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[Introductions]
DR. COHN: We want to thank you both for being available over the phone. We do know that we are getting into sort of the summer season and we do appreciate you making the availability for the time of this meeting.
Do you want to go through your testimony as well as the final DSMO recommendations?
MS. WEIKER: Sure.
DR. COHN: And please feel free to make any other comments that may help us understand the recommendations also.
MS. WEIKER: Good morning. Thank you for the opportunity to provide the committee with a final report regarding the fast track DSMO process. The DSMO has completed all the -- of the fast track change request process. There were 231 change requests that were processed. Fifty-two change requests were appealed, of which 14 were subsequently withdrawn.
Of the remaining 38 appeals, 32 were appealed and six were denied. The final category tally is as follows: Category A, 67; Category B, 21; Category C, 38, Category D, 85, Category E, 10, Category F, 6 and Categories G and H, 0.
Definition of each category is listed below. Category A are modifications necessary to permit compliance with the standard -- HHS, necessary items include something in the adoptive state or just limitation specifications -- as required by the standards, a data element or code set that is critical to the industry's business process -- there is an internal conflict within a standard.
-- are classified as additions or deletions of data elements, internal -- values, statements with -- exchanges in usage, changes in repeat counts, changes in formatting of -- explanatory language that doesn't fall into Category A. Maintenance classified as -- items classified as maintenance will require no further DSMO action. Items are to follow the SDO -- follow-up by the Department of Health and Human Services in regards to final rules -- classified as items --
Category D, appeals -- and finally, Category H, industry comments requests -- classified as items that require additional comments --
The DSMO requests the following Category A change requests be incorporated into an NPRM. I have listed all of the Category A change requests with the actual request and the final DSMO response. I don't plan to read all of the 57 change requests, but they are documented. These are all the Category A. Then if you chose here the --
DR. COHN: Actually, Margaret, I will apologize, but I think for most of us, this is the first time we have actually seen these requests together. I guess what I am going to suggest, assuming that you are willing, else we will sort of have to go through this again after your discussion, is to basically go through a very -- go through briefly what the request is and what your recommendation is in relationship to the request. Can we do that? Or is that going to be real onerous for you?
MS. WEIKER: I can do it, but it will take some time.
DR. ZUBELDIA: I do have questions on some of them.
MS. WEIKER: I think maybe instead of reading it verbatim, should we maybe give them one sentence about what the --
[Multiple discussions.]
DR. COHN: And then look at DSMO and -- I know, Kepa is commenting that he had some questions about -- I think this will be probably the best way for us to sort of go through it and make sure that we all have the same level of understanding.
MS. WEIKER: I start out with Request 113 and -- we will flip back and forth and in that way one of us can be reading the next one.
DR. COHN: Okay.
MS. WEIKER: We will tag team it.
Request 113 requested that the NCPDP back dated Version 1.1 be used instead of 1.0 and the DSMO response was that they recommended that the NCPDP Batch 1.1, be substituted wherever Batch 1.0 was named as appropriate.
DR. BRAITHWAITE: -- require an NPRM to change that -- we are planning to do that.
DR. COHN: I think that most of these things are going to need an NPRM.
Please, go ahead. 114?
MS. WARD: The next one, 114, was reference to removing the -- for national drug codes, which was the argument that you heard back in February and the DSMO response to that was that -- verbiage for allowing the usage of the NDC codes -- I don't have that verbiage in front of me, but the intent is that until something is actually -- comes down, other than a letter -- comfortable removing the qualifier. So, they are going to -- the qualifier will remain in there and there will be verbiage as -- I believe it says that it is not required under HIPAA but it can be or would be allowed to use in a certain situation.
DR. ZUBELDIA: Maria, the addendum pages on that show the qualifier N4 removed. There is a comment that says "Do not use unless it is required by HIPAA."
MS. WARD: Okay. That might be the language, Kepa. I honestly don't remember.
MS. WEIKER: -- discussed that the informational
-- that X12 had in regard to their technical solution to the situation and that is where that should have been addressed.
DR. FITZMAURICE: Would this preclude that someone who has already started to work in the NDC would then keep them -- re-revise their system to take NDC out?
MS. WEIKER: No.
MS. GREENBERG: I thought what the Secretary said was that -- what the committee said and I thought what the Secretary agreed, was that it would be allowed, but it wouldn't be required.
MS. WEIKER: That is correct. I believe that that is what I have been trying to articulate in --
MS. GREENBERG: So, it shouldn't say -- so not use unless required by HIPAA doesn't -- isn't the same as --
DR. ZUBELDIA: The technical solution that X12 is proposing is to not carry the NDC in the service line itself, but carry the NDC in an additional loop in addition to the service line. So, the service line would have a J code, which -- J7999, something like that -- and then a separate loop that in addition to a J code, you have one or more NDCs and you could have multiple NDCs for one service line. That is a technical solution that is in the addendum pages.
From what I am hearing Maria say now, they are not going to remove the NDC from the service line and they are going to allow it in both places. Is that correct, Maria?
MS. WARD: No, you are not hearing me, Kepa. I can honestly tell you that I am not clear on what X12 technical solutions -- and what you just -- the situation that you just explained probably is their technical solution.
DR. ZUBELDIA: Okay. So, the technical solution in X12 is to remove the NDC from the service line and put it in an additional loop, in addition to a J code. So, it supplements the J code with the complete description by drug.
DR. FITZMAURICE: Suppose someone has the NDC code in a service line and has a loop that would convert that to a J code potentially, would that also be acceptable?
DR. ZUBELDIA: You could have a J code in the J code supplemented with the NDCs.
DR. FITZMAURICE: However, you could not have an NDC supplemented with a J code.
DR. ZUBELDIA: That is right.
DR. GRIFFITH: The service line, the main -- calls for the J code and not the NDC code. So, you have got a J code with an option to include NDC codes, if necessary.
DR. FITZMAURICE: But if the Secretary's intent is to allow either an NDC code or a J code in there and in some that would mean in the service line, then that solution wouldn't work.
DR. GRIFFITH: The way that they are writing the notice of proposed rulemaking -- and, again, it is a proposal -- we are basically retracting the standard for drug coding for anything except retail pharmacists.
DR. FITZMAURICE: So, is there a -- use only J codes.
DR. GRIFFITH: So, it says there is no national standard for drug coding; therefore, it actually falls back to the implementation -- so, the implementation guide's solution as proposed by X12 would be to allow J codes supplemented by NDC codes. This gives people the opportunity to use either J codes or NDC codes.
DR. FITZMAURICE: So, they can use an NDC code without using a J code?
DR. GRIFFITH: According to the solution, you have to use sort of a miscellaneous --
DR. FITZMAURICE: So, they always have to use a J code.
[Multiple discussions.]
MS. GREENBERG: A placeholder J code?
DR. GRIFFITH: Yes.
DR. COHN: Just to further clarify also, remember there are other drug codes than just in the J codes. So, we should not --
[Multiple discussions.]
DR. ZUBELDIA: But there are some codes that say
-- as were classified and you could use one of those that is completely generic, entirely useless code, other than to supplement it with an NDC by itself --
DR. FITZMAURICE: Even when there is a J code that would work as well --
DR. ZUBELDIA: That is a coding issue. I guess you could --
DR. FITZMAURICE: All right. So, one could ignore the fact there is a perfectly good J code -- by putting in another -- and then a loop to the NDC.
DR. ZUBELDIA: Technically, you can do that. You may not get paid, but you can do that.
DR. GRIFFITH: It would be up to payers now to determine how they will pay and they may not pay on the J code. They may intentionally ignore the J code and say you can submit a J code but unless there are NDC codes, I will not pay for the --
DR. FITZMAURICE: I get your point that the J codes are already working. We have got an NPRM. Then we will get feedback that means what really work well.
MS. WARD: Request 115 --
DR. COHN: Hang on, hang one. We were just sitting here talking. I don't think we have completely resolved what we are doing with this one yet. Kathleen Fyffe is also -- do you need to -- on any of the issues coming before the --
MS. FYFFE: I am a member of the NECC, the NEBC, the NCPDP, HIAA.
DR. COHN: -- and I guess the question is -- it occurs to me there are sort of two issues here. One is in relationship to this request -- I mean, to this request and a response, that this really is not -- at least as I can review it -- I understand that there is a solution to it coming up, but actually the solution is not really identified here. There was an issue and you sort of said X12 will handle it, et cetera. We also know that there is a new NPRM coming in related to this.
It seems to me that -- Request 114 probably since it is already being handled by an NPRM, probably doesn't need to go forward to the Secretary in the current form it is.
MS. TRUDEL: Isn't this two halves of the same issue? Don't we need the regulation and the X12 change in order to implement the committee's previous recommendation? If we published this regulation without a change in the implementation guide, I am not sure we will be all the way there.
MS. WARD: This change is to specifically change the implementation guide.
DR. ZUBELDIA: A concern that I have with this is that the DSMO response doesn't include any changes in the implementation guide.
MS. WEIKER: Kepa, none of our responses go into the really nitty gritty details. I mean, that is what the SDO is for and -- will be forwarded all of the changes, the actual detailed technical changes to the guides for inclusions.
MS. TRUDEL: It sounds as though in this case, though, the subcommittee would really like to see those words, to make sure that the recommendations are appropriately being implemented.
DR. BRAITHWAITE: Those words were being -- in the updated implementation guide that will be adopted by the Secretary, including all these changes, but this is a special case where they think the committee needs to see the particular X12 response.
DR. COHN: We actually have two options on how to handle this. One is that we can somehow do something to review it or we can suggest to the HHS that they take special care in review of this particular request and make sure that the NPRM and the implementation guides jive.
What would be the interest of the subcommittee in terms of what they would like to see in terms of this one?
DR. ZUBELDIA: I think HHS needs to work with X12 and make sure that both the NPRM and the technical solution proposed by the SDO are in sync.
DR. COHN: Okay. So, I guess the recommendation here in whatever transmittal letter is is that we -- I guess the wording for HHS takes special care to make sure that there is continuity between the implementation guide and the changes --
DR. ZUBELDIA: And I believe that is the case now, but that needs to be verified.
DR. COHN: Margaret, I am sorry we are obviously stopping like this, but we sort of need to figure out as a group if there are any issues that we need to be commenting on. You okay?
MS. WEIKER: Sure.
DR. COHN: Are you okay with that resolution to that issue?
MS. WEIKER: Sure.
DR. COHN: Now do you want to look to 115?
MS. WEIKER: Yes.
115 and 118 I will do together --
MS. WARD: Well, now you threw me off, Margaret.
MS. WEIKER: 115, it typically says that you use local codes to -- and they would like the HEIC, the home infusion code set to be adopted.
Request 118 would as well like to see the home infusion coding system adopted as well. Our recommendations on these two, if the qualifier references the HIEC code, will be retained in the implementation guide with the following note.
This code set is not allowed to be used under HIPAA at the time of this writing. The qualifier can only be used if, one, a new rule named the HIEC code -- HIEC as in allowable code set under HIPAA; two, for property and casualty claims encounters that are not covered under HIPAA.
In addition, we are recommending that the National Home Infusion Association is strongly encouraged to attend the -- HCPC's(?) meeting that will be in August that will focus on -- in home infusion in an attempt to have their codes added at the time.
If the code set is still complete after that meeting, then --
DR. COHN: So, your current recommendation is not to recommend that HIEC codes for inclusion in the standard code set and you are basically suggesting that there be some other processes done prior to reevaluation of that.
MS. WEIKER: Yes.
DR. ZUBELDIA: I have a problem with the wording as it reads here in the DSMO response. When the Secretary does not adopt a code set as a standard, such as the NDC for drugs is not -- it is going to be repealed. It is not a standard. Then the industry is free to use that code set as necessary. Even though it is not a standard, it can still be used.
The wording here says this code set is not allowed for use under HIPAA. If the code set for the HIEC has not been adopted by the Secretary as a standard, it will fall back into implementation guide to allow or disallow its use. No?
DR. GRIFFITH: The Secretary adopted for medical procedures and diagnosis certain code sets. Those are the only code sets that can be used. In the case of the NDC, we are retracting any standard for drugs. So, therefore, it falls back to the implementation guide. But as long as a code set is specified for a particular data element and for procedure codes and diagnosis codes, it is, those are the only code sets that can be used.
MR. BLAIR: But it may be it is -- my reaction to what Kepa is saying is that HIPAA may not recognize it, but HIPAA doesn't explicitly say that it is not allowed. Is that what you are getting at?
DR. ZUBELDIA: Yes.
MS. GREENBERG: Well, it isn't -- there is a standard that has been adopted for procedures and you can't use something else. Isn't that what it comes down to?
MR. BLAIR: I think what Kepa was saying was that HIPAA may not recognize it for the HIPAA purposes, but Kepa is saying there are broader purposes than just that. S, it might be more appropriate to wind up saying HIPAA does not recognize it.
DR. ZUBELDIA: The question I have is a little different than that.
MR. BLAIR: I am sorry.
DR. ZUBELDIA: And maybe out of my ignorance. Is the HIEC only procedure codes?
DR. COHN: Yes, it is only procedure codes for home infusion services. It actually includes procedures and drugs -- just procedures. Then the NDC can be affixed on to it. So, I guess the answer here is that there actually is a set of procedure codes that are mentioned in the final rule and this is not one of them.
DR. ZUBELDIA: If it is only procedure codes, it is fine. If there are other things in the HIEC that are not procedures, that would need to be conveyed in home infusion things, that is a different story. And I don't know.
MS. GREENBERG: Well, procedure and materials, I guess, but those are -- HCPCS is named for that.
MS. WEIKER: These are for drugs and materials. It is all procedure codes.
DR. BRAITHWAITE: Another way of saying it is these codes would be used or are intended to be used in the same place as CPT codes and HCPCS codes in a procedure slot, the line item, and HIPAA currently does not allow that. It is not an accepted standard for that particular data field.
DR. FITZMAURICE: Do any of the payers want to have that extra detail that I guess you find in HIEC and there is just not a majority who want them or is it just a code set that doesn't have much use at all?
DR. COHN: I actually can answer that. I think it actually is a code set that actually has substantial use, but I think it is not the time or the place right now for us to second guess this particular decision. My recommendation on this one is I think we need to accept the DSMO response, but I think we also need to indicate to the Secretary that we intend to hold -- and get further into these issues later on this year or the beginning of next to decide whether or not -- I think, Margaret and Maria, you made a couple of very good suggestions and I think certainly later on in the year after the process is done, we need to sort of get into this and sort of see what -- see if there are still holes that exist that need to be dealt with.
So, I think that would probably be our letter to the Secretary in relationship to that. Obviously, we will all be pleased to see how the meetings in August goes.
MS. GREENBERG: The CPT meeting?
DR. COHN: Yes. I guess it was the CPT, HCPCS and HIEC meeting, to talk about home infusion issues.
MS. WARD: That was really the basis for our recommendation to them was that before we adopt an entirely new code set or before we recommend to anybody that that take place, they need to make sure that they have adopted all of the other possible avenues for meeting these codes.
DR. COHN: Okay. Continue.
MS. WARD: Okay. I think Request No. 127 was -- let's see, special program indicators, of which I believe there were a variety. The request was to make these -- the special program indicator data element not used and then to be able to convey that the information using condition codes, which are currently in a different segment of the implementation guides. So, the information can still be conveyed -- conveyed through using an actual data element in the implementation guide --
DR. BRAITHWAITE: Is this an issue where the 837 professional and 837 institutionally are diverging in the way they express this kind of thing?
MS. WARD: If this particular one is, I am not sure.
MS. WEIKER: It is.
DR. BRAITHWAITE: But the professional doesn't have the HI segment method of doing these condition codes.
MS. WEIKER: Well, because, Bill, the NUBC has set up a code list, and external code list.
DR. BRAITHWAITE: And NUCC has not.
MS. WEIKER: There is no external code list for professional or dental clients.
DR. BRAITHWAITE: Is there any requirement for these things to be expressed on a professional claim?
MS. WEIKER: Yes, I believe these are in the 837 professional guide. Yes. And a CON12(?), which would be a unique data element is in the professional guide.
DR. BRAITHWAITE: All right. So, it is a true diversion --
MS. GREENBERG: So, this wasn't -- it is only not used in the institutional guide.
MS. WARD: Correct. Right. The information -- essentially what is happening is the information is being expressed in both guides. it is being expressed through use of the data element in the professional and through use of a condition code, which is an external code set in the institutional --
DR. BRAITHWAITE: Was there any discussion of that issue in the two implementation guides diverging in the way they expressed these kinds of things? Was there any concern about that?
MS. WARD: Yes, there was. There was discussion about that. Some people, yours truly, felt a little -- X12 had also raised several other concerns about expressing data and via external codes versus data elements because then -- and you all will remember we got into the discussion about the data dictionary and defining usages for certain data is able to take place when it is in the guide, but not able to take place when it is being used -- so, there was discussion. I think there was quite a bit of discussion and the real issue here was that the data could be represented two different ways as it stands right now, as an element and as a code.
This is the agreement that the collaborating organizations who were clearly X12 and NUBC, perhaps some of the other -- this is what they agreed to.
DR. BRAITHWAITE: I just wanted to make sure the subcommittee understood what was going on here is that it is a method for sort of compressing the implementation guide to make it a lot easier to express multiple concepts by using an external code set, but it also as a side effect transfers control of what codes are available and what conditions might deal with those codes to the NUBC in this case, rather than through the DSMO and rulemaking process. I just want to make sure everybody understood what is underneath this.
MS. GREENBERG: Also, in this situation where actually this code may be used more on a professional than on an institutional, it has -- it may diverge, as you pointed out. For example, like with newborn birth weight, it was removed in favor of a condition or a value code, I guess, the NUBC, but it isn't collected and it was agreed it wouldn't be collected in the professional.
So, by moving from an element to a value or a condition code, you didn't create a difference between the two guides. In this case, you do, which I mean I guess has its pros and cons. I had a request, which may not be feasible and so tell us if it isn't, but in going through them this way, it is not clear which ones of these were appealed and now this is the result of the appeal process and which ones of these -- this is the agreement that was reached in the original DSMO and then there was no appeal. So, this --
DR. BRAITHWAITE: I don't think that should matter.
MS. GREENBERG: It doesn't matter. Okay. Because we had another document, which I thought was actually quite confusing because it didn't describe what the situation was.
DR. ZUBELDIA: Category A. All of these --
MS. GREENBERG: The only reason it makes any difference to me but I withdraw my request is that this gets back to the issue of contentious. I mean I guess the ones that weren't appealed, everybody agreed in the first place. The ones that were appealed, you know, there was less argument. But, I mean, I guess as long as you have got your bottom line here --
MS. WEIKER: Marjorie, it is the bottom line and when it came down and there was an appeal, when we withdrew and we voted through the appeal, it was unanimous. If something was contentious between two organizations at the beginning of this process, all of that has been worked out. It was agreed to -- yes, maybe we all aren't real happy with it, but when it comes forward to sitting as a group of six and saying this is how -- what we agreed to, we are doing that.
MS. GREENBERG: Okay. That is helpful to know. Thanks.
DR. GRIFFITH: The fast track report that we have available for everybody actually contains the history. So, if you want to look and see which requests were appealed, what the final response is, that information is there.
MS. GREENBERG: Okay. Thanks.
DR. COHN: I sort of am not going to second guess the group at this point. I have mulled over in my own mind the many issues between data elements versus code sets and certainly there is no perfect answer. Probably in this time frame is probably not the time to sort of revisit the whole issue, though.
Certainly, one would observe that if something is in a code set, it is much more amenable to change and there is obviously one -- who has control, but there is also -- knowing the difficulty that we seem to have getting final rules out --
DR. FITZMAURICE: -- with an NPRM.
DR. COHN: It doesn't go through an NPRM. So, there is obviously pro and con --
MS. FYFFE: Music to my ears. Does not have to go through an NPRM.
DR. COHN: It is something to mull over. I don't think that there is a -- I think that is something we are going to have to watch as we move forward. It is just sort of a comment, but -- it is just something to note to make sure that as we all move forward -- to make sure that there is a balance struck in terms of what goes in the code sets versus what becomes a data element.
MS. WARD: And we are very sensitive to the issue. I know that I have some opinions about -- that there are other items in here that -- code set versus element issues. It is just the same --
DR. FITZMAURICE: Maria, could I ask is your opinion that generally things should be in a code set because they are easier to change, so they should be in a standard because it feeds control within the SDO?
MS. WARD: You know, Michael, I don't know that generally I could answer that. I think it depends on what it is you are talking about.
DR. FITZMAURICE: In this particular case then.
MS. WARD: In this particular case, special -- I think that that probably is an -- it is an okay kind of data to be --
DR. FITZMAURICE: So, it ought to be ideally in a code set in both places, the professional and the institutional.
MS. WEIKER: Michael, I am going to interrupt Maria and say if you remember the last testimony whenever that was, I had somebody come in and -- paper claim form and taking the data from the paper claims and putting them into an 837 or taking an 837 and dumping them through a paper claim form and part of what several of the DSMOs that were present, as well as listening on the Internet got the feeling that the committee was like, wow, anything you can make, you know, this cross walking easier would also be beneficial.
If you look at the UB92 paper claim forms, there is no special field or special program indicator code. On a HCFA 1500, there is not just a field. There are multiple fields that they use to indicate what is being indicated in this code value. So, that is another thing that we considered when we looked at the external code set versus --
DR. FITZMAURICE: So, if I can push it, in an ideal world, the UB02 would then have code sets rather than specific variables for special programs, in your ideal world.
MS. GREENBERG: The UB02 will.
DR. ZUBELDIA: Michael, I think there is an issue with code sets and rules. If the code sets are just that, code sets, that would be great, but if the code sets are to incorporate rules as to when this code has to be used and when it is appropriate to use, then you are running into an implementation guide for the code sets. That is a completely different story.
[Multiple discussions.]
MS. WARD: -- and expressing it and a code set does not and Kepa at the last hearing was, I think, the one who brought up -- if a lot of this data were to become not used in the guide, but -- in a code set, that perhaps the code set maintainers need to do something along the lines of what the SDOs have done, which is get some accreditation that says there are processes and procedures in place.
Some people are just concerned that changes to these code lists now are just entirely -- it is a decision of the code set maintainer versus being open to a larger group, such as the DSMO group. But we don't want to have to go through --
DR. COHN: I know it is a tight balance. I actually think -- what I have done is added this to the issue -- I mean, we are not going to solve this problem today and this is one of those sorts of big -- and this is sort of in the medical informatics, you know, this data model, information model, you know, how come everything doesn't work and it is an ongoing issue, but I do think that we need kind of more of a leisure probably to get into these issues -- and maybe there are some principles that we can all agree to.
I actually appreciated your comments about reflecting a little bit on the paper form because I do think that that actually is an important issue that we would like to have as much compatibility during this transition period, which may exist for a long time, as possible between paper and electronic submissions.
So, I really do appreciate that. I mean, one also to be aware of words from Kepa as he tries to talk about -- code sets and data elements and, of course, many of the code sets do have guidelines. So, it does get muckier. I have just observed that there is not even a clear definition there.
DR. ZUBELDIA: Guidelines for use of the codes, but what we are talking about would be specific rules for a specific code. That is a little different.
[Multiple discussions.]
DR. COHN: I just have added this to when we start getting into terminologies and code sets later on in the year, I think we will all be reflecting on this a little bit.
DR. FITZMAURICE: This is helpful to me because it helps sets a basis for going through the rest of these as to when we should be concerned, when we shouldn't be concerned, what is idea and what is not ideal. I don't think all our work is going to be done when we get this finally published and in a real --
DR. COHN: Any other comments about this particular request before we move on? Kathleen? No. Okay.
Why don't we move on then.
MS. WARD: Request 128, this is to pursue some provider information at the service line level of claims. I believe it is the institutional claim particularly. It is situational and the requester wanted it to be marked not used. We are going to change the -- from required when the provider information is different than that carried in the 23 -- is at the claim level versus the detail level to the following language. Required when line level provider information is known to impact adjudication.
DR. BRAITHWAITE: The point here was that hospitals are worried that although they don't use or keep line level provider information now that the provider -- that the payers could force them to do it because it says they have to and this allows them to only do it when it, in fact, affects adjudication as opposed to every time and sort of is a nice compromise.
MS. GREENBERG: It is up to the insurers to inform them that it will affect adjudication.
DR. ZUBELDIA: A technical question I have on this is that so possibly the information at the line level is not supposed to be sent unless it is actually different from the claim level. By removing the required when the provider information is different, it is implying here that it should be sent at the line level when it could impact adjudication, even though it may be the same as the one at the claim level.
DR. BRAITHWAITE: And then that is consistent with the intent of this because, in fact, the provider information at the line level is always different in an institutional claim because it is the individual providers that provide the care and not the institution that provides the care at the line level.
So, this says you only need to do that when it really makes a difference, as opposed to all the time because it is always different.
MS. GREENBERG: Because at the claim level and the -- institution.
DR. ZUBELDIA: But you -- provider at the claim level and not have to repeat the -- provider on every line.
DR. BRAITHWAITE: You understand, though, that the rater and provider is the attending. who never does anything in the hospital. The people who actually do it are somebody else every time. So, this would -- it would mean that the provider identifier, if you followed the institutional guide as it currently stands accurately. But this would have to be added for every single line.
DR. ZUBELDIA: There may be some additional explanation of why this is inconsistent with the rest of the instructions -- in the guides. All the books say use only if it is different and this probably needs some additional explanation as to why to use it even if it is the same.
DR. COHN: What recommendation should we make and to who? It is not a recommendation to HHS.
DR. ZUBELDIA: No. I think it is a recommendation for Maria and Margaret to get back to the SDO
MS. WARD: I have an issue with that and I am going to be very blunt with it. These recommendations were developed by the work group in X12 and there was a variety of people and it was done at the X12 meeting where that work group had practically a hundred people that attended everyday. The -- solution of this type of thing are done or just about finished and I guess if Kepa has an issue that is worrying, that perhaps that should be a comment to the NPRM.
DR. ZUBELDIA: I will take care of it within X12.
DR. COHN: I was going to say maybe we should send Kepa to all X12 meetings. I think he is already there as it is.
Was that Maria or Margaret?
DR. ZUBELDIA: Margaret.
DR. COHN: I think there is an issue here that we need to be very careful. We know that you have gone through a very involved process. So, the intent here is to not try to second guess the modality -- particular issues that need to be brought forward to HHS. I think if we wanted to send something back to X12 -- a separate letter for -- implementation guide but it may be a little late for this implementation guide.
MS. WARD: Margaret's objection, though, is well-taken. It wouldn't be late for the implementation guide if a comment were made to the --
DR. BRAITHWAITE: Also, I should point out for the subcommittee that this is one of those cases where the philosophy of provision and implementation guides -- the provider can fill it out without having any instructions or knowledge about who it is being sent to is not true.
MS. GREENBERG: I know. That is what my point --
DR. BRAITHWAITE: And the SDOs have been incredibly good about trying to maintain that philosophy, but it is virtually impossible in today's world to do that, but they are moving in that direction and I just wanted to point out that the -- is violated by this, but it is one of those cases where --
[Multiple discussions.]
DR. COHN: Who wants to do 139?
MS. WEIKER: That would be Maria.
MS. WARD: Oh, thanks. You give me provider taxonomy.
The request was to remove the taxonomy from the professional implementation guide. I think you all probably remember this is one of the items that had a great deal of discussion in industry through -- where the DSMO landed on this was to change the requirement in the implementation guide from required to situational with a note at that -- that reads -- and I will add that the change is a result of the input that was received through putting this out on the Washington -- work site.
DR. COHN: I know this was a very contentious issue. Is the same issue for institutional also and it is just somewhere else here?
MS. WARD: Yes. It is in separate --
DR. COHN: Okay. Is the answer the same?
MS. WARD: Yes.
DR. COHN: Okay. Well, maybe we should handle both of those at the same time. Do we know off hand what request that is or should we just talk about it since it is the same issue?
MS. WARD: We don't know off hand. But we can find it.
DR. COHN: Request 200, which is for the attending physician, operating physician, other physicians, referring physician, et cetera --
MS. WARD: It is Request 200.
DR. COHN: Is that for the UB92?
MS. WARD: Yes.
DR. COHN: -- for the institutional --
MS. WARD: Yes.
DR. COHN: Okay. So, basically what you are saying is is doing it for that period. I know this is a very contentious issue. I know, Medicaid especially we are little problems with elimination of this. Personally, I think it is a very good solution.
Any comments? Bill commented it is not a perfect world --
DR. FITZMAURICE: The specific point on this one is that the provider has to know -- know whether or not to put the information in.
MS. WEIKER: I think what you are likely going to find is from an implementation perspective is that the payers and providers have this dialogue before they are actually in -- so, it won't -- it shouldn't be, I should say, a -- and it is not just Medicaid payers that need this, which is why at one point -- I know personally that other payers -- not just a Medicaid issue. There are other payers that use it.
So, the answer to you question is, yes, the provider would need to know if he had to sign it, but my expectation would be that that dialogue was --
DR. BRAITHWAITE: I think that is a good resolution to a very, very difficult problem and that will probably change over the years as we move forward, but for now is probably the best.
DR. COHN: Comment about this one? Everybody comfortable with that? Okay.
MS. WEIKER: Request 146 has to do with related -- information. The request was to remove the code for abuse and another party responsible. The code value for abuse, which is AA, will be removed and the code value for another party responsible shall remain.
DR. COHN: Okay. I don't see any comments there. Keep going.
MS. WARD: Request No. 147 was to remove the special programming codes, to remove a variety of codes, Codes 2, 3, 5, 7, 8 and 9, the definitions for which you have in front of you.
The -- response was to put a note that reads "Required for Medicaid only" associated with these codes because it was the Medicaid focus that indicated they needed to be -- the codes are not being removed. They are being --
DR. COHN: They are really the only ones who need this?
MS. WEIKER: According to -- this was posted out on the addenda of research where we could gather information and make sure in any case we are the only ones. This was discussed at the last X12 meeting both in the work group that handles the claim and in an informational form where anybody could come in, you know, and they were the only ones that expressed the need for these codes.
DR. COHN: Okay.
DR. FITZMAURICE: I have seen here the sentence that says some of the codes may violate the privacy rule. Is that possible? If something is required on a claim form, I don't think it violates the privacy rule.
MS. WEIKER: The requestor seemed -- that is part of the actual request.
DR. FITZMAURICE: Thank you.
DR. COHN: Okay. Shall we continue?
MS. WEIKER: Request 148, the order date, it was requested to have this removed from the 837 professional guide and the DSMO response was this will be removed.
DR. BRAITHWAITE: The same is true of -- 9150, I presume?
MS. WEIKER: 149 is -- Request 150 is for the estimated date of birth.
MS. GREENBERG: It was determined that none of these were actually needed by anybody.
MS. WEIKER: That is correct. It is not on a professional claim form (a) and nobody could come up with why they needed them -- retrieved from the actual referral if it is needed. So, we determined that they were not needed as the data elements in the 837.
DR. COHN: Okay. Thank you.
MS. WEIKER: Maria, I will let you do disability.
MS. WARD: Thanks, Margaret.
-- disability begins and disability ends. The request was for claims involving disability and -- not to require -- the recommendation from the -- the note would read "Not required for HIPAA" and then -- the message there is to say that it is not required for HIPAA but it is possible to use for other --
DR. FITZMAURICE: So, that is situational not under HIPAA but under generally a broader use of the 837.
MS. WARD: That is correct.
[Multiple discussions.]
DR. COHN: Any other comments about disability? Okay.
MS. WEIKER: Request 154 is the -- the request was to make this not required. There were no clear industry definitions on what is an emergency. The DSMO response was to clarify the definition. SC109 is to be made situational with the only valid value as a -- indicate it is an emergency and -- is known to be an emergency by the provider and the definition that the DSMO came up with for an emergency was that the patient requires immediate medical intervention as a result of severe life that should be threatening or potentially disabling condition.
DR. COHN: Okay.
MS. GREENBERG: Where did they get that definition?
MS. WEIKER: This is -- actually, this is the NUBC definition of an emergency that is contained in their NUBC manual.
MS. GREENBERG: Okay. So that it didn't come out of thin air.
MS. WEIKER: No, no.
MS. FYFFE: Is this a request that applied only to the institutional claim?
MS. WEIKER: I believe so.
MS. FYFFE: Okay. Well, that makes sense then.
MS. WEIKER: I am going to have to hang up from the phone I am on and go to another one. So, I will be right back in just a minute.
MS. FYFFE: This gets into the quagmire of managed care and reasonable persons and the patient bill of rights. I mean, it is just a very controversial --
[Multiple discussions.]
DR. FITZMAURICE: You think this is needed or not needed?
MS. FYFFE: Oh, I think it is needed, but it is just --
[Multiple discussions.]
DR. ZUBELDIA: Is there ever a case that they need to -- that is not an emergency?
MS. FYFFE: Well, what about urgent care facilities?
DR. COHN: This is, I think, a general -- it is not necessarily being seen in the emergency room, but this was an emergency wherever.
MS. FYFFE: So, it is an emergent case.
DR. COHN: I don't think it relates necessarily to the setting.
MS. GREENBERG: This kind of leaves it to the provider, which is probably the only way you can do it because --
DR. BRAITHWAITE: Well, except the patient bill of rights, he wants to give it to the reasonable person --
DR. FITZMAURICE: I thought it was an emergency --
MS. GREENBERG: That is another -- that was in another way, right, I mean, on the UB92 actually there is a place to capture what the patient thinks was going on.
DR. COHN: And actually usually isn't that the issue, you go to an emergency room and then the question is is it an emergency or not.
DR. BRAITHWAITE: Yes, and the current thinking has been for the last hundred years if you enter an emergency room, it was an emergency, but it turns out that that is just not true. Many people used the emergency room as their primary health care and they know it is not an emergency when they go there. So, that is why they do that.
MS. GREENBERG: But I mean in this particular usage, I guess --
DR. BRAITHWAITE: The provider is probably going to make a judgement that is reasonable for this context.
DR. FITZMAURICE: And who else could dispute it?
[Multiple discussions.]
DR. COHN: Shall we move on to 157? Are you both here or do we just have one?
MS. WARD: -- is to add a layer of the -- the reasoning that they provide here is specific to the -- what they are asking for in the professional guide is to add an lb. or pound qualifier -- in year seven and then to add a note -- the response, I think there was a little cut and paste typo here -- in pounds should be comma and then I am thinking it should have said should be added in accordance with that -- then a note would be required and claimed through counters involving -- medical equipment -- medical necessity.
[Comment off microphone.]
DR. COHN: Margaret is not on the phone and we don't know where to get her right now. I am going to suggest that we try to move through these recommendations in a reasonable fashion -- and then sort of finish up with a couple of minutes on the -- Maria, you are going to assist us with this as we sort of -- is that correct?
MS. WARD: Yes.
DR. COHN: So, 157 I think we have dealt with as this being weights for -- 159 is adding a route to support the designation of assistant surgeon for the dental claim. Is that correct? The issues? Okay.
161 is the values of ethnicity codes. This has to do, I think, with the 835, isn't it?
MS. WARD: 834.
DR. COHN: Okay. The 834. Basically it is just making the ethnicity code values the same as those required by the Federal Government.
DR. ZUBELDIA: Simon, there is a problem with that and that that is that element is a single data element that has one list and you can't go -- with just one single data element. You have to -- from ethnicity. This is a combined place and ethnicity element. There is really no solution that will be in compliance with OMB.
MS. GREENBERG: Well, we made a change but it wasn't in the 4010.
DR. ZUBELDIA: Yes, that is correct.
MS. GREENBERG: We made a change that was supposed to go into the next -- like the 4050 or 4030, but -- that would both use the length required by the Federal Government, which is being maintained by CDC, I believe. There is an external code list, as well as allowing reporting more than one. That was not in the current implementation guide.
DR. ZUBELDIA: But the issue here is that the Secretary will be -- specifically not in compliance with the OMB requirements.
MS. GREENBERG: What you are saying here is they have agreed to add additional codes.
DR. FITZMAURICE: Remember that it is not out of OMB compliance. I mean, it doesn't meet the OMB code set, but it is --
[Multiple discussions.]
DR. COHN: -- and then spend a little more time on the ones that are controversial. I guess 161 -- it doesn't sound like it is -- add additional codes to match and the observation was is that you can't do that.
MS. GREENBERG: Well, you can add the codes, but you can only select one. So, maybe that is why it --
MS. WEIKER: This was basically two-pronged because not all of the ethnicity codes were listed in the guides that were in the X12 standard. The first was the -- okay. Take all the codes that are in the X12 standard and add them to the implementation guide. However, there is the OMB -- code list and, of course, it does not match the code set that is in X12, but in order to use an external code set for that data element, there has to be changes then to the standard. That is the second part.
DR. BRAITHWAITE: Now, the standard has been changed for the 837 to allow the OMB code set.
[Multiple discussions.]
DR. FITZMAURICE: What is the long term solution, to have two variables instead of one variable?
MS. WARD: The long term solution is to have all the --
DR. BRAITHWAITE: -- external code sets indicated by the CDC.
PARTICIPANT: But you already need multiply occurring fields, do you not?
DR. ZUBELDIA: Yes.
MS. GREENBERG: To be consistent with the federal standard, yes.
DR. ZUBELDIA: The new guides will have that.
DR. COHN: Is there an issue now, Kepa?
DR. ZUBELDIA: Just recognize there is a situation with or without --
MS. GREENBERG: I guess it isn't clear to me, but I don't -- as to what additional codes were under 8.3. Not all the additional codes in the external code list for that aren't being added.
MS. WEIKER: Because you can't point to the external code list because DMG05 in the 834 won't allow -- so, the additional codes that are being added are anything that is in the X12 standard, that that data element are going to be added because they all weren't listed.
DR. BRAITHWAITE: And secondarily we will -- to the OMB standard in the next version.
DR. COHN: Okay. 167.
MS. WEIKER: 167 is for response for authorization and there is monetary amount field that maybe added, as well as merging two data elements but -- or eight data elements, but not each situational. So, basically the response was to change the data element requested to situational to come up with the condition statement so that you -- this was a non-controversial item.
DR. COHN: Comments? Okay. Let's move on to 171 then.
MS. WARD: 171 was a request for the 834 and -- again, non-controversial.
DR. COHN: Okay. 172.
MS. WARD: -- the 834 guide where they needed the ability to tie driver IDs together, such as, you know -- and cross reference them. So, they added an additional code value to a -- statement with a note to allow the tie back.
DR. COHN: Okay. 177. This is a -- issue?
MS. WEIKER: There are a number of them. What this is saying here is basically rewording -- for any particular code in the NDA statement I used.
DR. COHN: Any questions, comments? Okay. 178 is anesthesia modifying units, which is -- it is already in CPT and HCPCS, which don't need a special field. Is that right?
MS. WEIKER: Yes. Basically, there was a separate field, a -- statement that was added and it will be removed.
DR. COHN: Okay.
DR. ZUBELDIA: I had a question and maybe more for Simon. The -- modifiers P1 to P5 that were listed in this QTY(?) that has been removed are in the CPT book separate from all the other modifiers. Do you know anything about that?
DR. COHN: I have never heard of P1 through P5.
DR. ZUBELDIA: Physical -- and they are not as modifiers -- so, you look at the HCPCS list of modifiers or CPT list of modifiers, they are not listed. So, by removing this QTY, they either have to be added to the list of modifiers of --
DR. COHN: What you are referring to --
DR. ZUBELDIA: It is not a modifier. It is not a standard code set. So, by removing this QTY, they fall in the crack because they have nowhere else to go. P1 through P5 are used extensively.
MR. BLAIR: Can you help us, Margaret?
MS. WEIKER: It is hard to hear, Kepa. What was Kepa's --
DR. COHN: Kepa was commenting that these modifying units are actually not modifying units. They are the ASA level 1 through 5s.
MS. GREENBERG: So, this is actually -- these are not included in CPT or in HCPCS?
DR. ZUBELDIA: Well, this list in QTY have some CPT modifiers and also P3 to P5. So, there was a combined list. If you remove the QTY, there is no other place to put P3 to P5 or P1 through P5 essentially.
MS. WEIKER: Basically, I think what Kepa is saying is in this QTY, this -- but some of the qualifiers are for -- and some of them are not and if they remove it, the ones that aren't for -- what happens to them. Is that about it?
DR. ZUBELDIA: No, they are actually useful -- it is the P1 through P5 physical strata that the ASA uses.
MS. WEIKER: But P3, P4, P5?
DR. ZUBELDIA: That is correct. Those three.
MS. WEIKER: But not used for anesthesia.
DR. ZUBELDIA: They are used, but --
PARTICIPANT: But they are not modifiers.
DR. COHN: I have been thinking of how to handle this particular issue because I don't have my CPT book in front of me. And I don't have my implementation guide.
DR. ZUBELDIA: That is why the QTY was added to the -- to carry these because they are not modifiers. So, historically they bring the modifiers to the CPT code or carry the QTY separate.
DR. COHN: Is, indeed, the title of this field anesthesia modifying units or is it --
MS. WEIKER: Yes, it is. I have it open to that page, but I don't have a CPT book in front of me.
DR. COHN: We don't have enough information but I guess we need to mark this as an issue that requires further investigation by the Secretary.
MS. FYFFE: Let's defer it and move on.
DR. COHN: Okay. 184.
MS. WARD: Special claims -- the DSMO response is in the segments that carry the final manipulation information. No. 2 be revised to say this is only required in Medicare Part B, chiropractic -- situational.
DR. COHN: Okay. Next one, which is measurement of newborns.
MS. WEIKER: Basically, it was to remove data elements, actually segment. The DSMO response was to have a value code of 54 to report newborn --
DR. COHN: Okay. So, the definition of value code could be four years if it is a low birth weight or --
MS. GREENBERG: No, this is actually in error. I think what it says here, because the NUBC has added value code 54 to actually capture birth weight of all newborn, not just low birth weight newborn.
DR. COHN: So, it is basically -- you put 54 and then you put --
MS. GREENBERG: It says birth weight in grams. The NUBC came up with the terminology. I know it is grams and --
DR. BRAITHWAITE: The word "low" should be stricken from the --
DR. COHN: Well, and basically that it also gives you the newborn weight then.
MS. GREENBERG: The actual weight in grams.
DR. COHN: So, basically, this is -- okay. So, basically, we are fine. This is just a change from a code
-- from a field to a value code. Okay. So, probably the second sentence is in error.
MS. GREENBERG: Oh, well, now it says even given this value code, some parents have expressed the need for newborn weight. Actually, this is just wrong because what they have done is they have added a -- they didn't have a value code for newborn weight. They have added a value code that actually collects newborn weight in grams.
MS. WEIKER: Okay. I will fix this response, Marjorie.
MS. GREENBERG: And the NUBC has language for its use also.
MS. WARD: But it is for a newborn weight, Margaret?
MS. WEIKER: For birth weights.
DR. FITZMAURICE: Is it required for all newborns?
MS. GREENBERG: All newborns.
DR. COHN: 194.
MS. WARD: 194 is a request similar to some of the ones we were talking about earlier.
DR. COHN: So, basically, this is just taking causes codes out?
MS. WARD: Taking causes codes out of the guide, express them in code sets.
MS. WEIKER: And 195 is similar where we are talking about the special program codes that we had in a previous change request in the professional guide.
DR. COHN: Okay. We talked about 200, 202 is remove referring physician. Correct?
MS. WARD: That is correct for the institutional guide.
DR. COHN: For the institutional guide. That makes sense. Okay.
MS. WEIKER: The next one has to do with a date -- the note on the actual qualifier for the date, which says what type of date, what is the format, RDA, which is a range of dates in -- the note on that will be removed and we will leave the note on the actual --
DR. COHN: Okay. 209 is just adding a rough segment with a prior authorization number.
MS. WEIKER: Correct.
DR. COHN: For the dental claim, which is fine.
MS. WEIKER: The attachments, the next -- for the 278 request is to add the PW, the paper work segment. This would allow the referencing of attachments.
DR. COHN: Oh, references of attachment. Okay. I think that is fine even though they don't have the attachment standard yet.
MS. WARD: Margaret, do you know if this requires a DM?
MS. WEIKER: According to what I understand, it doesn't.
MS. WARD: The reason that I asked is because the subsequent May or whatever batch of requests came out and somebody entered this very request for the next version. I questioned the authors of the implementation guide, the co-chairs, whether or not it required a DM and I never got an answer back. If it requires a DM, it can't be done here.
MS. WEIKER: Go on to the next one while I look that one up.
The next one is for 277 and essentially it is to clear up the language in that so that it tells the implementer more specifically what it is that the -- is used for.
DR. COHN: And 216 looks like a similar sort of errata issue.
MS. WEIKER: Yes. Same implementation guide, same problem with the words there in the note.
DR. COHN: Okay. Are you including all the C's in here, too?
MS. WEIKER: No, because the C's follow the SCL process.
DR. COHN: Okay. I just couldn't tell whether the errata was a C or an A.
MS. WARD: I think the distinction here, Simon, was that the error or the language wasn't cause enough for people implementing correctly that we considered it an A.
DR. COHN: Okay. 231.
MS. WEIKER: If you go back to 210, the PW -- segment is in the 278 standard.
DR. COHN: Okay. Thank you.
231.
MS. WEIKER: This is the authorization on revenue codes.
DR. COHN: Okay.
MS. WARD: There is an agreement to do that.
DR. COHN: 234. This allows a space for --
PARTICIPANT: Placeholder.
DR. COHN: 238.
MS. WARD: This is a lot of words to express similar things that I just told you about, the 276, 277 implementation guide.
DR. COHN: Okay.
MS. WARD: It just -- the notes weren't written all that clearly. I actually wrote this request and I co-chair that work group. So, if you want to take my word for it, you can.
DR. COHN: I will take your word for it.
239 is sales tax. 243 is
MS. WEIKER: Pricing and repricing information.
DR. COHN: Okay. So, basically you just added an identifier.
MS. WEIKER: Yes.
DR. COHN: Okay. The next one is the same thing.
MS. WEIKER: Same thing. Two different requests.
DR. COHN: Okay. The next one, 245 --
MS. WARD: It just tells them whether or not they are submitting a home health -- the original or a subsequent -- the HCFA 45, 46, whether it is original or subsequent, which code is used.
DR. ZUBELDIA: Maria, I have a question. The DSMO response says there will be both a Code 1 and a Code 2 for the 485, 486 and for 486 only. I felt that the X12 solution was different from this and there was one code for the 485 and another code for the 486 and there was not a one code combining both.
MS. WARD: I think I heard most of that and you were saying -- I am sorry, Kepa, it is hard to hear you -- that the X12 solution was different than what you are seeing here?
DR. ZUBELDIA: Yes. I remember from the meeting, the X12 solution was different from this.
MS. WEIKER: Well, I don't see where it is different. The X12 solution said you -- if you refer it -- 485 and 486. If you are submitting only 486 data only, use Code Value 2.
DR. ZUBELDIA: That was changed in St. Louis to say use Code Value 1 for a 485 and use Code Value 2 for a 486 and if you are submitting both, repeat the segment twice.
MS. WEIKER: Oh, well --
MS. WARD: I never heard that and my understanding of the 485 and 486 is you -- the 485 always comes first.
DR. ZUBELDIA: That is exactly why they changed it.
DR. COHN: Okay. So, we have marked that and you guys will follow up with that and let us know what the answer is or you work with HHS and have the answer on that.
MS. WARD: I think we need to talk about that. Are we being charged now with going back to X12 to follow up on these or is HHS going to do that?
DR. BRAITHWAITE: The response is the X12 agrees to put an element note. We just have to fix the language so that it says that the X12 note will deal with the problem and then we don't have to worry about it.
MS. WEIKER: And being our response, I think, is high level enough to where it covers it, it is just when we get the request -- I mean, the actual solution obviously changed from what the requester originally put in. So, that would be given to Stanley by X12.
DR. COHN: So, why don't you change the DSMO response. Take out the word "both" and the word "only" in the last fuller phrase, so that it will say designate 485 and 486.
MS. WARD: Okay.
DR. COHN: Then X12 can deal with it.
MS. WEIKER: I think 247 and 8 are duplicates.
DR. COHN: Okay.
MS. WARD: Just add a mammography certification number.
DR. COHN: Okay.
MS. WARD: Saying that will be modified to say that it is required by more than just Medicare.
MS. WEIKER: Right.
DR. COHN: 250 is just wording also on anesthesia.
MS. WARD: -- to correct it.
DR. ZUBELDIA: A comment there is that it is required in a constant, right. All anesthesia claims would have it.
DR. COHN: That is what it says.
DR. ZUBELDIA: So, anesthesia claims will have it. It is a constant -- that is an X12 issue.
MS. WEIKER: We used that statement.
DR. ZUBELDIA: It is an X12 issue. They shouldn't do stuff like that.
DR. COHN: Okay. 253.
MS. WEIKER: 177.
DR. COHN: So, this is basically the same thing. 255 is
MS. WEIKER: It is for purchase services and it is to correct the note.
DR. COHN: Okay. Great. We have got another errata for similar sort of thing, 256.
MS. WARD: 276 is the date --
DR. COHN: It is basically termed a situational.
MS. WEIKER: Right.
DR. COHN: Then 282 we have seen before. It has to do with chiropractic claims.
MS. WEIKER: Right.
DR. COHN: 284.
MS. WEIKER: Allowed some additional code value to be used in the 835 that pertain to pharmacies and were pharmacy related.
DR. COHN: Okay. 287. It says X12 will determine options.
MS. WEIKER: That just means they are going to decide what the best technical solution is. In that narrative there, you have an Option 1, an Option 2 and an Option 3.
DR. COHN: Right, but they are going to do something about determining which is the best solution.
MS. WARD: That is correct.
DR. COHN: Okay. 288.
MS. WEIKER: This request was to add a statement note to exclude claims or encounters for religious, non-medical claims in the hospital, other types, for the principal admitting E codes and patient reason for visits. I believe that Medicare says you can't do this. It is a Medicare rule.
We had to change the note to say don't do this if you are Medicare.
DR. COHN: So, it now says required on all claims and encounters except claims for religious, non-medical claims?
MS. WARD: Right. This is the principal diagnosis code.
DR. COHN: Oh, okay. Got it.
MS. GREENBERG: Isn't required for religious non-medical claims.
MS. TRUDEL: -- because you don't have a diagnosis under those circumstances necessarily. For religious non-medical, you don't necessarily have a diagnosis because the person isn't receiving medical care.
MS. GREENBERG: But Medicare is paying for it?
MS. TRUDEL: It is sort of a successor to Christian Science facilities.
DR. ZUBELDIA: That also means that they cannot be used in those circumstances. Right? The situational requirements in the guides, if it is not required, it cannot be used. Okay? That is the definition of situational.
MS. GREENBERG: So, this lab thing, that means you can't then report a diagnosis?
DR. ZUBELDIA: That is correct. With the wording as is, you can't report diagnosis on labs, on lab claims.
MS. GREENBERG: Doesn't seem like a good --
MS. FYFFE: We have to work on the language on this one, I think.
DR. COHN: I don't think it is us. I think we need to ask X12 to work on the language.
MS. GREENBERG: I don't get where the lab came in.
PARTICIPANT: Hospital --
MS. GREENBERG: No, I know. But if you look above all the whole discussion I heard seems to be about the Christian Science or the religious non-medical.
MS. WEIKER: No, there is in that request, it is like the fourth -- in addition -- 14 did not require clinical diagnosis code.
DR. COHN: Okay. So, basically, you are saying that if it is not required, it can't be used?
DR. ZUBELDIA: That is right. That is the definition of situational. You use it when it is required and you cannot use it unless it is required.
DR. FITZMAURICE: So, a payer would have a bill from a lab and say I don't know whether to pay this or not. I don't know whether it is to diagnose diabetes or not to. So, I am surprised the payers don't want it.
DR. ZUBELDIA: I don't think they understood that.
DR. BRAITHWAITE: This is a non-patient --
DR. FITZMAURICE: It is a hospital other, which is separate from religious.
MS. WARD: I believe that that request was from HCFA, wasn't it?
MS. WEIKER: Yes, it was.
MS. WARD: And that we were trying --
MS. GREENBERG: HCFA doesn't want diagnosis on the lab?
MS. WARD: Those are lab only, diagnostic lab only claims. So, the only charge is on the one part. Institutional bills are just lab charges. So, what we were told was that the diagnosis wasn't required on that.
DR. ZUBELDIA: However, on professional claims, the diagnosis is required.
[Multiple discussions.]
MS. GREENBERG: And nobody else wants it either?
DR. COHN: It doesn't make sense because then how would they know what the -- let me ask you. It is 11:48. We got about four more pages. Can you guys stick around for that or do you --
MS. WEIKER: I will stay on until we get done.
DR. COHN: Okay. Fine. We will continue then.
289.
MS. WEIKER: 289 just adds some additional values for EPSVT(?).
DR. ZUBELDIA: I understand that X12's final solution after the meeting in St. Louis was different from this. You may want to check with them in your DSMO response. Check with John Bart(?) because I think the solution was different.
DR. COHN: -- their responsibility or HHS --
DR. ZUBELDIA: If they are going to report the solution as the X12 recommendation, it should be the X12 recommendation.
MS. WARD: -- Kepa, that is what we were told. But I will double check.
MR. BLAIR: Ask them if it was their final answer.
DR. COHN: We are trying to put the both of you between a rock and a hard place. Kepa is sort of saying -- they changed the word. Okay. So, I guess we are just noting that as a language question.
Now, what about 304?
MS. WARD: 304 was in error in the way we wrote the guide. We allowed for more than one subscriber in each area of the guide where you can identify the -- so, it is saying don't allow that.
DR. COHN: Okay. 316.
MS. WEIKER: This is to allow enrollment based upon a qualified medical court order -- made to allow that.
DR. COHN: 320.
MS. WARD: 320 is to add comments for the purchase service amount for acquisition costs for length of -- claims.
DR. COHN: 348 is a pregnancy indicator.
MS. WEIKER: Right. That discrete data element has been removed and been replaced with a new condition code. This is for the institutional guide and the NUBC has added Code B3.
DR. COHN: Okay. This is just the changing of a field for a data element.
MS. GREENBERG: Data element and the professional guide?
MS. WEIKER: Yes. It is still a discrete data element in the professional guide.
DR. COHN: I think we are fine with that at this point.
349, you are removing things.
DR. BRAITHWAITE: Yes. There is only one NDC. So, they are taking out the alternatives.
MS. WARD: But the IV, should that be there, Margaret, because IV is removed.
MS. WEIKER: The IV will not be removed.
MS. WARD: It will have the note.
MS. WEIKER: It will have the note that was placed in like 115 and 118.
DR. GRIFFITH: So, IV is the -- code, right?
MS. WEIKER: Right.
DR. COHN: So, there will be a note on IV.
MS. WEIKER: Right.
MS. WARD: Same note that we discussed earlier.
DR. COHN: Okay.
350 is the same.
MS. WEIKER: One is for the professional and one is for the institutional.
DR. COHN: Okay. 356 we have seen before.
MS. WEIKER: Yes. It is taxonomy.
DR. COHN: Yes. Comforting. 364 is -- we have seen that before.
DR. ZUBELDIA: I have a question that didn't come up before. It says required -- or DME with -- is this required in all DME things?
DR. BRAITHWAITE: The language in the response is slightly different than what we saw before.
DR. COHN: Did you guys hear the question?
MS. WARD: No.
DR. COHN: The language in 157 is different than the language here. So, we are sort of -- no, it is actually the same language.
DR. BRAITHWAITE: Margaret or somebody said that the language needed to be changed on the 157.
MS. GREENBERG: That should be added or something.
DR. COHN: What was it that was --
MS. GREENBERG: It was supposed to say something like patient weight in pounds should be added or -- there is a verb missing.
DR. COHN: Should be added.
MS. TRUDEL: And then note should read required --
DR. COHN: So, Medicare -- or Medicare equipment will --
DR. ZUBELDIA: But I have a question for Karen or Stanley. Is this required in all DME things?
MS. WARD: That is what the requester indicated.
DR. ZUBELDIA: The patient weight is required in all DME things?
MS. TRUDEL: -- dialysis.
DR. GRIFFITH: The request on 157, currently Medicare requires the patient weight to be reported on some certificates of medical necessity to consider payment on DME items.
DR. ZUBELDIA: But the response from DSMO says that it will be required on all DME claims. And I question that.
DR. COHN: I think that that is something we need to -- both for 157 and for here, we need to alert, I guess, HHS to take a careful look at this. I don't have the answer -- I don't think -- would quite do it.
MS. WARD: So, this needs to go back to X12.
MS. WEIKER: And I believe DHHS.
DR. COHN: Yes. I was looking at Stanley when we were talking about this.
PARTICIPANT: It wasn't requested by us.
DR. COHN: Oh, it wasn't requested by you?
PARTICIPANT: No.
DR. GRIFFITH: We will double check to see if it is required on all --
MS. TRUDEL: I have made a note that in general do we want to ask the DSMO organizations to expand this out to X12 and NCPDP, whatever, and take one last look at it to make sure that anything that got discussed, perhaps, at the -- meeting or whatever is accurately described in here.
DR. FITZMAURICE: They could probably come in later with a letter saying we would like to make the following changes in what we sent you, but I can see this dragging out then for some long time. We are waiting for them. They are waiting for us.
MS. TRUDEL: Margaret, is there a -- or, Kepa, is there a fast way to get X12 to take one last look at this and make sure that everything is accurate?
MS. WEIKER: What I will do, Karen, is I will send it to Gary Beatty(?) and say, Gary, I need you to verify that this is accurate, final, and I will point out the couple that Kepa had mentioned and have him just verify and say I need it back by and you all tell me a date.
DR. COHN: Need it back by --
DR. FITZMAURICE: When do we send the recommendation out to the Secretary?
DR. COHN: -- vote on the thing on Thursday, but I don't think it is reasonable for Gary to look at it in two days and respond.
DR. ZUBELDIA: Most of them are going to be minor technical issues.
DR. COHN: I think what we could do is to probably approve this with -- modifications with a meeting of the Executive Committee in mid-August and we could actually ask the Executive Committee to give final agreement that --
DR. ZUBELDIA: There are a few here that says X12 work group would build appropriate language and we haven't seen that. That could be coming to us in the subsequent letter that says we want to make these corrections and these are the open items that we have.
MS. WEIKER: Well, Kepa, we need to be careful, I think, that technical solution, that is going to be handled through Stanley. I am not going to send you all of the -- guides and then change it so you all can look at it cause I don't think you want to. There would be an -- guide for everything that you would have to go through.
DR. ZUBELDIA: Well, there has been two or three, like 287 says X12N will determine the option.
MS. WEIKER: Right.
DR. ZUBELDIA: We have to know which option.
MS. TRUDEL: Well, the only other possibility then would be that the letter to the Secretary would raise some of these things and say to the extent that we understand the solution, we agree with it, but there are cases where it may need to be more accurately represented or it needs to be more detailed. I mean, either we go on this document that we have or we have to wait.
DR. BRAITHWAITE: Well, in any case, it is going to be the final X12 document, the implementation guide, that gets incorporated by reference into the NPRM. So, that language, whatever it ends up being, will be --
MS. TRUDEL: Right. I think what the subcommittee needs to be concerned about now are the policy issues that you want to go on record about, not whether something is necessarily as well stated as we might --
DR. BRAITHWAITE: If the policy is okay, we don't have to worry about the actual X12 language because that will be put out by the NPRM.
DR. ZUBELDIA: The concern that I have is in cases where there is a discrepancy between the X12 guide that will be part of the NPRM and the recommendations from the DSMO. My purpose in that will be that the DSMO says we will follow X12 recommendation on this. Let's not tie the DSMO down to a solution that could be different from what the guides are saying.
MS. TRUDEL: Well, but this is the DSMO recommendations and they will recommend what they want to recommend. I don't think we are here to edit.
DR. ZUBELDIA: I agree.
DR. COHN: Margaret, I think -- your answer about when we need whatever revisions. What we are going to do is we will take this -- so far with whatever comments we have to the full committee over the next two days. I don't expect that we will have a chance for Gary to review things in the next 48 hours. I think that might be a little much, but what we are going to ask is the ability of the Executive Committee to make -- to be able to forward final modifications that X12 may come forward with.
So, I guess we would ask that Gary do the final review over the next several weeks. Is that what we are --
DR. ZUBELDIA: Yes. Essentially it is in the process that we would recommend this report as is, subject to further modifications from the DSMOs?
DR. COHN: I think that that is sort of what we are talking about, though we haven't made the -- report yet. I think that that -- we will ask the Executive Committee to decide on further modifications and approve them and --
DR. ZUBELDIA: Just get this one moving.
DR. COHN: Yes. Exactly. We are not going to wait on this one until September -- done perfect. I am sure you appreciate that, Margaret.
MS. WEIKER: Yes.
DR. COHN: Let's continue on them through -- let's see, we have got 366, which is an errata --
MS. WEIKER: This has to do with the J codes and the NDC codes. So does 384 -- oh, no. 384 has to do with the name segment. It allows an additional name and we are recommending that that segment be removed.
DR. COHN: Okay. 366 is sort of consistent with the discussions we were having earlier about the fact the --
MS. WEIKER: The J codes and the NDC.
DR. COHN: -- when X12 will come up with the -- so, 384, you are removing name segments.
DR. ZUBELDIA: These are additional names for -- names that are longer than 35 characters have to be split. What this is saying is the names will be limited to 35 positions.
DR. COHN: Okay. 386 has to do with -- it looks like replacement lenses and frames.
MS. WARD: You just need to change the note. The note right now has required all providers to provide this information. Payers are saying that it is not a requirement of theirs. So, X12 will change the note.
DR. COHN: 385 then is a --
MS. WEIKER: It has to do with attachments.
PARTICIPANT: Didn't we do this already?
MS. WARD: It is the same HL7 --
DR. COHN: Okay.
MS. WEIKER: This is to add some condition indicators in regard to condition of the patient.
PARTICIPANT: You are just adding a whole list of codes to define the condition of the patient at the time when attachments are prepared and ready for a 278.
DR. COHN: Interesting list of condition codes, but it is not for me to judge on the -- of those codes.
DR. GRIFFITH: These are actually from the X12 standard. This is another list of codes that was in the standard but not part of the original implementation guide.
DR. COHN: 417.
MS. WEIKER: It is to -- the code values of the 270 and 271. This is eligibility and we are going to -- the code.
MS. GREENBERG: I am a little slow here but this one about the name segment. So, I gather the situation here is that if the name now is more than 35 characters, which particularly a lot of hyphenated names are, you just can't collect it.
DR. ZUBELDIA: No, the problem is not for individual names. It is more for entity names. If you want to spell out Blue Cross and Blue Shield of Washington and Alaska, that is longer than 35 characters.
MS. GREENBERG: This isn't for individual names. Okay. Because particularly in light of the lack of a unique identifier, I don't think it should be -- individual names.
DR. ZUBELDIA: This will only apply if the last name itself is longer than 35 characters.
MS. GREENBERG: Even for individual names.
DR. ZUBELDIA: For individual names. But I don't think that is going to happen.
MS. GREENBERG: The last name.
DR. ZUBELDIA: The last name.
DR. COHN: Okay. Now, shall we take a little time and let's look at the -- since there are not a lot of them and as you commented, these are policy issues.
MS. TRUDEL: Can I make one other point? I notice that the items that were denied during the appeal are not included here and it might be helpful, I think -- I see two or them that might be somewhat controversial that the subcommittee might want to consider, the alternative -- codes and the Medicaid -- payment recovery.
MS. WARD: The Medicaid code standard recovery -- category, Karen?
DR. COHN: Category E?
MS. WEIKER: No, no, no, no. It is not in E.
MS. WARD: The response for 408. If you look at 408.
MS. WEIKER: The Department of Health and Human Services --
MS. WARD: Why don't we go through these?
MR. BLAIR: Could we focus, as Karen has suggested, on the two that are especially of interest?
DR. COHN: Well, let's go through the E's and then handle --
MS. TRUDEL: The E's are the ones that should be considered by HHS.
DR. COHN: Those other issues have not been -- 134 is --
MS. WEIKER: It is to allow the 837 dental to be used for dental predetermination.
MS. WARD: As it stands right now -- would have to use 278 authorization to do a preop or pre-identification for dental services. The dental community has always used a claim. The 837 supports it. Everyone is in agreement that it just needs to be clearly --
DR. COHN: Comments, questions? Everyone is fine with that.
223.
MS. WEIKER: This has to do with the J codes and NDC.
MS. WARD: I think that 223 can be disregarded. I think I said this to you guys a month ago.
DR. COHN: 224 also.
MS. WARD: Right. That was Joanne's and she was basically saying if you are going to make it through NDC, give us a couple more years for J codes. So is 224.
DR. COHN: 228.
MS. WEIKER: That is a correction. The current final rule says to use the NCPDP telecom version 5.1 and the batch version 1.0 for remittance device and payment and it does not handle certain things that you would have on a remittance device. So, the request was to make the 835 -- you all are doing that already.
DR. COHN: So, this is -- we are okay with this one.
347. I will read this one for you. Based on work with a cross section of health care organizations, it is clear that the current sets of codes do not cover all procedures and diagnosis and due to the evolving nature of health codes, there will always be a problem. The problem pertains particularly to certain specialties or emerging areas. We understand that the standards organizations are working to address these issues, which will reduce the scope of the ongoing problem.
Nevertheless, new and evolving procedures and therapies will always raise this concern. We recommend a temporary code that can be used for a fixed period of time with commitment to due diligence and having the procedures or diagnoses added to a code set. This will avoid an -- like the 999 code but at the same time recognize the evolving --
[Multiple discussions.]
-- each code set. They are asking specific subspecialty. X12 -- diagnosis and procedures codes are part of the medical code set as defined by HIPAA. Therefore, neither the DSMOs nor the X12 implementation authors have the ability to include any non-designated medical codes or code sets -- implementation guides.
X12 recommends that the requesters work with the maintainers of the designated medical code sets -- so, this actually is not a recommendation.
[Multiple discussions.]
MS. WARD: I think what we are saying is we don't think that it is within the DSMO or X12's area of responsibility -- at some later point in time we are probably going to have a discussion about the HIEC and other kinds of codes in a general way of saying that.
DR. COHN: Okay. Yes, I am find with that. It is actually not requiring the HHS to do anything. It is more policy --
MS. WARD: Right.
DR. COHN: Okay.
Then 361, isn't that the batch standard 1.1?
MS. TRUDEL: We have taken care of that also.
DR. COHN: Yes. Is there anything else here?
MS. WEIKER: No, that was it.
DR. COHN: Okay. 408.
MS. WEIKER: 408 has to do -- this does not have to do with -- this has to do with Medicaid programs and the confusion of encounter data. Medicaid requires their NCPs to submit electronic files to the contractor and when we discussed this, we believed that it was out of the scope of the HIPAA transactions. An encounter is a transaction from the provider to the payer.
DR. GRIFFITH: We will have an FAQ on the -- in the near future. Basically, this is a question where state Medicaid agencies have their health plans reporting encounters to them. The question is is that a standard transaction as defined in the regulations or not.
DR. COHN: I see. So, this is from managed care plans --
DR. GRIFFITH: To state Medicaid agencies.
DR. COHN: -- to state Medicaid agencies.
MS. GREENBERG: Is it? I think it is.
DR. GRIFFITH: We will come down on the -- I believe we will come down in the final that this is not one of the standard HIPAA transactions.
[Multiple discussions.]
DR. FITZMAURICE: It is not a required transaction by the payer to the --
DR. GRIFFITH: From one plan to another, according to the definition of encounter transaction.
MS. WARD: The definition in the final rules specifically states that it originates with the provider.
PARTICIPANT: But I guess Medicaid can be required to --
MS. WARD: But what -- their position was to change the implementation guide to support a need because it is a HIPAA required transaction and our response was that it is not a HIPAA required transaction. It is not that we can't change the guide and they should go forward and do whatever they need to do, but we won't change 4010.
DR. FITZMAURICE: So, Stan, were you saying that when the plan supplies the information on encounters to the physicians, the providers, that is not a standard transaction but when it goes in reverse it is?
MS. WARD: The definition of a claim or encounter in the final rule in other regulations starts out by saying -- I don't have it in front of me, but it is generated -- sent by a provider to a health plan or maybe -- something like that. But it is specific about the participants in that exchange of data when you define claim or encounter in the regs.
DR. COHN: So, I think we are in agreement about the fact that this is out of the scope.
MS. WARD: Stanley, you said there would be an MBQ?
DR. GRIFFITH: Yes.
MS. WARD: Explain that because there is some confusion in regard to that. Then there is our typical -- Karen, I know you mentioned the appeals that were denied.
MS. TRUDEL: The only two that I thought were really very pertinent were the alternative link codes, which is 137, which I think was handled very nicely in the --
MS. GREENBERG: 347.
MS. TRUDEL: 347. And then No. 296, which was the Medicaid --
MR. BLAIR: Could I ask for some clarification?
MS. GREENBERG: -- said the same thing, kind of.
MR. BLAIR: Margaret, could you please clarify for me because when I read that through this weekend, the word "denial," I wasn't clear whether it was denying the request from alternative link or whether -- because you have the word "uphold." It was apparently originally denied and the upholding would be to uphold the denial. So, if it winds up saying --
MS. WEIKER: You have our categories and then I think 137 was originally a no change, a Category D.
MR. BLAIR: No change meaning --
MS. WEIKER: I believe the submitter appealed this. They appealed the categorization of no change.
MR. BLAIR: No change meaning that --
MS. WEIKER: Meaning we are not changing the guide. We are not adopting --
MR. BLAIR: Alternative codes.
MS. WEIKER: -- code sets. So, the requester appealed that.
MR. BLAIR: And the final --
MS. WEIKER: And the appeal was you need to adopt this. We denied her appeal of changing our original categorization.
MR. BLAIR: Okay. The piece that I was a little confused with was that the description wound up indicating that we lacked detailed information about the codes, about the pricing, all that stuff. I know that, you know, they wound up sending at least to all the members of NCVHS binders with that information. I thought they did to all the SDOs and --
MS. WEIKER: No, they did not. They did not send us anything. You know, we had told them to work with the other code set maintainers and we keep basically getting the same answer is you should just adopt these and we will be glad to supply information and we say supply it and we never get it.
MS. WARD: I think the notes that I have on this particular issue, one of our primary recommendations to them, was that they needed to work in these initially with HCPCS, CPT and if that was not acceptable for whatever reason, then that needed to be done in -- it is sort of along the same principle as just adopting HIEC codes without recommending to the code set maintainers that they, in fact, work with the -- in an effort to just prevent, you know, naming all different kinds of code sets, standard codes under HIPAA.
So, we have no documentation -- discussion that they have had that conversation yet with the other code set maintainers. That was really our first recommendation to them.
MS. WEIKER: When she appealed it, she didn't say, oh, I have gone and done this.
DR. COHN: You know, I think in our cover letter, we maybe need to say that we are aware of the variety of code set developers who would like to have their -- would like to have their code sets -- national mandate in HIPAA code sets and that we are intending to have hearings later on this year to understand better the issues, et cetera, et cetera. I think we have gotten some possible language that might be appropriate for that. In the meantime, we advise
-- we are advising code set maintainers to have further discussions with DSMOs and other mandated or approved code set developers.
I don't think we have enough information right now to approve any new code sets, quite frankly.
MS. WEIKER: I think that is the point, Simon, and if the committee were to make a statement that reinforces what our statement is, which is at a minimum that they have the conversation that the already established main code set maintainers help us understand what happened in that conversation.
If that doesn't work, then we look at something else, but maybe to get that message that at least they need to work with those maintainers first.
DR. COHN: Jeff, are you comfortable with that?
MR. BLAIR: I am comfortable with that. I would just like to understand if I can -- Karen, does HCFA have any view or opinion with respect to alternative billing codes?
MS. TRUDEL: As far as I know, an awful lot of the codes that I have seen in that book may not even be Medicare covered services. I am really not sure. I think that the use of the existing code sets that are well-established is the appropriate way to go.
DR. ZUBELDIA: -- to another similar situation with the physician codes, they have been making a lot of noise lately about how to properly code eyeglasses and the lenses and the surface treatment and the tinting and frames and all that. So, this is going to happen with other concepts.
DR. COHN: -- unless when we talk about next steps -- but I think that there is a hope of -- I think we are so far saying we really don't think -- but we need to look at this area and figure out where the holes are and --
MS. GREENBERG: Is the ground rule for HCPCS codes that it has to be a service covered by Medicare?
MS. TRUDEL: No. It has to be a service that is in use and covered by someone.
MS. GREENBERG: I would assume like with plans that don't -- like managed care or whatever, don't pay by individual items or something. There might be some -- by some equipment or something that doesn't get itemized -- doesn't get paid on an itemized basis but someone might want the information.
MR. BLAIR: At least in my mind, it is a little bit of the chicken or the egg. If there is not a billing code, then sometimes people wind up saying that they can't cover it. On the other hand, there may be some of the alternative procedures, which in fact a payer may view as a less expensive way than dealing with it, than, you know, than other ways, but they don't have any way to, you know, to cover it because there is not a billing code.
The next question then comes in place is whether or not the alternative link ABC codes are the right codes to use to be able to cover those services --
DR. COHN: Now, I am going to suggest because it is almost 12:30 -- now, I -- since it is almost 12:30, I guess I am wondering if we are at a reasonable closing point for this sort of discussion.
Margaret and Maria, if you have any other comments and I think that we are comfortable with -- at what the recommendations are. Obviously, after lunch, what we will be doing is talking about whatever letter we need to be recommending to the committee to affix to these recommendations, as well as other next steps and then we will be moving into some other items.
Are there any words of advice that you have for us or guidance before we take a lunch break?
MS. GREENBERG: Don't call us. We will call you.
MS. WARD: I have a question about some of the dialogue -- regarding whether or not you were actually going to approve this document and then -- or approve it with some kind of a statement that says there will be subsequent modifications. I wasn't clear on where you guys landed with that.
DR. COHN: I think we have to -- and I think we are going to have to come up with some sort of wordsmithing to recognize that this is the document that we have to unfold. We don't have another document. But that you also recognize that there are likely to be further modifications coming forward from X12 and others, probably more along the lines of wordsmithing and sort of technical changes.
DR. GRIFFITH: And perhaps the final addenda that are developed would certainly be in concert with these final DSMO recommendations because what will be in the proposed rule are these addenda. This DSMO report will probably not be in the proposed rule so that the set of changes that finally get recommended -- perhaps the recommendation to the Secretary will be to assure that those addenda match the DSMO recommendations.
DR. COHN: Are consistent with the -- okay. Is that helpful?
MS. WARD: Yes. Would it be fair to suggest that you copy Margaret and myself on that letter?
DR. COHN: Yes. It will be public once we approve it at the NCVHS and I don't see any problem with -- you will get a copy of it very quickly.
MS. WARD: Just so we have it.
DR. COHN: Listen, thank you both very much. I know you have taken a lot of time out of a busy day and vacation days.
MR. BLAIR: Margaret, you are calling in from Hawaii. Is that right?
MS. WEIKER: I am calling in from Hawaii. I have to get back to the beach.
DR. ZUBELDIA: -- denials on the appeals that we have addressed those or --
MS. TRUDEL: I think perhaps after lunch, we might want to discuss 296 just so that you are aware of it, but I don't think we need to do it now.
MS. WARD: As long as HCFA hasn't changed their position on that, I think --
MS. TRUDEL: Right. No, I don't have a problem with it. I just want to make sure that the subcommittee members are aware of it because I think it is a little bit controversial.
MS. WARD: It is extremely controversial, so, I think that is a great idea.
DR. ZUBELDIA: 296.
MS. TRUDEL: We can do that after lunch.
MS. WARD: You don't need us for that.
DR. COHN: Okay. Well, thank you both very much.
With that, shall we take about 45 minutes until 1:15.
[Whereupon, at 12:30 p.m., the meeting was recessed, to reconvene at 1:15 p.m., the same afternoon, Tuesday, June 26, 2001.]
A F T E R N O O N S E S S I O N
DR. COHN: I think what we want to do at this point is to -- we have a draft measure. I think we overall are approving the document for submission or the transmittal date to HHS. We obviously need to come up with a transmittal letter, so the question is, we need to look at the draft we have and figure out what we need to do to modify it, change it or otherwise, knowing that tomorrow is the NCVHS meeting. We're not going to be quite done if we don't have something like this now.
Jeff, would you like me to read you this letter? It says, Dear Secretary Thompson: As part of its responsibility under HIPAA, the NCVHS provides advice to you regarding standard electronic transactions and code sets adopted under HIPAA. NCVHS has recently reviewed its first recommended set of changes to these standards as recommended by the designated standard maintenance organizations. The DSMOs are a set of organizations that have been designated by the Department to modify the standards based on industry input. That is the end of the first paragraph.
The second paragraph -- the good news is this is only two paragraphs long -- this first set of changes was produced by the DSMOs under a fast track process that the NCVHS requested to expedite these changes. This process required the DSMOs to do their review and analysis work in a compressed time frame, so the changes could be made to the standards through the first year after adoption, and what we wrote here was, in time to assist with additional industry implementation.
The DSMO representatives responded to the NCVHS request in extraordinary fashion, devoting substantial time and effort to meeting our deadlines. They are to be highly commended. The NCVHS has also reviewed the DSMO recommendations for changes to the standards. We advise you to accept all of these changes and begin the regulatory process to adopt these changes as part of the standards.
In addition, we urge you to expedite the process so that these changes can be part of the implementation process for health plan, providers and clearinghouses as soon as possible. We recommend the final rule implementing these changes be published no later than January 31, 2002. We appreciate the opportunity to provide you with this advice.
That is what we have right now.
DR. GREENBERG: I think it should be plans, health plans.
DR. COHN: Now, it seems to me that we actually have a number of additional items that came up in our discussion that we should be adding to the letter, I think, that we need to bring up and discuss.
DR. GREENBERG: Does someone have this letter on diskette?
(Simultaneous discussion.)
DR. COHN: It would be nice to be able to do that. Unfortunately we don't have a screen projected out on it, either.
DR. FITZMAURICE: Let's see how extensive the changes are.
DR. COHN: First of all, the change -- and I don't know exactly where this fits in here. Maybe it is after the third paragraph, except for all these changes -- but there is a paragraph that Carolyn and I have worked on, as part of a letter that has to do with code sets, saying that the -- I guess I can pull it out of the computer, but I think we need to make some sort of comment that it became apparent to us that there were a number of code set issues that we will advise those code set developers to work with DSMOs and other code set developers, and the DSMOs will take a look at these issues later on in the year.
DR. FITZMAURICE: I like that paragraph. It lets the Secretary know what we are going to be doing.
DR. COHN: Right.
DR. GREENBERG: This is the HEIC letters?
DR. COHN: Yes. It says, the NCVHS plans to review the DSMO responses -- yes, that's right. The NCVHS also is planning to address broader issues related to code sets and terminologies in late fall or early winter. One topic that we are likely to address are the gaps in the different code sets, and to the extent to which maintainers are working with industry to fill them, something like that. Something like we observed in this list that there appear to be a number of gaps or issues related to code sets and the HIPAA standards. NCVHS is planning to address broader issues. So I think there needs to be a paragraph on that.
DR. FITZMAURICE: Should I mark this up?
DR. GREENBERG: There might be something in this language here, too, on request 347 that they wrote, that you might want to add. I guess the response, here. That I guess had to do with the temporary codes. Maybe it was elsewhere. This is the acknowledgement that the current sets of codes do not cover all procedures and diagnoses.
MS. TRUDEL: There is also the statement in this HIEC letter that says, rather than adopting additional code sets, it is the recommendation that the interested parties continue to collaborate with the maintainers to assure that their needs can be met. That is something that needs to be said, too.
DR. COHN: We are recommending that the code sets as a first step work with the DSMOs and code set maintainers?
MS. TRUDEL: I think that is what the DSMOs say. Perhaps it is just the fact that the committee is endorsing that.
DR. GREENBERG: I think that is important. I think that is an important message both to the new code set developers and the maintainers.
DR. COHN: Now, other things that we need to include in this letter. One is the fact that --
DR. ZUBELDIA: And then you say begin the regulatory process. Then right after that period, I would put something that says that we will continue to receive minor modifications from the DSMOs to make changes before the regulatory process continues, or something like that. So the process should begin now, but before the regulatory process is finished, we will get additional changes.
DR. FITZMAURICE: The interest is going to be though that we have changes from the DSMOs. Then we send another set of recommendations to the Secretary. So we might alert the Secretary that we may have additional recommendations as the DSMOs or as the industry bring them to our attention. But that is what NCVHS can do, is, can make recommendations to the Secretary. But to do it just before the final rule is published is maybe a little bit late in the game. We may not want to say we're going to take all that leeway.
MS. TRUDEL: We could just say, we advise you to accept all of these changes subject to technical modifications or something like that.
(Simultaneous discussion.)
DR. GREENBERG: Technical corrections? In fact, corrections might even be better than modifications.
MS. TRUDEL: Am I adding the additional paragraph here?
DR. COHN: Yes, I think so. Weren't there a number of items that we wanted HHS to pay particular attention to, or is that something that we have the notes?
MS. TRUDEL: I think we have the notes, and we can make sure, especially when we get the addenda or any technical corrections that these issues were addressed.
DR. COHN: I think the Secretary pays special attention to items 148 and 153, 168, 174. Other things that need to be in a letter like this?
DR. FITZMAURICE: One minor wordsmith. That is, based on industry requests, it might be better to make that --
DR. ZUBELDIA: When you read it, you said input, based on industry input.
MS. TRUDEL: Input that is supposed to be, instead of request?
DR. BLAIR: We clearly don't have a history in Health and Human Services, but my thought is that as Secretary of Health and Human Services, the recommendations that we send to him should be significant issues and changes where he needs to make changes. A letter like this, I think maybe the bottom line as far as he is concerned is that the process is being run well, managed well, corrections are being made as we go along, and he doesn't need to worry about it, in terms of these activities.
MS. TRUDEL: Jeff, would you like to add that to - DR. BLAIR: I don't know.
DR. ZUBELDIA: And they need also to somehow express the concept that all of these changes are not imposing new requirements, but are removing requirements to facilitate implementation.
(Simultaneous discussion.)
DR. BLAIR: If this viewpoint is correct, then maybe this is more of a status letter than a letter where we are asking him to make recommendations.
DR. GREENBERG: No, because the whole process is supposed to be that the DSMOs make their recommendations to the NCVHS, the NCVHS makes its recommendations as an advisory committee to the Department. Isn't that the case?
DR. COHN: There are really two changes that we need to recommend. One is something at the end of the first sentence, where we talk about the fact that the reason for this fast track process which was to -- it would help ease implementation or something like that. The purpose of the fast track process was to review the transaction standards to assure that --
DR. GREENBERG: Don't you have, in time to assist with initial industry implementation?
DR. MASSEY: This was also the group of changes that supposedly were necessary for compliance.
DR. FYFFE: Consistent with the law and the statute.
DR. BLAIR: We don't want to tie it too closely to that language, because that implies that it will be out in the first year.
DR. COHN: So the first set of changes was produced by the DSMOs in their fast track process that the NCVHS requested to assure that the standards --
DR. ZUBELDIA: I would say to facilitate compliance with the standards.
DR. BLAIR: My thought is a little different, and I don't know again if this is right. My thought is that his focus is on whether we are responding to industry needs in a quick and effective way, as opposed to whether they are complying with us. That is a positive piece that we could offer, that this is a fast track process, it is put in place, it is responding to industry modifications and requirements in a quick way, and we can accept and adopt them.
DR. FITZMAURICE: Suppose you put requested to expedite these changes and assure industry acceptance. The first set of changes that was produced by the process. The NCVHS requested to expedite these changes and to assure industry acceptance.
MS. TRUDEL: I think we are facilitating implementation.
DR. COHN: Yes, this was the first set of changes that were produced by the DSMOs in the fast track process that the NCVHS requested to expedite necessary changes and facilitate implementation, facilitate successful implementation.
Then Jeff had a second issue which was for the amending of the process, which I think you were bringing up.
DR. BLAIR: I am bridging off even the viewpoint that he seems to be projecting of changing the name of HCFA, where it is less of a focus of being an administrator over the process to being an organization that is providing services to the industry. So I am just trying to position that a little bit along with that mind set, which is saying that this is a process which is being responsive to industry needs, to modify the laws, to make it implementable, to modify the regulations.
DR. COHN: So basically you are saying that the DSMO representative responded to the NCVHS requests in extraordinary fashion, devoting substantial time and effort to meet our deadlines. The process is responsive --
DR. BLAIR: To industry needs.
DR. COHN: To industry needs.
DR. GREENBERG: I think we should not lose the sentence, they are to be highly commended.
DR. COHN: Yes, this was in between. Was response to industry needs.
DR. ZUBELDIA: I think we need to put there the word industry consensus.
DR. COHN: Were successful in developing industry consensus.
DR. ZUBELDIA: I would not add anything between those. At the end of the paragraph, as an additional sentence, the process resulted in an industry consensus on the changes.
DR. GREENBERG: How about devoting substantial time and effort to meeting our deadlines and achieving industry consensus?
DR. BLAIR: Karen, you were about to say?
MS. TRUDEL: I was wondering whether the point you were trying to make, Jeff, was a little bit more global than that. Are we saying that this first fast track process validates the DSMO concept in general? Because I don't think that is coming through with the wording we have now.
DR. BLAIR: Correct.
DR. GREENBERG: But it says they are to be highly commended. We can also say something to the effect that this bodes well for this process. Not the fast track process, because I don't think anyone wants that again, but for the whole DSMO process that was put into place for making periodic changes or annual changes.
DR. COHN: I think this bodes well for -- because the DSMO process is an entire change in the management process. But that doesn't quite fit, and I doubt that that seems to Tommy Thompson. Bodes well --
DR. GREENBERG: You're saying the changed management process is not --
DR. BLAIR: Bodes well for the continued function in the changed management process instituted under HIPAA.
DR. FYFFE: Say it again, please?
DR. BLAIR: Bodes well for the changed management process.
DR. GREENBERG: Put into place by the Department?
DR. COHN: It bodes well for the changed --
DR. BLAIR: The changed management process.
DR. MASSEY: Do we have the phrase in there, the concept in there, that the process is responsive to industry needs?
DR. COHN: We did add, in achieving industry consensus, for the response. I think we got that concept. This process bodes well for -- Jeff, say those words again?
DR. BLAIR: For responding to industry needs.
DR. COHN: For responding to industry needs.
DR. MASYS: When you talk about the DSMOs being designated to modify the standards based on industry's request in the first paragraph, you talk about that. Maybe we can play off of that.
DR. GREENBERG: Everybody has to participate in the process. That is what happened.
PARTICIPANT: (Comments off mike.) It bodes well for a changed management process and continues to respond to industry needs.
DR. FYFFE: Yes, that is nice. That continues to respond to industry needs. That's good.
DR. COHN: So basically, the success of this achievement -- or the success of this bodes well.
DR. GREENBERG: I assume when we define industry very broadly, that includes perhaps the consumers of health care, public health, et cetera, because it really has to respond to all -- some people define industry more narrowly.
PARTICIPANT: Industry and user needs.
DR. GREENBERG: And the industry includes the Department. Initially it didn't respond to Medicaid, but it seemed to in the end. So as long as we're not just thinking private sector here.
DR. MASSEY: Maybe the health care system rather than the health industry.
DR. GREENBERG: Health industry needs. Yes, I am more comfortable with adding health in there.
DR. COHN: So should we move on to another item then? Is there anything more on this particular set of issues before we move into the next --
DR. GREENBERG: Karen wanted to brief us, or maybe she did while I was getting my lunch, on the pay and chase issues.
(Simultaneous discussion.)
DR. COHN: Why don't we do pay and chase, and then we'll handle these things next.
DR. MASSEY: The Medicaid state agencies as part of their part of liability will often pay an entire claim, then try and find a primary payor, go after that payor in an attempt to get money refunded to them. In the industry, that is basically considered subrogation, as opposed to coordination of benefits. They felt that that act of subrogation should be considered -- until the coordination of benefits transaction, they should be able to use the 837, the 835, and they have the standard transactions to do that. They requested the X12 make some minor changes to do that.
When we spoke to our Office of General Counsel, it was determined that subrogation was not the same thing as coordination of benefits. Therefore, it was not designated as a HIPAA transaction, and it is not a required standard as of this moment. The changes that they asked for in the 837 that cover subrogation should not be adopted under these set of changes, and they should not be considered required to be used under HIPAA. So our final response back to them was that pay and chase was not a HIPAA standard transaction, that we could in the future issue an NPRM and determine that it be a standard transaction, if the appropriate changes were made to the X12 set of transactions to support that business use.
DR. FITZMAURICE: Can I ask you a question? If the Medicaid agency does the same thing that another health insurance company does, in trying to get the other payors to pay their fair share based upon a contract that they signed, is it called coordination of benefits when a private insurance company does it, but subrogation when Medicaid does it?
DR. MASSEY: The difference is that the Medicaid agency -- subrogation is when the first insurance company pays the entire claim and attempts to get money back from another insurance company. Coordination of benefits is when the primary payor pays their share, forwards the claim on to the secondary payor or tertiary payor, and they each pay their share.
The difference is that under coordination of benefits, all the payments go to the provider. Under subrogation, the payment goes to the first payor in the health insurance plan.
PARTICIPANT: So are you saying in this case, it is better for Medicaid to delay payment and coordinate benefits? This they can't do.
DR. MASSEY: Yes, they are not permitted to do that.
PARTICIPANT: So they are caught in a trap here.
DR. ZUBELDIA: No, they can still do subrogation, and they can chase after the other payors using their own version of the 837. It doesn't have to be a HIPAA standard.
DR. FITZMAURICE: But if they choose to use the 837 to do that, they could.
(Simultaneous discussion.)
DR. MASSEY: The 837 is set up to pay from a plan to a provider, not from a plan to another plan. So those are -- there are some technical changes that need to be made to the 837, and basically 835 is another transaction supported in order for it to be used in subrogation.
My suggestion was that they work with the X12 organization to get the appropriate changes made, and then come back to us and say, there is a set of standards to support this transaction. We are likely to adopt the HIPAA transaction as a required transaction, and here is the way that it can be implemented, or here is the implementation to do that.
DR. COHN: Stan, one question. Does this have any impact on the data elements from the provider?
DR. MASSEY: No.
DR. COHN: Is this a completely a process between a payor and other payors?
DR. MASSEY: Yes, it is among payors.
DR. FITZMAURICE: Is it going to have to take time to work this out, or is this something that can be done pretty quickly?
DR. MASSEY: It is going to take a little bit of time for X12 to work it out.
DR. FITZMAURICE: More time than we want to take here.
DR. MASSEY: Yes. It has not been done. There are changes that need to be made about it, et cetera.
DR. ZUBELDIA: It would be a new standard transaction in HIPAA, more like the 271 roster. It is very similar to a 271 response to an inquiry, but it is still a different transaction.
DR. FYFFE: So it is a new and distinct mutually exclusive transaction.
DR. COHN: Bob, you had some issues?
DR. GERBER: Just small points that came up in the discussion this morning on the requests. In particular, request 191 on the newborn birth weight. I raised the question of the birth weight of Siamese twins that are joined together. Is that dealt with somewhere? It is not as obvious as one person, one week.
PARTICIPANT: How is it being dealt with now?
DR. GERBER: It is being dealt with through some process, but I think it will need to be recognized as an issue somewhere.
DR. GREENBERG: First of all, there are -- although I don't think it is preferred practice -- there are cases where there is not a separate bill for the newborn. If there isn't, it can't be reported, because it can't be reported on the mother's bill.
Also, there are cases where the baby is born en route, in the taxi or something, so they covered that eventuality, I know. If there are multiple births, there would have to be a claim for each birth. So it is un-perfect.
DR. COHN: Well, that kind of solves the problem.
DR. GREENBERG: It is really an NUVC issue, though, because it is a value code. It is an external code. I don't know if that one came up. The others came up, but --
DR. FYFFE: No, that has not come up.
PARTICIPANT: Do they have a code for cloning yet?
DR. GERBER: And 247 and 248 refers to the mammography recertification number. I am guessing that that is the NQSA facility certification number, and if so, will it be clear to everybody else --
DR. GREENBERG: What number are you?
DR. GERBER: Requests 247 and 248, mammography recertification is required for more payors than just Medicare. Is it the facility number, or is it some other number, and is it something that is at least clear to the people who will be leading this.
DR. ZUBELDIA: I think it is clear. The providers have the mammography recertification number for years now. It is being used today on the NSF claims.
DR. GERBER: I know in the FUSA, there is also a facility recertification number, and is that the same number. I'm just saying for my clarification. Also, no doubt some of the FUSA people will wonder if that is what we are talking about.
DR. FYFFE: Who develops the mammography certification number? Who is the originator of that number?
PARTICIPANT: The FDA.
DR. GERBER: That's why I'm asking if it is the same thing, because if the FDA has the responsibility for implementing the mammography place into that, then do they get a form which gives their number, so that you are a certified facility. I am assuming that was what this was. If not, it might be confusing.
DR. FYFFE: I think you bring up a good point. Not to be trite here, the zip codes come from the U.S. Post Office. We have got to find out where this mammography certification number comes from. It should be explicit.
DR. COHN: Other issues? Anything else on this first part? Karen is off writing this letter. I'm going to suggest that we move on to the second issue, which is the industry readiness question. Let me pull out the copy of the recommendations.
DR. GREENBERG: This is the same letter that is in the agenda book, right? It hasn't changed.
DR. COHN: I am passing around the letter. Underneath it are comments from Kathleen Fyffe, Jeff Blair and Kepa. I put them all together for easy reference.
DR. BLAIR: Did we have any opportunity to try to supplement the information received from the testimony with any recent surveys like from Phoenix Consulting, indicating the readiness of the providers on a more general level?
DR. COHN: We actually didn't send any of them around. I guess I would have to defer to those of you who have reviewed various documents, studies, departmental reports, et cetera, as you talk through these issues.
Does everybody have a copy of these recommendations? What I have also done is, there are a few statements that I have copies of that I'll pass around, and then one more that I received today that I just wanted to comment on.
Let me start with the letters for just a second, just to go through them briefly. I think we have seen some of them by e-mail. We have received letters -- first of all, the statement from the state of California, asking for -- indicating their support of a delay of two years after the final rule is published, and identifying the issue of local codes that were a major issue that is causing them to ask for that.
We have also received a letter from AAHP, reaffirming what they said in their testimony, which was asking for a 24-month extension to commence upon the effective date of the last administrative simplification regulation to be adopted. Then I just received today a letter signed by the American Academy of Facial, Plastic and Reconstructive Surgery, American Academy of Virology, a number of provider groups, the American Medical Association, AMGA, American Public Health Services Association, Medicaid directors, Association of American Medical Colleges, College of American Pathologists, Health Insurance Association of America.
It basically was reiterating what AAHP has described, which is a two-year extension.
DR. FYFFE: AAHP's last sentence is, AAHP is asking NCVHS to recommend to the Secretary that the two-year implementation period of the final rule on electronic transactions and code sets should be delayed until final rules have been issued for all of the administrative simplification procedures. So they don't say a two-year delay, they say other things.
Then in another place they recommended a 24-month extension of the deadlines.
DR. COHN: Right. In the letter from this group, --
anyway, it is basically to support the legislation S-836 and HR-1975 to extend the implementation period to two years after all initial administrative simplification rules have been issued, and national identifiers for providers and health plans are available. These bills do not affect the implementation of privacy regulations that went into effect in 2001.
DR. BLAIR: Both of these basically support the association and the resulting legislation.
DR. GREENBERG: I guess as the executive secretary, if we are going to be discussing any of these letters, any member whose organization is a signatory probably has to recuse himself or herself.
DR. COHN: You're probably right. I am a member of the American Medical Association.
DR. GREENBERG: Actually, Kathleen does not represent HIAA, but she is an employee. You are not a officer of the American Medical Association, am I correct?
DR. COHN: No.
DR. GREENBERG: Because generally in the waivers they do make that distinction, what your role is.
DR. FYFFE: When I sit here, I'm a fed and not representing the views of HIAA.
DR. GREENBERG: That's true, but on the other hand, the members still have to follow conflict of interest. You have a waiver, but --
DR. COHN: Maybe just to abbreviate this part of the conversation, my intent was not to have us discuss these letters, but more note that we have received them.
DR. FYFFE: Acknowledge receipt.
DR. COHN: Acknowledge receipt of them. I think this information is pretty familiar to us. We heard much of this in testimony at our last meeting. I at least in my preview of this didn't really find anything new. Hence, I really don't want to spend most of our time discussing this, though we may reflect on it as we look at our letters, which is really the focus of what I want to spend the next while discussing. So that's okay if the people remain at the table. Kathleen, is that okay with you?
DR. FYFFE: That's fine.
DR. BLAIR: The only thing I might add, Simon, is that the Department has been asked to look at S-836, and the letter finds huge problems with the drafting of that. The Department has not taken a position at this point on the delay per se. It basically says that the bill as drafted was impossible and unworkable for a whole list of reasons, including the fact that providers can't become covered in any of these if there are no standards for transactions for them to comply with, and therefore they are not covered in any of these, and therefore they won't comply with the privacy rule. Therefore, the intent, we believe, is that 836 would not affect privacy rule; it essentially guts it.
In addition to which, it does two things to the compliance side of HIPAA, which says first of all, you've got all the rules, and before anybody can comply with them, and HIPAA foresees a sequence of rules coming out over a 10 or 20 year period and this essentially cuts it off. Not only that, but it prevents anybody from having to comply with any type of rule that comes out after that date, because it replaces the compliance paragraph of HIPAA with something that only addresses how it happens today, and doesn't require any compliance with anything that happens after that.
So those are just three examples of what may be huge drafting problems with this rule, and it may need a lot of work before it could --
DR. FYFFE: With S-836 --
DR. BLAIR: The House bill is virtually identical.
DR. FYFFE: Not completely identical, but some language has the same effect.
DR. GREENBERG: This information has been provided to the Congress?
DR. BLAIR: It has.
DR. GREENBERG: Because this is a new development since the last time the subcommittee met.
DR. BLAIR: And we have responded to their request for technical assistance on this bill.
DR. COHN: That could be something that we go more fully in in the update tomorrow to the full committee.
DR. BLAIR: I wasn't planning on it. We are providing that technical assistance to Congress. If you think that will be useful information to all the committee members --
DR. FYFFE: Yes.
DR. COHN: It might be useful, especially since we will be discussing whatever letter we agree on. It might be a useful piece of information.
DR. BLAIR: Could I have a little bit of guidance in terms of a perspective on this? On the one hand, I read in these industry newsletters that only one bill out of fifty that is submitted to Congress ever winds up getting passed into law. Is there any perception or feeling, Bill, that you have about whether there is broad support for S-836 or not?
DR. BRAITHWAITE: There is a lot of activity, but I don't know if that translates into broad support.
DR. COHN: Shall we look through the letter and comment? I already sent this to you, but I think it would be useful to just go through it by section. I just took everybody's comments, I have not tried to modify them into a single document that we all have everybody's comments. What I am going to do is to read paragraph by paragraph and then we'll consider the various comments and see what we want to do with that, if that is okay with everyone.
I sense that most of you thought this was a good at least outline that we can then begin to hang whatever recommendations we want off of this. The draft of June 14 states, on May 31, 2001, the NCVHS Subcommittee on Standards and Security held hearings on the subject of industry readiness related to the administrative simplification of the implementation of the HIPAA regulations.
Testimony was heard from a number of industry representatives and advisory group bodies, including AFEC, Blue Cross Blue Shield Association, MGNA, NCPDP, X12, HL-7, AMA and state Medicaid agencies. From these testimonies as well as less formal industry roundtable discussions, the committee concluded the following.
Now, there are a couple of comments in that first paragraph. One was from Kathleen, when you said, what discussion, question mark. You might want to be more specific here, or omit the words less formal industry roundtable discussions.
DR. FYFFE: At this point, you could change it to say, and letters sent to the committee, the letters that we have just acknowledged earlier this afternoon.
DR. COHN: I guess I had a couple of questions. Number one is, for this list of testifiers, do we want to leave it at that? Did WIDI come and testify? Do we want to add them to our list of testifiers?
DR. GREENBERG: Yes.
DR. FYFFE: I think that it should be modified so that we have a comprehensive list of the testifiers as well as acknowledge receipt of the letters from the Blue Cross Blue Shield Association and also from the AAHP.
DR. COHN: This one letter is from about 40 different organizations. Do you want to list the entire list of organizations?
DR. FYFFE: You can do that, or you can -- I don't know if you need to attach the letter.
DR. ZUBELDIA: You can say from testimonies as well as written testimony and letters.
DR. FYFFE: Right.
DR. COHN: As well as --
DR. ZUBELDIA: Written testimony and letters.
DR. FYFFE: Written testimony and letters.
DR. COHN: Testimonies as well as written testimony?
DR. GREENBERG: Did you get some written testimony? You mean like California? It wasn't provided?
DR. COHN: Was it a letter?
DR. ZUBELDIA: It is a statement.
DR. FYFFE: It is a statement.
DR. COHN: Statements and letters?
DR. FYFFE: Correct, period. The committee concluded the following.
DR. COHN: The committee concluded the following, okay. There was overall agreement that HIPAA standards are necessary and viable. In all the testimony and comments heard by the committee, there was strong support for the administrative simplification provision for HIPAA, and for the efforts of HHS to promulgate the implementing regulations.
In all instances, no negative feedback was perceived. The only concerns voiced were the speed and timeliness of the regulations. Comments? Are you nodding your head?
DR. ZUBELDIA: Well, there was another concern expressed, and that was the time needed for implementation. Everybody was concerned with the regulations not coming out quickly enough, but there was also a concern with the time needed.
DR. COHN: The speed and timing of the regulations and compliance period.
DR. ZUBELDIA: And compliance.
DR. COHN: Do we have compliance period?
DR. GREENBERG: The time allotted for compliance or something like that?
DR. COHN: Bill, can I ask for your help, because obviously we need to come up with whatever it is we decide to put together for the final version. So are we okay with that?
Number two, there was general agreement that all the final rules, including security, claims attachments and national provider and payor identifiers, should be published as soon as possible. The reasons for this position were different for each entity, and included first, the final security rule is necessary to properly implement the final privacy rule. Two, the national provider identifier rule is necessary to allow payors to design replacement claims processing systems that are not dependent on the intelligence currently incorporated into payor assigned provider identifiers. Three, the final attachment rule is needed to provide a significant return on investment for those entities that are already processing most of the other transactions electronically.
We did actually have a couple of comments from Kepa in this one. First of all, on number two, he identified that the payor was one of the identifiers. So he mentioned national provider, payor and employer identifiers. I think we are in agreement with that one.
DR. BLAIR: Do we call it payor identifier or do we call it health plan identifier?
DR. COHN: It hasn't been proposed as the plan identifier in the statute.
DR. BLAIR: So provider identifier, health plan identifier or plan identifier, yes?
DR. GREENBERG: National provider and health plan.
DR. COHN: But you notice that the plan identifier did not seem, at least in the testimony that we heard, to be one of those things that people felt to be necessary for implementation.
DR. GREENBERG: Neither was the employer.
DR. BLAIR: No, the employer was not listed.
DR. FITZMAURICE: But they specifically mention the provider identifier as being key.
DR. BLAIR: Yes.
DR. COHN: Which one?
DR. FITZMAURICE: They specifically mention the provider identifier as being the key one.
DR. BRAITHWAITE: The reason to mention the list at all is to say, these are the ones where there was some rationale for asking for the delay. That was the reason for listing the ones here. I think employer is not --
DR. BLAIR: Not causing a delay.
DR. BRAITHWAITE: If we are agreed that that is the reason for the list, then Simon's modification makes sense. There was agreement for all the final rules, especially including those for security, claims attachments and provider identifiers, then the reasons to address those three.
DR. GREENBERG: The attachment rule, obviously the law allowed it to come out later. So now they are saying though that it doesn't work?
DR. FITZMAURICE: They're saying they want that second.
DR. COHN: There were delays in 1999.
DR. GREENBERG: I know. But it was always allowed to come out after --
DR. COHN: They didn't say they needed standards for birth certificates or exchange of patient information between electronic patient record systems and all the other possible standards that we are expecting over time. These were the ones they focused on because they had some reason to.
DR. FYFFE: Am I going to live that long? I hope so.
DR. GREENBERG: You're going to work that long.
DR. COHN: The changes that Kepa suggested was that the final provider identifier rule is necessary to allow payors to design changes to the placement of claims processing systems.
DR. GREENBERG: That are now dependent? Is that supposed to say, that are now dependent on the intelligence? Changes to or replacement of.
DR. COHN: That are not dependent on the intelligence.
DR. FITZMAURICE: To design systems so that they will not be.
DR. GREENBERG: See, right now it says design replacement claim processing systems that are not dependent, which is right.
DR. FITZMAURICE: But it reads correctly, if you go back to design. To allow them to design systems that are not dependent, because now they currently are.
DR. GREENBERG: Now they currently are dependent on intelligence. The way Kepa changed it, now that parenthetical phrase goes with current claims processing systems, so that isn't true.
DR. COHN: So it is not dependent on --
DR. BLAIR: So they are not.
DR. COHN: So they are not dependent, okay. The third bullet --
DR. FITZMAURICE: I would suggest putting the word myriad after into, because there isn't just one provider number that has this intelligence. Each plan has a different provider number that has different intelligence in it.
DR. COHN: Appropriated to myriad payor assigned identifier numbers?
DR. GREENBERG: It says payor assigned.
DR. COHN: That is an interesting point, and a reason for having these identifiers replaced.
DR. FYFFE: Presumably each payor devises the intelligence that they want.
DR. FITZMAURICE: Tommy Thompson want uniformity. He is going to enforce that on the whole Department for the stuff we do internally. That is the reason I brought it up, is to trigger the uniformity button.
DR. COHN: So incorporating into the myriad payor assigned. What I might actually say here is to the many payors.
DR. GREENBERG: Multiple.
DR. FYFFE: Do you need to edit that to say health claims attachment rule, do we not? Health claims attachments rule.
DR. GREENBERG: Health claims? Not just claims?
DR. FYFFE: According to the statute, it is health claims attachments.
DR. COHN: I figured this was a letter, not a regulation, so we didn't have to be so -- then we had the recommendation, too. The final health claims attachments rule --
DR. FYFFE: Health claims attachment rule.
DR. COHN: -- is needed to, and Kepa took out the rest of the sentence here and replaced it with, increase the number of claims that can be filed electronically to reduce subsequent paperwork.
DR. BLAIR: I like that. I would use process rather than files, though.
DR. COHN: Processed electronically?
DR. BLAIR: Yes.
DR. COHN: Okay. Is everybody okay with our observations? Let's go to the recommendations. Recommendation one, to achieve the desired rapid publication of final rules, the NCVHS recommends that the Secretary play a leadership role in providing for orderly transition to publication. This role could include, one, providing early guidance. The Secretary could provide early guidance to the industry through letters or white papers revealing the direction taken by HHS. For example, a letter or white paper illustrating the size, format and rules for assignment of the national provider identifier could help current entities make progress on system changes before the final rules were issued.
Let me just stop there for a second. Are we okay with that so far?
DR. FYFFE: National provider identifier is singular, right? The national provider identifier.
DR. GREENBERG: Right.
DR. FITZMAURICE: One question on formatting. Providing early guidance has capitals on each word. The next bullet doesn't have capitalization.
DR. GREENBERG: Same with the fourth and fifth.
DR. COHN: Okay. So we're all okay so far? The next one is opposing open-ended delays. We recommend that the Secretary oppose open-ended delays of compliance as being detrimental to the industry, and the possibility of a successful implementation process. It is imperative that we not undermine the current efforts and continue to promote the urgency of working on the implementation standards. The NCVHS observed that a fixed delay up to one year would not result in significant stoppage, and would allow the industry to continue on an orderly implementation schedule. Any delay greater than one year would incur of significant stoppage and disruption. Since most entities in the health care system must comply with the standards to provide the benefits for all, this is a critical point. The Secretary could support legislative efforts in these directions.
DR. GREENBERG: How about because instead of since?
DR. BLAIR: Good strong paragraph.
DR. FYFFE: Since most entities in the health care system must comply? So it should be because.
DR. COHN: Okay. Now we move into the --
DR. BLAIR: Our favorite.
DR. COHN: If a delay is proposed greater than one year, we recommend that it be accompanied by a schedule of interim deliverables/requirements so that the industry continues to move forward towards an orderly and successful implementation.
The comments here -- here is where it gets interesting -- it goes from complete deletion of that section to just taking out the greater than one year. Is that what Kepa did?
DR. ZUBELDIA: Yes.
DR. COHN: I think Jeff also basically --
DR. BLAIR: Same thing as Kepa, take out the one year.
DR. COHN: So basically we have got two people saying that if a delay is proposed, we recommend that it be accompanied by a schedule of deliverables so the industry continues to move forward.
DR. ZUBELDIA: Even a delay of one year.
DR. BLAIR: Or even a delay of six months, any delay at all. Any delay.
DR. FITZMAURICE: Can I ask, what is interim deliverable? Do you mean not wait until all of them are done, but keep coming out with them as we come out with them?
DR. ZUBELDIA: To give you an example of one possibility, it could be a delay of everything except the claim and remittance advice. A delay of one year for all the other transactions, and force people to the schedule for claims and remittance advice. That is an interim deliverable.
DR. FITZMAURICE: So an interim deliverable is a final rule, not in sequence, but all of them at one time.
DR. ZUBELDIA: Yes. It could be something else, but it could be something -- they still are spending one more year scratching their heads saying, oh my gosh, how am I going to do this, but they have to actually do something.
DR. FITZMAURICE: But an interim deliverable is a requirement, it is in the regulation, if it is another standard?
DR. FYFFE: No, he means implement the standards on a schedule.
DR. FITZMAURICE: On a sequential basis, not on an all at one time basis.
DR. GREENBERG: Then some wouldn't be delayed?
DR. ZUBELDIA: Yes.
DR. BRAITHWAITE: Or you mean implement them all and just delay the requirement for the process. Or implement them all, but require that everybody be ready at a certain time, but then give them time beyond that to actually do the training and stuff to make it workable.
DR. BLAIR: Could we go back in sequence? I think that Kepa and I have suggested virtually the same words, if there is any delay, and Kathleen had suggested that we completely scratch this paragraph, which we also have some sentiment for as well.
DR. FYFFE: I defer to Jeff and Kepa on this.
DR. COHN: So you think that one year solves the problem?
DR. FYFFE: Yes. But I do think that the words schedule of interim deliverables/requirements is a vague set of words, and we have to be more explicit about what we mean there. Because I read that and I thought, you know, some soft fluffy things that come out to help people. But if you want something that is going to be in the Federal Register, you can't be soft and fluffy, I don't think.
MS. TRUDEL: We are really talking about interim implementation of the requirements.
DR. BLAIR: Kathleen, if we followed that particular sentence with the example that Kepa just offered and we wanted to say, for example, to explain what that sentence means, essentially what Kepa was winding up saying is that there would not be a delay in the claim attachments and in the claim and remittance, but that other things -- I can't say it as well as you did.
DR. ZUBELDIA: Bill expressed a few more possibilities, like for instance the requirement for people to be ready on a date and to give them more time to put the testing and agreements in place.
There are different examples that we could use in here as examples of interim deliverables.
DR. COHN: How specific do we want to get in our information? Do we want to list three or four examples of possible ways to do this, or --
DR. FITZMAURICE: Does that mean somebody would be in violation if they don't have -- if the trading partner agreement was Signa on a certain date, even though the final rule isn't in place for let's say an attachment? If we are talking about a schedule of interim deliverables, are these deliverables trading partner agreements?
DR. COHN: For those transactions that they are required to file, yes.
DR. FITZMAURICE: That could happen before the final rule would be in effect.
DR. FYFFE: I think we need to give specific examples here. I leave it to you all. You have already mentioned two specific examples.
DR. ZUBELDIA: I think we will have the Secretary to have a few examples for consideration.
MS. TRUDEL: Is the implication that any examples are endorsed by the committee?
DR. FYFFE: So they are not recommendations, they are just examples.
DR. ZUBELDIA: Yes.
DR. FYFFE: I thought, are they talking about proposed regs or are they talking about guidelines or are they talking about if they ask questions of the website. I didn't know what you all were talking about. So we just have to be a little more specific.
DR. FITZMAURICE: Is what we are saying that we want to hold all the rules up until the last final rule is published?
MS. TRUDEL: No, that is not what we're saying in this sentence, though.
DR. BLAIR: With Kepa's suggestion, the word interim I think may not be appropriate any longer. I think what Kepa is suggesting, and I think that most of us are agreeing, is that it be phased implementations, correct?
MS. TRUDEL: If that is what we mean, we have to say that.
DR. BLAIR: Right, but not interim.
DR. GREENBERG: The interim, right. I think of it as a schedule of requirements or a schedule of phased requirements.
DR. BLAIR: And I think it would be very helpful if one of the options -- and I would probably like to see it as the first option -- would be Kepa's suggestion, because on Kepa's suggestion we would retain the current compliance dates for health claims and remittance transactions, correct?
DR. ZUBELDIA: Yes.
DR. BLAIR: And for the privacy regs, I think, is that correct?
DR. ZUBELDIA: Well, they would affect everybody that implements claims, which would be a majority.
DR. BLAIR: Right, and then we might offer something such as six months later would be eligibility and enrollment transactions or something like that. This is as an example. Then maybe you could give a second example where it might show something different.
DR. COHN: Why don't we just reference it with a sentence or two? For example, we recommended that --
DR. ZUBELDIA: Because the sequencing white paper has been flip-flopping lately on how to do the sequencing.
DR. GREENBERG: How about rather than giving examples, just saying something like, the committee would be happy to work with the Department on alternative approaches or something like that.
DR. ZUBELDIA: I'd like to be a little more assertive and give some examples.
DR. GREENBERG: Okay, that's fine.
DR. ZUBELDIA: Bill already has two.
DR. COHN: What was the third one we came up with?
DR. ZUBELDIA: The date of enforcement.
PARTICIPANT: If I may interject one quick point?
DR. COHN: Sure.
PARTICIPANT: In making the recommendations in the earlier examples, whether it was at the roundtable or some other points, about based implementation, it is very close to the idea of staggering the results. So I thought the feedback was very strongly in favor of harmonizing for compliance.
DR. FITZMAURICE: Well, I heard two things. One was that we wanted them all on the same date and then get us two years. I heard other people saying we do not want the delay at all, keep them coming as they come out.
DR. ZUBELDIA: Yes. And I didn't hear anybody saying we want to implement at once like a big bang. They said we want all the rules at once, but that the implementation would not be a big bang implementation.
PARTICIPANT: That is probably true. Then the final compliance date is effectively that, if you are harmonizing on the same date.
DR. FITZMAURICE: I think you have the same compliance date for all the rules, right?
PARTICIPANT: So I just wanted to throw that out there.
DR. FITZMAURICE: We can offer this bullet as a suggestion, not as something we heard, but as a suggestion, if we wanted to become more elaborate and pose different scenarios.
DR. BRAITHWAITE: Is there some way to -- this is the recommendation we heard at the meeting. Is there some way to propose interim deliverables without a phased implementation? What they wanted was, if this particular request in the hearing was, yes, if you do delays, then make sure there are interim deliverables so that people don't just stop working for awhile.
DR. BLAIR: Bill, I think we're vulnerable. If we use the word interim deliverables, what it implies is that they are really not due to a later date, and we are winding up doing something on an interim basis, I think we could effectively accomplish the same thing in terms of schedule adjustments, if we wind up saying that there are phased releases, phased implementation, a schedule. But if we use the word interim, I think we --
DR. BRAITHWAITE: I understand, Jeff, but interim deliverables was the phrase used in the hearing. Rather than us changing the phrase, I am asking the person who pointed out the fact that phased implementation was something that a lot of people recommended against, if only secondarily to getting all the rules out at the same time. I am reaching for some other deliverables that we can talk about adopting.
PARTICIPANT: As an organization, we have talked about a few different things. We still haven't come to a definitive position on what is a good option that doesn't include a phased process, where you are implementing two transactions that are two transactions. But there are some other options that are out there that we have thrown around, like the project manager approach, where you are getting the requirements and you're getting a design and you're doing your budgeting and getting your resources, and you are implementing and you're testing internally, testing externally. Theoretically something like that could be done on a larger scale than mandating that these two transactions are implemented on this date and these two on this date. It allows a little flexibility for people to implement transactions on different orders, if that is what they want to do.
That is just an example, but there have to be other alternatives out there.
DR. BRAITHWAITE: So the one example you have come up with is that everybody has to be ready on a certain date, and then there is more time for actual trading partner implementations.
DR. ZUBELDIA: One thing that a representative from an association mentioned in the hearing is that if he had his druthers, he would still do a sequenced implementation; he would just order the sequence differently. So I think the association was in favor of a sequenced implementation, so I don't see any conflict here.
DR. COHN: I guess the question was what examples do we need. I guess I'm also wondering whether or not we should call them phased -- call them interim or phased. It could be internal testing and external testing by an entity, which really isn't an interim deliverable.
DR. FITZMAURICE: Are these suggested things that we would have industry do? Do they not carry any force of regulation along?
DR. BRAITHWAITE: No, the intent was to in fact write these in the regulation. Otherwise they wouldn't have any effect.
DR. FITZMAURICE: So the sequence of compliance dates with the compliance is not with the final standard, but with the steps that you must take to get to the final standard.
DR. COHN: At least, that is one option.
MS. TRUDEL: If these interim implementation requirements are put in the regulation, is the subcommittee with their one size fits all approach, that it will actually work for everyone? That actually could be enforced and would be efficient, as opposed to counterproductive.
DR. ZUBELDIA: One thing that was pretty clear in the meeting last week in San Francisco is that there is no consensus on the sequence, other than, everybody seems to agree that claims and remittance advice come first, and then everything else is after that. WIDI has made their recommendation, but there wasn't a strong consensus, other than claims and remittance advice come first.
PARTICIPANT: Another issue to consider is that there is no undue regulatory burden that you are placing on providers in this process. A small provider, Monday-Tuesday doctor's office, is that going to be able to create the documentation to prove that they are compliant with this on this date? Or the people that are dependent on vendors? There are some issues that you have to consider there, and how you would measure that.
DR. ZUBELDIA: The discussion here is to lessen the regulatory burden.
PARTICIPANT: Right, and I just wanted to bring that up as you think about the phased or interim deliverable, what is realistic and what is actually workable.
DR. ZUBELDIA: So we wouldn't be replacing any regulatory burden. We would be reducing the burden, if we are talking about an extension.
DR. GERBER: I guess one suggestion would be to not use a modifier for deliverables. We are using deliverables, but we are having trouble in terms of phase versus interim. Deliverables itself can be defined, what they really are.
I agree with one of the issues the gentleman across from me raised, in terms of what those products should look like. I think there would be some cases in which it would be very difficult for a provider to implement efficient and effective pieces if they don't know what the system should look like in the end.
So what should be done, we need to look at what the product will look like somewhere down the road. There may be steps that may need to be modified later, in terms of training, in terms of implementation, in terms of the actual computer systems that are available to do this job. So I think we need to be very careful about these deliverables along the way.
I think it is important to have something that will show that some progress is being made, and people are doing the right steps and setting up the infrastructure needed to accomplish what the product in the end might look like. I think we have to be very careful about what those deliverables should be along the way.
DR. GREENBERG: Just that schedule of requirements. The problem I have with the word deliverables, who is delivering what to whom. I had actually interpreted it as the Department would have a schedule of deliverables for the NPRMs in the final rule.
DR. COHN: So a schedule of compliance.
DR. GREENBERG: It probably wasn't, but -- I'm not saying I was right. So I think the word deliverables -- I would just say a schedule of requirements. I guess if you want to have examples, you can.
DR. ZUBELDIA: I think it would be very useful to have examples, as examples, not as endorsement to do something.
DR. BLAIR: Especially if we say, for example, then we have one, then we say or, and then another example. Then I think it is pretty clear that they are examples.
DR. COHN: I guess the question is, are we getting rid of interim or are we getting rid of phased. We still need to indicate that some of the projects are ongoing, because otherwise people will look at this as, we'll hold this off for five years and we'll have a bunch of requirements in five years.
DR. GREENBERG: But it says orderly and successful, so it sounds like there is a schedule.
DR. MASSEY: We might use the term intermediate requirements on covered entities, to make it clear that we are talking about -- the intention is on plan providers and clearinghouses, not on the Department or anybody else. I like intermediate.
DR. FITZMAURICE: So each intermediate step would have a compliance date. If you don't have it done on that compliance date, you are in violation.
DR. COHN: Are we okay with that?
DR. BLAIR: I still like Marjorie's suggestion of the idea of organized schedule of requirements, something like that, orderly schedule of requirements.
DR. COHN: I know what you mean, Jeff. I read this over a couple of times, and I agree with you, too. But without something to indicate that something is happening along the way --
DR. BLAIR: Do you think the examples might run into that? The examples would wind up indicating that the claims and remittance would go forth unchanged right away, and the others would have to wait.
DR. COHN: I think you still need to use an adjective. The question is, which one you write. Are we basically okay with this one?
DR. FYFFE: Yes.
DR. GREENBERG: Where did it end up?
DR. COHN: I think what we are talking about is, first of all, I think we have a couple of examples. I think the most recent wording -- though we're not going to argue much more about the wording, delay, the schedule, intermediate, the requirements on covered entities. Do you have a comment on this particular issue?
PARTICIPANT: (Comments off mike.)
(Simultaneous discussion.)
DR. ZUBELDIA: What are the examples that we listed so far?
DR. COHN: The examples are doing the claims and remittance advice first, and delaying the other transactions. Another would be having all the transactions ready by a specified date, but allowing additional time for implementation and testing with trading partners. Another would be to implement all the transactions on a specific date, but allow the process to be delayed.
DR. ZUBELDIA: Code sets and identifiers.
DR. COHN: Code sets and/or identifiers. Is everybody comfortable with those? The next one, rapid issuing of identifiers. Delays in issuing identifiers for some subsets of entities in the health care system will cause increased expenses to those who must run parallel systems on the old or new systems simultaneously. The NCVHS recommends that once the system for assigning provider identifiers is ready, identifiers should be issued very rapidly to all providers, so that transition time is limited. Comment?
DR. BRAITHWAITE: The first comment is that this is in opposition to what we proposed. That is, because we have the money to issue Medicare identifiers, we won't have the money to issue identifiers to other providers. This would say, abandon that scheme and do it all at once. So that is a very strong statement that is contrary to what we proposed for identifiers. We have probably got that in the comments as well.
DR. COHN: Of course, this is where provides -- certainly a lot of people have UPINs.
DR. GREENBERG: What did you say?
DR. COHN: I said a lot of people had UPINs.
DR. GREENBERG: That's what I thought you said.
DR. COHN: What I'm saying is, that alone is a large bulk of providers. It doesn't cover everybody.
DR. BRAITHWAITE: This would say, even if you could do all new UPINs, don't. Wait until you can do everybody all at once.
DR. ZUBELDIA: That is what we heard from the association.
DR. COHN: Kathleen, do you have a comment on this one? No.
DR. ZUBELDIA: There is a big mystery with the payor I.D., but I suspect that the payor I.D. will follow the same kind of logic, once it is revealed. The coordination of benefits, we found with the payor I.D. won't work.
DR. COHN: If everyone agrees with what we are saying here, though I am mulling about, there are many, many classes of providers, some of which are easy to identify and some of them which aren't, in terms of definitions. Are we saying that every possible potential provider has to be identified, has to be ready to deliver before we can even start?
DR. GREENBERG: I don't know why you're saying that.
DR. COHN: The person who testified recommended it, so they would not have to run parallel systems that dealt with the old identifiers and the new ones at the same time.
DR. GREENBERG: Wait. For any given provider you wouldn't be using the old and the new.
DR. COHN: We're talking about payors.
DR. GREENBERG: You're talking about systems, okay.
DR. COHN: The payor has to maintain both systems as long as there are providers who continue to use the old numbers. Maybe an answer, I don't know if it solves the problem, but in the first sentence it says, to some subsets of entities in the health care system. We need to get rid of that part, because basically we just talk about delays in issuing identifiers will cause increased expenses, it is best to get them out rapidly.
DR. BRAITHWAITE: The thing that causes increase in expense is not the delay in the identifiers, it is the delay in having everybody switched over. So once you start assigning the identifiers, the cost increases, because then you have two systems in place, and the cost doesn't go down again until everybody is going to be going. So it is the time between the start of the new identifiers and the new enrollment identifiers.
DR. FITZMAURICE: So you have two different identifiers that you have to recognize, whether it is an old or new when it comes into that space.
DR. BLAIR: It almost seems like that is an extremely complex transition issue. I am almost wondering whether we should even begin to try to come up with a solution for that at our level. I think there are going to be many different ways to do that.
DR. ZUBELDIA: Maybe one recommendation to the Secretary is to identify the additional funding for this to take place.
DR. BRAITHWAITE: I think we do that later on.
DR. ZUBELDIA: Particularly on the identifiers, there is no funding. In the first paragraph on this page, we are saying the Secretary could support efforts in these directions. Here, maybe we should say the Secretary should search for funds for this rapid transition to happen.
DR. BRAITHWAITE: Once this case is presented, of course, the only way you can do it is to gather the funding first, and then make it all happen at once, all at the same time.
DR. COHN: As I'm looking through here, the previous bullets and the next bullet fall together. This one is an odd one, sticking out. It either needs to move, or maybe even dropped, which I guess is another issue.
DR. BLAIR: Could I suggest it be dropped? I really don't think we are going to be able to come up with a really good, implementable recommendation for this one.
DR. FITZMAURICE: Actually, what we heard is that the providers are critical, and that the Secretary needs to find money for it.
DR. BLAIR: Yes, but money for what? What is the criteria for spending it?
DR. FITZMAURICE: For the providers so they can get these identifiers.
DR. BLAIR: I guess if it was more clear.
DR. FITZMAURICE: Maybe incorporating this in number two, saying the identifiers are a particular --
DR. COHN: Let's take a look at putting it down in two. Hold that thought, okay?
DR. BLAIR: Okay.
DR. COHN: Let's go on to the next bullet, and we'll come back and look at this one. The last one is flexibility, which really does follow logically after the previous one we were talking about, delays. Realizing that the administrative sub-title of HIPAA requires compliance within 24 months, the NCVHS recommends that the Secretary explore the flexibility available to him for enforcement under Section 1176 of HIPAA, and publish his intent to utilize this flexibility in enforcement to ameliorate industry concerns.
DR. BLAIR: Well said.
DR. COHN: He may do this by monitoring the implementation situation in the industry, in granting criteria based leniency in enforcement as deemed necessary. I think that is actually pretty good.
DR. BLAIR: Yes, excellent.
DR. ZUBELDIA: There was a concern expressed by the AMA and the state Medicaids both that the states will require the providers to be compliant, and even though the Secretary may be lenient in the enforcing of the rules, the states may not.
DR. FYFFE: Such as New Jersey? They don't have the final rules out yet. They have proposed rules.
DR. BLAIR: But that is what the states may decide to do. That is not part of what our responsibility is.
DR. COHN: That is number five, where we are talking about the history of accreditation organizations, and maybe also six. Maybe we can add state into that area if we decide we want to do that.
DR. FITZMAURICE: One thing we can do with this is put a period after 1176 on HIPAA, and not tell him how to do it or when to do it. I don't know that the HIPAA law allows him to determine when he is going to enforce it and when he is not going to enforce it. I think just letting the Secretary know that there is flexibility available, that we heard that he should be flexible on enforcement might be enough to give him a hook to use.
DR. COHN: Just like we had examples above, I think these are actually very reasonable. These will tell the industry how they might go about it.
DR. BRAITHWAITE: And publish his intent. That could be as simple as putting out the enforcement rule.
MS. TRUDEL: I have a question. When we write something to the Secretary, do we normally recommend that you do something, or do we recommend that HHS do something? We are writing to the Secretary, so we can't say we recommend to the Secretary; we should say we recommend that you, or we recommend that the Department.
DR. FITZMAURICE: I think all this requires is to be consistent within the letter. You could say Secretary, you could say HHS.
MS. TRUDEL: The letter is to the Secretary.
DR. COHN: Yes. I think this one is definitely you, or maybe his is okay here, but possibly available to you for enforcement.
DR. GREENBERG: Yes, I was wondering about that, too.
DR. FITZMAURICE: We just don't want the Secretary to be treated as something different than HHS. HHS should do this, but you, Mr. Secretary, should do this.
DR. GREENBERG: Well, the Secretary explore the flexibility available to you. You're writing to him.
DR. FYFFE: Can we please take a five-minute break?
(Brief recess.)
DR. COHN: Recommendation one.
DR. GREENBERG: That was a long one.
DR. COHN: That is a long one. Number two, and we will take a look and see whether identifiers fit in with this one. The committee recognizes that to achieve rapid publication of the final rule, it is essential that the Secretary apply the necessary resources to reaching this goal. This would include the ability to require means for promulgating the rules and implementing the identifiers.
DR. ZUBELDIA: Can we have two paragraphs in number two?
DR. COHN: Sure we can have two paragraphs.
DR. ZUBELDIA: Because this bullet on the identifiers, if you remove the bullet heading, will fit under two as a second paragraph.
DR. COHN: I agree with you that the idea fits well under here. The question is how much -- whether you put all of it under two.
DR. ZUBELDIA: There are two ideas under two. One is the rapid publication of the final rules, and promulgation of the rules, and the second idea is implementing the identifiers. Maybe this bullet needs to move under two on a separate paragraph under two, and have the two ideas in separate paragraphs under two.
MS. TRUDEL: It's going to be that one of the issues gets lost.
DR. COHN: I agree with the idea that it needs to be there. The question is, do we still have the problems that were previously described about the identifier, or does it somehow get ameliorated?
DR. GREENBERG: When you say all providers, that is what concerns me. Someone might -- it could mean all nurses.
DR. COHN: I agree, that should be -- I think to subsets of entities, it is probably unnecessary also. We should say delays in issuing identifiers will cause increased expenses to those who run parallel systems.
DR. GREENBERG: Yes, you could just say that, delays in issuing identifiers will cause increased expenses.
DR. ZUBELDIA: It is not delays in issuing identifiers; it is the time it takes from the day you issue the first identifier until you have got it available for everybody. Maybe not necessarily issued for everybody, but available for everybody. If that time is long -- and that could happen five years from now, you could start issuing identifiers five years from now, but if that transition time is long, it is more expensive than a short transition time.
DR. GREENBERG: You mean from the time you issue the first one to the last one?
DR. ZUBELDIA: Yes, the transition time. So we are really talking about delay in issuing the identifiers. We are talking about how long it takes to issue the identifiers.
DR. FITZMAURICE: Isn't that covered more under number two? Should be issued very rapidly to all providers? In the first one we're talking about delays --
DR. ZUBELDIA: The delay doesn't matter.
DR. GREENBERG: Subsets was an important word.
DR. FITZMAURICE: That's not what we heard, though.
DR. ZUBELDIA: That is what Harry was talking about. As soon as you start issuing identifiers, he wants everybody to have the identifier within three months.
MS. TRUDEL: The other part of that was, they wanted the NPI rule very rapidly also.
DR. ZUBELDIA: So they know what is there.
MS. TRUDEL: So that you know what is there. So I think both sides of it are important. Perhaps if we just said issued expeditiously, so that transition time is limited.
DR. ZUBELDIA: We are still saying issued. Should we say, should be made available to the providers?
MS. TRUDEL: Nobody knows what that means.
DR. FITZMAURICE: I think issue is better. Enumeration, people maybe aren't sure what enumeration means, but they know what issuing is.
DR. COHN: What I am hearing is that the first sentence isn't important, the second sentence is important.
DR. FITZMAURICE: The first sentence in the bullet, we remove them.
DR. COHN: Let me read over what we have here, with some of the all's and whatever removed, since Bill is going to have to revise it. Under two, we are saying the sentences here are fine. We are talking about adding either as a last sentence or as a new paragraph to that section the thing about rapid issuing of identifiers, without how to do rapid issuing of identifiers. Basically, we are saying that delays in issuing identifiers, and then getting rid of the next seven, eight words, will cause increased expenses for those who must run parallel systems to accommodate the old and the new numbering systems simultaneously. The NCVHS recommends that once the system for assigning provide identifiers is ready, identifiers should be issued very rapidly to providers so that the transition time is limited.
Now, Kepa is coming up with an issue right now which we are arguing about, whether -- the issue has to do with delays in issuing the identifiers, or whether it is the issue that once you start turning them out, you should have them completed as quickly as possible. That is really the issue.
DR. BRAITHWAITE: I agree with Kepa. That was the intent of the original paragraph that said delays in issuing the identifiers to some subset, which meant not the delay in starting the identifiers, but the delay between the first person who gets an identifier and the last person who gets an identifier, is the critical time frame.
DR. GREENBERG: Yes, that is why you can't take that out, because that is the point.
MS. TRUDEL: The logical conclusion to that though is, let's just wait a real long time before we even start.
DR. BRAITHWAITE: Exactly. Wait until you can do it fast, but don't do it until you can do it fast. That is what I heard.
DR. FITZMAURICE: But that conflicts with the priority that they gave us. So we hear two things: don't delay and get them out fast.
DR. BRAITHWAITE: And for two different reasons, and we have explicated both.
DR. BLAIR: One of the things that makes me feel a little bit uncomfortable is that the testifiers we heard from did not include HMSIS or the American Medical Informatics Association or CHEM, all of these groups who basically said, don't have any delays. We are writing our letter in response to those people that have asked for delays. I almost felt as if we may have lost a little bit of balance here.
MS. TRUDEL: Yes, but are CHEM and all those organizations covered by the rule?
DR. ZUBELDIA: Yes, they are all vendors.
DR. BLAIR: Vendors and consultants, and HMSIS is also a trade association of management engineers and hospital information, and AMIA is the American Medical Informatics Association.
DR. COHN: But I think this piece here, there is a logic that is hard to escape about, we don't want to run the old and new systems simultaneously. I don't think IMI or anybody else would say just take as long as you want. So I don't think we have to worry about that. I think the question on this one is, what exactly are we trying to say. We want to get them out fast, but is what we want to tell the Secretary, wait a really long time and get them out rapidly, or do we want them out soon and we want them out rapidly. We already said roll them out soon, and there are reasons for that. Here, what we are saying is, we want them out rapidly as soon as they are ready to come out.
DR. BLAIR: So maybe you ought to say, in addition to having them available as soon as possible.
DR. ZUBELDIA: That is where this fits into the part that says the Secretary should have the necessary resources to reaching the goal. That is where it fits.
DR. GREENBERG: It's not so much delays in issuing identifiers. It is a prolonged period during which identifiers are issued. That is too wordy, but that is what you are talking about. DR. COHN: Prolongations in the process of issuing identifiers.
DR. ZUBELDIA: The other thing that has to be somewhat recognized is that providers will continue asking for new identifiers for a long time. They are going to initially receive their own personal identifier, but then entities will keep asking for identifiers for a long time. So I don't know if it is even possible to achieve that three-month issuance time frame that Harry was talking about.
DR. COHN: Prolonging the process of transitioning to a new identifier will cause increased expenses?
DR. ZUBELDIA: I would say prolonging the transition process.
DR. BLAIR: Yes.
DR. BRAITHWAITE: It is the industry that is going through the transition process, and it is the Secretary who is going through the process of assigning the identifiers, is what we are trying to address.
DR. BLAIR: Then use that phrase, the process of assigning identifiers.
DR. GREENBERG: A prolonged process for issuing identifiers will cause increased expenses to those who must run parallel systems?
DR. COHN: Sounds good. Going once, going twice, okay. Up to three.
DR. GREENBERG: And we are putting that down there with two.
DR. COHN: Yes. Actually it is a separate paragraph in two. Then three is, the committee believes that the change process within HHS should be expedited, so that changes in standards that were voted on by the industry and recommended by NCVHS are promulgated in final rules as soon as possible. To assure this process, the NCVHS recommends that the Secretary provide the necessary leadership and resources to have these changes advanced as soon as industry consensus is achieved.
DR. GREENBERG: This is consistent with the other letter?
DR. BLAIR: Yes.
DR. GREENBERG: This is referring to those changes.
DR. BLAIR: Yes.
DR. GREENBERG: Maybe you should say, a separate letter has been sent to you on this subject.
DR. FYFFE: Yes, I think there needs to be a little more specificity here, because the change process -- what is that?
MS. TRUDEL: If we said it in another letter, do we have to say it here?
DR. BRAITHWAITE: The problem is, this is a broad statement about all letters of recommendation from us, not just referencing the one that is about to hit him. So I think this is a broader -- whenever you get one of these, you've got to act on it, not hang around for a year.
DR. COHN: Maybe the HIPAA change process within HHS.
DR. FYFFE: Yes, that's good, the HIPAA change process.
DR. COHN: Should be expedited so that the changes in standards, maybe processes including the privacy rule?
DR. BRAITHWAITE: Well, this was voted on by the industry.
DR. COHN: Oh, that's right, that's right.
DR. FITZMAURICE: Could I just suggest something? The committee believes that HHS should expedite the change process, just to make it more active?
DR. GREENBERG: What?
DR. FITZMAURICE: The committee believes that HHS should expedite the change process, so that the changes in standards that are voted on by the industry and recommended are promulgated in final rules as soon as possible.
DR. FYFFE: Yes, that's good. So the committee believes that HHS --
DR. FITZMAURICE: Should expedite.
DR. FYFFE: -- should expedite the HIPAA change process.
DR. COHN: Number four. We'll read this one over, we'll look at the changes, and then we'll also observe that we have a letter that was sent out from the committee. We'll decide what we want to do on this one. Since the data requirements of the HIPAA standards for electronic claims are not identical to their use in current paper claims forms, the NCVHS recommends that the Secretary ask the NUCC and AUDC to explore ways such as issuing the implementation guide for each paper form to make the data used on paper claim forms compatible with the HIPAA standards.
Now, we got some wordsmithing from Kepa, where he says the data used on paper claim forms the same as that in the HIPAA standards. That was one option.
DR. GREENBERG: It says, and recognizing that the electronic claim format covers a variety of paper forms beyond just the claim?
DR. ZUBELDIA: And then at the end, strike the word claim forms.
DR. GREENBERG: I don't get that.
DR. ZUBELDIA: I think something that could be misinterpreted is that we are recommending that all the data elements from the A-37 included in the paper form. I don't think that is appropriate.
DR. GREENBERG: That isn't appropriate.
DR. ZUBELDIA: If you read this and don't know that the claim form and the A-37 is not the same thing, some could interpret it as all of the A-37 is to fit into the paper claim form.
DR. COHN: That is why I used the word compatible with paper standards.
DR. GREENBERG: I think that is better.
DR. MASSEY: The discussions on this I thought took a slightly different tack. The concern wasn't so much making the data on the electronic forms match the data on the paper form except perhaps for standard code sets, but there are not uniform instructions like in the implementation guide for completing the paper form, and people were interested in getting a uniform set of instructions in the paper form, because the data differed so much.
DR. GREENBERG: That is what this letter says. This says something different than what this letter says.
DR. MASSEY: Yes. That is where I thought the discussions went, as opposed to what this particular paragraph says.
DR. GREENBERG: I thought that the NUVC at least does have an implementation guide.
DR. FYFFE: The NUVC? Yes.
DR. GREENBERG: It does.
DR. FYFFE: Not the NUCC, though.
DR. GREENBERG: It doesn't?
DR. FYFFE: No.
DR. GREENBERG: That was why I was wondering why we were writing the NUVC to tell them to do something that I thought they had.
DR. COHN: Is what they have inconsistent with the HIPAA standards?
DR. GREENBERG: That's a different issue. That is what is in here.
DR. COHN: Let's talk about here first.
DR. GREENBERG: Okay. Can you also change that first since to because?
DR. COHN: I think rather than saying compatible, maybe it is consistent with the HIPAA standards.
DR. ZUBELDIA: That is better.
DR. GREENBERG: So you are not doing something one way and another one another way.
DR. COHN: I actually disagree with what Kepa wrote, because we don't want to get into the bigger aspects.
DR. ZUBELDIA: No, if you say consistent, then it is fine.
DR. FYFFE: Yes, use consistent. That's fine.
DR. COHN: I think the question is as we look at this one, do we want to -- I guess we can think about it later, but at the end of here, we can say that the National Committee is also sending a letter to the NUCC and NUVC on this issue.
DR. GREENBERG: The thing is, do you make it consistent by issuing an implementation guide? Or do you make it consistent by -- you might have to actually make some changes.
DR. FITZMAURICE: Add some variables to the paper product.
DR. COHN: Why don't we finish this letter off, then we'll look at the other letter, then we can reflect back and see if want to also put a sentence in there that we might send them a letter ourselves.
Number five. There was some difference of opinion here. Kathleen felt we should just remove the whole thing.
DR. GREENBERG: Did we hear that? Where did that one come from?
DR. FYFFE: No, where did number five come from?
DR. COHN: That is where we started asking them about -- the discussion we had about the issue of having the Secretary using regulatory authority to grant waivers, et cetera. We heard people saying, oh, no, that won't work because the industry and states and others might decide to enforce this, and we'd have to do it, anyway. That is how I remember the discussion.
DR. BLAIR: How does five read?
DR. COHN: Five reads, it is also recommended that the Secretary work with industry accreditation organizations to delay using HIPAA compliance as part of the accreditation process until the Secretary determines that the organizations have sufficient time to comply.
DR. BLAIR: I don't know that we need this.
DR. GREENBERG: No.
DR. FITZMAURICE: I tend to agree. JCHO don't accredit these people based upon the HIPAA requirements until they tell you to.
DR. GREENBERG: I don't really like it myself.
DR. COHN: Kathleen wanted it out.
DR. BLAIR: I agree with Kathleen.
DR. BLAIR: Simon, is that our last point in the letter?
DR. COHN: That is the last point.
DR. BLAIR: I have one other idea that I thought was missing from the letter, but I don't have a really crisp suggestion for how to edit. So let me just describe the problem, and maybe you can decide whether it should be in there or not.
My thought was that the letter was basically asking the Secretary to start focusing on these things and to consider whether or not to issue some type of relief. The thing is, it never says when. We are in a dynamic situation, and we have seen dramatic changes on the providers side, in terms of their stepping up in terms of their readiness to implement. That is continuing to go on. If we are able to get the security regs and the provide I.D. out anytime within the next three, four, five months, that may change the perceptions and readiness of the industry a lot more.
So I am kind of at a loss to know whether we should recommend that the Secretary try to make those changes now, or if the Secretary feels that the security regs and provide I.D. is going to be out in a few months, then test the water at that time to see what would be appropriate delays and where.
What are your thoughts on this?
DR. FITZMAURICE: It sure would change my views if all that happened in five months.
DR. BLAIR: You don't think that is going to happen? Because if it isn't going to happen --
DR. FITZMAURICE: Not personally.
DR. COHN: You're saying it won't happen in five months?
DR. FITZMAURICE: Jeff talked about having security out, having the provide identifier out. I'm saying that is optimistic, and would increase my esteem for the Department beyond what it already is.
DR. BLAIR: Actually, given your statement, --
DR. FITZMAURICE: It's a personal statement. It is not a statement of policy.
DR. BLAIR: That's okay, but if that would be the assumptions that we are working on, maybe we ought to state our assumptions. If it is not realistic to expect those regs before the end of the year, then maybe we would recommend that those decisions -- that the recommendations that we made in this letter be implemented by September or October.
DR. COHN: I am actually not sure. I am listening. The question is whether or not we can use words like immediate or urgent.
DR. BLAIR: Or the next three to four months.
DR. COHN: I don't think those time frame are very helpful for any of these particular recommendations. We're saying in the next three or four months take a leadership role? No, we're saying, take a leadership role. I don't think we want to say, in the next three months, or you're going to not be flexible in the enforcement. We certainly don't want to tell him in the next three or four months oppose open-ended delays.
Maybe there is a final sentence, or whatever words --
DR. BLAIR: My rationale for suggesting this was based on a different assumption than what Michael just said. Given what Michael said, I'm inclined to wind up saying let's leave it the way it is.
DR. COHN: I think my concerns are a little greater perhaps than the level of -- without having been a party to the whole process here, the people that are involved in doing this are very good people, immensely overworked, competing demands. They need some help. The Secretary needs to devote some attention to this, because otherwise, just talking about it is not going to make things happen.
So it is more dynamic; it is time for some more resources, it is time for some more tension in all of this.
DR. BLAIR: There is one other thing that concerns me, though. I think we have come full circle, withdrawing my suggestion on time frame, okay? But the other thing that concerns me here is just the act of our writing this letter, and this will be a public letter. It is opening the door to recommending that the Secretary delay compliance dates and all. I almost feel like the industry might slow up or delay or accelerate their intentions for delay as a result of our writing the letter.
DR. FITZMAURICE: You want to say the committee is recommending a delay?
DR. BLAIR: I think people could interpret this letter as saying NCVHS is recommending a delay.
DR. GREENBERG: A one-year delay, it kind of looks like. I was on the path that Jeff was. I was wondering if the committee wants to say initially that in fact it would prefer no delay, but in light of what they have heard, if there were going to be a delay, these are all the considerations.
DR. BLAIR: I endorse that phrase. I think that would be very helpful, if we could make that statement.
DR. FITZMAURICE: Nobody wants a delay. People would like to have the system in place and running. I don't want a delay. The reality is that they came in and described a lot of reasons why they thought a delay was in order. We do have, if a delay is proposed, but on the other hand, we have, NCVHS observed a fixed delay, as opposed to, the NCVHS heard that a fixed delay would not result in significant stoppage.
It is as though the committee is recognizing that some delay may be inevitable at this point. That's just the way I read it. That may not be the intent. This wording is such that, at most one year, is what the committee seems to recognize.
DR. COHN: I think it is actually giving me some pause for thought. As I tried to write this review, based on the conversation we had the last time and everything else, I tried to stay relatively neutral regarding a delay or not a delay, but more the characteristics; if there is a delay, let's have it be like this as opposed to like that, and let's make sure that no matter what happens, we don't undermine what is going on, and we need all of this other stuff. Indeed, if this is being interpreted as asking for a delay, I think I have gone too far in the other direction. On the other hand, I'm uncomfortable -- and we have to look at ourselves about whether or not we would be against any delay.
Based on our last conversation, we didn't necessarily want to get into that. I guess what I am wondering is whether we need to look at here -- certainly we have opposed open-ended delays. Realistically, if you are going to Congress, it is hard for me to imagine that anyone is going to go for a one-year delay. Maybe that is what happens at the end of these Congressional processes. But it takes longer to get it through Congress than it does to get the delay.
DR. FYFFE: When I think about the fact that we are a federal advisory committee, and also that we have had hearings and input, I think that in line with what Marjorie and Jeff have mentioned, I think we might be obligated as a federal advisory committee to give our opinion or our advice, and also report what the public has said during open public testimony.
So we have to take a stand whether we agree with the testimony or not, and then we also have to report the themes of the testimony. If we are not comfortable as a subcommittee in speaking for the whole committee, then we have to get the whole committee speak on this and have that documented in a letter to the Secretary.
DR. BLAIR: I think we might be able to do that without too much difficulty. On the first recommendation, you go down to the -- I think it is the second, maybe it was the third one, the one where we wind up indicating that if there is any delay, maybe that is the place. If we could put the phrase that Marjorie selected right in front of that, saying while the committee does not recommend a delay, it recognizes that there is considerable pressure from the industry or from some sectors in the industry for a delay. If the Secretary chooses to respond to those pressures, then here are our recommendations.
DR. COHN: Well, the Secretary isn't going to listen to Congressional issues.
DR. BRAITHWAITE: Yes, the Secretary can't arbitrarily change the compliance dates without an act of Congress. The Secretary could take a position on it, respond to Congressional approval and that sort of thing, if the NCVHS recommended that he take such a position.
DR. FYFFE: So we are advising the Secretary on what his position should be.
DR. GREENBERG: By saying the Secretary could support legislative efforts in these directions, -- maybe that is what you want to do, but it is suggesting that you do that. Without resolving this, I do like the change from -- instead of the NCVHS observed, the NCVHS heard that a fixed delay. Then you are not necessarily agreeing with it; you're just saying you did hear that. Observed kind of sounds like concluded to me.
DR. ZUBELDIA: I would add, or heard from some testifiers.
DR. BLAIR: Yes, some testifiers.
DR. GREENBERG: Because it wasn't universal.
DR. ZUBELDIA: I don't think we heard from the people that don't want a delay.
DR. GREENBERG: No. I think the people who don't want a delay think it could delay things.
DR. COHN: Do we need at this point a comment that we heard from a number of testifiers that are going to a year delay?
DR. FITZMAURICE: We heard both ends of the spectrum. We didn't hear anybody in the middle saying, ease into this, do it now, do it later. No delay, some delay.
DR. BLAIR: What about that phrase that Marjorie suggested?
DR. COHN: Marjorie, what was the phrase that you suggested?
DR. GREENBERG: Jeff said it slightly different, but something to the effect that while the committee would prefer no delay, if there were some delay or something, we feel that these points are critical.
MS. TRUDEL: I think this is the more important recommendation. The way this is phrased now is a recommendation that isn't a recommendation. We don't actually say we propose a delay. This is why, even though we heard some other stuff, we say, well, we oppose open-ended delays, and we really would rather not get into any at all, but if you did. But there is no clear statement that says, this is what the committee thinks about the more important issue that is on the table.
DR. GREENBERG: Right, should there be a delay or shouldn't there.
DR. FYFFE: What is our advice to the Secretary?
DR. FITZMAURICE: One, that he spend resources, take leadership and put things out as fast as you can so that there is no delays. It could be recognized in industry that delay is inevitable, and we recommend that it be --
DR. GREENBERG: May be inevitable.
DR. FITZMAURICE: But assuming that the Secretary has the power to delay --
MS. TRUDEL: We are not necessarily asking him to do something. We are simply informing his decision-making process.
DR. BLAIR: The other piece is that whatever we recommend may go directly to Congress. If Congress interprets this as us recommending a delay, it just --
DR. FITZMAURICE: We heard some people that did not want a delay, and we heard some people that wanted a delay, wanted a two-month delay, a two-year delay, or wanted, get all the standards out and then a two-year delay.
DR. GREENBERG: Which is really the open-ended delay. But you never explicitly said that that is what you mean.
DR. COHN: I guess we had better clarify a little more what we mean by open-ended delays.
DR. GREENBERG: That is what people are sending these letters about, that the proposed bill is about; wait until they are all done. It is my impression the subcommittee really doesn't support that.
DR. ZUBELDIA: I think we need to clarify that. We need to state that, that we consider that an open-ended delay.
DR. GREENBERG: That is an open-ended delay.
DR. BLAIR: Maybe the reason we are having such difficulty being explicit about our recommendation is that we don't have enough information, probably no one has enough information at this point, to explicitly say, this is the piece that should be delayed, and it should be delayed for this much. The next part in the phase should be delayed this much. That work hasn't been done. Maybe our recommendation should be along the lines of, no delay should be announced until it is assessed which transactions will not be ready by which portions of the industry.
PARTICIPANT: Do you think we should capture the idea of further delay? Because this process has been delayed. I think the Secretary needs to know that the process has been delayed. The Secretary is continuing to delay the process. We can't put a date on when new transactions are coming out.
DR. BLAIR: Yes, that is true.
PARTICIPANT: If you want to take a position, I think you should make it clear that the process has been delayed. If the Secretary agrees to a delay, he is agreeing to a further delay.
DR. FYFFE: That is a very good point.
DR. ZUBELDIA: Because actually, the implementation guides have been out since 1988.
DR. GREENBERG: Since what?
DR. ZUBELDIA: The transaction implementation guides have been out since 1998.
DR. GREENBERG: I heard you say 1988.
DR. ZUBELDIA: '98.
PARTICIPANT: I think the draft regs have been written since about that time, too.
DR. COHN: I'm sitting here scratching my head a little bit, because I'm unclear how to proceed. We have got Kathleen leaving in six minutes. Jeff has just lobbed a bombshell in the middle of the table, which I am really trying to stay very far away from.
Let me just try to clarify at least my understanding and see from our HHS staff about it is right or not. First of all, my understanding of our role as an advisory body is not to report what we hear in testimony, but to take our expertise and our knowledge, supplement it by what we hear, and fabricate it into useful recommendations for the Secretary.
DR. GREENBERG: Actually, it is both. It is a combination. Usually a full report from the committee would report on what the committee heard and then what the recommendations are, so findings and -- but you're right, our job is to report it.
DR. COHN: This letter was not meant as a report on four hours of hearings. It was more of a synthesis of recommendations and views and things we heard, filtered by our own experience, only because this is so political, that this is not a discussion of fact anymore, but more what we believe are successful strategies and approaches and whatever. So I hadn't when we put this together felt the need for us to talk about the fact that XYZ didn't want to know delayed implementation, A, B and C said one year, others said two years, but with fixed milestones, and XYZ said two years, but wait until after all the final rules are out. So I guess I need a little bit of guidance based on this discussion. I am hoping we don't have to do that, but it would certainly take a significant amount of revision of this letter, to lay out all the various possibilities we heard.
DR. GREENBERG: You could say opposing open-ended delays including a delay until all the rules have been finalized, something like that. I think being explicit that you are opposing that --
DR. COHN: That is why I say we don't need to lay out all the various options that we heard in hearings.
DR. GREENBERG: I agree. No, no, I certainly wasn't suggesting that.
DR. COHN: I guess the other question is, what do we do about what it is we are recommending or not recommending.
DR. BLAIR: This is a possible solution to our dilemma. I think we all feel very comfortable with a statement of opposing open-ended delays. If we then have another paragraph that says, before any delays are considered, the following assessments of industry needs need to be taken, which haven't occurred yet. They are the things that we have tended to mention, is, which transactions will the industry not be ready for, which code sets will they not be ready for, how much time will they need for these things, is it the whole industry or not. All of those questions really should be answered before any action is taken for a delay.
DR. BRAITHWAITE: That is a delay.
PARTICIPANT: Asking for an assessment, you have just delayed the process another year.
DR. COHN: I guess I am mindful of all of this. Certainly we gave our best shot on this. We are not doing perfect work. I am aware that at our last meeting -- one reason why we are meeting today was that everybody is very painfully aware that we are not going to reach consensus on these issues in relationship to this. The best I thought we could do is to get to our positions. Recognizing also that as I said, the Secretary is not the one making the final decision on this one. We can send a letter to the Congress advising them to think about X, Y and Z before they do a law, but the Secretary doesn't have the opportunity to -- the Secretary can support or not support laws, but we can't advise the Secretary to do X, Y or Z before considering a delay.
I guess I had thought that we all agreed that the whole issue of open-ended delay, which needs to be further defined -- we know what we mean, but we need to define it so the Secretary and others can understand what that is -- we are all definitely against. I had thought that we said we wanted to keep it in here, but that probably a one-year delay would probably not hurt things too bad, that we ought to have some interim deliverables and all of that. I thought we were also saying basically that if there was a delay, it absolutely had to have the interim deliverables, et cetera. We're all right in saying we do not favor a delay or not. I was trying carefully to skirt that issue. But it is really the will of the subcommittee on how we approach this thing.
DR. BLAIR: Maybe if we go back to Kathleen's suggestion, that could reconcile it. I think we agree on all parts of the letter, and Kathleen had indicated that we strike the third item within the first recommendation. Kepa and I had just modified it to say any delay. If that paragraph is deleted, then we don't go down the path of saying, if there is a delay. Maybe all the other items in the letter are okay.
DR. ZUBELDIA: The reality of the delay is being considered in Congress. So I think we need to address it as a possible outcome. I would rather have a recommended solution if that happens than be silent on it.
DR. GREENBERG: If you strike that, you lose this whole idea of -- we couldn't figure out how to phrase it, but these intermediate requirements or interim deliverables -- or whatever.
DR. ZUBELDIA: But I think we need to make a strong statement that says the committee opposes a delay, period.
DR. BLAIR: Yes, I agree.
DR. GREENBERG: Well, that is the question.
DR. FYFFE: Yes. Again, the letter should state what our position is, what our counsel or advice is to the Secretary, and then also report what the industry has said, because we had all those hearings, in an open public process. That needs to be documented in the letter.
DR. BLAIR: I think Marjorie has said it, Kepa said it, and I certainly agree. I think we have to have a definitive statement saying that the committee does not support a delay at this time.
DR. FYFFE: We might actually say that the committee does not support any further delay.
DR. BLAIR: Okay, any further delays.
DR. FYFFE: Let me ask Bill, does the Secretary understand that there has been tremendous delay already since this law was signed in 1996?
DR. BRAITHWAITE: I don't know.
DR. BLAIR: I agree with Kathleen, to have the phrase does not support any further delays.
DR. ZUBELDIA: Going with what Simon said our role is, we can say, we have heard requests for a delay, and after hearing these requests for a delay, the committee does not support a delay.
DR. BLAIR: Or additional delays.
DR. ZUBELDIA: We can report that we heard the requests, but we did not recommend it.
DR. COHN: We could in fact change that paragraph. It is currently saying proposing open-ended delays to say, proposing delays, and say that while the committee has heard requests for delays from a variety of many stakeholders, the committee did not recommend any delay. In addition, we recommend that the Secretary propose open-ended delays such as that found in 836, and then the rest of that paragraph.
MS. TRUDEL: Do we want to say the committee particularly opposes?
DR. BLAIR: Yes.
DR. GREENBERG: I kind of like that. The committee is saying, we don't support a delay, and we particularly oppose an open-ended delay.
DR. BLAIR: Yes.
DR. ZUBELDIA: That is a clear statement.
PARTICIPANT: Are we saying here that we heard from a number of industry sources that asked for a delay?
DR. GREENBERG: Yes, we have to say that.
PARTICIPANT: Is it necessary for the committee to put in a rationale for opposing a delay?
DR. GREENBERG: We also heard from people who didn't support a delay.
DR. BLAIR: I think the way you phrased it, we have heard from a number of industry sources that asked for a delay.
DR. ZUBELDIA: Or we heard from a number of industry sources, including those that asked for a delay.
DR. GREENBERG: That is a little different.
DR. BRAITHWAITE: We could say that we heard from sources that have opposed it and from those that did not have a delay.
DR. COHN: I realize we do not have a real quorum, but we're just drafting a letter, so it is probably okay. I heard that three or four of us are obviously supportive of the piece that you are describing. I'm just trying to think about what the letter is going to look like, and also trying to think of whether we are opening up what I would describe as a hornet's nest.
DR. ZUBELDIA: If there is a delay, there has to be specific use of that time, and the specific use is to help in complying with the law, because right now the delay is without specifying what is it we do with that extra time.
In fact, this same issue came up in the previous meeting last week, to consider the impact of a delay in the implementation schedule, by moving the entire schedule up by one year, we didn't find anything to be done in that additional year, nothing. No deliverables, no progress, absolutely nothing.
DR. GREENBERG: You could just take a deep breath and let everyone take their vacation time.
DR. ZUBELDIA: One more year to scratch our head.
DR. COHN: Kepa, I absolutely agree with what you're saying. That was why we were targeting an amended implementation. Let me ask everybody else at the table also, it was really more of an issue of -- I was walking into this saying, gee, a delay if it was used constructively, it could help ease the implementation burden and ease implementation, maybe not the worst of all possible worlds. It might not even necessarily be a bad thing.
Obviously, I am hearing from both of you that now we need to move forward. Maybe I'm just reading it without having looked at the letter.
DR. GREENBERG: I don't think they're saying that.
DR. ZUBELDIA: I'm not saying under no circumstances would it be appropriate. I realize that a delay if used constructively could be real appropriate. But a delay under the circumstances that are being proposed now, I don't think it is justified.
DR. GREENBERG: I think the Secretary is facing a bill that recommends this wait until everything is out there. If you get too subtle -- because people didn't see here and go through DSMO request 136; they're not into that. If they get too subtle either with the Secretary or with the industry, it just sounds like the committee is recommending a delay.
Maybe this is sort of subtle, but by saying you are not supporting a delay, no delay has been proposed by -- you have thought of ways in which it could be used constructively, but no delay has been proposed by either the Congress or any of the testifiers that we are ready to support. If there were a delay, you would particularly oppose. So to say that we don't support a delay, because there is no delay that has been proposed that you support, if that is the case, and then you say you particularly oppose open-ended delay, and then say if there were a delay, it would be necessary to any delay to -- I think that follows logically.
DR. ZUBELDIA: If there was a delay with a specific proposal, like they don't solve the four solutions as they all apply, or options or examples. I would say well, yes, maybe that helps. But right now there is no consensus as to -- nothing.
DR. GREENBERG: You don't want to put your head in the sand and say, no delay no matter what. Full steam ahead, but there is an iceberg there, forget it.
MS. TRUDEL: I think Marjorie's point is, we haven't heard a proposal for a delay that you think we support. We especially don't like an open-ended one. In order for a delay to be beneficial and actually do something productive, we think these are the things that the proposal would have to include.
(Simultaneous discussion.)
DR. GREENBERG: Yes, that is where I was trying to go.
DR. BLAIR: One thing that is helpful, Simon, is, I am very gratified with the unanimity that is expressed around the table right now. At least we don't have a split committee. We all seem to be saying the same thing.
DR. COHN: That is why I'm giving you the eye. You can't see me doing that. I would venture that that is exactly the case. I think that many of the issues -- we have to see how this part turns out. If we do this right, I think you are probably right. This gets into an issue that is very controversial. Knowing how difficult it is to get consensus or even a majority consensus in the committee, I was trying to steer us away from the bull in the china shop. But I think we are going to have to handle it in one way or another.
DR. GREENBERG: Is Clem not going to be at this meeting at all?
DR. COHN: Clem is not going to be here.
DR. GREENBERG: In all honesty, I don't know how John feels about this, but most of the rest of the committee is going to defer to this subcommittee.
DR. FITZMAURICE: Well, the technical stuff that we have heard.
DR. GREENBERG: Yes. They have not been following; they couldn't, and they are not involved. I don't mean that -- or anticipate some interesting discussion with the committee, and that is essential, obviously, but I do think --
DR. COHN: I think there are probably some of the newer members who would probably defer to this committee.
DR. GREENBERG: Maybe defer was the wrong word
DR. COHN: Anyway, I think we can probably work on this and see what we can come up. I think the very worst that can happen is that we don't have a letter, in which case we wind up not being able to give anything to the Secretary.
DR. ZUBELDIA: I think that would be bad.
DR. COHN: That is my concern, too.
DR. GREENBERG: I think so, too.
DR. COHN: But that is the very worst that can happen at this point.
DR. BLAIR: But I feel like we are not that far from being able to accommodate the suggestions that we have heard in the last 20, 30 minutes. Don't you think we're pretty close?
DR. COHN: I'll reserve my comment.
PARTICIPANT: There was just one question in item five, regarding working with the accreditation organizations. There is still a question about that one. I certainly agree with dropping the wording as it is now, but if there is any value in showing that we are working in a cooperative manner, perhaps wording reflecting that. I assume somebody put wording in here because we are able to show that we are going to work with them. If so, one possibility might be to recommend that the Secretary work cooperatively with the industry accreditation organizations regarding the potential HIPAA compliance issues that may be relevant to the accreditation process.
That is softer, and it shows value in working with them. If there is no value, then I understand dropping it. We talk about working with industry, and it would also be good to make a positive statement about cooperating with the accreditation organizations.
DR. BRAITHWAITE: We haven't done any of that so far, so that is a thing to look forward to.
DR. GREENBERG: If you were going to keep this at all, I would add it to the last bullet. It relates to flexibility and enforcement.
DR. ZUBELDIA: I would keep it out.
DR. GREENBERG: I would keep it out, too.
DR. COHN: May we now look at this other letter quickly and decide what we want to do with it? Then we will adjourn.
DR. GREENBERG: This is the one to the NUVC and NUCC?
DR. COHN: Yes.
DR. GREENBERG: I don't think this has to go to the full committee.
DR. COHN: I think so.
DR. GREENBERG: Does it? Maybe, I don't know.
DR. COHN: Let me just read this one. The NCVHS Subcommittee on Standards and Security recently held hearings regarding implementation issues in the electronic transaction standards adopted under HIPAA. While the focus of these hearings was on electronic transactions, there were several issues on the paper claim transactions that were brought to the subcommittee's attention.
The regulations that adopted standard electronic transactions did not apply to paper transactions, and gave providers the option of continuing to use paper. However, several witnesses expressed the need to provide a more extensive guideline for complete new paper forms. They also recommended the use of standard identifiers and code sets in the paper forms, so that the processing of paper and electronic claims could be better aligned. In particular, there were several recommendations for the standard implementation guide for paper claims. This guide would detail the data content and format of the paper claims and would specify the allowable code sets. This guide would be analogous to the implementation guides that have been developed for the standard electronic transactions.
The NCVHS believes that implementation guides with claims would be valuable products for the health care industry. We recommend that your committee consider developing such a guide, and that we work with all segments of the industry in its development. We appreciate the opportunity to provide these recommendations to you.
We have so far observed that there is an implementation guide for UV-92.
DR. GREENBERG: Yes, and I think if the NUVC got this, they would say, what?
DR. BRAITHWAITE: We have to rephrase it so that it says guides that are consistent.
DR. GREENBERG: That is a separate issue, but to indicate they don't have the guide would be wrong.
DR. COHN: The question is, do we want to -- we have two options here. One is that we send this letter to the NUCC and NUVC. The other option is that we just forget about this one and figure that they will get a copy of the one that goes to the Secretary.
DR. GREENBERG: You can be a little more proactive, and after sending the letter to the Secretary, send them a copy of this letter and point to this point four, about the value of -- as a courtesy, to let them know that you have sent this, and also as a little encouragement about making their paper forms consistent with the HIPAA standards. This is certainly something that is under discussion in these groups, actively.
DR. FITZMAURICE: Send to them the Secretary's letter that was already sent.
DR. COHN: That is probably how this ought to be -- this is more of a cover sheet.
DR. GREENBERG: That is what I would recommend, because it is problematic the way it is right now.
DR. COHN: What we will do then is, rather than try to wordsmith it on the spot, what we will do is to tell the full committee, as soon as we get the first one approved, we'll send a cover letter that is a note to the NUCC and NUCV, notifying them --
DR. GREENBERG: And I don't think they would have to approve that note.
DR. COHN: Are there any other items for today?
MS. TRUDEL: We have to -- that other letter.
DR. COHN: What other letter?
MS. TRUDEL: The morning letter.
DR. COHN: Oh, the first letter. Do you want to read it out for the subcommittee?
MS. TRUDEL: As part of its responsibilities under HIPAA, NCVHS provided da, da, da. That is the first paragraph, it is exactly the way it was before. The first letter produced by the DSMO's as a fast track process, the NCVHS requested to expedite changes that are necessary to facilitate successful implementation. The process required the DSMO's to do their review and analysis work in compressed time frame, so that the changes could be made to the standards during the first year after adoption, and in time to assist with initial industry implementation. The DSMO representatives responded to the NCVHS as requested in extraordinary fashion, devoting substantial time and effort to meeting our deadlines and achieving industry consensus. They are to be highly commended. Their success bodes well for the ability of the changed management process to be responsive to future health industry needs.
That is a paragraph. I'll stop there and take any changes.
DR. COHN: It says the HIPAA changes the long term process --
DR. GREENBERG: To continue to be responsive? Also, do you need that language twice, about to facilitate successful implementation?
MS. TRUDEL: We talked about successful implementation.
DR. GREENBERG: I don't know if you need the phrase after both the first sentence and the second sentence.
MS. TRUDEL: In the first sentence we say, necessary to facilitated successful implementation, and then in the next we say, the time to assess with initial industry implementation. Are they okay?
DR. COHN: Yes, they're fine.
MS. TRUDEL: The NCVHS has reviewed the DSMO recommendations for changes to the standards. We advise you to accept all of these changes, subject to technical corrections, and begin the regulatory process to adopt these changes as part of the standards. In addition, we urge you to expedite the process so that health plans, providers and clearinghouses can draw up these necessary changes as soon as possible. We recommend that the final rule implementing these changes be published no later than January 31, 2002. End of paragraph. Any changes?
DR. BLAIR: We advise you to? Should we say recommend that you? It's softer.
DR. GREENBERG: Where is this? Oh.
DR. COHN: I don't know that we need to urge them to accept all the changes.
MS. TRUDEL: Recommend that you accept?
DR. COHN: That's fine. All the technical changes, subject to technical corrections.
MS. TRUDEL: New paragraph. It is clear that the HIPAA code sets do not cover all procedures and diagnoses. This will always be a problem due to the evolving nature of health care. This seems to be particularly true in certain specialties or in emerging areas of care, including mental health, disability, long term care vision and hearing and wellness services.
We endorse the DSMOs' position that such code set gaps are most appropriately filled by modifying existing HIPAA code sets. We are planning to address broader issues related to code sets and terminologies beginning sometime in the late fall or winter. One topic we are likely to address will be gaps in the HIPAA code sets and the extent to which the maintainers are working with industry to fill them.
That initial language came out of the DSMO writeup.
(Simultaneous discussion.)
DR. GREENBERG: I'd take out that detail about the mental health and --
DR. COHN: Yes, I would take out that sentence about mental health, disability and long term care.
MS. TRUDEL: Emerging areas of care, period.
DR. COHN: Yes.
DR. ZUBELDIA: I would say, we are going to address these and broader issues.
MS. TRUDEL: Now it says, it is clear that the current HIPAA code sets do not cover all procedures and diagnoses. This will always be a problem due to the evolving nature of health care. This seems to be particularly true -- or how about, evolving nature of health care, especially with respect to certain specialties or emerging areas of care?
DR. ZUBELDIA: Let's strike that out. Evolving nature of health care, period.
MS. TRUDEL: Especially with respect to certain specialties or emerging areas of care.
DR. GREENBERG: I think we leave that in.
DR. COHN: Why don't we to stop after, the evolving nature of health care, period.
MS. TRUDEL: Okay.
DR. ZUBELDIA: Yes, I agree with that. It makes it easier.
MS. TRUDEL: Okay. I just picked up too much detail out of that one.
DR. COHN: We endorse the DSMOs' position that such code sets are most appropriately filled by modifying the existing HIPAA code sets. I think the DSMO position was that they should start with them.
DR. ZUBELDIA: Yes. If it doesn't fit, make your own.
MS. TRUDEL: We are saying most appropriately, because we want them to do it that way if they possibly can, isn't that right? That is what they are saying.
DR. BLAIR: But don't we have some code sets that are being asked to be considered?
DR. GREENBERG: I would have to say, we endorse their position that the requesters -- or however you want to refer to them, I'm not sure, but that says requesters -- work with the maintainers of the designated medical code sets to request --
MS. TRUDEL: Requesters work with --
DR. GREENBERG: Maintainers of the medical code sets, of the currently designated medical code sets to request whatever additional codes are necessary. That is I think what you are supporting.
MS. TRUDEL: Code sets to request -- I'm sorry?
DR. GREENBERG: Whatever additional codes are necessary.
DR. FITZMAURICE: So what, we are telling some place like Alternative Link to get those into an existing code set?
DR. ZUBELDIA: And into HICPICS.
DR. COHN: I think they are saying to work with them to identify the gap, isn't that what --
DR. GREENBERG: I was just reading what they said here. They actually say, recommends that whoever work with the maintainers of the DSMO code sets to --
DR. BLAIR: That is clearly the first thing we should try. I don't think we want to say it in a way that implies that we are precluding considering new code sets.
MS. TRUDEL: So then we need the statement after what we have got here, Jeff, that says prior to something else, right?
DR. ZUBELDIA: Before new code sets can be considered.
DR. BLAIR: There you go.
MS. TRUDEL: We endorse the DSMO position that requesters work with the maintainers of the currently designated code sets to request any additional codes that are needed before new code sets are considered.
DR. COHN: That's not quite --
MS. TRUDEL: No, I know.
DR. BRAITHWAITE: Simon, do you have this letter on your machine?
DR. COHN: Which letter is that?
DR. GREENBERG: I think maybe you need to say something like, or gaps that identify. We endorse the DSMO position --
DR. COHN: I think what we're saying is that they ought to discuss and develop -- try to develop strategies for addressing that, to try to address the gaps, or address the needs.
DR. GREENBERG: The first strategy should be to try to address them through the current code sets.
(Simultaneous discussion.)
(Whereupon, the meeting adjourned at 5:00 p.m.)