[This Transcript is Unedited]
Renaissance Hotel
999 9th Street, N.W.
Washington, D.C. 20001
Review Draft Letter to Secretary on DSMO Recommendations
DR. COHN: It is 2:45 p.m., Eastern Daylight Time. I am Simon Cohn, chairman of the subcommittee. I just want to welcome the subcommittee members, HHS staff and others here in person.
I also want to remind those present that we are on the Internet. So, please make sure to speak into the microphones.
The purpose of the meeting this afternoon is to review the final draft letters to the Secretary, hopefully, to be brought back to the full NCVHS tomorrow. Then we will ask Jeff Blair to lead a discussion of plans for the August 20th and 21st hearings on patient medical record information standards. Then we will review subcommittee issues and plans for the remainder of the year, including dates for future hearings.
Finally, I know that John Lumpkin has asked us to take a look at NHII recommendations to see if there is anything else that we want to recommend.
With that, let's have introductions around the table and then around the room and then we will get into the issues, which will, obviously, be the letter to begin with.
I am Simon Cohn, member of the committee.
DR. BRAITHWAITE: I am Bill Braithwaite, HHS staff to the committee.
MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee.
DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation. I am a member of the committee.
MS. TRUDEL: Karen Trudel, Centers for Medicare and Medicaid Services, staff to the subcommittee.
DR. SHORTLIFFE: Ted Shortliffe, Columbia University, member of the subcommittee.
DR. LUMPKIN: John Lumpkin, director of the Illinois Department of Public Health and visitor to the committee.
DR. COHN: We need to have others around the room introduce yourselves.
MR. WYLIE: Tom Wylie(?) with the American Association of Health Plans.
MR. WILLIAMS: I am David Williams(?). I am with the Blue Cross and Blue Shield Association.
MS. WILLIAMSON: Michele Williamson, CDC, National Center for Health Statistics.
MR. KLINGER: Gene Klinger, contractor.
MS. SCHULMAN: Kathryn Schulman(?) with the American Hospital Association.
MS. DUFFY: Kathryn Duffy with the American Medical Association.
MS. ROBINSON: Marietta Robinson(?), NCHS.
DR. COHN: Okay. First of all, let's -- obviously, the next while is going to be spent reviewing the draft letters. Let me first of all make a comment that I don't think we are going to be looking or spending time on the first letter, which is the transmittal letter, only because the changes recommended by the full committee were technical and not particularly for us to review. So, we will move to the second letter.
Now, having said that, I also did want to just acknowledge that since our meeting yesterday, we then received a letter from a subgroup of JHETA(?) that included CHIME(?) and AHIMA, AMIA(?) and others, that apparently had been a letter that had been sent to Congress requesting that there be no delay in HIPAA administrative simplification implementation.
Then we have also received an e-mail from a representative from the public, David Williams, Blue Cross/Blue Shield, which I don't have exactly in front of me, but I will try to just give you the sense of the letter, which was, obviously -- is this the e-mail that you sent me?
MR. WILLIAMS: Yes, sir.
DR. COHN: Oh. No, this actually is not the -- okay. I think you had asked me to share it with the committee. This is, I guess, the letter -- I am sorry. Is this a different letter than yesterday? Same one. Okay.
The e-mail that we received yesterday, which is expressing concern with using examples, related to possible phasing of implementation. I just wanted you to know that.
The letter that I am now receiving, which was sent -- I guess we received yesterday also, as I understand, is basically a letter from a number of signatories, including Blue Cross/Blue Shield. It is once again reiterating support for a two year implementation delay, that date, which will begin after all the transactions have been released.
With that, shall we move into our letter. Are there any comments about any of these letters or any comments before we move into the letter? Okay.
Karen, it looks to me like you are intending to lead us through some modifications or changes?
MS. TRUDEL: No, I am just repairing some typos.
DR. COHN: Okay.
Well, this is, I think, the first -- no, I guess this is the letter. Okay. Unfortunately, you have my copy of the letter, but having said that, I think we heard that there was a request early on in the letter that references the purpose of the standards and that was to provide administrative simplification and cost savings.
DR. BRAITHWAITE: This was John's suggestion to add something about the purpose to the introduction, I presume, John, is where you wanted that.
DR. LUMPKIN: Yes. The experience I have had talking about the NHII, which mostly has been in the context of HIPAA conferences, is that when you put it within that context, there is a lot more acceptance of what HIPAA is and what the requirements are leading towards.
DR. COHN: Okay.
MR. BLAIR: Did you have a place like right within that first paragraph, where you felt that the sentence could be most appropriately added?
DR. SHORTLIFFE: If I could suggest, it seemed to me that the obvious place was after the first sentence in Point 1.
DR. COHN: Yes, I agree.
DR. SHORTLIFFE: Because Point 1 says there was overall agreement that HIPAA standards are necessary and viable and then why. That is the missing sentence.
MR. BLAIR: But that is part of the observations from the testifiers. I thought that John's suggestion was in the initial introduction to the Secretary in terms of putting in context what these hearings were about.
DR. COHN: Well, probably the other option is the second -- at the end of the first sentence of the first paragraph and that is sort of the other option.
DR. LUMPKIN: Well, you know, thinking about the location and what Jeff just suggested, it could start out a little something along the lines, the NCVHS has a longstanding commitment to the transformation of the health information systems to improve the quality of care. A first major step was the adoption of administrative simplification provisions of HIPAA, something along that line.
Then as part of its role to monitor and advise the Department on the -- in this direction, the committee on May 31st had hearings and that would transition. So, it would be a couple of sentences in front of that.
DR. COHN: The very beginning. Okay.
DR. BRAITHWAITE: That makes sense. So, John, why don't you move over next to Karen and just type those two sentences in. You are so good at this.
DR. COHN: Dr. Braithwaite, I was surprised that you weren't writing feverishly as he was talking.
DR. BRAITHWAITE: I am not good at writing that fast. I don't take shorthand. Don't have my keyboard in front of me either.
MS. FYFFE: I can't draft anymore without a keyboard. I don't know how I did that for so many years longhand.
MR. BLAIR: Is there another suggestion to modifying the letter, other than the second issue that John offered us, that we might be discussing while John is wrapped up with Karen, modifying the letter?
DR. COHN: Was that the additional example?
MR. BLAIR: Yes.
DR. COHN: I think there are actually a couple of areas. I guess we could talk about that additional example. There are a number of other areas that we need to be looking at, but -- they will come up with something. Okay.
PARTICIPANT: There was a question about a fourth bullet under --
DR. COHN: Yes, exactly. I am sort of -- I am looking at my notes here --
MR. BLAIR: Yes, but that is the one I think that involves John. So, I was suggesting that we hit the other ones and --
DR. COHN: Let's hit some other ones. I guess the -- there is a sentence that we had -- had been suggested that we put in on Item 3, which goes there was testimony from a number of industry sources for a delay in HIPAA standards compliance dates, as well as from a number of others that oppose a delay. The NCVHS has not heard a delay proposal that we can support. And then a new sentence being inserted right there, which says a delay that is not coupled with a strategy to productively utilize the additional time is unlikely to contribute to a successful implementation.
Does that sound okay --
DR. LUMPKIN: That has to be accepted by the full committee.
DR. COHN: Okay. So, we will add that in there and we can take a look at it after John is done with his introductory paragraph. It is already in there? Okay. Great.
DR. SHORTLIFFE: The only thing is do you really want to split an infinitive, I guess?
DR. COHN: Okay. Now, I actually would like to spend a little time with us looking at -- John, are you okay with -- or did you give up on that first paragraph?
DR. LUMPKIN: I actually gave it to Karen and she is going to work on it.
DR. COHN: Okay. Well, do you want to talk about your issue then, the other -- I was going to move -- talking about opposing delays, but -- okay. Well, let's talk about opposing delays for just a second here, which is -- at this point, the way it has been structured, I guess I am wondering as we look through that bullet, and I will read it again to everyone, it seems that there is a lot of unnecessary stuff there. I guess I need the subcommittee's help in terms of figuring how much we can surgically remove without damaging the meaning.
The bullet at this point says the NCVHS opposes any of the proposed delays in the compliance dates for the HIPAA standards. The committee particularly opposes the -- delays of compliance dates, such as that found in Senate Bill 836, as being detrimental to the industry and the possibility of a successful implementation process.
It is imperative that we not undermine current implementation efforts and continue to promote the urgency of working on the implementation of standards. Now, that all, I think, fits together pretty well. We might want to say that is found currently in a Senate bill just because some of these bills have a way of being modified, amended and all of this.
I don't know if that is reasonable, but I think that probably is a good way to --
DR. LUMPKIN: Could I suggest maybe a way to start into this?
DR. COHN: Yes.
DR. LUMPKIN: That the opening line may be something along the lines of health care entities are constantly in the process of changing and replacing health information systems.
MS. FYFFE: How about continuously updating?
DR. LUMPKIN: Continuously updating health information systems. Lack of clarity as to direction and requirements leads to -- can lead to substantial additional cost down the road.
Therefore, the NCVHS opposes any delays.
DR. COHN: In the compliance dates for the HIPAA standards.
DR. LUMPKIN: In compliance dates because it will add additional uncertainty into what is and will be required. I am just sort of tossing out some language. Then that sort of -- so, it gives a rationale.
DR. COHN: That is good.
DR. FITZMAURICE: I think also you may want to have in there something about it will postpone the time at which these cost savings can become effective. After all, that is the major goal of this.
DR. LUMPKIN: I think that there is a return on investment for cost savings -- I mean, a return on investment for doing administrative simplification. We all believe that that is the case. But there is a cost of delay. So, the return on -- I think the cost of delay is much more real to people who may have their doubts about the return on investment piece.
So, we can do both.
DR. COHN: Unfortunately, we are still on the first paragraph here, it looks like. How are we doing?
MS. TRUDEL: This was John's first couple sentences.
DR. LUMPKIN: Are you about to read them to us?
MS. TRUDEL: Oh, sorry.
The first sentences are: The National Committee of Vital and Health Statistics is committed to the transition of health information technology to improve the quality, efficiency and effectiveness of health care. Administrative simplification beginning with the provisions of HIPAA is an important step towards this goal. Then we start on May 31st, 2001.
DR. LUMPKIN: I would think the National Committee on Vital and Health Statistics identifies or has identified the -- I am looking for a word like "maturing" of the health information technology, the --
MS. TRUDEL: Evolution. No?
DR. LUMPKIN: Something like that. Evolution of health information technology as a means to improve -- Bill is frowning.
I just say that because I don't think the Secretary cares what we are committed to. But if we make the distinction that the evolution of the system is a means to improve quality, efficiency and effectiveness, therefore, it is good to have that happen. I don't know if evolution is the right term.
DR. ZUBELDIA: Implementation.
DR. LUMPKIN: Yes, better. Better.
MS. TRUDEL: I will read it again.
DR. COHN: It is still not right.
MS. FYFFE: Well, really you are saying it has been identified as being important as a means to improve.
MS. TRUDEL: The NCVHS has identified the importance of health information technology as a means to improve the quality, efficiency and effectiveness of health care.
MR. BLAIR: Recognize the importance?
MS. TRUDEL: Recognizes the importance?
DR. COHN: And it is actually probably the appropriate application -- the importance of the appropriate application of health information technology.
DR. LUMPKIN: Okay. Sure. Fine.
DR. COHN: Recognize the importance of the appropriate --
MS. TRUDEL: Application?
DR. COHN: Application of -- I am struggling a little bit because I actually don't think that we are typically technology driven. So, I am sort of am a little concerned about the way we are describing sort of our role in this thing.
DR. LUMPKIN: I am sorry?
DR. COHN: I said I don't think we are particularly technology driven.
DR. BRAITHWAITE: The standardization of the interaction is more important than the application --
DR. LUMPKIN: Yes, it is the importance of the standardization.
MS. FYFFE: -- information standards? Because then we say administrative simplification in the next sentence.
MS. TRUDEL: It is the importance of national standards for health information technology. We have to have national standards in there, don't we?
DR. LUMPKIN: No. We are doing standards in order to do -- I mean, there is a good and we are doing standards in order to enable that good. I think that technically you may be correct, but to the audience that we are speaking to, I am not sure that that difference -- the difference trying to be technically correct may be confusing.
MS. FYFFE: Yes. I think if you say the appropriate application of health information technology, I really think that that meets the needs of the audience.
DR. BRAITHWAITE: Of course, the appropriate application requires standards. So, that meets our --
DR. LUMPKIN: And it is technology in the broad sense as opposed to a specific technology.
DR. COHN: When we say effectiveness of health care and lower costs.
We have administrative simplification beginning with the provisions of the Health Insurance Portability and Accountability Act. What do you mean that the administrative simplification provisions of the Health Insurance Portability and Accountability Act are an important step towards this goal?
DR. LUMPKIN: Well, no, because there is administrative simplification that extends beyond HIPAA. And if we talk about different steps, the first step is HIPAA, but there are other steps down the road. That is what the NHII is beginning to describe.
Or we could say implementation of the administrative simplification provisions of HIPAA.
DR. COHN: Is an important step. Okay.
DR. LUMPKIN: Is an important step and you can probably just put a period and end it.
MS. TRUDEL: Shall I read it one more time?
DR. COHN: Yes.
MS. TRUDEL: The NCVHS recognizes the importance of the appropriate application of health information technology as a means to improve the quality, efficiency and effectiveness of health care and lower costs. Implementation of the administrative simplification provisions of HIPAA is an important step.
DR. BRAITHWAITE: Could you say while lowering costs?
MS. TRUDEL: While.
DR. BRAITHWAITE: Actually, we have repeated the important concept. Maybe an important step could be replaced by something --
MR. BLAIR: Major step, critical step?
MS. FYFFE: How about essential. Is essential.
DR. COHN: Good.
MS. FYFFE: Is administrative simplification capped?
DR. BRAITHWAITE: Well, administrative simplification provisions would not be capped, but if you said Administrative Simplification subtitle, it would be.
DR. SHORTLIFFE: Since this second sentence presumably follows from the first, I wonder if putting the word "accordingly" before "essential" would be a good idea. Implementation of the administrative simplification provisions of the health insurance act is accordingly essential.
DR. BRAITHWAITE: Or start that sentence with "accordingly."
DR. COHN: Okay. Now, let's move down to this bullet that we were just talking about, which is opposing delays and see if we can construct some of our thoughts in relationship to that. That is down in the second bullet, I think. No. Same bullet of recommendations. I am sorry.
I guess the question that I had had, even before we moved to John's issues about the beginning rationale, I am actually first of all wondering about whether or not there is value here to be mentioning the fixed delay up to one year in this particular paragraph. It just seems a little odd.
DR. LUMPKIN: Yes. That could probably just sort of be almost a lead in to the next dot point as the beginning line of that.
DR. BRAITHWAITE: And start the next bullet there instead of --
DR. LUMPKIN: And then say a delay would not be -- but if it is considered --
MS. TRUDEL: Are we making this all one big bullet then?
DR. LUMPKIN: No, I would just demote that phrase down to the next bullet.
DR. COHN: I don't think we understood what you just said.
PARTICIPANT: You mean make it part of the next bullet?
DR. LUMPKIN: That is correct. Cut it from the --
DR. SHORTLIFFE: Or just get rid of it.
DR. LUMPKIN: Cut it and then past it.
DR. COHN: Where?
DR. BRAITHWAITE: At the beginning of the next bullet.
DR. LUMPKIN: The first bullet, the bullet we are talking about is imposing delays. That should be about imposing delays. Then the next one is, well, a delay, if there is a --
MS. TRUDEL: I am hearing several different things. I think what I am hearing you say is take bullet No. 3 and put it under bullet No. 4 and demote it.
DR. LUMPKIN: Well, have it at the same rank, but as the -- just cut that and then paste it right in front of the word "if."
[Multiple discussions.]
DR. SHORTLIFFE: I think it would be helpful -- I think it would be clarifying to the beginning of this bullet if it said the NCVHS heard persuasive testimony or something like that. I mean, it just says it heard. It is sort of like there has been a rumor mill or something. I thought that we needed to say how we heard it.
PARTICIPANT: Heard testimony.
[Multiple discussions.]
DR. COHN: -- we wanted to have as currently found in Senate Bill 836.
Now, John, you wanted to include --
DR. LUMPKIN: Yes, probably at the end.
DR. COHN: Of that bullet.
DR. LUMPKIN: End of that bullet, another sentence saying --
MR. BLAIR: Now, when you say the end of -- could you help me understand the context of where you are?
MS. TRUDEL: -- of the opposing delays bullet?
DR. LUMPKIN: That is correct. So, we would say opposing delays, NCVHS opposes any of the proposed delays in the compliance dates for HIPAA standards. The committee particularly opposes open-ended delays of compliance dates, such as are currently found in Senate Bill 836 as being detrimental to the industry and the possibility of successful implementation process.
It is imperative that we not undermine current implementation efforts and continue to promote the urgency of working on the implementation of standards. Industry facilities -- folks --
DR. COHN: Testifiers?
DR. LUMPKIN: No. The people that are doing this. I don't know if there is a term --
[Multiple discussions.]
Industry participants are making health information system decisions -- are currently making health information systems and without clarification can make choices that will lead to additional costs without clear direction. I don't have the right words in there. They don't quite flow right.
MR. BLAIR: And may make costs instead of can make.
DR. LUMPKIN: Yes.
DR. BRAITHWAITE: But isn't that the argument for the delay?
MR. BLAIR: He is making it the need for direction.
DR. LUMPKIN: For direction. By delay, let's say I am getting ready to buy a system, if I think this thing is going to be delayed for three years, my life cycle for this particular --
DR. BRAITHWAITE: Well, then, you just don't do anything for three years and you wait until all the rules are out and so you know what it is you want to do.
DR. LUMPKIN: My old system doesn't work. I have to buy a new system.
DR. BRAITHWAITE: Well, the old system only doesn't work if you change the standards, but if you don't have to change the standards --
MS. FYFFE: No, it is old because it is old.
DR. BRAITHWAITE: So, you are talking about the ongoing change process not the ones forced by the addition or the adoption --
MS. TRUDEL: So, it is industry implementers, who need to upgrade systems for other reasons.
DR. COHN: I am sorry, John. I don't buy this. I think it is confusing. If we are confused by it, think about how --
DR. LUMPKIN: Yes. Undo. Delete. Never mind. I think I am going to go to --
[Multiple discussions.]
-- where I am appreciated.
MS. FYFFE: Have we talked about your enforcement point yet?
DR. COHN: No. That is, I think, our next issue here.
MS. FYFFE: Don't leave before you do that, John. John can't go to the other meeting until he --
DR. COHN: That is right. I think we are now down to the --
DR. ZUBELDIA: I have a question, though. On this third bullet, do we need a title for that bullet? The first one says "Providing Guidance, Opposing Delays." What is this first third bullet?
DR. FITZMAURICE: Orderly implementation?
MS. FYFFE: It is not parallel construction.
DR. ZUBELDIA: Delayed considerations?
MR. BLAIR: Isn't this an "if"? Originally, it started out if a delay is considered.
PARTICIPANT: Yes. If a delay is considered. That, I think, is the key phrase.
DR. SHORTLIFFE: Contingency kind of notion.
MR. BLAIR: Ooh, contingency. That is it. Contingency.
DR. COHN: Contingencies actually. There is more than one possibility here.
MR. BLAIR: Providing contingencies.
DR. COHN: Does that sing to people?
MR. BLAIR: I think it is providing contingencies not providing for.
PARTICIPANT: I agree.
DR. BRAITHWAITE: We were thinking about a fourth example that involved having people who are making good faith effort file a plan in order to get an extension. That is how I interpreted the concept.
DR. LUMPKIN: So, essentially what it is, allowing an extension based upon demonstration of good faith effort and a plan for full implementation.
DR. ZUBELDIA: Would that be as an example in the flexibility in enforcement?
DR. LUMPKIN: No.
DR. BRAITHWAITE: He wants to keep it out of that because it will be a statutory enabler of the Secretary to legally extend the compliance date under these conditions, as opposed to just not enforcing but still leaving the legal requirement in place.
MR. BLAIR: John, could I make a couple of suggestions to tighten that up a little bit because I am trying to make sure that it is interpreted within a tight context of how I think you mean it and not more broadly interpreted in a way that it might be abused?
Would you consider, for example, if we added the word -- and I don't remember exactly the phrasing there -- I think I wanted to use selected extensions, not --
DR. COHN: Limited extension, Jeff?
MR. BLAIR: Selective or --
DR. COHN: Limited.
MR. BLAIR: -- limited. And the other thing that maybe you could help me with a little bit is that you have the phrase "good faith," could we add a little bit more substance to that idea?
DR. ZUBELDIA: Some examples of good faith.
MR. BLAIR: Yes. Either examples or just even a few words to sort of indicate that we are really looking to see the people and working to make progress on this and that the requests are not just --
MS. FYFFE: Not just a delaying tactic.
MR. BLAIR: Exactly.
DR. LUMPKIN: We would want to know whether or not we would consider, you know, Unitarianism being a good faith or not, right?
DR. COHN: You are bad, John.
DR. BRAITHWAITE: I think we ought to put the word "statutory" in there as well, making this truly a statutory extension. Statutory extension in selective, limited cases.
MS. TRUDEL: Wait a minute. Select -- statutory extensions in limited cases?
DR. BRAITHWAITE: In limited cases, based on --
DR. ZUBELDIA: That is already in the law.
MS. TRUDEL: It is already there, yes.
Could be permitted based on demonstration -- we are just trying to make the construction parallel.
DR. ZUBELDIA: Could be --
DR. BRAITHWAITE: This is good because this is, in fact, one of the things we heard in the testimony.
DR. LUMPKIN: Okay. Based upon demonstration of significant progress, instead of good faith --
MS. TRUDEL: Demonstration of --
DR. LUMPKIN: Go down to good faith --
DR. COHN: Based on demonstration of significant progress or just significant progress.
DR. LUMPKIN: Based on demonstration of significant progress.
DR. ZUBELDIA: You want to give some like an example of what would be a demonstration of significant progress?
DR. BRAITHWAITE: No. The Secretary can fill that out.
DR. LUMPKIN: Demonstration of significant progress and a plan for full implementation.
DR. COHN: That looks pretty good.
MR. BLAIR: Could we consider using the word "may" instead of "could"?
DR. LUMPKIN: You already said that once before.
MR. BLAIR: I know.
DR. LUMPKIN: And we forgot to do it.
MR. BLAIR: This was someplace else, I think.
DR. ZUBELDIA: We have "could" in all the other bullets.
MR. BLAIR: Oh, okay. So, it is consistent.
MS. FYFFE: How does this avoid litigation? In your experience from Michigan, I mean.
DR. LUMPKIN: Well, actually, Illinois, but --
MS. FYFFE: Oh, I am sorry. I have got Michigan on the brain.
DR. LUMPKIN: Michigan is another state and they have Big 10 teams and so do we, like Northwestern, my alma mater.
But I think that what this does is it just puts in a different issue because it takes it out of enforcement and facilities and plans don't like to be enforced.
DR. BRAITHWAITE: It still requires an act of Congress to statutorily allow the extension of the compliance date, which means you are not violating federal law when this is done, as opposed to like enforcement approach, which means you are in violation of federal law and just not going to be punished.
MS. FYFFE: I got it. Thank you.
MR. BLAIR: May I ask if we could now -- now that we have added a fourth example, if we read all of the four examples so that we could look at them in context for consistency?
DR. COHN: Sure.
Karen, do you want to go?
MS. TRUDEL: Health care claims and remittance advice transactions could continue on the current timetable and other transactions could be delayed to support a phased implementation or all transactions could be required to be ready for implementation by the compliance date but additional time could be given for implementation and testing with trading partners or all transactions could be required for implementation by the compliance date, but the requirements for implementing adopted code sets and/or identifiers could be delayed or statutory extensions in limited cases could be granted, based on demonstration of significant progress and a plan for full implementation.
DR. LUMPKIN: I think what Jeff has just done is that probably we ought to start out that line with all transactions could be required for implementation by the compliance date, but statutory extensions or limited cases could be granted based upon.
MR. BLAIR: What about in the first one just calling that a phased implementation? Maybe an additional sentence to it might indicate that this is similar to the suggestions from many testifiers that there be a phased implementation or this is consistent with testimony from a number --
DR. BRAITHWAITE: That is a general statement that could apply to any of these because all of these have been suggested --
MR. BLAIR: Well, that is true.
DR. COHN: I think the first one is actually fine the way -- I think this is actually looking pretty good. Thank you very much for your help. We do appreciate it.
MS. FYFFE: Our subcommittee consultant.
DR. BRAITHWAITE: We did have a comment from someone about the federal agencies requiring people to comply with the standards before the current compliance date.
DR. FITZMAURICE: I think Kathy suggested that as a good faith or --
DR. BRAITHWAITE: We didn't hear about it in the hearing.
MS. FYFFE: We need to talk for a few minutes about that. Do we have anyone from CMS in here that
could --
MS. TRUDEL: I am not familiar with that.
DR. BRAITHWAITE: Since we didn't hear about it and we don't have any experts to talk about it, I think we ought to leave that one out of this.
DR. COHN: Yes. I mean, I think we can deal with that at the next meeting if it turns out to be a --
MS. TRUDEL: That is an issue that I can take back and provide to the encounter data folks, though.
DR. COHN: Great. I think that is probably reasonable.
DR. BRAITHWAITE: I had one -- just one minor thing for accredited standards committee X12. It should be accredited standards committee X12N and then in the parentheses, it should be ASC X12.
MR. BLAIR: By the way, I had always thought that the name of the committee is ASC X12N, Accredited Standards Committee X12N. I hear from time to time people referring to it as ANSI and I thought that ANSI had requested that that not be used in the name several times. Is that not correct.
DR. ZUBELDIA: You are correct, Jeff.
MR. BLAIR: So, this should be ASC X12N.
DR. ZUBELDIA: It should not be ANSI X12.
DR. BRAITHWAITE: ANSI accredits X12 but it is not part of the title.
DR. ZUBELDIA: On the issue on the code sets, isn't it true that the codes, like the HCPC codes will be changing at the end of this year as part of the normal course of changing HCPC codes every year?
DR. COHN: They change every year, yes.
DR. BRAITHWAITE: They get updated every year.
DR. ZUBELDIA: So, I am not sure what is the thing with that October 1st date.
DR. COHN: Oh, I think it was the issue that you couldn't use local codes or level 3 codes.
PARTICIPANT: Level 3.
DR. COHN: That is not -- I don't think we need to pursue that particular conversation.
Could we go down to that -- I guess the only question I have and I am otherwise fine, under "Recommendations," is the title "Providing Contingencies." Is that the right title there? I am not sure that I quite understand.
DR. SHORTLIFFE: You say in the second bullet that you oppose delays, but you acknowledge that there may be delays and now you are sort of doing some contingency planning if such delays occur. Maybe the problem is having -- parallel as a third bullet. It is sort of in a way a separate paragraph possibly, rather than a bullet under a recommendation. Your recommendations are really your first two.
DR. COHN: Somehow really eye catching, which would be if a delay is considered period. And basically just -- I mean, once again, I don't know. I am just sort of looking at this providing contingencies doesn't --
DR. ZUBELDIA: And then also have the if a delay is considered in the middle of the paragraph right there where it is, have it in both places.
DR. COHN: Yes. I am just sort of throwing it out. I am just not sure that -- I mean, maybe if we can come up with another word describing -- I am just not
DR. SHORTLIFFE: -- because it really is -- you are saying you oppose delays, but you are acknowledging that they may occur. If they do, you are trying to say, well, look if, in fact, you have to try to accept delays, here are some suggestions for how to deal with that and here are four. So, in that sense it really has to do with the whole delay issue and in that sense is part of your second bullet.
DR. COHN: Then it becomes if the delay is considered period.
DR. SHORTLIFFE: You don't need to have parallel lead in anymore.
DR. ZUBELDIA: The first bullet doesn't go -- doesn't talk about the delay topic. Bullets 2, 3 and 4 -- no, 2 and 3 talk about the delay. Four actually doesn't quite talk about the delay either. It talks about flexibility and enforcement.
So, it may be Bullets 2 and 3 need to be a recommendation, too.
DR. BRAITHWAITE: That is what Ted is saying, Kepa.
DR. SHORTLIFFE: That is what I am saying. Put them together.
DR. ZUBELDIA: Well, promoted from a bullet to a recommendation, too.
DR. SHORTLIFFE: Except it really falls under your -- No. 1 says to achieve the desired --
DR. ZUBELDIA: But maybe that should be the preamble to all the recommendations. Then number the recommendations because all the recommendations are to achieve this rapid publication of final rules. If you go to Recommendation No. 2, it talks about that again.
MS. TRUDEL: I am not going to do this until I am absolutely sure. What I hear you saying is that the lead in paragraph will simply be a paragraph. It will not be numbered and the recommendations themselves would be numbered and the first bullet would be 1, the second bullet would be 2. Will the third bullet be under 2 or --
DR. ZUBELDIA: Yes, it will be under 2.
MS. TRUDEL: Then the fourth bullet will be 3?
DR. ZUBELDIA: Yes.
MS. TRUDEL: I am going to push the button. Speak now.
DR. COHN: So, this is going to be the lead in to the recommendations because it is more than rapid publication of the final rules. It is successful implementation.
MR. BLAIR: Well, it says that.
DR. COHN: The point here is to achieve the rapid publication of the final rules. The rest of this doesn't have to do with the rapid publication of the final rules. We need to do something with that sentence, I guess, is what I am saying.
MS. TRUDEL: Wait a minute.
PARTICIPANT: Maybe we should just accept the changes.
MS. TRUDEL: Wait, wait, wait. We can't do this because there is more than one recommendation.
DR. ZUBELDIA: We just renumber the bottom ones.
DR. SHORTLIFFE: And then you have to be sure your lead in really applies to all the recommendations, not just the first couple.
DR. BRAITHWAITE: And it may be that we just delete the lead in and start out from No. 1.
DR. COHN: Let's go and take a look up higher. I think the numbering, we are fine here. So, we are getting rid of the --
DR. SHORTLIFFE: How about just taking out to achieve -- all you needed to say there in your lead in is the NCVHS recommends you take a leadership role and that applies to all the recommendations.
DR. COHN: This role could include, this role should include --
DR. BRAITHWAITE: Leadership role could include or do you want to do all --
DR. COHN: Gosh, I wouldn't be working so hard writing this if I didn't want them to do all of them. Should or could, I really actually don't care.
DR. SHORTLIFFE: Should, I think. You know, you are making a recommendation.
DR. COHN: Okay. So, we have got one -- let's take a look at -- let's take a look at 2 here just to see how this looks. Recommendation 2, let's take a look at Recommendation 2 again. We sort of lost part of it here. it is called opposing delays.
That is probably a better -- get rid of the title there. And that is the second paragraph, right? I think that looks -- what do you think?
DR. ZUBELDIA: That looks better that way, I think. Recommendation 1 is providing guidance. The second is opposing delays. That is where it talks about contingencies. The third one is flexibility and enforcement.
PARTICIPANT: Which is not parallel.
[Multiple discussions.]
DR. COHN: Okay.
MR. BLAIR: The only piece that I -- maybe you have done this and I just haven't been able to keep track. Providing or allowing flexibility, I would tend to think that that should come earlier in the letter than the contingencies. I almost feel as if the contingencies should be the last thing that we offer. What do you think?
DR. BRAITHWAITE: Well, they go with opposing delays. That is the only thing. The contingency really is basically part of the -- you are requesting that he oppose the delays or we say we oppose the delays altogether and suggest that he do the same, but if he should choose not to, then we lay out some suggestions for how to deal with that.
MR. BLAIR: Well, I do understand that thread and that is a rational way to do it. My only concern is that if the Secretary reads that, then the Secretary then has to make a mental transition back to a different mind set when he starts to look at the allowing flexibility.
In other words, we are really -- in the back of our mind, we are assuming that there would not be delays with allowing flexibility or statutory delays, official delays. You see what I am saying?
DR. SHORTLIFFE: The issue of flexibility may come up even if there are delays.
MR. BLAIR: Okay. That is true.
DR. COHN: Apology, Jeff. What were you suggesting at this point for the flexibility? Did you want to have it as No. 2 or --
MR. BLAIR: I wasn't sure because, you know, I am not sure that I have a mental image of where things are. My concern was that if we discuss the options for delay and then after that in the letter, we then go back to this idea of flexibility in --
DR. COHN: I think what you are suggesting maybe is that the flexibility and enforcement be No. 2 and have it be before the delay discussion?
MR. BLAIR: -- that way without breaking other things, can you do that?
DR. COHN: I think so. Shall we take a look at that for a second. Do you want to move Item 3 to --
MS. TRUDEL: Between the two paragraphs in 2?
DR. COHN: No, no, before 2.
MR. BLAIR: The intent of this change was that the last thing the Secretary reads is the options for delays.
DR. COHN: Well, it is not going to be the last thing.
DR. SHORTLIFFE: Well, it won't be because there are still more recommendations.
MR. BLAIR: See if the flow is okay. Otherwise, you know --
DR. BRAITHWAITE: The first two, at least, are things that the Secretary can do without an act of Congress.
Providing early guidance, allowing flexibility and enforcement, opposing delays.
DR. COHN: Look at the next one now.
PARTICIPANT: So, No. 4 is implementing rapidly.
MS. TRUDEL: Publishing rapidly.
PARTICIPANT: Well, it is both promulgating and implementing rapidly.
DR. ZUBELDIA: We are not putting titles on these things, right?
DR. COHN: We sure are.
DR. BRAITHWAITE: On the first three, yes.
The title for No. 5 is "Supporting Changes." For No. 6, "Exploring Consistent Standards for Paper" or something shorter than that.
DR. COHN: Okay. Is that a wrap? Not that I don't want to spend until 5:00 on this particular document, but are we comfortable with this that we can accept the changes that have occurred, time to print this out, people can look at it tonight and any other minor changes -- if we need to, we can print out another version for the full committee tomorrow, but I think it looks pretty good at this point.
DR. SHORTLIFFE: This gets voted on tomorrow, is that right?
DR. COHN: Yes.
Maybe it is actually probably could rather than should.
Let's go back and look at the introductory on the recommendation. I think it is probably -- as I look at this, probably it is could rather than should. Let's go back to -- just go back and change it back to where we were there.
Okay?
PARTICIPANT: Yes, that is fine.
DR. COHN: Why don't we accept the changes and we will get it printed. Actually, as I say that, can we move on to other business and maybe take a peep -- look at a cleaned up paper copy of this as the last item of business today?
MS. TRUDEL: Do we have access to a printer?
DR. COHN: I believe we do. So, I guess the question would be -- at least that is what I understood. Maybe I am mistaken about that but --
[Multiple discussions.]
Why don't we accept changes then.
DR. ZUBELDIA: -- draft at the top?
DR. COHN: How about if I let the technocrats here on the corner -- and Jeff, do you want to talk about -- lead us through -- and then we can -- at the August hearings.
MR. BLAIR: Should I begin? Are we all convened at this point or --
DR. COHN: Yes, I think we are convened and Jackie is actually passing out, I guess, the proposed agenda for August.
MR. BLAIR: Do you all have a copy of the tentative agenda for August 20th and 21st? Kathleen and Ted, are you able to find that?
DR. SHORTLIFFE: Yes. Got it.
MR. BLAIR: Got it. Okay.
Let me give you a feeling for this because it is unusual that we wind up having a subcommittee meeting in August, but we are really trying to make sure that we have time to evaluate our options for selecting standards for message format standards for PMRI by the end of this year.
So, in order to allow time to review the feedback from the questionnaires that we sent to all of the SDOs, we scheduled a meeting in August. Now, in addition to that purpose for the August meeting, Marjorie in our last meeting mentioned that it might be useful for us to get a background of the metadata registry to understand the role that that has. That kind of escalated a little bit and we began to see that this might be an opportunity to educate the subcommittee on a variety of related activities that influence the development of standards and terminologies.
So, we crafted a day and you see that agenda, on the 20th, and the purpose of that day is to allow us within one day to not only understand what each of those activities are, but how do they relate to PMRI message format standards and how do they relate to each other. That would hopefully enable us to look much more critically at the results the next day that we are assuming that our contractor will be presenting to us on the morning of the 21st.
So, let me just sort of step you through that agenda just a little bit. By the way, I didn't explicitly indicate that in that agenda piece, but everyone of those entities has a component of maybe 50 or two-thirds of the time being a presentation and a third to a half the time allowing us to ask questions on each of those topic areas. So, that is included within the time frame for each topic.
The first one is the metadata registry, which -- I don't think I want to go too much into explanation as to what these things are, but the metadata registry is -- not only includes all of the DSMOs, but it also includes many government agencies that are contributing their data to be able to wind up being able to compare data entities in an organized manner.
This we hope will be useful to the SDOs in the future to coordinate standards developments, as well as to vendors that may be looking to see how they implement different standards and what data elements are consistent among different standards so that they could have translations or interface engines, if necessary, or users, understanding what the definitions of different data elements are.
So, that project is moving forward. So, that is the first presentation. The second one, while it is a presentation of the HL7 reference information model, for our purposes it is broader than that because it is really how are they using a reference information model as an enabler to generate version 3 message format standards.
So, we are going to be asking them to take us through the entire process of how they expect to build, develop and generate message format standards, hopefully, not only more efficiently and more quickly, but also in a manner where they are more consistent with other message format standards and in a manner where they are more interoperable and with greater levels of data comparability.
So, that is the next piece. Following that is a presentation on a model, which actually looks very similar. It was originally developed in Europe. Australia wound up adopting it and renaming it to calling it the good electronic health record. It had been the good European health record.
It uses many of the same principles that are used in the development of the reference information model, but in this case it is for defining the content of an electronic health record.
The next piece, again, is a little bit of trying to get at methods and techniques. We are looking for the folks from SNOMED to present to us the development of a reference terminology based on ontological principles, to be able to drive down to provide clinical specificity with medical terminologies so that we could understand the role that reference terminologies may play, as we begin to step forward into that area later on this year.
Then the last piece, of course, is the role of the unified medical language systems. Betsy Humphries should be presenting that to us and how that relates to and is different from a reference terminology. Then following that, we would have -- and I guess I missed it because we would have an introduction, hopefully, by Chris Shute(?) for maybe 15 minutes as he begins to wind up putting these things in perspective for us and then at the end, hopefully -- and I just spoke to Chris yesterday on the phone. So, I think he is going to be with us all day long and he will be able to listen to the kinds of questions we have, the kind of issues that are raised and he would be able to help us in kind of a concluding 30 minutes or 45 minutes at the end of the day, to help us resolve any issues in terms of how these different methods and models and terminologies are used and how they could relate to our selection of message format standards the next day.
Questions on this day of it before we go into the next day.
DR. COHN: Sounds like a great day.
DR. BRAITHWAITE: Yes, this is health care modeling and terminology 101. That is great.
DR. SHORTLIFFE: A very useful survey of key issues.
DR. COHN: Jeff and I have talked about this a little bit and my own feeling is I think this is all great, I agree. My only issue is is I want to make sure there is a little more time at the end for us to discuss and get into the issues. We need to figure out how to maybe compress things a little bit just because I think there is nothing worse than just really getting into the issues and then it suddenly being 5:30 at night and we have to stop.
Other than that, I think the issues are very germane and we just need to figure out a way to provide for enough discussion at the end.
MR. BLAIR: Great.
Onto our morning of the 21st. Let me make a note to myself. The agenda for the 20th, revise the time frames to allow more time for discussion at the end of the day and review that with Simon.
Simon pointed out a problem on this one because at the time when I did this, I didn't realize that we were going to -- or I forgot that we were going to have the privacy sessions in the afternoon. So, it would be a long day. So, we probably would want to compress this.
This would be essentially the contractor -- I don't know if I am allowed to indicate the name yet because it probably hasn't been officially released. Is that correct, Michael?
DR. FITZMAURICE: You can release the name.
MR. BLAIR: I can release the name. Okay.
We are expecting Margaret Amatiokin(?) to help us once again. I think we are very happy about that.
As of this Friday, all of the SDOs have indicated that they will have the questionnaires to me over the weekend. I will go ahead and forward those all to Margaret and we have a framework that we have developed for her to begin to assemble that information and present it to us in a manner that could be as easy for us to digest and understand.
It is probably not going to be a one time thing. What we are envisioning is that we wanted to give her enough time to present it maybe from two perspectives, maybe from a perspective of looking at the individual SDOs and what they are presenting and then looking at it from a perspective of going across all of the SDO responses and looking at it from the standpoint of interoperability issues and comparability issues and quality issues.
That has not been locked in at this stage, but that is a general intent is that if she could assimilate that for us and present it to us with at least two perspectives, that that might help us to analyze things. What we are anticipating is that that presentation will reveal certain areas where we either failed to ask the question specifically enough or we didn't include certain questions or we wind up having additional questions.
So, this is going to be our first introduction to the candidates for PMRI message format standards and we are looking for this to raise a lot of issues, concerns. That is the objective of this morning. We will then wind up trying to address those issues either in October or November by either having additional testimony or additional questions or whatever it may take, based on what we learn.
I think the other piece Simon pointed out is that we should start at 9 o'clock instead of at 8:00. So, we need to abbreviate that time somewhat.
DR. COHN: We are going to have to see what the Privacy Subcommittee decides tomorrow since their dates are a little bit up in the air also apparently.
MR. BLAIR: So, we may have a little latitude, you mean?
DR. COHN: We may. We will know tomorrow better about that one.
MR. BLAIR: Okay.
Questions, concerns, suggestions?
[There was no response.]
Thank you, Simon.
DR. COHN: You are welcome.
Now, let's talk about the remainder of the year and look at our issues and figure out when we should be having hearings, et cetera, for the rest of the year, as well as maybe take a little bit of a look into 2002.
I have a list of issues that I will pass around. I think we are going to do this sort of in two phases. One is that we are going to look at the issues that I have been sort of tracking and sort of see if these are the right issues or if there is anything else that we are missing that we need to have on our sort of current issues list for the subcommittee.
Then let's take a look at our hearing dates and see if we can make the final decisions about what we are going to be doing in the fall and maybe we can look beyond.
Now, I have here seven sort of issues and activities that the subcommittee is involved with, some of which are happening, some of which are proposed as what I consider to be important issues.
The first one is tracking the implementation of the HIPAA standards, which we have just spent the last while dealing with. The second is changes in updates to current standards and new standards. We have just gone through a process about that, but we certainly have not in any way dealt with new standards, such as first report of injury and any others.
The third is electronic signature, which we haven't talked about for awhile, but we were dealing with earlier this year. The fourth is enforcement and compliance. Fifth is PMRI, which we were just talking about. Sixth is an issue that has been sort of off -- it has always been sort of on our plate but if you can notice, since I have an A through H on it, I am sort of seeing it as perhaps a bigger issue that we need to get back into.
It is sort of a basic code set issues, which include -- I am sort of starting more from the HIPAA view, the HIPAA administrative and financial transactions view of the world, which is the issues, I think, we have been seeing coming up, having to do with code sets versus transaction issues, what should be in a code set, what should be in a transaction is a data element and many of us saw this as a very interesting issue that was coming up yesterday, one without an answer, but we need to get a little better handle and probably provide some guidance in terms of what ought to be where, as well as how to resolve conflicts.
There is the local code set issue, which we have talked about and probably need to be looking at to see how it is moving forward in terms of getting resolved or if there is something we need to be doing about that. There is the terminology versus code sets and sort of just that dichotomy, knowing that they are sort of the same thing, but there are sort of differences also.
By that, I mean, typically, a lot of times code sets have specific domains; whereas, terminologies usually seem to be more -- maybe this is more the reference terminology view of expansive in terms of their coverage. There is the code set holes in the current transactions that we once again identified and we know we need to do some hearings around groups that may feel that their code sets are worthy of becoming mandated HIPAA standards, but have not yet been named.
There are open maintenance issues, which were brought up previously and we have really not asked the maintainers about their processes. We have talked about ICD10-CM, have not talked about TCS, but probably maybe some point in time for some discussions around that.
Medical device codes and then H, which is others to be determined because there is always more code set issues to be dealt with.
Now, the -- I have a note here, which says to start hearings in December or early next year in relationship to some of the codes. That was once again just a proposal for us to consider.
The final activity that we are involved with is certainly letters to the full committee on upcoming NPRMs and we are hoping to see some soon. That would sort of be our hope, but that is an activity that we are involved with, as well as the annual report.
Ted.
DR. SHORTLIFFE: NPRM.
DR. COHN: Notice of proposed rules. Normally what happens is is that there are a lot of standards, for example, claims attachments and health plan, which are going to -- have not gone through a notice of proposed rule. At the time when they come out we typically review the notice and provide comments for the committee to be forwarded to the Secretary.
We actually had that opportunity with some of these changes. For example, the changes coming from the administrative and financial transactions are coming out as notices of proposed rules that we have public comment on and then the Secretary will make final rules on them.
First of all, are these sort of the right issues that we are talking about? Are we missing anything big?
MR. BLAIR: Simon, I get embarrassed when this happens, but I didn't mentally lock into your reading of the list until after you hit Item 4. Could you just reread Items 1 through 3?
DR. COHN: Oh, sure. One is the issue of generally tracking implementation of the HIPAA standards and that includes financial administrative security and identifiers when they come out.
The next one is changes and updates to the current standards and new standards. Third is electronic signature and then fourth is enforcement and compliance.
MR. BLAIR: Thank you.
DR. COHN: Fifth is PMRI. Sixth is code sets and seven is sort of a lot of miscellaneous letters and all of that we have to do from time to time in relationship to the activities of HHS.
MR. BLAIR: It is a good list.
DR. COHN: Are there other things that we need to be delving into? Anybody in the audience feel there are any other issues that we should be -- David, do you want to come to a microphone?
MR. WILLIAMS: Being relatively new to this process, I am just going to throw this out here and you can tell me if you have already addressed it. But there is a growing indication that there might be a number of other regulations that --
MR. BLAIR: Would you identify yourself?
MR. WILLIAMS: I am sorry. David Williams. I am with Blue Cross and Blue Shield.
MR. BLAIR: Thank you.
MR. WILLIAMS: There might be a number of other regulations out there that interact with the HIPAA regulations. I know you have talked about -- you have probably talked about Graham-Leach-Byley(?) and privacy at some point, but there is a growing concern that there is some possibility that the DOL claim regulations that just came out might interact with HIPAA transactions and code sets in some ways.
We still haven't had a chance to flesh that out as an organization, but there is some growing concern there that there might be a bit of overlap.
DR. FITZMAURICE: David, what are the DOL claim regulations?
MR. WILLIAMS: They are regulations that came out late last year that the Department of Labor basically put out. I am not an expert on them, but my understanding is that they specify some things that you have to -- some information that you have to provide to claimants, for example.
DR. FITZMAURICE: Is this different from workman's compensation?
MR. WILLIAMS: Yes, it is. It includes things like pre-service claims, which would effectively be a preauthorization or an eligibility certification that this is where potentially some of that interaction with HIPAA comes in and full service claims, like the actual claim or an appeal. So, there are some regulations that are there that talk about the language and the timing and there may be some problems with HIPAA.
DR. FITZMAURICE: This is for all claims?
MR. WILLIAMS: It is beyond worker's comp. But that is one of the areas --
DR. FITZMAURICE: Forgive me if I seem to be in the dark on this but --
MR. WILLIAMS: I am not an expert on it either. I just wanted to throw it out there as something that maybe you want to talk about or look into a little further.
DR. COHN: Okay. David, we would certainly invite you if you do analysis on this, if you do determine that there is interaction, if you would notify us in a letter or something like that. Notify us of your concerns. So, that might get some things started.
Great.
Ted.
DR. SHORTLIFFE: I hesitate to ask this because it must be -- you know, it is part of the kinds of tradition and understanding of those who have been on the committee for awhile and as a newcomer, I need to better understand the context of the subcommittee's activities.
We are advisory to the full committee, as I understand it basically, but in the area of standards and security, which is our bailiwick on this subcommittee, what is the committee's responsibility with respect to standards and security? That may seem like an odd question, but the committee does not set the standards. So, presumably we are in a position to provide as a committee advisory input into the Department and into the Secretary -- is that right? -- not so much for legislation, but presumably for rules and other standards of the sort that can be declared as requirements by the administration. Is that right?
I am trying to understand exactly how we interact with what finally happens out there in the real world.
DR. COHN: I think I can partially answer your question, though not from memory, but I can point you to sort of our understanding as well as some documentation that might be very helpful for you. The good news is is that the National Committee was recently rechartered back in 1996, actually in the same piece of -- in the administrative simplification reg.
There are about 16 pages there, of which about three of them have to do with the role of the NCVHS, which not just includes security, but -- and standards, but all the various roles we have. So, that would be something I think very useful to review.
Now, in relationship to the standards, however, there is wording in the HIPAA bill, HIPAA law, that says that the Secretary will rely on the recommendations of the NCVHS in relationship to identification of the standards -- selection, of which I am trying to remember and I am not quoting it exactly.
But essentially our role is to work with the public, health care industry, identify and make recommendations to the Secretary. In these particular areas, the Secretary is supposed to rely on us because of our expertise and the fact that we have been talking to the public and industry.
DR. BRAITHWAITE: That is amplified, Ted, by the fact that we are a Federal Advisory Committee Act committee, which means we can meet on a regular basis under the rules that we operate under and on a regular basis recommend things to the Secretary.
Groups like a standard developing organization can't do that because they violate the Federal Advisory Committee Act if they do that. So, we are the channel through which all the voluntary work on standards ends up coming to the Secretary and brought in as a recommendation.
DR. SHORTLIFFE: So now that we are embarking on your --
DR. COHN: I was also going to comment that there is also a charge in here that has --
DR. SHORTLIFFE: I have read the charges, but just for the practical view of what we are really doing, I am trying to get the kind of cultural grasp.
So, the PMRI effort, which is just getting
going --
DR. COHN: Phase 2 is just getting going.
DR. SHORTLIFFE: Phase 2. But we started doing hearings earlier this year. What do you envision as happening at the end of that process?
Now, I see us trying to get informed, having hearings, trying to make sure we fully understand exactly what the various activities are that are out there, trying to understand the tradeoffs among them. What, 18 months, two years from now, as this process moves along, would we actually do with our impressions of the -- I mean, this may seem -- in fact, it isn't obvious to a new member.
PARTICIPANT: It is a very basic issue.
DR. COHN: Now, I think what we see -- and, Jeff, help me with this one in terms of PMRI specifically, that we are likely to have a report based on the hearings and information that we have assembled, plus our expertise, that provides some background information as to sort of the current status of what exists out there, as well as recommendations for the Secretary of things that he can do to sort of either to move things forward in relationship to PMRI standards.
Now, we had a first document, which I think you probably have reviewed, that had a large number of recommendations, some for funding, some of which -- demonstration projects, et cetera, et cetera. This one we are hoping to get a little more specific and actually be recommending certain standards.
Now, in terms of saying these ought to be the standards or is this the standard that looks good and you need to give it a little more funding so it can ripen to the point where it can actually be a national standard. Now, our experience, and I will just speak personally, for all of this is is that as valuable as the Secretary acting is and sometimes the Secretary acts and sometimes the Secretary doesn't act, that usually the health care industry, the process that we go through in terms of eliciting comment, getting everybody to think about it, having ourselves think about it, that by the end, usually the process and the recommendations because of the process -- yes, it helps guide the industry, reduce risks.
If you are someone out there in the industry trying to decide what to buy, what to do, and there is no guidance from government or elsewhere about what they ought to be doing, if we can provide some guidance and direction, then that is usually very useful to the industry, especially if you are making expensive purchases or moving off in certain directions.
DR. SHORTLIFFE: So much of standards development -- I don't mean to side track us except you asked for a discussion about the future and as presumably someone who will be on the committee for awhile, it would be very helpful for me to understand these things now and it may help me understand what we should be doing in the future as well.
In the standards development activity, which is so crucial to so much of what we envision happening to improve quality in the health care setting, consensus development is always a crucial part of it. You seem to be suggesting that one role that this committee plays is through the mere fact that we exist and have hearings and have folks come and have an opportunity to talk to us, that a kind of consensus development process goes on actually within this committee, if you will, even though, you know, there are the standards development organizations that are seeking consensus with their members and the like, I am trying to understand how we complement that role here because the -- especially PMRI seems to be an area in which forcing standards down the throats of the industry or -- it isn't going to work, really, I don't think.
It seems to me that it is very likely that there needs to be this sort of coming together of people that recognize the importance of it and that basically get on the same bandwagon and see that with appropriate compromise, everybody is headed in the same direction. The role that we as an organization within government can play with those in the private sector, who are working on exactly the same problem, I am trying to understand the kind of -- the sense of the dynamics of how that ought to work optimally and how that interacts with which rules get defined and the government provides guidance because in some of these areas, the government is more capable of providing absolute mandates than in others, it seems to me.
So, privacy protection, yes, mandates are there. In some of the PMRI stuff, it seems to me that might not be as good an analogy, but I may be wrong.
DR. COHN: No, actually, I generally agree with what you are saying. I think that part of the issue as we move off into PMRI -- and I know it is an issue that Jeff has mulled over -- we are all aware of that.
So, part of what we will be getting into with relationship to PMRI, as we talk about it and we get into these standards, we are going to have to be asking ourselves, well, gee, what should we be recommending. Is it that we are recommending this? Yes, you should be using that standard or should we be recommending that the Secretary test this particular set of standards and if it works, at that point, mandating them or is it something that we should be saying to industry, gee, if you are going to do this, use the standard to do it with?
There are all sorts of tools that we have. Certainly, we don't have the same power or at least we don't believe we do in relationship to PMRI that we do with the HIPAA mandated standards and we are all well aware of that. But, you know, taking it from an industry view -- and I sort of differ a little bit with you about the fact that everybody is at this point happy to go on it their own way and avant garde and laissez faire and all of this stuff --
DR. SHORTLIFFE: I don't think I said that. I hope I didn't.
DR. COHN: Well, I think you were sort of saying that people are happy to be off in standards groups and develop things locally and --
DR. SHORTLIFFE: I didn't say that --
DR. COHN: That is, I guess, what I was hearing from you. I think many of us have recognized that there are many standards and in some cases they are competing standards for the same thing and anything that we can do to lessen the risk for industry and those who are making investments in these systems and approaches by guiding them as, well, gee, this one appears to make more sense, has greater industry acceptance, appears to be the right way, rather then having them go down a path where, you know, it may be that later on the industry or government does not go down that direction, is, I think, something that is a win-win for all.
I mean, you can't always prevent people from buying a Betamax, but, you know, you do what you can.
MR. BLAIR: Could I try to --
DR. COHN: Sure -- and Ted, I may be over --
MR. BLAIR: The HIPAA law, the phrase that we have to stand on isn't a whole lot. It is a few paragraphs and with respect to PMRI and while I don't have a perfect memory, it is something to the effect of the NCVHS will study and make recommendations relative to the adoption of uniform data standards for patient medical record information and the electronic exchange of that information.
The recommendations were due last year, last August. What we chose to do, because we worked on that really kind of for like two years, and we had, as many people from the industry testified to us as possible in terms of what direction we should take, how we should focus on things, and while it did say uniform data standards for patient medical record information, that is not as specific as HIPAA legislation was for financial administrative transactions, where it specified the exact message format that should be standardized.
It was much easier for the NCVHS at that time to look at the candidates and, you know, there was only a limited amount to choose from, so to speak, and things -- it was also less mission critical. I mean, when you get into patient medical record information, you have many more concerns about things being done in a manner where information has -- there is a higher level of precision that is needed. There is a higher level of completeness that is needed. There is a higher level of immediacy that may be needed.
So, we are in a different environment, which has many demands that financial administrative transactions don't have. So, we listened to the testimony from I guess it was 91 testifiers, and the report that we generated didn't specify specific standards. You might say that the report basically gave a framework for how we would proceed over the next several years and it wound up saying here is our basic assumptions. Here is the status in the industry. Here is the direction that we are heading. Here is the status of medical terminologies and message format standards and ontologies.
We really have a long way to go. As a matter of fact, we have such a long way to go that rather than winding up recommending specific standards, we wound up in a sense painting a landscape of recommendations, where the first two recommendations basically addressed how we would proceed with selecting standards, but the rest of them said we have a lot of work to do just to accelerate the development of PMRI standards and terminologies and to even better understand better issues in terms of how to improve data capture, how to look at the cost benefit issues, how to look at how standards might relate to things internationally because when you get into the clinical perspective, it is -- you know, these standards tend to be more international, how they relate to privacy and security regulations, on and on and on.
So, I don't know if you have had a chance to take a look at the report or not, but basically that -- we wound up doing that report because we really didn't feel as if things were mature enough for us to go forward and select standards right away. Now, after we did that report, the first -- actually it is the second recommendation said that we would use the guiding principles that we set forth in the report, which we have modified a little bit, to try to select the first phase of PMRI standards. So, even now we are not going the second stage and it will be complete. It is iterative.
The first stage we thought might be what Clem referred to as low hanging fruit, Clem McDonald. So, we have gone down that path to see if we could apply the guiding principles for the selection of PMRI message format standards. We have gone to the SDOs and said basically if we go down this path, do we have the right criteria for selection. We asked them to critique, you know, the questionnaire, make sure we have the right questionnaire. We got critiques from that back in I guess it was December and February and March. Then we sent the questionnaire out and gave them, you know, a couple of months to fill it out and we are going to get those questionnaires back.
When we get these back -- Ted, I think your concerns and anxieties are shared by many people on the subcommittee. There is a lot of ambiguity in this area. If we can wind up pulling the directions, the technologies, the standards together in a manner where we can build consensus in the industry for support, then great. But I think it remains to be seen in the hearings we have in August and October and maybe November, how far we could go with that and we may have to have different kind of recommendations if the answers are not clear.
I think I won't take time to go through all of the different types of issues and ambiguities, but I would be more than happy to do that with you separately if you like. I bet you they will probably match with a lot of the ones that you have probably identified.
Am I answering your thoughts or your questions?
DR. SHORTLIFFE: Yes. I think this background has been helpful and the interesting thing is that you can look at your first PMRI report but not know this context, you see. This is the point, you see.
MR. BLAIR: I see.
DR. SHORTLIFFE: I can look at a report but trying to fully understand what went into creating it, how it is viewed as being part of a continuum, where you had to make compromises in what you were able to put in it, et cetera, that is not really reflected quite the same way. So, I was trying to get a bit of a feel for that.
In talking about whether there is a another thing to go on the list, as I think about this and listen to this discussion, what comes to my mind and it may be totally constrained by the way in which, you know, this organization, this entity is authorized and funded and all that, but there is a way to sort of potentially use this committee to achieve what the individual SDOs can't one at a time.
In a way maybe it is doing that.
PARTICIPANT: Like a catalyst.
DR. SHORTLIFFE: In a much more kind of visible way. You see, I don't think that the community as a whole knows very much about the NCVHS and its potential role in this area or what it had to do with the HIPAA rule or so forth. These are things that those of us that think about this everyday know about, but I don't think that there is a larger community out there that is aware of the potential role that NCVHS might play in trying to get at some of these thorny problems having to do with what it is going to take to develop PMRI standards and the like.
Maybe this is more of a discussion for the full committee and a little introspection about the committee and it may be inappropriate for a brand new member to even ask the question, but in a way I am aware coming in that there is so much going on here that I didn't know about before and it is important to the entire community out there and they are not that familiar with it. I don't think we have a million people out there on the other end of these Internet connections, although there are some, I am sure.
But they probably are folks very much in the SDO community, for example, and, you know, not a lot of even information technology folks from industry or the like, unless they are very much involved with standards. I think there is a set of activities in the NCVHS meetings which are of incredible relevance to a much larger community than is tracking it or fully familiar with it.
So, we need to think a little bit, I think, as a committee about whether that matters, is it a problem, are there missed opportunities because of that. I guess that is sort of what I am coming to.
DR. COHN: I agree with you. I don't know where exactly the place to bring this issue up -- but I will just reflect a little bit, when I came on the National Committee, it was apparent to me that there was a lot of very good work being done, but as you commented, the -- you know, a lot of times the communications were dropped or the documents that were produced, it was sort of like you never saw them. They just sort of went somewhere.
I think one of the things we have all been trying to do is to focus on what I tend to describe as communication with what it is we have. Now, unfortunately, we don't have tens of thousands of us to spread the word, but I think it is once again I think something we just need to be well aware of because half of what we do is really communication and getting it out to the industry, as well as getting it back to the Secretary. It is something, hopefully, maybe in August, you know, on the second day, as we look at sort of where we are, you know, it gets to be part of that issue of like what do we do with this information. What do we need to do now?
Help and thoughts are certainly appreciated on this one. I think this is sort of an ongoing issue. The other balance, of course, is that you have got to also be producing things that are worthy of being communicated. That is the tension that exists here.
We will keep in mind the communication. I think we will make sure to talk about that in August.
Mike.
DR. FITZMAURICE: Just a word, as we carry this out to the end, we are going to be making recommendations to the Secretary on PMRI standards, but they are not going to be the same kind of recommendations as are on the other HIPAA standards. We don't have that charge. So, the Secretary might see us recommending a particular standard to be used for a particular purpose, but the Secretary will have choices that he doesn't have under HIPAA.
He can choose to ignore it. He has all those choices. He can choose to ignore us under HIPAA, too. He can choose to say, well, let's try it out in my own agencies. Let's try it out in particular programs. Let's not make it mandatory on the industry because he may not have that power. But let's put it out and say to the industry we think these are good standards and whenever you do this function, we would like you to consider these standards first.
Those are the kinds of things, I think, that we -- the impact that we see coming from our recommendations. They are input into the Secretary and then the Secretary will have to see how they fit in with his vision. So, his vision is important and our addressing his vision is important for these standards.
MR. BLAIR: Could I add to that that in the four years that I have been on the NCVHS it seems as if the NCVHS has a very good track record of making recommendations that are accepted. I think we want to be careful, as we have been, that any recommendations we put forth are ones that are pragmatic, that are viable, where we have considered industry acceptance; in short, where we have framed them as well as possible, so that we could continue this record of having the Secretary accept and implement the recommendations.
DR. COHN: With that, let's talk about the next half of the year and sort of where things begin to fit in. Now, we pretty well know what we are doing in August. Now, let me just observe that we have actually currently three different hearing dates scheduled for the fall and I think we need to reflect a little bit about what we can do, where we need to be, what the priorities are.
I guess I am going to suggest that we try to drop one of the dates for a variety of reasons, but let me just review the dates that we have and then the question gets to be is when we pull in what to be discussed, just so we begin to do a little planning.
Now, first of all, I think you are all aware that we have after August, the next scheduled dates you are all holding are October 9th and 10th. And then after that, we have done some checking with you all and have asked about the day before the NCVHS meeting in November, which is November 14th and -- we haven't really checked about the 13th, but certainly the 14th, I think we have checked on and we know that there is a quorum available for a meeting.
Then the final one dates we have for this year are in December and they are the 13th and 14th. I think you all have those dates.
DR. SHORTLIFFE: In the November date, you were talking about meeting in Orlando, rather than here, right?
DR. COHN: Yes. I don't think we can commit to it yet, but it is likely that if it happens, it will be -- I think it will likely be in Orlando, but we certainly do reserve the right at this point to have it up here instead, since it will be the day before an NCVHS meeting.
DR. ZUBELDIA: Simon -- is holding November 12, 13 and 14, a HIPAA implementation success in Orlando.
DR. COHN: Right.
DR. SHORTLIFFE: That is the reason for the meeting there?
DR. COHN: That is why we were --
DR. ZUBELDIA: So, you are saying take the last day of that HIPAA success for the NCVHS meeting or piggyback after the HIPAA success?
DR. COHN: Well, unfortunately, I -- I think we are discussions with them about that, the issue being that the 15th is the first day of the NCVHS meeting in November. So, we really only have the 14th if we choose to hold hearings down there. I think that is the proposal we are discussing actually I think with WEDI SNP(?) at this point.
DR. SHORTLIFFE: If we did this, the NCVHS meeting would still be up here? So, we would all hop on planes and come up here that night in between.
DR. COHN: Yes. Is that something doable for everybody? Okay.
DR. ZUBELDIA: It would be in Orlando, right? The NCVHS meeting would be in Orlando?
DR. COHN: No.
MS. TRUDEL: The subcommittee meeting would. The full committee meeting would be here.
DR. COHN: I didn't check people's availability for that Sunday, which is Veteran's Day, but I didn't think anybody would want to hold hearings on Sunday.
Now, I guess as I am looking at these dates, we have got these five dates held in the fall, plus, of course, another four for full NCVHS meetings. Our going in proposal was to cancel the October hearing dates, not that we couldn't use them. I mean, we seem to always fill whatever dates we choose, but the issues have to do somewhat with the fact that Dr. Braithwaite is going to be out of the country and generally these things are benefited by both Dr. Braithwaite and Ms. Trudel's attendance at these meetings.
But, once again, before I do that, I wanted to just make sure it is okay with everybody that we do cancel those --
MR. BLAIR: Could I ask if we could hold off until the August hearings before we decide to let go of those dates because I just don't know what conclusions we will have after we see the results from the surveys on the PMRI stuff? Could we kind of hold it until we know that?
DR. COHN: That is certainly a reasonable -- how do people feel? Obviously, I am trying to rationalize your fall, but we can also wait until late August to do that.
MR. BLAIR: Yes. Thank you.
DR. COHN: Everybody okay with that one? I guess we won't knock them off after all.
Jeff, I guess I should ask you, I would like us to get into some of the code set issues.
MR. BLAIR: Me, too.
DR. COHN: Either in December or the meeting after that. What is your view at this point of how much more time you will need for your -- not for your, but for the PMRI discussions. Is that likely to be something -- a December session or is it too early to tell?
MR. BLAIR: If things go -- if we feel a certain degree of comfort from what Margaret tells us and we only need to follow up to maybe get some additional clarifications from some of the SDOs and it is not major activities, then I think all we would need is the December piece to wrap that up and in December, I would hope that by that point, we really are beginning to draft recommendations, you know, for the PMRI selection.
If things are more difficult for us and we want to actually have some hearings in October because we actually need to ask questions of some of the SDOs and things are a little bit more ambiguous, then maybe we need to stick in that October date. In terms of the medical technologies, I would think that we certainly could begin to have maybe like an afternoon, maybe in the December time frame --
DR. COHN: I don't know if these were medical terminologies but they are code set discussions.
MR. BLAIR: Okay. Code set discussions.
DR. COHN: I am not sure a half day is going to do much to get us started, but I guess we are going to have to -- I guess one of the things that we are going to have to think about is ways to efficiently deal with the PMRI and we will have a better idea about that after August.
Obviously, we have got multiple competing demands here because we obviously have implementation of HIPAA. We have got electronic signature. We have got PMRI. It is a question of when we do code sets. I would be happy to postpone that until probably January, early February, something like that, if we need to, but it sounds like that is going to be sort of the question. We will know better after August. Is that correct?
MR. BLAIR: Yes, exactly. I think after August I think we could probably have a pretty good idea of what time requirements we would have.
DR. COHN: Okay. I guess I should ask -- I mean, this is not something we have talked about in terms of PMRI -- are you anticipating a report or a letter?
MR. BLAIR: Simon, to be honest with you, I have tried to step back and wait until I see where the information leads us.
DR. COHN: Okay. Well, I guess then as a I say this, I think my sense as we look -- the code sets are an area that we have not focused on for awhile and really do deserve, I think, a pretty good look and I don't know -- I would have to think about whether or not -- I think the lead off is beginning to look at the HIPAA issues around holes, where people have gotten in relationship to working with the code maintainers and others and beginning to sort of grapple with how do we handle the holes in HIPAA and where are there -- or the HIPAA administrative and financial transactions and where are they and, you know, do terminologies -- do clinical terminologies have a role? Is it just code set issues?
If so, how best to fill them and we sort of start there and then work out from that. But it is likely to be a couple of hearings, I would think, in the year 2002. Now, I don't know that anybody -- I mean, I do have the issue of ICD-10 on the list here. I don't know that that is something that -- we will have to sort of play that one by ear to see if there is really anything to discuss about that at that point. Certainly, I get a sense that the industry feels that they are having enough change to deal with right at this moment, but we may decide it makes sense to ask them when things will be stabilized enough that they can begin to engage in a discussion around ICD-10.
I think what we will do -- I mean, I know it sounds sort of funny that we are just in June right now, but certainly by August we will be beginning to check people's calendars for January, February, March time frame and begin to sort of figure out what we need to be doing at that point.
Kepa, I guess I should ask, do we have anything on electronic signature that we should be dealing with either today or during the next couple of months?
DR. ZUBELDIA: No. The SDOs keep meeting on it and having conference calls and they are sending some case studies that they put in together, but we still don't have any standard that could be adopted. They are working on it.
I will keep monitoring the list and their programs and I will bring something up when they get closer.
DR. COHN: Okay. I think we have discussed then the issues. I mean, I am hearing the issues. I am hearing the additions. I am hearing that we don't have enough time to do everything we want to do, as usual, but life would be boring otherwise.
Now, are there any issues in relationship to issues for the subcommittee or anything that we have dealt with so far today?
DR. ZUBELDIA: I have a question and this is more for HCFA. During the presentations on privacy today, they talked about technical assistance and how the Office of Civil Rights is going to provide technical assistance. What additional technical assistance could the Department or HCFA provide for the implementation?
I mean, there is an FAQ. There is the web site. There are implementation guides. What else can -- and I am trying to be creative and see what else can be done to help people? I am not sure, I mean, other than just hiring an army of consultants and sending them out and get the work done, I am not sure.
DR. COHN: Is that an open-ended question or were you asking for a response from -- now, is that in response to the briefing this morning from OCR that was primarily about privacy technical assistance? At least that is how I read it.
DR. ZUBELDIA: Yes. They are doing privacy technical assistance. Is there something that can be done with code sets, with identifiers? For instance, I suggested to the NEME(?) representatives that they probably should publish the metrics that they develop that does the mapping between the existing local codes and the new national codes, even though they haven't been approved yet. They haven't been assigned a new national code yet. If they provide that kind of information early on, it will help the industry.
We have talked about the white papers on what the NPI will look like. That would help the industry. What other things can be done to help the industry along those lines? I was kidding when I said get an army of consultants and get it done. I don't think that is a viable option, but things along the information for the transition that the industry can benefit from. I don't know what other things could happen.
DR. BRAITHWAITE: There certainly is an army of consultants out there waiting to pounce upon the opportunity to make a buck in doing this if we give them some material.
DR. ZUBELDIA: Yes.
MS. TRUDEL: I almost don't know how to answer. I think there are an awful lot of possibilities and some of them relate to privacy, some of them relate to how the Department is working with industry groups like WEDI SNP. I think we are looking for opportunities wherever we can find them. In terms of CMS itself and its own programs, we are working on a more consolidated, I guess, outreach plan and proposal and how to deal with the Medicare fee for service providers, Medicare's trading partners, in terms of coordination of benefits, Medicaid's state programs, managed care organizations.
I think we are trying to not let any opportunities go unused.
DR. COHN: You know, Kepa, I was actually going to comment that at least from my view, recognizing that government doesn't have -- I mean, we know the government doesn't have infinite resources, but to me the biggest thing that the government could do to help with implementation has to do with getting the final rules out as quickly as possible and providing early guidance on the things that are in the pipeline that are about ready to come out. I think if there was a single thing that I would be asking them to do at this point, it would be that sort of activity as opposed to having us think about more widespread educational efforts.
I mean, not that you all don't go and talk -- aren't talking enough, but it is just -- I think I would rather see you have more to be able to talk about.
DR. ZUBELDIA: It just occurred to me when you mentioned CMS. A lot of people don't know about CMS yet. Maybe this is a good opportunity to tell them about CMS. In the process maybe explain how is it that CMS is going to be compliant. What has been their technical solution to bring the -- into HIPAA compliance. Maybe that is a solution that other people can copy and give a technical seminar or a series of technical seminars as to how we did it as examples that other people can copy.
I don't know, that kind of assistance that would be purely technical and it may be just to train consultants that would go out there and duplicate the effort, but some things that will practically help the industry.
DR. COHN: Jeff.
MR. BLAIR: Have we made any effort to engage the accreditation organizations, JCAHO, with respect to incorporating the privacy regs into accreditation requirements? I would think that, you know, that might be a vehicle for enforcement. I just cringe. I step away from the enforcement piece, but, you know, it may be a constructive guidance, as well as monitoring, like a partner in seeing to it that these things will be done.
DR. COHN: I guess I would have you hold the thought for the Privacy Subcommittee meeting tomorrow, to see if there is anything on that. I will observe just in our letter that we just produced --
MR. BLAIR: Bill, are you able to answer that? No?
DR. BRAITHWAITE: Well, we have heard that at least one and probably several of the accreditation organizations will be adopting the HIPAA standards as part of their accreditation process. I just don't know to what degree and what level of detail.
MR. BLAIR: That didn't get directly to your question. I am sorry. It was kind of a tangent.
DR. COHN: It is getting, I think, close to 5 o'clock, if not a little after. I know John had asked us with any remaining time to mull over the recommendations for the national information infrastructure. I know that group will be meeting in another hour or so.
I guess I would only suggest that perhaps all of you -- in case any of you haven't read the recommendations, you might look at the recommendations and see if there is something there that jumps out at you or needs to be either strengthened or modified. Many of you are actually on that work group. So, I guess I will let you have that discussion with John at 6:30 tonight.
Now, with that, why don't we adjourn.
[Whereupon, at 5:00 p.m., the meeting was concluded.]