[This Transcript is Unedited]
Humphrey Building
200 Independent Avenue, SW
Washington, D.C.
Introductions and Announcements
Review of Draft Letter Regarding Administrative and Financial Transactions
Review of Draft Letter Regarding PMRI Terminology Standards
I want to welcome those who are listening in on the Internet. Those on the Internet will probably observe that we are running about half an hour late. Over the next 60 minutes or so, what we are going to be doing is spending some time going over the two letters that we have just reviewed in the full committee. The one that we will obviously be spending the most time with is related to the administrative and financial transactions. The other letter was, aside from some small wordsmithing changes, basically okay, but I think Dr. McDonald was going to be proposing some alternate language for one of the bullets.
DR. MC DONALD: Yes. I can't think of the alternate language yet, but --
DR. COHN: Well, Dr. McDonald has a couple of minutes to think of alternative language on that.
MR. BLAIR: Could I mention one piece?
DR. COHN: Please.
MR. BLAIR: We focused on those 12 terminologies that met the technical standards. However, there still is certain terminology developers that are providing information, and by the time we make our final recommendations, one of those -- there may be an additional 13 or 14 that meet the technical standards that weren't listed.
We don't know, but there are some other terminology developers that are asking for reconsideration, so we still could attach the ones that we had there, but since it isn't in concrete yet, maybe if we just refer to the fact that there were 12. Just a thought.
DR. COHN: Yes. Obviously I think we recognize that this is not the final report. This is just a view of some key elements.
MR. BLAIR: Right, just a status letter.
DR. COHN: Clem, if you have ways to tighten up any of the bullets, we would welcome them. But what we will do first is to get started on this letter of administrative and financial transactions.
I would just comment that we are going to do that, briefly discuss the PMRI letter, if there are any changes, otherwise we'll just do some wordsmithing off on the side, then we'll spend a couple of minutes talking about the August hearings, which I think as many of you know, have now expanded to three days, August 19 through 21st, the first day being on drugs and device terminologies, and then following up on the 20th and 21st, the report back on the cost impact study on ICD-10. There will be some discussion around progress being made on the claims attachment standard.
Are we ready?
PARTICIPANT: Just about.
DR. COHN: Would it be helpful if we spend a minute talking about the -- even in this brief meeting, we should probably do brief introductions. Again, I am Simon Cohn, chairman of the subcommittee. I would also remind those on the committee, if there are issues coming before us for which you need to recuse yourself, you should state that.
Stan?
DR. HUFF: I'm Stan Huff with Intermountain Health Care and the University of Utah in Salt Lake City. If it should come up in this session, I am highly aligned with HL-7 and co-chair of the LOINC committee.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the full committee and staff to the subcommittee.
MR. BLAIR: Jeff Blair, Medical Records Institute, vice chair of the subcommittee, member of HL-7, HINSIS, ASTM, and I am not aware of anything that I need to recuse myself from, other than my silly jokes.
DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation, member of the committee and subcommittee. I am a member of X-12, SPUP, also a member of Affect. I don't know if there is anything that I need to recuse myself for.
DR. PICKETT: Donna Pickett, NCHS, staff to the subcommittee.
DR. HOUSTON: John Houston, University of Pittsburgh Medical Center, subcommittee member and attorney. But I won't recuse myself on those grounds.
DR. HARDING: Richard Harding, a member of the larger NCVHS committee, not a member of the subcommittee. I am a member of the board of trustees of the American Psychiatric Association and the Mental Health Association.
DR. MC DONALD: Implying that you think our behavior is dysfunctional?
DR. HARDING: No.
DR. MC DONALD: Reserving judgment.
MS. AULD: Vivian Auld, National Library of Medicine and staff to the subcommittee.
MS. BEEBE: Suzie Beebe, NCHS, CDC, staff to the subcommittee.
DR. HUNGATE: Bob Hungate, member of the committee, principal of Physician Patient Partnership for Health, and so long as we are doing full disclosure, group insurance commissioner, chair of that organization in Massachusetts, and Medicare beneficiary.
DR. SCANLON: I'm Jim Scanlon with HHS Office of Planning and Evaluation, and I am executive staff director for the full committee.
DR. LUMPKIN: John Lumpkin. I am with the Robert Wood Johnson Foundation, and member of the subcommittee.
MS. TRUDEL: Karen Trudel, Center for Medicaid and Medicare Services, staff to the subcommittee.
DR. COHN: While we are getting things up on the computer here, obviously I didn't introduce myself. I am the chair of the subcommittee. Knowing that we will be talking about the quality report in about 45 minutes to an hour, I do need to publicly disclosure that I am a member of the CPT editorial panel. Under one of the bullets there is the mandatory procedure coding system. Obviously I am recusing myself from those discussions.
Anyway, just to briefly go through what we are going to be doing over the next several minutes --
DR. MC DONALD: My mouth is now empty.
DR. COHN: Oh, you can introduce yourself.
DR. MC DONALD: I'm Clem McDonald from Indiana University. I am director of the Regenstrief Institute. I am chairman of the LOINC committee, I am active on the HL-7 organization.
Agenda Item: Review of Letter on Administrative and Financial Transactions
DR. COHN: Anyway, over the next several minutes, our first priority is to review the letter that we were just discussing on the administrative and financial transactions. Hopefully you will be seeing that up on the screen in just a couple of minutes.
Does anyone want to talk briefly about whether there are any modifications we have to the terminology letter? We will also consider those. Time permitting, we will discuss the August hearings which are three days. At that point we will move into a joint session with the quality subcommittee to talk about some of the aspects of that agenda that relates to standards and security.
Is there anything else that we are missing that needs to be brought up today?
So where are we with our letter?
MS. FREEMAN: I had started making changes downstairs, but I think the most important thing to do right now is to concentrate on that one section.
DR. COHN: Mary, get the microphone closer to you, please.
MS. FREEMAN: I think the most important thing to do right now is to concentrate on that one section. So my suggestion is, we just start de novo.
DR. COHN: The section you are talking about is the recommendation two, which is described as, provide flexibility in transition.
MS. FREEMAN: Some of these marks that are up there are from previous edits. I apologize, I didn't get a chance to clean them off.
DR. ZUBELDIA: Why don't we use the version that we got here, the one we used in the e-mail?
MS. FREEMAN: I believe it got changed.
MS. TRUDEL: Mary has already made some of the changes that were discussed in the previous session.
DR. COHN: I think we will be okay with this one. I think we all need to be looking at this version here.
DR. MC DONALD: Just to be clear, these are changes that happened today after the discussion?
MS. FREEMAN: Some, and some of -- what I didn't get a chance to go through and wipe it all out.
DR. COHN: I believe the reds ones are ones that were made today. Kepa?
DR. ZUBELDIA: I would like to start with the version that we have, make sure that we are all in sync.
MS. FREEMAN: I just looked at your version, and it is not the same as what was read.
DR. ZUBELDIA: The one I just gave you is the one (words lost) which is the same as this one.
DR. COHN: Why don't we go through paragraph by paragraph, through what we have written here, making sure that it is the same as what is up there, and then we'll start making some changes. Is that okay with everyone?
DR. MC DONALD: I'd like to get clarity on what version we are working with.
DR. COHN: I believe we are working on the version that you have in front of you, which I believe is with a couple of minor changes the same version as she has up there. We're looking at item two here.
MS. FREEMAN: You want to start with item two then?
MS. TRUDEL: Are we okay with the document we've got?
DR. MC DONALD: That's what I'm not sure about.
MS. TRUDEL: Why don't we just start one paragraph at a time, make sure that what is up there is what is here, and that we have made whatever changes we need.
I have already looked at the first paragraph. The first paragraph is the same in both places. I think John wanted to make one change in it to take out foremost providers, so that the last sentence ends, implementation deadline, period.
DR. COHN: Last three words.
MS. TRUDEL: To comply with the October deadline, period.
DR. COHN: The cursor wasn't where it should have been.
MS. TRUDEL: You have to hit Enter. Second paragraph looks the same to me.
MS. FREEMAN: It is.
MS. TRUDEL: The next paragraph is okay, so down to the next one. We now need to say, significant number may not meet the October deadline.
DR. COHN: Is that a significant number of the industry?
MS. TRUDEL: Number of providers that we need to test with the clearinghouse or payor indicate that a significant number may not meet the October deadline. That's okay.
DR. COHN: We think that needs to be changed. Do we want to say substantial segment of the industry?
DR. MC DONALD: if you are not going to have minority, then I think substantial segment would be better.
MS. TRUDEL: Okay.
DR. HOUSTON: Back down to the bottom line, significant number of -- I think we said covered entities.
MS. TRUDEL: I think the concern that we heard though was specifically related primarily to providers.
DR. ZUBELDIA: We heard the providers complaining about the payors not being able to pass through.
DR. HOUSTON: Since this was a Gardner quote, we may want to see if Gardner actually -- no one confirmed what Gardner said. Didn't they imply it in their presentation?
DR. HARDING: The second word of the second sentence, industry. It was brought up before that that may be a nebulous term, and that it should be corrected in another part of the letter, to covered entity or another --
DR. COHN: Substantial segment of covered entities? No, that doesn't sound quite right.
MS. TRUDEL: When we say industry, we tend to mean providers, plans, clearinghouses, vendors, billing services, so it kind of includes covered and non-covered entities, or covered entities and their trading partners or business associates.
DR. HARDING: If that is somewhere in there. But that isn't my understanding of what industry is.
DR. COHN: Steve, do you have a --
DR. STEINDEL: If we are going to deal with the language on the word industry, we need to deal with it in the very first paragraph, because that is where you introduce the word.
DR. COHN: Industry readiness?
DR. STEINDEL: The subject of industry readiness.
DR. HARDING: Do you want to say health care industry?
DR. COHN: Would health care industry be okay?
DR. HARDING: That would be better.
MS. TRUDEL: All right.
DR. COHN: If we do that, then we are probably okay leaving industry further down. I think we have solved that problem.
So I think we finished bullet one. Bullet two, we got rid of the third --
MS. TRUDEL: Right, we separated one bullet out.
DR. COHN: So these are the changes that we all agreed to during the discussion.
DR. HOUSTON: But I think with regards to the third bullet point, in addition I think we need to do some wordsmithing on that bullet, because it was a carryover from the --
MS. TRUDEL: Right, it was split up.
DR. HOUSTON: So it really doesn't go in this particular case. I would start with, some providers are in denial, others believe they will need another deadline extension.
DR. COHN: So get rid of still?
DR. HOUSTON: I think still is -- it is just, in addition didn't --
DR. COHN: Okay, so we leave that alone?
DR. HOUSTON: Either way.
DR. COHN: I'm not sure if I see any other changes necessary here. Is everybody okay?
DR. ZUBELDIA: I have a question about the word non-compliant claims. Should it be non-conformant claims or non-standard claims? Later down we ask about what is the definition of compliance, or to clarify the definition of compliance. Perhaps here we should say the non-standard claims will be accepted, regardless.
MS. FREEMAN: Maybe non-standard, non-compliant?
DR. COHN: So you are suggesting both non-standard and non-compliant?
MS. FREEMAN: No, I'm saying that non-compliant is the jargon we use about HIPAA.
MS. TRUDEL: I'm not sure the term non-standard has a clear definition.
DR. COHN: I think probably non-compliant is okay here. Shall we move on to three?
MS. BEEBE: I have a question.
DR. COHN: Yes, Suzie?
MS. BEEBE: It says that -- I actually agree with Kepa about the non-compliant. I think we will get in trouble later when we do talk about the time frame with the dates.
But anyway, when we say will be accepted regardless, I don't know what -- regardless of what, if that is clear.
MS. TRUDEL: I think it is regardless of the deadline.
DR. HOUSTON: Regardless of the compliance.
MS. TRUDEL: Or will be accepted after the deadline.
DR. COHN: Okay, let's look at three then. I think we actually decided that the log jams and all that were okay.
DR. HOUSTON: I'm just going to reiterate my point one time, and then I'll keep my mouth shut. This is going to the Secretary. I just think that as such, a certain amount of wordsmithing, or a certain formality is appropriate. We use shakeouts and huge and load; I understand that at times it is nice to use terms that are descriptive. There is a slang issue.
DR. ZUBELDIA: A term like pileup.
DR. STEINDEL: Simon, I actually agreed with John when he first brought it up, and I agree with him again.
DR. COHN: Clem?
DR. MC DONALD: Just to clarify, I don't think by definition those are jargon. I think they are colorful words. I think jargon are things that are specific to industries. There is a definition for it. I don't think they qualify as jargon. You may still not like them. Jargon would be acronyms used in various fields.
DR. COHN: I think this is something we can handle offline.
MS. TRUDEL: I was going to suggest a compromise. I think the term logjam is maybe a little slangy, but it is very descriptive of what could happen, in one word. The shakes out I agree with you on, and maybe we could say, as HIPAA implementation proceeds, --
DR. HOUSTON: Major lags or major delays? Lag, I could take it or leave it. A substantial load of non-compliance of electronic claims.
MS. TRUDEL: We can handle shakes out, we can handle load.
DR. HOUSTON: Causing a huge number to be rejected. I think if we are looking for something other than substantial, --
DR. COHN: So rather than huge, you want large? Humongous?
MS. TRUDEL: Humongous?
DR. COHN: Probably rather than huge, we're talking about large.
DR. HOUSTON: Payors are not adequate to deal with a substantial number of non-compliant claims, potentially causing --
DR. COHN: I think they have gotten the idea, John. I think they have got words for huge. Is there anything else here?
So I think we are down into recommendations. We probably should just read through the recommendations. One was, oppose delay. The committee believes that the October 16, 2003 deadline should not be extended.
MR. BLAIR: There was one time in that paragraph, and I wish I could tell you exactly where, but at the beginning of where we said we oppose a delay --
DR. COHN: That is where we are right now.
MR. BLAIR: Shortly after that, it was a sentence that used the word delay again. The sentence was really trying to indicate that there had already been an extension. I think the word extension is a more appropriate word to describe what happened than to have said that we already have a delay. Do you see where that is?
MS. FREEMAN: So you would say, Jeff, have not taken advantage of the one-year compliance extension that already was afforded?
MR. BLAIR: Yes, thank you.
MS. FREEMAN: If we say, many covered entities have not taken advantage of the --
MR. BLAIR: One-year compliance extension.
DR. HOUSTON: I think already afforded is redundant. If it is an extension, the assumption is that it was afforded.
DR. COHN: Okay. So it goes, however, it does appear that most providers, most payors, large plans --
DR. ZUBELDIA: Payors and providers?
MS. TRUDEL: How about covered entities, because you are leaving out the clearinghouses.
DR. HOUSTON: There is a difference between large and small providers. That was the distinction.
MS. TRUDEL: Small providers aren't making --
DR. HOUSTON: Exactly, so we need to keep the distinction of large provider. You don't need plans in there. Plans are redundant with payor. So it is payors and large providers.
MS. TRUDEL: I think what we were trying to say is that these people are already working and extending -- I see what you're saying.
DR. COHN: I guess the question is, I would open up how specific we want to get here. I'm wondering if we shouldn't use the term covered entities, as opposed to trying to make this rather oblique distinction. Is there some major value to trying to wonder who isn't in that?
DR. ZUBELDIA: Are we trying to say that it does appear that most small providers are not making the investment?
DR. HOUSTON: That is what was implied or stated earlier, that there was an issue of small provider compliance. I thought I heard that.
MS. FREEMAN: Not necessarily.
DR. COHN: I guess the question is, since we are not saying anything further about that, what does that distinction gain us in this paragraph?
DR. HUFF: (Comments off mike.)
MS. TRUDEL: That is true. There is an underlying assumption in the recommendation that plans are more ready than providers. If that is not the case, then the recommendation doesn't seem to have any --
MR. BLAIR: Right. Our recommendations really start to be balanced. In the one hand, we don't want to put an undue burden on those who have complied, so we want to describe who they are that are mostly in compliance, versus those that are unlikely to comply, and identify those, and then show that there is an interdependence between the two because of the sending and receiving. So I guess we are forced into that in order to have balance.
DR. STEINDEL: I kind of agree with Simon, that we are making an oblique distinction here, a subtle distinction that may not be picked up. Can we use something like most covered entities with the possible exception of small providers, some type of language like that, so we spell out the group that may not be compliant?
DR. COHN: You are saying most are compliant?
DR. STEINDEL: Most covered entities with the possible exception of small providers, are making the investment.
DR. HOUSTON: I want to make sure we are consistent with number one previously, which talked about a large percentage of non-compliance without distinction.
DR. STEINDEL: I was just commenting on the language in the sentence.
DR. HOUSTON: I just want to be consistent.
DR. STEINDEL: I find that the distinction we are making here is very subtle, and it is not going to be -- the Secretary is not going to see it.
DR. HOUSTON: I would be happy to just leave it as most covered entities are making the investment.
DR. COHN: What we can do is leave it as it is right now, with this wording. I think the question would be whether or not this shows back up in the recommendation in two. If it doesn't, then we leave it.
DR. HOUSTON: Or if we do propose, such as with the privacy rule, where additional outreach is provider to small covered entities, which we are not making. That would be the only way the distinction is meaningful. I'm not saying we would do that, but --
DR. ZUBELDIA: You want to leave it like this?
DR. COHN: I think it looks fine. We'll come back and look at this one. We will see if it reflects any way in item two of the letter. If not, we'll just --
DR. HUFF: (Comments off mike.)
DR. COHN: Do we want to leave it providers or turn it into covered entities?
DR. HUFF: (Comments off mike.)
DR. COHN: Kepa, what do you think?
DR. ZUBELDIA: I think it looks good like this.
DR. COHN: Leave it that way? Okay.
DR. HOUSTON: The sentence that starts with, rather the committee believes, it is redundant. In the next sentence it has already been stated, and numerous times throughout this paragraph.
DR. COHN: John, what are you saying before we start crossing out sentences?
DR. HOUSTON: The thing he just highlighted really is redundant, with everything else.
DR. COHN: I don't think it is exactly redundant. You are talking about penalizing those who come into compliance. I think what we are saying here is, if they get another extension they will only be asking for yet another extension.
DR. HOUSTON: But you say in the previous sentence that extending the implementation deadline once again will just cause another extension to occur, because they are not going to take it seriously. But that's fine, I don't care.
DR. HUNGATE: Along those same lines, when I read that, I really want to move the third sentence to the second sentence, and then put the other two together. So take the however out. It does appear that most covered entities are making, so you put the positive down first, then come back to the exception. It is sequencing.
DR. ZUBELDIA: Move that to before many?
DR. HUNGATE: Yes. It just seems to me that you are going to recommend; put the strong piece first and then put the other pieces behind it. Covered entities have not taken advantage of the compliance extension, and would be unlikely to do so with a further extension.
DR. COHN: With the second and third sentence, this would be, it does appear that most covered entities with the possible exception of small providers, are making the investment to comply with this deadline.
DR. ZUBELDIA: Give me a second.
DR. COHN: Then it goes, many covered entities have not taken advantage of the one-year compliance extension.
MS. TRUDEL: However, and then comma, and then, extending the implementation deadline once again is unlikely.
DR. ZUBELDIA: So we want however before many? You want however here?
MS. TRUDEL: The two sentences contradict each other.
MR. BLAIR: The problem that I have with the word many in that sentence, many haven't taken advantage of the extension, is, many times when I hear the word many, I tend to think of the majority or more than half. Here is where I feel like we need to have a different word than many to indicate that -- and I had picked substantial minority, but something to imply that it is a large number, but it is not a majority.
DR. MC DONALD: I don't think that many means majority. We should get a dictionary out here. It blurs over to that.
DR. HUNGATE: Isn't the many maybe a large number, but representing a small percentage of the transaction volume? That modifier?
DR. MC DONALD: Many is more than a few. I think depending on what we are trying to convey, don't worry about it very much. If it is just a couple of outliers, or there is a real number here. I think many is more compact than a substantial number.
DR. COHN: How about if we say, however there are covered entities who have not taken advantage of -- no?
DR. ZUBELDIA: How about some?
DR. COHN: That was what I came up with.
MR. BLAIR: Some and leaving many out says to me the number may not be enough to worry about. What number are you going to stop worrying at? If we quantify it at no number, or some, which implies a small number, the Secretary may say, gee, I don't need to worry about those. If we say many, as Clem points out, generally speaking a lot of people think of it as a majority. It doesn't mean a majority.
MS. TRUDEL: Do we really need this sentence?
DR. HOUSTON: I'm thinking that you can simplify this because really, there are two sentences there. What you are really trying to do is say, we don't want to delay because a delay or an extension -- because of the fact that it will motivate non-compliant providers to not take the deadline seriously. It is one concept that it sounds like we are really trying to get across here.
MR. BLAIR: I think Karen is right.
DR. COHN: We don't need the sentence?
MR. BLAIR: We don't need the sentence.
DR. COHN: Let's get rid of it and see if it works.
DR. MC DONALD: It seems like that is going to make the argument to forget about worrying about it, especially since it is a small number of providers.
DR. HOUSTON: I think it reads well. I'd take out the last two sentences, too.
DR. MC DONALD: You're right. You're saying oppose delays. You don't have to say it three times.
DR. HOUSTON: Yes, exactly. Especially the first and the last sentence are really the same thing. Deadline should remain October 16.
DR. COHN: I think I would leave the last sentence in, but maybe the sentence right before it.
DR. MC DONALD: The last one is exactly the same as the second one.
DR. COHN: Steve?
DR. STEINDEL: I agree that the last sentence says the exact same thing as the first sentence, but I also agree that it should be left in for emphasis.
DR. COHN: What about the sentence before?
DR. STEINDEL: The sentence before can go out.
DR. ZUBELDIA: Going once, going twice, gone.
MS. TRUDEL: I do have a concern, the way I am reading it now, it looks as if that second sentence is saying there really isn't any problem. We are saying we are making the investment to comply with the deadline, but we want to make sure that we don't lose sight of the fact that even the ones who are making the investment still may not make it in time.
DR. COHN: Right.
MS. TRUDEL: But I think we made that point.
DR. COHN: Are we okay now?
MR. BLAIR: Yes.
DR. COHN: Now we are getting into what we think is the main part of the work here. This is, provide flexibility in transition. Despite opposition to a deadline extension, the committee -- our opposition to a deadline? Anyway, a deadline extension. Yes?
MR. BLAIR: Could I suggest something for consideration?
DR. COHN: Please.
MR. BLAIR: This paragraph that we have here starts getting into refinements and specifics of flexibility. What if, instead of having this sentence here, we follow it with the paragraph that indicates flexibility in enforcement, so that it doesn't -- this is the one that looks like it is contradictory, like it is contradicting the paragraph before it, which you are saying absolutely no extension in the deadline. If the paragraph that follows this say no extension in the deadline, but flexibility with enforcement, and then you have an additional paragraph after that, that says, since you will be flexible in enforcement, there are certain considerations or technical details about how to be flexible with enforcement, and give guidance.
MS. TRUDEL: So that first sentence could say, provide enforcement flexibility during a transition period.
MR. BLAIR: Right.
DR. ZUBELDIA: But there is the paragraph on enforcement.
MR. BLAIR: I was going to move that paragraph up --
MS. TRUDEL: The legal basis for doing this is the enforcement authority and flexibility that the Secretary has.
MR. BLAIR: Right.
MS. TRUDEL: There isn't any more --
MR. BLAIR: Right, and then you characterize what had been that middle paragraph, and move that down after the enforcement paragraph, and you will characterize that as technical guidance on how to support the flexibility and enforcement.
DR. HUNGATE: I'd like to argue a little bit for an alternative wording to the statement, provide flexibility in transition. It goes in the direction of recognizing the management burden that compliant covered entities have in dealing with non-compliant entities.
MR. BLAIR: With the change that I suggested, that sentence wouldn't be there anymore, because it is going to be flexibility with enforcement. Then that paragraph that starts with the flexibility, the one that you just referenced, would then be supportive to the details of the flexibility with enforcement.
DR. HOUSTON: But I would argue then that these remedies aren't available unless an enforcement actin actually occurs. What we are trying to do is say that covered entities without going through enforcement by HHS could select these options in order to more effectively perform a transition.
I would argue that if I am a covered entity, if it says enforcement, I can't do anything until somebody comes to me with an enforcement action and says --
DR. STEINDEL: I think Kepa just deleted some key words, flexibility and enforcement during a transition period.
DR. HOUSTON: But my point is, unless there is actually an enforcement occurring --
DR. STEINDEL: I agree with what you are saying; unless they actually do an enforcement, they are not going to be in any trouble. But we make it clear that this flexibility and what we are allowing during the transition period only is flexibility during that period. If you are caught outside of that transition period, then full enforcement would take place. That is the way I am looking at the way it would be enacted.
DR. COHN: Probably this is, provider flexibility and enforcement during the transition period.
DR. HOUSTON: Yes, exactly.
DR. COHN: Karen?
MS. TRUDEL: I know what you are saying. The piece of it that is missing is that you have to tell people that you are going to do that, and maybe even encourage them to exercise the --
DR. HOUSTON: It seems like you can't do any of these things unless enforcement occurs. I think what we are trying to do is make a recommendation that can be implemented by the industry to lessen the impact during this transition period. Unless somebody actually comes back and says, you are not complying and here are your options, it doesn't appear that covered entities have the right to do any of these things, absent enforcement.
MS. TRUDEL: So let's go back to the recommendation and the testimony that we heard. What I think they were saying was, use some flexibility and something to make sure that plans understand that if they are accepting non-compliant transactions, they are not jeopardizing their own compliance status.
DR. HOUSTON: Right, so a risk of non-compliance.
DR. ZUBELDIA: And we have that in the next --
MR. BLAIR: I'm not sure everybody understands how the game is played today. I don't know what you are really into, but the payors have no hesitation in saying we are not going to deal with this right now. They don't need any enforcement guys to help them out with that. I think if the good payors feel they have to go by the law of the land -- and some of these things are going to -- we will have bugs in the specs, for sure, so you can end up with some really funny situations.
DR. HOUSTON: I would argue as payor's counsel that we can't provide any of this flexibility, because nobody has come to enforce it yet. Until that occurs, we should simply do what we are supposed to do.
MR. BLAIR: Which would be to reject the claims?
DR. HOUSTON: Yes. Then if it is attempted to be enforced, then we can avail ourselves of these options.
MR. BLAIR: I think it is important to know what really might happen. That is an important point, because I think the payors would love that opportunity, some of the payors would. Some of them are saying they are worried about it.
MS. TRUDEL: The payors are saying that if they don't have this kind of flexibility, they are worried about dealing with the mountain of paper.
DR. HOUSTON: It should simply say flexibility during the transition period. Enforcement concerns me.
DR. COHN: That's fine, so let's get rid of enforcement.
DR. HOUSTON: Condition precedent to being able to do certain things.
MR. BLAIR: I'm a little worried about your eliminating that flexibility and enforcement. The main thesis of what we are suggesting is that you don't change the compliance deadline, but that you offer flexibility and enforcement. So if we don't have that phrase in there, --
DR. HOUSTON: There is a legal meaning to it.
DR. COHN: I think the lawyers are advising us about the word enforcement.
DR. STEINDEL: But couldn't the Department lawyers say just the opposite, the law says there is a cliff deadline on October 16, and it either happens or it doesn't happen? The only flexibility CMS has is in enforcement. They really have no flexibility in changing the transactions. They just have flexibility in enforcing the rigidity of those transactions.
DR. HOUSTON: By the way, I understand and I agree with what you are saying in that regard, but many covered entities would say that enforcement is condition precedent to the point where they can --
DR. STEINDEL: My reaction to that is the same type of reaction we are having to the attorneys that we heard about this morning, who are overreacting to the privacy reg. Let's not write the is letter, and let a cliff happen on October 16.
DR. COHN: John, I think you are making a point here. I guess what I am hearing is the in-enforcement is a problem that you have, but that you are okay with provide flexibility during the transition period, with the next sentence talking about enforcement.
DR. HOUSTON: Exactly, or simply we say in the next sentence that enforcement should mirror this transition flexibility, or enforcement strategies should support this enforcement strategy.
MR. BLAIR: I still have a problem with that. The reason I have a problem with that is that this whole last year was the transition period. The compliance deadline is October. What we are saying is, we are not going to extend the compliance deadline, but to ease the way, we are winding up saying that there should be flexibility with enforcement. I have difficulty throwing that away as a phrase, because that seems to me to be the core of what we are recommending.
MS. TRUDEL: Flexibility in transition is not possible without flexibility in enforcement. I think that is what you just said, that they really support each other.
MR. BLAIR: We have to say that the deadline remains. So the only other flexibility that is left is the flexibility with enforcement.
DR. HOUSTON: Of whose enforcement, though?
MR. BLAIR: Of HHS or CMS.
DR. MC DONALD: Would it help if we put that in, if we identified the enforcee? Or is that still the same problem?
DR. HOUSTON: Again, I'm just worried about the covered entities simply standing back and saying, absent an enforcement action against me, I can't deviate from these, because it is a condition precedent to them actually showing flexibility. That is my only point.
Again, I'm just trying to think logically through this. I understand Jeff is doing the same thing. We want to be practical about it, but we also want to make sure that --
MR. BLAIR: What I think helps us is that we reversed the paragraphs, where we wound up saying things like, a payor will not be non-compliant if they accept a non-compliant transaction during this period, that is an example of the flexibility in enforcement. So what we are doing with that paragraph is, we are changing it to the examples of how you can be flexible.
DR. HOUSTON: I would agree with that. I think that is much more palatable, if we gave examples, or couched it in terms of what is permitted by an otherwise compliant covered entity, and stand silent as to what the penalty is actually to the non-complying covered entity. That makes sense.
DR. COHN: I guess I'm a little lost at this point about what this is going to look like. I have seen provide flexibility and enforcement during a transition period. John, you are okay with that now?
DR. HOUSTON: Right, couched in the terms that Jeff said; a covered entity that is otherwise compliant would not be a subject of an enforcement action, due to its willingness to accept a non-standard transaction and some of these other things that we have bullets down there for.
Is that what we were saying, Jeff?
MR. BLAIR: Exactly. I think that whole paragraph virtually gave examples of the flexibility that we would allow.
DR. HOUSTON: It does, at least the second and third bullets.
PARTICIPANT: Maybe a title, post implementation, and then have as a lead-in, for a short period of time, the Secretary may want to consider the following.
DR. HOUSTON: Kepa, you might just simply want to say, a covered entity would not be considered out of compliance if they, colon, and then there are a couple of bullets down below, for a limited period the --
DR. ZUBELDIA: So you are talking about merging these two paragraphs into one.
MS. TRUDEL: You get rid of all of this provider flexibility, and you start with the bullets then?
DR. HOUSTON: Yes. I think what you are doing is basically giving examples of how a covered entity that is compliant would be able to do things that otherwise would put it out of compliance in order to accommodate a non-compliant covered entity.
DR. ZUBELDIA: Well, flexibility in transition, like we have in the printed copy under number two, flexibility in transition, right? All you are doing is taking this last paragraph in number two in the printed copy and moving it to the top.
DR. HOUSTON: Yes.
MR. BLAIR: Kepa, that should be flexibility of enforcement during transition.
DR. STEINDEL: I believe what is being suggested is, make the paragraph that starts with number three the introductory paragraph to the bullets and remove the present introductory paragraph to the bullets.
DR. ZUBELDIA: Is there anything we want to keep from it?
DR. STEINDEL: I think we need to review that, but no, a covered entity that is otherwise compliant would not be considered out of compliance if, colon, and then the bullet start, or however we want to phrase that grammatically.
DR. ZUBELDIA: Do we want to say something about the computer testing with trading partners? So this would become the first bullet.
DR. COHN: What was that last? We just lost the first bullet, I think.
DR. ZUBELDIA: This very first bullet, right there.
MS. TRUDEL: The one you are on right now?
DR. ZUBELDIA: Yes. Do you want to remove that?
MS. TRUDEL: If you look at a covered entity that is otherwise compliant would not be considered out of compliance if, that first bullet doesn't match.
DR. ZUBELDIA: So this should be moved somewhere else?
DR. HOUSTON: Yes.
DR. ZUBELDIA: Here?
DR. HOUSTON: For the moment.
MS. FREEMAN: Down here we start, all covered entities.
MS. TRUDEL: Is this an alternative or is this a prerequisite? Are we saying it is not considered out of compliance if it has staged compliance requirements for claims? The bullets as they originally stood were talking about easing the non-compliant folks into compliance, not to deal with the compliant -- not the other way around.
DR. COHN: I guess we had a couple of words after covered entity that have seem to have gotten lost in all of this stuff, which was actually pretty good.
DR. ZUBELDIA: Right here, this paragraph that I highlighted, you could say something like flexibility in transition could include for example. Right now, we are changing it from for example to some very specific things.
DR. COHN: We had a sentence here that made a lot of sense, that got lost. We said a covered entity that is otherwise compliant would not be considered out of compliance if it accepted non-compliant transactions from a covered entity. Wasn't that it? Then maybe what we need to say is that other things -- there needs to be something else and then a colon.
MS. FREEMAN: Maybe we should forget these bullets and just start with new bullets. That is what I am hearing.
DR. HOUSTON: The two bullets starting for a limited transition period as well as permit compliant covered entities, if you take those two bullets and move them up, those are the two salient parts. We could just simply start out with for example.
DR. ZUBELDIA: I like the one we had before, flexibility in transition could include, for example.
DR. HOUSTON: Right.
DR. COHN: Kepa, before you remove this one, I still think that there is a value to that sentence, whatever we had at the end of that sentence. You are saying explicitly something that I think people need to hear, which is that a covered entity that is otherwise not compliant would not be considered out of compliance if they accept a non-compliant transaction during the transition period.
DR. HOUSTON: Period, then say for example.
MS. TRUDEL: No, no, no, there needs to be something at the end. Otherwise compliant would not be considered out of compliance if it accepted non-compliant transactions, period, for example.
DR. HOUSTON: My point is, if you go down to the second bullet point underneath there, I'm saying there are two different things you can do. One, you can provide a minimum claim, which somebody might argue is out of compliance.
MS. TRUDEL: No, they are both non-compliant.
DR. HOUSTON: Okay, so if we just keep those two bullets, we are hitting both points, I think. If you take out for the first bullet everything before allow, wouldn't be considered out of compliance if.
MS. TRUDEL: I think Kepa's concern is that we are limiting it here, and he was trying to make it two examples.
DR. ZUBELDIA: Give an example rather than a square hole.
DR. HOUSTON: Why don't we say if, comma, for example. No, if for example, colon. You just simply take out everything before allows, put in it allows. Then you could say that second bullet would be to allow non-compliant covered entities to submit claims in current electronic format, it permits a non-compliant covered entities to continue, because we are already talking about the transition period above, so we don't have to worry about transition period here, it is redundant. To accept non-compliant claims, or something like that.
MS. TRUDEL: And accept is different too, because that assumes that the plan would be able to accept a non-compliant claim, but wouldn't be able to generate a non-compliant remittance advice.
DR. HOUSTON: Why don't we simply say, continue to use non-compliant electronic formats?
MS. TRUDEL: That would include both.
MR. BLAIR: If we say continue to use, it is broader. It could be across the board. Whereas, if we say continue to accept non-compliant ones, that means that it will also be accepting the compliant ones as well. So could we make it a little narrower and say, continue to accept?
MS. TRUDEL: Accept implies receive, as opposed to generate. My concern was that we were saying that they could accept a non-compliant claim, that even if the provider wanted one, they couldn't generate a non-compliant remittance advice. But I think what you are saying is an important point, too. We need to make the point that this is in addition to being able to accept and generate compliant transactions; it is both compliant and non-compliant.
MR. BLAIR: Right. So maybe if you just said what you say, then we would accept non-compliant claims and generate non-compliant remittances if required or if necessary, or during the transition period.
MS. TRUDEL: How about, allows a non-compliant --
DR. ZUBELDIA: Allows trading partners.
MS. TRUDEL: No, because really, we are talking about a compliant covered entity, a compliant health plan to continue to use non-compliant and compliant electronic formats.
MR. BLAIR: When you say use, then it says they haven't made a switch, so I was just trying to restrict it. Allows them to accept or send these things.
MS. TRUDEL: Accept or send?
MR. BLAIR: Accept or send.
DR. COHN: Let me just read this, because I'm getting a little confused. It says, during the transition period, the covered entity that is otherwise compliant would not be considered out of compliance if for example it allows for claims to be submitted in the HIPAA standard format, but maybe it is only the minimum data elements that are required to adjudicate the claim?
DR. ZUBELDIA: It seems like if they take something that isn't required to adjudicate the claim, it will not fit in here.
MS. BEEBE: Kepa, doesn't X-12 consider transactions to be minimum data sets, anyway?
DR. ZUBELDIA: But this word are, are required, is disturbing, because there is no such definition of what is required to adjudicate the claims. I would say, only the data elements they need or they require.
DR. COHN: That allows claims to be submitted in the HIPAA standard format, only the data elements that they require to adjudicate the claim. Are you okay with that?
MS. TRUDEL: Yes.
DR. COHN: It allows a non-compliant covered entity to continue to use both compliant and non-compliant electronic formats.
DR. STEINDEL: If it is non-compliant it wouldn't use a compliant electronic format.
MS. AULD: Yes, shouldn't this say otherwise non-compliant covered entity?
DR. ZUBELDIA: We already have this.
DR. COHN: Yes, that is already up there. It allows a non-compliant covered entity to use --
DR. STEINDEL: Why not say transact claims using non-compliant electronic formats?
MR. BLAIR: Is this an example that is specific to a payor situation, where we could wind up saying -- we don't need to say covered entity; we could wind up saying that it allows a payor to continue to accept and receive non-compliant formats during the transition period.
MS. TRUDEL: But I think the it that it refers to is the payor.
MR. BLAIR: Right, but I think it would be helpful if we referred to that as a payor.
DR. ZUBELDIA: Say a payor allows a non-compliant provider to continue to use.
MR. BLAIR: There we go.
DR. COHN: To continue to use, or maybe just to use?
MS. TRUDEL: I think we were trying to make a distinction between the non-compliant transactions that are just missing some data elements and the ones that are using old proprietary formats, pre-HIPAA formats.
MR. BLAIR: Yes. The assumption is that they are going to use what they were using before, which could be anything.
DR. HOUSTON: So the provider could continue to use non-compliant.
DR. COHN: I think we need to say something. Payor allows a non-compliant provider to use -- a payor using a non-compliant provider to use non-compliant electronic formats.
MR. BLAIR: You don't have to say non-compliant
in front of provider. Just say, provider to use non-compliant.
DR. COHN: Do we need to say something about during a limited transition period? It is pretty far away.
MR. BLAIR: It is already up there, in the original sentence, during the transition period.
DR. STEINDEL: Isn't the first example also a non-compliant electronic format? So I think we need to be more specific and say something like --
DR. HOUSTON: Why don't we say a proprietary non-compliant format, because the other one is a standard format.
DR. ZUBELDIA: A legacy?
DR. HOUSTON: A legacy or some word, pre-existing.
DR. COHN: Pre-existing, probably.
DR. HOUSTON: What happens if a payor though can't provide a remittance in the standard format? Aren't they also non-compliant?
DR. ZUBELDIA: We are using the word use.
DR. HOUSTON: But it says a payor allows a provider to use. Why couldn't it just as easily be a provider allowing a payor to provide remittance?
DR. ZUBELDIA: It is between the provider and the payor. They are using an old remittance advice format.
DR. STEINDEL: Can we say something like, a payor -- I just lost the words. I was going to use something like, allows transactions to a provider using pre-existing non-compliant electronic format.
MS. TRUDEL: I think it was fine the way it was.
DR. COHN: Why don't we -- what was it before, Kepa?
MS. TRUDEL: No, now it is okay. A payor exchanges transactions with a provider in a pre-existing non-compliant electronic format.
MS. BEEBE: Can we go back to the first bullet, where you say they require? Who is they?
DR. ZUBELDIA: The payor requires.
DR. COHN: Is there anything else we want to have here?
DR. HOUSTON: Why don't we say, rather than allows, the payor accepts the claim submitted?
MR. BLAIR: Yes.
DR. HOUSTON: Accepts a claim submitted in a HIPAA standard format.
DR. COHN: Do you want me to read these two bullets? The question is, is there anything else we need to put here? It says, provide flexibility and enforcement during a transition period, the committee recognizes that HHS has not yet issued a notice of proposed rulemaking regarding the substance of enforcing HIPAA's electronic standards and code set provisions. However, the committee believes HHS enforcement could provide some flexibility by promoting voluntary compliance by covered entities without limiting CMS's ability to take enforcement actions against those covered entities that are not taking steps to comply.
During the transition period, a covered entity that is otherwise compliant would not be considered out of compliance if for example a payor accepts claims submitted in the HIPAA standard format, with only the data elements that the payor requires to adjudicate the claim. A payor exchanges transactions with a provider in a pre-existing, non-compliant electronic format.
Anything else here?
DR. HOUSTON: I think it is important to make a distinction that -- you are setting the stage at the top by saying that the covered entity that is otherwise compliant is doing something with a non-compliant entity. We never talk about a non-compliant entity. I think the point is that we need in those bullets to acknowledge that it is a covered entity doing something with a non-compliant entity.
DR. ZUBELDIA: I think that the concept that we heard in the hearings was that the provider perhaps is compliant and can send compliant things to the Department such as Medicare, but needs more time to convert the other payors over to the standard transaction format.
DR. HOUSTON: Right.
DR. ZUBELDIA: So both entities would be compliant per se, but they need more time to establish the relationships in compliant mode.
DR. HOUSTON: They may not be compliant, though.
DR. ZUBELDIA: The question is, what if one is not compliant at all?
MR. BLAIR: So we are talking about covered entities that are compliant with at least one business partner?
DR. ZUBELDIA: That's right.
MR. BLAIR: So that is what we are saying when we say that they are otherwise compliant. They are compliant with at least one trading partner.
MS. TRUDEL: That is not compliance.
MR. BLAIR: What?
MS. TRUDEL: That is not compliance. Whoever they are not able to send electronic transactions to could still file a complaint about them.
MR. BLAIR: Right, but that is where we are giving enforcement flexibility.
MS. TRUDEL: We are not saying they are compliant.
MR. BLAIR: But we are saying -- okay, then maybe we could say that a covered entity is capable of sending a compliant transaction with at least one trading partner. Then we would give them flexibility as we define in the recommendations.
MS. TRUDEL: Right, I think that is something that maybe needs to go down below. But I would not take out that otherwise compliant that you have got highlighted there.
DR. ZUBELDIA: I wouldn't take it out. I think we need to define what it means, what that is talking about.
MR. BLAIR: I was trying to define what otherwise compliant meant, and that otherwise compliant meant that they could send -- that a covered entity could send a compliant transaction to at least one --
DR. COHN: That is not the definition of compliance. Compliance is compliant.
MR. BLAIR: But that is what I am saying. It would be a covered entity that could send a compliant transaction to at least one other trading entity. We therefore say -- so that changes the word otherwise compliant.
DR. HOUSTON: Just take out the word otherwise.
MR. BLAIR: Yes, take out the word otherwise.
DR. HOUSTON: During the transition period, a covered entity that is compliant would not be considered out of compliance if for example.
MR. BLAIR: Well, a covered entity that could send compliant transactions to at least one trading partner.
DR. COHN: No. I think people know what compliance means.
DR. HOUSTON: This is a bright-line issue in my mind. We are talking about -- the non-compliant entity, even if it has done nothing, it is going to be subject to whatever enforcement action occurs. But in all fairness, that covered entity still needs to have revenue, especially if it is a provider. So I think what we are trying to say is that --
MR. BLAIR: Maybe what we are talking about is not black and white; it is partial compliance. And partial compliance is if a covered entity can send at least one compliant transaction to another trading partner. We define that as partial compliance.
DR. COHN: It is not a legal term, to my knowledge.
MS. TRUDEL: There is no such concept. You are compliant or you're not.
DR. STEINDEL: My concept of what we are trying to do and why we are trying to find wording is, as was pointed out time and time again, they can just send paper, and that is what we want to prevent. So what we are trying to do is allow some flexibility. We don't want the compliant entity to say sorry, we're not going to pay you because we are getting it in an old format, and then they say I still need to get paid, and then they mail in paper.
MR. BLAIR: Right, it is a burden on everybody. I agree completely.
DR. COHN: We need to move along. We need to somehow come to closure on this rather rapidly. We have two bullets. Beyond that, I'm not sure what the rest of this --
DR. ZUBELDIA: Otherwise stays, right?
DR. COHN: Yes, I think otherwise is fine. The question is, do we want to have one example where the provider is compliant and the payor isn't?
DR. ZUBELDIA: Yes, I think we need to have an example like that.
DR. COHN: So basically, a compliant provider exchanges transactions with -- during the transition period, a covered entity that is otherwise compliant would not be considered out of compliance if for example a provider exchanges standard transactions with some payors, but is waiting to be tested with other payors. But exchanges non-compliant transactions with --
DR. STEINDEL: What if the payors that they haven't completed testing with will not accept non-compliant transactions?
DR. COHN: Back to paper.
DR. STEINDEL: That is the obvious course, back to paper, but that is one of the implications of this. I personally feel that we don't need that bullet.
MS. FREEMAN: We've got it. We've got it in the first two.
DR. STEINDEL: Bullet two, could you just put at the end vice versa, something like that? We are getting to the point with that bullet where we are forcing payors to accept the non-compliant transaction, which we had a large discussion about earlier.
DR. ZUBELDIA: This would not be required.
DR. STEINDEL: If a provider sends a non-compliant claim to a payor who is not going to accept a non-compliant claim, the provider is going to turn around and send paper.
DR. ZUBELDIA: Yes, but nothing is going to force that payor to accept a non-compliant claim.
DR. COHN: So we like that bullet, or are we getting rid of that bullet?
DR. STEINDEL: I'm not sure it does anything.
DR. ZUBELDIA: How do we give an example of a non-compliant payor and a compliant provider?
DR. STEINDEL: I think in that case, what you have is, a provider will file a complaint against the payor, and they will be subject to enforcement.
DR. COHN: Let's take a look at the remaining bullets here. We've got, requires that all covered entities and their trading partners have --
DR. ZUBELDIA: These are not for examples anymore.
MS. FREEMAN: I would take out the next two bullets, because the last bullet now, reminding of the necessity of establishing milestones, is really what that third bullet is all about. The third bullet is specific in establishing milestones.
DR. STEINDEL: The third bullet did contain one significant point. The significant point it did contain was that it talked about the transition period extending only until April.
DR. COHN: Maybe we need to say that up at the beginning.
DR. STEINDEL: So at some point we have to capture that date.
MR. BLAIR: How did we come up with giving them six months?
MS. TRUDEL: That was in the WEDI testimony.
DR. COHN: Jeff, what were you thinking about in terms of the transition period?
MR. BLAIR: I guess my mind set was, 60 or 90 days, and six months seems like an awful long time.
DR. COHN: If you remember, Jeff, there was also one testifier who said there shouldn't be any end to the transition period. So I think others would say that this is obviously -- so what is going on here?
DR. ZUBELDIA: Do you want to put this somewhere?
MS. FREEMAN: I think that was an artifact of reversing those paragraphs.
MS. TRUDEL: I think we have already said it. We've said it up above now.
DR. COHN: Let's look and see what above is. Do we want to say provide flexibility in enforcement during the six-month transition period?
MS. FREEMAN: A transition period not to exceed April, whatever that date is.
DR. COHN: That would be fine, too.
DR. ZUBELDIA: In this first line?
DR. COHN: Yes, transition period, comma, not to extend beyond April whatever it was.
DR. ZUBELDIA: What about this part?
DR. COHN: We further advise the Department to remind industry trading partners of the necessity of establishing measurable milestones and developing a firm schedule for testing and deployment during this transition period, period.
DR. ZUBELDIA: And zap the rest?
MR. BLAIR: Yes, you can zap the rest.
DR. COHN: That is actually not a bullet. The third one is not a bullet. Do you want me to read this section again? Here it is. Provide flexibility and enforcement during the transition period not to extend beyond April 16, 2004. The committee recognizes that HHS has not yet issued a notice of proposed rulemaking regarding the substance of enforcing HIPAA's electronic standards and code set provisions. However, the committee believes HHS enforcement could provide some flexibility by promoting voluntary compliance by covered entities without limiting CMS's ability to take enforcement action against those covered entities that are not taking steps to comply.
During the transition period, a covered entity that is otherwise compliant would not be considered out of compliance if for example a payor accepts claims submitted in the HIPAA standard format or with only the data elements that the payor requires to adjudicate the claim, or a payor exchanges transactions with a provider in a pre-existing non-compliant electronic format.
We further advise the Department to remind industry trading partners of the necessity of establishing measurable milestones and developing a firm schedule for testing and deployment during this transition period. These are covered entities rather than industry trading partners, the last paragraph.
Yes, John.
DR. HOUSTON: One point. In the sentence that says, however the committee believes that HHS enforcement could provide some flexibility by promoting voluntary compliance, it is not voluntary compliance, it is compliance, isn't it?
DR. STEINDEL: Yes, it's not voluntary.
DR. HOUSTON: This is mandatory compliance, promoting compliance with something that is mandatory, while still giving them the ability to enforce where otherwise a covered entity is not doing anything.
I don't think it is voluntary. What we are saying is, you've got to comply, but where there is an egregious attempt by a covered entity not to comply, knowingly not make any attempts to comply. CMS does have the ability to take appropriate enforcement actions. So we are saying the flexibility comes where somebody is trying to comply, but maybe is not successful.
MS. FREEMAN: Some people suggested good faith.
DR. HOUSTON: That's good, good faith compliance would be a more appropriate use of --
DR. COHN: Okay. I think we are done with this section. Kepa, are you comfortable with it?
DR. ZUBELDIA: How will this apply to providers if the payor is out of compliance and the provider has to send claims in NSF UB-92 to a payor that is out of compliance? How does this apply in that case, or does it?
DR. HOUSTON: That second bullet was intended to cover that.
MS. TRUDEL: No. If the plan is out of compliance, the provider files a complaint.
DR. ZUBELDIA: So if the plan is out of compliance, the provider files a complaint.
DR. HOUSTON: But the point was, in that second bullet, it may be better to say payor and provider exchange transactions in a pre-existing non-compliant format, says that yes, you have got a compliant provider, it still needs to deal with cash flow, so therefore it is going to have the ability to still transact with the non-compliant payor.
DR. LUMPKIN: And to be truthful, most providers, if it is a choice between being out of compliance with the feds in Baltimore and not getting their bills paid, they are going to make the decision that is going to get their bills paid.
DR. ZUBELDIA: That is an easy decision.
DR. LUMPKIN: Yes, it will be an easy decision for them. So during this transition period, again, unless I missed it in the budget, CMS didn't hire a whole bunch of HIPAA police, so it is not like there are these forces that are going to come into a doc and say, oh by the way, you sent out this non-standard transaction and we are going to fine you.
DR. HOUSTON: I agree with you, but somebody could make the conscious decision to simply stand behind the enforcement, stand behind the non-compliance as a reason not to cooperate.
DR. LUMPKIN: Right, but I think when we are looking at it from the guys at the provider, the provider actually has more protections in this. If they can do a standard transaction and the vendor doesn't, then they are not going to be the only ones there. That payor is going to be fairly high profile. It is going to be high profile enough that CMS is going to come knocking on their door.
Now, if I am a payor, it is totally different. I am worried about CMS knocking on my door because I am trying to do the right thing with the providers. So I just don't think it is an equal relationship here. What we do covers the ones where we have the major concern. The rest, I think the marketplace and other forces will take care of.
DR. COHN: I think beyond this, we just have a couple of wordsmithing, where we take the industry in the second line here, turn it to covered entities. And I think we have a Secretary there, request the Department work with the industry, next sentence.
DR. ZUBELDIA: With covered entities or with the Secretary?
DR. COHN: Yes, the Department work with covered entities. I think that's it. I want to thank all of you. This was not the easiest wordsmithing. I am once again reminded of the clean documents under the microscope of the NCVHS are very rarely clean documents.
DR. MC DONALD: We've got one more.
DR. COHN: Just a minute. Kepa, are you okay? Just give it to Marie, and we'll have it for tomorrow.
The next item is the wordsmithing on the first letter.
Agenda Item: Review of Draft Letter on PMRI Terminology Standards
DR. MC DONALD: I think I have a simple solution. We could describe the study a little better, go into the context of it. Then I started thinking, what would happen if we picked any other attribute and took it out, what would come to the top? Then I started thinking, this is gratuitous. We don't need to say this bullet at all, because the next bullet says what you want to do. We don't say enough about the study or whoever. I don't see the purpose of it. We don't use this anymore.
So the simplest way is to take the bullet out, in the spirit of what I was hearing in these other things.
DR. ZUBELDIA: What is the --
DR. MC DONALD: It says, they ranked number one if you took out this criteria. What if you took out another criteria for someone else?
MR. BLAIR: I can't see what you are referring to, so you have to read it to me.
DR. MC DONALD: This is the second bullet after the, it is premature to recommend terminologies. When the candidate PMI terminology were evaluated against NCVHS criteria for selection in March 2003, SNOMED CPT ranked number one in both the technical and the overall assessment when the cost of licensure was excluded.
Then it goes on to say, in the May hearings, users specified broad support for the adoption of SNOMED CPT and support for SNOMED CPT was dependent on clarification of licensing costs.
DR. STEINDEL: I agree with Clem that that bullet is redundant.
MR. BLAIR: Which one is redundant?
DR. STEINDEL: The first one is redundant, and we can remove it without changing the impact of the letter.
MR. BLAIR: The only thing I would say before we decide to remove it is, the first one is based on a technical evaluation, the second one was based on user testimony. That was the difference between the first and the second bullet.
DR. MC DONALD: But we didn't say that we chose it because of that.
MR. BLAIR: What?
DR. MC DONALD: We didn't say we supported its use because of that. We didn't tie anything to this statement.
MR. BLAIR: But what we are doing on the letter is, we are not making the recommendation. All we are doing is listing observations to help CHI with its deliberations for July and August.
DR. MC DONALD: But then I would suggest we include the report of the assessment, the whole thing. It just seems like it is gratuitous, it just sticks out. Specifically when you said, if you excluded one criteria, it came out high. What if you exclude another criteria? Who would come out?
I think the other people on that list would say -- I don't know, we haven't analyzed that. Does it come out high no matter which one you remove?
DR. STEINDEL: In actuality, this refers to the preliminary rankings of the terminologies that Walter did, and not based on the clarification sent back by the manufacturer. There may be some inversion on who ranks number one when the clarifications come in. So this may not be totally correct. I don't think it adds that much, to the point that we really want to make to the Secretary, which is in support of laboratory LOINC and in support of SNOMED, efforts for SNOMED CPT.
DR. MC DONALD: Yes, we said we want it.
DR. COHN: Jeff, are you okay with that?
MR. BLAIR: So to my understanding, what we are removing is the bullet that refers to the ranking of SNOMED as number one?
DR. COHN: Yes.
MR. BLAIR: Okay.
DR. COHN: Any other comments on that? So I think we have both letters in pretty good shape. Steve, I'm going to give you the final version here, if that is okay.
DR. MC DONALD: We've got to thank Kepa for that hard work in listening and editing.
DR. COHN: Kepa, thanks for your hard work. Now, I'll just say very briefly, you all know about the hearings on the 19th, 20th and 21st.
DR. MC DONALD: Of what month?
DR. COHN: Of August. The 19th is drugs and device terminologies, 20th and 21st will be a combination of up update on claims attachments, a set of discussions on the report back from Rand on the ICD-10 cost impact, as well as obviously a fair amount of testimony in relation to that, as well as other peoples' learnings about cost impact of ICD-10.
I guess the question is, should we try to put on that schedule something around the quality discussions? Are you available at some point during that period? Because we did such a good job of getting to it today.
DR. HUNGATE: If we could join us tomorrow morning, that would certainly -- since we didn't get to it. Is there any hope of that?
DR. ZUBELDIA: I have already committed some time to a privacy subcommittee. There is an issue that I am bringing to that subcommittee.
DR. HUNGATE: So it is not practical for you.
(Remarks off the record regarding meeting arrangements.)
MR. BLAIR: Is there somebody that is going to be able to update the PMRI letter?
DR. COHN: I was hoping that Steve was going to do that for us.
MR. BLAIR: If not, I could do it on Thursday as soon as I get back. I understand we are going to just delete one and remove those words initial in a couple of places, and those are the only changes.
DR. COHN: There are a couple of wordsmithing, but basically we are accepting the modifications with Walt Sajanksy's bits of wordsmithing and all of that.
MR. BLAIR: So is there somebody that is here to do that? DR. MC DONALD: What has to be wordsmithed?
DR. COHN: The letter that we were just talking about, the PMRI letter. These are minor edits.
MR. BLAIR: Do you want to leave it to me for Thursday?
DR. COHN: Yes, that would be fine. I don't see anybody raising their hand, so I think that is a reasonable way to go. We have a version here that we can reference. Everybody has most of it except for a couple of wordsmiths.
The other thing is, tomorrow morning from eight to ten is a meeting with the Privacy and Confidentiality Subcommittee. One of the topics there is a joint hearing on the security rule, as well as whether we should have a joint hearing on the enforcement rule. So that will be a conversation. There is obviously a fair amount of overlap between these two committees already.
DR. MC DONALD: Is there any agenda for the privacy committee?
DR. COHN: I don't know. Maybe in your booklet.
DR. MC DONALD: To comment on it, we have had some experience with it. I think there are some good things. In contrast, the IRB's interpretation of all this business is very muddled.
DR. COHN: You're talking about the privacy rule now? Are you going to come tomorrow morning?
DR. MC DONALD: Well, I don't know whether that would be something -- it is crazy stuff. They are taking their privacy role strongly, but it doesn't have much to do with what HIPAA says. They just do whatever they want.
DR. LUMPKIN: So that is new for IRBs?
DR. MC DONALD: What?
DR. LUMPKIN: That is something new for IRBs?
DR. MC DONALD: Well, they have always had -- they are claiming de-identified data has to be approved, stuff like that.
DR. COHN: Well, I think that that is a very legitimate question, and I would advise you to come with us to the privacy meetings tomorrow morning. As I said, the main discussion has to do with the joint hearings on enforcement and security, but there may very well also be time to talk about that. That may be an issue that deserves some further evaluation.
Any other issues for the subcommittee before we adjourn and let John start the NHII work group? With that, this meeting is adjourned.
(Whereupon, the meeting adjourned at 4:20 p.m.)