Hubert H. Humphrey Building
200 Independence Avenue,
S.W.
Room 505-A
Washington, D.C.
DR. LUMPKIN: Good afternoon.
We will start off with introductions. I would like to remind everyone that we will be broadcasting over the Internet, so, please speak into a microphone. So, we will do introductions so people can recognize the voices.
My name is John Lumpkin and I am chair of the Subcommittee on Standards and Security and also Department of Public Health, this month.
DR. MC DONALD: I am Clem McDonald from Regenstrief Institute in Indiana University.
MS. FYFFE: Kathleen Fyffe, Health Insurance Association of America.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Health Care Policy and Research.
DR. BALL: Judy Ball, HHS and staff to the subcommittee.
MR. STREIMER: Stewart Streimer, Health Care Financing Administration and liaison to the full committee.
DR. SUZMAN: Richard Suzman, National Institute on Aging, NIH.
DR. COHN: Simon Cohn, Kaiser Permanente.
MR. BLAIR: Jeff Blair, Medical Records Institute and a co-chair with Simon on the work group for CPR.
DR. JANES: Gail Janes, CDC, staff for subcommittee.
[Further introductions off microphone.]
DR. LUMPKIN: Thank you.
We are going to go slightly out of order and proceed to the second item on our agenda, which will be the update on claims attachment and standards on the claims attachment standard.
Stew.
MR. STREIMER: Thanks, John.
I apologize for not being here this morning, but I see in my absence, I lost my name plate. This is my punishment, I think.
DR. LUMPKIN: The first part of it.
MR. STREIMER: I have something to look forward to.
DR. LUMPKIN: Thank you for all the stuff that you volunteered for this morning.
MR. STREIMER: I would like to ask the subcommittee if I could also do -- if you notice on the agenda, there are three items that I will be presenting on. If I could do the update on the claims attachment followed by the maintenance and upkeep of the transaction standards and basically provide a little bit more time to talk about the issue segment of my discussion this afternoon, if that would be okay?
DR. LUMPKIN: That is fine.
MR. STREIMER: First, an update on the attachments, transaction standard -- and also let me add that Karen Trudel, who I am filling in for this afternoon, is unable to make it and sends her regards to the subcommittee -- regarding the attachment standard, I think the last update the subcommittee had was in June of this year. A significant amount of progress has been made since that time.
I would like to mention Clem McDonald has been instrumental in working with the work group on the attachments and they express their gratitude for his participation. I think Clem has contributed to the point where a lot -- I am very pleased with the status report that I can give today.
The work group on attachments met the week of November 3rd. They came to Baltimore to complete a significant amount of work on the NPRM. And at this time what the department is thinking about proposing are basically two X12 standards associated with the attachment. One is the X12 275, which is the attachment itself. One is the X12 277, which is the standard that will be used by a payer to request additional information or to request the attachment per se.
I think the addition of the 277 is new since the last update you have had. It certainly makes sense for those two particular standards to go together and we are pleased to say that work is far enough long that we can propose both of those standards at the same time.
In addition, the proposed X12 attachment standards will support HL7 LOINC codes. LOINC codes are the logical observation identifier names and codes. I think everyone is more familiar and has an easier time with LOINC codes than that, but those will be supported -- the LOINC codes will be supported by both attachment standards, the 275 and the 277.
We are also looking to accommodate six types of attachments. I think when we reported last we were only looking at three attachments. Now we are looking at six. They are for ambulance services, emergency room notes, rehabilitation services, laboratory results, medications and other types of notes.
A quick status of where we are in support of that proposal. Both the 275 and 277 implementation guides have been finalized by the appropriate X12 work groups. These implementation guides are scheduled for draft publication as non-HIPPA guides. Now, I emphasize that they will be published as non-HIPPA guides because not until the NPRMs are published -- is published, really we are looking at one NPRM -- will they be considered HIPPA guide. We are looking at that about the middle of this month.
So, hopefully by the end of next week we will have those draft guides on the Washington Publishing Company Web Site. And you can keep your eyes open for that.
Both the 275 and the 277 will be able to accommodate all six of the attachments that I just mentioned. The six attachment LOINC tables, all of the LOINC codes that have to go with the various attachments have been delivered to the HL7 special interest group for final review, which is an important approval process for those to be included as part of the implementation guide that will be issued for the 275 and 277.
All HL7 attachment-related documents are scheduled for formal approval by HL7 membership, by a special electronic ballot sometime next week, giving the membership about 30 days to comment and at this point in time, we don't expect any concerns or difficulties to arise during that comment period and once that is approved, then we can expect that those HL7 codes will be available with the Washington Publishing Company, 275, 277 implementation guide.
If there is a problem. If there are concerns that are raised during the comment period, there has been a time frame built into about January, mid January, to do a second ballot, to approve those HL7 LOINC codes.
Again, as I mentioned, we hope to have all of the HL7 documentation on the WPC Web Site sometime in January, thus allowing a complete review of both the X12 implementation guides and the HL7 codes. We have made arrangements with X12, HL7 and Washington Publishing Company to have documentation, the HL7 attachment documentation and the X12 implementation guides available on the HIPPA Web Site as soon as the Secretary publishes the notice of proposed rulemaking.
At this point in time, while we are getting the approval on the HL7 codes and that we have the final or the draft final 275 and 277 implementation guides, we are seeking WEDI(?), NUDC, NUCC and ADA comment on the attachment standards. As you know, the legislation requires that consultation process and those comments in that consultation will be important as the department clears the notice of proposed rulemaking.
Our goal is to have the NPRM begin clearance next month, which means there is still a lot of work to be done, but we are optimistic that by the end of December we will be able to have that in clearance. Now, from all of our experiences, we know that clearance can take some time, but at least the staff level work will be complete.
Once the documents are published in draft -- now, I may be backing up a little. I don't want to confuse anything. When I say "published in draft," that doesn't mean a notice of proposed rulemaking. Once they are published in draft, as I said, sometime in January on the Washington Publishing Company Web Site, we are going to engage the Texas Medicaid State Agency in discussions regarding testing the standard. They have come to us expressing an interest in doing that.
I think we will all agree that that is very important to the success of the standard and we are very pleased that they have come forward to offer their assistance.
DR. MC DONALD: Which state was that?
MR. STREIMER: Texas.
Now, there is one -- well, there is more than one -- there are a couple of issues of particular concern to us and maybe these are issues for the subcommittee to consider now or to just think about and get back to us. These are issues associated with the utility of the attachments. As we understand it, clearly, there needs to be varying flexibility among payers in terms of the types of information that they request to adjudicate a claim.
One of the things that we will be sure that is very clear in the NPRM is that attachment information should only be required for claims adjudication. That is the goal of the attachment standard. It is not intended to collect all kinds of information and to burden the providers with more information than is necessary to adjudicate the claim.
That is our goal. Also, we don't believe that attachments should be required for every claim. If there are issues that require certain kinds of information to be submitted with every single claim, we think those are the kinds of issues that should go back to the 837 work group and that should be discussed with those individuals.
As a matter of fact, a special X12 work group has been established to look at attachment issues and claim-related issues so that if information is being requested of a provider on every single claim, that maybe the appropriate place for it will be the 837 implementation.
So, that is pretty much where we are today. So, I would open it up for questions. And, by the way, I do have Barbara Redding here with me from HCFA to handle the difficult questions that you may have.
I am sure Clem has much to contribute as well.
DR. MC DONALD: Just a clarification a little bit. It is the 277 is carrying more than the LOINC codes. It is carrying an HL7 message, which is a bona fide HL7 message, as though results were being sent without being in the boxcar that is carrying it. But it has been tightened down a lot to make it easier. So, that has to be reviewed. That is also being reviewed, not just the codes.
I guess the other thing is I have heard from the people on the CIG, from the insurance side, that there is some interest in not making the 837 anymore -- the word I heard used was "monstrous" in size and complexity than it is now. So, I don't know if that has been settled or whether there is still -- there was some thought to making an attachment-like thing that would make the structure simpler, that would go along with the claims, as it can now, rather than continue to have the -- I don't know how many, 2,000 fields in that or something, 2,800 fields?
So, I don't know. Maybe you are saying it is settled. I think everyone agrees that we should not burden the providers at all. I mean, the AMA, I think, would like to -- I mean, many of us that are providers would have no burden or not any more burden and we shouldn't use this as an excuse to pile on in any case, but the issue about just
-- if it is always required, there is some particularly inelegant, structurally inelegant issues regarding making a field out of a lab test when the lab test changes every couple of months to a different name, things like that.
DR. LUMPKIN: Any other comments, questions?
DR. CONWAY: Tom Conway, American Medical Association.
If I could ask, are there any other states being considered for the pilot, besides Texas? The reason I ask is because I am understanding that Texas is only EPSTD for Medicaid and I just wondered if you wanted some adult claims as well?
MR. STREIMER: Texas is a state that has approached us and we would certainly welcome any other volunteers. I certainly cannot commit at this time whether we would --
MS. FYFFE: What is P-S --
DR. CONWAY: EPSDT, the early periodic screening and diagnosis and testing.
DR. LUMPKIN: It is a program for kids and it provides additional testing other than just well child, lead testing, developmental testing, screening for early childhood diseases. It is an enhanced package off of Medicaid and there is a required participation by states. I think they have to be at 85 percent by this year or last year.
DR. MC DONALD: Well, some of the attachments won't probably fit real well with that, I mean, ambulance and rehabilitation. The laboratory one would and one other thing, what you call the other, just to elaborate on it, that is really the common standard narrative text reports, like this chart, summary out notes --
MR. STREIMER: Nurse's notes.
DR. COHN: Stewart, perhaps you can just review for me again the timing of all of this stuff. I heard a number of different initiatives that all seemed to be sort of layered on each other. Some of them had to do with publications of things that weren't the NPRM, things that were the NPRM, beta testing, maybe alpha -- beta testing, I guess, is how we best describe this.
I was trying to figure out how it all it worked in terms of a time frame that resulted in a successful implementation of a national standard.
MR. STREIMER: Okay. In terms of time frame, the 275 and the 277 implementation guides, the X12 guides, those are basically done. And those will be available in draft on the Washington Publishing Company Web Site. I believe I said sometime next week. That was the goal.
The HL7 portions that need to be completed are going to ballot around November 18th and there will be a 30 day comment period and without any -- assuming no problems in that balloting, we should have the approved HL7 documentation on the Washington Publishing Company Web site by January or sometime in January. Okay?
That way it will reside with the X12 implementation guides. So, all of that material will be available sometime in January. Now, the NPRM, okay, that is basically the actual documentation supporting the standard. The NPRM will begin the clearance process, hopefully, in December and at this point, I won't speculate what the publication date will be, but I would expect that if it begins in December, it won't -- the publication of the NPRM won't be before the summertime.
DR. COHN: Okay. And then the testing will occur --
MR. STREIMER: I think that is something we still need to work out. We haven't come to closure on all of the testing requirements, but we are hoping that the testing will start as soon as soon as possible after the January date when all of the documentation is available in the Washington Publishing Company Web Site.
However, we just need to be careful in managing the testing process because we don't know what could happen by the time the NPRM is published, the comment period, the final rule, et cetera. So, we have to develop very well thought through testing plans and we just haven't at this point in time.
DR. MC DONALD: Neither of these are really brand new message constructs. The 277 has been around a long time and the ORU, which is what is stuck inside, has been around a long time. So that it is not going to be like this is a brand new widget. The things that are specific about it are the things such as what are the actual questions that are asked in a questionnaire and one of the, I think, quite beautiful phenomenon in this whole process, which at the beginning I would have not bet anything that we could have got anything out that anybody could use, was as people came around the table on these various conference calls to decide what, for example, should be on a form, and if you look at the ambulance form, which is a good example, every company had their own and the words on them weren't sufficient for a normal human being to know what the question really was often.
After a short period of -- after about three sessions, the aggregate of people who really knew what was what came to pass and things such as one of the questions was was the patient hospitalized or not. The ambulance drivers don't know it because they are out of there before the patient gets hospitalized. I mean, just simple coherences like that came out.
So, it was really quite neat and the other thing, I think, to brag about is that the X12 HL7 collaboration was wonderful and the insurance company guys -- most they were insurance industry people on the -- from the X12 side. There was a very nice mixing and joining of intellectual spirits.
DR. LUMPKIN: Jeff.
MR. BLAIR: This question is really directed at maybe some thoughts about what you might be doing with claims attachment standards with the HL7 CIG beyond the things that you have discussed with us so far. There has been a flurry of activity in Europe and the U.S., which I think would pertain to health claim attachments; namely, tagging certain data elements within free text whether the
-- whether it is transcribed information or whether it is entered in some other way with XML tags.
Just for those other folks that might not be as familiar as Clem probably is on it, HL7 also has an SGML, XML, CONA(?) special interest group, which is working on that in terms of message formats. A brand new ASTM committee has just formed to take a look at putting in place XML tags for electronic health care documents for document formats and a third group is about to form with respect to content and structure in the record in ASTM and a SEND(?) committee was formed this summer, a SEND task force to use XML tags to tag data elements within electronic health records.
So, there is this flurry of activities and I would suspect that there must be -- have been some discussion about your next step with respect to health claim attachments and I am wondering if that includes using XML tags. I guess I am really directing -- well, I don't know, Stewart or Clem, whoever.
DR. MC DONALD: Well, I will be happy to take a stab at it.
XML is a language for specifying standards and when you specify them, you have to specify a syntax or a grammar and you have to specify the words, which we were referring to as tags. Then with that, one can make a standard. But having a BXML doesn't make it be a standard because you and I could each invent our own so that actually having this flurry of different groups, we have to make sure that they don't flurry too far afield.
The time constraints of this particular business did not permit the planning or the commitment to a new kind of syntax because then we would have been in a kind of wild new territory. But I know a version 3 of HL7 is committed to using XML as a transport syntax. So, there is certainly a way to get there.
I think our major focus on the committee was to get anything done, using the existing tools because those we wouldn't have to go through two years of balloting or a year and a half of balloting on. So, I think that it is definitely on the horizon.
The way the NPRM works, I think, is that it basically locks us for two years and in that time frame we
-- or some years, is it?
MR. STREIMER: It is really one year after the final rule is published.
DR. MC DONALD: Oh, well, okay, not so bad. Actually, when we started, it seemed like a lot. During that time period, I -- I just don't know how fast it will be before we will have an agreement on the syntax would be. But certainly when HL7 is XMLized, it will automatically have an XML variant.
I should also say that there is the capability now to tag subheaders on the reports in the documents when people wish to do that, at least in some of the standard reports, like discharge summary and op notes that are relatively standardized from the joint commissions historic requirements.
DR. LUMPKIN: Any other questions?
I have a couple.
To what extent will this X277 standard allow requests to flow from the payer to the provider for information that could be transmitted in the 837 but wasn't included because it is not a required field for that particular transaction? For instance, it may be one of the values that are optional in the 837.
MR. STREIMER: I am going to ask for some help on this but I will add that the 277 is a transaction that is used for more than just the attachment. For example, if you recall in the transaction in code set reg, the 277 is the response to the claims status inquiry, as well. So, that it can be used for other purposes but maybe -- is there something -- you are going to come up here --
DR. LUMPKIN: Come to a microphone so folks out in CyberLand can hear you.
MS. REDDING: We have been thinking through this issue and we currently at least think that allowing people to use the 277 in the context of a HIPPA standard, I mean, people can do whatever they want with a non-HIPPA 277, would be walking into claims correction territory and, indeed, that might be a very good subject for standardization in the future, but not very many people have come together in order to reach a consensus how that should best be done.
So, at the moment at least, we think that the 277 should not be used for claims correct, which is really what you are talking about.
DR. LUMPKIN: Well, I am interested in that issue because one of the things that we heard, at least I thought I heard when we had our hearing, was that sometimes requests are made for claims attachments, sometimes because the information on 837 may not include the clinical -- the small little bit of clinical data and frequently what happens is that if someone just wants to know the blood pressure, do they have to generate a whole claims attachment, if they just want to know this one little piece, a laboratory result to verify, and that what we have gotten to is that the insurer asks for a piece of information. The provider doesn't want to figure it out or expect it and they just send the whole chart.
So, to what extent can this mechanism allow us to minimize some of the -- I mean, we just don't want electronic ties or automate a bad system. Will it help us improve the system that is in place?
MS. REDDING: Well, the thinking at the moment on the rules for using attachments would be that you could have anywhere from 1 to n data pieces in an attachment. So, in those circumstances, if you just wanted the little piece that you just described, you would request that on a 277 and the individual receiving that would return only that piece in the 275s.
DR. MC DONALD: So, to be more specific, you could ask for hemoglobin in the current -- I am not absolutely sure about that -- you probably could ask for hemoglobin in the current -- and only get that back as a little bitty attachment.
The way I say "probably," I wasn't in the last conference call and I don't know all the intimate --
MS. REDDING: It depends on what you all have codes for, but if you have a code that tags that topic, you can have a one topic attachment.
DR. MC DONALD: There is a further challenge in that -- not challenge, a further set of issues is that which one of those hemoglobins do you want. Now, they are all tied -- the attachment assumes everything is tied to the claim. That is, you don't want results from some future thing --
PARTICIPANT: From a different episode.
DR. MC DONALD: Yes. But, you know, you can't just say it is in a date window because if you are looking for a head CT that has supported some activity, it might not have been done at that visit. So, there are ways to specify the range, whether you want one or all.
What we think would be the easiest for people to deal with, instead of saying this particular hemoglobin code, because there might be three of them, just say give me the hematology from that date for that visit and you are going to get -- you are not going to get that much anyway.
DR. LUMPKIN: So, essentially, the answer depends upon the robustness of the coding system that is used --
DR. MC DONALD: No, no. The answer depends upon what the reg says exactly about which -- no, there is a code for hemoglobin.
DR. LUMPKIN: But given that, the quest for additional clinical information, which the system is designed to try to automate depends upon the robustness of the code system that allows the payer to request specific clinical information. The more robust the code, the easier it is for the provider to know exactly what the payer wants. But that works both ways. If it gets too specific --
DR. MC DONALD: That is true.
DR. LUMPKIN: If it gets too specific maybe he has got to work -- he has got to wrestle too hard.
MS. FYFFE: Just a couple of comments and I might need your help in order to be factual about this, but right now the 837, if I am not mistaken, most of the fields are optional.
MS. REDDING: They are actually conditional.
MS. FYFFE: Conditional. Okay. Which means they are not mandatory.
MS. REDDING: It means that they are mandatory only under certain circumstances.
MS. FYFFE: Okay.
MS. REDDING: And if the conditions for the field to be present are present, then the field must be filled out. It is a lot different than optional, which is something you might choose to use or not.
MS. FYFFE: Right. So, getting back to John's question about whether or not the claim would have sufficient information on it so that overall you could reduce the number of attachments, the answer is it depends on -- I think a lot on the way the contracts are set up between the payers and the health plans and the payers and the providers.
MS. REDDING: I don't understand that.
DR. LUMPKIN: Well, I think the issue then is is that it depends on whether or not the 837 is conditional based upon the claim code, the procedure code that is inserted because certain information will be tied to a procedure code and that procedure code relationship of that information is going to be dependent upon the provider because not every provider is going to request that same information.
Now, if you have got a system up front that generates the 837, it can build that into there. If you put down a procedure code for diabetic ketoacidosis and they want to know what the hemoglobin A17 was before, then, you know, maybe that is sort of a conditional, even though there is not a place on -- but that is an example of a conditional one.
The issue I was raising was if you have -- if you send in an 837, you fill in all the forms that appear to be conditional, but the payer wants that one bit of information, which could have been transmitted as part of a conditional field. Does it now get, you know, transmitted, not as a correction? There really is a request for additional information.
MS. REDDING: No, it isn't. It is a correct because if the individual did not fill out the 837 in accordance with the conditions given in the implementation guide, they have made an error. It is a claims correction.
In the case of the 837, which is not the case with all of the transactions, if the individual filled out every field in accordance with the instructions, the payer doesn't have the right to ask for more information, claims information. They may ask for attachments that will help them determine coverage or medical necessity, but the claim is defined.
DR. LUMPKIN: Okay. And I have to apologize because I am just kind of looking at it from the guy who is filling out the form.
MS. REDDING: So are we.
DR. LUMPKIN: And in that regard if you fill out
-- people think that the attachment is part of the claim. It is just part of the claim that you have to send later because you don't get paid if you don't send it in.
PARTICIPANT: It is part of the medical record.
DR. LUMPKIN: So, I think that what we are getting to is if it is additional information to justify the claim that was submitted, then it could be included in the attachment.
MS. REDDING: Say that again.
PARTICIPANT: I am struggling to --
MS. REDDING: If the claim is complete, it is complete. If you need more than that on claims, you need to go for the next update of the standard.
DR. LUMPKIN: Or a claims attachment.
MR. STREIMER: Can I try your question another way?
DR. LUMPKIN: Okay.
MR. STREIMER: Suppose the claim comes in missing a piece of information to fully adjudicate the claim and the information that is needed can come in on an attachment. The request goes back to the provider on a 277 saying we need this additional information to complete the adjudication. Does the provider send back a 275 or do they send back a corrected -- would it lend itself to be a corrected 837 or could they submit a 275 attachment to fulfill that need?
MS. REDDING: This is a case of a claims correction.
MR. STREIMER: The way you presented it, yes.
MS. REDDING: There are a lot of different ways claims are corrected electronically today. So, barring a proposed rule on the way claims are corrected, the individual could just about do whatever they please. They could --
MR. STREIMER: The provider.
MS. REDDING: The provider. There is a way to resubmit an 837 with a marker that tells you it is a corrected claim. There are many insurance companies that have on-line interactive claims corrections, where the only thing you ever see on the display is the piece that is in error. There are -- I don't know of anyone using a 277 for that, but that could be done, but it would be outside of the HIPPA standards transaction.
MR. STREIMER: So, essentially the trading partners can establish a protocol.
MS. FYFFE: Yes. Which is what I was trying to say before in terms of the contract. I mean, you could -- if you are a provider, you could -- have to send different information on the same case to different insurance companies. It is just a way of life. Okay? Say you had a child that was covered by Medicaid for part of the stay and two other companies for the remainder of the stay, God forbid, but these things do happen. Medicaid and the other two payers may expect completely different information.
MS. REDDING: Based on the way that standards are currently being -- based on the way the standards were proposed, the individual that is in that situation, we just put everything that applies on a claim. Then it would be a complete claim no matter where it went.
DR. LUMPKIN: But that is if they fill out all the thousand fields.
MS. REDDING: Not necessarily. It depends on the conditions. It would be an unusual case that would require every field.
DR. MC DONALD: The wording and all the details of the final discussions get fairly complicated and I am not sure I captured them. But there certainly was discussion both at the big open meetings -- there were discussion claims attachment they had in Chicago, a large number of insurance payers and providers and in other meetings that there was some anticipation that the question of more stuff could be sent back as an attachment. So, it may not have come out that way.
Now, clearly, all more stuff is not yet defined. So, there is a lot of more stuff that couldn't be defined. But when we get into this business -- you weren't here when the first question came up, but this business of wanting lab tests to verify something, the darn one field thing doesn't work very well because today it is hemoglobin A1C and tomorrow it is going to be, you know, some other test and that has happened in the hard enzymes fairly rapidly
In thyroid studies, you can find a variety of alternative studies that would satisfy. So, I guess I would hope that in the ultimate -- you know, these are only six attachment areas that are being discussed. So, there is a lot more to be dealt with, but when it gets all said and done, it would be nice if the users would get one message saying I need something more, for whatever reason, and they could automate, look in their system and send it back and very specifically.
So, I am in favor of what you are hoping for.
DR. LUMPKIN: Bob.
MR. MAYES: I just want to make sure that -- we may not be being clear. The conditionality of an element is not a contractually agreed upon -- that changes from one contract to another. The conditionality of the element is spelled out within the implementation guides. They are not optional. They are conditional, but it is not conditional defined by AETNA, conditional defined by Blue Cross/Blue Shield or others.
MS. REDDING: People contributed to --
MR. MAYES: Yes, I know, but I mean you can't -- so, you wouldn't be in a situation that you are describing, Kathleen, where this company would say, oh, these five are conditional and this company would say, no, no, these ten are conditional. That is exactly what HIPPA was trying to get away from.
MS. FYFFE: Doesn't the regulation also allow for trading partner agreements?
MS. REDDING: The regulation -- the proposed rule stipulated that to the extent that the trading partners are used to define data content, they would be rendered obsolete by HIPPA. There were lots of other reasons for trading partner agreements, not least of which is legal. That is outside the scope of the rule.
DR. LUMPKIN: Just kind of stretching our example of the diabetic, one company wants a hemoglobin A1C. The other one wants fasting glucose and the other one wants a tolerance test or something like that. So, you could have a stay covered by three companies, have a standardized form and all three would want different information to evaluate that claim. That could potentially generate three transactions and three attachments, each with that additional bit of clinical information that would be different.
That is not necessarily bad, as long as the codes that come back to the providers says we need this information, which then provides the basis to automate the basis -- you know, the response. So, it may be that -- I think we will just want to look at that if this goes on. And that really raises my second question, which is would a hearing between now and when we expect NPRM to come out, which would be summer, on the 275 and the 277, would that be something that would be helpful to the process?
Not that we necessarily have room in our schedule to do that --
MR. STREIMER: My inclination is once the implementation guides are available, it might be very helpful when people have the opportunity to review the full expectations under the standard. I don't know, Clem, how you would feel about that.
DR. MC DONALD: I feel fine. I just don't know -- it seems like it is done and that it might be a bit late to start -- I mean, there will be a feedback process out anyway.
MR. STREIMER: We just need some help from HCFA about -- we were raising this deadline because after that everything is frozen.
DR. MC DONALD: Well, the process, though, that we have engaged in is that we have had standards that were already out there. The issue is whether or not the standard meets the -- or should be the HIPPA standard for a claims transaction, attachments. So, does this fit is an issue, which either can be resolved -- I think maybe some issues may be addressed in a hearing, which would make the comment period perhaps a little bit easier to manage.
MR. STREIMER: How about if I ask the work group and report back to the subcommittee?
DR. MC DONALD: Okay. When would the comment period hit? From the NPRM?
MR. STREIMER: Yes.
DR. MC DONALD: Given the best estimates --
MR. STREIMER: Well, if it is not published until the summertime, let's say, of 1999, that is when it would start.
DR. MC DONALD: That is when the comments would start?
MR. STREIMER: That is when the comment period would start.
DR. LUMPKIN: Okay.
We have an interloper, who has a question.
MS. COLTIN: Sorry. When Barbara was giving her answer earlier, she was very specific about information that was needed to adjudicate a claim. And it raised a question in my mind as to the purpose of a claims attachment and whether or not it is limited to what is needed to adjudicate a claim because in a managed care environment, we are often not adjudicating these claims but we may be adjudicating payment to a physician on some other basis, such as a capitation with a bonus for meeting certain performance targets. Performance targets may be based on achieving certain hemoglobin A1C levels in their diabetic patients.
So, I just want to be clear that when we are talking about the purpose of a claims attachment that we be broad enough to recognize the physicians are compensated on a variety of different bases, not always claim by claim and that the information needed to pay them may be broader because of that.
MS. REDDING: I should have said claim or encounter.
MS. COLTIN: Maybe it wasn't really a question but a comment.
MS. REDDING: In the standard, both claim or encounter are identical.
DR. COHN: Thank you very much for that comment.
Stew, I actually just wanted to ask you a couple of questions about process. I think we had talked about this, perhaps, six months ago when the work started on claims attachments. I noticed that you have both ambulance services and ED notes here as actuaries to be standardized. I am certainly well aware that HL7 is in the process of signing off and X12 is.
Can you describe to me the process that involves perhaps the wider, non-standards communities in terms of signing off on these particular standards, recognizing that they obviously impact in this case the ambulance entities, companies, others, in the case of emergency room notes, another wide variety of users, who may or may not be of standards activities.
MR. STREIMER: Well, correct me if I am wrong, but my expectation is to the extent they participate when the groups that are involved, HL7 or X12, they would have that opportunity. Otherwise, they would not have that opportunity until such time that the notice of proposed rulemaking is published.
DR. MC DONALD: It was better than that and broader than that. We have to distinguish -- and these lines are hard to paint, but the standards groups aren't going to be responsible for what the specific questions are in a particular attachment. Let's say we have got a hip fracture attachment. There isn't one. I have never heard of one, but let's -- and you want to know ten measures and that is kind of agreed up that when you get a hip fracture, these are the ten measures they have got to have before you can have a hip implant or something.
Those questions wouldn't be developed by the standards groups. They made -- I mean, I don't want to say this wrong -- they wouldn't be -- there is still some rule development going on about who is going to real control those questions that would help technically with it, that would help to make sure they are coherent, they would critique it. They would do all that kind of stuff, but there is going to be sort of a broader body that is kind of -- I want to say one of the UU(?) committees or both of them or some other one that is still to be invented will probably have ultimate control over this vocabulary of questions, this list of questions.
So, what happened actually in terms of the question refinement, it really -- it was an offshoot of the proof of concept group, which solicited widely, and included at a meeting in Chicago, to have other participants and activists and they typically did have some broad -- one of the principal -- the DEEDS(?) database for ER was the principal source of ER questions and it was boiled way down because that is a pretty big one and that was developed in a large collaborative activity with the American Emergency Room -- and all these other different things.
I know that the ambulance one had at least three ambulance companies on because that was the first time that everyone really understood what these questions were. I was on a phone call on that one. It was like an epiphany. You know, all of the sudden now we are no longer arguing what these letters mean. Here is someone who understands. And that is where they came up -- they don't know whether the patient is admitted or not and how can they then be asked to record whether the patient is admitted when -- so there has been in this specific one a fair amount of activity in a fair group and with some real active effort to bring people in. Now, it is hard to get volunteers in.
They would have liked hundreds and they probably had tens in the groups. I wasn't the main -- I mean, I was just on some phone calls and the claims -- the proof of concept team was really sort of the leader -- the lead agencies on that and they were pulling in people and if there is someone here from there, they could maybe speak to this better.
DR. COHN: Maybe I could just make a follow-up comment. The reason I was asking that question really had to do with -- I mean, I am really, first of all, all in favor of a claims attachment standard and I want it to be excellent and I want it to be well-used and have everybody, as much as we can have everybody satisfied by it be satisfied by it.
This standard is different than the other standards in the sense that it hasn't been out there and been in use. So, it hasn't gone through iterative processes of improvement, people getting used to it, roughing out the edges and all of this stuff. So, part of the question gets to when you come out with a new standard and it seems you are also beginning to identify standards around certain areas, how many people not in the standards community but in the business community have really signed off on things.
I think the comments made tell me that there has been some discussion in the business community as opposed to the standards community. It is something that the committee ethic needs to follow up on to really get a much better idea of really how fully business participation is. And based on that, we can decide whether to have hearings or not.
That was really why I was asking that question.
MR. MAYES: Simon, this is Bob Mayes. Two comments to your comments actually.
One is that this standard is, of course, a little different in that -- than the other ones, than the other transaction standards in that there is a more clear delineation between the structural components of the standard, in other words, the wrapper and the message segment as being a standard and in the content. They are not as tightly linked. All the rest of the standards, they are really pretty tightly linked and do we add another field to the claim?
This one, we are standardizing the particular structural components and we are doing it in such a way that it can accommodate many, many, many different contexts, packages, if you will, messages. So, the whole issue that we are struggling all the way through with how do we do the content definition because very clear or very important in this particular standard.
Now, the other thing, though, to remember when you talk about the breadth of business input, it still is a claims attachment. Let's give it the broadest definition of that. But nonetheless it is a particular segment of the industry that is requesting certain information for a business process. There was, in fact, a fair amount of insurance participation on the development of these. So, when we talk about an ED notes standard as a claims attachment ED notes, it is not the same thing as if you were talking to a group of ED physicians, saying, well, how would you structure your note within your record system in an emergency department.
It is from the insurance perspective. If I am requesting certain information on an emergency room visit to adjudicate a claim, what would that information be and how would I structure the question? So, it is important to get participation but this isn't the same thing as defining like a CPR or even a subsection of a CPR. This is defining a specific business attachment, if you will, a business transaction.
DR. LUMPKIN: Unless your specialty is emergency medicine.
DR. COHN: Yes, right.
DR. MC DONALD: To the credit of that activity, and, again, I would -- that was when I wasn't on the phone call very often -- they did accede to only drawing -- almost only drawing questions from a document that had already been developed by the emergency community and they didn't take the whole set because it would have been too much of a load, but they took the questions as they were in almost all cases. There might have been one or two other ones.
MR. MAYES: I mean, I am just saying it has a specific purpose, a specific business purpose, the claims attachment. We just have to keep that in the back of our mind, that this isn't a surrogate or a piecemeal definition of a CPR.
DR. LUMPKIN: You have to realize that you are operating at a slightly -- at a disadvantage since both Simon and I are board certified in emergency medicine and Clem is a practitioner of that. In some regards, particularly for that particular specialty, the form -- if you define the claim attachments, you define the form. I have been in situations where it has taken us a year, year and a half to develop an emergency department record in one institution just because the forms are so small. What do you put on and what don't you put on.
Now those decisions are going to be made because by defining the claims attachment all that stuff becomes now mandatory instead of optional based upon the local facility. That is not saying that is necessarily bad to have that sort of standardization. I am just trying -- and Simon -- we are just trying to ascertain to the extent that we will -- and HHS will hear from a particularly vocal group if they feel that they have not had an adequate amount of input into that particular subsegment of claims attachment.
DR. COHN: Dr. Lumpkin, thank you very much for those comments.
Certainly my view -- and what you said, I think in some ways convinces me that my comments were accurate in the sense that this will to a large extent structure these areas or the information in these areas. And to say it is just from an insurance point of view is probably missing a lot of the point about how things really happen in health care.
MR. MAYES: Well, I would hope that you would resist that at all costs to have the way that information is captured about how health care is delivered to an individual be driven by the reimbursement policies of the day. I mean, you know --
DR. COHN: No, no, I -- my comment is -- let's see, what is my comment -- my comment is I think in some ways this is the leading activity. This is the one that leads us into this area and certainly I would not state that insurance companies need to be excluded from the conversation. My concern was is to make sure that everyone was fully represented. Now, actually having participated in the DEEDS process, which has been referenced now a number of times, whereas, I am very confident that they produced a very high quality result, I am also very aware that that meeting was a meeting that was a voluntary meeting where everybody put their two cents in a couple of years ago and with no particular expectation that it would necessarily show up as a legislated --
DR. LUMPKIN: Never would really happen?
DR. COHN: Well, I don't think that there was the intent there and all I am saying is now as we come back to this a couple of years later, one should not necessarily assume that things are exactly the same as they were a couple of years ago. So, once again, I think we are talking about process. This is just the leading edge. If we were talking about pharmacy issues, I think we would be coming up against the same issues of what sort of process do we go to to assure that all the right constituencies have had their input into what this area of standardization looks like. There is what we are grappling with.
DR. MC DONALD: I wish you could have been -- were more involved, actually had been more involved because, one, I think you would feel a little better. I have to tell you that I felt awful in the early months and I feel relatively good now, but one has to be aware there is really -- there is about three different kind of beasts in this attachment, which really are almost unrelated to each other and there is one of them, this form-like thing and the good example is the ambulance attachment, always has been a form, always had a fixed number of questions on it, always had sort of a statistical -- you could see the cluster of the same questions on a lot of the forms, but it just wasn't standardized.
And even often it wasn't very intelligent. I mean, there was crazy stuff on it. The process -- if we are lucky, this process will hone those forms down, make them smaller, more pertinent and make them more understandable and have them -- and they will be absolutely uniform across everything. And those things will imbed themselves in the practice of -- they are going to make sure those questions are answered in your clinical systems so that gets answered.
But that is the minority. Now, there is another set of them that are like known things in the chart, the discharge summary. I mean, they are identified, named, everybody knows about these and they can know where to find them and pull them out.
Now, there is no then -- having named all those as retrievable documents in this attachments creature doesn't specify when they get sent or how they get sent or they all get sent or not all get sent. They are already being done, but it gives the players a way to say send me this and I know what you are talking about. I can send it to you.
The laboratory is like that. It is just a way to say it. This is all laboratory stuff. It doesn't say which one you send or which ones you do. I mean, one could -- I mean, that is another layer that could get imposed on top of it. So, that is not going to shape anything and, in fact, the beauty of that one, it has been shaped to take stuff as you have it. You know, just give me your hematology or give me your hemoglobin.
So, when you look at the three different kinds, the one kind is completely enforcing and it will -- and I think the same thing will be true of the rehabilitation attachment, which already exists as forms, as fixed forms. And we looked at our charts and we found they put stamps on the charts that kind of corresponded to some of the questions you saw on some of the examples of attachments.
Now, hopefully, at least folks will be able to get those and know what they are. But the real struggle of this -- and if you say that, you know, let's get everybody in here and say we are all going to be happy with this, I will guarantee that everyone will not be happy with any kind of an attachment standard for two reasons. There are two sides of the house. One side wants no attachments. The other side wants to do as they please.
So that neither side can be happy when you say this is sort of the catalogue, the questions you can ask and you have to go to some body to rationalize any additional questions. You can't just tomorrow make up a question and bugger some guy with it. So, that is the good side for the practitioners.
On the other side, the practitioners would like to have no attachments and that doesn't mean they just want bigger claims forms. They just want to be less hassled with all these different questions. There is good arguments -- I have heard them all -- on all these sides. So, I can also guarantee you whatever middle ground you pick, everyone won't be happy with it.
MR. STANIK: Thank you, Dr. Lumpkin. I am Dan Stanik from NCPDP. In retail pharmacy, per se, we don't use attachments, but we are very interested in the progress of what is going on, very pleased. Things are going well with X12 and HL7.
I just have a question regarding the attachment on medications. Where is that information coming from? Do you foresee the possibility of that working with retail pharmacy with the NCPDP Telecom 32 and what impact do you think that will have on retail pharmacy, if any, at this time?
DR. MC DONALD: It didn't come up. Now, that doesn't mean it shouldn't or wouldn't. The context of the drugs came up as in discharge medications, discharge from the hospital, discharge from the ER. Actually, that is in the DEEDS attachment. And those are typically the orders, not the filled. And I think at this stage we couldn't presume anything more than that and often it will actually be just by the narrative note.
So, it is like free text. I mean, would you have like CIGS and --
MR. SANIK: There is free text and there is also structured basis, but there is a structured variant if they wanted structures, but it usually entails seven structures.
DR. MC DONALD: Okay. Thank you.
MR. SANIK: But I think, though, that this would be something that in the next version as we got more bold if we could really tell what got filled, it would be wonderful, or send it to them, it would be wonderful.
DR. LUMPKIN: Well, we are way over time. I am going to take Kathleen and then a suggestion.
MS. FYFFE: When you say attachments for ER notes and then other types of notes, that implies something that is free form. So, does that mean that it could just be anything? I guess my question is are you going to try to train every emergency room in this country and every ER doc to take certain types of notes for some sort of standardization of ER notes?
DR. LUMPKIN: Simon, what percentage would be your guess of docs in emergency department that dictate their notes now? It is getting up there, isn't it?
DR. COHN: Yes. I would say it is certainly over half.
DR. LUMPKIN: Over half. So, I mean, in a sense we are at a position where the process of converting the form or a dictated note into an electronic transmission would just mean whoever is doing the in-coding or the software that they are using, the voice activated software could just abstract those particular fields into the form. So, it is not -- it is actually a decent choice given the state of automation of that particular record.
DR. MC DONALD: The easier example is discharge summary and operative notes, which are literally just narrative text, but you can't put anything in there. You can't put your kids drawings in there or something like that. There is an expectation that there is not going to be stupid fraudulent or fraudulent content, that this is the formal thing you used in your hospital called an operative note. And there actually is sort of expectations of the pieces of that, too, of what should be in there.
DR. LUMPKIN: And the vast majority of those are also dictated.
DR. COHN: I was actually going to sort of comment. I think in some ways what we need to do is we all need to take responsibility to go and review the implementation guides when they come out in some detail and then perhaps bring this back for further comment after we have done that.
DR. FITZMAURICE: Two comments. One is that ASTM and the American Association of Medical Transcriptionists are beginning a process to standardize what the reporting format of the dictated notes would look like, not going in but what comes out, and that might then lend itself to standardization down the road of what goes on in attachments, particularly from emergency rooms.
The other point I wanted to make was that I went to a conference last week for public health people and health service researchers came together, sponsored by NCHS, NCVHS, AHCPR and CDC. And as they learned, some of them for the first time, about HIPPA, they were saying, well, you mean, this 837 claim is already solid. It is in concrete and we can't add our own data to it. Yes, that is pretty much the case.
Well, then, I guess we need to work on attachments. So, it got me to thinking if I am a state public health department and I want to regularly receive information from the treatment of patients, maybe it is hospital discharges, maybe it is physicians, suppose I wanted to pay for getting the information. Do I start the standards process by saying if I could define a standard for getting -- say if the procedure is I gave an immunization shot, then the attachment I want is here is the serum I used. Here is the vaccine I used.
If a patient was discharged from the hospital with a given diagnosis, then this is the information I want. So, if this is conditional, could I as a public health department define a particular transaction, hire a clearing house to receive that transaction and then do I go to a content committee, do I go to a standard developing organization to learn just how to specify those variables and then I can have my own transaction, which is not a claim. It is not a this or that, but it might be a separate transaction or it might be an attachment to an existing claim. It might even part of the claim itself that is conditional upon what the diagnosis or the procedure is.
That may be too complicated a question to address very well in the time that we have but I want to raise it as something, an item for further discussion.
DR. LUMPKIN: Well, actually hold that thought. We are going to have two panels at the February meeting, one on the use of standards for surveillance and then we are going to have a panel on the -- using a case study looking at the implementation of HL7 standards for immunization registries.
DR. FITZMAURICE: Great.
DR. LUMPKIN: So, that will be at the February meeting.
DR. MC DONALD: Could I just -- not to answer the question, but to pivot off it, I was at the same meeting and we have got to be very careful to distinguish transmissions which are voluntary for many different purposes from those that are obligatory. I mean, when we start making legal bonding to these things, everybody -- it changes the whole dimension so that the attachment structure could be used for a lot of different things.
So, public health has other data sent along but some of the people in the field -- and they may be right -- think that if they make it part of the claim, then everyone is obliged to collect those other 20 questions. Well, my expectation is that would cause a backlash against the process we are undergoing.
So, we wouldn't want to make it obliged, but if in a given state or something was set up or whatever and here is the mechanism that is sent and it is fairly easy, I mean, have -- we have always -- in voluntary standards it has worked best not to hit anyone with a club.
DR. LUMPKIN: Well, there are -- we will talk about that at the next meeting, but there are 65 diseases that require mandatory reporting.
DR. MC DONALD: I understand.
DR. LUMPKIN: So, it is not a voluntary endeavor, but let me suggest this, since it is going to go back to the work group. I think that there are some questions that have been raised here that if there aren't some of the key groups that were involved in this process, the College of Emergency Physicians, the fire chiefs, the ambulance associations, if they have not been -- and I am not saying that they would necessarily change the process, then I think we ought to have a hearing, at least give them a chance before the NPRM is published because this group is also a very vocal group and we don't need to get into -- turn into the mix a group of folks who say these rules are being published and no one ever talked to us.
So, we just need to assure that I think some groups have been involved. We probably want to look at all the six areas for the attachments to make sure that they have had a chance to have some input and if not, then we can provide a hearing to allow that to happen.
Well, that was a short 15 minute discussion. But thank you. Again, I think, you know, the issue of attachments is kind of a small item, but I think everybody is looking at the potential and there is a lot of concern. Will too many people try to be hanging their wagons on the
-- hitching their wagons onto the attachment horse and cause problems. So, I think we are really going to have to look at this closely.
Why don't we go to maintenance and upkeep. Is that next?
MR. STREIMER: Yes. I am not going to promise 15 minutes, though.
DR. LUMPKIN: We haven't even gotten to enforcement. Let me ask Bill if there was -- before we jump into that. We had you on first for update. Is there anything you wanted to add to what you said this morning?
MR. BRAITHWAITE: No.
DR. LUMPKIN: Good. Okay.
MR. STREIMER: Data content. First of all let me put this in an appropriate context that what I am about to say are more thoughts and ideas and not any HHS proposals for consideration and for that reason, I would like you to keep that in mind. Not until the final rule is published will you see held HHS -- the public will see what HHS is proposing in terms of data content management.
As you are all aware, the issue of data content and managing data content was part of the transaction and code set notice of proposed rulemaking, where we asked for a comment on that very issue. In working through all of the comments that we received, we have had basically a number of guiding principles and that seems to be the common cliche these days, but one has been foremost in our mind and that is the legislative requirement that we cannot update standards more frequently than once every 12 months and that we have -- that we provide 180 days at a minimum to implement any modifications to the standard.
I say that very -- at the outset here because it is very important to understand that particular guiding principle, if I may, in the context of existing processes that are used to update standards. Those existing processes, for example, the process used by X12, don't necessarily integrate well with a no more frequently than 12 months, 180 day implementation time frame.
With that said, I might -- I want to say that we have been working with the various data content bodies that currently exist, the ADA, the NUCC, the NUDC, the NCPDP, X12N. We have been working with all of them and these committees themselves have certainly been very much involved with data content, even before HIPPA and the relationship has been a very positive one.
Out of those data content committees, the NCPDP right now is the only completely self-contained organization regarding data content. They became ANSI accredited in 1996 and they established both data content and messaging standards for the pharmacy sector.
To make a long story short, one of the proposals that we see before us is that the NCPDP could simply continue their role as a data content body for all pharmacy transactions. One proposal that we have heard about and that I am going to talk briefly about is that to have the NUBC, the NUCC and the ADA maintain data content for the X12 transactions and having them work with X12 for the work on the messaging aspect of data content.
In late September, we met with Mark Siegal, who is the chair of the NUCC and Mark agreed to facilitate and coordinate conversations with the other data content bodies, including the NCPDP and X12, ADA and NUBC and, as I said, the chair of the NUCC, to develop a paper for the department, which outlines a proposal for roles and responsibilities for each of the bodies.
The proposal would include such elements as which body would oversee which transactions. Now, there has been a number of -- there has been a lot of discussion about whether some of these data content bodies should deal with non-claims-related transactions, like enrollment and disenrollment. The charge put to the NUCC in their coordinating effort is to include all of the transactions in their discussion, to come back to the department with some kind of proposal that would address data content and messaging for all of the X12 transactions that have been proposed in the NPRM for transactions and code sets.
We had asked that a process be articulated in how we could update the standards and maintain them in line with the legislative mandate or the guiding principle that I had just mentioned. We want a process that would allow for one stop shopping, for entities or individuals that wish to make a make a change to data content so that they don't have to call 50 million people to try to get their input into the process.
We want to have at least two open meetings per year with all data requesters invited to present their needs and to participate in the decision-making process and there would be no fees charged with participation in these open meetings.
There needs to be a process, which allows for coordination across all of the content bodies, whether it is to have an overarching committee to see that process or just to have a process itself, just as long as there is coordination among all of the bodies and that the process would agree to follow all American national standards institute of protocols.
So, basically, we took this request and put it back to the content bodies themselves and we are waiting for a proposal from them that we will be more than happy to share once we have it. That proposal is not due until sometime this month and basically I expect -- I haven't heard anything to the contrary that would delay it any further than this month.
We are looking forward to that. Some of the other proposals that we have heard from the comments in the NPRM is simply to have X12 be the overarching data content committee and let all data content issues be X12 issues. And as I mentioned, we have also heard that maybe the five or -- the five content committees that I mentioned could not basically coordinate among themselves, but to have another body, maybe a sixth body, be an overseeing body to manage the ADA, the NUCC, the NUBC, X12N and the NCPDP requirements.
So, that is pretty much where we are with that.
Jeff.
MR. BLAIR: This sounds like a similar discussion that came up in NCHISB by these same members that -- at least the impression I had was that they were thinking that the Health Care Informatics Standards Board was an appropriate forum to be able to deal with this.
Are there some thoughts that have changed on that or --
MR. STREIMER: Let me just say since we are in a rulemaking process right now, we are considering all proposals and as I mentioned that being one of them in effect because they would be overseeing the whole process. There is nothing right now that I could say is the direction we are taking.
MR. BLAIR: Okay. When you started to talk, I didn't hear the introduction. So, I don't know who I am speaking to.
MR. STREIMER: Pardon me. I am sorry?
MR. BLAIR: What is your name?
MR. STREIMER: Stewart Streimer.
MR. BLAIR: You are Stewart. Okay. Thanks.
DR. LUMPKIN: Other questions?
DR. MC DONALD: Well, just -- maybe it is a question or comment, this issue of -- we have talked about it in a couple of different ways, but whether we are talking about an abstract message where all the -- more of the stuff is in the content or in the codes or we are talking about -- I guess what I would plead to think about is trying to reduce the structural changes and make the changes occur in content.
I also try not to make the definition of "claim" as something that has to always be there, but to make -- talk to the people doing the IS parts of this and see what they would like in terms of being able to make those codes. And then you have a kind of an easier time of it. You can kind of keep it in vocabulary venues or content venues.
Then you might be able to do your standards easier and the messenging people shouldn't care a whole lot if the structure isn't required to be changed.
MR. STREIMER: And I am hoping that that would facilitate the timeliness of the update.
DR. LUMPKIN: Let's take a case study then. What would be the plan, for instance, in dealing with the change from ICD-9 to ICD-10, would that fit within that category? How would we address that?
HIPPA, I mean, the NPRM says ICD-9. By the time it is implemented, ICD-10 will be in place. So, the question is using that as a case study, how would you foresee HHS, by rule, making that change?
MR. STREIMER: HHS would have to publish notice of proposed rulemaking proposing ICD-10.
DR. LUMPKIN: Would that be the one change for that 12 month period of time?
MR. STREIMER: Well, unless you are suggesting changes to ICD-10 once that is the adopted standard, like changes to ICD-9 during the interim until such time that ICD-10 is adopted. But it would have to be a process or updating those particular code sets.
DR. LUMPKIN: Well, changing the rules to now require this spot to be ICD-10, would require rulemaking. Would that be the 12 month drink at the trough of changing the standards.
MR. BRAITHWAITE: I think it would, John. But it would not be the only change. I would expect an evolution of these standards over time that would involve a significant number of changes each year to keep up with business needs and process needs and so on. Changing from ICD-9 to 10 would require one of -- it would be incorporated into one of these every 12 month issuances of a rule, but certainly the changes to codes within that coding system would not be necessitate any rulemaking.
DR. LUMPKIN: So, the process of managing the changes that are required seem like they would be quite complex unless it was clear that there was a date certain. In other words, all the rules have to be in the queue by February 15th or they have to wait for the following year.
DR. MC DONALD: Something like that, yes. Well, if the code changes within a code set don't have that same regulation --
MR. STREIMER: There are two issues here. One is what will require a rulemaking process before such time that it can be adopted and then there is the issue of what will not require a rulemaking change and both are complicated processes.
DR. COHN: As you go through this current rulemaking process that seems to have taken a relatively considerable length of time, how does that become a timely process? I mean, I think many of these things will not have much applicability if it takes what we have just done to change a rule each year.
MR. STREIMER: I think from the point of the data content, aside from a wholesale new ICD version, we would not -- or we would hopefully not have to go through any rulemaking because I agree. I don't see that we can -- or we have a lot of control over the rulemaking process. However, we are working with our general counsel in terms of looking at not only where do we draw the line trying to be sure that we can put as much to the non-rulemaking side of that line as possible, but are there other things that we can do or think about that might simplify the process and even today we might have to do rules. Tomorrow we might not.
For example, there are different kinds of processes to get the information out to the public. For instance, just publishing the notice in the Federal Register is one of those ways. If we were to have the ability to do just that rather than go through a formal rulemaking, that would greatly simplify the process and we are looking at various options to try to do that.
DR. JANES: So, if I understand you correctly, you are saying that at this point you are not sure whether, in fact, this yearly update is going to require a new rulemaking process. Is that what you are saying, Stewart?
MR. STREIMER: It depends on what the update is whether it will require rulemaking.
DR. JANES: Maybe yes, maybe no?
MR. STREIMER: Yes. Correct.
DR. LUMPKIN: For instance, there are agencies that routinely make some changes to their specifications without going through a rulemaking process. So, the issue is where does it fit within that magnitude of change and not only do you have to discuss with the council about whether or not you can use that methodology but there also will need to be an assessment on each change, whether it fits in the group that requires no change as within a code set, where you probably aren't really doing anything that -- you know, you add a new disease or something like that, like a change in CPT-4. You wouldn't expect that that would require any action by HHS if there is a change in CPT-4, unless they were to change the length or something like that of the format.
Then there may be some things, which may fit in in between that could be done by just publishing a notice. Then there are those things that would require a rule. Is that kind of the range?
MR. STREIMER: A major structural change to an X12 transaction set, which would require new structure, new version will require a new rule. Something a lot less than that may not require a new rule.
DR. COHN: Can I go back to sort of an earlier comment that you made, only because I was just pulling up my copy of the legislation on my computer here. This is an area that I perhaps need a little bit of clarification on and that has to do with between now and the, I guess, 12 months after the implementation of the standards.
I guess I am a little confused about how this was all -- how things are going to change over the next while. I mean, it is clear from the legislation that after 12 months of a standard, one can have a change to that standard.
As I read the legislation -- I am not a lawyer, first of all, so I don't always understand all of this quite as well as I might, but it is unclear to me whether the standard is going to be initially identified in the final rule. Does that stay as the standard for between four months to allow for initial implementation and then the 12 months after that since it is called the identification of the initial standard?
MR. STREIMER: I am not a lawyer either, but I think the law does -- I mean, we could even make a change after 12 months after adoption, which would make changing the standard at that point in time during the time it is being implemented very cumbersome for everyone to try to do that. But I think the way the law reads under the modification section is -- and a little bit further is that there will be no changes during the first 12 month after the standards are adopted. And that once the standards are adopted and modifications thereafter, there will be no changes 12 months after that, no sooner than 12 months.
MR. BRAITHWAITE: But since people have two years to implement before they must legally comply, as people start to implement and they give us feed back about what works and what doesn't, it gives us a mid course correction capability to issue a rule, which changes the standard as necessary to make it more implementable in the middle of the implementation process, in addition to the emergency clause that allows us to put in changes at any time, if they are absolutely necessary to allow implementation time.
MR. STREIMER: But that in itself is complicated when you have to do a rule to make that change.
DR. COHN: So, I guess I am now speaking as someone who is actually going to have to implement these standards. So, what is going to happen is is that we will have the final rule and industry will be sent out to implement that standard, except that likely it is going to change before they actually implement it.
MR. STREIMER: Say that last part again.
DR. COHN: Okay. Sometime next year --
MR. STREIMER: That it will likely or will not likely?
DR. COHN: It will likely, is what I understand because I am -- as I read this, I think I understand why you are saying this but I am also a little concerned. So, basically what is going to happen is we are going to have the final standard identified for implementation in 24 months, except that -- and we were going to send out people in the community to start ready to implement that standard, knowing that that standard doesn't really have to be implemented, in fact, will not be required for 24 months, but we also know that every 12 months during that period, there will also be changes to that standard. So, people won't be implementing that standard, they will be implementing the standard two cycles down the line.
Am I understanding this correctly?
MR. STREIMER: Let me just say that I think to the extent possible, the department is going to be very sensitive to not changing the standard during the implementation period unless circumstances warrant -- unless we change the standard, the public could not implement it the way it is set.
I think we have to be sensitive to that or else we will not have administrative simplification.
MR. BRAITHWAITE: That is what I meant by mid course corrections. I am talking about changes to make it easier to implement not, you know, wild changes in the goals or something like that that would blow away all the work that people had done up to that point in implementation.
DR. LUMPKIN: But my impression from talking to RDP staff, that the biggest cost is going to be installing an EDI engine and once you have the engine installed, making -- tinkering with that engine is less significant because most of them are fairly sophisticated devices of just changing a little bit of the mapping that is there.
So, I think it is not necessarily as bad as it sounds. If there is a need to tinker with it because it is not working well -- and the few people who may have actually gotten it to work, would not have a major undertaking as if we were to do a dramatic change in the standardized. So, I think, obviously, we want to minimize the changes but if we do have to make some minor tinkering, it wouldn't be disastrous.
DR. COHN: I am certainly not saying that what is -- that this is necessarily a bad thing, because if, indeed, it makes it more usable, I think we are all in favor of that. I just, however, would, I think, implore the department to keep that sort of concept in mind as opposed to making larger changes.
I know all of our organizations are different sizes and what a small organization can do in terms of training, getting people set up, getting the databases set up to really handle things is probably different than what a large organization needs to be doing and we just need to be aware of that and probably followed along as it moves forward.
MS. COLTIN: I had a question regarding the claims attachment standard, which seems to me that there are a lot more things that are changing within the health care environment that are causing managed care organizations, at least, and hopefully other payers as well to have new information over time.
That is one attachment where within this time period I could clearly see that other types of information may need to be requested beyond the six types that are currently identified. One example is there a new performance measure being talked about around control of hypertension, which would require blood pressure, which is currently not in the 837 and the only way for plans to get that and if performance is, in fact, tied to compensation or there are other reasons for needing to collect this information from a business standpoint, not the least of which is being held accountable by the Federal Government in many cases, that we would come back and say need a vital signs attachment that will allow us to get blood pressure in any number of other vital signs, for example.
Given the kind of time horizon that you are identifying where the claims attachment standard is being defined right now with only these six components, will that impede the process of being able to add new components such that not only could that only be done once a year, but during this introductory phase might have to wait even longer if you are being sensitive to change.
DR. MC DONALD: At risk of falling off one side of the other of this razor's edge, the attachment was designed to be sort of a lightweight easy to enhance for lots of kinds of purposes and not necessarily restricted to financial things at all.
Since it carries an ORU message, it can send any kind of clinical data. I think formally what is allowed during this ramping up period is that we -- and it was the intention is that additional attachment specs will be set but all it is going to be is code lists. It is not going to be any new segments. So, the machines will be all taken just -- and those will only be voluntarily used. They will be voluntarily -- and that is another way to shake them out.
Then if they are -- the ones that are needed for the financial side, they might be then -- because there are a whole series of other attachments, the SRD, which is really mostly lab results, which has not yet been formalized. So, some of those that have to be formalized and would be then finally at the right time, but if we wait for that day to do them, you are dead. So, the idea is we could ramp these up for voluntary use, which would also give us an opportunity to tune them.
But this tuning is going to be easy because it is really -- the hard part was definition what was precisely what you mean when you say you want something. What you see on some of the forms is the date and the first thing, what date of what. Well, there is only one data, but, you know --
MR. STREIMER: That introduces a -- that is a good example of something that I need to take back in terms of whether that kind of upgrade or enhancement is such that we need to go through full rulemaking or whether we can do something less than that to accommodate the business need that comes about more frequently, you know --
DR. MC DONALD: The other advantage of sort of pushing things to the code side is it is lighter weight. It is lighter weight for those compilers. It is lighter weight for all the processers and the only place it gets difficult is in the argument about who has to do additional data collecting.
I think in terms of a voluntary standards guy, I never want to be between two groups trying to push each other. Here is the vehicle. You guys fight it out about whoever is fighting it out about what is required. As a clinician, I don't want to have to fill out anymore forms, but this could be automated, so maybe we don't care. I do take blood pressures on everybody.
DR. JANES: I just had a quick question for Steward.
Stewart, am I correct that both the data maintenance organizations and also this process we are talking about both have to be incorporated in the final rule, that this has to be decided before the final rules comes out?
MR. STREIMER: The final rule will spell out what the process will be.
MR. BLAIR: The things that I heard in today's meeting, I think there was a missing perspective, which might -- is this Kathy -- yes, your comment -- and that was in some of the previous sessions -- and maybe it was because I attended one of the HL7 claims attachment CIGs -- the initial attempt was to try to do a lot more with claims attachment CIG and was just different to get your hands around things and get it defined.
If I recall correctly, about a year ago there was a laundry list of about 17 areas, not six and it was a matter of what could be done in the time frame. So, I didn't get the impression that the six were all that were considered, but it was that these were what could be achieved in the time frame and that, in fact, once these are in place, it tends to create a foundation upon which it will expedite additional things because these framewords can be then used, as Clem said, on a voluntary basis, probably much more quickly.
So, I think that this whole process served as a catalyst to move things forward and I wouldn't look at the six as a limiting factor, but as a starting factor.
DR. MC DONALD: Some of the six are pretty big. When you talk about the other notes, it covers a lot of sins.
DR. LUMPKIN: I think we are going to have to move on.
I hope this was perhaps helpful to flesh out some of these issues. I think it certainly was helpful for us.
Thank you.
Let's jump to enforcements, standards enforcement. There was a discussion at the Data Council where there was interest in this committee holding a hearing.
MR. BRAITHWAITE: Yes. And I am not so sure that we are ready for that. The comment -- the NPRMs that we sent out basically said that the law requires us to enforce this. You know, if don't comply with the standard, we get to fine you a hundred bucks. There is a not a force behind that sort of line. There were three pages of legal exceptions that you could get out of being fined a hundred dollars, which would take several years of process before you actually got fined a hundred dollars.
That is a personal interpretation of how that came out and the comments that we got on the various NPRMs were more supportive of a kind of the position we took, which was let's see what and see what happens. Let's see how implementation goes. Let's see how the private sector responds to what they need to do in terms of getting mechanisms set up for testing and certification and accreditation and how the various standards get incorporated into various other organizations that see the legislation, like JCHO and NCQA and so one.
So, there is a lot more enforcement than just how do you slap a fine on somebody. So, we wanted to kind of kind of sit back and wait to see how all that sorted out.
The comments that we got sort of concentrated on details of definitions and process and on timing. As you might imagine the timing comments were basically give us more time in a variety of different ways; that is, don't enforce it for five years or two years or one year or whatever beyond the deadline initiated in the law or, you know, give you exceptions and favors and kinds of different ways of saying, you know, don't look at us too hard for awhile until we sort it all out.
Then the other set of comments was more on, well, what is a violation anyway. How do you count up the thousand violations that it takes to get up to the maximum fine or is a violation that is a whole claim that is submitted where there is one error or if you have ten errors in a claim, is that ten violations, all kinds of questions like that that they wanted more detail on.
And then details on the process, more details about, you know, what is the process by which the government is going to send out the EDI police and what is the process by which I can appeal my hundred dollar fine and so on. The NPRM said let's wait and see what happens before we set up this huge bureaucratic process. On the other hand, it takes a long time for us at HHS and the rest of the government to set up that kind of process.
So, we are exploring options the department, such as setting up an implementation team like for the other standards, but setting up an implementation team that would involve the kinds of people like the Office of the Inspector General, who would be involved in the enforcement process to guide us through a process of coming up details that were asked for in the comments in as much as can lay out and then with the expectation that we would refine that in later final rules.
We will probably come out when we come out with a final rule with some more details, some more refinements of what the definitions and process might be, but that the final, final rule on enforcement will probably be one of these mid course correction kinds of things as we get further into the process.
So, that is kind of the background. Do you want to say anything more about that, Stewart or --
MR. STREIMER: No.
DR. LUMPKIN: Jeff.
MR. BLAIR: I don't know if we have the latitude if we look at this, the corollary of a punishment, which is an incentive. My thought is that for the most part, these standards are going to be incorporated into vendor packages. I think there is going to be -- I may be wrong, but my perception of the market place is that for the most part, a vendor is doing to do just what they do with standards that exist today and they will be putting on the brochures and advertising at trade conferences, that they are -- just like they wind up advertising that they are HL7 compliant, that they will probably want to say that they HIPPA compliant.
MR. BRAITHWAITE: Just having returned from several conferences, they are already saying they are HIPPA compliant and we haven't even put out the final rule yet.
MR. BLAIR: Then that may be a greater driving force than the threat of a following because if there is value to the vendors in being to advertise that they are HIPPA compliant, that may be where we have leverage at far lest cost and with far greater effectiveness because what we might be able to do with much less expense is adjust a couple of minor tests in terms of the early users or the beta test sites of these things just to verify, you know, the compliance at both ends, that they are HIPPA compliant and that, in fact, there would be some indication from the Department of Health and Human Services that, yes, they are HIPPA compliant or, no, they are not.
That may give us much greater leverage with a lot less cost than trying to have fines.
MR. BRAITHWAITE: I think that Congress's original intent was that -- I mean, the whole purpose for passing this along in the first place was to safe the multiple billions of dollars promised by the industry and if the marketplace won't people to meet the standards, the hundred dollar fine is certainly not going to increase their compliance.
DR. LUMPKIN: Simon.
DR. COHN: Very good comment, Jeff. I actually was just going to follow this issue of compliance. I think it is hard for people to determine whether they really are compliant, much less this issue of fines. I mean, how do you know if you are compliant; therefore, how do you know you are not compliant. I know we had had discussions previously around that issue of trying to encourage there being some sort of mechanism in place.
Is that likely to be in any way part of final rules or touched on in any way?
MR. BRAITHWAITE: Well, there are mechanisms that are in place to day and I expect that there will be more before people are required to comply legally with these standards. I forget what it stands for but the ENACH(?) group is an organization that has put together a mechanism that you can send your transactions to and they will certify that they are compliant transactions.
As trading partners start exchanging these standard messages and if they disagree about whether they are not standard, there is a place that they can both go to to find out who is not in compliance if their message are not properly getting across.
So, I think that mechanism is already in place and as someone said that the people who are trading this kind of information are not only partners because they have signed an agreement with each other, but they are competitors in a sense and will squeal on each other very quickly if a person -- if they can show that they are compliant and the person they are exchanging information with is not.
The only question is what do we do about that when somebody, you know, calls up the 1-800 HIPPA line and says I just tried to send a transaction, a standard transaction, to this person and they can't understand it and they say they are HIPPA compliant and we know they are not. So, go and find them.
So, it is that level of detail that we have to get to at some point in this process.
DR. LUMPKIN: It is all Microsoft's fault.
MR. BRAITHWAITE: We just call Bill Gates and have him set the standard.
MS. COLTIN: In addition to the notion of, you know, vendors developing products that are HIPPA compliant and the fact that, you know, so many organizations are upgrading their systems, the Year 2000 issues and other, you know, driving forces, another way to think about this is there are lots of laws out there that, you know, everyone should comply with but that, in fact, as a condition of doing business with the Federal Government, you have to agree to a contractual requirement to adhere to a law that you should be adhering to anyway, but it becomes a condition of the contract.
So, it seems to me that simply by making it a contractual obligation, you are going to have what we call turtles down the line in that, you know, the plan isn't going to want to violate its contract. The penalties for that could be more severe than the legal penalties. Losing the contract could be a major business threat.
If HCFA and OPM required it as a condition of contracting with payers that they be HIPPA compliant, payers will, in turn, will build it into their contracts with providers because we are none of us going to want to be at risk to violate the provisions of the contract, never mind the law.
So, I think there are lots of other ways to deal with this and if you have to be compliant to deal with one major contractor, you are not going to have a non-compliant system for one and a compliant system for the other. I mean, your system is going to be compliant for everyone.
Then there are other mechanisms that are also in place under a number of those types of contracts for audit. So, for instance, when HCFA does it HEATUS audit, they do a systems audit at the same time. That is one component of the HEATUS audit. They could clearly look to whether the systems are HIPPA compliant or not.
So, I think there are other ways to look at enforcement that are, quote, voluntary but not quite.
DR. LUMPKIN: So, I get the impression that maybe we don't think about hearings in the near future at this point.
MR. BRAITHWAITE: Well, because it takes quite a while to set up a hearing, we should think about it quite a few months before we actually have to do it. But I think that we have got a lot more internal work to do before we can lay out some options that would make good sense to have a public hearing about it, in my opinion.
DR. LUMPKIN: Okay. Works for me.
We have just about exhausted our allotted time and we do have another work group that has a meeting. The only item that we haven't hit was discussing a few issues from public comments and NPRMs. Can we get maybe --
MR. BRAITHWAITE: A brief overview maybe, like how many comments we got and sort of a general sense of what the comments were like.
DR. LUMPKIN: I think we have heard before how many comments we have gotten. Maybe a general sense of what they were like, besides the time. The time we already heard.
MR. BRAITHWAITE: Very hard to characterize, as you might imagine, with as many comments as we got. But, in general, the comments we got addressed things like the policies, particularly in answers to the questions that we laid out, which were mostly policy questions in the various NPRMs. In some cases they were technical errors or suggestions the implication guide or the standard itself be changed. About 30 percent of the comments we got on the transaction regulation, for example, were of that character and we have forwarded them to the implementation team at X12 to get their response and suggestions about whether that means tweaking the implementation guide or putting a data maintenance through the whole long process to change the standard itself.
A lot of comments supporting the standards and the process, which was very nice to see and then the kinds of ones that I talked about already, which were more, you know, well, that won't work for us because we are special or we need more time and it is more timing issues and then some peculiar ones. For example, on the employer identifier regulation, we got a lot of comments that came back that privacy and confidentiality of information when it was identified.
And I think that unless I hear otherwise from folks -- and I have been going around the country asking people for more clarification about this -- and unless we hear more clarification about this, I think it was mostly a case of misinterpretation, where people felt that their identifiable information was going to be associated with their employer's identifier somehow and that would make it more vulnerable to inappropriate disclosures.
But some of them were very, very difficult to interpret. There doesn't seem to be a rationale behind it that made sense given what we were proposing.
There were some comments or a series of comments like for the rules that -- where we were much more explicit in the role itself, like for the NPI, for the national provider identifier. Many of the comments and discussions that we had here at the committee and the suggestions that we put forward to the secretary as a committee were also repeated by other organizations so that the national provider identifier, for example, a large proportion of the comments said make the database, just identify providers, forget about putting everybody's practice addresses in there, forget about associating people with the very dynamic process of being associated with various groups and so on.
Just uniquely identify the providers and you will make things simple. And, oh by the way, make it ten digits, not eight, alpha numeric characters while you are at it. So, a fair number of the 5,200 and something comments were directed towards sort of refining our definition of what an NPI was and how the system ought to work.
On the other hands we asked questions like, well, what kind of registry process should we set up? Should we mostly have federal health plans or should we set up some contracted central authority to do this kind of thing? And the comments we got there were on both sides without a preponderance on one side or the other.
So, I don't know what we are going to do about that one.
MR. STREIMER: Well, I know we don't have time to go through this. I brought a paper that I could share that really gets at a couple of the key issues, especially associated with the national provider identifier. I think Bill did a good job laying out what we have heard. Now we are just wrestling with trying to deal with some of these issues, as Bill points out, not so much that we are not dealing with all of the others, but we are still at a point in terms of who do we enumerate with an NPI is still a key issue for us and a key issue that we are dealing back and forth with.
I think it is a very important issue, not only whether a particular provider type should get an NPI, but once it is decided that they should get an NPI, the extent in terms of, as Bill mentioned, their practice location and how that will play out, there are still a number of these nutty issues that we are wrestling with that we need to work through and certainly the subcommittee's involvement in helping us work through some of these issues would be welcomed.
DR. LUMPKIN: I think one of the things that we could certainly do on that is recognize it. Everybody has the potential of becoming a health care provider and just give them a number at birth.
[Laughter.]
Simon.
DR. COHN: I was just curious, in my review of the various NPRMs and certainly -- and comments that I have seen, actually the security NPRM, at least from what I saw, that seemed to be eliciting the most comment. I don't know if either of you have had a chance to look at any of the comments coming back or have any comments, though. You do reflect it on the transaction standards and the unique identifiers. Any comments about the security --
MR. STREIMER: I think if I may, I don't have a count of how many comments we have received on that one yet, but the comments vary. I mean, we have received, on that particular NPRM a large volume of very positive comments in terms of the approach the department is taking in terms of laying out security requirements and being sure that they are scalable and recognizing the needs of the small provider against the large provider.
But we are also hearing in some instances about in the cost concerns of the small provider and the large provider to meet the needs of the security standards, where we thought by having a scalable approach, we were very clear in terms of that, it would certainly or hopefully a lot less for the small provider than the large provider. There are a still a lot of concerns out there about that cost.
So, like all of the NPRMs, we are getting the full spectrum, but I will say that -- and of all of the NPRMs, I think that is one where I have seen the most, very positive, very clear, very positive feedback from the public that we have put out a very clear, concise NPRM.
MR. BRAITHWAITE: In my skimming of the MISAR(?) comments relative to the times -- the timing at which you had to meet the security requirements, people wanting more time or wanting to be able to do asynchronously from instituting the other standards and then the cost issue, which came up with -- came up from those people who don't have or haven't turned on the security facilities that they do have. So, they are running naked right now and it is going to cost them a significant amount of money to put appropriate security measures in place.
If you go to most major -- and as I said, I have been running around the country talking to folks about this. You talked to most major organizations and they already have in place fully HIPPA compliant security systems. And then there are others that have none. And it is the ones who have none that are going to experience the cost.
Of course, the people who are already have it say great, now we will have a level playing field to work on because every other industry in the country has recognized and insisted that everyone of their members appropriately protect information that is of value to them and usually this is, you know, corporate information of some kind. So, this law makes it clear that information about individuals is important and that will be secured.
So, I have not heard a single feedback from anyone,except a small provider, who didn't really understand the scalability aspect of it. I have not heard that the requirements were onerous, that they were anything other than the industry standards that are out there that should have been already implemented if people had done the right thing.
So, I think our industry will have to deal with that cost issue, but I don't think there is a way around that. I think it is something that has to be dealt with as part of doing business and should already have been dealt with that way and for those who haven't, they are going to have to bite the bullet and do it.
DR. LUMPKIN: Great. Thank you. That makes me feel more secure.
Why don't we take a ten minute break and then we will go the work group. The last item on the agenda is the progress report from the work group. I think we will make that as the first item of the next agenda.
[Whereupon, at 3:35 p.m., the meeting was concluded.]