[This Transcript is Unedited]
Quality Hotel Courthouse Plaza
1200 N. Courthouse Road
Arlington, Virginia 22201
DR. COHN: Welcome to the Subcommittee on Standards and Security for the National Committee on Vital and Health Statistics. My name is Simon Cohn. I am chair of the subcommittee.
We will start by just introducing people around the table. I will remind everyone at the table that we are being broadcast live, as well as welcome those on the Internet.
Jeff, would you like to introduce yourself.
MR. BLAIR: I am Jeff Blair from Medical Records Institute. I am a member of the committee and a member of the Subcommittee on Standards and Security.
MR. KENT-SMITH: I am David Kent-Smith. I am the chief clinical officer at GCPR Framework Project and I am staff support from the Veterans Administration.
DR. FERRANS: Richard Ferrans, staff for the Workgroup on Computer-Based Patient Records.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to NCVHS and staff to the Subcommittee on Standards and Security.
MS. FRAWLEY: Kathleen Frawley, member of the subcommittee.
MR. SCANLON: Jim Scanlon, HHS, staff director for the full committee.
MS. BEBEE: Suzie Bebee, NCHS and staff to the CPR workgroup.
DR. ZUBELDIA: Kepa Zubeldia, member of the subcommittee and I work for Envoy Corporation.
DR. MC DONALD: Clem McDonald from Indiana University School of Medicine and Regenstrief Institute and I am on the subcommittee. I am a member of the subcommittee DR. COHN: Others in the audience.
MS. CAPLAN: Laurie Caplan from the National Home Infusion Association, representing the Home Infusion EDI Coalition.
DR. COHN: Let me just take a minute to review for the next two hours, as well as do a couple of housekeeping and announcements. What we are going to do is we are going to start out by discussing the draft of this letter to the Secretary and certainly, I think, as you all saw this morning, it is still pretty drafty. We are trying to tighten it up and help is appreciated. So, we will spend about the first half an hour going through that.
I will apologize for those on the Internet because we will be projecting this onto the screen, but we can't think of any better way to handle this.
Now, after that, we will be talking and Kepa Zubeldia will be leading the discussion about the October 26 and 27 hearings on PKI and we will be talking about some of the questions as well as the type of presenters that we need to discuss the issues.
After that, Jeff Blair will be presenting a beginning work plan on sort of next steps for patient medical record information. Hopefully, by the time we finish discussing that, Dr. Braithwaite will be returning and we will be talking a little bit about the remaining HIPAA regulations and the current status.
Now, I did want to make a couple of comments. I think as you all know and you are going to be very proud of this, we actually did finish up the initial report to the Secretary on patient medical record information. I think we have all had a number of conversations about the future of the work group and what we are doing is really reabsorbing the work group into the full subcommittee.
What this means is is that the activities and the next steps -- since membership with the work group and the subcommittee was the same, as most of you will observe, we will be taken as part of our own and we will just flatten the administrative layers a little bit. What this means is for the staff support, that we actually invite you to continue and to be involved and we would very much like your participation.
I have actually asked Jeff Blair to become the vice chair of the subcommittee and what he will be doing is focusing a lot on next steps related to patient medical record information. That will be one of his chief focuses. I know that many of you have been working on the work group will be being staff to that work. So, I think functionally we remain pretty much as we have, but, once again, we are just trying to flatten the administrative structure a little bit.
So, Jeff, thank you very much for being willing to be vice chair.
MR. BLAIR: Thank you. Thank you for asking me.
DR. COHN: Are there any questions or any comments about that before we try to move into the issues in relationship to this question -- to the letter?
[There was no response.]
Okay. Mike, do you want to try projecting up so that we can take a look at this one? Certainly, I think, comments are well appreciated.
DR. FITZMAURICE: We are projected up, Simon, and there are no changes on the first paragraph nor the next two bullets. So, we have moved down to the externally maintained code sets.
DR. COHN: Actually, that is not true.
DR. FITZMAURICE: It is not true?
DR. COHN: I think the first bullet after the first paragraph would need some modification.
DR. FITZMAURICE: Oh, that is right. The levels.
You can see up there the first bullet is issues surrounding code sets, both related to externally maintained code sets and the widespread use of local, non-national, non-standard codes in health care transactions and --
DR. COHN: No, actually we -- this, as I said, was sort of on the fly here. What we are talking about was getting rid of -- both related to externally maintained code sets. The question is is whether we add and replace this where it says the widespread use of local, non-national and non-standard codes in health care transactions and replace that and basically and a need to transition from the use of Level 3 HCPC's codes, parentheses, locally developed and maintained, non-national, non-standard to the exclusive use of national Level 1 HCPC's codes and/or Level 2 HCPC's codes.
Does this help understanding or does this make things worse?
DR. FITZMAURICE: What is it that would be deleted?
DR. COHN: We would get rid of the "and the widespread use of local codes in health care transactions." Does this help or does this confuse the issue more?
DR. ZUBELDIA: I think it confuses it more. I think the source of the confusion element in the HCPCS introduced with the CDT codes replacing the D codes. Level 1 of HCPCS is CPT. Level 2 used to contain dental codes, which are now gone.
DR. COHN: That is true.
DR. ZUBELDIA: So, Level 2 actually -- actually the CDT may be considered as Level 1.
PARTICIPANT: Level 3 has CDT codes.
DR. ZUBELDIA: No, that is Level 2, Helene. Level 2 had the D codes in it and they are gone.
DR. COHN: So you think adding this is actually further confusing --
DR. MC DONALD: The problem is these levels don't mean anything to the average person and they are not even clear -- I mean, you know, when you keep hearing them. So, the question is -- I am still confused. Do local codes get registered anywhere as though they are really in HCPCS? So, they are just local codes. So, I mean, you would definitely want to get rid of the -- that is an issue, getting rid of the widespread use.
Maybe you say something generally and make the transition, changes in what is being represented -- there is a problem with HCPCS and go on to describe it in more detail later.
DR. FITZMAURICE: The process now is that where you have local codes, you submit those local codes on some grant authority or an industry consortium will figure out what should be consolidated and given the code because local codes are -- some codes are coming across states and they can all use one number instead of five or six different numbers.
DR. MC DONALD: But the local codes aren't registered in HCPCS. You can't go to a file and find them all.
DR. FITZMAURICE: That is right.
DR. COHN: You have to go to local files, I think, local Medicare or in Medicaid carriers. Shall we leave it as it is and get rid of that additional --
DR. MC DONALD: I think you want to say generally without -- that there is another issue without having to tell all about it here, because this is just a bullet.
DR. COHN: So, we will get rid of -- I am happy to do that. I am struggling to increase clarity for everyone. So, I would be more than happy to remove that and we can go back to the way it was.
DR. MC DONALD: Is that the new stuff?
DR. COHN: Yes. That was some stuff that I just added. So, let's get rid of that.
DR. ZUBELDIA: I liked the first part of that sentence you added. Maybe we should say something, exclusive use of national HCPC codes, Levels 1 and 2.
DR. MC DONALD: Was that the first place we get into -- there is another place we talk about --
DR. COHN: This is about the second paragraph of the paper. So, maybe we need to have it down under Item 2.
Well, let's get rid of that.
DR. FITZMAURICE: Permanently or do you want to just store it?
DR. COHN: Why don't you store it somewhere in case we ever need the wording.
I am going to have to start reading this so that you can catch what we are doing here. It is back to where it was. So, we are okay.
DR. FITZMAURICE: The next changes are down under 1, externally maintain code sets, that section of the letter. One insertion I made was after external code sets include codes for provider taxonomy, place of service and so forth, after taxonomy, I inserted, parentheses, specialty and type, closed parentheses. So, it reads, "External code sets includes codes for provider taxonomy, [specialty and type], place of service, claims adjustment reason, claims status and remittance advice remarks." Everybody agree?
DR. ZUBELDIA: On remittance advice, I think the formal name is payment remarks, but -- advice sounds very clear to me but --
DR. MC DONALD: We can always put a parentheses in there.
DR. ZUBELDIA: Just leave it.
DR. COHN: You are fine with that?
DR. FITZMAURICE: Moving further down --
DR. MC DONALD: Is it remittance advice remarks? Is that what it was? Okay.
DR. FITZMAURICE: The testifier stated that these processes should consider -- and I would -- there was another word in place of "consider." I substituted "consider" in place of it. That all right with everybody? It reads, "Testifiers stated that these processes should consider..." -- instead of respond to -- "...all bona fide business needs, permit balanced participation from across the health care industry, and provide an available mechanism, such as a web site, to receive requests..." -- and here is an insertion -- "...publicize deliberations and disseminate decisions."
So, the only changes here are instead of "respond to," "consider," replace that, and at the end the addition of "publicize deliberations and disseminate decisions." I just switched the order of those two.
DR. COHN: Okay.
No. 2 then, we changed the title a little bit, where it is called "Illuminating HCPCS Level 3, Local Codes," as opposed to just HCPCS Level 3 Local Codes."
DR. MC DONALD: Somewhere at the beginning, I think, you need a two-liner summarizing local codes -- you were going to do that, weren't you?
DR. COHN: It is not in here yet. She has it in her hand. Do you want to read what you have? This question should be a footnote, do you think or --
DR. MC DONALD: I think it is a couple sentences. It is important to give a context.
MS. FRAWLEY: The only thing that I am not tremendously familiar with are Level 2 codes. So --
DR. COHN: Which are maintained by HCFA. Those are the ones that everybody was sort of --
MS. FRAWLEY: What I put -- I thought it would be like the second sentence after the first sentence. So, testified movement away from Health Care Financing Administration's counter procedure coding system, HCPCS. Level 3 local codes is required by the final rule for standards transactions but is possible, but will require significant effort and resources. And then I thought we would insert, "The Health Care Financing Administration's common procedure coding system, HCPCS, is comprised of Level 1, Level 2 and Level 3 codes. HCPCS Level 1 codes are based on the American Medical Association's current procedural terminology and are used to classify procedures and services provided to patients.
HCPCS Level 2 codes are alpha numeric codes and I don't know anything more about the purposes of those codes. Level 3 codes are local codes, which are used by payers to identify items, such as durable medical equipment and supplies.
DR. COHN: Actually, no, that is what Level 2 codes are is --
MS. FRAWLEY: I have it written down, so --
DR. ZUBELDIA: First of all, there is a definition of all this in the HCPCS web site. I have my laptop. If you want, I can go to my room and get it now.
The Level 2 codes are national codes to be issued -- they are issued by HCFA to be used when there is not a Level 1 code that is appropriate. So, if you don't find it in the CPT, then you go look in the Level 2 codes. They cover -- they used to cover dental, injections, all kinds of supplies, non-medical codes, home infusion, all kinds of things. Then Level 3 is to be used by payers at their discretion for anything that is not covered by Level 1 and Level 2.
MS. FRAWLEY: Okay. I know it is payers for Level 3. I just didn't know what it was covering.
DR. MC DONALD: Level 3 codes and local codes are synonymous?
DR. ZUBELDIA: Yes. Local codes are Level 3 codes and they can do anything they want.
MS. FRAWLEY: Right. It is a mandate that providers have to use those codes.
DR. COHN: Kepa, you actually said it very well. The two of you together, that makes a nice little paragraph. Do you think you can work with Kathleen -- I mean, this would be more of a matter of fact than conjecture.
DR. ZUBELDIA: I can get my laptop. It will take about 20 minutes to get to the room and back, but I can get my laptop and --
MS. CAPLAN: Excuse me. I was just looking -- I was reading the transcript from the meeting in June and there is definitions in this text.
DR. COHN: Do we need to make any comment about the code or -- I don't think it is necessary for this --
DR. ZUBELDIA: I think that the only difference that HIPAA has made on Level 1, Level 2 is the issue of the dental codes. The dental codes used to be part of Level 2 and now they have been removed out of Level 2 and the CDTs have been incorporated by reference, the same as the CPTs are incorporated by reference and constitute Level 1.
I haven't heard one way or the other whether the CDTs will be a Level 1 or a Level 2.
DR. MC DONALD: What is the preponderance of things down in Level 3? Are there really other kinds of supplies and procedures or are they --
DR. ZUBELDIA: You have everything. Anything from influenza vaccines that are under a different programs to --
DR. MC DONALD: [Comment off microphone.]
DR. ZUBELDIA: Oh, yes, by program. They have different codes, to combinations of procedure code and place of service or procedure and program under which the patient is being treated or payment program and the different figures in states and different commercial figures assigned Level 3 codes.
In fact, in the State of Texas, they have a Level 3 that has the letter at the end of the code, where you have established -- they put the letter at the end. There are all kinds of things in Level 3s.
DR. COHN: So, I think we are going to put something up here, sort of a combination of these two, plus the notes that Mike was taking.
DR. MC DONALD: Why don't we just propose that that get -- I worry about making a montage of five things.
DR. FITZMAURICE: It is becoming a very long letter now.
MR. BLAIR: Question. J codes, are they related to any of these?
[Multiple discussions.]
DR. COHN: Would you offer it as a footnote or do we need --
DR. MC DONALD: I just suggest we let Kepa and Kathleen work out a nice paragraph. It doesn't have to be verbatim out of that -- give people a sense of what it is.
DR. FITZMAURICE: Whenever the HCFA's maintenance process was talked about, it is talked about as the HCPCS Level 2 maintenance process. Is that the way we want to describe it?
DR. ZUBELDIA: You may want to clarify that it is the national Level 2 codes. There is nothing else other than national codes in Level 2. But if people are not familiar with that fact.
DR. COHN: I thought we -- hoped that would be clarified in that paragraph we are talking about.
DR. ZUBELDIA: Okay.
DR. FITZMAURICE: Let's see. Where are we?
DR. COHN: Why don't you read through this --
DR. FITZMAURICE: All right. So, I guess we will go to the first bullet, the HCPCS Level 2 maintenance process. Level 2 is the only change there.
DR. MC DONALD: Who funds that process, the maintenance process?
[Multiple discussions.]
DR. FITZMAURICE: She doesn't fund it. She is the process.
DR. MC DONALD: The reason I brought it up is as the requirements expand, the whole thing may break if it is really just based on a single person.
DR. COHN: Well, it is supported by HCFA.
DR. ZUBELDIA: One of the problems that we are going to have to face is that some of the local codes are for procedures that are not paid for by HCFA. So, are they allowed to use federal money to make a national code that is not for the benefit of HCFA or Medicare or Medicaid.
DR. FITZMAURICE: It is a good question but maybe that is subsumed under the authority --
DR. COHN: There are actually a lot of HCPCS codes that are not paid for by HCFA. Remember, HCFA, Blue Cross-Blue Shield and HIAA sit on there and if you look through the HCPCS code, you see many of them are indicated as now paid for by HCFA.
DR. ZUBELDIA: But by Medicare. There are a lot of national codes paid for by Medicaid. When --
DR. COHN: But they only paid for by HIAA or only paid for by Blue Cross --
DR. ZUBELDIA: When the association built their codes, they had a whole table of codes they brought over that had been created by the association but that haven't been created or maintained by HCFA. It was just --
DR. COHN: Let's keep that as an issue and let's take a look at the bullets and then see if we handle that through our bullets or if there is something else we need
to --
DR. ZUBELDIA: Because I understand that HCFA cannot pay or has some problems paying with the provider IDs or providers that are not Medicare providers. So, this could end up being a similar issue. Can they pay for the maintenance of --
DR. FITZMAURICE: The only changes in this last paragraph are adding Level 2 after HCPCS, such as the HIPAA Level 2 maintenance process. We go down to the next bullet, representation. I added "we recommend." I added the word "recommend" rather than the word that was there before. All of my changes are in bold and "other" replaced "our." Simon noted that when he went through it.
Again, the Level 2 is inserted at that point.
MS. FRAWLEY: Could I suggest, Mike, where we say local codes, we might want to put HCPCS Level 3? It is in the process for evaluating. Right where you are now.
DR. FITZMAURICE: Put local codes in parentheses?
DR. COHN: Maybe this is actually a place to put Kathleen's concern that she just told me about, which is the process must be also capable of prompt response and -- and thus be able to handle needs that are exclusive to a single pair.
[Multiple discussions.]
HCFA exclusively?
DR. MC DONALD: For those who are in -- is anybody here from the insurance industry? The question is what would a fast response be. That is, it would not require temporary codes. That is, what is the real turnarounds on this things?
[Multiple discussions.]
I just want a sense of what the expectation would be from those who now make up the local codes. Would I have to wait a long time to get them?
DR. ZUBELDIA: What I am hearing from some of the states, they want things within a month. But I think at that level, they can put a local code. If it is going to take three months, they can use a local code for awhile and then use the final code.
DR. COHN: A temporary Level 2.
DR. ZUBELDIA: Temporary Level 2, national temporary code.
DR. MC DONALD: I mean, because the pragmatics of it, if we have to do it real fast, we are never going to be aligned across codes that are similar. There would be no opportunity to do that comparison.
DR. COHN: Okay. Well, are we fine so far?
DR. FITZMAURICE: Simon, this is where you added another bullet. Is that right?
DR. COHN: That is a bullet. I couldn't figure out how to put a bullet in there. I would be technically challenged by Word Perfect.
DR. MC DONALD: This came from Lisa and that is not how I heard it. What I heard is that people are now making local codes out of CPT codes. That doesn't say that they should be making them Level 1. At least that is not how I understood what she said. She is just pointing out that people are also fiddling with the other codes to get the localness.
DR. COHN: I think they are actually --
DR. MC DONALD: I really worry about going way out if we don't understand what the picture and then having some other political feedback about this that we got it wrong.
DR. ZUBELDIA: I think there should be a process for the local codes, Level 3, today, to become national Level 2 codes --
DR. COHN: Or Level 1.
DR. ZUBELDIA: Or Level 1. Exactly. So, the process should allow somebody to go to a CPT panel and say we need this CPT code at the national level.
DR. MC DONALD: Do we need to put that in the letter? That is an intent.
DR. COHN: That is actually what this bullet is. Do you want to read this one?
DR. FITZMAURICE: Some of the local codes may need to be considered for inclusion in Level 1 HCPCS, closed parentheses, CPT, closed parentheses. We recommend that you put the AMA on notice to expect an increased volume of potential requests for new codes.
DR. COHN: I thought that was pretty benign.
MR. BLAIR: That is pretty direct.
DR. MC DONALD: What does that really mean, to put them on notice? Can't we just say that there could be an increased demand for --
DR. FITZMAURICE: You inform the AMA to increased volume.
DR. MC DONALD: They are going to read this, too. So, you don't -- would the Secretary actually send a letter to the AMA if you follow these rules, saying you are now on notice?
[Multiple discussions.]
MS. FRAWLEY: I like advise.
DR. MC DONALD: I was thinking we would be better off saying there could be a potential increase in requests for CPT codes.
MS. FRAWLEY: Take on notice out.
DR. COHN: Now, the question is is this something that has to do also with CDT also?
MS. FRAWLEY: There are two problems. There is EDT and then there is also the problem that HCFA may also wind up with an increased number -- requests of codes --
DR. COHN: Well, we actually do know that HCFA will be under Level 2. That was the bullet before. This was just more of a -- other groups will also get increased volume. So, the question is is do we make this a little more generic?
DR. MC DONALD: I would almost be -- where it says we recommend, I would almost -- just state the fact that provisions may need to be made for increased demands for CPT and/or whatever we are going to say, code development or code applications. Now that I have said it, I can't restate it. I mean, what we are doing is we are saying we are in charge here and you do this, rather than saying here are the facts and everybody may want to be aware of this.
DR. ZUBELDIA: That may be true in Level 1 HCPCS, which is CPT or in CDT codes or there could be an increase of codes in ADC. I don't know if there is a process -- I don't think there is a process to handle new -- for instance, I understand a few years ago -- I don't know if it is still a problem -- where is not an ADC code for distilled water because they could not identify the manufacturer.
DR. COHN: We have a couple of options on how to handle this one. One of them is talking about Level 1 and CPT, we could talk about other procedure code sets.
DR. ZUBELDIA: Other national codes --
DR. FITZMAURICE: Some of the local codes may need to be absorbed by other code sets, ought to be alerted.
DR. ZUBELDIA: Other national code maintainers should be alerted.
DR. FITZMAURICE: Shall we say the AMA, under the code maintainers?
DR. MC DONALD: I don't think I would name them -- maintainers should be alerted to increased -- potential increased volume of requests for new codes.
DR. FITZMAURICE: Is that what you said?
DR. MC DONALD: Yes, except you could put the potential and take out the expected, to a potential increased volume of requests for new codes or something like that.
DR. FITZMAURICE: Should be alerted to --
DR. MC DONALD: A potential increased volume.
DR. ZUBELDIA: I would say national code developers should be alerted to potential increased volume.
DR. COHN: Does that look okay?
DR. FITZMAURICE: The next paragraph, the current process for considering a request for a new HCPCS code --
DR. COHN: That is HCPCS Level 2.
DR. FITZMAURICE: Level 2 -- includes a criterion requiring the demonstration of a significant frequency of use. This was inserted. The concern is that past use must be demonstrated for adoption of a new HCPCS Level 2 code; whereas, what is important is its expected future use. We recommend that the criterion be dropped.
Do we want to say instead of that we recommend the criteria be modified to reflect the value of the new codes future use? I am not sure what we want to say there.
DR. MC DONALD: It seems like that third and fourth line are a little bit redundant with the fourth, fifth and sixth. So, we could say includes a criteria in requiring the demonstration of -- past use and then you could then say whereas the most important is this expected future use. You wouldn't have to say the concern is, I don't think. You can take out the "whereas."
Well, now it is not clear that you want to take out the past use. It is going to be modified to reflect the new codes. It does not then explicitly say instead of the past use. We may be better to say -- we have got two choices. We can say take out the thing about past use -- that is probably what I would do. Otherwise, say take out the past and put in the future.
DR. MC DONALD: We are just saying -- we are just going to add something.
DR. FERRANS: That can still be used to --
DR. FITZMAURICE: To eliminate past use or to replace past use with future --
DR. COHN: Well, I think if it has been used a lot in the past, I think that is not probably a bad criteria.
I think we are talking about.
See, this doesn't say -- well, it is ambiguous in what we really mean.
DR. FERRANS: What if you put to drop the requirement for past --
DR. MC DONALD: Well, first, we have got to decide in our own mind, do we want to insist on a require future use and get rid of past use. Do we want to just get rid of past use and let them -- not speak to what the criteria have to be? I don't know.
DR. COHN: Actually, do you think what it says right now is bad?
[Multiple discussions.]
DR. FITZMAURICE: -- past use and then start off with recommending that it be modified to reflect the value of the code's future use and not talk about what is important.
DR. ZUBELDIA: I would leave that one.
DR. FERRANS: I was going to say if you put the greater value of expected future use, the greater value of the new code's future use, then you are implying that on a weighted amount, that future use is more important than the past use. That is a stronger statement than what you have now.
DR. MC DONALD: Well, the original statement is to remove all dependency on past use. That is not important. I didn't hear that testimony. So --
DR. COHN: I think we are fine. We can look at it tomorrow if we change our mind on that one.
Let's keep going.
DR. FITZMAURICE: The next bullet is an addition, all of it is. In addition to these topics mentioned by the testifiers, the committee recommends that HCFA develop --
DR. MC DONALD: That is good the way it is now.
DR. FITZMAURICE: As HCFA develops instructions to the Medicare contractors on the use of NDC codes and Level 2 HCPCS codes that replace local codes, these instructions be disseminated to the public. This will assist the rest of the industry in their implementation of the same or similar procedures.
DR. MC DONALD: That is perfect, except I thought I heard one slight modifier in yours. You said timely -- early release of --
DR. ZUBELDIA: Yes. I don't know where to fit that. They should be disseminated through a public -- as soon as possible, as soon as they have them. But it just makes the sentence so long.
DR. MC DONALD: At the same time.
DR. COHN: Great.
DR. FITZMAURICE: Is it the rest of the industry and their implementation or the rest of the industry and its implementation? I suppose there --
DR. COHN: Its implementation.
Yes, Kathleen.
MS. FRAWLEY: The NDC, if you don't know what it is, I think you need to spell it out.
DR. MC DONALD: WE could do this later. But just make sure anytime you have an acronym, the first time it is spelled out.
PARTICIPANT: Were you able to hear that comment, Mike?
DR. FITZMAURICE: Yes, Roman numeral II.
DR. COHN: Okay then?
DR. MC DONALD: Excellent sentence.
DR. COHN: Great.
DR. FITZMAURICE: This one --
DR. COHN: We are talking about getting rid of a lot of this one.
DR. ZUBELDIA: Let me ask a question. How about codes that have been left undefined in the final rule? The final rule says for these four or five or six purposes, you use Level 2 codes. Well, there are Level 2 codes for other purposes today that I don't think the intent is to eliminate them, but they are not explicitly named in the final rule.
Like we were talking about home infusion, there is national home infusion codes today in Level 2, but they are not explicitly named in the final rule saying for home infusion you use HCPCS Level 2.
DR. FITZMAURICE: So, the trick is that if they are still in Level 2, then they are applicable, even though they weren't named in the law. Level 2 codes were incorporated by name.
DR. COHN: Well, for the purposes in certain areas. Level 2 HCPCS is mentioned, but it is not mentioned in the --
DR. MC DONALD: We need to make an assertion then that we could just make another bullet and say something to the effect that although the law says, dah, dah, dah, dah, day, we interpret it to mean the existing Level 2 subject matter is still applicable.
DR. COHN: The way the J codes are being removed is because they aren't mentioned -- they are not mentioned in the NDC. So, I think we should remain silent on this particular issue at this point. We may want to hear some additional testimony because there are actually a lot of other areas. It is sort of like when an area has not been defined, which I think is --
DR. ZUBELDIA: The reason is that the HCPCS Level 2 -- it says HCPCS -- by HHS, which is Level 2 -- for all other substances, equipment, supplies, for other idents, used in health care services. So, if it is not a substance equivalent supply -- no, I guess it covers other items.
DR. COHN: This is not the last letter we are going to write on this. This letter doesn't have to be perfect. It has to be -- what we say has to be right, but we don't necessarily have to be completely comprehensive about everything because there are going to be other issues that are going to come up as we delve into this more.
DR. FITZMAURICE: Three, HHS resources in promoting industry implementation. I will just start reading it through. A number of experts and industry representatives suggested that HHS should assume a more active role, parenthesis, and increased funding, closed parentheses, to actively promote the implementation of the HIPAA data standards by the industry.
DR. COHN: The question is is we were trying to write -- a sentence there about the HCFA's Y2K activities as a model and then we have another sentence about HHS monitoring and coordinating and HIPAA implementation with a bunch of various groups and whatever. As we look at that -- the question is -- I think I can get rid of that whole area. Maybe we can write up a sentence that sounds convincing around HCFA's Y2K --
DR. MC DONALD: I am agreeing mostly with you but I think you could convey most of the real additional luggage by including at the top implementing -- by the industry -- see, instead of saying "promote," by monitoring -- educating, monitoring and testing is really what is interesting, by providing education, monitoring and testing or something like that.
DR. COHN: Well, but to actively promote the implementation -- to actively promote --
DR. MC DONALD: No, I think what you want to leave -- just those phrases you could put at the end in some way. I don't think you have to say by the industry -- through education, monitoring and testing.
DR. COHN: So, let's get rid of -- so, basically, we are okay here and let's take a look at the final sentence. So, let's go down --
DR. FITZMAURICE: So, we are going to get rid of that sentence, for example?
DR. MC DONALD: Not yet.
DR. COHN: This is we recommend, right?
DR. MC DONALD: What I was suggesting and I am not sold on this is to say HIPAA data standards by education testing --
DR. COHN: This is the recommendation? He needs to go down -- let's go down and look at the recommendations. I think I agree with what you are saying but let's get down to the recommendation area.
We recommend the Department closely monitor the progress of implementation, but that there needs to be sufficient resources provided to ensure that there is adequate technical support.
DR. MC DONALD: Those three things is what gives you some concreteness to what we mean. The education, monitoring and testing.
DR. MC DONALD: The three phrase thing, we could say, there are sufficient resources to ensure adequate support for education and testing and -- education, monitoring and testing of the implementation.
DR. FITZMAURICE: So that it is parallel. Not only should the Department do this, but it must also devote significant resources to assure that there is -- for education, monitoring --
DR. COHN: Knock out all those other sentences. Great.
MS. FRAWLEY: Are we going to take out that sentence that starts with an additional suggestion was --
DR. COHN: Yes.
DR. ZUBELDIA: That also gets rid of my syntax error.
DR. COHN: -- sufficient resources to ensure that there is adequate technical support, education, monitoring and testing -- okay. Fine.
DR. FITZMAURICE: Technical support for education, monitoring and testing. How is that? I put a "for" in there.
DR. COHN: Well, that changes it.
DR. FITZMAURICE: Well, I will take the "for" out.
DR. COHN: Comma.
DR. FITZMAURICE: Oh, I see what you mean. Monitoring is also above, monitor the progress of national implementation. Do you want to take monitoring out of this sentence? Not only should the Department closely monitor the progress of national implementation, but have sufficient resources to ensure there is adequate technical support, education and testing.
DR. COHN: Sounds good.
DR. FITZMAURICE: Funding to deploy identifiers. Here, I am not sure what we want to say because the original sentence stressed the need for adequate funding; whereas, I think the intent is that the identifiers be there when they are needed, be there on a timely basis, however you do it. Funding is one thing but you also have to keep to a time pattern.
DR. COHN: I think we need both.
DR. FITZMAURICE: I like the recommendation. I just don't know that we got there the right way. The recommendation is that we recommend that HHS provide adequate resources to assure that the HIPAA identifiers are available as soon as possible. To all users?
DR. ZUBELDIA: All providers --
DR. FITZMAURICE: Providers and payers.
DR. COHN: We have employers, providers --
DR. ZUBELDIA: Providers and payers. I think they found a solution about the payer thing, but on the provider side, they are still looking at only Medicaid providers.
DR. COHN: Providers, payers and employers.
DR. ZUBELDIA: The IRS is doing the employers.
DR. FITZMAURICE: Then not available to them, available for them, for identifying them.
DR. ZUBELDIA: Yes.
MS. FRAWLEY: The other thing is that the numbering is off. That actually should be Item 4, Items 4, 5 and 6.
DR. ZUBELDIA: It gets confused with the bullets that have the numbers before.
DR. FITZMAURICE: Testing and compliance of software.
DR. COHN: We added the word "software" up here. Hopefully, that is okay with everybody.
DR. ZUBELDIA: It changes the meaning, though.
DR. COHN: Well, should we have that in there or should we --
DR. MC DONALD: I don't think we are testing -- I don't think we care a whit about what the software institution does as long as it puts out the proper message as specified by the standard.
DR. FITZMAURICE: So, we are focusing on the process. You want to focus on the outcome.
DR. MC DONALD: Well, you need something else. We need to say what we are talking about to test here. You know, you buy a telephone and you don't care how it works inside as long as it does the ringing and the dinging and sends the voice around the right way.
DR. COHN: That is right.
DR. FITZMAURICE: Are there any other changes you want to make in this?
DR. MC DONALD: You might want to -- the header is very clear but maybe you need to add a word or two to make it --
DR. ZUBELDIA: -- a chance to take an active role in support for testing. I don't think they can provide for testing. They can provide support for certification maybe.
DR. COHN: Like certifying the certifier, like our next sentence? That okay?
DR. FITZMAURICE: Or for certifying compliance.
DR. FERRANS: Quality assurance for certification or --
DR. MC DONALD: Well, if you could just take assist --
DR. FERRANS: Can you say quality assurance for certification rather than technical support? Because that is really what you are saying, right? You don't want them to do technical support for -- you want them to do quality assurance for certification.
MR. BLAIR: Is it that or is it criteria for certification?
DR. MC DONALD: Well, I think the intention is that we have got a problem. We have got three different certifiers and they are doing it different ways. So, somebody -- some role has to get -- someone has got to run a test that says they all should come out this way.
MR. BLAIR: Or is it national standards for certification?
DR. COHN: Do you think it is maybe just support for certification?
MR. BLAIR: Well, even if it is support, part of what I am hearing is that people are saying we need coordination of at least what I think is -- you are saying is we need coordination of the criteria for certification. No?
DR. MC DONALD: These things should come out the same. So, I don't think you have to be that general. I think you need some mechanism to assure that the certifiers are all certifying the same thing.
DR. FERRANS: How about a quality assurance mechanism for certifying bodies?
DR. MC DONALD: We are losing the reference that we are talking about certifying the compliance test.
DR. FITZMAURICE: How about take an active role in providing support for uniform certification?
DR. MC DONALD: How about compliance certification?
PARTICIPANT: Uniform certification.
DR. MC DONALD: I think that works.
DR. FITZMAURICE: The roles should include activities such as certifying the certifiers, so that purchasers would not be mislead by unsupported claims of HIPAA compliant software or services.
DR. COHN: Great. Okay. Next?
DR. FITZMAURICE: That turned out to be much better than I thought it would.
DR. MC DONALD: This is a paragraph I had trouble with because it is vague and I --
DR. COHN: This is what we did. We took away the number and this turns out to be sort of a paragraph. Do you want to read it?
DR. FITZMAURICE: Like a closing paragraph, almost closing
Finally, the role of software vendors in HIPAA implementation was identified as critical. Providers cannot become compliant solely through the use of vendor products and services. But they cannot become compliant without vendors either. Testifiers recommended that NCVHS and HHS continue to assess the progress being made by vendors in making their HIPAA compliant.
NCVHS intends to track these issues closely. We also recommend that you consider what the federal role should be in encouraging compliance in certification of products.
DR. MC DONALD: I can't turn this into a realizable thought. Do we mean we want FDA testing level on vendors' software? Or do we mean that we just worry about it a little bit? Is there any likelihood of funding to go into every shop of every vendor and detect this and monitor it?
MR. BLAIR: Maybe at the level of this letter, we don't have to go quite to that level. Maybe it is sufficient that we state thais as an intent and that those are the types of things that just simply may need to be worked out.
DR. COHN: Question: Are you responding to the last sentence?
DR. MC DONALD: I am saying the role of software vendors is critical. Dah. What does that tell anybody?
DR. FITZMAURICE: We are saying we recommend the market work in this instance.
DR. COHN: What we could say is the NCVHS intends to track these issues closely and will keep you apprised of issues as they --
DR. MC DONALD: But of what exactly? Of how well the vendors are doing? And how can we tell that?
Jeff had some different thoughts and that is this is a multi -- there is an administrative aspect to it and we are really, I think, talking a lot about the security side. It doesn't come across. I don't get a message out of this.
DR. FERRANS: Clem, to me the issues are going to be the vendors' claims of having HIPAA compliant products. But I think in terms of whether they work or not or a number of other things, I think what you are going to see and what you are starting to see is that health care organizations are going to hold vendors contractually responsible and that if for some reason their products are not in compliance, they are going to be required at no cost or at some fixed cost to come into compliance.
I mean, I think the market place is going to address some of those concerns.
DR. ZUBELDIA: What happens if we do track the vendor products and we find out that the vendor products are not compliant? What happens then?
DR. FITZMAURICE: We don't certify them. We don't certify the certifiers who certify them. We take away their certification.
DR. MC DONALD: If you are going back to the -- I can see how that makes sense. If you are going back to the certifying thing, we are going to watch how well they are doing or something.
DR. ZUBELDIA: But I think it needs to get further than that and if we find that a year and a half from now, vendors' products are not compliant --
DR. FITZMAURICE: They will be out of business.
DR. ZUBELDIA: Should we encourage compliance by encouraging some tax credits or something to people that need to become compliant?
DR. FERRANS: Which products are you referring to because there is the code set products and then there is -- I mean, security is going to be a whole different issue. It is not -- I mean, the idea of -- the idea of certification for any product having to do with security is going to be a whole different order of magnitude.
DR. COHN: In the interest of time, shall we get rid of this paragraph?
MS. GUILFRED: I have a real problem with it.
DR. COHN: This is actually more to us than anything else. So, I think if we want to get rid of it, I don't think that there is any damage to do. So, let's get rid of that and we will have one less paragraph the Secretary has to read.
MS. GUILFRED: Simon, since that was probably the basis of my testimony to the committee, I think it is vitally important that the Secretary, as well as NCVHS, be aware of the importance of the ability for the providers to be able to capture the information that is going to be required in the claims. That was the way I interpreted that paragraph to speak to the importance of that issue.
DR. COHN: Well, I would say first of all that I agree with you that the issue we think is critical. I think we are going to be intending to have some hearings coming up relatively shortly, looking at that. The question is is there anything that is helped by having this paragraph in this particular letter? Was it just that we need to have hearings focused on underriding this issue?
MS. GUILFRED: I think the topic of the hearings were early implementers and I think what was said clearly at the meetings, both by the provider, as well as the clearinghouse panel was that the issues were not technology issues as to could the transactions be formatted in the X12 format, but rather where is the going to be obtained in order to get it into the format.
The clearinghouse has clearly said that the information was not -- they say we can formulate anything. We just don't have the information to put into the box. If you recall, my testimony was that approximately 60 percent of the data was not there. So, it is going to be up to the providers unfortunately -- and I am speaking of hospital providers at this point, institutional providers -- they don't have the ability for the most part to be able to just put that information out there. They have to rely on their vendor to give them the ability to store that information in the proper format that it needs to get around to the --
MR. BLAIR: Helene, is there a few words or a sentence that you could add that could add a little bit more substance to this paragraph?
DR. MC DONALD: Let me respond to that, though, before we go to that. I would like to --
DR. ZUBELDIA: Michael, if you undo it, you could put that paragraph back, that entire paragraph.
DR. MC DONALD: You want the paragraph back? That paragraph didn't say anything like what you just said. So, I still remain in the same state and it initially is availability of data and then we had a different problem than just vendors because some of that is capture. That is, you know, users' input. People aren't getting their bills out now. Is this a radical increase in data that we are going to need? I didn't think so.
MS. GUILFRED: Yes, it is a tremendous amount of new data that is being -- either required under certain circumstances or under the situational requirement and if it is situational, then you have to capture it because you can't capture it situationally.
DR. ZUBELDIA: NFECT(?) is doing a study on that right now with one of the war groups to find out what the difference is. But, for instance, one of the things that was mentioned the other day is the provider specialty that has to be filed with every professional claim with the A37, is not even on the paper form or the NSF. So, you cannot take a system that is currently producing the NSF and map it into A37 without a look-up table somewhere that would populate provider specialty. There are other elements like that and the vendors need to do that.
The question is what do we need to do besides monitoring that it does happen?
DR. MC DONALD: Well, it seems like what we should do is if we could get the word out that these are the differences, that would sure make life easier for everybody.
DR. ZUBELDIA: And I think that is where Simon's thing of having additional testimony on that specific issue is important because it will raise the awareness of the industry, that you cannot just map from an NSF A37.
DR. COHN: Right. In think, hopefully, we will have some of that data to discuss --
DR. ZUBELDIA: The result of that can be either to raise the awareness or to change the requirements and say if for so many years, you have been paying claims without a provider specialty, why do you need provider specialty. I think at that point is where Helene's point could also be brought in.
MS. GUILFRED: If I understand what they tried to do within the X12 work groups was that they tried to do what you talked about, Clem, that was occurring with the claims attachments, was anything and everything that anybody wanted got thrown into the pot. I have done some analysis on the X12 formats and just from the November 1999 to the May 2000, significant changes, reductions of certain elements that were there in the November 1999 --
MS. FRAWLEY: I am just looking at our time. We have other things on our agenda so that we need to close discussion on this letter.
DR. COHN: I want to take a look at the subcommittee to see if others have feelings about this. My own conclusion on this is that I recognize it as a pertinent issue. I would like, however, some collaborating data, as well as a better sense of exactly the issue before I start writing a letter to the Secretary about it. I would like to actually get a little data and hopefully some action steps, if possible. So, I would defer this paragraph into our next letter.
MS. GUILFRED: Within the presentation you had all that data. If you need a copy of that, I would be more than happy to give it to you.
DR. MC DONALD: Could I rephrase what -- I think what -- we need a whole discussion of this issue with the various alternatives. It may not be just adding more fields to the vendors. It may be negotiating are these really reasonable. There is going to be a hearing on this and then that letter -- all these issues could be raised together. That is what I think Simon was saying and I would agree with.
MS. GUILFRED: I just think that if you leave it out of this letter that the point is going to be lost.
DR. MC DONALD: It was lost in that paragraph. I didn't get that --
MS. GUILFRED: The paragraph needs to be rewritten, but I just think that if you leave it out, that you have left out a major portion of both my testimony, as well as the clearinghouse testimony.
DR. COHN: What are the desires of the subcommittee? Kepa, comment?
DR. ZUBELDIA: I think it will be more effective by having separate hearings and a separate letter on that issue.
DR. COHN: Jeff.
MR. BLAIR: I would like to -- well, is there any chance that there could be a suggested clarified few sentences or paragraphs that maybe Helene could submit and we -- would we have time to discuss it tomorrow morning at all?
DR. COHN: This is a recommendation that this paragraph will not be in the letter. If you want to work on the side with Helene and come up with something to present to the full committee --
MR. BLAIR: It would be appropriate for the full committee.
DR. COHN: Well, maybe that is the next place that this goes in the interest of time and all that. But certainly, if you can come up with a sentence or two that you want to bring up independently, I think that is welcome. But I am hearing -- I am sort of seeing that there is a consensus in the panel that for the moment we should not include that in this letter at this point.
Okay. I want to thank everyone and why don't we move on to the next issue. We do appreciate the issue and concern.
Kepa, do you want to talk a little bit about plans for October hearings?
DR. ZUBELDIA: Yes. And I will make it quick. I think it is under Tab 10, under Tab 10 of the book.
What we are looking for for October is testimony on the issue of electronic and digital signatures and the -- no one talks about electronic signatures and the NPRM, the discussion was that electronic signatures that have specific requirements and only digital signatures would have to meet those requirements. Well, since the proposal came out, there is a continuous improvement of technology and I think it is a time where we need to look at new technologies and also the results of the business applications of the existing technology and new technology into health care and see what has happened since we had hearings on this two years ago -- three years ago -- and the proposal came out.
What I am proposing for that meeting in October is four panels. One on the differences between electronic signatures and digital signatures more on the business side, rather than having an in depth technology discussion. Why are they different? What are the benefits and the disadvantages of each one?
Then to have a panel on business uses of electronic signatures, like for people that are actually implementing electronic signatures today or that have experience with either electronic signatures and also some of the other initiatives, non-health care initiatives involved. We have some applications of signatures in banking and other industries. And what is their experience with signatures? How easy it is to apply, how effective it is? What are the things that they have been able to do with signatures they couldn't do without signatures?
Then to have a panel on government and electronic signatures. The IRS has been using electronic signatures for a few years. The electronic signature in -- the FDA had a rule on electronic signatures about four years ago. What has happened with all those and how the different also state laws effect these digital signatures or electronic signatures.
Then to have a panel on existing projects in health care and find out why they are using electronic signatures, what kinds, what are the players they found, what are the requirements and how to make it work in health care?
Under this Tab 10, I proposed some possible questions for the different panels and I would like to either more panels or a different focus for these panels and what are the questions that we should them and also do you have a list of potential testifiers. We have built a list, a preliminary list with about 20 something people that could testify on these issues, but we always need to have as many as possible because not everybody will be able to come.
MR. BLAIR: Kepa, you know this subject much more than I do, but I have sat through a number of meetings where we have had multiple days of -- other than NCVHS -- where we have had multiple days of testimony from folks that were using PKI and in a lot of ways I was a little bit confused.
As I look at this agenda, I am kind of trying to think of how do I get to in a sense the bottom line. Let me tell you what I have heard and maybe you could give me some ideas of why you have crafted it this way because, you know -- I am assuming you are a couple of steps ahead of me on this.
For example, I have heard testimony from -- you know, this was in other hearings, from Kaiser, from the AMA, from a group in Connecticut, a California consortium and it seemed as if everyone -- well, I don't know about the AMA, but all of those that were implementing basically were saying that they just used the ASTM guidelines for electronic signatures, that the issues that they had weren't related to the adoption of those technical guidelines or specifications. The issues that they had were related to how did they come up with certification authorities and that that seemed to be the open issue.
The AMA was stepping in because it was winding up saying that it wanted something that was consistent with its current board certification and its current procedures for certification. Others were doing it because they were concerned with certification across multi-faceted health care institutions and they were thinking of hospital accreditations. So, they were looking at certification from that issue.
So, in short, educate me. It seemed as if the issue here was the certification issue not what standard is the issue for technical implementation. What am I missing?
DR. ZUBELDIA: I think you are right, but I want to take a step back. Certification authorities represent one specific technology and that is digital signatures and PKI. There is a standard for digital certificates. But in all these pilot projects going on, everybody is centering on the digital certificates. I think we need to get -- take a step back and say, well, why PKI. Are there other simpler solutions than PKI? And will they meet the requirements?
For instance, Signature Dynamics is one of the companies that I think should be coming to that electronic signature panel, Signature Dynamics is an alternative to PKI and it will be in compliance with this legislation that passed this summer. However, it is not PKI-based. Since we had the hearings three years ago, the technology has advanced. Maybe we didn't need to lock ourselves into digital signatures with PKI with the certification authority situation that has proven to be very, very difficult.
So, I would like to see those two and then within the PKI side, I think we need to find out what are the problems and does it work. We have heard somewhat about certification authorities and the difficulty in issuing certificates. I haven't heard much about the signatures themselves. Once you have a digital certificate, how do you sign a document? How do you verify the signature of a document?
What is involved? From the business perspective, how do you integrate this into your business flow? I think we need to know about that. I want to not take anything for granted. I don't want to take PKI for granted. I don't want to take certification authorities for granted.
MR. BLAIR: Then let me ask one other question on that.
Can we give some consideration of what would be the criteria if we are going to make a recommendation? What will be the criteria for our decision? I am saying that only from the standpoint that with all the things that I have heard, I came out just overwhelmed and not knowing how to decide which alternative is best.
DR. ZUBELDIA: I think the criteria should be the criteria outlined in the proposed rule of non-repudiation, data integrity and all of this criteria that the proposed rule specifies in signatures.
MR. BLAIR: Well, is there something that we could do when we receive testimony where the questions that we are asking these people would reveal information on those criteria that would enable us to make a decision and a recommendation?
DR. ZUBELDIA: I think you are right on target. We need to ask that kind of question. We first need to ask are the criteria in the proposed rule the proper criteria to define the signature and then if those criteria are correct then how we go about to do this.
DR. MC DONALD: You elaborated on some things I didn't understand from just the questions and I think that that is very appealing. What is the minimum thing that would work and still could be used might be another way to be thinking about this. But there are problems galore and as someone who has been working on this and it comes down to how often do you have to put in your password and things like that.
In the model of, say, taking a contract, wrapping it in a text isn't quite the same as the model when you are getting individual items of information if it is all wrapped up. Most databases don't have each data element wrapped up. I don't even know if any can. So, there are some issues about when you unwrap it and maybe the intended use. What scope of things is likely to have to have -- you like to know if someone is dialing in from San Francisco, that that is who it is, so they are not going to -- you know, they can get into your database. That is one thing.
The other side of it is if you have got to wrap all the communications individually into certificates, then how do you manage that because existing databases won't have a place to put all that?
DR. ZUBELDIA: That is why I think we need to take a step back and not center just on PKI digital signatures, but ask these experts that deal with this digital electronics all the time, what is it that they believe that we should be using in health care with the assumption that what is in the NPRM are our requirements.
DR. FERRANS: Kepa, are there people who are not with the vendors, who we would consider somewhat security experts, who could address those in somewhat of a neutral fashion, the way that we have people do that for privacy before the committee?
DR. ZUBELDIA: There are a few consultants, but it is very difficult to get impartial consults. They typically get excited about a specific product. That is why one -- I would like to have a government panel with other agencies that are actually doing this and that have had experience with different technologies and see what they recommend because I think they would be more impartial than a specific vendor. But that is one of the panels.
DR. FERRANS: The other question that I had was with respect to the new federal law that had been passed on signatures, would someone also be there to explain that in the context, as you mentioned, state law so that we understand how all of these things would impact one or more choices to meet the standard, the proposed rule that is?
DR. ZUBELDIA: We hope to bring somebody to testify from the commerce group that passed that law, somebody that would know why they did it that way and what the advantages are. And can we use that in health care or should we not use that in health care and what are the relationships with different state laws and how they did that where a state claims ownership of all these signature and electronic commerce.
We could also bring in some people from the states that have a state digital signature act; Utah, Washington, North Carolina, Minnesota, Texas, California, and find out where they see they fit within the federal health care signature system.
DR. COHN: I guess I will speak for myself and I have been looking at these questions and, obviously, talking to Kepa about this, but I don't consider myself the world's expert on PKI or on digital signature. I haven't attended as many sessions on these things and the thing I like about this approach is that we evaluating what is the problem we are trying to solve. I think that is an important thing, especially if we are going to write a letter to the Secretary with some recommendations down the way.
Now, I don't know that we are going to come up with the solution at the end of the day and a half, but I think if we can really get our hands around what exactly is the problem and be able to articulate it real well, that that will be better than most of us have been so far because it is terribly confusing now, where people confuse technology with business cases, et cetera, but one of the problems that I have been having with all this is that in the last four years, since the law passed, I was expecting to have had some standard for signatures, electronic or digital, I don't care, but some standard for signatures.
There is no such a thing. Even today, there is no standard for signatures. There is standard for digital certificates, for PKI digital certificates, but nothing for signatures. So, I think it is time to look back and say what happened. Is it too complex? Do we need to go that route? Do we need to look at other possibilities? And find out from the experience that people have had where are they and why and where should we go.
DR. FERRANS: Kepa, I wanted to make one more point along that and then a point from the computer-based patient records work that we were just doing. There is also an issue of intraoperability here and that if we end up that we have two different technologies that are able to meet the standard within the NPRM, what does that do from the ability to pass a signed document that was signed in one system using one technology to a different one? What kind of barriers does that impose to the issues we were talking about intraoperability?
MS. FRAWLEY: I just wanted to make a comment. There is an ASTM standard E1762, electronic authentication of health care information that is an ASTI(?) accredited standard, that addresses several of the questions that are raised in this document and there is an ATM subcommittee that is working on issues related to digital signatures and digital certificates, but there is a standard out now for a couple of years now on this very issue.
When I saw this document, some of the questions that were raised here, I know we struggled with when we were working on that particular standard in terms of can you affix multiple signatures to a document and, you know, a number of questions, though.
I think the problem is that a lot of people aren't aware that some of those standards exist. Probably, it would be helpful to get feedback back to ASTM if there is a need for revisions because certainly it was developed several years ago. I mean, that work started in 1993, 1994. I think the standard was published probably in 1996.
So, it is probably up for a review cycle at ASTM anyway, but I do know that ASTM did submit a letter on the NPRM for security. They are outlining a number of the standards that were, you know, ANSI accredited that should be considered. I guess that one of the things I am struggling with in our discussion here is is that my understanding at least based on some information that Bill had given us I think at the June meeting, that security, standards and the whole issue about digital signatures are going to be two separate NPRMs.
DR. COHN: Right.
MS. FRAWLEY: Right. Will there be two separate NPRMs? I mean, two separate final rules.
So, I guess what I am struggling with is if the Department is looking at digital signatures, then I guess the question that I am wondering is why are we even looking at electronics?
DR. ZUBELDIA: The reason why this was triggered is because the act that was passed this summer said electronic signatures. I don't think we have even considered electronic signatures as being able to meet the requirements specified in the NPRM. The NPRM specifies certain requirements for signature that may be met by electronic signatures today that were not met by electronic signatures two years ago and those electronic signatures may be able to meet all the ASTM requirements.
The technology that we have today is different from what we had three years ago and what we need to look at is what are the requirements and --
MR. BLAIR: Could I suggest this because for the presentations that I have heard, almost everyone of them said that they were using those ASTM guidelines for electronic signatures. Either we include an invitation to ASTM to present their standard to us or we include a question on it for those folks who are testifying, whether or not they are using the ASTM standard and if so, why or why not.
DR. ZUBELDIA: We need to do both.
DR. MC DONALD: Just some comments. It is a guideline, right, rather than a standard and I think it gives the general things you have to do to make this do right. It doesn't give you a mechanical set of programs that you can code to because -- which is good, because you can do many within it. So, I think when Kepa was talking about the specific standard, he was talking about -- you know, like IT, you know, it is actually just a hard coded thing and it always behaves the same.
MS. FRAWLEY: Well, there are some follow-up standards that came out of that subcommittee. So, you know, the first piece of work was, you know, the guidelines for electronic authentication, but then there were several other standards that have subsequently come out that the subcommittee produced. They are very technical standards. I wouldn't even been able to begin, you know, to be able to describe a number of them to you. But, certainly the ASTM web site, you know, does have standards listed, you know, that have been published. I haven't been at meetings recently in terms of some of their work, but I do know what they have been trying to struggle with is a number of the issues that are identified on here.
DR. COHN: I think we hear that we need to get the information from the ASTM.
DR. MC DONALD: In terms of the scope or the context, there are signatures to say -- or maybe these aren't called signatures to say that I am who I am, so I can get on.
DR. ZUBELDIA: [Comment off microphone.]
DR. MC DONALD: Then there is the issue about the final verification -- because this is certainly the person who applied for this number or this is the person they say they are, which is, I guess, part of the certification. You know, do they take your fingerprint at the -- does someone who knows you look at you and say that is a tangled, tough problem, you know, to -- because I can sign up for 20 certificates and that doesn't tell me who I am. It is a little bit like the counselors at hospital numbers.
Are you going to grapple with that issue, too? Because it becomes important when you are taking legal --
DR. ZUBELDIA: I was planning on bringing people like somebody from the AMA or Intel, California Medical Association, Tunitas(?), Chime(?), Minnesota that are currently working on this sort of PKI project and find out how they do it, why they do it that way and what is appropriate for health care.
DR. MC DONALD: What I am saying is if we just have them come and say what they are doing, there is a specific issue that we should make sure is clear and that is how do we know it is that specific human being. I know it is that certification, but --
DR. FITZMAURICE: But how do they know the person?
DR. MC DONALD: Yes, which is a different -- because PKI and then you can go down and you can finally sign in and show your driver's license, but is that enough if someone who doesn't know you looks at you.
Now, in the hospital settings, you typically go to somebody and get your passport. It is a similar problem. That is what we are looking at.
DR. FERRANS: Clem, I think that the vendors, because I am familiar with some of them, will be able to explain the systems of how they answer specific questions that only the person would know. You know, they have a -- how they are implementing biometrics as the user authentication piece of the puzzle.
DR. MC DONALD: I think we should put it down, though, as how do you know this is a person that -- not that they have assigned them that certificate.
DR. COHN: I actually think that the conversation has been very useful. I would like to wrap this one up so we can move onto the next thing.
DR. FERRANS: This one, is that in January, NIST issued that little information processing standards publication 186-2, which is their digital signature standard. That is also very relevant to this and actually a very good explanation of some of this stuff. So, for federal agencies, NIST would be a good one.
DR. COHN: Okay. Great.
I was concerned, I think we are left wondering, you know, if, indeed, all this work has been done, why the digital signature standard isn't part of the proposed final regs. I think that is part of I think what we need to be looking into because I think the industry needs some direction in all of this. I think that is why we are going to be looking at all of this right now.
MR. SCANLON: Another reason for assuring that we have NIST there because actually we defer to NIST. HHS deferred to NIST on the digital signature standard in favor of a broader approach. So, wherever they are, we want to have them talking about it.
DR. ZUBELDIA: Did NIST advise the panel of commerce for the E Sign Act that was passed this summer?
They probably got a chance to comment on it, Kepa, but it was passed, as you know, by Congress and often federal agencies get a chance to testify and to comment on the proposal, but it is up to Congress ultimately.
And as you said, FDA is also -- issued a proposed rule dealing with --
DR. ZUBELDIA: What I would like to get from all the members of the subcommittee is additional questions on these panels and proposed testifiers. We have a list of a few testifiers, around 20, but I want to get as many as we can because not everybody can come to testify.
DR. COHN: Well, let's talk about a process then because you, obviously -- I don't want people to start popping throwing either zingers or additional questions at this point. It would seem like we need to have people work at the questions and if people have additional questions beyond which we have talked about, you need to e-mail them to Kepa.
Now, in terms of possible presenters, you want to e-mail out to the subcommittee your proposed --
MS. FRAWLEY: It would be good to know who is on it for --
DR. COHN: Exactly. That way we can add additional names based on what you are seeing there. Does that work for everybody?
MR. BLAIR: Kepa, what is your deadline and time frame for when you need to have those from us?
DR. ZUBELDIA: Soon. The hearing is in about a month.
MR. BLAIR: Just give us a deadline because, you know, we are traveling and we will be driven by your deadline. So, please give us a date.
DR. ZUBELDIA: How about the close of business on Monday next week.
MR. BLAIR: Thank you.
DR. ZUBELDIA: And I will send the e-mail with the proposed testifiers and I will send this also electronically, this document electronically, so you add questions to it if you want -- if you want to do it that way or just send me the question and I will send the list of the proposed testifiers and you will get that tonight.
DR. COHN: Kepa, thank you very much. I think it is going to be a wonderful set of hearings.
Why don't we move into the next issue, which is the patient medical record information, sort of planning for next steps. Jeff, do you want to take the lead on this?
MR. BLAIR: May I have your help a little bit with this? Michael, do you have this in electronic form on
your --
DR. FITZMAURICE: No, I don't. I don't have a file of that with me.
MR. BLAIR: So, we don't have a copy that we can edit then, right?
DR. FERRANS: I have one.
MR. BLAIR: Can you be our --
DR. FERRANS: Sure. This is the document you e-mailed out, selection of PMR standards, work plan, draft?
MR. BLAIR: Correct. And as you probably can see if you have had a chance to glance at that, this is not a definitive work plan. This is our first draft. It is virtually almost conversational because a number of these points here are really to wind up saying, you know, are we crafting this the right way, are we heading down the right direction.
We at least have the guiding principles for the selection of standards and we already have a reservoir of information that could help us. So, this is a matter of taking some additional steps forward that might help us.
The first two major work plan items are to wind up saying what are the priorities for standards and terminologies that we would focus on for patient medical information. Clearly, we can't wind up covering the entire domain or spectrum and it is assuming that our priorities would be driven by either a combination of the low hanging fruit of standards that are easy and then where there is a good deal of consensus that they are appropriate ones and/or those that are major barriers and/or those that are major barriers that really need -- this is where we really need the help to create intraoperability and comparability.
The second major initiative is what is our criteria for selection because we can go on to some of those other work plan items, we need to have in place an agreement on our committee as to what our criteria for selection will be in a little greater detail, if possible. We already have the guidelines for selection, but if we could drive those down a little bit more to where we can quantify those, because clearly whatever we do select, there will be those that were not selected, that will ask us to justify our choice and the better we are able to quantify our choice, then the more defensible they are.
Is there somebody that might be able to read the first one? How much time do we have for this? Like 30 minutes or something?
DR. COHN: 30 minutes.
MR. BLAIR: So, we are not going to wind up looking for a final draft document that is full of wordsmith. I think we are going to just maybe at least agree on the basic concepts and directions within each of these work plan items and then for our October meeting, we can have an updated draft, but at least by that time we could start working on these directions if we at least agree to these major premises.
Who would like to read our first one here?
DR. FITZMAURICE: Under activities and time frames? Time frame, September 19th and 20th, 2000. The activity is review, update and agree on the work plan. Identify and request staff support for specific activities in the work plan. That is what we are doing right now.
MR. BLAIR: Okay. Shall we go on to our next one?
DR. FITZMAURICE: The next item is the time frame is October 3 of February 2001 and during this time period, we would agree on high priority areas for PMRI standards. The high priority areas will probably be the ones with the greatest impediments to the functions that are considered the most necessary/valuable.
We might do this by creating an initial draft of the high priority areas for the October standards and security meeting, update the list in the meeting, distribute the draft list of selected experts in November and December and revise and review the priorities with the SSS in January and February.
MR. BLAIR: Could I have comments on this approach for prioritizing where our focus should be?
DR. MC DONALD: It is not specifically an approach, but I wonder whether we are making it harder than we have to make it. I mean, we have -- there are codes and there are messages and we can't just make up new fields of work. And there are three or four big outfits out there and why aren't we narrowing the scope in terms of what is available that is being used by industry? I am assuming that is part of one of the requirements.
MR. BLAIR: Well, actually, I think -- for instance, if we took HL7, HL7 has like 20 different messages. Which of those are the ones that we should especially focus on? There are various stages of implementation, various stages of intraoperability and comparability. So, that is one dimension I think we have to focus on is within a standards development organization, which other one.
The other one is that even if we looked at ASCX12N and HL7, which, of course, you know, the largest one, there is also IEEE. There is also NCPDP. You know, there are some others.
DR. MC DONALD: I believe that is a very narrow spectrum and I think they have that domain. NCPDP has a narrow spectrum and they own that domain. So, it is not a matter -- you can't say okay, the local pharmacy, why don't you use HL7 or IEEE. They are not going to use it. I mean, we don't go through a lot of this work in some of these areas if we are going to recommend -- you want to go with the flow to some degree and if we start out not going with the flow, we are going to --
MR. BLAIR: If we sit down at one meeting and we just decide, I think that --
DR. MC DONALD: I am not suggesting that. I am just suggesting laying out some guidelines in terms of what is really out there and being used by industry and start with that and then we can maybe narrow down the particular issues.
MR. BLAIR: Let me put it this way. If, for example, we were to say one of the major impediments is that we really need to have intraoperable standards between -- and critical work stations and labs and we wind up saying that is the nucleus and somebody on our committee or some experts wind up saying you are really missing a major issue here because the real issue is that we are moving onto XML and we don't have intraoperability between ASCX12 and HL7 and that is a major problem.
DR. MC DONALD: Europe is going with HL7. I mean, you change the industry by no matter what we think up and I think we should start out with who has strengths in the marketplace in given domains and working -- because we can make up questions -- we can invent special problems, but the industry kind of decides in this country.
MR. BLAIR: I am not disagreeing with the fact that market acceptance is a driving force. I think I was making a slightly different point. The point I was making is that I think it is worthy of careful thought as to what are the major areas for intraoperability that we should focus on as the high priorities. Where are the barriers or where are the -- where is the low hanging fruit? And focus on those first. We can't do the whole -- you know, the whole spectrum of critical communications or medical terminology in 18 months. I think it is just a beginning, and still have consensus.
DR. ZUBELDIA: Look at high volume implementations first, for instance.
MR. BLAIR: One of the things would be market acceptance. I mean, you know, I think that clearly where HHS and communications have been very -- message has been very widely accepted, the market is already kind of choosing that and those are kind of low hanging fruit and we could recognize that.
The other pieces are that maybe there is a piece, whether it is decision support or whether -- we could go down a whole list of what ifs. We ought to get them down together and wind up saying, well, where is some other impediment -- the whole purpose of what we are doing here is to move the ball forward faster and if we can be a catalyst to the standards development organizations, if we could be a catalyst to the movement of the intraoperability, by focusing on where the barriers are and the impediments, then we are performing a valuable function.
So, that, I think, is the intent here.
DR. COHN: I guess I am hearing sort of a difference between, you know, how standards, those that do not get acceptance look versus let's focus on the areas that are really the most problematic.
MR. BLAIR: Both. Really a blending of both, really.
DR. ZUBELDIA: I think we probably need to blend in -- other than HL7 also, things like DICOM(?).
DR. MC DONALD: Oh, yes.
DR. ZUBELDIA: Really low hanging fruit and it is easy to say look at this, very easy to adopt.
DR. MC DONALD: I really wasn't trying to pick out a specific individual standard, although I had some interest in HL7 because I worked with them as a volunteer. But it is just that I don't think -- I think if we say we in our wisdom around this table and the various political forces can somehow see the reality that is in ten years of industry, I think it is arrogant and it is chutzpah.
If they haven't done it, it is either because it is too hard or it is not worth that much. I think we should start out -- there are three or four or five, I don't know, where you can kind of say in this area, well, in this subset of that area or we are not going to worry about vocabulary until later -- I mean, vocabulary has got another set of issues and that may actually unfold itself pretty nicely, too, because depending on some of the current negotiations between NLM and Summit(?).
But I think if we make this thing a big exercise and we have no idea how this is going to turn out, so let's just be kind of abstract about it, I think we are going to spend a lot of time and have a whole lot of work and maybe come up with the wrong answer.
MR. BLAIR: I almost feel as if I could change places with you and I would say virtually the same thing and that is why I think we only allowed about four or five months to wind up having decision on what the high priority areas would be.
DR. MC DONALD: If it isn't an area that is out there in the industry, it will be another five years before we can do anything about it.
MR. BLAIR: Well, I guess that, you know, when you write a thing that you -- I don't know we seem to have a --
DR. COHN: Reflecting on how we --
[Multiple discussions.]
-- high priority areas, the PMRI, which is like let's keep it simple.
MR. BLAIR: Yes. Well, I think we have to if we are only going to have -- in a four month period of time, we may only have two or three meetings or conference calls or something, be able to come to this list. I would think we would have to keep it pretty simple if we only have that much opportunity to do that. No?
DR. COHN: Richard, you were going to make a comment.
DR. FERRANS: Let me just say that from the standpoint of high priorities areas, I think there is a little bit of a slipper slope there or a big one in terms of, you know, we had a lot of testifiers talk about, gee, if we had standards, they would enable decision support systems, which would solve the issues that the Institute of Medicine addressed in their report and to focus on that rather than some of the fundamental intraoperability questions that are addressed by some of the standards that have a lot of market share and acceptance and beyond just having a lot of market share, but are mature enough that we can pick, I think that we can sometimes get it at cross purposes because we have to build a foundation for them.
So, somehow I think we should make it when we do have testimony or in this process, that we look at, gee, if we do pick the -- I think it is important that we are able to articulate to ourselves and to others that if we do pick the standards, such as HL7 or whoever, that we say this will address some of these priority areas. This is how this will provide the building blocks to addressing that down the road.
I mean, I think it is important that we articulate that, but I think we need to focus on the low hanging fruit, so to speak. I agree with that.
DR. COHN: Do you have some feedback?
MR. BLAIR: I do. Is it the consensus of the group that this work item is generally appropriate or on target with the time frames?
DR. ZUBELDIA: I think that we need to build into that item asking the standard setting organizations for what is low hanging fruit.
MR. BLAIR: Well, what if we do this? Because I don't know if we are going to -- you know, are we going to bring in all of the SDOs to testify to us in October?
DR. COHN: No, not for this topic.
MR. BLAIR: Yes. So, my thought was -- because I am really very sympathetic to Clem's piece is that we come up with our list of the combination of the low hanging fruit and the combination of those areas, which are major impediments that might need to be focused on and that I could prepare that for the October meeting. We could look at it. We could change it, refine it and then wind up taking that list out to experts and to the SDOs and ask them to see if there is a consensus on that list.
That keeps it simple. It keeps it straightforward. It looks for verification of what we think is a reality in the marketplace. How about that?
DR. MC DONALD: Well, let me -- I am not sure if this disagrees or -- I think you could almost come up with competing specific proposals that then could galvanize some things, like, for example, who else is going to do images besides DICON? But you wouldn't say support DICON's reporting standard because it is not out there yet and it is kind of a -- they are working together with HL7. You would say for result messages and ADT, it would be HL7. You wouldn't just name a standards group. But I think we could get to something we could get closer to, you know, faster and then tie together with why we need it and what we needed, but I think if you start out from sort of the abstract principle, you won't get there as fast.
MR. BLAIR: Exactly.
DR. COHN: Kepa, did you have a comment or -- and I guess I would comment that I think we really realistically probably have October and November, not knowing what the -- at this point, not knowing what our hearing schedule looks like and --
MR. BLAIR: Again, realize that this is not a decision. What this is is where are our priorities to focus on in the rest of the steps for the next 18 months. Okay? That is all this is, our priorities.
DR. FERRANS: So, in the work plan draft what it sounds like -- and correct me if I am wrong -- it sounds like rather than agree on high priority -- well, agree on high priority areas for PMRI standards and that at the October meeting, we would discuss, you know, how to come up with the prioritization methods.
MR. BLAIR: Yes. And you probably noticed we laid it out over like I think a three or four month period. So, you know, the first time in October we may have disagreements or validations. We want to get it out. We want to get feedback and in January or February before the committee decides on what our high priority areas are by, what is it, March did we put down or something like that?
DR. MC DONALD: Would you be receptive of sort of an argument paper about this that or this that or are these alternative sets of real things we got to deal with, that are sort of -- you know, you can guess within two anyway, as sort of a -- as a stalking horse? And if someone would punish me and remind me, I said I would do that, I would do that.
DR. FERRANS: Is there any problem if we drop the second sentence, which is the one about the high priority areas will probably be the ones with the greatest impediment? If we were silent to that and we said we were going to agree on the high priority areas, we would create an initial draft of the October meeting, update the list and distribute the draft list, send to experts, I mean, does that sound reasonable?
MR. BLAIR: That is fine with me.
DR. ZUBELDIA: The high priority areas will probably not be the ones that have the greatest -- it would be the ones with the low hanging fruit.
DR. COHN: I guess I would just for the sake of our scheduling, give ourselves October or November as the time that we go over it, based on what our --
DR. MC DONALD: Are these additional meetings?
DR. COHN: No, no. This would be the -- sometime during the October hearings or November -- if we have time to do that, we will do it then. Otherwise, we will do it --
MR. BLAIR: Can we go on to our next work item, which I think is -- and they have kind of been -- you know, as you start -- after these first three, the others are sort of dependent on the completion of these first few. So, could we go on to our next?
DR. FITZMAURICE: The next one has a time frame of October 2000 through May of 2001. It reads under "Activities," "Establish a method or procedure to assist us in the evaluation of PMRI standards and terminologies. The governing principles would be a good place to start. It will be helpful if we could quantify the characteristics and attributes of the candidates so that our selection is defensible. This is a challenging task and we will probably need the time to go through a few drafts of these methods or procedures. We will probably need to complete this task by May 2001, in order to use it as a framework for updating the profiles of the candidates discussed in the next activity."
MR. BLAIR: In the profiles, we did have the inventory of clinical information standards, which if you recall basically had profiles of each of the standards and data sets and vocabulary systems and it included information on things like market acceptance, coordination with other standards, your ability to update it and maintain it, cost things. I guess the thought is that before we could update that or send that out for updates, we need to be sure what our criteria for selection really would be and if we could get that to the point where we could get closer to quantifying it -- I know we are not going to get there all the way.
DR. MC DONALD: I was hoping by this time we would be, you know, arguing about the boundaries of how much of a standard you are going to propose because this reminds me of the Internet protocol arguments that went on ten years ago. ISO SI was king because -- everybody knew it was king and no one uses it. It is only IT now. So, it is so dominant, the market issue is so dominant in the decision processes that
-- I agree that we want to have some formalism just because, you know, that is good, but if we start out saying, well -- I mean, it is so easy to fall down the wrong path and we will pick old SI over -- instead of IT on the basis of this high level thing.
If you go to the purchasers of the institutions and the hospitals and they are going say, well, shoot, we can't do that. So, you end up with sort of a big exercise for no purpose.
MR. BLAIR: Well, I don't think it is for no purpose. No. 1, one of the criteria clearly is market acceptance and I think I agree with you, there should be a very heavy rate on market acceptance.
DR. MC DONALD: Well, it is not like there is 20 choices in most of these --
MR. BLAIR: But I think that you have identified in your past that you personally, when it comes to medical terminology, feel that there should be a very heavy weight on cost of the terminology, licensure. I think that that is something that is a criteria in your mind that you apply and I think that other pieces are the ability to create continuous updates and maintenance of terminologies, which in one way is, you know, an issue to be selected whether or not a terminology is part of the UMLS, for example.
So, in short, I think that -- I think it would be helpful if we go through this process where we document our basic criterias, I think we are going to be converge pretty quickly on them. I think we know what they are. But I do think we ought to have these documented so that when we go through this process we have it defensible and it doesn't appear as if it was arbitrary or that we --
DR. MC DONALD: But it is just that -- and I want to stay out of the vocabulary discussion.
DR. FERRANS: Jeff, for some reason when I read it, I thought it meant that we were going to develop some kind of scoring system, which, you know, I guess it is me reading the white instead of the black on this, but I think what you were just saying is documented, trying to be as objective as possible, so it is at least in the record.
MR. BLAIR: Yes.
DR. FERRANS: Okay.
DR. FITZMAURICE: Ready for the next one?
MR. BLAIR: Before we go on, is there general acceptance of this then?
PARTICIPANT: I think there is.
DR. FITZMAURICE: Next, the time frame is June through September of 2001. The activity is to update the profiles of standards and terminologies that are the best candidates to address the high priority areas. We have a running start on this with the information that we gathered for the inventory of clinical information standards.
The SSS should probably review the inventory and decide how it should be updated. We should probably update the profiles of standards and terminologies so that they more closely reflect the criteria for selection of PMRI standards. We should also make an effort to verify that we are not overlooking any viable candidates.
MR. BLAIR: Comments?
DR. MC DONALD: Well, it is the same comment, you know. It isn't that hard and I don't think we need to go through an update of that thing to come up with the criteria and the candidates. I mean, say you are going to buy a computer now. It is going to be Microsoft or Lennox or -- you are not going to have to go out searching the marketplace to figure out, well, I heard about this new rule and you are not going to buy it. So, it is the same thing. I mean, I think we are making it too laborious. I don't see the need to update that. We have got a document that you have just published, medical records. It has got a nice page describing the guts of the standards world, two pages. You have got 90 percent of what you need there.
Now, we may have specific questions and then we go back with the criteria and verify those are true, the ones that are sort of serious candidates.
DR. FERRANS: So, this could be a shorter time frame, I think, is what you are saying, rather than June through September. This might be a 30 or 60 day effort.
DR. FITZMAURICE: What would be the product of this activity? As I read it before, it looked like an update of the inventory of clinical data standards and expanding the profiles that on the ones we have picked, we know more about them.
But I don't think that is it anymore. I think we are not updating the inventory.
DR. MC DONALD: Get to the point where we can start some serious discussions about some proposals and maybe that takes three months, but not then start again another three months to decide and have hearings about the alternatives and inventions and the -- there will be lots of things we haven't thought of related to -- well, maybe some have about, you know, what subset of a given standard would one sort of start with as being something that would be supported?
DR. FERRANS: Should we say this is June through July or should we change the content of what we are doing those months?
DR. MC DONALD: Well, our goal is to pick some subset of standards, right? So, let's get to that goal as we can.
MS. FRAWLEY: Yes. I think that we could compress the time frame between September 2000 and September 2001 because as I read, you know, what we need to do over that year, I think we can compress that down quite a bit. My concern is that the last part of the work plan, which is really where most of the effort needs to be directed, we have very little time, you know, to identify it. I think Clem's point is well-taken; you know, get everything out on the table and go from there because I think we are going to need more time towards the latter part of the work plan. I don't see that we have enough time there.
So, what I would see is taking the first page of the document and just compressing this down. There is a lot -- you know, it could be written a lot simpler in terms of what we are going to do and could have a shorter time frame and then leave a longer period of time for us in terms of the evaluation process and also in terms of the identification of areas where there are no standards or where there needs to be an ongoing work effort and then coming up with the recommendations.
DR. ZUBELDIA: This one that says October 2000 through May 2001, could actually be October through December and then instead of June through September, do it generally through May?
MR. BLAIR: Michael, are you capturing this or should I try to capture this on --
DR. FERRANS: This is Richard. I am capturing it, yes.
MR. BLAIR: Okay. You are capturing it.
DR. FERRANS: I don't think we have consensus on the change. I think the recommendation was to compress the time lines. If I look on the subsequent page about the time line of October through December 2001 about matching the characteristics and attributes of the candidates.
Perhaps if that activity started in May, then that would be -- I think experience tells us this is sort of what we ran into last time, where we had a work plan that had a lot of time for the testimony and then we were sort of saying, gee, we have got a short period of time to make the decisions on this one -- this October through 2001 is really what Clem is talking about, which is let's make a decision.
If we were going to collapse a time frame, I would recommend that that activity start in May so we have more than six months to match it up, negotiate, talk to people about if they need to make changes, all those sorts of things, so that we can make the recommendations --
MR. BLAIR: Now, is it October through 2001 or 2002?
DR. FERRANS: This would be May 2001 through December 2001, to take that entire time frame to match the characteristics and attributes of the candidates against the criteria for selection. So, that would imply that by May we would have this list of initial candidates based on --
DR. COHN: I was going to comment that just be aware at least in my view this is an ongoing activity that gets sort of handled in cycles. Standards are going to be maturing. They are going to be sort of available and we will be wanting to implement them as we move forward. So, let's just keep that in mind.
DR. ZUBELDIA: Also, we don't need to pick all the fruit in the first harvest.
DR. COHN: That is what I think I am trying to say.
DR. MC DONALD: Along that line then, we ought to also distinguish some categories or choices that I think we know ahead of time. There will be message model, something standards and there will be vocabulary standards, some of which have been chosen actually already. I don't know whether -- unless everyone was not thinking vocabulary at all in this range.
MR. BLAIR: You know, when I think of vocabulary, that is an impediment and that is something where I think it would be unfortunate if we missed the opportunity to drive forward some standard -- some terminologies that need work. I mean, many terminologies need work and if they are going to wind up being -- serving as a mission critical activity in a clinical setting, you know, the best of what we have out there in vocabularies needs to -- needs enhancement in terms of implementation guides, software, version controls and greater breadth and depth and clarity and feedback from users and responsiveness. I mean, there is a lot of work to be done there and I don't think we want to just wind up saying, well, none of the terminologies is up to that point. So, we are not going to -- you know, we are not going to recommend anything here. I think we have to sort of -- in some cases, I think we may recommend things with the idea of this is an important area. This is a barrier to our being able to move forward with clinical decision support. It is a barrier to be able to wind up having meaningful outcomes data, barrier to being able to capture clinically specific information and right now, the best that is out there is such and such, but it needs this, this, this and this.
DR. MC DONALD: That raises another point is that if we -- we ought to explicitly say, I think, in the planning that we are going to talk about scope of -- you are saying pick a standard. Does that mean if you have the standard and -- we pick all of it? I think not. I think we are saying that we are going to pick a subset --
MR. BLAIR: Right. Functions.
DR. MC DONALD: Because we have time --
MR. BLAIR: Right.
DR. MC DONALD: And we can kind of enlarge that subset over time.
MR. BLAIR: Right.
DR. MC DONALD: And it might be part of vocabulary, too, but on the other hand if you say I am going to buy a Chevy, I can't go out there and tell them to put a Mazeratti(?) motor in it. So, if you have picked them, you know, you are a little stuck. I mean, do you think we can pick them conditionally, that they would --
MR. BLAIR: That is a real problem.
DR. ZUBELDIA: Maybe we need to have a hearing to talk about that.
MR. BLAIR: Well, the only thing that I am trying to suggest here -- I think we may need hearings. I think we want to make sure that when we have hearings, we know what questions we want to ask so that the answers will enable us to come out with decisions. That is what we are trying to do with this work plan.
DR. MC DONALD: Well, actually, I am not too worried if we pick one and it doesn't have everything because market forces do give us that -- well, maybe we don't have market forces.
DR. FERRANS: What should we do about the time line?
DR. COHN: I think we need to go back to the drawing board. I think we are all agreeing that they need to be compressed. Maybe we need more time to think about things. We actually need to probably reflect that in our PMRI recommendations we didn't just have a hammer. Everything isn't a nail in the sense that we recognize that there were some things that are mature standards that we should be recommending moving forward on them and other things that were candidate or areas that need more focused research and effort to come to the point of a standard, et cetera, et cetera.
So, we may as we look at some of these things recognize that there is in certain areas we really can't sort of say, yes, that is okay and it needs x, y and z, that we will just need to say that there are certain -- that certain things need to be --
DR. MC DONALD: That is for next year.
DR. COHN: That is for next year or whatever. So, we just need to be flexible in that as we wander into this.
Kathleen, it looks like you have a question.
MS. FRAWLEY: Well, just a comment.
I would hope that we would enlist the efforts of the standards development organizations to provide information to us and not necessarily rely on the hearing format. I think the approach would be to send a letter to the organizations and let them know what we are doing and have them provide all the information to us so that we are not out there searching to find out, you know, whether something exists or not and, you know, pull things in that way as opposed to, you know, trying to do it ourselves or I think, while hearings are good, we don't always get the information that we need.
Again, we have the short time frame. It always sounds like a lot of time, 18 months, but being realistic that the subcommittee is only one of many activities that everyone is involved in, we only have so much time we can direct to this project.
DR. COHN: And this subcommittee has a couple of other things on its plate, too.
DR. ZUBELDIA: I would say you have to start that pretty early on because of the cycle of meetings that the SDOs have. We want to make sure that they have the opportunity to respond within one of their meetings and then come back to us. So, we need to get going.
MR. BLAIR: Incidentally, the point you just made, that is why I initially allowed, what was it, June through September, is because in many cases when -- if we wind up agreeing on the issues that are used for selecting the standards and we wind up saying where do you stand on these issues so that we could decide, it may take two months or three months for an SDO to respond. In some cases, they have approval processes, where their meetings, you know, don't fall within that time frame and they feel very uncomfortable giving a response without having their meeting -- you know, their constituency agree on how they respond.
DR. MC DONALD: The first thing is the kind of things that we are likely to ask them doesn't need the whole constituency. They all have passports and are creatures that can meet more frequently than the big whole meeting.
Secondly is I am proposing we don't repeat the whole 90 page document for this purpose because that will take us three months, but rather put them in a book of 10 or 8 or 9, you know, groups that we are going to have to talk with and once we get our questions, some of -- not a question, some of it will be a question, so we can send either a set of smaller questions or those particular things we are worried about. I don't think we can get into the mode where we say -- you know, there are certain questions we can't demand of them, like, you know, have you become communist or something. I mean, you have to --
MR. BLAIR: That was my first question.
DR. MC DONALD: I still see it -- the ones that are really out there, we all know who they are. We wrote about them in the last report that just came out and we can -- we are going to have a lot of struggle just figuring out what we mean when we say things, what we are trying to do. I think we just need to get into that grappling as soon as we can.
DR. FERRANS: Along those lines, I had a question. When you talk about the grappling, according to this work plan and I realize this is all going to get reworked, but, you know, a year -- January 2002 to review the recommendations with the full committee and then send those to the Secretary, where I would presume that that would begin some sort of rulemaking process, do you all have any sense of us saying, gee, you know, there is one we find out about in the spring. It is one of those low hanging fruits and would we perhaps rather than wait until we have them altogether and send them over as a bunch, but send the standards individually over have them approved the committee and send them to the Secretary? Is that something that is feasible or not feasible doing sort of serially?
DR. COHN: Maybe I can make a comment on that because I think you are beginning -- we probably will continue the discussion a little bit into November, but there are a number of different things that the subcommittee is doing at the same time. One of them has to do with the whole process that relates to new standards, which is related to the MOU, related to HIPAA financial administrative transactions, et cetera.
So, that is related to this, but not the same thing. So, I think as we have that other process that we are also having to deal with. Now, as we say that, you know, are we going to discover a neat standard that we just want to send a single page letter up to the Secretary, I think we would have to think very hard about that. There is a whole set of processes that are in place.
DR. MC DONALD: But on the other hand, we have already decided this is not going to be a one-shot deal. So, it is just a question about how big the interval is between shots.
DR. COHN: That is right.
MR. SCANLON: Except the first one will have to carry the weight of --
MR. BLAIR: There is one other piece that I would say, Clem, because on one sense, I very much agree with your feelings that this is not that hard, we sort of know who the best candidates are and, you know, on the other hand, Clem, what we are really beginning to do here is we are defining standards that are going to be implemented nationally in many different settings and they are the core of what will be the mission critical information infrastructure.
I do think that we would be wise to simply document what our assumptions are, document basically the criterias we are using, take the extra time to do that because we -- this is something where we may get push back from the industry. You know, you and I tend to be involved in that portion of the industry that is proactive, but there is a large portion of the health care delivery system, which is struggling for various reasons and it is difficult for them to move forward.
So, I just feel as if it is worthwhile and wise for us to document what our assumptions are, add our rationale and --
DR. MC DONALD: How much time are we spending on this arguing about it and the other part of it is we can't assume that -- saying everyone must use this standard recommended by NCVHS. I would actually assume it is going to be much softer and it is going to be stuff like this encouragement or that encouragement so that we are not -- number one, we are not going to get that much push back. No. two, the government is going to wisely want not to fight a pill market fight if the market isn't already working that way.
So, I don't think we are going to be in black and white territory in this domain as we were in the other domain.
DR. COHN: Jeff, rather than continue the discussion, I would rather wind it down, if that is okay with you. I think what we are hearing if I can sort of just try to put things together, I think we are hearing overall interest in willingness to move forward in all of this. I guess from my own view, I would like to see something that potentially also begins to put in -- we may need hearings on what subjects and not the specific topic, but there may be times when we need to do that.
There are a bunch of other things that are on the agenda and what we want to do is we want to make sure that everything sort of fits over the next year and we all know that Dr. McDonald put in 45 days for the NCVHS and probably some of us have other jobs.
We need to make sure that is all sort of comes together in a way that is doable. I actually do like the fact that everybody is sort of coming up with ideas and ways that we can get reliable information captured in a way that doesn't require hearings because I think there will be time left for hearings when we are trying to make decisions about things and want input.
Having said that, I think we have heard that we need to see this again. We will be talking about it in October or November. We have the letter, hopefully, done for tomorrow. We have upcoming some issues around the October hearings for speakers and questions.
Unfortunately, Dr. Braithwaite didn't make it back from his privacy discussions this afternoon which I guess I am not surprised about, but we will hold off those discussions and about other NPRMs and other issues either into October or November, based on availability and how the schedules work.
Is there anything else or are we at a point where we can adjourn?
MR. BLAIR: Yes.
DR. COHN: Okay. I want to thank everyone and we will continue on. See you in the morning.
[Whereupon, at 5:25 p.m., the meeting was concluded.]