[This Transcript is Unedited]
Washington Terrace Hotel
1515 Rhode Island Avenue, NW
Washington, DC
Subcommittee:
Staff:
Agenda Item: Call to Order, Introductions, Review Agenda - Simon Cohn, M.D.
DR. COHN: I apologize to members, staff, those in the audience for our delay, but I think you all know there were some issues related to transportation that were beyond any of our control.
Anyway, good morning. I want to call this meeting to order. This is our third day of three days of meetings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The committee, as you all know, is the main public advisory committee to the US:place>:country-region> Department of Health and Human Services on national health information policy. I am Simon Cohn, chairman of the subcommittee. When I'm not here, I'm actually the national director for health information policy for Kaiser Permanente.
I just want to welcome fellow subcommittee members, HHS staff, guests, and others here in person. I think as you all know, we are not actually on the Internet for these sessions, I believe due to server issues at the VA. Given the problems with viruses, worms, and others that have been occurring this week, I guess none of us should be surprised.
There will be, however, a transcript made of the meeting, as well as I think parts of the session will be accessible once the Web is back in service. So, I would ask all of you to make sure you speak clearly and into the microphone, and identify yourselves when speaking.
This morning we are going to be changing the agenda around a little bit. We are still going to handle all the same issues. Rather than starting with the claims attachments, we will be talking about CHI. Jared Adair is here, not Stanley Nachimson, but Steve Steindel. Both will be talking about CHI, and providing and update on status, as well as some of the specific domain areas that they are working on.
We will then, I think at that point, move to claims attachments with Stanley Nachimson. I think Stanley will also be handling the CMS HIPAA update. After that we have a reactor panel to talk about HIPAA issues, knowing that we are just a couple of months now from the actual implementation date for the administrative and financial transactions. And as we all know, this is a major issue we need to track closely over the next while. We will obviously be discussing the HIPAA implementation issues, and we are obviously thankful there is a panel joining us for that discussion.
As commented, we will take some breaks this morning, but we are going to be adjourning right around 1:00-1:15 pm as planned.
Now, as always, I want to emphasize that this is an open session. Those that are in attendance are welcome to make brief remarks if you have information pertinent to the subject being discussed. We obviously ask that you identify yourselves, and try to be brief and on point.
We will also try at the end of the morning to make sure that there is an open session, to make sure if anybody has any other comments that they want to make, that we have a chance to hear them.
As you all know, we also take letters, both by regular e-mail, as well as by the Internet, and certainly by Federal Express and all of that, and consider them as we go through deliberations on any of the topics that we consider.
Now, with that, let's have introductions around the table and around the room. As is always the case, if there are issues coming before the subcommittee today that you have a conflict with, or any issues for which you need to publicly recuse yourself for, please so state in those introductions.
Jeff.
MR. BLAIR: Jeff Blair, Medical Records Institute. I'm a member of AMIA, ASTM, HL7, HIMSS. And I'm not aware of anything that I need to recuse myself from.
MS. GREENBERG: I'm Marjorie Greenberg from the National Center for Health Statistics, CDC, and executive secretary to the committee.
MS. PICKETT: Donna Pickett, National Center for Health Statistics, CDC, and staff to the subcommittee.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, liaison to the full committee, staff to the subcommittee. And I also will be presenting the CHI report.
MS. ADAIR: Jared Adair from CMS, and I'm here as a guest today, invited I think.
MR. NACHIMSON: Stanley Nachimson from CMS, and I'll be presenting a little bit later today on several topics.
MS. AULD: Vivian Auld, National Library of Medicine, staff to the subcommittee.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to the National Committee, and staff to the subcommittee.
MS. BURKE-BEBEE: Suzie Bebee, ASPE, staff to the subcommittee.
DR. HUFF: Stan Huff, member of the committee and subcommittee, with Intermountain Health Care in Salt Lake City, and the University of Utah in Salt Lake. I am a member of HL7, and vocabulary co-chair within HL7, and also a co-chair of the LOINC committee. Anyway, if we talk about HL7 and LOINC, then I will need to recuse myself.
MS. SQUIRE(?): Marietta Squire, CDC, NCHS, and staff to the subcommittee.
MS. GREGO(?): Kim Grego, Hogan and Hartsen(?).
MR. DI CARLO: Michael Di Carlo, Health Insurance Association of America.
MS. GLISS(?): Joanne Gliss, American Clinical Lab Association.
MS. TORAKASKI(?): Irene Torakaski, American College of Surgeons.
MS. J. FRAZIER: Judy Frazier, American Optometric Association.
MS. TRENTI(?): Nancy Trenti, American Psychiatric Association.
MS. BICKFORD: Carol Bickford, American Nurses Association.
MS. WILLIAMSON: Michelle Williamson, National Center for Health Statistics, CDC.
MS. ECKERT: Karen Eckert with Medispan.
MS. FREEDMAN: Maria Freedman, CMS and staff to the subcommittee.
MS. LESH: Kathy Lesh, the Calvert(?) Company.
MS. C. FRAZIER: Chris Frazier, American Academy of Professional Coders.
MS. KOFNAR(?): Mary Kofnar, American Medical Association.
MR. EMERY: Jack Emery with the American Medical Association. I also am substituting for Michael Bebee this morning as a presenter.
MR. ALMANSON(?): Todd Almanson, American Hospital Association.
MS. PROFITT: Sue Profitt, Bowman American Health Information Management Association.
MR. TUMI(?): Said Tumi, American Informaticist, Veterans Health Administration.
DR. COHN: And just by way of public recusal, even though I don't think that any CPT issues are coming before the committee today, as everyone knows, I sit on the CPT editorial panel, and therefore would recuse myself on any issues about that. Also, as I have said all three days, I do work for a very large health care provider, and we use lots of clinical terminologies, but we have contractual relationships with almost that we may want to discuss either CHI or in any other session that we may have.
Jared, with that, would you like to lead off?
Agenda Item: CHI Update - Overview - Jared Adair, CMS
MS. ADAIR: Thank you.
I'm here today to talk about CHI, the Consolidated Health Informatics. In light of the time constraints, I will spend just a few moments giving a review to people about what CHI is, and then introduce Steve Steindel to talk about the particular domains that we wanted to talk about today.
So, let me quickly go through for people what CHI is. Consolidated Health Informatics is a federal effort to adopt standards for the use in our federal system. We recognize the importance that that might have to other entities, so that we have asked the NCVHS Standards and Security Subcommittee to work with us, to allow us to come and present what our choices look like they are going to be.
Actually, let me step back here. We want to come to talk twice with the NCVHS on each domain that we want to take a look at. The first is to tell people what domain we are working on, as well as the inventories that are available in those domains, standards in those domains to take at, and a little bit about our thought process and preliminary findings. And to see if we can get input here from the private sector as to what their thoughts are in that area.
We have also talked to Simon and Jeff about the opportunity to come back before we go final with any recommendation, and see what your thoughts are. And that is our plan. And that way, we hope that when we make selections of adopting a standard, that in fact the private sector will think that we have done a good job. I think the tipping point is kind of the term that Gary Kristoferson(?) from the VA has used on many occasions, and I will borrow at this moment.
And so, we really do want to get the advantage of your valuable input here, so that people will think that we have in fact adopted common sense standards as we move forward. We appreciate Jeff and Simon allowing us to do this with you. We are working on them on a rather aggressive schedule. Our goal would be to have gone through our 24 domains by the end of the calendar year.
So, that is an aggressive schedule. We understand we need to balance our movement forward with prudent adoption, and with insuring that we get valuable input. And when we get controversy around one, for us to step back and say what else do we need to be considering here?
In order for it to be successful, we have committed to sending material in advance, so that people can take a look at it, so we are just not hitting folks cold with what it is we are talking about. And so, in that vein, I believe we have sent you materials on lab result and content and unit in advance.
And without further ado, I will turn it over to my esteemed colleague, Steve Steindel from the CDC.
Agenda Item: CHI Update - Presentation on Lab Results Contents and Units - Steve Steindel, CDC
DR. STEINDEL: Thank you, Jared.
We would like to present to you the reports from the Work Group on Laboratory Result Content, which subsumed the area of units, as you will see when make the presentation, because of the way we defined laboratory results.
The first thing that the work group did was to define what a laboratory result is. We said that it consists of the result itself, results units if applicable, normal ranges, or any indicator flags associated with those normal ranges, and any comments associated with the result. So, by making that definition of the laboratory result, we actually subsumed the other CHI domain of units. So, we chose to make a recommendation both of those areas.
Then we went ahead and looked at the laboratory result itself, and found it was a complex entity. We defined it as having four different characteristics. The first characteristic was a numerical result, including such things as titers. And numerical result does not need a terminology.
Then the next type of result we found was ordinal results such as plus 1, plus 2, et cetera, that a lot of laboratory results are expressed as. These also do not need a terminology, however, there are some comments I'm going to make concerning ordinal results in some of our recommendations with regard to test methodologies, since those are important in interpreting those results.
Next, there are results that are expressed against the cut off value. These are results such as positive or negative, or greater than or less than. And these are also results that do not need a terminology.
Lastly, we get to alpha-numeric results, descriptive results. Finally, we have a set of results that do need a terminology, and this is what the recommendation will focus on in the result area, the alpha-numeric results.
We also noted two things with regard to the results. One is the existence of the indicator flags themselves, which we're not making any recommendations for, because they are very dependent on the type of result that is involved. And the second is the comment abbreviations, which we noticed were quite frequent in the laboratory area, and we noticed that there were no standards for that. That is our comment, and we will express that a little bit later.
We also noted that in the federal health care domain where CHI standards apply first, and hopefully outside later as the tipping point principle that Jared alluded to, do include non-human laboratory test results. These include animal. They also include plant material, environmental specimens, et cetera. We have found that the terminology for non-human test results is weak, and that much work needs to be done in that area.
Other than that comment, virtually all that I will say is more applicable to the human area, and I will probably re-express the need to work in non-human area at the end of my discussion.
We looked at various terminologies in this area. We looked at MESH(?), because they contain a lot of laboratory results; the National Cancer Institute NCBI taxonomy for organisms; SNOMED CT; LOINC; a lot of UMLS category 0 terminologies that also express laboratory results; and HL7 Version 2 and Version 3 in particular for units.
Out of those domains what we decided to recommend to the CHI Council, and was approved by the CHI Council, and now we wish to discuss with you and hopefully get your approval as a final recommendation is our primary recommendation is to use SNOMED CT. And we have listed a various set of hierarchies of SNOMED CT. If one just says we recommend SNOMED CT, that covers everything. And what we did was only focus on those hierarchies in SNOMED CT that did pertain to laboratory results, and those are the hierarchies we are asking for approval on. That is our primary recommendation.
We do have a secondary recommendation in that we found in the area of organisms in particular, for research purposes, SNOMED CT is a clinically focused terminology. It has roughly 17,000, probably a little bit more clinically valid organisms. For research purposes, and for some of the purposes of epidemiology, et cetera, that we in CDC engage in, there are a lot more organisms that are identified.
So, we are also recommending for those purposes, the NCBI taxonomy maintained by the National Cancer Institute, which has roughly 100,000 organisms listed in it at this point. Naturally, there is a fair degree of overlap. The 17,000 organisms in SNOMED CT are there, and there is a high degree of synonymy. An organism is an organism whether it exists in SNOMED CT or it exists in NCBI, so we can relate the two terminologies fairly clearly.
Because of the need to transmit or translate between the two terminologies, we are recommending that if possible, people transmit the information on an organism both as a SNOMED code, and the UMLS CUI(?) that represents that organism, so that one can easily switch between the two terminologies if necessary.
That is our principal recommendation with regard to result and content. This applies just to the alpha-numeric results. Remember, I listed four classifications for laboratory results.
I'll pause at this point and ask if there are any questions concerning our definitions of the results, or that recommendation, which I think one can assume is the primary recommendation of the report.
DR. HUFF: I would just say that I certainly support those recommendations. I think that's a very rational and appropriate thing, both the way that you classified the results, as well as your choice for the terminology.
DR. COHN: I would actually also agree. I guess the only question I would have is in the UMLS currently are the mappings and equivalences --
DR. STEINDEL: Actually, they are.
DR. COHN: So, that works very well then.
DR. STEINDEL: Well, there is a codicil to that.
DR. COHN: There always is.
DR. STEINDEL: SNOMED CT does not exist in UMLS at this time. It is being added post-federal license, and will be released in the UMLS in the January timeframe. There are mappings that exist between SNOMED CT Version 3, SNOMED International and NCBI through the UMLS CUIs. So, they do exist, but they exist for the previous version of SNOMED CT, and we will presume they will be maintained when SNOMED CT is added.
DR. COHN: I would just ask are there any questions from the audience?
DR. STEINDEL: We note that there are no conditions that apply to this recommendation, however the work group did note that as with all terminologies, there are gaps, areas that need to be filled, and this is true of virtually any recommendation that we will make.
The next part of the results that we were talking about were the units associated with results. This was listed as a second CHI domain that we are reporting on for approval. We looked at the units area, because it is intimately tied with the laboratory results.
We found that the general standard for units in this country is defined by an ISO standard and a corresponding ANSI standard that are perhaps a little bit dated, and are in the process of being replaced. But for the purposes of laboratory test results, and it appears also for the purposes of medical information, they are relatively complete.
There are some gaps noted in some common units that has to do with measurements of jewelry measurements like carats or something like that, that we don't necessarily use routinely. So, we didn't feel that was a major problem.
These unit tables are maintained at this point and distributed through HL7 as part of their standard. So, making the notation the ISO/ANSI standards appear to meet our needs, what we are in part saying is the HL7 unit specifications meet our needs. We do note that the HL7 is in the process of discussing updating that unit standard to a more recent version. And our recommendation equally well applies to that.
We have looked at that more recent version, and just see it as an improvement over what we are already recommending, and has no major impact in the area of laboratory or medical information. So, our point of view is transparent, and our recommendation is to use the HL7 unit codes, which are essentially the ISO/ANSI unit codes.
I'll pause there for questions.
We have discussed content coverage. Our investigation of the SNOMED domains in this area, except for the fact that gaps always exist, appear very, very complete for all areas of laboratory results that we would be interested in. We do note two areas that are associated with laboratory results that we could not find standard terminology. There are bits and pieces that exist in various terminologies, but no organized terminology that exists to cover these areas. And we have a request that some standard development organizations maybe take this up and look at it.
The first involves standard comments, because comments are routinely associated with laboratory reports. A lot of standard comments like hemolyze, lipemic, et cetera, exist in multiple terminologies. But more complex standard comments like descriptions of microbiology test results, interpretations with respect to cut off values, that type of information that laboratories routinely transmit as part of a comment is not standardized.
The example that I like to give when I'm talking about this is there is one laboratory that I will not name, that I was told uses a standard comment in reporting gonorrhea results of some gonorrhea seen. And I personally have a problem interpreting what that means. And we feel that there should be some standardization for stuff like that, so that it can be exchanged more understandably.
DR. COHN: Is that a comment, or is that the result?
DR. STEINDEL: I think they send it as a comment. And I don't think they give a result of whether it is positive or negative.
DR. FITZMAURICE: I would wonder, if they say some gonorrhea not seen?
DR. STEINDEL: The other is the interpretative equivalent, being a little pregnant. I find that one to be a good example of the need for standardization of comment.
The other area is abbreviations. And this is not just true in the area of laboratory. Laboratory uses a large number of abbreviations. But the medical care profession itself uses a huge number of abbreviations, and it occurs all the time in reports, et cetera.
We probably should look at the ability or the need to standardize those abbreviations. Several people have published lists of abbreviations, and we would like to encourage an SDO to take this up, and see if they can create some type of standardized list of abbreviations.
DR. COHN: Can I ask a question about that one? I occasionally get books that have standard abbreviations in them. I would have to look to see who publishes them. I guess I have had some sort of a vague sense that somehow JCAHO or some other accrediting organization has had some influence in this area. I don't know that they actually keep the list, but they sort of try to manage some of this field.
DR. STEINDEL: That are several people that try to manage this field within their group. But we're asking that somebody, and we're not designating who, perhaps this subcommittee would like to point to a group, a group will stand up and recognize the need. But we would like somebody to take on the task of being the respected keeper of the abbreviation list, so we can use that interchangeably in messages, that we can point to a standard abbreviation.
We note someplace in the report that one of the members of the work group, Jules Berman from the National Cancer Institute, has done a lot of work with abbreviations. And I think he found for one abbreviation, I think over 40 different meanings. So, this is not uncommon.
DR. COHN: And these are abbreviations used in lab reports, or abbreviations in general?
DR. STEINDEL: In general. So, we are just noting that as an aside, not necessarily with respect to result content. I have discussed the need for comment. I have discussed the need for abbreviations.
We also note, and this was actually discussed at this subcommittee with respect to devices two days ago, ordinal results. It is very difficult to interpret an ordinal result without actually knowing the method that was used for the ordinal result, or results against a cut off value.
If a result is reported against a cut off value, you need to know what the sensitivity and specificity of the test was. You need to know exactly what the cut off was that was used, because it varies from method to method. Even for something as simply as a urinalysis, there are some subtle differences between what 1 plus means with one method versus another method.
So, for strict interpretation, it is useful to know what method is used to actually run that test. And it's not particularly important within an institution, because people know how to interpret the ordinal tests within the institution. But if the information is ever exchanged between institutions where varying methods could be used, then it becomes.
And what we are recommending is that method list be available that we can point to, that we can specifically use a code or some type of designator to say what the specific method was. And we believe, but are not certain, that the FDA, as part of their 510(k) approval process -- this was pointed to at the discussion two days ago with devices -- does maintain that type of list.
We are asking that this become more formal, and if the FDA is willing to assume that task to help us in that area, but we do feel the specific method is needed for part of the transmission of the laboratory results, and we are making that as a note to the recommendation.
And then of course the last thing I would just like to repeat is in the non-human content area. We would like a comment from this subcommittee endorsing the observation that we made that the non-human content area needs strengthening. And that I think it would be helpful if the subcommittee did endorse that, so we can go to the various other areas of the federal government and ask for support in filling out those areas.
For example, I sit as liaison to the SNOMED editorial board. The American Veterinary Association has been working closely with them for a long time, but there is absolutely no funding for it. And it would be very nice if the areas of the government that are involved with animal specimens, work with the American Veterinary Association to strengthen that area of SNOMED, for instance.
I believe that concludes my report. Are there any questions?
DR. COHN: I guess maybe I have a question or two. You set of recommendations about what to do about some of these areas that are not covered, obviously are pertinent issues. As I think about all 24 domain areas that are going to come before us, there are obviously going to be gaps of varying sizes.
Is it useful for some prioritization to take place as we need to look at some of these outstanding issues? I mean I can imagine the next several months there are going to be some really important gaps, and some gaps where I'm sort of going, yes, veterinary or the environmental health sciences gap is important, but it ought to be handled by the environmental organizations within the federal government.
Are these meant as part of the report that we are sending this out? Or is this somehow meant to be a prioritization?
DR. STEINDEL: These are identifications of gaps that we have found, that we have noted to the CHI Council. As you note, I think many of the reports that come forward will note gaps of varying sizes. I think what we are looking for from the subcommittee is, at this point in time, an acknowledgement that yes, we are not aware of anything that fills those gaps.
If I could speak for Jared, and I think is safe to say, there is a lot on CHI's plate right now. It would probably be best for us to look at the galaxy of reports when they are finished, and note those areas of gaps, and then come back to the subcommittee and note that we have found these gaps, and this gap is important to fill now.
MS. ADAIR: And just to add what I would say, we will differentiate between our priorities. I think that Steve was very clear when he said we are suggesting adoption of this one with no conditions. I mean there are gaps there, but they are not ones that would impede our adoption or our use. It's just when you take a look at it in its full robustness, we wanted this note.
There will, however, be times, as we have talked previously when we come that there will be in fact additional adoption. If the gaps we have identified are a little more pertinent or of priority for us and our adoption, we would have to be working standard maintenance organizations to insure that they could -- if you will allow me -- fill that gap.
And so, we will have differentiations between our priorities. This one, it was absolutely right in acknowledging what they are, but they do not impede. That's why he said it was a non-conditional -- I think was the term you used. It will not impede our adoption. We want to let people know when we did our evaluation, this is what we found.
Is that fair?
DR. COHN: Yes.
MS. ADAIR: We are in synch.
DR. FITZMAURICE: I find that this report is particularly well done, particularly the gaps and the explanation of what the gap is. And you can infer then what the problems are in interpretation. I might suggest that when you talk about the final recommendation which you are recommending, it looks to me like you are making three recommendations. You are recommending SNOMED CT. You are recommending NCBI. And you are recommending UMLS. But you might be recommending LOINC when you talk about UMLS also includes the complete LOINC.
Is that true, that you are making recommendations of three different standards? I'm looking at the paragraph at the top of page -- you might also put page numbers on it too -- top of page 3. You have a paragraph right under lab results, contents, final recommendation.
And it looks to me like there are three recommendations there, the SNOMED CT, expanding UMLS, the NCBI taxonomy codes, and then thirdly, I think you are recommending LOINC, but you are just stating UMLS also includes LOINC, so maybe by inference you are recommending LOINC.
DR. STEINDEL: No, we are making a comment there more than a recommendation, because what we are noting there is that LOINC contains test names which had been approved by CHI. But we are specifically pointing out that LOINC also contains a taxonomy for anatomical pathology test names.
DR. FITZMAURICE: Could that be used, or should there be a mapping to SNOMED, and so it doesn't matter then which one you use?
DR. STEINDEL: I think there already is a mapping to SNOMED for those.
DR. FITZMAURICE: I'm saying --
DR. STEINDEL: I see what you mean. There is a little ambiguity there. We'll clarify it.
DR. FITZMAURICE: I think the report overall is exception. Very well done.
MR. TRAMISI(?): Said Tramisi from Veterans Health Administration. A question for Steve. The normal ranges that you are going to use, are you going to use the milligrams or international units? There is so much variation in what units are used across the world.
DR. STEINDEL: We noted in the report that we are not making a specific recommendation on normal ranges, because they vary so much from test to test. But that the normal ranges that are appropriate for the test be transmitted. The important point that we are making is that the transmission of normal ranges is an essential part of the reporting of the laboratory test result. Because of the variation of normal ranges, we can't make a specific recommendation that this normal range be used or that normal range.
MR. TRAMISI: Could a recommendation be made that we use both systems. There is the American system, the British, and international system.
DR. STEINDEL: As a clinical laboratorian, I will respectfully not touch that comment.
MS. BICKFORD: Carol Bickford, American Nurses Association. For those gaps that you have identified that require more work, that are not necessarily only in health domains, how is the federal government then collaborating on the interagency initiatives to put all these pieces together?
For example, we are focusing particularly on health care and the health informatics piece, but some of these have implications for other standards of work, and other industry components. So, what is the next level that takes these gaps and begins collaborating on resolution at a bigger government level?
DR. STEINDEL: Jared and I are looking at each other. Who is going to answer this question?
MS. ADAIR: I'm going to posit your question a little differently, and then I'll answer it, and you can tell me whether it was a fair representation of the question. What are we doing once we have identified these gaps? And we want to be working with the standard maintenance organizations. What impact are we doing about it?
MS. BICKFORD: I was looking at it at a bigger perspective. Some of these have more importance, not just for health care, but all of the science environment. So, I know that you are doing something in relation to standards for health care pieces, but some of them have bigger standards implications.
MS. ADAIR: Well, I think the issue is I think we are going to handle these pretty much the same way we handled all of the gaps, which is that we will sit down with the standards maintenance organizations, talk about what these gaps are, ask them what their path is to remedy them. And I will confess that those that are of priority for us, we would want to see in a shorter timeframe than those that we would not be necessarily using. The conversations would be the same; the expectations for results would be different.
DR. STEINDEL: And I think, Carol, what was not transmitted in this report to the subcommittee was the actual make-up of the work group that put the report together. Because there was a realization that there were some areas that are not specific to human health care, we deliberately sought out representatives from other federal agencies that were not specifically involved with human health care. Like for instance, somebody from USDA was part of this group.
So, we are trying to make the other federal agencies aware of both the CHI process, and also input into the process in the areas that are applicable to their domains.
DR. FITZMAURICE: I guess part of what I read into Carol's question was you have identified the gap. Whose job is it to fill it? And I sense a willingness if resources and missions permit, that that's an area that you are will to delve into and work with the standards maintenance organizations and standard developing organizations to help fill those gaps, because there is a federal need, as well as a private sector need. Is that a good reading of it?
DR. COHN: Maybe I should jump in, because I think we are talking about prioritization at the beginning. And I sensed that some of them may be priorities, and some of them may just be observations. Jared, am I missing that one?
MS. ADAIR: Well, when we do the analysis, and it is, as Steve indicated, a full analysis, whether or not it would be a priority for us or not within a CHI purview, which is the health purview, we'll take a look at what those other issues are. But as you note, when talked about the non-human conditions, it did not prevent us from adopting.
So, I, in good conscience, couldn't have that be as much of a priority as something that would have been more germane to our adoption for humans. And so, it is a matter of priority, both in our adoption activities, as well as our conversations with the standard maintenance organizations.
But our goal, and I'm sure the goal of the standard maintenance organizations is to have a standard as robust and reflective as possible. And therefore, we feel responsible to tell them, when we looked at it, here is what we found. We would encourage you to correct those gaps. If I had to choose, I would want them to be working on the conditions that would have been having to do with what our need was at the moment. It is a prioritization when there are scarce resources.
DR. STEINDEL: And, Mike, I think you are very aware of what the resources are that are available to CHI to actually put this in. It's a zero. And so, I think part of this recommendation, and we did note in our specific recommendations that maybe FDA would like to handle devices. That's a decision that that agency will have to make.
MS. ADAIR: However, I would add to this conversation that in the discussions that I have had in the past with the standard maintenance organizations as we went through the first five, and talked to them about what the gaps were, we found great receptivity from the standard maintenance organizations.
To be candid with you, what they basically said was wow, nobody has really looked at them that carefully to really tell us, or exercise it to really tell us what those gaps are. We are very appreciative, and yes, we will fix it. So, I think that their reception is very telling in their desire to make it as robust as possible.
DR. COHN: Well, now, obviously this is our first time going through this process. I guess my recommendation -- obviously, I'm going to look to the subcommittee -- but I think that the appropriate response to these sorts of recommendations is for us to put on table a motion about basically accepting the report and endorsing the recommendations. I think that that is our role in this. Or obviously, if we don't endorse the recommendations, we could not endorse the recommendations. But I think that these are pretty good.
Obviously, what I'm referring here is I think what's in the written report, recognizing that it sounds like there needs to be some little bit of a clarification of text in some places, or at least in relationship to that one comment around LOINC, and exactly how that is referenced there, since as Mike commented, it's a little bit ambiguous.
But is that something that the subcommittee is comfortable doing at this point?
DR. HUFF: It sounds like they are on the right track.
DR. COHN: Jeff, would you like to make that motion?
MR. BLAIR: Sure.
DR. HUFF: I'll be glad to second the motion.
MR. BLAIR: Before making the motion, since it's the first time we have gone through this, do we want to use the word endorse? Do we want to use the words that we agree or concur, and with the phrases with caveats? What is the particular word of a motion that would be appropriate for us?
DR. COHN: Well, to my view there is the term called accepting the report. There is endorsing the recommendations. Now, if there are caveats, we obviously need to express them. And I guess I hadn't thought that wordsmithing was on the level of a caveat, because I think from my view, we are basically -- and I think they are aware of it, and we'll see a slightly revised final version that we can put in the minutes. And if we think it's at somehow at variance with our conversation, we'll obviously bring it back.
So, I was thinking that the operant words are accepting and endorsing. If there are caveats, we can express them. But why don't you go forward, and then Marjorie has a comment.
MR. BLAIR: Then I would make a motion that we accept the report, and we endorse the recommendation with a caveat that the references to LOINC be clarified.
DR. COHN: We have a second on that?
DR. HUFF: I would like to second that.
[Whereupon, the motion was duly made and seconded.]
DR. COHN: Marjorie, did you have a comment?
MS. GREENBERG: It has been noted that actually, there is not a quorum of the subcommittee.
DR. COHN: Actually, I think there is.
MR. BLAIR: There are three out of five.
MS. GREENBERG: There are actually six members on the committee, because John Paul Houston is also a member. He participates primarily for security matters. On the other hand, we don't actually require quorums per se for the subcommittee, but for the full committee.
Just from a process point of view, I think you can go ahead and express this sense of the subcommittee. From a process point of view, I don't know whether it might be important just to get these endorsements endorsed by the full committee. Is that your intent?
MR. BLAIR: Marjorie, I would ask a question. Are there NCVHS rules that if an individual has not attended NCVHS or subcommittees for so many meetings, whether they are still on?
DR. COHN: Jeff, I don't think you want to go there.
MS. GREENBERG: Because his participation is limited to a certain aspect of the subcommittee's work. But I guess just the broader question, is there a sense that these endorsements need to be go forward to the full committee? And I don't know that actually there is a plan to educate the full committee, or to re-present these things to the full committee. I think that is really probably not intended. So, this might be a somewhat informal process.
DR. COHN: Well, Marjorie, you are bringing up a whole host of issues. First of all, let me apologize to our presenters that even as the chair I didn't realize what the make-up of our subcommittee was. I had been working under the assumption today that we had a quorum, so I obviously had not been informed of the actual recent changes in membership. So, I just have to apologize.
Now, I think that there are two separate questions.
MS. GREENBERG: Well, he's on the roster.
DR. COHN: Well, I apologize for not looking at the roster. I certainly would just apologize to our presenters.
In my view, there were a couple of different issues. One is approval by the subcommittee. And then the question beyond that is what from there. You are beginning to mix both issues. I guess given that we don't have a quorum, I would say that we can move forward, but it will have to be re-visited by the subcommittee when we actually have a quorum to basically approve our recommendations.
Really, once again, my apology. But I still think that we could vote to bring this to the full subcommittee, which is what I think we can do at this point. Now, having said that, I think we then have a conversation how we deal with this in terms of the full committee.
I was actually going to have a conversation with our chair about that, only because in my own mind I think it would be valuable, and we are trying to put into this process, something where there is actually a communication from the full committee that is endorsing these, because I think it would be valuable.
But I was also concerned that we don't necessarily -- I don't think that the full committee would necessarily want to go through an hour's worth of discussion on each of the domain recommendations. So, I was actually mulling over what process that might be.
MS. GREENBERG: I think the executive subcommittee needs to discuss this. I think there is a way that it can be handled. The reports can be made available to the full committee. And then if anyone has any issues, they can raise them. Whatever is an expeditious way, but also at least exposes the recommendations to the whole committee without the need for presentation, unless what I would think would be the rare case, where there really would be issues or concerns that were identified by the full committee, that weren't identified by the subcommittee.
So, I would think that a September breakout session where I would expect you will have a quorum, you can re-confirm, finalize this approval.
DR. COHN: Are the other subcommittee members comfortable with this? My apologies to other subcommittee members.
MS. GREENBERG: Well, I apologize myself as the executive secretary, because it was Mike who brought this to my attention. And in my mind, there really was a quorum also.
DR. COHN: I'm glad to know I'm not the only one on that one. I guess we need to get clarification from one of our subcommittee members, whether or not he's really a full subcommittee member or not.
MS. GREENBERG: That's sometimes why we have something called corresponding members, who want to be involved, but don't actually count towards a quorum.
DR. COHN: Exactly. So, I think we'll get some clarification on that. It still makes sense to vote.
DR. HUFF: Yes, I think we should. Is there any precedent for just asking for e-mail confirmation of this, so it doesn't have to take committee time at some future meeting?
MS. GREENBERG: Generally, we try not to do actual formal votes by e-mail, because there is no public involvement. We can do a conference call. I think we should ask Jared and Steve, by not having this really formally voted on until September, is that going to cause any problem?
MS. ADAIR: I believe the only issue will be for us it's a matter of timing at the subcommittee. Should we have to go through the briefing, which we would in case you wanted, it would delay the presentations. We have already an aggressive schedule.
If we are allowed to just say based on the presentation at the last meeting, can you do a show of hands, a vote on what we presented last time, or ask if there were any outstanding questions on that one, I think it would be fine.
DR. COHN: I think we would endeavor to expedite, given that we have had a full conversation. Obviously, I can't speak for members not present, but I think that would be certainly the intent of the --
MS. ADAIR: If we could deal with that as an exception basis, as opposed to another full presentation, I think that would work.
MR. BLAIR: Maybe it's possible for us to even have an answer to Jared prior to her meeting with respect to this issue. We have three votes here. That may be enough.
DR. COHN: And actually, as it is, there is going to have to be a conference call between now and the full committee meeting to review the ICD-10 document, and approve its transmittal. So, we will basically assure that there is a quorum for that, and we will basically deal with it during that open conference call.
MS. ADAIR: If is all right with the people that are here, we will, in our minds, say that there is no barrier to the suggestions, the recommendations that we have made. We will come back again obviously, for confirmation of that. But we are not going to ask the work group to go back and do significant kinds of work in this area. We'll kind of in our mind, move on.
DR. COHN: Yes.
MS. ADAIR: Is that fair?
DR. COHN: Yes, and we apologize for parliamentary issues, but Marjorie, thank you for bringing them to my attention.
MS. ADAIR: Thank you for the opportunity, and I would like to publicly Steve Steindel and his work groups, whose names I don't remember all of, but they did a great job. The presentation was wonderful, and the material is well thought through. Thank you.
DR. COHN: And I just have a final question. Since I suggested the motion, and one was made and one was seconded, I guess we don't have to have a non-quorum vote at this point. Clearly, there are no caveats or concerns by at least anyone that is present.
Thank you very much for a very good presentation, and very good work.
MS. ADAIR: Thank you.
DR. COHN: We will clearly get this process worked out.
MS. GREENBERG: One thing I think we need to decide is if we want to include Steve's report in the background materials for the full committee meeting. If the subcommittee takes its formal vote, then it could just take it right to the full committee at that meeting.
DR. COHN: Right.
MS. GREENBERG: Steve, is there going to be a minimal revision of the report? Just e-mail us the final one, and we will include it in the background materials.
DR. COHN: Well, hopefully, we will have voted on it by that time.
MS. GREENBERG: That's true, on the conference call you mean.
DR. COHN: Exactly.
MS. GREENBERG: I do think like for example, the demographics one, there might be broader interest in the full committee. So, it will be important to expose these to the full committee, but to do it in an expeditious way.
DR. COHN: Yes. Is everybody comfortable with where we are at this point? Obviously, this is the first time we are doing this new process or this particular set of issues.
Now, I think we probably ought to move on to discussion of claims attachments. Is everybody okay with that? And then after that, we'll take a break.
Stan, welcome.
Agenda Item: Claims Attachment - Stanley Nachimson, CMS
MR. NACHIMSON: Well, first, my apologies for being late. I was stuck in a traffic jam. I was frustrated and screaming inside my car, and I'm sure that the folks that were in the accident did not realize that they would significantly delay my presentation this morning.
The only thing that kept me in any good humor whatsoever was the plate that my wife had brought home yesterday from the store that read, "There are three kinds of people in the world, those that are good at math, and those that are not."
Let me move into the discussion of claims attachment. My name is Stanley Nachimson. I am the lead of the team in the Office of HIPAA Standards at CMS that develops the HIPAA regulations, and is tasked with the interpretation of those. I appreciate the opportunity to talk to you this morning about the status of our adopting a national standard for the claims attachment transaction.
The claims attachment transaction is used to convey certain additional information that a health plan may need to make a final decision on the adjudication of a claim. Usually, it is clinical information about a patient, for example, lab results, x-rays, or emergency room notes.
The adoption of this standard is required by the administrative simplification provisions of HIPAA. Unlike the other transactions for which HIPAA required standards, there was actually no existing standard for claims attachments, nor were many attachments being exchanged electronically back in the 1996 period.
This committee has in fact been involved in the development of the standard for attachment for several years. In 1998, NCVHS voted to recommend that the department use HL7 standards in the attachment transaction to convey clinical information within that transaction. Since that time, we have been working actively with both the X12 and HL7 organizations to develop a standard electronic attachment transaction.
In the last several years a proposal was developed. Six standard attachments were created based on the most common sets of attachment information that are being exchanged today. And a proof of concept project showed that the proposal could work. However, that proposal used HL7 Version 2.4 standards, which had been in use for several years.
During this time, since 1998, we have been developing a notice of proposed rulemaking which would propose adopting a HIPAA standard transaction for claims attachments. HL7 meanwhile, has been moving ahead with later versions of their standards.
Late last year in discussions with the organization we determined that it would benefit the industry to use the later version of the HL7 standard. And the department should consider holding off publishing the NPRM until a new proposal from HL7 could be presented. That proposal would use HL7's clinical document architecture to exchange information, rather than the earlier version of the HL7 standards.
Clinical document architecture was approved as an ANSI accredited standard in November 2000. Clinical document architecture or CDA, documents are encoded in XML and can be displayed in a human-readable form on a computer using Extensible Style Sheet Language, or XSL. HL7 has presented a proposal for the department using a subset of the CD architecture to make up contents of attachment data to be exchanged between trading partners.
This proposal allows for two variations for sending attachment data within the standard. These are either sending codified, structured data using LOINC values to request the data to be sent. Or captured, scanned images of paper or other medical records.
The proposal is designed to increase participation in the delivery of electronic health care attachment data. For a relatively small investment, plans and providers can implement the scanned variation of the standard, which expedites the exchange of information, and eliminates some of the manual processing. Those plans and providers that want to take advantage of the more codified structure, and are willing to invest in the technology, will also have the opportunity to do so if the proposal were adopted and used.
HL7 is in the process of balloting the documents to support this proposal, the general structure, and the six specific attachment booklets. These booklets are for ambulance attachments, emergency department, rehabilitation services, clinical reports, lab results, and medications. Approval by HL7 is expected in September.
Once that approval is granted, the department will consider this proposal, not only in the context of HIPAA, but also in how it fits in with the CHI initiative that we just discussed, and the electronic health record initiative. We expect at this point to publish an NPRM early next year with a proposal for an attachment standard under HIPAA.
I thought I would shorten things up a little bit to save time.
DR. COHN: Stan, obviously, I'm delighted to hear about the progress being made. What is the rule of X12 in relationship to this? Do they also need to ballot this particular item?
MR. NACHIMSON: The role of X12 in the transaction is that the X12 standards are used as the wrapper basically for the attachment information that is being sent. My understanding is that the X12 and HL7 folks have been collaborating to make sure that this revision of the HL7 standards can work within the X12 wrapper. So, I don't think there is anything major that X12 needs to do. The guts of this proposal, and the language is really the change to HL7, which fits within the X12 wrapper.
Now, that being said, the entire transaction, once the proposal comes forth and we would even get comments on it, we would expect that both X12 and HL7 would have to ballot the final transaction.
DR. COHN: So, in other words, there will be a process here where both standards organizations are going to need to reach final agreement on both aspects?
MR. NACHIMSON: Absolutely.
DR. COHN: Great. Michael?
DR. FITZMAURICE: Stan, could you explain again that there are two variations? One is a codified structure using LOINC and the LOINC definition for variables, and the other one used scanned documents. I probably didn't get a full understanding of that latter one.
MR. NACHIMSON: One way that providers can send information to health plans would be based on the LOINC value in a structured XML document that is then coded -- medical records, laboratory results, or even encoded x-rays, digital images that would be sent within this wrapper. That's the more sophisticated variation.
The less sophisticated variation would be to allow a provider to scan an image or to make a copy of a medical record or a laboratory report or even an x-ray, and send that scanned image by a computer to the health plan. Now, the difficulty for the health plan is that it is simply just a copy of a paper record.
And in terms of processing it, they would not be able to take too much advantage of a computer processing of that information. Basically, a human would probably have to take a look at that, and make an interpretation. If a health plan and provider were able to use the more codified information, it could eliminate most of the human interpretation.
A provider's computer could understand the request for the information, codify the information, send it back to the health plan, and the health plan processing it can essentially auto-adjudicate the claim by looking at that information, and say here is the information. We can now make a decision on that claim. Those are the two variations.
DR. FITZMAURICE: Is there a standard for how it is to be scanned? That is, Adobe Acrobat, Microsoft Photo Editor? Is there any standard for how it is to be scanned and sent, so that it can be interpreted when it is received?
MR. NACHIMSON: I don't believe that the actual scanning is standardized in this process. It just says that you can send a scanned record.
DR. STEINDEL: I have a comment and a question.
MR. NACHIMSON: I thought perhaps you had an answer.
DR. STEINDEL: That's my comment. Actually, the CDA document requires that items like scanned images be sent in a standard MIME format. And that can include virtually the formats that you enumerated.
DR. FITZMAURICE: But somebody could send it in DICOM, and somebody could say I can only take Adobe. And so, for us to work together, we have to a trading partner agreement.
DR. STEINDEL: No, the MIME format itself actually specifies what the document format is. And most readers can read the various MIME formats that are sent, or recognize them.
DR. FITZMAURICE: That would preclude then using Adobe or using Photo Editor or DICOM from sending it.
DR. STEINDEL: No, you can. They are part of the MIME format. PDF is listed in the MIME format exchange specification, I believe.
But that leads to the question that I wanted to ask. When you are talking about a scanned document, I'm presuming it can also be interpreted as an unstructured document. For instance, if the document existed in the institution as a computerized text document from a transcription service or something like that, that document itself can be sent in an unstructured format. It would not have to be scanned. Likewise, an image could be sent in that format as an unstructured document.
MR. NACHIMSON: Yes, so in this proposal at least as put to us, those sort of free form text, if you will, could also be sent along with that. Now, I call that the less sophisticated variant of the proposal. But one of the strengths of this proposal based on the HL7 presentation to us is the ability to sort of implement a less sophisticated version right away, and allow folks to move to more sophisticated version.
DR. HUFF: I was going to answer the same question as you already did. Basically, the HL7 data type follows the MIME pattern. What you have in that data element is a major MIME data type and subtype. And so the major type says this is an image or this is a document, and then the subtype says if I'm an image, I'm PDF or I'm a TIF or I'm JPEG or I'm whatever.
It does put some requirement on those sending and receiving to support any of those MIME types someone might send. You could have more complete standardization if you said particular subtypes should be supported. But now you are binding yourself in a way that may not be good. So, I think the way it is, is probably the best way.
DR. STEINDEL: If I can just add a comment to what Stan is saying. MIME is not an HL7 standard. MIME is a standard that exists in the computer industry.
MS. GREENBERG: Even asking this question may be going beyond my level of understanding on some of these technicalities, but is this less structured, standardized, whatever option a new option that wasn't included in the previous version that has been presented to the subcommittee for the claims attachment standard?
I remember quite a while ago a discussion about whether structured or unstructured data should be allowed, and I think the committee actually took a vote and supported only the structured data. Now, I may be wrong on this. Do you have the same memory?
MR. NACHIMSON: I did a little bit of checking before I came here. The vote that you are referring to is actually what I referred to in 1998, was what would be included in the binary part of the X12 transaction. The decision was should we allow unstructured data, unstructured data plus HL7 standards, or only HL7 standards. And the decision was to use the HL7 standards.
Now, this question is really within the HL7 standards, they will allow the use of this scanned information. And I believe, although I didn't do enough research, I think that the Version 2.4 would have allowed within it, the use of unstructured text or these faxed documented, but I could be wrong there.
MR. ARGES: My name is George Arges.
Stanley, a quick question. With respect to the attachment in the NPRM that is planned to come out, are there any plans to include some business rules to describe the use or the request for the attachment, so a provider would have a better understanding as to how and when the attachment should be used? And what would be the obligation of the health plan to basically use this information for the adjudication of the claim? Is it appropriate for the health plan to destroy that information as part of that process?
I guess what I'm hearing from providers is when the current transaction standards take effect, they are getting requests for attachments, even in paper copy. Their concern is violating the privacy rules. And I just wanted to know whether additional guidance would be provided with respect to the appropriateness of the request, and how it should be handled when a request is sent to the provider.
MR. NACHIMSON: Those are a lot of questions that I can answer relatively quickly. We will be defining the claims attachment transaction and its appropriate use, and hopefully, some of those business rules would be included both within the definition and also in the explanation of when a claims attachment transaction should be used and not used.
Within the context of privacy, there is within the privacy rule, a statement that anything that follows a standard transaction is already determined to be minimally necessary. So, that if a health plan uses a standard transaction, they don't have to worry about considering whether all of the elements of all that transaction are minimally necessary for their use. So, the provider can feel comfortable in sending it, and not violate the privacy rules. The health plan can feel comfortable in receiving it, using it, and not violating the privacy rules.
Now, in terms of whether or not that information should be destroyed, I think that's a question beyond the claims attachment discussion. It probably goes to the access to that information by other folks in the organization, under their whole privacy policy.
MR. BLAIR: My question gets to really the same issue, because I have no problems with the fact that HL7 would be the vehicle for health claim attachments. Whether the envelope is something that is a scanned image or structured image, I think both have their pluses and minuses.
The piece that is of concern to me is the rules. If we are going to have scanned images, then I think we have to think very, very carefully about the rules when these electronic health claim attachments are appropriate, because we are winding up offering something that might be very easy to use, and we are trying to move the industry to using health claims, responses and remittances which are specific.
If this is used by payers inappropriately to circumvent their compliance with the rest of the HIPAA financial administrative transactions, that would be unfortunate. So, I would just hope that the rules would be in place where this is used appropriately, and not abused. So, echoing George Arges' question.
MS. BURKE-BEBEE: I sit on the attachment SIG at HL7, and this discussion has been going on there. Their feeling was that there are those in the industry that use the scanned images that would be left out of that loop if it wasn't included. And that it may even push them back to paper.
DR. COHN: I don't think that Jeff was arguing against scanned images. I think he was concerned that every claim might wind up with a request for a claims attachment. Am I misstating, Jeff, your concern?
MR. BLAIR: Actually, two aspects. I think that since this won't be probably ready for people to use for at least another couple of years if our regulatory process is consistent with the ones we have had before, then maybe my concern really is not that great, because people will have experience complying with the financial administrative transactions for at least a year or two before this becomes available. So, maybe my concern is mitigated by that.
But then the other piece is what Simon just described, plus the confidentiality and privacy issues.
MR. NACHIMSON: I think I actually read two concerns here. Let me make sure I understand them. One, I think there is a concern that if we allow scanned images, health plans or providers will simply just make a copy of the entire medical record and send it forward and say, well, here it is, you can figure it out, as opposed to sending in the relevant information. That's one concern that I thought I heard from George and Jeff.
Then the second concern that I heard is a fear that health plans are on every claim or near every claim are going to say, well, you can send the standard, but by the way, you also need to send me these other five pieces of information. And those are going to be an attachment. And if that differs from health plan to health plan, we have lost standardization. So, in crafting the NPRM we will make sure to address those couple of issues.
DR. COHN: I'm actually reminded we all have a long history in claims attachments, just like the rest of the HIPAA regulations. This is an area where obviously, we probably need to take a little more look, and hear a little more from the industry during the winter time or fall time, at some point.
Certainly, I think the hope would be, and Jeff, maybe I would say this a little differently, that if you think about it, the HIPAA deadlines mandate use of the standard, but there is nothing about it that prevents use of that standard before a HIPAA deadline. And I think that's a very good thing.
I have heard repeatedly from the industry over the errors that claims attachments, if done right and properly applied and used, could be something that might actually be helpful to the whole health care industry around administrative simplification. And if indeed this standard is done right, people might voluntarily choose to use it before the mandated date of the implementation.
Now, I say that sort of holding my breath. But certainly, I think we have heard repeatedly over the years that in many cases there are already a lot of electronic claims transactions occurring, and that many people felt that a lot of the value of the HIPAA implementation would be getting some of these things around claims attachments done electronically.
So, I guess we should have hope that it will be a good standard, that some of the guidance even coming out of the NPRM would be value to help set rules for the industry so there is not abuse of the standard. And maybe this will be, as I said, like PMRI standards, that there is just voluntary industry adoption.
MR. NACHIMSON: I also would like to remind folks that this will be a notice of proposed rulemaking subject to public comment. So, should we not address concerns that have been raised here today and in other place in the NPRM, folks should certainly bring them to our attention in the comment process, not that I need to prod many people. But we would certainly be looking for industry comment in response.
DR. COHN: And as I said, I think it would be the intent of the subcommittee, time permitting, that we would try to hold a public session to get wider comment before the release of the NPRM, but hopefully after the standard has been approved the standards organizations.
DR. FITZMAURICE: When do you expect that the NPRM will be published?
MR. NACHIMSON: Our current schedule calls for a February publication, but I've been wrong before on predictions. I wouldn't take that one to the bank.
DR. COHN: If we're okay then with this first discussion on claims attachments, I'm going to suggest we take a 15 minute break, and then we'll get together and talk about the HIPAA update, and then have the reactors panel.
Thank you.
[Brief recess.]
DR. COHN: Just to remind those, we actually are changing dates for the October hearings. And they are moved to later, to being the 28th, 29th, and 30th of October, just so that you are all aware. Part of the conversation at that point will be ICD-10, CHI, PMRI letter. I don't we're going to get to claims attachments by that time, but you never know.
Anyway, Stanley, I think we are asking you at this point to give us a HIPAA update, and then we are going to have a reactor panel to discuss what they see as the issues with implementation.
Agenda Item: CMS HIPAA Update - Stanley Nachimson, CMS
MR. NACHIMSON: Thank you very much.
Now, I will focus my remarks this morning on an update on the implementation of the HIPAA electronic transactions and code set standards. If you want an update on regulations, I can also do that, but let's talk about what seems to be of primary interest to the industry, the October 16 implementation date for the standard transactions and code sets.
CMS continues to work with all segments in the industry to work towards a smooth transition on October 16. We issued some compliance guidance at the end of July which we hoped would provide health plans, providers, and other covered entities an opportunity to develop contingency plans while still moving towards compliance.
We indicated that we would consider on a case-by-case basis, covered entities' good faith actions to achieve compliance in evaluating any complaints against them for non-compliance after October 16, especially in regard to their contingency plans, and their operations in the transition period just after October 16.
So far, the reaction to our guidance has been generally favorable, with occasional concerns still be raised by folks that said we either went too far, or we hadn't gone far enough. So, I guess we are sort of at roughly the right position.
The Medicare program continues to be in the forefront of meeting the October 16 date. All our contractors are able to test claim and remittance advice transactions, and move providers into productions. That's all across the country. There are still a few issues remaining with the coordination of benefits transaction, but most contractors can successfully test them.
Slightly over 10 percent of electronic claims submitted to Medicare were in the HIPAA standard format during the July 19-August 1 period. Now, our percentages have been creeping up every roughly two week period that we measure, not quite as fast as we might like, but they are generally going from 7 percent to 8 percent to 9 percent to 10 percent.
So, we continue to have a fairly large number of folks in testing, although the numbers that we would still would have anticipated even at this date. We are less than two months away from compliance, so we are continuing to hope that folks move to test.
DR. FITZMAURICE: Excuse me, Stanley, did you say that 10 percent of the claims being submitted were already in standard format?
MR. NACHIMSON: Yes, 10 percent of the electronic claims are coming in the HIPAA standard format. CMS is continuing its outreach efforts to the entire community to make sure that they understand the need for testing before October 16, that they get in line. We are having our contractors contact each of our submitters to say if you are not ready, when will you be ready? We need to schedule you for testing.
The agency is meeting with industry segments to identify obstacles and issues in complying with the October 16 date. We have held meetings so far with health plans, and with the clearinghouse and vendor industry, and we continue to do so. We also plan to meet with provider organizations.
I would like to talk about some of the issues that at least have been raised in these meetings. First, in our meeting with health plans, major issues, one, the difficulty for publicly traded companies to announce contingency plans which may appear non-compliant.
It was expressed to us that those that have stockholder, their attorneys are still saying even though we have issued guidance where we would appear to allow some flexibility, because we still mention that the law is the law, their lawyers are still raising concerns that they could not issue publicly, contingency plans that would appear to go against the HIPAA regulations. That was raised to us.
Secondly, plans noticed that even though they are focusing their testing on clearinghouses and submitters, billing services, and even their large providers, but they are still getting questions from a number of their small providers, wondering what is happening, why they haven't been tested. When are they going to be able to test?
And thirdly, the concern that there are a number of common missing data elements in the transactions. A large number of the transactions are missing a couple of data elements, subscriber's date of birth, for example, or the Social Security number, or other identifying number of a referring physician, and yet many of the plans are saying they don't need that information. And what happens there, where a transaction comes in with a piece of information required by the transaction, but the plan doesn't really need that information to process the claim, what should their reaction be?
The vendors and clearing houses expressed to us their concern about the burden of re-enrolling. Many plans are using HIPAA as a reason to re-enroll all of their providers and submitters for electronic data interchange, making them sign EDI agreements all over again, saying that they are meeting the HIPAA standards.
It's a burden, especially on clearinghouses that deal with a large number of payers, to have to sign all these agreements basically in a short time period. The same thing with the billing services, because they represent a large number of providers, they may have to sign a large number of agreements for a large number of plans.
Vendors expressed a concern about certain plans that are rejecting entire batches of transactions when there are errors in only a small number of transactions in that batch. For example, a provider will submit 2,000 claims to a health plan or a clearinghouse will submit 2,000 claims to a health plan, and the health plan will say claim 3 and claim 17 you are missing a piece of information, therefore, we are rejecting the entire batch. You need to go back and resubmit the entire batch, which is considerable work for the vendors, especially when they are representing a large number in a batch.
And there were also concerns expressed to us as to the readiness of state Medicaid plans. Unlike the Medicare program that is basically centrally run, CMS does not run the Medicaid plan in each state. Although we have oversight responsibility, really, it's the authority of each individual state to operate their Medicaid plan, and they are in a wide range of states of readiness.
The agency continues to monitor the readiness of state Medicaid plans, and those where there appears to be some major problems, we are trying to work with them on an individual basis to bring them up to speed.
I want to reiterate that the issue of the missing data, the common missing data, and the need for that data is common to both plans and providers. We have heard from both sides of the industry that say that there is a piece of information that is required in the standard, yet 90 percent of the health plans don't need that information. But we have to send it on each and every claim, and the health plan is responsible for looking for it on each and every claim, and technically should reject a claim that doesn't have that information.
That, I think, is indicative of the standards process, or at least of the development of the standards to date, where if one or a few health plans indicated a need for that information, it was included in the standard. I think this also presents an opportunity to revise the standards, based on both provider and plan expertise.
The concern that was raised to us even working with the X12 organization is that prior to HIPAA it was heavily plan-influenced and vendor-influenced, and the provider influence was not as great at the X12 meetings, for one reason or another. Not to place blame anywhere, that just happened to be a fact of life that plans and vendors participated very heavily in the X12 organizations; providers, not as heavily.
We have expressed to the provider industry that this is now an opportunity that they need to take to spend some more time with the X12 organization, and the other standards organizations so that their voice is heard, not only through the regulatory process, but also in the actual standards development process. And I think that's one of the lessons that we are beginning to learn. We will continue to monitor all segments of the industry, and hopefully work with it to resolve issues and present guidance.
I think the move to standardization certainly has raised several issues regarding the way that we wrote the regulation. Why must all data be sent on a standard? Can't plans and providers agree among themselves on what information should be sent, as long as it's within the standard? But both of those arguments seem to run somewhat counter to standardization, and those were some of the agreements that perhaps led to the standardization.
I think we have a balancing act. I refer to the comment I made about the plate. There are three kinds of transactions, those that are standardized, and those that are not. I think there appears to be perhaps a practical place in the middle that maybe we will eventually get to, but the way the law and the regulations are currently written, we're not there yet.
I think the interplay with other laws and regulations is also coming up. How does HIPAA work with that state clean claim payment rules, for example? In several states health plans are required to pay claims when they have all the information necessary to pay the claim. They have a certain amount of time once they get that information, to pay the claim.
It's slightly counter to the HIPAA requirement that all the information that the standard requires is on the claim, as opposed to all the information that a health plan needs to pay the claim. That concern has been raised to us.
There are also some precedents in the law that say if the electronic transaction is good enough to make a decision, you need to go ahead and make that decision, as opposed to meeting all the requirements of the standard. So, these issues I think will be dealt with in the months to come as we move through the October 16 date.
DR. COHN: Stan, a question. You brought up obviously a number of issues. Especially the last couple, are these subjects of FAQs? Is this the subject of revised regulation? What is your view?
MR. NACHIMSON: I think this is on an issue-by-issue basis. The concern about missing data, or not sending all the data, I believe that's a regulatory question. As has been explained to us by our attorneys in interpreting both the law and the regulations, they feel that it's clear that the regulations and the implementation guides say that if a data element is required, it is required. If it's not on a transaction, that transaction is not compliant.
The flexibility that we have is not in the interpretation of the implementation guide or the regulations, but in the enforcement. And that's what we have used in our guidance. That's how we will be handling some of those issues. But some of the bigger issues, the clean claims issues and others I think really will need, if we choose to do that, regulatory guidance.
We have in our regulations, planned a modifications rule that is scheduled for publication in the middle of spring. We are working on a number of issues that would be included in that rule, again, a notice of proposed rulemaking. It's possible that some of those issues will be in that proposed rule. Again, that's really after October 16.
But I think one of the things that we don't want to rush towards anything before October 16. We want to see what lessons we learn from the implementation on October 16 and beyond. We think we've got some flexibility on the enforcement side, as we have expressed in our guidance, so folks should take a look at that in making certain decisions, at least in making their contingency plans, and perhaps continue to bring up in the meetings that we have scheduled and beyond, these issues to the agency, so that we can see what we can handle through regulation, and what we can handle through guidance.
MR. BLAIR: Stanley, I guess it was back in May when our subcommittee -- I guess it was the full committee discussed what kind of guidance you would give on enforcement. So, we had a chance to think about those issues, and how you strike the balance. I want to indicate my sincere compliments for the guidance letter on enforcement. I thought that was extremely well done.
It had to be a balance between maintaining the integrity of the compliance deadline, and yet providing appropriate flexibility for those entities that are proceeding with a best effort, and with the right intent, and giving them both the flexibility and assistance that they would need to comply. So, I thought it was an outstanding guidance letter.
MR. NACHIMSON: Thank you very much.
MS. BURKE-BEBEE: Stanley, I have two questions. You said 10 percent of standard transactions being used July 19-August 1. Which standards? Is that the 837? Which transactions?
MR. NACHIMSON: Those were for claims transactions.
MS. BURKE-BEBEE: And another question I have about non-compliance, is it part of a new amendment to ASCA(?) that CMS will be accepting paper after October 16, or is that not true?
MR. NACHIMSON: Suzie, you are referring to the regulation that was published on August 15, which is a Medicare regulation. I need to emphasize that this requirement is for Medicare only. That all claims submitted to Medicare October 16 and after must done so electronically, except in certain situations, which we outline in the regulation, those from small providers, those for Medicare demonstration projects, for roster billing for vaccination, and for situations where there are two or more payers primary to Medicare.
So, on or after October 16, we would expect most claims that are submitted to Medicare would be done so electronically. The way that the law is written, if someone that does not have one of these exemptions submits a claim on paper to Medicare, the initial claim to Medicare, those services will be considered non-covered.
DR. FITZMAURICE: I have two questions, Stanley. One of them is that there is a matter of good faith. Has CMS considered that as people may complain about non-standard transactions, that structuring their complaints that can you show us that X percent of say 1,000 transactions are being rejected because they don't meet standard forms. So, that could be -- I hate to use the word evidence -- but a quality measure.
When you go out for enforcement, you set priorities. And if only a couple of transactions are not standardized, then that is not a sign of bad faith. But if say 40 percent of submitted or 60 percent of submitted transactions are not in standard form, that might be less than good faith, and evidence of a pattern of non-compliance. So, that would be where you put your enforcement.
And then maybe some guidance that health plans might consider a separate charge, or they could probably think of it on their own, for non-compliant transactions, because it would cost more to process a non-standard than a standard transaction. So that you have economic incentives moving everybody to become compliant.
And you don't have a large sphere in the enforcement arena of a couple of transactions will hit me with a large fine, a $100 per transaction, but a pattern of transactions that aren't compliant might be evidence of less than good faith. Using quality measures as a way of approaching enforcement, rather than a strict either it is or it isn't compliant.
MR. NACHIMSON: A lot of the issues that you raised are actually issues that are being considered in the development of the enforcement regulation that the department is undertaking. That will detail how we are enforcing, and what criteria we are going to use to enforce all of the HIPAA standards, privacy transactions, and code sets, and the others. Those are being considered.
In terms of the good faith efforts, we did not want to set any particular guidelines, because we need to take a look at each situation individually, and maintain on a case-by-case basis. So, we are not comfortable saying if it's 40 percent, you are okay. If it's 30 percent, you are okay. But if it's 20 percent, you are not okay. We need to take a look at the entire picture.
I would agree with you that there certainly will be some prioritization that takes place, depending on the number and the extent of complaints that we get, if any, on October 16 and beyond.
DR. FITZMAURICE: For the number of people you have, I think you are doing a very good job. I want to shift to a second question, and that is there have been recent regulations that have come out regarding I guess the enforcement. I want to ask you if some of the recent regulations could be interpreted as allowing that a standard transaction required of all other health plans and providers, such as pharmacies and PBMs, would not in fact be required of the Medicare health plan. That is, is Medicare being treated differentially in some of the interpretations of the regulations that are coming out?
MR. NACHIMSON: The short answer is we would hope not. Let me explain the way that CMS is structured, and how we relate to the Medicare/Medicaid health plans. There is a separate office for HIPAA standards in CMS, which is charged with responsibility for producing the regulations, outreach on HIPAA, and the enforcement of HIPAA throughout the industry.
That office is separate from the Medicare folks, and the Medicaid folks. We have been talking about a firewall between our organizations, so that we are not accused of favoring one side or the other. We try very hard not to treat the Medicare program any differently than we would treat any other program.
That being said, there are certain decisions that the Medicare program may be making from a business perspective to move more slowly to comply with certain parts of the transactions than others. Will they be treated any differently than any other health plan? I don't believe so. If there is a complaint filed against the Medicare program, we will take a look at that, just as we would take a look at any other health plan, look at their good faith efforts and contingency plans, and evaluate that on an individual case-by-case basis, the same way that we would do for anyone.
The Medicare folks come to us for advice on what we think is compliant, what we think is not compliant, and they may choose to take that advice one way or the other. But if they were to be not compliant, and there was a complaint filed against them, we would investigate that as part of our responsibilities.
MR. BLAIR: Stan, you mentioned that we already have 10 percent compliance. Is that as of today, or August 1, or is that based on a monthly basis or weekly?
MR. NACHIMSON: That's roughly a two week measure that our Medicare folks get. That was for the period July 19-August 1 of this year.
MR. BLAIR: So, there will be a new number in another week?
MR. NACHIMSON: They get these about every two weeks.
MR. BLAIR: Was the general feeling that that exceeded expectations or met expectations, or was below?
MR. NACHIMSON: I would say that that was below early expectations. And unfortunately, in line with the trend that we have seen from roughly our April or May time period, where is maybe a 1 percent increase in this percentage each month.
So, we are still somewhat I think disappointed in the performance of the providers that we are dealing with in the fact that we don't have more -- let me give you an example. Again, for that July 19-August 1 period, Medicare has approximately 150,000 submitters of electronic claims. And 17,000 of those are in production using the standard, and a little over 10 percent. And only another 5,400 are in test.
So, you can see from those figures that there is still a significant number that have not even begun to test. Some of that could be that they are dealing with a particular clearing house that is testing with us on behalf of one provider. Once that test goes through, all of their providers will be compliant and submitting claims; same thing for the billing service. But we are still I think disappointed in these results to date.
Obviously, we are making efforts so that these numbers increase, and we hope that they will increase in the September time period. The problem will be if all the providers come to us on September 28 and say, all right, we are ready to test, obviously, the Medicare contractors' staffs are not equipped to handle 100,000 submitters testing in a two week period.
MR. ARGES: A follow-up question to Jeff's question. The 10 percent that you mentioned, is there a breakdown between whether it's fiscal intermediary or carrier? And you mentioned a clearinghouse. So, if a clearinghouse submitted, and you don't know the volume then of number of providers that work with that clearinghouse. So, the actual numbers might be a little bit higher if a provider uses that clearinghouse? Am I correct?
MR. NACHIMSON: I think that's fair to say. Let me answer your first question. I don't have the breakdown between intermediaries and carriers. We do have those numbers back at CMS, but I don't have those on this particular piece of paper. Again, it is possible that if a submitter, like a clearinghouse, is approved and in production with us, providers that have not yet used this submitter or this submitter has said they have not yet gotten the correct information from those providers in order to produce a HIPAA compliant claim, that the numbers could jump, hopefully dramatically.
DR. COHN: Stanley, I presume you are sticking around for the reactor panel? You'll be part of the reaction.
MR. NACHIMSON: Hopefully, I'll be able to react to the reactors.
DR. COHN: Well, why don't we move into the next phase here, where we actually ask the reactor panel to come and join us, which is Tom Wilder from AAHP, George Arges, and Jack Emery, representing the AMA. A number of you have opening comments, and then obviously, we'll have a bit of a discussion.
Tom, I have you identified as being first. Is that correct?
Agenda Item: Reactor Panel - HIPAA Implementation - Tom Wilder, AAHP
MR. WILDER: Sure, that's fine.
Thank you very much. My name is Tom Wilder. I'm with the American Association of Health Plans. I do want to thank you for the opportunity to meet with you today, and discuss the reaction of our health plan members to the guidance that was issued on July 24. I do want to apologize. I do not have written comments. My oral statement will be rather brief.
Just to give you a sense of who we are, we represent around 1,000 health plans, which consist of HMOs, PPO, POS, other acronyms, other similar type health plans. And it ranges everywhere from large national carriers who provide coverage in every state, to small plans who may provide coverage in a single city. Our members collectively provide coverage for around 170 million people across the country.
In talking to our members, I think by and large they were pleased with the guidance. They feel like it went as far as CMS was able to do so within the bounds of the statute and the regulations. And it gives them the flexibility that they believe they need after October 16 to continue processing transactions.
Quite frankly, the big issue for our members that was addressed in the guidance was their ability to, for a period of time after October 16, continue to process claims under their old legacy systems. So, for those submitters, whether it is a provider or a clearinghouse, that may not have fully implemented all the transactions, they could continue to accept transactions in the old electronic formats.
How long they will continue to do so I think will depend on each plan, on their business operations, on their needs, and on where their submitters are. I think for most plans, at some point they are going to reach a critical mass where quite frankly, it's more cost effective for them just to in a sense, cut off that small percentage of submitters that are not using the new formats.
I think also the guidance sets out some pretty good guideposts for all covered entities in terms of what they need to do for good faith compliance. And health plans have been very actively involved in testing with their submitters, and providing outreach to their provider community through meetings, through oral communications, through letters, and through putting information up on their Web sites, and having help desks available where people can call in with questions.
I think the guidance does point out one kind of global issue that I understand CMS is going to be addressing, and I think it's something that this committee, actually NCVHS has been asked to address, and that is to, after the smoke has cleared if you will, take a period of time and kind of step back and look at this entire process, and see what has worked, and what has not.
Particularly, the process that is used for making changes to the standards and code sets. As you know, a lot of these requirements are really set out in law. As the guidance pointed out, for example, the implementation date is statutory. CMS, even if they wanted to, couldn't change it. A lot of the requirements in terms of what standards had to be used, the conditions under which they needed to be used, the particular code sets are set out in regulation. That process is pretty time consuming.
So, one of the things that I hope NCVHS and CMS will do, with considerable input from the industry is just think through what the process is from start to finish to get a particular code set or standard approved or modified, and look at how that process works, clearly define it so everybody understands how it works, so they know if they need to get something fixed, who they should go to.
And also think about some kind of process to handle issues on an emergency basis. I do know there is obviously this fast track process. But one of the things that we are finding is there may be these kind of issues that you need a quicker kind of response to. It can't be handled through guidance. It's an issue that needs to be addressed for real change. So, how do you do that on a basis that is fair to everybody, so everybody gets their voice heard, but you can get a quick change.
With that, I will wait for the other presenters, then I'll be glad to address any questions that you may have.
DR. COHN: Tom, thank you.
George Arges.
Agenda Item: Reactor Panel - HIPAA Implementation - George Arges, AHA
MR. ARGES: Again, I would like to thank the subcommittee for the opportunity to present providers' concerns around the progress being made in implementing the transaction standards, and our reaction to the recent guidance on compliance.
The guidance does take an important first step in recognizing, as AHA urged in May, of the importance of maintaining uninterrupted payment for hospitals and other providers of care. However, the guidance fails to create the safety net that providers are looking for in order to be assured that their payment will continue after October 16.
The guidance primarily addresses the enforcement aspects of compliance. The field also needs guidance to outline the contingency with specific actions to lessen the most harmful consequences of implementation, disruption to payment.
The area that Stanley, and the area that was not addressed in the guidance, although CMS had indicated that it is still under consideration is whether the claims to comply with the HIPAA format and code set requirements can be processed by a health plan without fear of being cited for a violation of HIPAA if the claim has non-material data elements missing or incorrectly reported.
We believe CMS should make it clear that health plans can process a claim for payment if they find non-material errors that do not affect their adjudication of the claim. Ideally, the health plan should also communicate back to the providers about these errors, so that over time providers will take the corrective measures for future submissions.
The lack of guidance on the handling and acceptance of the transaction standards does create a wide variation in how health plans intend to handle situations where batch submission of claims reveal an error in one or a few, as Stanley mentioned, within the claims being submitted.
Many health plans have indicated that the entire batch will be rejected, a move that only adds, we believe, to the inefficiencies and costs of processing claims for both providers and the health plans. We believe CMS should clarify in another guidance that health plans should not reject the entire batch of claims because one of several claims contains errors.
Even though some health plans may argue that making these changes at this stage is costly, they need to begin making such changes, because it represents the correct and common sense business practice to apply now, and into the future. Indeed, some of the more progressive health plans have already made such adjustments.
Between now and October 16 it is important for all covered entities to understand what specific actions demonstrate their good faith efforts to implement the standards. The CMS guidance encourages health plans to begin testing the transactions with providers in order to demonstrate their good faith efforts.
The AHA, however, continues to hear from hospitals about their frustration at being unable to test with many health plans, or the lateness of the testing schedules issued. CMS may need to outline more specific performance expectations in order for covered entities to clearly understand what steps they need to take before October 16.
For instance, health plans that do not intend to begin testing with the provider until early October we believe have failed to demonstrate a good faith effort. Similarly, clarification that a health plan's testing effort can only involve the use of a clearinghouse rather than the direct testing of claims that originated from providers would also help in defining proper outreach and testing efforts.
At this late date, however, the focus should be on developing specific contingency plan components that would insure hospitals and other care givers will continue to receive payments after October 16. Payments must match the payment for similar services that were rendered before October 15, unless there was an agreed upon change in the reimbursement amount.
Additionally, the turnaround time for claims submitted must also match the pre-HIPAA timeframe. At a minimum, CMS should immediately make clear that these components are elements of the contingency plan for the Medicare program, and encourage other health plans to also follow suit.
CMS's failure to act decisively on these remaining issues will only prolong the confusion and difficulty arising with implementation of the standards, and will increase the possibility of large scale payment disruptions. Without guidance, we will not see the administrative simplification efficiencies that Congress and the public expected with the adoption of these laws.
More importantly, inaction needlessly threatens to disrupt the financial operation of health care providers throughout the country. Providers' primary responsibility is to care for patients. Make providers' administrative operations more complicated because of differing health plan interpretations of the standards only threatens patient care.
We are asking the NCVHS to urge CMS to respond quickly and decisively to the critical issues not addressed in the recent guidance before the October 16 deadline is upon us.
I thank you.
DR. COHN: George, thank you.
Jack Emery.
Agenda Item: Reactor Panel - HIPAA Implementation - Jack Emery, AMA
MR. EMERY: Mr. Chairman and members of the subcommittee, first of all, let me apologize for my voice. I'm a baseball fan. I went to a baseball game last night that had terrible umping, and I had to express myself.
My name is Jack Emery. I'm assistant director for federal affairs for the American Medical Association. The AMA is pleased to share with the subcommittee today, the preliminary findings of a recent online survey of more than 500 physicians. The survey attempts to assess physician knowledge and their readiness of the HIPAA transaction and code set standards which go into effect on October 16.
Before addressing the survey findings, let me say that the health care community has made considerable efforts and progress towards meeting the requirements of the October 16 transaction rule. Despite those efforts, a substantial portion of the community will likely encounter problems unless additional flexibility on enforcement is not forthcoming.
The July 24 CMS announcement on enforcement of the transaction and code set standards was a necessary initial step, but further relief will be necessary in order to assure that claims processing transactions function smoothly and cash flow is not disrupted. We believe that CMS should lead the way to a smooth migration by establishing a post-October 16 in which covered entities that are making a good faith effort to comply with the transaction standards, may continue to rely on their legacy claims systems, and not be subject to claims denials and/or civil monetary penalty.
We are pleased that the administration has finally published on August 15, just two months before the transaction standard goes into effect, an interim final rule addressing the requirements for electronic submission of Medicare claims. That rule implements a new administrative simplification compliance act requirement to submit claims electronically to Medicare starting October 16.
The rule also provides an important exemption process for the small physician practice of fewer than 10 full-time equivalent employees. CMS estimates that 83 percent of physicians, practitioners, and suppliers, the Part B side, already submit electronic claims to Medicare. That still leaves a large number of entities that do not file electronic claims, and who will potentially be affected by this requirement.
CMS has indicated in that rule that there is no requirement for small practices or providers to submit a waiver in order to be exempt, but instead may audit those practices which do not submit claims electronically. The AMA is hopeful that the exemption process will function smoothly. To be certain, we will monitor the exemption process, and would be pleased to work with CMS to identify problems or questions raised by the physician community.
The AMA House of Delegates, our policymaking body, at its annual meeting in June of this year reaffirmed policy which states that the American Medical Association support necessary legislative and/or regulatory changes to mandate that health plans continue to accept non-standard electronic claims from physicians during a reasonable transition period following October 16, 2003, when the HIPAA transaction rule takes effect.
To support our advocacy efforts for regulatory change, and I emphasize regulatory change -- we are not at this point, pursuing legislative changes -- the HIPAA survey was undertaken. A written copy of the preliminary findings of our survey should be available to you at your desk. If not, they are certainly in the back of the room.
July 25, 2003 to August 14, 2003, the AMA conducted an online survey of member physicians to determine their familiarity with the HIPAA transactions and code set standards, and their preparedness for implementing the standards by October 16. The respondents are representative of the AMA member population.
Looking first at their familiarity with HIPAA transaction standards and code set. More than one-third of the physicians report that they still do not have a good understanding of the HIPAA transaction requirements. That's two months before the HIPAA standard is to go into effect.
More than two-fifths of the physicians are not aware of the required new patient information. This is information that physicians are now going to be required, if they haven't previously submitted as part of electronic transmissions, and those include payer responsibilities, payer identification, claim or frequency type code which need to be included on the claim form.
More than two-fifths of the physicians who do not currently collect each of those required new data elements indicate that it would take a considerable amount of additional work on their part to collect the information.
The majority of physicians have not receive information from either Medicare or their private payers about the new data elements that they will be required to submit. Most, 83 percent of the physicians are aware that the compliance deadline is October 16. A large majority of the physicians are aware that failure to meet the standards may result in non-payment of their claims and penalties under HIPAA.
More than one-fourth, 27 percent of the physicians are not aware that Medicare will require submission of electronic claims by October 16. That survey result finding was done before the rule was published, but most physicians don't read The Federal Register, so they still will have a fair amount of education to get to that point.
As far as preparedness for implementing the HIPAA standard, 2 out of 5, 41 percent of the physicians had not completed an operational assessment of their practice by comparing the activities of their office to the HIPAA transaction requirements. Almost one-third of physicians do not have an implementation plan for the HIPAA transaction requirement.
Fifty-five percent of the physicians have not started testing for the new standard -- that is sort of consistent with what I think Stanley had suggested -- between their practice and health plans. Twenty-nine percent of the physicians have initiated testing.
The survey shows that of the 84 percent of physicians who have completed testing between their practice and health plans, 93 percent expect to complete testing by October 16, 2003. In our view, this seems very optimistic, given the large number of physicians who haven't yet tested, and the short time that there is left to test.
Fifty-six percent of the physicians have not started testing for the HIPAA electronic transaction and code set standard between their practice and their clearinghouse or billing service. That's important, because 57 percent of physicians rely on a billing service or clearinghouse to submit their claims.
More than one-fifth of the physician practices will not be compliant with the HIPAA electronic transaction code set standards by October 16, 2003. Of those physicians, 65 percent will submit claims by paper.
The main reasons given by physicians for not being compliant are 58 percent did not have enough staff, 48 percent feel they need more time to complete implementation, 47 percent need more information about the standard. Eight percent of the physicians state that their Medicare carrier has notified them that they will not be ready to take claims in the format by October 16, 2003, and 9 percent say that their private payers have told them the same thing.
We appreciate the very important role the NCVHS continues to play in advising the secretary on HIPAA matters. Your letter to the secretary on HIPAA contingency planning was timely and insightful. The physician perspective we are sharing with you today suggests that while progress has been made towards HIPAA compliancy, additional flexibility and relief is still much needed.
That relief should come with a smooth migration to HIPAA compliancy by having CMS establish a post-October 16 period in which covered entities that are making a good faith effort to comply with the transaction standards may continue to rely on their legacy claims systems, and not be subject to claims denial and/or civil monetary penalties.
I thank you, and if I can answer any questions, I would be happy to. I should say that this report obviously is preliminary findings. A final report will be available sometime next week. We hope some of the questions that you may ask today about that will be clarified in that.
DR. COHN: Jack, just for clarification, I presume we'll be receiving a copy of the final report?
MR. EMERY: You will.
DR. COHN: Okay, great. Questions or comments from the subcommittee or from CMS?
MR. NACHIMSON: I would like to respond to a couple of things. Some of the things we can respond to positively. Tom mentioned a process for revising the standards and the need for emergency change issues. Part of the regulation that I mentioned we hope to publish in the spring, we have already started some preliminary work with the designated standards maintenance organizations to find a way --
I mentioned hoping to publish a proposed rule next year with some modifications and revisions. Part of that rule will suggest a way that we can streamline the process of changing the standards. We have already started to discuss that with the designated standards maintenance organizations.
Some of the ideas that we are trying to work on is ways to avoid sort of the double commenting period between the DISMO(?) is going through an entire commenting process, and then the federal regulatory process on top of that, duplicating public input. We are looking at ways to allow the standards organizations themselves to make some more of what might be considered minor changes without it having to go through the entire regulatory process. So, we are sensitive to the need for speeding up that process.
I don't think we have thought about the emergency change process, and I think that's something that we can bring up also with ourselves and the designated standards maintenance organizations to see if there is a way that we can work on coming up with some sort of an emergency change process.
There were a number of comments on the claim versus batch rejection. And I guess the call for CMS to sort of issue something that says you've got to do it by a claim. There is nothing in the implementation guides or the X12 rules or any of the HIPAA law that requires a batch rejection or a claim rejection. This so far has been an individual business decision.
In the Medicare program although I think we started off giving our contractors the flexibility to do either one, we are leaning very towards making sure that our contractors reject at the lowest level. In some of the discussions that we have had, it's not quite as clean a claim versus a batch rejection. Sometimes you have to reject all of the claims from a particular provider or for a particular patient as part of the batch, but you don't necessarily have to reject the entire batch.
We are certainly sensitive to that, and again, we are looking at it from the Medicare perspective, being able to reject at the lowest level possible. And we would hope that health plans make the business decisions to do that.
I certainly appreciate the offer from the AMA to help us out on looking at the physicians that continue to submit claims on paper, and what we can do to put that information out. I think the comment in your survey that physicians did not hear about the requirement to submit to Medicare electronically is certainly valid under the rules.
Even though I think the law is very clear that claims had to be submitted electronically, we didn't have a specific date, or the specific exceptions that we could talk about until the regulation was published. Our Medicare contractors are already in the process of developing information, and sending out information to Medicare providers that will talk to them about what they need to do to make sure they are compliant with this particular requirement.
And hopefully, we'll do a good enough job of educating physicians and hospitals and other providers, so that they understand the situations that they need to submit electronic transactions, and the exceptions to those requirements.
DR. COHN: I actually had a question and comment on a slightly different issue, though actually probably related. I was actually wanted to delve in a little further into the batch versus single claim issue. And in my own mind I guess I had thought about previously whether or not this was a business issue, or whether it was really a legislative and regulatory issue.
Obviously, I'm delighted to hear Stan's comments about the advisory he is providing to your carriers and financial intermediaries about how to handle that. I guess the question is in terms of health plans, is there additional guidance or regulation that needs to occur in relationship to this?
And I'm curious to hear what the providers, as well as what Tom, the representative of the health plans, think about this one. But it appears to me that this becomes very quickly a business issue. And I guess I'm thinking, recognizing that whereas Medicare has required everything to be electronic, there are, at least to my knowledge, no regulations that require everything sent to health plans to be electronic.
So, if a health plan were to create too many barriers to appropriate submission of claims, a provider might choose to start submitting things in paper, which would certainly not be in the interest of the health plan, number two.
Number two, the other option, if a whole batch was rejected because of a single claim, it would seem to me that a provider might have the option to start submitting smaller and smaller and smaller batches, which might cause IT issues on the side of the health plan.
Now, I guess the question I had is am I missing something in this analysis? And I'm also wondering whether or not this is conversation, that there is an issue of communication that maybe needs to occur by the American Association of Health Plans to its member health plans, if indeed the analysis that I'm presenting is correct. Am I missing something here?
MR. ARGES: I was going to say maybe a simple statement, as Stanley had indicated that CMS is planning to do, and that is basically to advise their own Medicare contractors that they should begin making plans to review claims at their lowest level, the submission at the lowest level.
That's not to say that if a batch is entirely syntactically incorrect, you send the whole batch. But if you can process 80 percent of the claims in that transaction, and 20 percent for whatever reason, contain errors, then it just seems to me to make sense that you put those in another bin and send those back to the provider for correction, but you process the other 80 percent.
That to me, a statement about that, I think is something that needs to be done. I know that there are programming issues at this point in time, but I think making that statement now would at least get people moving in the right pathway.
MR. EMERY: Mine is a little bit different take on one of your questions, and that is about what private plans are and are not requiring. We are picking up anecdotal information that suggests that some health insurance plans are, as part of their contractual relationships with providers of care, are requiring claims to be submitted electronically.
And actually, on the comment that Stanley had made earlier about billing services and clearinghouses expressing interest in having those that use those services re-enroll, we are hearing that as well. But that they are also using this as an opportunity to increase their fees, which is sort of a double whammy for us.
Because so many of the physicians rely on billing services and clearinghouses, they've got a captive audience. And we don't have an awful lot of choices about the clearinghouses or billing services that we use, because there just aren't that many of them out there right now looking for new business. In fact, some of them are leaving the business, because they can't become HIPAA compliant, or guarantee compliance by the 16th.
DR. COHN: It sounds like a good business to be in for the next couple of months anyway.
MR. EMERY: I'm not sure it's a good business to be in, because there is an awful lot of pressure on them at this point to do the testing, because for physicians anyway, most of the physicians, they are going to test for their billing services, rather than with the carrier, because that is where they submit their data to, that's where they submit their information.
DR. COHN: Tom, obviously, I'm curious about what your thoughts are on all of this.
MR. WILDER: I want to start with a caveat, as I always do, that I am by no means a technical expert in transactions and code sets. I think this issue of rejecting a batch for a single error kind of points out the tension in HIPAA that Stanley mentioned in his comments, between meeting the business needs of the parties, and developing a uniform set of rules for people to follow.
From talking to our members, it is my understanding that there are situations where a single error may in fact, if you will, ruin the entire batch. And again, I apologize, I can't give you specific examples. But as Stanley mentioned, there might be an instance for example, where in Medicare you've got to reject an entire set of claims from an individual patient or from a provider just because of a single error.
I think in looking at these kinds of issues it's one thing to say to people you are not required to reject. There is nothing in HIPAA that says you have to reject an entire batch because of a single error. That's radically different from saying you must accept an entire batch, and just reject that one claim with that one single error, which is an entirely different proposition, because from a payer perspective, there may be business or operational or software reasons why that happens.
DR. COHN: So, I guess what I'm hearing from you is it sounds like you have had conversations with health plans around these issues, and you are working with them in terms of having discussions about all of this?
MR. WILDER: Again, there are a number of issues that we are talking to our members about. This issue of rejecting a batch because of a single error are issues that we have talked about.
MR. ARGES: Would be best if the technical experts from the health plans could identify those situations where they believe the batch is appropriate to reject? Whereas, if a claim that contains an error in and of itself, that should be processed, if it can be processed, but not reject the rest of the claims that are okay.
If an individual claim, for instance, is missing a particular item, reject that claim, but not the batch. Again, a batch I would think, if the elements that are part of the envelope are incorrect, I think that might be something that would cause a batch to be rejected.
MR. WILDER: I'm always glad to talk to our members to get a better sense, not only for this group, but for myself as to why a particular batch may be accepted or rejected based on what kind of data elements are or are not in there, and to share that with this group.
But again, I'm not sure I can say in all 100 percent of the situations, these are the kinds of errors that will cause the entire batch to be rejected by every payer. And in 100 percent of the circumstances for every payer and every submitter, these are the circumstances under which this particular error will not -- I just don't think you can do that.
DR. COHN: I'm sure that is information system-dependent.
Stanley?
MR. NACHIMSON: Actually, I have a question. Sometimes we want to be able to able to separate out business issues from HIPAA issues, and also things that are caused or relevant to the implementation of these standard transactions from things that are already existing. I guess the one question that I have that keeps coming up, is this something that is being done today pre-HIPAA or pre using the X12 transaction? It's only being magnified by the fact that we have this transition?
Today, when folks submit their proprietary transactions, are batches rejected when there are errors in only a couple of claims? I wish I knew the answer for Medicare, and I don't.
MR. ARGES: What I have heard is that there are just different inconsistencies, even within the Medicare program, from the intermediaries. One intermediary had indicated that they will reject at the batch level, but they said if the advice was given from central to do it at the lowest level, they would make those changes. But they just didn't feel that they had the authority to do that.
MR. NACHIMSON: I didn't make myself clear. Today, when we are talking about non-HIPAA transactions, transactions that have been coming in over the last several years, does this issue exist today where health plans reject a batch of electronic claims simply because there are errors in one or two of them?
MR. ARGES: I haven't heard of that as being a problem. I can't really comment authoritatively on it, because I really haven't heard about it as an issue. But the fact that I haven't heard about it as an issue, I would think that it is not on that basis.
MR. NACHIMSON: So, it appears to be something of a result of switching to these X12 transactions.
DR. STEINDEL: Stanley, I'm not talking as an expert in particular, but a batch is a unique entity under the X12 transaction. It may not exist in the present electronic transaction world.
DR. COHN: It's certainly something we should check into, or maybe Stan, you can sort of identify it.
I want to just go back to one of the questions I had here, which I am hearing about, but sort of got lost as we went across the discussion here. I guess, Tom, maybe you can help me on this. What I was positing, or at least the question I have in my own mind is, is there a major business case that will cause health plans to make sure that as much as possible, claims are accepted, dealt with, and expeditiously as we move into HIPAA, or is there not?
And that was really what I was trying to posit here. Because obviously, if there is a business case in and of itself, there is really very little need for federal regulation, FAQs, or anything else. On the other hand, if there isn't, then we probably do need to look to the federal government to assist with the issues.
And if I were a health plan -- which I do resemble in some cases -- Kaiser Permanente is an integrate health environment, as you know, but I was positing, well, I would faced, if I did not help with this transition and help make it successful, with providers going down to paper, which would obviously be a major cost, inconvenience, problem if I were trying to deal with claims.
And we obviously began to hear from Jack that may not be an option, because of contractual relationships with some providers. And then there was the other issue of being faced with smaller and smaller batches as providers reacted to having claims rejected when one claim was bad out of a relatively large batch, which might also have unforeseen and negative consequences for claims processing if you're a health plan.
So, from your view, is that a business case? Is that a concern you think being held by health plans? Or is that not sufficient? Am I mistaking the business case here? What is your thought?
MR. WILDER: I'm not sure this would totally answer your question, but the one thing that I hear over and over from our health plans is they don't want paper. They want to engage in electronic transactions. As the AMA survey points out, a high percentage of transaction today are electronic. So, anything that is done to make people step back to doing paper is a bad thing.
MR. ARGES: Say that again.
MR. WILDER: Anything in HIPAA, anything in regulatory pressure that pushes back to using paper transactions is very, very bad. As we all know, it's a lot faster and a lot cheaper quite frankly, to process stuff electronically. And in many cases, it's a lot more desirable, just because of the real time connectivity, for example, in pharmacy claims. So, paper bad. That's the one thing that has been pounded into my thick skull by our member is paper is very bad.
DR. COHN: Is there a concern at all by health plans that they start getting very small batches being sent by providers, rather than larger batches? Is there an issue there, or is that something you would have to ask them?
MR. WILDER: That is something I would have to ask them.
DR. COHN: I just sort of exploring the business case here, just because obviously I worry less if plans are incented to try to make all of this work, and not reject things unnecessarily, or if there are different incentives that will likely occur on October 16.
MR. ARGES: The only concern I have, and it actually deals with the interim rule a little bit, and it deals with CMS's it's all electronic or nothing approach. My concern is if people are making a good faith effort, and they believe they have interpreted the implementation of the standard correctly, and the FI let's say believes that they have interpreted the standard correctly, but for whatever reason they keep failing that submission of that claim, I think a provider should have a recourse to go to paper as a means of getting that claim finally adjudicated.
One of the things that concerns me is there is really a closing of the door, if you will, with Medicare, at least for the time being, one paper. And there might be an opportunity as paper being the last resort, for at least a six month period. I think it's important to at least allow some flexibility. I don't think providers want to submit paper as their first choice. It probably is going to be their last choice.
DR. COHN: George, for better or for worse, I actually read the recent electronic Medicare claim rule. I felt that I almost needed a paper work reduction act, because it was 48 pages precluding 2 pages of regulation, but that happens sometimes, I'm well aware with the government. My understanding is that that regulation only applies to the initial Medicare submission. And anything that is post the initial Medicare submission actually can occur in paper. So, if indeed there is a problem with the initial Medicare submission of a claim, it could actually be followed-up with paper.
Stan, did I misread that?
MR. NACHIMSON: No, I don't think you misread it. I would interpret it perhaps slightly differently, at least as explained to us. Again, I just want to remind folks that I'm on the Office of HIPAA Standards side, and not on the Medicare side, and that's a Medicare regulation. But since we get questions about it anyway, we have some education.
If a claim comes in on paper that should have come in electronically, it will be rejected. At that point, the provider has the opportunity to appeal that rejection. And you are absolutely right, Simon, appeals, because they are not the initial Medicare claim submission, could come in on paper. So, the formal appeal process can be done on paper.
I would say then as an absolute last resort, they can use paper to try and get their claim paid, but it's a cumbersome process. But I think on the fiscal intermediary side though, we do allow for the adjustment of claims, which again, can be done on paper or through phone calls, and need not be done electronically.
So, there would be a process where, in the instance of an implementation guide issue, or a piece of information that maybe is missing, the intermediary could call the provider and say we are missing this piece of information, can you tell me what it was? And then go ahead and continue to process the claim.
MR. ARGES: I just think again, the way it comes across is you try to do it electronically, which I think is the appropriate thing, but you need to make it less cumbersome in terms of accepting paper as a final submission process.
MR. NACHIMSON: This was an interim final rule that asks for comments. So, I would certainly urge people that feel that they want to make comments on the rule, to do so. It's sort of my standard comment speech. We do this for comment, and we are obligated to take a look at the comments.
With an interim final rule with comment, the rules are we get the comments, and then at some point we are supposed to publish a final rule. I'm not sure when that final rule -- I don't think there is a requirement in terms of timing for the final rule to come out. But we are obligated at least to take a look at the comments. So, I think that's a worthwhile comment to be made.
MR. EMERY: I just wanted to say at least from the AMA's perspective, when ASCA(?) was being debated in the Congress, the idea of giving an exemption for small practices and small hospitals was the idea that in some rural areas there either wasn't the electronic capability, there were billing services or clearinghouses available. That it would be potentially more burdensome for small providers and small physician practices.
We certainly don't disagree with that. But we don't want to send a message either that we think paper is the way to go, or paper is the way to avoid HIPAA. That's a wrong approach to take, because that's putting your head in the sand. That's not where the health care community is going. We need to move to electronic medical records and electronic claims.
And the vast majority of physician claims are coming in electronically already. But there are good reasons, and I think George pointed out a very salient point, that if the electronic process isn't working, there ought to be a fall back, and that fall back may very well be paper. We hope that that electronic process will work, but it's not the right message to send to the health care community, if you want to avoid all this, go to paper. That would be costly for everybody.
DR. COHN: Comments or questions? Am I the only with questions about all this?
DR. FITZMAURICE: I guess one question. From a couple of comments that Stan has made, it seems to me that within CMS there might be an office of national HIPAA standards policy and enforcement, and an office of Medicare operations, division of HIPAA implementation and compliance. And we might be putting people in an uncomfortable position by not having two people from CMS, one person to testify on national HIPAA policy and its enforcement, and someone else to say here the problems we are having as a health plan.
So, to separate the standards and enforcement from the health plan aspects, so that we can get people speaking about their areas of expertise. I'm not saying that Stan doesn't have great expertise. I'm saying that there seem to be two separate viewpoints on this. We may not be seeing the whole problems that the Medicare health plan has, because we are not talking to all of the people who do the operations, just to the people who are doing standards policy and enforcement.
It's just a thought. I don't ask for comment on it.
DR. COHN: Yes, I think Stan is nodding his head, and agreeing that he is feeling a little uncomfortable wearing all these hats at once.
MR. NACHIMSON: I only brought one with me today.
DR. COHN: Obviously, this is meant to be a conversation. And I think at this late date, we are not necessarily trying to produce letters for the full committee in September to then somehow vote on. By late September are getting really close to the deadline at that point. But obviously, what we want to do is track this, and try to help CMS and their office identify issues and concerns.
Now, obviously, we have talked some about the batch issue. We have heard CMS, their intent, talking with financial intermediaries and carriers around taking a helpful or liberal approach to dealing with that batch issue. Obviously, it sounds like, George, you were the one who brought that issue up, it sounded like at least in some ways you were happy to hear that.
MR. ARGES: I think what has been discussed, at least with the open door presentation was a good starting point. What I would like to see happen is really fleshing out a little bit more of the specifics around one of the elements that they talked about in the guidance document. And that was you have to have contingency plans.
But what does "contingency plans" mean? I think if you laid out some components to do that, and I think to me that's probably the most essential element at this point in time, because everything else we are really, as you said, at a late stage in the game. But at least a contingency plan is really what you need to take in the event there is a bit of a melt down, there are problems that occur.
What are prudent measures that would demonstrate that a health plan has in fact adopted an appropriate contingency plan? So, that there isn't any second guessing about what needs to be done.
MR. NACHIMSON: May I respond to that? Actually, a number of folks in the Office of HIPAA Standards have stated that we are probably not going to rule on the adequacy of folks' contingency plans. A contingency that a business takes is really up to them.
What we are looking for primarily are the good faith efforts that they have taken to become HIPAA compliant, and allowing them to develop an appropriate contingency plan, whatever that is for the business, assuming that they have made good faith efforts, and for some reason there are still some difficulties in getting claims paid or doing business in the HIPAA format on and after October 16.
So, we would say that a contingency plan again, is really up to the individual business, whatever is appropriate for them, given that they have made the appropriate good faith actions. So, I think we would be a little uncomfortable in specifying what a contingency plan is.
MR. ARGES: Well, it's that word "appropriate" that bothers me, because you have mentioned it several times. And the question then becomes how would you view what was appropriate?
MR. NACHIMSON: The decision on appropriateness is up to the business. It's not a judgment that we will make. We will say you have a contingency plan? Fine. It may not be HIPAA compliant. For example, continuing the use of legacy systems. For example, I'm saying a business has made the decision. We would then say, all right, you have made a contingency plan. Let me look at your good faith efforts and make sure that you have done enough to try to become HIPAA compliant. And if that's okay, we certainly would not penalize you because of your contingency plan, whatever it is.
MR. ARGES: But to me, a statement of continuity of payment, which I think you have implied in the guidance was there, that should be an element that is a cornerstone of the contingency plan, at least as part of that. Now, it could be that you use legacy systems to process it. It could be that they remove some of the non-material components on that. I'm not saying this is an evaluation of what a health plan is doing or not doing. But just defining some core elements that would say that these are prudent steps that one is taking to basically insure continuity of payment, would be positive, and would be welcome.
DR. COHN: Jeff, you had a question?
MR. BLAIR: Jack, I wanted to thank you for this survey. I have to confess that I don't entirely understand why there is such a large number of providers that either didn't seem to get the word after all of these years that HIPAA has been discussed and debated, and I'm just assuming that professional associations like AMA and AHA and others have been offering education and alerts for some time now on this.
So, with all of the efforts that you have made, and CMS has made, and NCVHS has made, and the trade publications have made, apparently it still wasn't enough. So, we are obviously struggling to try to avoid real, severe problems on and after October 16.
My question is that this won't be the last time that efforts will be made to try to encourage the health care community to adopt standards to facilitate and improve quality of care, reduce medical errors, reduce costs. Maybe it won't be in the form of a mandate with a deadline like this. Maybe it will be in other forms with incentives.
But nevertheless, there is going to be continuous movement. What can we learn? When I say we, I'm talking of the entire health care delivery system, both the federal government and the professional associations, what can we learn from this experience to better community to health care providers about what they need to do to get ready to make these changes in the future?
MR. EMERY: It's a fair question. And let me recall for you if I can, some comments made at your last meeting by I think his name was Carl Cunningham from the American College of Physicians. And Carl's comments at that point, first of all, and this is not meant to be offensive, but pointed out the many, many practical problems in dealing with small practices.
How changes of this magnitude, of this sort, HIPAA transaction standards and code sets, how difficult it is to get the attention of a physician, of perhaps a practice manager who is only there for a year or two or three, and then they've got to train somebody new. That that is difficult.
We have learned in part I think if we go back and look historically at the year 2000. There was a great deal of angst and concern I think on the part of the administration, and on the part of the many of the health plans about whether or not the small physician practices, those that we represent in fact would get the message, and would understand what the many requirements would be for the year 2000.
The year 2000 pales in comparison with HIPAA. And so, it is a much more difficult process to get their attention, to get them to commit to action, to commit the resources to take the action that is necessary.
Now, having said that, understand that the primary purpose of every physician is to treat patients. And they see a large number of patients every day. So, what need then is if a physician is going to be treating patients, is an adequate staff, adequate resources, so that when they are not concentrating on practical practice problems, they are addressing the many rules and regulations that they have to comply with.
They look at this, HIPAA, for the most part as being burden, not in fact a long-term benefit that will come from standardization, which is ironic, because it was the physician community probably more than anybody that said we need standardization. Now, we've got it, and physicians quickly forget that, that ultimately they will benefit from this process.
One of the things that was interesting, Jeff, I think in the survey finding was that we actually shared the survey with CMS beforehand, and said are there other questions we could ask that perhaps may help a little bit to address some of the concerns you have about not only communicating today's requirements, but the future requirements perhaps of whether or not it's HIPAA or whatever else may be on the government's agenda.
So, we asked where do you get your information? What's been the most helpful, what's the most useful? And the response was 72 percent of physicians get it from the AMA. About 50 percent, which would be third or fourth down on the list would be information coming from the carrier.
MR. BLAIR: But I'm sure that you were communicating, you were letting them know.
MR. EMERY: I will tell you that we did perhaps more on the privacy rule and requirements, because of it was the same requirement for all practices. Where the transaction standard and code set is not. You deal with a coding service, you deal with a clearinghouse. You submit directly. Some may do it as part of a group. So, there is not a uniform answer that I think the AMA or the medical specialty societies can provide that is a pat answer, that will answer every physician's concerns about how you cope with HIPAA.
So, we did a fair amount of information, at least as far as information about obligations, responsibilities, requirements, but we could always do more. When we can work in partnership with the administration to get that information out, it's better, rather than just relying on CMS.
Frequently, just as an example, physicians don't look at what they get from CMS, because the information that comes from CMS formally goes to the billing service or the clearinghouse. It doesn't go to the doctor, because the claim comes from the billing service, and the information goes back to the billing service.
So, it's a problem that another group, the Practicing Physician Advisory Council in CMS is now addressing. That's an advisory committee like yours, set up to advise the administration on sort of practical problems, perspective problems on dealing with the Medicaid program.
MR. BLAIR: Would you say from what you are saying, that the next time there is any kind of a government initiative to try to encourage another towards standardized electronic communications, that a coordinated education program with AMA and AHA and maybe AHIMA and the health plans, all of the professional associations need to be pulled together to develop a coordinated communications plan in advance?
MR. EMERY: That helps. And in fact, I think this administration has already done it, because they have open door forums. George just mentioned on recently. They certainly had it on HIPAA. They had those frequently. And it's a new leaf for the government basically, to communicate, and that is to have monthly conference calls with the big groups, whether or not it's the hospital groups or the physicians groups, the nursing home or whatever else.
Those work. They are helpful. They are beginning to pay benefits back in getting people more involved earlier in the process. And that ought to be encouraged.
MR. ARGES: One other area in coordinated communication, really looking at how the implementation transaction standards were carried forward, in hindsight, looking at the OSCAR(?) requirement, and looking at the term testing to begin in April, I think we left that door wide open.
Testing should have begun in April, but testing should have been given a date certain of when it needed to be concluded by. I think if testing had been given a date certain for completion, I think it would have gotten people's heading looking in the right direction. It would have allowed us to basically identify well ahead of the date certain when it had to go live, what particular issues or problems were cropping up.
And I think if we had a mechanism to quickly resolve what we learned from the testing, I think it would make the job a lot easier. Most health care providers are really in the business of taking care of patients. They basically do things probably at the last minute, that they need to do administratively, only because that's the nature of their game. But they will do it.
But they also need to be given dates certain. And the problem that we are having, at least from the hospital perspective is the inability to conduct the testing. And now we are going into a phase where it's anybody's guess as to how things will work on October 16.
DR. COHN: I think I should also just add to the tableau of issues and why things are the way they are. This is a recognition of human frailty, and the fact that we can only remember and prioritize so many things in our minds or in our lives. And I think the reality of the privacy rule having its final implementation date in the middle of April, and the fact that everybody was very focused on that, making sure that that happened, caused people not to start thinking much before that time was completed, about the next deadline.
And that's likely going to happen with the next deadline for HIPAA and all that. And maybe there is a lesson here. We probably should take to heart that we should make sure that there is enough timing between deadlines so that people can gear up on the next project. I know that a large organization like Kaiser Permanente is capable of having three or four priorities going on at the same time, but I know that many small and medium-sized practices, small hospitals, many environments are in a situation where they are dealing with the next deadline.
And indeed even though I have a two page Do List personally, I tend to be on the top two or three, making sure that those really get handled. It's just sort of an observation of how we are as humans in all of this.
I see all of us nodding our heads, which is probably an important lesson as we begin to come up with the dates for implementation of future HIPAA regulations.
We have obviously been talking, and I know that Stan has been writing feverishly. I guess as I'm listening to things, I'm hearing that there are obviously lots of concerns. There is certainly unfinished business. In some of these areas like the batch issue and all, I think words coming down from CMS, at least to its intermediaries, I hear AAHP in trying to deal with the issue.
I also hear that there are business reasons why the industry hopefully will make it all work, recognizing that on top of everything else, CMS has provided a soft landing memo and option for October 16.
Are there other key pieces that need to be in place? Obviously, I know that there is uncertainty in all of this, but is there some major other area that CMS has not addressed, that the committee has not addressed, that the health plans don't feel that they have any latitude around, that if they were addressed, might help with the implementation on October 16? This would be a very good time to let them down.
MR. ARGES: There are a few items that are required items in the implementation guides that sometimes make it impossible or difficult for the provider to basically meet them. And those required elements may cause a hang up, and cause needless frustration on the part of the provider to basically try and comply with those elements.
For instance, the physician and tax identification number on the institutional claim, where you have the report the attending or referring physician on the claim. It's not necessary for adjudication. Many physicians are saying I'm not an employee of yours, and therefore I don't want to give you my tax ID number or my Social Security number, but yet it's a required element. I wish in hindsight we would have made that situational, and indicated what and when it should be applied, and the necessity of it for each and every claim.
There are other items as well, insured's birth date. If there is a secondary subscriber, you may not have that information readily available, because the subscriber may not be there. They may be estranged, or just not available to basically provide you with that.
MR. EMERY: Diagnosis on a lab claim.
MR. ARGES: On the clinical labs, the diagnosis code may not always be readily provided when all you get is a specimen that is provided to your facility to basically test.
So, these are the types of things that still are looming, but require some immediate alternative to basically keep things from bogging down.
MR. WILDER: The only issue I would bring up, and we actually went in and visited a couple of weeks ago with Jared and Stanley is an issue for some of our members having to do with retail pharmacy claims for drugs and supplies. And it's an issue that we may ask that you put on your agenda for one of your next meetings.
DR. COHN: I guess I don't know, what is the issue?
MR. WILDER: I'll very quickly raise it, and again, I apologize. We have been talking to CMS, and we have an ongoing dialogue, so I don't want to -- but it's our understanding that in a retail pharmacy setting, that after October 16, you would use the NCPDP telecommunications standard for drug claims, but you would use the 837 for supply claims.
And it is our reading of the rule, as well as interpretation from a number of the pharmacy groups that in fact you can use either the NCPDP standard or the 837 for a supply. And we are concerned, because at least right now, NCPDP is a real time kind of response situation, where the retail pharmacist would find out immediately whether or not that's a covered benefit in the formulary and so on. And whereas at least now, the 837 is not set up for that.
But again, I don't want to go into it in any great detail, because as I say, this is our view of the issue. I know in talking to CMS, they have a different perspective, and I don't want to go into an in-depth debate here, because as I said, we do have an ongoing dialogue with CMS on this issue. But that's the one big thing that has kind of popped up on our side.
DR. COHN: Stan, do you want to comment?
MR. NACHIMSON: We are looking at the issue, and looking at ways to resolve it as expeditiously as possible. This is one of these things where I think it's an unanticipated result of where we thought we were doing the right thing, and perhaps it wasn't. We're not sure if and how we can resolve before October 16.
DR. COHN: Yes, well, I think this obviously is a comment that probably applies to a couple of the last comments. The comment of how to handle this. Similarly, George, your comment, which I am very sympathetic to that. This has taken such a long time to get into an implementation, that we all get smarter every day.
And I'm just reminded that a couple of years ago we were all around the table when we talked about a fast track process to re-evaluate the standards, make sure that there weren't unnecessary or onerous requirements that were in the standards. I'm sure you remember sitting here with us at that point. And we went through really what was a year long process trying to weed out things that somehow had gotten into these standards, that really were not necessary, or ought to have been situational or whatever.
Yet, here we are a year and a half later, wishing that we had done some more pruning, which I think what we are describing. Or at least gotten the dialogue more effectively going.
MR. ARGES: I would hope in the future that any time an item is required, it has to meet some sort of test where each and everybody who has to report it, is capable of reporting it. Otherwise, we shouldn't put the sign required on an element. Make it situational, and let the situational usage define it. That way, I think you will provide greater flexibility in its application.
But the concern right now is the fact that it was made required, or the required note sometimes still left a lot to be desired in terms of this application. But I think these are lessons that we have learned. And maybe going down the road, or if you are looking at it from other applications, just be certain that when you do assign the term required, that it has met some sort of acid test that everybody can meet.
DR. COHN: Yes, I think this begin to reflect on the whole standards development process, which is I think something we obviously will be talking about as we move forward. I'm not sure I have a good answer right this second for what to do about that one, but I'm sure that Stan will be thinking about it. And I think the important thing is just to get these issues out in the open.
As I said, the intent of this was not to produce a letter, but to make sure that we are at a point where things are so close to implementation, that we just need to be grabbing these issues, making sure that CMS is very well aware of them, and see if there are some things that can be done that don't require regulation, but might be able to help us smooth the bumps with the implementation.
I saw Stan writing them down. I do know that in September we'll obviously have time at the full committee meeting for an update on HIPAA as part of the agenda. And I think that we should hopefully expect maybe CMS will be able to run through a lot of these issues, as well as what their proposals are around fixes or guidances or whatever, just to make sure that obvious bumps that we are seeing, that there may be something in place, or at least we can articulate a response that might help with that known bump.
And I know Stan's e-mail is always open. Mine is to as well, obviously, letters and all of this stuff. But I just think we need to collect these issues, and see if we can come up with maybe not perfect or elegant solutions, but things that help make sure that in the middle of October we can look back on it, and say well, that worked okay. Or at least not as bad as we thought it might be, or whatever terms you want to use. And so I just think we need to make sure that the communication remains open.
MR. ARGES: I was going to say that the National Uniform Billing Committee met earlier this month, and we also approved some recommendations with respect to some transition issues where you are using a certain code that was a UB code, that as of October 16 will use the X12 code.
So, we defined some steps that can serve as guidance, and hopefully the industry will view it as a common understanding of what the date on the claim means, and what the code means as of that date.
DR. COHN: Any other questions or comments? I feel like I've been monopolizing this particular session, but obviously I think it's really important that we make sure this sort of goes along okay.
Stan, any comments?
MR. NACHIMSON: Just that in the agency, we're trying to strike a very delicate balance between the requirements of the law and the regulations, and the obviously need to continue the business of health care in this country. Certainly, the last thing that we want to happen is for a patient to walk into a doctor's office or a hospital office on October 16 and be told that they are not going to get health care, because the doctor or the hospital is not HIPAA compliant.
We are very aware of that. That was one of the reasons for the compliance guidance. We obviously need to continue to strike that balance between our responsibility for enforcing the law and regulations, and continuing the business of health care in this country. Hopefully, we'll be able to walk that very delicate line.
DR. COHN: Is there any other business coming before the committee, any comments from the floor, questions?
DR. FITZMAURICE: When is the next time we get together?
DR. COHN: Let's just go through the schedule very quickly.
MR. BLAIR: We're in Washington, so you're supposed to say, I'm glad you asked me that question.
DR. COHN: The full committee is meeting on September 23-24. Obviously, the agenda is still tentative and still being worked on I believe, for those two days, but right now the subcommittee is meeting on the morning of the 24th, as I understand.
MS. GREENBERG: A tentative agenda has been sent out. It's already wrong obviously, because I think it includes an hour for the PMRI letter discussion.
DR. STEINDEL: Marjorie, I think you indicated that we meet twice, once on Tuesday and once on Wednesday.
MS. GREENBERG: That was an original proposal.
DR. COHN: I think that this agenda is going to continue to evolve. The key issues on the morning of the first day, there will be a HIPAA update and discussion of I think some of the outstanding issues, and hopefully how CMS is beginning to address them and all of this. That will be less than a month before the date of the HIPAA implementation.
Now, dates for the next subcommittee full meeting, which as you all know, and I want to thank you all, is up to three days now. We are hoping not to add a fourth day. This will start on October 28, and adjourn on the 30th. We don't know which topics will be which days, but there will be certainly a discussion on CHI, maybe some issues coming forward on HIPAA, depending on what happened 10 days before. There will be certainly discussion around ICD-10, and the PMRI report hopefully will be coming forward for final revisions, and can be taken to the full committee hopefully the next week.
The full committee meeting in November is on the 5 and 6. And then the last subcommittee meeting of the year is on December 9-10. As I commented, we will be shortly beginning to query members for hearing dates in the first half of 2004. So, hopefully, we can confine our meetings to two days at a time in the first half of the year.
MR. BLAIR: Then we do not plan to meet as a subcommittee in September, the day prior to the full committee meeting?
DR. COHN: There is no plan at this point. The only reason at this point we would meet the day before is if there are extraordinary CHI issues that need to come before the committee, that somehow need to be resolved prior to that. At this point, I'm not anticipating that will be the case, but that would wait on staff discussions to identify that.
MR. BLAIR: Do you want us to hold that time in case CHI needs time for us?
DR. COHN: I think the staff who is in charge of this area is nodding his head no.
DR. STEINDEL: If anything, Jeff, no more than to the middle of next week.
DR. COHN: There will also be a conference call by the subcommittee occurring probably sometime in the next two weeks I would imagine that will relate to a discussion of a ICD-10 cost-benefit analysis to assure that we think it's adequate to be distributed to the full committee.
MS. GREENBERG: I would think it would be right after Labor Day.
DR. COHN: We'll let everybody know, and try to get that scheduled. The other issue will be assuming there is a quorum present, discussion and hopeful ratification of the CHI lab results recommendations.
DR. FITZMAURICE: Is it okay to submit the draft ASCA report to the full committee so that we can get their feedback as well?
DR. COHN: Since we don't have a quorum, I will informally ask if there are any issues? I reviewed it, and I thought it was fine to be submitted to the full committee. Is there any objection from the subcommittee members on the ASCA report? Well, hearing none, I will take the prerogative of the chair, and agree that it needs to be forwarded on to the full committee for review.
MS. GREENBERG: Thank you to both of you.
DR. COHN: Yes, a very good document.
DR. STEINDEL: Mike and I would like to assure you that we did correct for your dermatologist.
DR. FITZMAURICE: We figured it was not skin off of our nose.
DR. COHN: Okay, well, jokes aside, I think the meeting is adjourned. Thank you very much.
[Whereupon, the meeting was adjourned at 1:05 pm.]