, where it says long-standing debate over -- that that is still, as far as I believe, still a debate, and that certainly came through also in the testimony. It was just how far down the road is that.
MR. MC DONALD: What I would really like to do is delay it, not so much just write another letter and put a sentence in it. When is the next meeting?
MR. COHN: August for a hearing and then September for a meeting.
MR. ZUBELDIA: Do we have any more discussion on the motion? We are now talking about changing a paragraph.
MS. GREENBERG: I made a friendly amendment.
MR. MC DONALD: That is what we could do. I just don't know if it is feasible or reasonable.
MR. STEINDELL: Are we okay except for the actual final form of the letter and we know what form the letter will take but we don't have the wording for it?
There is precedent to go in front of the full committee and ask for executive committee approval, based on the principles that we enunciate at the committee, and draft the letter over the next three weeks and have the executive committee look at it, get approval from the subcommittee and then the executive committee.
Then we are only delaying three or four weeks instead of three months.
MR. BLAIR: That would give you time to review the testimony and deciding whether or not you want to express your concerns.
MS. GREENBERG: The full committee is meeting three months from today.
MR. COHN: Those are alternatives.
MR. MC DONALD: A strong minority, not report, but the negatives that may be involved in this and some other options or issues that we should wrestle with, such that the NPRM would come out -- they do often say we don't know about this or this, they have these nice statements, and they are going to get good comments. People would trust us to know what we are doing. I don't feel that trustworthy right now.
MS. GREENBERG: Your comments are still related to PCS?
MR. MC DONALD: Yes.
MR. ZUBELDIA: So, what you are suggesting is adding or changing one paragraph in the draft recommendations. Here it says, the publication of the NPRM would serve the general purposes.
You don't want to say that. You want to be very specific as to what it is we want to accomplish with the NPRM.
MS. WILLIAMSON: This is probably going to take more than just a paragraph. Basically, the language, as it is written in the letter now, keeps CM and the PCS together. So, the letter is going to have to be revised to separate the two, so that the issues that Clem or the minority opinion about some additional concerns about PCS can be clarified and expanded upon.
MR. MC DONALD: The other thing is people kind of think that ICD 10 PCS must be from the World Health Organization. So, that is a little misleading.
MR. COHN: Can I just make a suggestion just to move the process forward, since we seem to be pulling our hair out a little bit, what hair we have?
Clem, are you suggesting that we table this?
MR. MC DONALD: I am not opposed at all. I think that the idea of having an NPRM that would really explore the issue would be good, so I am not opposed to this, and this letter doesn't come close to that.
MR. COHN: I guess what I am asking, do you want to hold the letter until we have had a chance to further discuss it?
MR. MC DONALD: I guess a couple of weeks.
MR. BLAIR: What if I withdraw the motion that I made?
MR. DENEHER: With all due respect, I don't understand why Steve's recommendation is not the right solution, which is, just to quickly encapsulate it, which was that a vote was taken, was seconded, and Clem is not in disfavor to move toward NPRM and then vote on it with the greater executive committee and then, in the interim, take two, three, four weeks to actually write the letter.
MR. MC DONALD: That would be all right if, indeed, it would allow -- the committee would allow a fair amount of raising questions.
MR. COHN: Let me explain to you why I was concerned about this particular process, because I think what we are talking about is a major change in the tone of the letter. This is something that Clem is not on the executive committee. Are we going to send this around to everybody to get their opinions?
I think that that is personally not workable. If this was just word smithing and we had gotten it 98 percent right, I would say, absolutely, what you are describing. I think what we are hearing is we have got it about 67 percent right. I may be off on the percentages a little bit, but there is some stuff that really needs to happen with this letter that everyone needs to agree with.
MR. ZUBELDIA: If it is more than just changing a paragraph, we probably ought to discuss it at the entire subcommittee meeting.
That would give Clem more time to look at the testimony. If necessary, we can bring some additional people to talk about the cost issues, and then draft the letter before the next full committee meeting in September.
MR. DENEHER: Can I push back on you guys for a second? It sounds like you are trying to get some of the MPRM process stuff into that subcommittee.
I guess that I think Clem's goals and objectives would be served by raising his concerns and then -- I guess what I am getting at is, what I am hearing you delve into are really things that the NPRM process would do. You are trying to do that at the subcommittee level.
MR. ZUBELDIA: We are trying to recommend to the Secretary to start an NPRM process. That process is going to take a couple of years. I think that a three-month delay is not as dramatic a delay in the overall scheme of things.
I feel a little more comfortable with saying, let's table this for now and take a look at it in our August meeting with Clem's full information and the option to bring somebody to testify on cost issues. Then, bring it up in September, at the full committee meeting.
MR. MC DONALD: The key is just to write the letter. If we are claiming this is the right thing, we can the look everybody in the eye and say, this is the right thing.
MR. ZUBELDIA: I think it is worth having the consensus of the subcommittee on this issue. I think just waiting three months to obtain that consensus, rather than a dissenting opinion now or even a partial recommendation now for ICD 9 CM and holding in the PCS recommendation, it would be better to have just one recommendation for both together, if that is the way we are going to go.
MR. BLAIR: Yes.
MS. BURKE-BEBEE: You are saying to not take this to the executive in July in Chicago, but to do it in August.
MR. ZUBELDIA: Yes, including our subcommittee meeting in August, and take it to the full committee in September.
MR. COHN: By the end of the August meeting, we would have an agreed-to letter which then goes into the packet.
MS. BURKE-BEBEE: Is there any conference call possibility?
MR. BLAIR: Clem, there is one thing that I do feel very strongly about, is that I just feel it is really important that we are all working with the same initial information.
MR. MC DONALD: I will read the testimony.
MR. ZUBELDIA: Do we have access to the transcripts of the meetings yet?
MS. BURKE-BEBEE: The last I looked, they weren't posted yet.
MS. GREENBERG: We have all the transcripts. I just want you to come to my office with me on Monday so I can tell my staff. They are going to be broken hearted.
MR. ZUBELDIA: How about Jeff's motion? Do you want to withdraw it or should we just table it?
MR. BLAIR: You can go either way, whatever you preference is.
MR. COHN: Why don't you withdraw it?
MR. BLAIR: I will withdraw the motion.
MR. COHN: Thank you all. This is not easy stuff.
MR. MC DONALD: Marjorie, if you get a replacement for me, this won't come up in August.
MS. GREENBERG: You have certainly given me a motivation.
MR. COHN: Recognizing that it is almost 5:00 o'clock, we just need a time check, since we are running about an hour and a half late on the agenda, at this point not surprisingly.
Are we prepared to go on to 6:00 o'clock? Okay. Now, why don't we -- Brady, as you still there?
MR. D'AGOSTINE: I am still here.
MR. COHN: We appreciate your forbearance here. Do you want to talk some about your assessment process or at least your statistical evaluations for the compliance extension plans?
MR. D'AGOSTINE: For the assessment, for the compliance extension plan, all I did was draft and disseminate to everyone on the subcommittee just a basic extended line and analytical plan, basically just delineate the sampling methodology that we would have. Most of the information would come in electronically via CMS' web site, autocompliance plan, but some of that will be coming in on paper and we will need to sample that, so we ensure that analyses that we do via our statute would be representative of all the providers.
That is basically what this paper describes, is that methodology. The only thing that I did want to include in here, and I need to talk to Karen a little further, I understand that she has some newer numbers on the number that she received via paper and electronic. I need to put those into the algorithm and maybe update the sample size based on that. As well, I need to incorporate a time line. I need to state in here that we are also going to be doing some cross tabbing or some analyses of different subpopulations.
Other than that, for those of you who have more experience writing documents for the NCVHS or for the government, please add into it as necessary. I am kind of used to the business world and the writing style there is a little bit different than for the government.
MR. COHN: Brady, I don't know that you needed to write anything differently. I just had a question about your sample sizes which, as I read them, said basically that you would take everybody that submitted things electronically, which I thought was very appropriate. I had some trouble figuring out, based on your calculations, that you were positing that you only needed 43 paper notes evaluated.
I didn't send you an e mail but I was trying to mull over in my own mind -- I was looking for enough to show that there was a lot of difference between the two populations and, if there is a difference, being able to identify that; correct?
MR. D'AGOSTINE: The sample size is like geometrically related to the numbers in your sample. For instance, say two thirds of them -- we estimated 666,000 were going to be electronic. That adds a lot of precision and a lot of power and granularity. If one third of that was on paper, it wouldn't take too many of those to -- we are moving out five percentage points on either side of our estimate, which we are taking a worst case scenario of 50 percent.
It doesn't take very much. The concerns that you have of it being a smaller sample size are reflected in the fact that you are taking two thirds of a million of things that you know about and all of a sudden you are expanding your error plus or minus five percent. So, the concerns you have with smaller sample size are reflected in that uncertainty, in the plus or minus five percent.
MR. ZUBELDIA: Brady, a concern that I have on that, first is that, of course, the number of paper submissions for ASCA would be a lot less than one third. So far there are about 20,000 that are coming in electronically --
MS. BURKE-BEBEE: About a thousand on paper.
MR. ZUBELDIA: So, it is a ratio of about 20 to one, five percent. So, it is not 33 percent, it is five percent.
MR. D'AGOSTINE: Actually, we could rerun it so that it is plus or minus three percent and actually end up having about the same sample size.
MR. ZUBELDIA: The other concern is that there is a lot of incentive to filing the form electronically, very strong incentive, because you get an acknowledgement of receipt and so on.
The people who are filing on paper must be because they have a very strong reason to file it on paper. I think that probably -- this is just a guess -- it probably is just because they cannot express some additional something on the electronic filing that they want to file on paper. If that is the case, we may have to increase a little bit the paper sample size to reflect those additional concerns that are motivating them to file on paper so strongly.
MR. D'AGOSTINE: Basically, what you do is you will take the proportion that were correct and you are going to weight them for their relative weight in a total population. So, even though you are only taking a sample size of 48, when you bring that together with the information from the electronic, it will be given a weight of one third or 333,000 as currently constructed.
Even though it is a small sample size, those numbers are still very valuable in the overall numbers. The way it is constructed right now is, in order to minimize the sample size -- I know that the resources are limited -- when we are talking about error rates, we are just talking about error rates for the entire population. If we want to make inferences on the paper submission population by itself, the sample size would increase dramatically.
MS. TRUDELL: I haven't actually gone down to the mail room to look at the ones on paper. The first few that I saw were basically they took the model compliance extension plan and they wrote very small in all the spaces. I don't think it is somebody trying to convey additional information. I think it is people who don't have computers or don't have access to the internet. That is a factor, too, that sort of sets up a subpopulation.
MR. SCANLON: Again, for the electronic version that is on the CMS web site, and apparently for the paper version as well, it is basically a precoded form. I was wondering, isn't it a situation where these could be used to tabulate the sample size?
MS. TRUDEL: I had been anticipating using the entire population.
MR. FITZMAURICE: The question of, would it be interesting or necessary to consider that the paper submitters are from an entirely different population from those that submitted electronically, and could you aggregate it across all the answers to get a statistical test of, do they have different variants, for example, are they different population?
MR. D'AGOSTINE: In fact, that is probably the first test we will perform, is to determine whether those populations are different and, if not, possibly just use the electronic data and then you won't have to worry about the error in each side because you will have all the data. We use the data from the electronic side to infer for the entire population. I can't say that in the study design, because we don't know that yet.
I would surmise that they are probably different, if not in their entirety, but remember, we are going to be looking at each of these individual questions. So, if I can't say this about every questions, then I don't want to move in that direction.
I would surmise that they are probably different, because the people who submit paper are not as technologically adept as those that are. That is one of the things that we are gearing toward here in the first place.
MR. FITZMAURICE: That is a suspicion. It is good that you are going to be testing for that first.
MR. COHN: Obviously, this is just the basic methodology. I think the questions we will have to mull over between now and August would be, what kinds of things would we want to be investigating.
MS. GREENBERG: Thank you, Brady.
MR. COHN: Yes, thank you.
MR. D'AGOSTINE: It gave me a chance to platform.
MR. COHN: It is easy to see why you are the senior statistician for your company.
MR. D'AGOSTINE: Now that I am an executive, I don't get to do this as much. So, it is good for all.
MR. COHN: We do appreciate it.
MR. ZUBELDIA: I didn't know Microsoft worked to do this fancy stuff.
MR. COHN: With that, we can look at the questions and think about what questions we can be asking the data. Should we move on to talking about subcommittee issues for 2002, plan for the meeting, hearings?
MR. COHN: Do you want to lead off? This has to do with, I think, Alternative Line steps.
MS. GREENBERG: Actually, I received a call from a reporter, who wanted to write an article on the subject of what was happening with the Alternative Link codes, and told me that it was her understanding that, at the August meeting of the subcommittee, there would be some additional testimony from providers, payers and others about the needs for the codes.
I said, well, I think I checked with Simon and Karen and that wasn't our understanding. So, I told her that and left it, that it wasn't currently planned for the agenda.
Then I got a call, as I said, from Molina as well. Definitely, that was her understanding. I said, there is fortunately an answer here, at least as to what was said at the meeting.
I said, they are going to be meeting again in the next week or so, but at least this is what was said at the meeting because there is a transcript, but we don't have it yet.
I just got the transcript yesterday and I read the pertinent part, and I can understand why there was confusion.
Toward the end of the discussion with Alternative Link, Dr. Zubeldia said -- well, most of the discussion was about Alternative Link's interest now, after not feeling that it was able to work successfully, at least at this point with AMA, about getting the code set adopted or incorporated or in some way adopted into the HCPCS coding system.
So, there was a lot of discussion about that and whether that would entail a completely new code set, would require a rule and all of that. But put that aside.
At the end, Dr. Zubeldia said: I think they should probably start exploring that -- this is whether HCPCS structure could accommodate the codes -- and have a report from the HCPCS national panel at the next meeting, which would be August.
In the meantime, in the next meeting, we should probably bring some providers and payers to talk about this so if there is, or when there is, a solution as to what is the proper home for this coding structure, we would have a better opinion as to whether to recommend that it be adopted or not.
Then Ms. Molina said: We would also like to encourage the panel to invite academics and perhaps folks from MCAM to the next meeting as well, so that we are not only representing the need to establish payment, but the need to measure outcomes.
Okay, however, then Dr. Cohn said: I guess I would agree with you, Kepa, but I am just sort of trying to think of the process we are describing here.
I do not know that, pending the outcome of whatever discussion occurs, I guess with the HCPCS panel, or recommendations by the national panel or otherwise, that we need, at that point, we need to hear from them first before we start mobilizing to hear from the constituency, just because there may not be a need.
That is really the only issue that I think we need to explore. As you know, we are trying to figure out what the answer to the next processes are, and we are just going to have to see what happens, at which point Dr. Zubeldia said -- and only you can tell us what you mean by this, Kepa -- So, that is some more homework.
MR. ZUBELDIA: We were going to hear from the HCPCS panel before we invite anybody else.
MS. GREENBERG: Yes.
MR. ZUBELDIA: There is homework for us to do before we can get anybody else involved.
MS. GREENBERG: I think that was the last word although at one point it was suggested that at the next meeting -- that is how I read it, too. So, I need to get back to them now that the transcript is available.
So, at the August meeting, if the HCPCS panel is prepared to report back, you want to hear that.
MR. ZUBELDIA: Like a 10-minute report from the HCPCS panel.
MS. GREENBERG: Then you will decide if you want additional testimony.
MR. ZUBELDIA: If we need to hear from other people or not.
MS. GREENBERG: They do need to know this. They were going to start mobilizing people and getting people to do testimony and all that. If it is not going to be for August, they need to know that.
MR. MC DONALD: Alternate Links, is that alternative medicine?
MR. ZUBELDIA: Complementary medicine, and procedure codes, to take a look at the overlap between the two code sets. There are some other things to look at before we move forward.
MS. GREENBERG: In the transcript are some of the questions that were raised.
MR. ZUBELDIA: If they said they would need the codes, we probably -- well, we will see what happens.
MS. GREENBERG: So, you want to hear from the HCPCS panel in August, if they have something to report.
MR. COHN: Tom Christoffeson(?) was unclear whether he was going to be there in August or September, whoever it is.
MS. GREENBERG: In any event, you are not now seeking testimony from payers and providers on the AGC codes for the August meeting.
MR. ZUBELDIA: No, not for the August meeting.
MS. GREENBERG: Okay, thank you.
MR. COHN: Let's talk a little bit about -- we have three hearings coming up in August, October and December.
Jeff, the issues for the subcommittees would be what we are thinking about meetings happening over the next while, recognizing that some of this is pretty fluid. Let me just run through these, and I know Donna is the keeper of all the code set issues, so she will help remind us about some of those.
The first ongoing issue we have is tracking implementation, which is just an ongoing issue. I didn't identify any additional action that needed to occur on that in the next six months. As I said, I think December is open at this point.
MR. BLAIR: In tracking HIPAA implementation?
MR. COHN: Tracking HIPAA implementation and the specific item on that one.
Item two, I will just run through what I thought, these are changes and updates to current standards and new standards.
I think a DSMO group had asked to come and report to us and talk to us in October. I thought that would be a good time for that and it would actually be a good time to talk to them also about how implementation was going and all of that also.
There is electronic signature. The last time I talked to Kepa, there was no action pending for the next six months.
MR. ZUBELDIA: There is still no action and we will postpone until some time next year.
MR. COHN: Enforcement and compliance, similarly, I have not heard any need for action on that, but I would defer to Karen, if there is a need for us to have further hearings on that topic later this year.
MR. BLAIR: If it is budgeted.
MS. TRUDELL: It is budgeted. The plan and provider ID are both budgeted.
MR. MC DONALD: For next year?
MS. TRUDELL: Yes.
MR. MC DONALD: There is a newsletter I get and Bill Braithwaite was quoted in there as saying -- now I may be all wrong -- that we will soon have the doctor thing and there may be some provider things with it, the institution IDs.
MR. BLAIR: Jim, you had given us a briefing on that.
MR. SCANLON: Bill was speculating, but the regulatory plan we issue is still probably the best bet. I think Karen told us about the security and claims attachment were sort of protected for later, were protected in the regulatory plan for August. I don't think we projected the provider ID.
MS. GREENBERG: Is that 2002?
MS. TRUDELL: It is in the fall or our next agenda somewhere. I can't remember what month it is, and the plan is proposed.
The concern about lack of funding was so, because we do have funds in the President's budget and Congressional justification, and those are sufficient to build and enumerate in 2003.
As long as those funds stay where they are, the regulations continue to move.
MR. MC DONALD: And that is a seven digit figure?
MS. TRUDELL: I can't comment on that. This is a public forum.
MR. COHN: This will be an NPRM before it comes out. This is not something we need to comment on. You can write your congressman.
Item 5 is PMRI next steps. I think it is to begin hearings on health care terminology in August, at least for one day, and then we can sort of see where it goes from there into October or December for additional discussions.
The next item is the Administrative Simplification Compliance Act. We already talked a little bit about the analysis today.
There is the issue of publishing reports on solutions, and we need to find some time to talk about it. We haven't had a chance. I don't know whether you want August or September for that topic.
Our responsibility within the legislation is to publish reports on effective solutions. That might even be an August or September discussion.
Code set issues, I wrote further discussion in August. Clearly, we are going to have further discussion in August about that letter to deal with.
Donna, you have other items? There was a white paper on DSM and hopefully helping form a letter in relation to DSM and what we should do about that.
MS. GREENBERG: I don't know if we made copies for everyone, the American Psychiatric Association testified on this and they also sent a letter, I guess it was a letter to the Secretary with a copy to you as chair of the subcommittee, and a copy to John Lumpkin.
MR. COHN: So, anyway, there is a white paper.
MS. WILLIAMSON: The white paper is being expanded to include some of the issues addressed in the letter, which was also addressed in the testimony that they provided to the subcommittee.
MR. COHN: Obviously, this issue also includes responses from the HCPCS national panel, may involve something about alternative health care as it comes forward.
Obviously, the letters to review seem to be every meeting. Those continue on. What I wrote down at number nine is this issue about including the HIPAA process.
I think that maybe October, especially when the DSMOs are here, we may actually have some input from the regulatory -- what do they call it?
MS. TRUDELL: Secretary's Regulatory Reform Commission.
MR. COHN: It may be that they may have some suggestions. I think we need to reflect on that one a little bit.
As I look through this one, August day one is clinical terminology, step one. Day two will be the letters on the code sets, the white paper. With any additional time, code set issues.
October is sort of a combination of the DSMO presentations on recommendations on updates and changes to current standards and new standards, as well as perhaps a conversation around improvements in the HIPAA process.
Right now, December is sort of to be determined.
MS. TRUDELL: October has to include the ASCA discussion.
MR. COHN: Yes.
MR. BLAIR: We might want to accept testimony on some of the PMRI issues.
MR. ZUBELDIA: We need to keep our ears open for the Kennedy bill, the e health bill, that was just introduced. If something happens with it, it could turn HIPAA upside down.
It was introduced last week and it essentially requires providers and payers to adopt the latest technology, without defining what that means, the latest technology for implementing administrative transactions and requires the use of the internet with a secure web site.
The concern is that the latest technology could mean XML instead of EDI, which is a 20-year-old technology. If it means XML, it is back to the drawing board.
MR. MC DONALD: Write a translator.
MR. ZUBELDIA: It was introduced last week, last Wednesday. It hasn't gone anywhere yet.
MR. COHN: It hasn't gone anywhere yet, okay.
MR. ZUBELDIA: There is a similar proposal in the House. It requires the use of an internet secure site to send transactions.
MS. TRUDELL: It doesn't say what that is?
MR. ZUBELDIA: It doesn't say what that is. It doesn't say what the latest technology is.
MR. MC DONALD: You will never get there, because it won't be the latest.
MR. BLAIR: Do you have any idea who is behind it?
MR. DENEHER: Web MD.
MR. ZUBELDIA: I don't think so.
MR. D'AGOSTINE: I have another thing. There is a thing today in the Kaiser Daily Report that the Blue Cross Blue Shield Association says they expect the introduction of legislation to delay all the HIPAA rule enforcement until all of them are in place. They are doing it again.
MS. BURKE-BEBEE: Simon, I am going to be working toward the August meeting. It looks as though the terminology is on the agenda, the new letter will be on the agenda that we have just discussed, the white paper, DSM, and also there was the HCPCS panel issue, 10 minute report, that kind of thing.
MS. GREENBERG: If there is something to report. What about the second bullet under six? When did you want to discuss how you are going to map that?
MS. TRUDELL: We could start running you reports when we have a critical mass of data. We just don't know when -- they are starting to go up, but it is about 800 a day.
MR. ZUBELDIA: Twenty thousand is a pretty good mass.
MS. GREENBERG: What I am wondering, though, is what kind of strategy you want to pursue. You will get these reports and basically they will indicate what some of the problems are that people are having with compliance.
So, what kind of strategy do you want to pursue to be responsive to the requirement that you publish reports on solutions to these compliance problems.
Do you want to somehow partner with WEDI SNIP? Do you want to get a consultant to work with you? Do you want to hold hearings? Those are the things you need to be thinking about.
MR. MC DONALD: Don't we have to know the compliance problems before we find a solution? We haven't gotten to that stage yet.
MS. GREENBERG: I am not saying what will the solutions be so much as how will you arrive at them.
MR. MC DONALD: Is there money for consultants and things like that?
MR. COHN: Within reason.
MR. MC DONALD: Let's get a consultant.
MR. COHN: I think it would be useful certainly to have a conversation to talk about what the issues are. I think WEDI SNIP has done a good volume of work. I think it would make sense to have a conversation with them to understand it, sort of see what they think about it.
MS. BURKE-BEBEE: What is our time frame on that?
MS. TRUDELL: There is no time basis. I guess on a flow basis.
MR. D'AGOSTINE: There is not a date in 3323.
MS. GREENBERG: Given that now people are supposed to be compliant by October 2003, sooner rather than later, obviously.
MR. COHN: Maybe we can do some of this stuff in August. Is there a way to run some things and see if there is anything there between now and October?
MS. BURKE-BEBEE: Wouldn't some of the testimony that we are going to hear from early adopters possibly feed into that?
MR. COHN: When are we hearing that?
MS. BURKE-BEBEE: Tracking implementation, aren't we supposed to be hearing about implementation?
MR. MC DONALD: I think there is a problem with looking at it on the front end, because we will put a negative spin on it, if we talk about it in the early end, how we are going to check on compliance.
MS. GREENBERG: That is not what we are talking about.
MS. TRUDELL: What we are talking about is using those compliance plans to try to correlate, based on things like geographic location, provider size and type, what the compliance problems that people are having are, so that we can take a look at it.
MS. GREENBERG: Like a technical assistance type of thing.
MS. BURKE-BEBEE: I had suggested that we could hear from early adopters that could tell us what their problems were.
MR. COHN: I think we have already heard from early adopters. I don't think there are early adopters any more. This is not October or even August. A year ago was early adoption. I think we need to be hearing about late adoption problems.
I think we have to take a look at the agenda. We have taken a whole day for clinical and we have got a letter, and we know how long that is going to take. The question is, do we spend our time better listening to some early adopters or do we do better looking at some of our data, talking to WEDI SNIP about how they are identifying and beginning to work that.
Maybe in October, we are talking about the DSMOs, about changes in updates. Obviously, they are getting issues around changes in updates because people are having trouble, at least I would imagine, or they have needs for additional functionality. So, the would be a good group to hear from.
We are also going to be hopefully hearing about issues that people have with the process, which I think is more the problem than probably standards at this point. I hear many more times a week that people are frustrated than the standards aren't out yet, than I do about the specifics of the 837 or whatever.
MR. FITZMAURICE: Also, about the length of time it takes to change them once they are out.
MR. COHN: That is true. So, maybe October is maybe the focus of that.
MR. ZUBELDIA: I hear a lot about transition issues, what to do between now and October 16, 2003. That is a topic that I don't know that there is anything we can do about it. It just comes up constantly. The last few months it has just been a constant issue. If you become HIPAA compliant today and you want to submit claims to a payer that is not HIPAA compliant, what do you do.
A clearinghouse can't solve the problem because there is a disconnect. Today the concern is, the type of service is not in the HIPAA transactions. So, how will they pay those? The clearinghouse can't make it up. There are issues like that coming up all the time. The transition will go away. Certainly, October 16, 2003, they are gone. So, I don't think there is much we can do about it.
MR. MC DONALD: The payer makes tons of money because they don't have to pay that claim.
MS. GREENBERG: Just a word of clarification. On this letter which tomorrow you are going to withdraw, I guess --
MR. COHN: I don't think it was ever on the table, actually.
MS. GREENBERG: You presented it.
MR. COHN: We will hold it, I am sorry.
MS. GREENBERG: Then you are not going to have any more testimony in August. You are just going to work on the letter.
MR. ZUBELDIA: There could be, if you determine in the next couple of weeks that we absolutely need to hear from the people that would talk about the cost issues.
MS. TRUSANA: They are not going to have that data available if you just give them one or two weeks notice.
MR. BLAIR: Within the next two weeks, so that they would have five weeks or six weeks.
MR. ZUBELDIA: We would have the critical decision and we could put a panel together for August that talks about the cost.
MR. MC DONALD: I would just hope that I could figure some of this stuff out. I can get some input. I wasn't looking for testimony. It may be useful, but I am not looking for it.
MR. ZUBELDIA: If you are not looking for it, then we are not looking for testimony in August.
MR. COHN: I was going to ask Jeff to talk about day one in August. Are we generally okay with the way things are going over the next couple of months?
I am struggling because there doesn't seem to be enough time. Having said all this stuff, my concern is that we have a lot of very important things that we need to be doing and it is really a question of juggling.
I need help from all of you if you think there is something that it is more important that we handle it sooner. With that, Jeff, do you want to talk about day one?
MR. BLAIR: Yes, and given the time and given that I want to head to the bathroom as soon as possible, I am going to make this pretty brief.
Simon and I had talked about how we might begin to proceed with the second phase of PMRI standards, being the clinical terminology recommendations. We thought that we would use an approach that was similar to the approach that we used in developing the PMRI message format standards.
Namely, reviewing a work plan for how we will proceed, and I plan to get that to you in an e mail fashion before the end of July, with the idea that there will be at least one iteration for people to comment and correct before we get to our August meeting, when hopefully we get far enough along on the work plan that we can wind up saying, yes, we agree to the work plan.
I am actually going to be mentioning four different aspects to this piece, and then there will be a little bit more in the August meeting. The first piece would be before the end of July, the work plan for how we are to proceed. The second would be modifying the criteria for the selection of standards so that it is appropriate for what kind of terminology is as we modified it, to be appropriate for message format standards. We do the same thing here.
So, it would just be taking the original guiding principles from our report to the Secretary August of 2000 and making those modifications, also get that all to you by the end of July.
The next thing would be -- these are all initial drafts. These are just to get the process moving so you won't be seeing this stuff for the first time at this meeting. The initial thing would be some kind of framework or scope for what would be included in the clinical terminologies, PMRI clinical terminologies that we would be looking at, and how they might relate to each other.
Again, by the end of July I will get that to you. The last thing would also be the very first cut at a questionnaire that we could send to the code set developers, that would assist us in gathering information from the code set developers, just like we did with message format standards.
Out of those four things, whatever you are able to do in terms of reviewing those and giving me some feedback in early August, I would update those so that we could then look at them August 28.
Then the other piece is -- whatever input you all could give to me on the 28th. There may be some initial presentations that we could start to pull together that would sort of give us guidelines on the issues, maybe some additional discussions on characteristics for quality, code sets, so that we are all understanding the criteria as well as possible.
MR. FITZMAURICE: Jeff, by that do you mean code sets about quality or desirable characteristics of a code set?
MR. BLAIR: Desirable characteristics of a code set. The only reason that the word quality crept into my vocabulary was that when Peter Elkin, for example, took the work effort that at least the trail that I remember is Jim Sumido doing his original desiderata and then Chris Schute and Simon wound up making the ANSI-HISP document on the criteria for a good terminology.
Then that thread seemed to have continued with Peter Elkin formalizing a little bit in an ASTM document, what would be a quality clinical terminology. So, that is how it crept in.
I would really appreciate any suggestions or guidance that you have in terms of anyone else that you feel should be giving us foundation information on how we approach these issues for the August 28 day.
MR. COHN: I would imagine we would probably want a panel of people to provide us some guidance around some of this stuff. Clem, I think you have some suggestions.
MR. MC DONALD: I don't know. I think it is pretty well described, but there are some code sets which I don't know much about which I would like to know more about.
MR. COHN: A review of where we are, the landscape of clinical terminologies in 2002.
MR. MC DONALD: The med wrapping charges at drug companies.
MR. COHN: I think that gets at the issue of what is a clinical terminology and what is not. I did talk to Betsy Humphries who is not going to be able to join us for August, but she said she will send experts to assist on the question of what is a clinical terminology and what is not, which we may have a couple of days and still not have the answer.
MR. STEINDELL: Simon, I am a little concerned about if we talk to the usual group of informaticians to give us guidance. We are going to get the same guidance that we have in the past at multiple meetings.
We might want to consider, for guidelines, hearing from some people who are actually involved with making these types of decisions or implementing them.
I was thinking about maybe bringing in someone from the NHS in England, who have given a lot of thought to what types of decisions we should be making in terms of putting in an implementable terminology for PMRI.
MR. BLAIR: Do you have some individuals? I will put it this way. Please send me a list of folks.
MR. MC DONALD: I would like to hear that approach.
MR. COHN: I think learnings from that would be useful, rather than whether they are successful or not.
MR. BLAIR: I have to confess that my philosophy is that the people who are recognized in the area are recognized because they have had some degree of success either in conveying their ideas or in terms of implementation.
So, my thought is that we need the folks who are traditionally recognized as well as those that are diverse that could offer different perspectives and insights. I think we need both.
MR. STEINDELL: I have no problem with that. I am just concerned with just looking at the traditional people that we have.
MR. MC DONALD: What about the WHO people?
MS. GREENBERG: They tend to focus more on classifications.
MR. BLAIR: Does this feel like a good way to proceed?
MS. BURKE-BEBEE: Is this going to be the full day?
MR. BLAIR: Yes.
MS. GREENBERG: So, you are going to hear from some code set developers or terminology developers?
MR. BLAIR: In August, I wasn't thinking so much from code set developers at that point. I think that we are going to kind of position ourselves with the criteria for selection and the questionnaire so that, maybe, in December it would probably be that we would actually start hearing from the code set developers, and we would want to hear from the users at that point.
My thought was that in August we would hear from people who could influence either the way we craft the questionnaire or who we invite or what our scope is, give us a good solid footing for our proceeding.
MS. BURKE-BEBEE: So, would it be like what we did with the message formats where we had HL7 and some of the other ones, have the questions beforehand and prepared, so that they could then come in and talk to us about the survey and the questions that we would want to pose, making a foundation for further testimony?
MR. BLAIR: Yes, but my thought is that on August 28, that would probably be the day when, as a group, we decide that we are satisfied with the draft of the questionnaire and we would be ready to send it out for comments and critiques.
MS. BURKE-BEBEE: We did send that out to the experts to get feedback if it was a good survey.
MR. BLAIR: Yes, I think we do the same thing.
MS. BURKE-BEBEE: So, we wouldn't necessarily have them testifying or helping us at the meeting. It would be on line or something?
MR. BLAIR: Let's see in August what we decide is necessary to get good feedback.
MR. COHN: Is everybody comfortable with this so far?
MR. MC DONALD: Yes, I think it is time to move the agenda.
MR. COHN: I think the last question, and we are almost ready to adjourn, the agenda in August is going to require to spend more than one day.
We don't want to do a letter and have this happen again in August. I just want to give you fair warning.
Are there any other questions or concerns? John, thank you for joining us. I think we have plans for the next two hearings and you have more than enough on your plates already.
[Whereupon, at 5:53 p.m., the meeting was adjourned.]