[This Transcript is Unedited]
Hubert Humphrey Building
200 Independence Avenue
Washington, D.C.
DR. COHN: Good morning. I want to call this meeting to order. This is the first of two days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics.
The committee, as most of you know, is the main public advisory committee to HHS on national health information policy.
I am Simon Cohn. I am a physician and national director for health information policy for Kaiser Permanente, and chair of the subcommittee.
I want to welcome fellow subcommittee members, HHS staff, and other interested parties to this meeting.
I also want to welcome those on the internet. I believe we are on the internet today. Speaking of that, I want to remind everyone to speak clearly and into the microphone, so that the people on the internet can hear.
Now, the focus of hearings over the next two days is HIPAA administrative simplification. The role of the NCVHS in HIPAA administrative simplification is two-fold.
First of all, in complying with HIPAA administrative simplification, the secretary is to rely on the recommendations of the NCVHS.
Second, the NCVHS has also been asked to track implementation for both HHS and Congress, and identify implementation issues and barriers and recommend strategies to mitigate these issues.
Now, the purpose of the hearing this morning is to talk to representatives from the designated standards maintenance organizations, hereinafter referred to as the DSMOs, to better understand your recommendations for transaction standards changes.
This afternoon, we will broaden the discussion to include representatives from various industry segments. In addition to the discussion about the DSMO process and results, we will also be talking about implementation readiness and transactions and general readiness issues.
Obviously, all of this is intended to help the NCVHS develop sound, informed recommendations for the secretary, which we will talk more about on Friday.
I actually want to take a moment also to specifically thank Carolyn Trudell and Stan Knockmanson and Bill Braithwaite, for their help in putting together this hearing, which I think you will all find pretty interesting.
With that, I would like to have introductions around the table. I would ask that the subcommittee members please indicate during your introduction, first of all, whether there are any issues coming before the subcommittee today upon which you need to recuse yourselves.
Also, since I think every subcommittee member is involved with one or another DSMO, I think you should probably also indicate which DSMO, if you are involved with them, you should at least indicate that affiliation, not that you have to recuse yourself in relationship to that discussion.
I guess I will start out myself by mentioning that I am a member of the National Uniform Claims Committee.
DR. BRAITHWAITE: I am Bill Braithwaite, HHS staff to the committee.
MS. FYFFE: Kathleen Fyffe, member of the committee. I work for the Health Insurance Association of America.
As for DSMOs, I represent HIAA on the National Uniform Claim Committee, the National Uniform Billing Committee, the National Council for Prescription Drug Programs. HIAA is a member of WEDI. Are there any others? I think that is it.
DR. ZUBELDIA: I am Kepa Zubeldia. I am president and CEO of Claredi Corporation. I am also the president of the Association for Electronic Health Care Transactions, and in fact will this afternoon testifying. I am a member of X12 and NCPAP.
MS. GREENBERG: I am Marjorie Greenberg from the National Center for Health Statistics, CDC. I am the executive secretary to the committee. I am also a member of the National Uniform Billing Committee.
MS. BEEBE: I am Susie Beebe of NCHS. I am a member of X12, HL7, WEDI.
MS. WARD: My name is Maria Ward. I am with First Consulting Group. I am here today representing Health Level 7, as the DSMO vice chair.
MS. WEIKER: I am Margaret Weiker with EDS. I am the DSMO chair representing NCPDP.
DR. FITZMAURICE: I am Michael Fitzmaurice, Agency for Health Care Research and Quality and liaison to the national committee, staff to the Subcommittee on Standards and Security.
My agency sponsors meetings of the Health Informatics Standards Board, of which many of the DMSOs are members.
MR. BLAIR: I am Jeff Blair, vice president of the Medical Records Institute. I am vice chair of the Subcommittee on Standards and Security. I am a member of HL7 and just, I guess, for full disclosure, I am a member of ANSE HSP and a member of ASTM and I think that that is everything that might be relevant.
MR. SCANLON: I am Jim Scanlon. I am with the HHS Office of the Secretary for Planning and Evaluation, and I am the executive staff director for the full committee.
MS. TRUDEL: Karen Trudel with the Health Care Financing Administration. My organization is a member of the National Uniform Billing Committee, the National Uniform Claim Committee, X12, Health Level 7, and NCPDP. I represent the federal liaison to the board of directors of WEDI.
DR. COHN: Could we have introductions around the room, please?
MS. ADLER: Jackie Adler, National Center for Health Statistics.
MS. KLEIN: Sally Klein. I represent Medicaid agencies from the National Association of Medicaid Directors.
MS. FRANK: I am Sheila Frank. I work for HCFA in the Medicaid Center.
MS. JONES: Katherine Jones, NCHS.
MS. SCHULTEN: Catherine Schulten. I am here representing Sybase and AFEHCT.
MS WILLIAMS: Michelle Williamson, NCHS.
MS. JENCKS: Debbie Jencks, the National Center for Health Statistics.
MR. HUTRO: Rusty Hutro(?), Medic Computer Systems.
MS. RECORD: Carol Record(?), American Optometric Association, coding committee.
MS. FORAKOWSKI: Renid Forakowski(?), American Optometric Association, manager of their eye care benefit sector.
MS. EMERSON: Mary Emerson, Health Care Financing Administration.
MR. GRAHAM: Garth Graham. I am an intern at ASPE.
MR. REYNOLDS: Harry Reynolds, Blue Cross and Blue Shield of North Carolina.
MR. RODIE: Dan Rodie, American Health Information Management Association.
MR. TATE: Michael Tate, American Dental Association.
MR. LANDON: Rich Landon. I am here today to speak on behalf of X12, an insurance subcommittee. I am employed by Blue Cross Blue Shield administration, and I am a member of most all the DSMOs except for NCPDP.
MR. PETTICORT: Doug Petticort. I am here for the Coalition for Health Information Policy.
MR. EMORY: I am Jack Emory with the American Medical Association.
MR. ACHMUNSON: Stanley Achmunson(?) from the Health Care Financing Administration.
MS. RALSON: I am Mary Etta Ralson(?). I work for the National Center for Health Statistics.
MS. ALT: I am Vivian Alt from the National Library of Medicine.
DR. COHN: Now, before we jump into our first briefing, I was going to ask Karen Trudel to brief the committee on a recent letter we have received from the Secretary of Health and Human Services.
MS. TRUDEL: This letter is dated May 29. Since most of you have not seen it, we will pass it out, but I will also read the salient portion of it.
This is from Secretary Thompson to Dr. Lumpkin, the chair of the full committee, and it relates to recommendations that the committee made to the Secretary for modifying the standard.
Your recommendation to modify the standard would retract the adoption of the National Drug Code as the standard medical data code set for reporting drugs and biologics for certain standard transactions.
This response is to industry problems with transitioning from the HCPCS codes to NDCs for reporting drugs and biologics.
These problems were initially presented by representatives from the health care industry at the NCVHS public hearings on February 1, 2001.
We reviewed the testimony from the hearings and agree that the providers, health plans and health care clearinghouses in attendance raised a number of compelling concerns regarding implementation of the NDC.
We intend to pursue your recommendations by publishing a notice of proposed rule making. We expect to do this in the near future, so that we can resolve the issues before substantial work by the industry to convert to NDCs is underway.
I think that is pretty much the gist of it.
DR. COHN: We want to thank Secretary Thompson for his quick response to our concerns. Hopefully that will continue as we move forward with other suggestions for changes to the final rules and implementation guides.
With that, I think that our first briefing is with the overview of the DSMO process and results about the expedited process for transaction standard changes. Margaret, did you want to lead off the discussion?
MS. WEIKER: Good morning and thank you for the opportunity to provide the committee with a progress report regarding the fast track DSMO process.
Before I go any further, I just want to with Maria Ward, who is the vice chair of the DSMO, a happy birthday.
The DSMO has completed steps one through four of the fast track change request process. There were 231 change requests that were processed.
While each organization had a separate internal process to address the change request, the DSMO used the following ground rules and steps to address the request.
Our ground rules were, each DSMO will have a spokesperson. The chair, vice chair and secretary will serve as facilitators, gate keepers and timers, and timers will be kept to facilitate discussion of all items during the meetings. Those were our ground rules.
The steps are as follows: Step one. All steering committee member organizations will classify, by a majority vote of the organizations present, the change requests, regardless of collaboration status, into one of the following eight categories.
Category A is modifications necessary to permit compliance with the standard or law. According to DHHS, necessary items include something in the adopted standard or implementation specification conflicts with the regulation, two, a non-existent data element or code set is required by the standard, three, a data element or code set that is critical to the industry's business process has been left out; four, there is a conflict among different adopted standards; and five, there is an internal conflict within a standard implementation guide.
Category B is modifications. Those were classified as additions or deletions of data elements, internal code list values, segments, loops, changes in usage of segments, data elements, internal code list values, changes in usage note, changes in repeat counts, changes in formatting notes, or explanatory language that doesn't fall into category A.
Category C is maintenance, classified as items that do not impact the implementation of the transactions. Items classified as maintenance will require no further DSMO action. Items are to follow the SDO process.
D, no change, classified as items where the implementation guides already meet the need requested or where the requester was unable to substantiate the request to the extent that the guides should be changed. It may result in follow up by the submitter for further action.
Category E, DHHS policy, those are classified as items that require follow up by the Department of Health and Human Services in regard to the final rule.
Category F, withdrawn by submitter, classified as items that the requester withdrew during the business analysis phase, and have subsequently been removed from the change request system.
Category G, appeal, classified as items where a collaborating DSMO or the originator does not agree with the outcome of the business analysis phase.
Category H, industry comment request process, classified as items that require additional comments from the industry to determine consensus. That was step one.
Step two, a majority vote by the collaborating organization for change requested in category A above will be taken where, based on individual DSMO recommendations, consensus already appears to be reached. The recommendation will be agreed to as well.
If there is disagreement on any recommendation in this step, it will be removed and tabled for further discussion in step four.
Step three, a majority vote by the collaborating organizations for change requests in category B will be taken, where, based on individual DSMO recommendations, consensus already appears.
The recommendation will be agreed to as well. If there is disagreement on any recommendation in this step, it will be removed and discussed later in step six.
Step four, discussion will occur for each category A change request. Each collaborating organization spokesperson will have three minutes to present their recommendation.
After this discussion concludes, a five-minute open discussion of the collaborating organization spokespeople will occur to reach consensus.
If consensus appears imminent, an additional five minutes will be given. If consensus has not been reached, the change request will be tabled. If consensus is reached, the consensus recommendation will be drafted.
Step five, address step four tabled requests. Five minutes of open discussion with the collaborating organization spokespeople will occur.
If consensus still has not been reached, a vote will be taken. Each collaborating organization has one vote, and a two-thirds majority is necessary to move the disposition forward.
If a two-thirds majority is not reached, the request will be referred back to each collaborating organization for further discussion and a final resolution to the original change request process. If consensus is reached, the consensus recommendation will be drafted.
Step six, discussion will occur for each category B change request. Each collaborating organization spokesperson will have three minutes to present their recommendation.
After the discussion concludes, a five-minute open discussion of the collaborating organization spokespeople will occur to reach consensus.
If consensus appears imminent, an additional five minutes will be given. If consensus has not been reached, the change request will be tabled. If consensus is reached, the consensus recommendation will be drafted.
Step seven, address step six tabled requests. Five minutes of open discussion with the collaborating organization spokespeople will occur.
If consensus still has not been reached, a vote will be taken. Each collaborating organization has one vote, and a two-thirds majority is necessary to move the disposition forward.
If a two-thirds majority is not reached, the request will be referred back to each collaborating organization for further discussion and a final resolution in the original change request process. If consensus is reached, the consensus recommendation will be drafted.
After the above steps were completed, the 231 change requests were categorized into the following categories: Category A, 37; Category B, 33; Category C, 50; Category D, 95; Category E, 7; Category F, 6; Category G and H I lumped together and there are seven.
The category A change requests are listed in attachment A of the handout. The category E change requests are listed in attachment B, and the category H change requests are listed in attachment C. I did not attach the remainder.
The DSMO recommendations and categorizations have been posted to the DSMO web site. I was hoping to say that it is done.
We are having a little bit of technical problems at the moment. So, if you go out there, you wouldn't be able to see them, but it should be resolved today.
The DSMO is currently in step five of the fast track change request process. Step five is as follows: The SSO will communicate to each of the collaborating organizations the proposed changes for them, to review and confirm that the solution satisfies the disposition recommendation.
From the date of communication, all collaborating organizations will have 15 calendar days to review the proposed solution.
SSO changes confirmed to satisfy the recommendation will be incorporated into the appropriate documentation. SSO changes not satisfying the recommendation will be referred back to the SSO for further development.
The collaborating organizations will have seven days to come to a consensus with the SSO. If consensus is not reached, the collaborating organizations may invoke the appeals process.
The category A change requests, which are applicable to the X12 N implementation guides have been posted to the web site of www.wpc-edi.com/addenda.
In conclusion, it is known that some of the recommendations and categorizations of the change requests will be appealed by the requester and formally appealed by a collaborating organization.
This will add more time, approximately 20 days, to the final resolution of the fast track change request. Once final resolution is achieved, all category A and category E requests will be forwarded to this committee.
The DSMO needs guidance on how the committee would like to receive this information; for example, a listing of the request and the affected implementation guides.
After completing a couple of cycles of the normal change request process outlined in the MOU, the DSMO will be evaluating their performance and making any necessary modifications to the process.
Some of the DSMO organizations have already recognized areas where they believe improvement is needed.
Each DSMO organization continues to be committed to operating within the expedited process to assist HHS and the industry in making the necessary changes within the first year as described in section 160.104(b) of the final rule.
Our concern is whether or not the department can meet the October 16, 2001 deadline as described in the final rule.
It was disheartening to learn, after all the preliminary work had been done, that the fast track changes will be subject to an NPRM.
We began this process with the expectation that it would result in a final with comment, and this is in part what led us to be supportive of a fast track process.
The NPRM may be published in 2001 and a comment period will follow, resulting in an extended period for issuing a final rule.
Most organizations across the country have already invested heavily in evaluating, testing and implementing the transactions and code sets.
Information in the yet-to-be-released NPRM may affect their implementation, as it may well require additional evaluation, testing and implementation cycles.
It is our responsibility to impress upon you that what we are discussing here and the decisions we make will have a significant impact on the industry.
In short, we believe that all the DSMOs did a commendable job in rising to the challenge and addressing the needs of the industry in such an expedited fashion.
As it is with any consensus process, not everyone was pleased with the outcome of a particular request, but we do believe the process worked.
DR. COHN: Margaret, thank you very much. Maria, do you have some testimony?
MS. WARD: No, Simon, Margaret and I actually drafted this together. I am just here to join in her.
DR. COHN: I guess we will have questions and discussions at this point. Maybe I should start off first, only because I am a little bit confused by the testimony and maybe you can help clarify some of the issues for me.
You had gone through a description of a number of steps, a seven-step process, and then you reference that you are on step five, and apparently step five if of a different process as I understand it.
Maybe you can describe to me that process and how many more steps there are, which I think is the process that has to do with the reaching final agreement on the recommendations.
MS. WEIKER: Right. Basically, the seven-step process that I outlined was the process that we went through when we were building consensus.
It was the business analysis phase to address each of the change requests. So, that was the seven-step process that is outlined in the testimony here today.
Step five is part of the overall MOU process, and there are basically six steps to that process.
DR. COHN: Can you go through step five and step six, then, to describe what happens?
MS. WEIKER: Okay. Step five is basically we have gone through the business analysis and that has been forwarded to the appropriate standard-setting organization to update the implementation guides. So, that has been done and that is part of step five.
What each of the collaborating organizations have to do at this point is go out and look or, if it is forwarded, depending on the mechanism, and verify that the actual change request that was agreed to in the consensus process is actually implemented correctly.
For example, I need to add -- let's say there was a change request to change shoe size. Well, X12N in the 837 put it at the header level, where it really belonged at the detail.
So, that is the type of thing that each collaborating organization is doing at this point. Also, at this time, if there is an appeal either by the requester or the DSMO, the collaborating organization, that is filed, and that is a separate track.
After this step is completed, then the recommendations are gathered, formulated, whatever you want to call it, and then forwarded to the national committee, you all, so then you can make your recommendation to the Secretary.
DR. COHN: So, the time frame is?
MS. WEIKER: Well, we have to wait for the appeal process. That is going to be -- if the web site is done today, then it will be approximately 20 days before we actually know, will there potentially be any additional changes to any of the implementation guides, based upon the appeals.
From there, the implementation guide would be changed. The collaborating organizations would need to look at that change, although I don't think we would go through the entire 15-day cycle because we would have to hurry up, and then we would forward it to you.
So, it could be 30 days. I know there will be appeals. So, it is going to at least be 30 days.
DR. COHN: I have a couple of other questions. I guess I will go ahead. I had the opportunity to look, I guess, at your complete 75-page spreadsheet of suggested changes, and I know that many of you have -- everybody has received a copy. I don't know that everyone of you has read it.
One of the great advantages of having long air flights is that you can look through such things.
I was actually curious, only because as I was looking at this, I hadn't made a major distinction between category A modifications and category B modifications.
Yet, I see in your recommendations that it appears that you are not in any way considering category B modifications to come forward. Can you discuss that and explain the rationale behind that?
MS. WEIKER: Well, basically per the direction of Health and Human Services and HCFA, and with what the final rule says, it was changes necessary to permit compliance.
So, we asked HCFA to come up or to assist us in developing rules around things necessary to permit compliance.
If you look at category A and the five sub-bullets under that, you see what we determined to be necessary to permit compliance modification. If it was a modification and it didn't fall into one of those five, then it was categorized as a category B.
DR. COHN: What are your feelings about modification B? How should they be handled?
MS. WEIKER: The modifications will go into the next version of the implementation guides.
DR. COHN: Okay, which will then have to go through yet another NPRM.
MS. WEIKER: Right.
DR. COHN: How important are they to the industry, from your view?
MS. WEIKER: From my view?
MR. BLAIR: Can I get a clarification right there, to that question? Isn't the requirement for an NPRM restricted only to category A but not B? Is that right?
DR. COHN: Category C, I think.
MS. WEIKER: Category C is maintenance and that follows the appropriate SDO or SSO process. So, I found a typographical error. That is an maintenance. That follows X12N's or HL7's normal process.
MR. BLAIR: Then can I refine my question a little bit? Simon, I think it does link into the thread of your question here.
Could you just clarify to me whether all of the items within category A require an NPRM? Exactly what items, A and B require an NPRM, but within A, do all of the sub-items require an NPRM? I am trying to understand.
MS. WARD: Jeff, this is Maria. I think the fundamental distinction between category A and category B is that category A is the items that the collective DSMO steering committee felt were necessary to permit compliance. So, those were the things that were really germane to this whole fast track process and let's get it in within that.
The Secretary can make changes in the first year of implementation. The category As fit within that bucket. If the department has determined that the way we move forward with that is requiring an NPRM, then that is the way it is going to be, and that is what we have been told.
So, the category As will require an NPRM. They are the fast tracked, need to get them done as soon as possible addenda or modifications to the version 4010.
The category Bs are things that we recognize need to be done and will be part of a collective DSMO conversation, but will result in changes in a future version. So, they don't fall under that urgency of get them done in the first year.
Presumably, future versions will also require NPRMs. So, I think they both require an NPRM. The difference is the timing in which these things get executed.
DR. COHN: Could you introduce yourself?
DR. MC DONALD: Clem McDonald from Indiana University and Regenstrief Institute.
DR. COHN: Do you need to recuse yourself from any of the discussions today?
DR. MC DONALD: I just wanted to have you introduce yourself.
DR. MC DONALD: I am also a member of the HL7 group that does this kind of work.
DR. COHN: Okay, go ahead.
DR. MC DONALD: The thing I am trying to clarify on the particular question, it sounds like there are two kinds of concerns and I don't understand the sequence of events that led to them.
One of them was there was a fast track put in place -- and I am paraphrasing your note. The industry kind of rose to the thing, worked their tail off, thought this was going to get this fixed to make the standards work better, and then found out that it needs a whole other process.
I guess I would like to understand who said that and why is that true, or do we know it is true, and does it have to be true.
MS. WEIKER: From our perspective, we have been told that it is true by the department when we met in April to go through these.
So, the who decided it is true, ultimately, I am not sure. I am assuming it was probably general counsel of the department.
We, as the DSMOs, have been told by the department that that other process is an NPRM, and that it does have to happen.
DR. MC DONALD: What I read between the lines in here is that everybody is kind of getting knocked down and they are demoralized, and why are we doing all this stuff if it is going to go another different way.
From other people in the industry, and from you specifically, is this going to have an effect, if they can't make these changes in a fast way?
DR. ZUBELDIA: The question that is being tossed around is, this is going to happen before October 16. If it is not going to happen before October 16, we might as well just go through the normal process. That is the question.
DR. COHN: Maybe we should ask some of our HHS representatives to comment. Mike?
DR. FITZMAURICE: I look at it kind of differently. I look upon it as a dual challenge. I see that the industry was challenged to come up with the most immediate things that were necessary to happen in order to make the standards work.
They have met and they have done it. I don't know when the final turnover of, here are the final issues that we have finally resolved are, but they have met with us and they have told us what those issues are going to be.
The second part of that challenge is to the department. Can the department put this into place and get it out by October 16.
If the industry has met its challenge, then the industry is now challenging us.
MR. BLAIR: Is October 16 good enough for the industry to put it into their implementation plans.
MS. WARD: I think it depends on what we are talking about for October 16. If we are talking about an NPRM that requires a 60-day comment period and then some time before a final is issued, with people shooting for an implementation live date of October of next year.
Taking off my DSMO hat and putting on my what-it-means-to-implement-this-stuff hat, I would say we are pushing it.
DR. COHN: Maybe I should go back to square one which is, we are all wondering, the advice about the NPRM was delivered in a credible way by --
MS. WARD: By Stanley and Bill. So, credible, yes. I don't know how credible they are. [Laughter.]
DR. BRAITHWAITE: As far as I know, we have been internally discussing trying to find a faster way to make this happen, but I haven't yet received word from our general counsel that there is an approved way to do that. There are lots of reasons for that.
DR. MC DONALD: So, there is still some reason to be optimistic? As I recall, there are a couple of things that are broken and we are sort of fixing it.
This may be analogous to the NDC. Does that go to the NPRM to fix it, the NDC codes?
DR. BRAITHWAITE: At this point, an NPRM is being generated for that. Without a different way to do it, that is what we have to do.
MS. WARD: That is separate, though, right, Bill? That wouldn't be part of this NPRM.
DR. MC DONALD: But it analogous.
DR. BRAITHWAITE: That and the fact that the Secretary has said we are going to do it at least lays the groundwork for the industry, knowing that the process is at least moving forward on that particular item.
We have sort of found a way around waiting for the NPRM to get out and all that, to make sure that people know that the NDC issue has at least been resolved within HHS. Whether we find similar ways to deal with these other problems or not, I don't know yet.
DR. ZUBELDIA: I haven't seen what issues have been classified under G, appeal. It seems to me like if anything has been appealed, there is not really a consensus.
If it is being appealed, and that is going to take an extra month, is it worth saying that we will put this into the standard fast track process, as a result of the normal means, let's save that month now and come up with things that really do have a consensus.
Then, when it comes in the NPRM, there won't be arguments about it. Everyone will agree on the NPRM and it can be fast tracked to a final rule without much problem.
Even if it is appealed and it is resolved within a month, the NPRM provides a second mechanism of appeal where it would delay the whole process again, and it may not come out in October.
If you take those things out now and put everything that has a consensus through the process, that could go much faster. Is it possible to do that? Is it worth it to do that?
MS. WEIKER: With the whole MOU process, and the fast track was based on the existing MOU process, we would be throwing out the appeal mechanism that exists in the MOU process.
Some of the appeals that I know will be forthcoming is to appeal some of the categorization of the actual recommendation.
It is not so much to appeal what the DSMOs agreed to. It is to appeal the categorization.
There are some category B items that people believe should be category A items. It isn't so much that we haven't reached consensus on some of those. It is the categorization.
Yes, there are seven that we know already that will be appealed to get further industry input, and that is going on right now.
Those items, I think, are very important that we get consensus. One of them is taxonomy. I think it is very important with how you are going to do taxonomy in the first round of these implementations, Kepa, rather than putting it off.
MS. WARD: To provide a little more background on that appeal, too, we sort of added another layer to the category that we called appeal when we met in April, the DSMO steering committee.
Items where two or more collaborating organizations could not agree on the disposition of a particular request, those organizations agreed that, instead of invoking an appeal right away, let's put that out for more public input, and those organizations also agreed.
So, in line with a greater consensus on these issues, those organizations also agreed that, based on the public input, we would have a better idea as to how to move forward with those.
Hopefully, by doing that, which we have done -- we have included them on the Washington Publishing Addenda web site -- there is a separate little title that actually says appeals, so that people understand they are different from the modifications.
Hopefully we will gain more insight from the industry and be able to have more of a consensus-based opinion on those issues. They are not actual appeals. They are really more out for another round of public input.
The ones that, once this is all posted, if individuals decide to appeal the outcome, I agree with Margaret, that some of them, it is probably in the best interest, at least like taxonomy, for us to get through that now versus waiting, who knows how long.
DR. COHN: So, taxonomy is a category B currently.
MS. WEIKER: No, for the professional guide, it is a category H. The recommendation was to make it a situational data element, where currently it is mandatory.
The situation would be -- I am paraphrasing this -- necessary when Medicaid is needed. The discussion was, are there other health plans in the country that may need it besides Medicaid, and maybe they weren't involved in some of the X12N, 837 conference calls.
In that regard, that is being put out for additional comment to go, if you are a health plan other than Medicaid, let us know if you are going to need taxonomy. That is the professional guide.
Then, for the institutional guide, it is being put out -- the recommendation was to make it not used for institutional, and it is mandatory now.
There is comment being sought to, is this going to cause anybody a problem if you don't have taxonomy on an institutional claim.
I think it is very important. Some of these are very important that they be decided now, versus I am going to implement where taxonomy is mandatory and then have to turn around and either have it be not used or situation and have developed my situation changes based upon having some kind of provider type and speciality and have to go back and rip that code out and put in more code.
DR. MC DONALD: A question is, what can we do? It sounds like -- I really want the committee's input. To me it sounds like there are some snags in the administrative road.
On the one hand, we want to make it easy and agreed upon and the best way to get this up and get this out so that it works for everybody.
On the other hand, if we are going into it knowing it has all these snags, it is going to have bad effects.
DR. COHN: Clem, I actually sort of agree. I think what we are seeing is a number of different snags and issues, some of which we can help and some of it we can't.
Some of it has to do with the fact that it takes a while for the industry to come to consensus, if, indeed, that can ever be achieved. That is, I think, issue number one.
We are hearing that the DSMO process is itself -- I really appreciate the fact that you have expedited the process. It still takes a while for them to come to consensus and we are still hearing that it is a month or so, maybe longer, away.
Then we are also hearing that there is a government process that maybe we can make some comments about, that maybe some of this stuff needs to be expedited within the government.
DR. MC DONALD: I guess that is what I would like to see. They have got normal life problems and we are sort of contending with those and making progress, the way I heard it, and I hadn't heard all this before.
I heard it that there is sort of a surprise, in April versus February, in this additional process which could be six or nine months. It is an unpredictable length of time.
DR. COHN: Let me just add one thing and I will let Stan clarify a little further also. I need to go back and review my law a little bit, but my memory is also, in the midst of all of this, there is a question of what do you do during the first year up until October 16 versus a final rule or decisions that are made after October 16.
During the first year, which I think is until October 16, changes can only be made to ensure implementation, but if a final rule comes out October 17, then you can do whatever you want. Is that the correct interpretation?
Stan is nodding and disagreeing with my interpretation on that. Have I confused it completely?
MR. NANINSCHEN: There are certainly a number of processes that are opposing each other that are going on. The first concern about getting this out as a final rule with comment versus a notice of proposed rule making, we are bound by the Administrative Procedures Act, I believe.
We have been working with our Office of General Counsel. There are certain reasons that you can't issue a rule as a final with comment as opposed to a notice of proposed rule making.
In our discussions with our office of general counsel, we have not been able to convince them that this situation meets any of the reasons. I don't know them off the top of my head, but we have not been able to convince them that this situation meets any of those reasons.
That is why we are unfortunately bound to produce this as a notice of proposed rule making, versus a final with comment.
I think what we are looking for in terms of the time frame, never mind when we need to publish and get this information out.
It is certainly critical that the industry understand the changes that we propose to make, whether it is done in a notice of proposed rule making or final with comments, so they can start changing their implementation process.
What we hope to accomplish is that the final rule be published in time so that the first set of standards will be the standards with addenda, as opposed to the current standards happen to be adopted on October 16 and then six months later or three months later these first changes take effect.
According to the law, the administrative simplification law, people have to have at least six months of time to implement any changes.
Take October 16, 2002 as the current deadline for implementing the HIPAA standards. Move that back six months which is, I think, April, if I am not mistaken.
So, we have to have a rule effective by April 16, 2002 so those changes can go into effect October 16, and you need to move back another two months to February 2002, because whenever we publish a rule that has major implications, the Congress has 60 days to look at it.
We need to get a final rule published by February 16, 2002, in order that this new set of changes be implemented October 16, 2002.
That is the guideline that we are going by. We are trying as hard as we can to set up a schedule that everybody can implement on October 16, 2002, these revised standards.
Changes could still be made, but considering that DSMOs have already talked about this, a lot of the issues have already been discussed, my guess is that industry could possibly take the issuance of an NPRM and the addenda as published as fairly good guides and say, gee, this is really what we need to implement.
Hopefully what we need to do is get out a proposed rule as soon as possible once the addenda are agreed to by the designated standards maintenance organizations, and that is our intention, at least at this point.
DR. COHN: Stan, just to make sure I understand, that is of course assuming that there are not compelling arguments made by industry during the comment period that would otherwise change the final rule. That is correct, isn't it?
MR. NANINSCHEN: That is absolutely correct. Even a final with comment would expose us to that. If there is a comment, then we would be forced to revise the final rule based on those comments.
So, the public, the industry, anyone still has the opportunity to comment on a proposed rule and the department must answer those comments.
DR. MC DONALD: It sounds like a way out -- I am overstating it -- might be to just find a way, once this is agreed, get it out in public with some label on it so that people are aware that this is what is likely to be coming. That helps in terms of planning. Then grind through the process and if we can make those deadlines, things will be all right. Does that sound better?
One of the things I read in here is that people are quitting. I mean, they are getting demoralized. I over-read that maybe. The demoralized was in here.
MS. WARD: Well, you over-read it and you also were part of a work group meeting a couple of weeks ago for one of these groups where some of that was expressed, I think. So, you have been exposed to that a little bit from the industry.
DR. MC DONALD: So, subliminally, you have planted it.
MS. WARD: Planted a seed. We already knew the time line that Stanley was talking about going into all of this, and understanding that that is the time line that the department has to work under, given the stipulated 60 days, four months or six months or whatever it is, gets us in under the deadline before October 2002.
I am not certain that the reality of what it means to implement these things is necessarily on that time line. So, will it work? According to a time line, yes.
Is it going to be problematic for people? I am speaking now from being out there and helping health plans implement and having been doing it for a year. It is going to be problematic.
Even if we make those dates, it is going to be problematic. Folks don't want to wait until next April. They are doing this now.
Even if we have an NPRM, I think the reality is, from where I used to work where I commented on those and where I work now where I work with people who comment on those, I don't think they are going to move on an NPRM.
I don't think they are going to move to make changes based on an NPRM. I think they are going to wait for a final.
DR. COHN: I am sort of listening to all of this stuff. Certainly I know from my organizational experience, if something is problematic in an NPRM, you don't implement it.
You hope and you basically take their word for it on things like, for example, the NDC code issue which, if you have to implement and then pull back, could be tens of millions of dollars from any organization.
I guess as I think about that, it is unlikely that people will implement that based on the current piece, if there is word that the HHS will likely not require it be implemented.
Now, as we talk about this process -- I am just sort of reflecting a little bit on what you are saying in terms of changes and all of that -- the whole spirit of HIPAA is an ongoing change process.
So, yes, we are doing things sort of fast right now, but this issue of six month change, six month notice, year notice, whatever, is going to be part of life as we move into the 21st Century further.
Are you beginning to reflect that the industry really can't manage that sort of change cycle and we need to reflect on some sort of a different change cycle?
MS. WEIKER: I think the issue is, this is the first time a lot of the health plans and providers are having to implement these standards.
There is a bigger hurdle now than there will be, let's say, two years from now, where all I have to do is add a new data element or something like that, or take out a data element or whatever.
A lot of people are having to re-tool their whole systems. Some are replacing their entire claims adjudicating systems today, buying translators, talking to clearinghouses, et cetera.
It is because they don't do these standards today. So, two years, three years from now, it won't be an issue because the infrastructure, the base, will be in place. The base isn't in place today, except for possibly NCPDP. I had to throw that in.
DR. COHN: Let me make one final comment and then Jeff, you have a question coming up here. I was just reflecting, as you were beginning to answer this question, that the issue that we are dealing with is an issue that is common to all of the HIPAA final rules.
I am thinking specifically of privacy, where there is exactly the same issue of the desire by the Secretary to want to make changes, to announce and sort of telegraph to the industry upcoming changes, but yet having to go through whatever process.
Maybe one of the roles, one of the things we need to think about tomorrow is, is there a need for a recommendation for some sort of an expedited process that ensures integrity of the process.
It is just like we asked the DSMOs to expedite things. Maybe there needs to be some activity coming from HHS to similarly expedite all of these things.
So, it is a thought. I don't think we need to act on it right this moment. It is certainly not just a financial and administrative transaction issue. Probably for the industry, this is small in comparison to the effects of the privacy final reg. Jeff?
MR. BLAIR: This may be hope against hope, but Stan, I heard -- correct me if I misunderstood you -- but I thought I heard you say that you had failed to get -- you had tried or failed to get the issue of NPRM to be put aside, the requirement for the NPRM to be put aside.
It seemed to imply that you had made some arguments to see if that was really necessary. So, I guess my question is, is this just, at this point, a dead issue that we should accept, or is there an opportunity for a compelling argument or request from another source other than the DSMOs, that might give us the opportunity to see if this is necessary.
MR. NANINSCHEN: This is a discussion that we have had with our office of general counsel and the supposed experts in there on the administrative procedures act, and their reading of the exceptions to the requirement for a proposed rule, to us, is that we do not meet any of those -- I think there are three exceptions -- we do not meet any of those three exceptions.
If there are some experts available to the committee or someone on the committee who is more familiar with the requirements of the administrative procedures act and has some experience to explain why this situation meets one of the exceptions, I am sure that they would be happy to listen to that.
MR. BLAIR: Is it worth even going down this path or should we just accept that as a final decision?
DR. BRAITHWAITE: I think from the perspective of the general counsel's office, they have considered it under some great amount of pressure from us to find a way to make it happen.
Clearly, there is some logic that says that it should be possible, given that the reason for putting out an NPRM is to make sure that the public knows what we are planning to do and gets a chance to comment.
Since the kinds of changes we have just been talking about have already gone through an industry-wide consensus building process, which is at least as complete as what the NPRM would produce, there is some logic to say, well, we have already been through that process. Let's put it out as a final and give an opportunity, at least, as a final rule with comment, for other people to add in if they haven't been part of that process.
The logic is there. The reason for doing it is there. The APA and the way our general counsel has interpreted it didn't foresee this kind of process, I think.
Recommendations to the Secretary would certainly be valuable in what the general counsel's office could look at.
Recommendations to Congress about tweaking either the APA or HIPAA if there is something else going on that might warrant tweaking the HIPAA rule, they could tweak it to make sure that this is clear, that this is the process that they intended, and that the delays imposed by the APA are not out of their idea of how this should work.
There are several ways we could explore, but clearly, adding one long consensus-building process to another long consensus-building process is not what anybody thought was the right thing to do here. It is just that we are kind of stuck between a rock and a hard place.
MR. BLAIR: Then my next question would be, is NCVHS the right vehicle or an appropriate vehicle or a compelling vehicle to make the recommendation that would, in a sense, paraphrase that you have just said.
DR. COHN: I think that is not a question for Dr. Braithwaite. It is probably a question for the subcommittee members and the members of the full NCVHS.
I think we have noted that as an issue, since we are going to have to discuss what sort of recommendations we need to bring forward to the NCVHS tomorrow. I think that will be one of the topics for discussion.
I think, once again, just as we noted, it is a general issue related to HIPAA administrative simplification, not just a secondary problem related to the administrative financial transactions. We may generate some additional support because of that.
DR. ZUBELDIA: Going back to my previous comment and Bill's last comment, of adding one long consensus-building process onto another long consensus-building process, I think if we could add a short process, a 61-day process or a 62-day process to the consensus process, I think that would be very beneficial to the industry.
I think if the industry was to see that the DSMOs have built through consensus and that everybody agrees on this and that it is going for a proposed rule that will be very shortly after the end of the comment period followed by a final rule, with a commitment from the department to have the final rule within a week after the comment period or something like that, I don't think that is even possible, but if there is true consensus in the DSMOs, there would be very few comments during the comment period, because everybody has agreed to it, essentially.
If that is possible, then we may be able to do it, but there is another thing to consider, and that is the requirement that the Secretary not change the rule more than once per year.
I believe that clock is reset once this amended rule comes out with the modifications from the DSMOs. So, that would clock the further changes for another year.
This is something that has been discussed. If the process is such that the final rule for these DSMO changes cannot come out before October 16, it may be better for the industry to not come out with a final rule at all, so that the changes can be done maybe by the end of the year. If there is something that comes out before October 16, nothing can be changed for another year.
DR. COHN: Kepa, maybe you can clarify this for me. Going from today to October 16, how do you expect a new final rule to be completely published with congressional comment between now and October 16, 2001?
DR. ZUBELDIA: We have the 60 days for public comment on the NPRM.
DR. COHN: Right, and then 60 days for congressional comment.
DR. ZUBELDIA: That would be for the effective date. The final rule would be published just a few days after the 60 days. We could still make October 16 for the final rule.
Now, the effective dates may take another couple of months if they get notified, but it would make the final rule by October 16.
MR. NANINSCHEN: Much as I wish we could promise that we could get a final rule out within a week after the comment period closes, I don't think that is doable. That is seriously nowhere within the realm of possibility.
I think, Simon, you asked a question earlier about this first year period and just to clarify it for everybody, the standards can be changed at any time during their first year, if it is necessary to permit compliance to the standard.
After that, the Secretary can only change each standard no more frequently than once a year. It is important to realize that if we change the 835, if we change the remittance advice standard during a year, we can certainly change a claims standard or an eligibility standard at any other time. The one-year period is per standard.
The NDC standard can be changed and then the claims standard can be changed. We are not subject to publishing just one rule a year changing any of the standards.
DR. ZUBELDIA: But these DSMO changes affect all standards except for maybe NCPDP.
MR. NANINSCHEN: So, we will be held for at least a year with the changes.
DR. BRAITHWAITE: It was my impression, Stanley, that the changes allowed in the first year -- that is, the changes required for compliance -- were independent of that annual process.
So, we could, in fact, publish a final rule six months from now or whatever that makes these changes and then go right ahead into the change process.
DR. ZUBELDIA: Even if the final rule is published after October 16 of this year?
DR. BRAITHWAITE: I think so, but we will have to talk to our lawyers about that. The intent of this first one is to change things necessary for compliance. It is a different process for a different purpose, not to, well, here is the next annual update of the standards.
I think we can get them to agree that this next round, which is the things necessary to make compliance possible, will not be setting any clocks for when the next change of standard can happen.
MS. GREENBERG: I had just a question of clarification. Did you still want to continue on this topic.
DR. COHN: Did you have something to follow up on this?
DR. ZUBELDIA: This is a slightly different topic.
DR. COHN: Okay.
MS. GREENBERG: I wanted to ask Margaret for clarification on the taxonomy for the institutional guide. You said that the DSMO recommendation was D, not change?
MS. WEIKER: No, it is currently mandatory in the institutional guide. I believe the DSMO recommendation was to make it not used. I believe that is a category H item.
MS. GREENBERG: I guess there is nothing here that made it clear that that was the recommendation, that it was not used. It does say category H. I guess I am a little confused by how to read this.
MS. WEIKER: Basically the discussion, when the DSMOs met, was the recommendation by the NUBC was basically to say make it not used.
Then from there, it was between X12 and the NUBC. There was no consensus between those two organizations. So, they made it category H, to gather further information. Right now, the recommendation would be to make it not used, from mandatory.
If you have, Marjorie, a need to have taxonomy in the institutional guide, I strongly urge you go out to the Washington Publishing Addenda site and put in your need.
MS. GREENBERG: I am just confused by it because you had two SDOs who didn't agree.
MS. WEIKER: Right, which is why it is an H. We could not reach consensus on that particular change request. So, we made it a category H to gather further information to see if we couldn't find some middle ground.
DR. COHN: On top of that is a B. So, you are not bringing it forward anyway, or you are not sure.
MS. WEIKER: We are not sure at this point. We have to wait for the cycle to run for the category Hs, which will be done -- X12 is gathering information and X12 meets next week.
After that meeting, I plan to have another steering committee meeting, so we can address these H items. Also, we will have a very good idea at that point about how many appeals we have, so that we can all get our calendars in order so we can meet and get this done.
DR. MC DONALD: There are actually two things in that. What was the nature of the disagreement? I had heard, I think, previous testimony that the problem with the taxonomy was that, at least for institutions, they didn't have a way to implement it.
They had some simple things and there really wasn't a pragmatic way to identify the category of the provider in the billing cycle. Is that correct?
DR. COHN: For the institutional claim?
DR. MC DONALD: Yes, that is my recollection, that it was a burden that the institution didn't have a physical way to link a provider to a specific specialty through the various flows of what happens. No institution has that capability.
DR. COHN: The institutional claim would be for the taxonomy of the institution, wouldn't it?
DR. MC DONALD: No, it requires the X12 taxonomy.
DR. COHN: The institution is part of the provider taxonomy. Institutions are providers.
MS. WARD: I would like to bring George Arges to the table.
DR. COHN: I guess my suggestion at this point is, rather than trying to solve -- we all have our --
DR. MC DONALD: I was trying to understand how deep it was, what was the disagreement. I can learn that off line.
DR. COHN: I was just going to suggest doing it after break.
DR. MC DONALD: My initial question was, there is a thread or a theme in the testimony -- and I want to make sure I am reading the right testimony. This says, my name is Maria Ward.
MS. WARD: HL7.
DR. MC DONALD: Is that not the testimony you just gave?
MS. WARD: We gave the DSMO steering committee that testimony.
DR. MC DONALD: It might still be the same one. I don't have time to read that one over. It says something about revising the guidelines for the review and opt-in process. It is not clear what the issues are here.
MS. WARD: I think that will probably come in my testimony.
DR. MC DONALD: Oh, you are giving testimony. I came in a few minutes late.
DR. COHN: We need to break in just a second. My hope is that we will get a level deeper as we look at specific elements.
I have one question before we break, though, and that is really for both Margaret and Maria, just a piece of clarification.
We have talked about As, Bs, Cs, Hs, Es, et cetera, et cetera. If a final rule was to come out after October 16, 2001, would your preference be for HHS to consider both A and B under those circumstances, or would you only be still at that point speaking for As going forward?
MS. WEIKER: We didn't make that decision right now. All those B categories, the implementation guides would have to be modified, and that is an effort by the co-chairs of X12N.
I don't believe there are any NCPDP category Bs, but that would place another great burden on the volunteers in X12N to get those implementation guides completed and up to date in time to hurry up and meet some other deadline.
I would just caution us to try to come up with a plan and then let's stick with that plan. I know there are going to be people who appeal category Bs, and they should be As.
If they have a compelling argument, the collaborating DSMOs or even all of the DSMOs will agree to make the change. I hate to just blanket make all Bs and A. There are too many of them. Some of them can wait.
MS. WARD: I think our preference in a perfect world would be to fix everything as fast as you can. I agree with Margaret, the burden that would place on the X12 work groups and the co-chairs and the folks who have been working pretty hard to try to get us to this point, I don't want to speak for Rich or X12N, but I am part of that management team, too, and I don't think it is possible.
DR. COHN: Kepa wants to give the final comment before we break.
DR. ZUBELDIA: Yes, I am going back to the thought that is coming to me that this is not going to work. If it takes longer than October 16 of this year, people still have to implement this stuff in their system.
If it gets delayed until next spring, that doesn't give anybody enough time to make the changes, much less to test the changes and make sure that everything works.
We have to have a very firm resolution with very clear indications without arguments as to what are the things that have been approved by the DSMO that nobody agrees on, and these are the things that are moving forward.
If there are things with arguments, with appeals, with disagreements, that would have to be moved back to maybe next year's changes or whenever they happen, maybe at the end of this year, next spring or whenever.
Whatever we can do today to send a very clear signal that this is what the DSMOs have agreed, this is what everybody has agreed, and it is not going to change between now and the final rule, whenever that happens, I think that would be extremely important.
If there is any question in the industry that any of this stuff in the proposed rule could change, people will hold back and not implement it. They will wait for the final rule. If people wait for the final rule, they will be achieving nothing with the fast track.
DR. COHN: Obviously, the intent of the fast track was to help ease the implementation and make the implementation more successful, not delay it.
It is time for a break. Any final comment?
MS. WEIKER: I have a question, Simon. How do you all want the change requests that we do agree upon -- or is that going to be part of tomorrow's discussion -- how do you want us, as a DSMO, to present those to you? Is that part of tomorrow's discussion? Do you want a letter with them all outlined?
DR. COHN: I think a letter with them all outlined might be a good way. Kepa?
DR. ZUBELDIA: I think the addenda, as published on the web site, they look great, and a cover letter on those, I think, would be fine.
MS. WEIKER: So, in that PDF format that they have, or Word, or whatever.
DR. COHN: I guess I haven't seen that, so we would have to look at it. Is that basically a letter with a list?
MS. WEIKER: Yes, we can put a cover letter on that.
DR. COHN: Why don't we break for 15 minutes and we will come back and continue the discussion.
[Brief recess.]
DR. COHN: This is actually the first panel of our hearings. This is meant to be a roundtable discussion of the DSMO process and results by the various participants in the DSMO process. Margaret Weiker, we have you on as the first testifier. Would you like to start?
MS. WEIKER: Good morning, Mr. Chairman and members of the committee. I am Margaret Weiker of EDS. On behalf of the National Council for Prescription Drug Programs, NCPDP, I would like to thank you for the opportunity to testify before the NCVHS Subcommittee on Standards and Security.
NCPDP is committed to participating in the HIPAA DSMO process and welcomes the opportunity to share our experience with this process.
The impact on NCPDP internal process. NCPDP opted in on 15 requests that were either related directly to the NCPDP standards, or to the pharmacy services sector of the health care industry, or contained a pharmacy component.
The standardization co-chairs and maintenance and control co-chairs performed the majority of the work by reading and evaluating each request.
Requests were referred to the appropriate work group for discussion and recommendation. The director of standards development at NCPDP led the effort of tracking and posting the recommendation to the web site.
Our internal process has not been challenged since NCPDP work group meetings were already scheduled. Therefore, no special meetings or conference calls needed to be held.
For requests that involved X12N and NCPDP, we provided input to the X12N work group co-chairs.
Our observations regarding the DSMO fast track process. NCPDP supports the development of and compliance with a set of guidelines regarding the review and opt in process.
NCPDP believes there are flaws with the existing process that will be evaluated to determine if they exist in the overall process or may be attributed to the fast track process or to the learning curve of the new process by the organizations and volunteers.
An example would be to opt in on a request and then not provide a recommendation, but to defer to another organization.
NCPDP believes, in this case, an organization should withdraw from being a collaborating organization on that request, since they cannot offer a recommendation after evaluation.
These guidelines should, at a minimum, include rules for opting in on a request, formulating an appropriate recommendation, and withdrawing from participation.
All DSMOs should have an opportunity to review and provide comments on the guidelines and, once agreed upon, they should be implemented.
It is NCPDP's testimony that developing and following such guidelines will improve the current process.
With the number of change requests entered concerning the addition of code sets, NCPDP believes a relationship should be established with the currently designated code set maintainers to expedite these requests and to gain additional background information.
It was disheartening to learn that the addenda identified in the fast track process will be subject to an NPRM instead of a final with comment, as suggested at the February National Committee on Vital and Health Statistics meeting. This will delay a final rule and may impact implementation dates.
The fast track process has had a definite impact on the industry. The members of the DSMOs are primarily volunteers, and much time was spent in reviewing and formulating responses to the requests.
In addition, there was confusion in the industry as to whether to stop assessments and remediation efforts and wait for the outcome of the process, or continue and evaluate at a later time.
In conclusion, since the fast track process will not have to be repeated, NCPDP has every reason to believe the normal DSMO process, as outlined in the MOU, will work well, with the addition of a few tweaks.
DR. COHN: Margaret, thank you very much. Maria Ward from HL7?
MS. WARD: Good morning, Mr. Chairman, and members of the committee. My name is Maria Ward. On behalf of Health Level 7, I would like to thank you for the opportunity to testify before the NCVHS Subcommittee on Standards and Security.
HL7 is committed to participating in the HIPAA DSMO process and welcomes the opportunity to share our experience with this process over the last four months.
We would first like to point out that the discussions and testimony heard today are only relevant to the fast track process that was implemented in response to the committee's request for help in addressing issues with the X12N HIPAA implementation guides.
You will recall that, at the February 1 NCVHS meeting, as a direct result of industry testimony to the committee, that changes to the implementation guides were necessary for implementation.
The DSMOs were asked to help develop a process to address the request for changes in an expedited manner.
It is important to put this in context, because we don't want to make assumptions or statements about the DSMO process as it was outlined in the MOU, or developed by each of the DSMOs.
There has been frustration expressed in the industry because of the significant work effort that went into addressing these requests in such a short time, and the belief by some that we may not have always made the best decisions.
Again, this is tied directly to the fast track process, not the normal DSMO process. Indeed, the normal process has not yet run through a full cycle. So, we, as DSMOs, are not in a position to speak to its success.
We expect that, within the next few months, the normal process will have completed for at least one batch of requests.
Impact on HL7 internal process. HL7 provided input to the DSMO steering committee testimony delivered on February 1 of this year.
At that time, we stated that we have only addressed a small number of requests. Even though 231 requests were addressed in the subsequent fast track process, HL7 has still only responded to several.
The majority of work went into reading and evaluating each request and subsequently determining which of those will have an impact on HL7.
Given that only several requests will affect our standard, our internal process has not been challenged nearly as much as that of X12Ns.
We have, in fact, addressed a few relevant change requests in orderly and consensus-based fashion. For the reason for the requests that involve X12N and HL7, we coordinated with both the X12N work group and task group chairs in formulating our response.
Specifically, HL7 elected to opt in on requests concerning a need to include clinical supporting information with the X12N 278, which is the precertification, preauthorization transaction, and the request to develop an XML representation of the implementation guides.
We are actively working with X12N on the development of attachments for the precertification, preauthorization implementation guide. By doing this, the need expressed by the industry for clinical information to accompany the 278 will be met.
Observations regarding the DSMO process. These observations are based on participating in the fast track process.
First, HL7 supports the development of, and compliance with a set of guidelines regarding the review and opt in process.
We believe there were flaws in the existing process, such as DSMO's opting in on requests that do not affect their constituents, or opting in and not providing a recommendation for solving the problem.
In our role as vice chair of the DSMO steering committee, HL7 has been working with the steering committee chair to develop such guidelines.
These guidelines should, at a minimum, include rules for opting in on a request formulating an appropriate recommendation and withdrawing from participation.
All DSMOs will have an opportunity to review and provide comment on the guidelines. We hope that all the other DSMOs will also see the benefit of such guidelines and support moving forward with this recommendation.
It is our testimony that developing and following such guidelines can only improve the current process.
Second, it was surprising and somewhat disappointing to us, as well as most, if not all, members of the DSMO steering committee to learn that the addenda identified in this fast track process will have to be subject to an NPRM.
This was shared with the DSMO steering committee in April at the reconciliation meeting, after all the preliminary work on the fast track requests had been done.
When the need for an expedited process was expressed at the February NCVHS meeting, the DSMOs, with great effort, responded to the challenge.
We made a decision to establish a fast track process based on the expectation that the results would be published as a final with comment, as suggested in February.
The DSMOs undertook this task at the committee's request because we believed that there was a chance to make changes within the first year of implementation as described in the final rule for transactions and code sets.
This is important because it caused a significant number of people, in not only the standards bodies and data content committees, but also those implementing the transactions, to set aside other tasks and give complete attention to this monumental undertaking.
Again, this was all with the expectation that there would not be a need for an NPRM and an extended time frame in which to implement the changes.
Implementing the fast track process had a definite impact on the industry, particularly on each of the DSMOs, as they had to review and consider each of the 231 requests.
Likewise, many implementers tried to understand what was taking place and, once they did, to get their request entered before the deadline.
This was a large work effort for all parties, especially for the X12N volunteers, as almost each of these requests affected their standard.
We are operating in an environment that relies entirely on the work of volunteers for everything from developing a standard and addressing national implementation issues to advising the Secretary.
In this particular effort, many of the volunteers took on large work loads to make this happen in the required time frame and are now wondering if this was futile, since an NPRM must be undertaken.
As entities begin to implement HIPAA, they may be less likely to support as much industry activity for their employees as they have in the past. We are already seeing this happen.
Additionally, as those who have carried so much of this volunteer work load become over-extended, their productivity will diminish. We have also begun to see this happen.
These are time consuming tasks that employers are paying volunteers to do on company time. Perhaps the lesson learned from the fast track process is, whenever possible, we should be more sensitive to making additional requests of industry volunteers without some level of assurance that HHS knows what the process will require on their part, if that is even possible, and can support the process sufficiently to achieve the goal.
In conclusion, we would like to recognize that this undertaking was deemed necessary by all parties involved at the February NCVHS meeting. Because of that, each of the DSMOs rose to the challenge.
This was a task of monumental proportions and, all things considered, we have accomplished a great deal in these past months.
We believe the process allowed us to discuss the consensus decisions of the respective DSMOs, to debate the merits of many of those decisions, and ultimately to arrive at a solution that will best support the needs of the health care industry.
We further believe that the DSMOs, specifically the hundreds of individuals who worked so hard on this, are to be commended for a job well done.
Too often we get so caught up in all that we have yet to do, that we don't pause to reflect on all that we have already accomplished.
Going forward, we welcome the opportunity to work in accordance with the original DSMO process as described in the MOU.
We do believe there is room for improvement and we will work with the DSMO steering committee to address that. Ultimately the process will allow all DSMOs a greater opportunity to consider all requests and formulate well-thought-out recommendations.
DR. COHN: Maria, thank you very much. Richard Landen, from X12?
MR. LANDEN: Members of the subcommittee, my name is Rich Landen. I am co-chair of the X12N insurance subcommittee health care task group, or TG2.
I would like to thank you for this opportunity to testify today regarding the recent change request process for the X12N HIPAA implementation guides, adopted under the transaction standards requirements for the Health Insurance Portability and Accountability Act of 1996.
As an autonomous organization, and especially pursuant to accreditation of X12 by the American National Standards Institute, X12 must follow its ANSE-approved processes for the development of its standards, and the X12N insurance subcommittee must follow its approved internal procedures for the development, approval and modification of implementation guides.
I stress that this is an autonomous organization and, as such, we are bound by our own internal rules.
Those internal requirements have been woven into the obligations to support the DSMO process and abide by the DSMO memorandum of understanding.
For the DSMO change request process, X12N's process included, first, gathering information, discussions and then making recommendations at our work group, then our task group levels.
The normal discussion, debate and, especially, the further research of the issues were severely constricted by the demanding time frame of this fast track process.
Second, X12N then consolidated all of the recommendations into the X12N responses. Normally, each change request generally affected just on work group within the health care task group but sometimes they crossed work group lines.
When they crossed lines, we would have to reconcile recommendations from different work groups. So, X12N management, task group two health care management, and task group 3, work group 3, what we call the HIPAA coordination management, reviewed the work group and task group recommendations for consistency and for conformance with the HIPAA guidelines specified by HCFA for the DSMO fast track process.
X12N's representative discussed our assumptions and concerns with the DSMO steering committee. Where possible, we sought compromise and consensus.
Compromise and consensus, as is probably obvious to you, does not equate to unanimity. There are always dissenting opinions. As we go through further iterations of public comments, be they on the X12N, Washington Publishing Company web site, or through the NCVHS committee hearings, or through the public comment period after the NRM, we will continue to hear from the minority for whom our recommendations do not well suit their business requirements.
Third, after reaching DSMO consensus, X12N posed its technical solutions and posted them to an online public conference for the modifications and appealed items. That address is given in the handout here. It is www.wpc-edi.com/addenda.
Fourth, after the public comment period closes June 1, tomorrow, X12N will review the comments, render its decisions about the addenda and prepare to vote approval of the addenda.
As someone mentioned earlier, we are meeting next week in St. Louis. Note that X12N is still discussing whether to hold its final vote in our June meeting, or to wait for the final vote until after resolution of the 60-day public comment period on the addenda, pursuant to the new HHS NPRM on the proposed changes.
That means we would finalize our work but not conduct a vote until we had the benefit of the HHS public comment period, give our advice when consulted by HHS and HCFA staff about the technical issues raised by public comments, found a resolution to those public comments, made whatever subsequent further modifications to the addenda were called for by that HHS public comment period, and then put it to a final vote.
The alternative there is to have a final vote now so that the industry has a solid target to shoot out, but run the risk that after the NPRM and the NPRM's public comment period, possibly having to reopen those guides and then re-approve them and republish them, which creates its own set of headaches and its own set of challenges for the internal X12 and X12N processes.
X12N has documented its internal development and maintenance process, for those who are interested, in what we call the X12N implementation guidebook, and the handout gives the web site URL where you can view or download the handbook, and also the memorandum of understanding adopted by the DSMOs.
As the health care industry continues to prepare for implementation of the transaction standards -- and again, that is our real target in all this, is having the industry implement -- most of our discussion has been about process but the real goal here is the successful implementation by the stakeholders.
Also, we need to consider, then, compliance with all applicable HHS regulations. X12 has received comments and change requests to the HIPAA implementation guides, either directly or via the change request system established by the DSMOs.
X12N welcomes these change requests as opportunities to improve the implementation guides and gain additional industry input.
Sadly, some of the covered entities, and not just covered entities, but affected entities -- business partners, business associates of covered entities -- are only now beginning to look at our implementation guides in detail.
While this makes those organizations' input very important as they are identifying gaps and identifying problems that have heretofore not been identified, it also implies that some of the requests from those organizations are going to be resurrecting some long-settled debates over some very thorny issues.
Sometimes new information is provided by the people requesting changes. Other times, no new information is provided.
HHS has categorized changes to the HIPAA implementation guides as either maintenance or modifications as described earlier by the DSMO steering committee leadership.
X12N's corrections to the HIPAA implementation guides can be either modifications or maintenance to the implementation guides.
At least the industry has begun the DSMO change request initiative in an attempt to meet the deadlines. Implementation on an October 16, 2002 implementation deadline, without sufficient lead time, may well prove fatal to some or many of the industry implementers.
As a DSMO, X12N has participated in the accelerated or fast track process to review changes submitted to the DSMO change request system through the end of February 2001. That was as requested by, I believe it was this group in your January meeting.
I do want to take a pause here and really complement Margaret and Maria, particularly, for being here at that meeting and bringing to the rest of us in the DSMOs the information and the outcome and actually crafting this fast track process under, shall we just leave it politely as extreme duress from some of the affected parties. So, Margaret and Maria, thank you very much.
X12N reviewed the change requests to determine which changes are really necessary for the health care industry to comply with the regulation and which changes can wait for the next version, or our maintenance to the implementation guides.
At our February meeting this year, X12N approved a process for the publication of addenda through the already-published HIPAA implementation guides containing corrections.
These corrections can include both modifications and maintenance items. Only changes that are modifications are actually required to be sent through the DSMO change request system.
X12N provided the technical solutions regarding approved DSMO change requests, of the collaborating DSMO, through X12N's online conference beginning May 2 of this year, which allowed time to verify that the technical solutions satisfy the disposition recommendation of the DSMO collaborating organizations.
That is one of the points in the memorandum of understanding, is a feedback loop that the standards development organization's proposed solution really meets the need for which the change was requested.
So, if a requester wanted to add an orange to the 837 claim, it is an opportunity for the requester and the other DSMOs to verify that the solution proposed by X12N actually created that orange and didn't create a pineapple.
Based on the DSMO process, X12N has included changes necessary for HIPAA compliance into addenda for each affected HIPAA implementation guide.
These addenda are now available for public comment on the Washington Publishing Company web site. More than 75,000 e mail notices were sent to various list serves, including the HHS HIPAA regs list, list of individuals who had previously downloaded or purchased implementation guides from Washington Publishing Company, associations, newsletters, et cetera.
Even though 75,000 were sent out, what then happened is that many of the recipients further forwarded those announcements to other list serves. So, the actual number of e mails is several multiples of 75,000.
At its upcoming June trimester meeting next week, X12N will be holding informational forums for the addenda to be published for the HIPAA implementation guides.
These informational forums, as the name applied, will be informational only and not provide an opportunity for the introduction of new changes or new issues with the addenda.
These addenda will then be submitted to the National Committee on Vital and Health Statistics, and ultimately Health and Human Services, for inclusion in the HIPAA rulemaking process as quickly as possible.
X12N has approved project proposals for the development of the next versions of the HIPAA implementation guides. The current regs specify implementation in October next year, version 4010. X12 is considering versions 4040 or 4050 for the next round of HIPAA implementation.
Those guides could be available through HHS and the health care industry perhaps as early as February of next year. That is not a commitment. That is an estimate.
At our June meeting, we will begin discussion or which version or versions and which time frame to recommend for the next HIPAA transaction set implementation guides.
X12N has some concerns. Regardless of how efficient DSMO and the standards setting organizations make their development processes, the health care industry is still bound by the federal rulemaking process, which has demonstrated itself to be very slow.
There is concern regarding this process as to whether it will meet the needs of the health care industry for timely changes to the standards, to incorporate newly-identified business requirements, and new technologies, for example, the web and the internet. It is a trade off between stability and innovation.
Some of the issues we have identified, any changes received after the February 2001 cut off date to the HIPAA implementation guides will have to wait until at least 12 months after the effective date for the addenda to be adopted. So, we have got a minimum one year between different versions of the guides being adopted.
This process may lead to version conflicts between implementation guides with addenda versus other implementation guides without addenda.
This could lead to transaction interoperability and implementation cost issues. We are trying to work on those issues but we have not necessarily found solutions.
Even if change requests received after February of this year are required for compliance with the regulation, they will not be included in the agenda.
You recall, earlier I mentioned that, as we have new organizations now starting to look at the implementation issues, as they identify problems, those problems will be reported, but there will be no time to resolve those problems and no mechanisms to do so prior to the October 16, 2002 implementation date, for which we will eventually have enforcement regulations in place as well.
X12N recommendations and conclusions. X12N's members -- and I need to compliment them all for their very hard work. There were a lot of people who took time out from their real jobs to put maximum effort into this fast track process, and to try their best to ensure that the X12 implementation guides are the best they can be for HIPAA implementation.
X12N's members and their organizations are all volunteering their time and effort. I think you have heard this theme several times.
We need to recognize the limits of their availability, the need to utilize their expertise and knowledge wisely.
Second, I think you have heard this theme. X12N does not want a fast track process again. We want a consistent standard change process where there is an orderly, stable and predictable cycle, including health care industry consensus, for changes to HIPAA implementation guides.
Third, X12N will continue to monitor and evaluate its process. Currently we are conducting a survey of the X12N task group and work group co-chairs and members, to determine where improvements are necessary in our own process.
Fourth, HHS should begin developing a new rule for the next version of the HIPAA implementation guides, which X12N hopes to complete draft copies by February of next year.
HHS needs to develop a fast track process of its own for rule making. Without that, there is the fear that the health care industry will be held back from the ability to change within the 12-month minimum time line as stated in the final rule.
Finally, HHS, DSMOs and the industry need to re-evaluate naming X12N implementation guides down to the level of version, release, subrelease and publication date.
We should consider possibly naming the standard setting organization and its currently published implementation specification, not to be published more frequently than once a year.
That concept is kind of like what was done with the code sets. You name the code set and it is up to the code setting organization to apply their process for updating the code sets.
Although we at X12N are proud of the high quality of these first X12N HIPAA implementation guides, we also know they are not perfect.
These are new standards for an industry that has heretofore not embraced standardization. The fact is, HIPAA awareness is still low in some segments of the industry.
Many who need to complete a detailed analysis of the implementation guides have not done so to date. X12N is working on identifying those changes that are necessary for the industry to comply with the regulations, but only detailed business analysis and industry-wide implementation will manifest all the issues.
In the meantime, we need to deal with the change management process we are bound by now and, if possible, evolve it to better meet the needs of the health care industry.
I look forward to your questions and thank you again for this opportunity to testify today.
DR. COHN: Richard, thank you very much. Dr. Walter Suarez from NUCC?
MR. SUAREZ: Thank you, Mr. Chair, members of the committee. Good morning. My name is Walter Suarez. I am executive director of the Minnesota Health Data Institute and a member of the National Uniform Claims Committee, representing the public health and health services research agenda from a state perspective.
I am also one of the chairs of the NUCC's data subcommittee and heavily involved with the DSMO change request process quite a bit.
It is my pleasure to appear today on behalf of the NUCC before this committee, and I thank you for the opportunity to testify.
The NUCC is comprised of key parties who are affected by health care electronic data interchange. Those are at either end of the health care transactions, such as payers and providers.
In addition, the NUCC includes representatives of standard development organizations, regulatory agencies and the National Uniform Billing Committee.
Criteria for membership are a national scope on representation of a unique constituency affected by health care EDI, with an emphasis on maintaining or enhancing the provider/payer balance in the original NUCC composition.
Each committee member is responsible, and in intended to represent, the perspective of the sponsoring organizations and the applicable constituencies.
My very statement here summarizes the NUCC's perspective of the DSMO process and the results of the recent proposed changes to the transaction standards adopted by the HIPAA act of 1996, and the following comments will address NUCC's position as well as other issues of concern to the NUCC.
Number one, with the transition of the medical community to electronic transactions and the future implementation of the standards adopted under HIPAA, it became essential that a process be established that provided coordination for the maintenance of the administrative implementation standard within the health care industry.
That process was the HIPAA DSMO change request process. The major benefits to the public, the government and the health care organizations with this new process was the development of a single point of entry and a formal standardized format for maintenance requests.
There is somewhat of a filtering process for all change requests, and the model is also contingent on three elements:
One, the ability to deliver a request quickly to all the DSMO participants and their representatives and constituencies.
Number two, the process of deliberation by all the committees. Number three, the coordination and consensus of the business needs for all users affected by the administrative transaction.
Each DSMO, which consist of data content committees and standard development organizations, represents a specific industry segment, and they are responsible for maintaining applicable data content and data conditions, as well as technical expertise and the maintenance of the HIPAA implementation guides.
The overall HIPAA DSMO change requests have confirmed that coordination is essential and thorough discussion of all the potential transaction user groups is critical.
It is only unfortunate that the process wasn't established long ago when the transactions were initially being developed and many of the problems that our committees have recently experienced could have been perhaps avoided.
The NUCC met last week and the overall opinion of the committee was that all the DSMOs worked very cooperatively and the coordination was really outstanding. However, there were several problems that were the
result of the fast track process that was initiated.
The number of requests that needed review confirmed that the one size fits all assumption may not be the most viable solution for all potential users of the standard transactions.
The process also uncovered many implementation challenges, such as unresolved issues -- for example, local codes, NDC codes and others. In addition, there are unanswered questions regarding some of the code sets not having guidelines identified in the final regulations indicating how the codes should be applied.
While the code sets that were identified will be standardized, how they are interpreted may vary.
Although the DSMOs reacted quickly in the fast track process, the NUCC does not believe that another final rule for transactions and code sets will be published in a timely manner.
There are also many unanswered questions regarding the delays in publishing of the other HIPAA regulations. The committee discussed the fact, at last week's meeting, that with the change in the administration, several management positions at HCFA remained unfilled, and this may be a contributing factor to the delays in publishing other HIPAA regulations.
As more rules get delayed, it creates more implementation problems. For example, the security and privacy and transaction rules, which are all tied together, are particularly important for implementation of all the other rules.
In its original comments on the transaction NPRM, the NUCC recommended that implementation of all the rules should be coordinated.
Another big problem that many organizations are challenged with is how much money to budget for their HIPAA activities and really when to budget those money requests.
The NUCC discussed a recent Gartner group study that found that many organizations have indicated they are not going to be able to comply with HIPAA implementation time lines.
The DSMO change request process brought out some flaws in the overall design of the data capture that is trying to be achieved.
Are there too many elements or segments being proposed to capture the data, versus codes that would be sufficient?
NUCC also discussed the fact that things can be more easily changed with an external code set rather than going through the rule making process.
The NUCC members are all supportive of the administrative simplification principles and goals, but there have been a lot of changes since we first started working on administrative simplification.
There are many new technologies and new players at all the different tables. The NUCC believes that the goal of administrative simplification should continue to be pursued. However, we should probably take a step back and see what changes can be made to this process.
Perhaps we need to focus on standardized content and not on a standardized method of transmission. Maybe too much weight has been given, or was given, to the finding of technical specifications and not enough to the actual content.
The NUCC believes that the industry should test pilot any new transaction for modification to existing standards before submitting them to the Secretary for inclusion as a national standard, and that there be a good cross section of the industry represented at that testing.
In addition, the committee indicated that we should make sure that any proposed standards are out in the community and preferred to be in national use before it is adopted as a national standard, the so-called de facto standard approach.
Thank you for this opportunity to present the views of the NUCC and I would be pleased to respond to any questions you might have.
DR. COHN: Thank you very much. George Arges from the American Hospital Association representing NUBC.
MR. ARGES: Thank you. Mr. Chairman and members of the National Committee on Vital and Health Statistics, I am George Arges, chairman of the National Uniform Billing Committee.
On behalf of the NUBC, I want to thank you for the opportunity to testify on the recent DSMO review process.
Overall, I would also like to commend the members of our committee, as well as all the other DSMO participants, for quickly tackling a number of important issues related to the HIPAA implementation guides on transaction standards.
The HIPAA DSMO web site allowed the public to submit requests for changes or clarification to the implementation guides.
Each of the DSMOs reviewed the change requests and selected those that they felt were important. The NUBC expressed an interest in reviewing approximately 72 change requests.
As a result, we convened several conference calls and held a special on-site meeting that also included a co-chair from the X12N 837 work group. The NUBC also solicited state UB committee input.
In addition, I participated in various X12 work group calls, as well as an ad hoc provider group conference call, spearheaded by Dave Moertel from the Mayo Foundation.
The ad hoc group was formed in response to the February 1 NCVHS hearing. At those hearings, the NCVHS considered several clarifications and corrections to the transaction standards and code sets.
One of the major areas requiring clarification and correction was the use of the National Drug Code.
As you know, last September, the NUBC wrote to the Department of Health and Human Services about the problems that could occur in the institutional provider setting with the elimination of the HCPCS J codes.
We indicated that there could be costly consequences for hospitals if the NDC was the only code set allowed for the reporting of drugs and biologics on the institutional claim.
Again, the NUBC is appreciative of the subsequent NCVHS recommendations to the Secretary of Health and Human Services that allows a continuation of the HCPC J codes.
The DSMO steering committee also met in San Diego last month to present the findings and recommendations of our respective organizations.
For the most part, the data content committees carried forward the committee's recommendations for each of the change requests that they selected for review.
There were, however, last minute changes by the X12 representatives, who unilaterally changed the recommendations from their own X12 group review.
We went into this final meeting knowing where each other stood, and when these recommendations were changed at the last minute, it became a source of frustration.
It is expected that each of the DSMOs are to consult with their respective constituencies on the change request issues and to then formulate a consensus opinion on behalf of their organizations.
Therefore, when the DSMO representatives come together and review each other's positions, they can be assured that they have developed a majority position that they can move forward for public comment.
Three important change request issues are under appeal and, therefore, the corrections to the implementation guides are on hold.
It is troublesome to know that the needed changes are being held up pending the appeal. In addition, there is no time limit for follow through on the appeal process.
The DSMOs need to establish an appropriate time frame for resolution of appeal items. Unless quick resolution occurs to those items under appeal, it can needlessly create costly retooling for many providers and payers.
As many of you may recall, our charge was to correct errors, provide guidance and, where there was uncertainty as to the requirements, to be sure that the necessary usage requirements are identified and appropriately put into place.
From the NUBC perspective, there are three areas where there is still disagreement. The three key areas of disagreement, from the DSMO process, are of major concern to providers. They are the National Drug Code, physician line item billing, and provider taxonomy code usage on the patient bill.
The NDC issue, this issue, the establishment of the new segment, 2410 in the implementation guide, drug identification for the reporting of an NDC, still does not define the situational usage in any practical terms.
The note simply states, to use the NDC when it is necessary to further define the service provided in the SB202.2 segment, which the NUCC views as clearly insufficient.
While the NUBC helped win the victory in reversing the final rule's discontinuation of HCPC J codes, we need to be vigilant about the wording in the X12 implementation guide.
As it stands, the guide's wording allows for the reporting of the NDC whenever the service line item requires greater clarity.
This is unacceptable. The problem with the usage note is that it is not conducive to administrative simplification because it does not explain to the provider the instances under which the NDC will be required.
Providers need to know ahead of time the circumstances that will require them to use an NDC. If providers report a HCPC J code and then follow up with an NDC, this does nothing for simplification of the billing process.
Another problem with this is that most hospitals' charge systems only have the ability to assign one clinical code set per service.
In the instance of compound or cocktail drugs, mixtures of drugs, it would be impossible to indicate the exact NDC codes, since there are no specific NDCs for these situations.
All situational usage items must take into account how the information is an essential component to the adjudication of the claim, especially when other information is provided at the service line.
Recommendation. Because the guide fails to provide the specific business rules, we urge that the NDC, the loop 2410 be removed from the institutional guide.
Item 128, physician information at the service line level. The issue, a request to remove all industry usage requirements for the reporting of physician information at the service line was made for data elements in loops 2420-A, 2420-B, 2420-C and D.
Currently, institutional providers do not report physician or other care giver information at the line level. The rationale for removal is due to the enormous cost associated with having to comply with a set of requirements not necessary for claims adjudication, even though the guide defines this as situational usage.
Although some provider system software can capture this information at the time care is rendered to the patient, only a small percentage of these providers currently subscribe to this additional system feature from the service vendor, less than six percent.
Moreover, virtually none of those who subscribe to this added feature have the ability to interface this information with their billing record without costly redesign.
Currently, some state programs indicate that they have a need and utilize level three HCPCs to capture similar information.
The final rule on transaction standards was very clear about the elimination of level three HCPC codes, the local codes.
It also suggested that, when applicable, those level three HCPC codes should go through the HCPC committees for possible assignment to HCPC level one or level two codes. It did not condone substitutional level three HCPC codes for a new discrete data element.
The recommendation is to remove the loops of reference physician information at the service line.
The third item was item 200, provider taxonomy. The issue here, the item cost for the inclusion of physician specialty on every institutional claim and is linked to the prior item, number 128.
This is at the claim level. Institutional claims do not need to have the physician specialty on each claim. The physician specialty assignment is an integral part of the national provider identification file, and should be routinely captured in contracts that many health plans require providers to file.
Recommendation. This item should be removed from the institutional claim, as claim adjudicators can obtain specialty through a national provider identifier or in their own health plan files.
Other related issues. There are still important issues that remain. For instance, the use of external codes as referenced in the implementation guides has caused some confusion as to their required use.
The design of the NUBC's data set is robust and relies on codification of many important health reporting requirements.
The reason for this approach is the dynamic nature of health care, especially with government programs like Medicare, which often rely on short notice for the establishment of new codes to meet congressional mandates.
The NUBC has prided itself as being able to meet many of these challenges without a major disruption to the Medicare program.
The reason we were able to do so is, in large part, attributable to the UB's code set that includes value codes, condition codes, occurrence or occurrence span codes, and revenue codes.
These specific code sets allow codification of new changes without a reconfiguration of the fundamental construct of the UB92.
Such a design adds stability to information systems that support the development of the UB92. It also provides a return on the investment in billing information systems.
Today, the NUBC is proud that hospitals submit more than 98 percent of their Medicare claims electronically.
The recommendation, we would ask the NCVHS to expressly recommend adoption of these external code sets as contained in the UB data set for use within the institutional transaction set for billing.
Again, these include value codes, condition codes, occurrence codes and revenue codes.
These code sets are referred to in the implementation guide. However, there is some confusion among users as to whether they fall under HIPAA's compliance mandate. We believe that they do.
Finally, the NUBC will soon ask the NCVHS to consider business rules around the use of clinical code sets, as well as those around the UB data set.
These rules, we believe, are important for standardizing the standard, and making certain that the entire health care community understands their obligation to maintain and update changes made to these code sets.
Today, the NUBC is also embarking on an examination of the entire UB code set. In part, this is due to the moratorium to changes to the UB92 structure that is set to expire next year.
In anticipation of the expiration, we conducted a national survey to learn of areas requiring change. We are also preparing for a possible expansion of the clinical codes to recognize the eventual adoption of the ICD10 CM as well as ICD10 PCS. In addition, we are looking at adding more information about the initial patient encounter.
Last year, we tackled a persistent problem associated with many emergency room claims. We noticed that many emergency room claims required further follow up because a final diagnosis on the claim may, upon initial review, appear out of line with the resources delivered to the patient.
Upon investigation, we learned that many health plans have strict rules about in-plant care versus out-of-plant care.
With the enactment of the Balanced Budget Act of 1997, it also included language about the prudent lay person.
The prudent lay person concept in the BBA allows an individual to determine whether they need to seek emergency room care without penalty.
The problem is that the claim did not contain a full picture of the events that cause the emergency visit.
After study, the NUBC added a new data element, the patient's reason for visit code. This change further elaborates on the events that led to the emergency visit.
As a result, many managed care companies have reduced their medical review backlog by 40 percent and have seen corresponding reductions in staff resources as well.
For providers, this change has reduced the need for additional follow up with medical record information and has improved providers' cash flow.
For patients, there is less administrative hassle associated with having to explain why it is they sought care outside their health plan.
The NUBC plans for further enhancements, to include possible expansion of external cause of injury code as well as physician initial diagnosis.
We believe these will provide a more complete story for the claim and will further improve on administrative processing of claims by avoiding costly medical necessity reviews.
Although there are still unresolved issues that the DSMOs need to work through, the NUBC is willing to lend its support.
The NUBC will continue to research some of the unresolved issues to offer workable solutions. Again, thank you.
DR. COHN: George, thank you very much. I guess I want to start out by actually thanking you all. I have heard, I think a number of times in this morning's session, that obviously the expedited process is tough, and I think you really have the appreciation of certainly the subcommittee and the full NCVHS on what I think has been a tremendous amount of very high quality work. I really want you, first of all, to know that you really do have our appreciation.
Looking around, I obviously have a number of questions for the panelists. I am curious if there are other -- I guess I should start out and lead off with a couple of these issues.
Obviously, I am first of all hearing that there is a variety of testimony and issues. The first piece had to do with the actual process, and I am hearing that you are all recognizing that there are improvements that need to be made to the process.
I would imagine -- and I guess I am looking at Margaret -- that the DSMOs are fully capable of meeting together to come up with changes to the process that will resolve some of the issues identified?
MS. WEIKER: Yes, Simon, I think we can fight it out amongst ourselves.
DR. COHN: Good, okay. Did you have a general comment?
DR. BRAITHWAITE: I also want to thank all of you for the amount of work put in. Since I did sit in on some of those meetings, I realize what conflicts are involved and what an amount of personal effort it took to pull off this process.
I want to assure you that the process is not totally dead within HHS, that all possible mechanisms are being explored to try to get a final rule out with these changes as quickly as possible, and I will follow up on that even further.
DR. COHN: Other comments? I have a list of questions here. Let me just ask one question and then I will let Kepa continue, and I am sure others will have questions also.
It actually had to do with the overall issue of code sets. I am just sort of curious. I have some thoughts about the potential role of the DSMOs and the relationship to it, but I am curious about what all of your thoughts are, recognizing that there were a number of external code sets, where the code set developers requested changes and requested inclusion in the HIPAA standards.
Most of these were not considered, but what do you see as the upcoming role of the DSMOs in relationship to aiding the NCVHS in identifying what ought to be moved forward?
MS. WEIKER: I will start. When the original MOU was developed, we did not anticipate reviewing additional code sets. Basically, that is in most of our organizations. It is not in our expertise to do that.
The final rule on transactions and code sets, however, named us to look at additional external code sets for inclusion. Again, that is not our area of expertise.
As in NCPDP's testimony, I believe we need to develop some type of relationship with these code set maintainers.
The home infusion coalition, the alternative medicine group, all submitted requests to look at or add their additional code sets.
In the final rule on transaction and code sets, HHS, HCFA did look at home infusion and had reasons not to include them.
Basically, we need to find out why they didn't include them, or did the requester actually go to a named code set maintainer and try to get their code sets added, or where were there holes in their code sets?
Did they go to those organizations and attempt to get them added and for some reason they wouldn't? We don't have that background.
Maybe that is a fault of the web site, where we need to add something that says, if you are requesting an additional code set to be named to provide some of that information, yes, I have gone to the HCPCS committee. They refused to add my code list because.
That would give us more detailed background of why, to help us or aid us in a decision. Basically, for the external code sets that were in the first round, we asked that they work with the existing code set maintainers and, once they have done that and either their needs are met and it is a dead issue, or their needs are not met, then they come back and provide that extra detail, so we have that knowledge and background to evaluate their requests.
DR. COHN: Other comments?
MR. ARGES: Yes, I want to comment. I do think that we have an obligation as part of a process to basically still take up the requesters consideration for the review of those code sets.
It is more than just a code set. I think we need to understand how that code set fits into a particular sector of that health care industry.
Particularly with the home infusion, the more I look into it, the more I see it does have, to some extent, a limited application and it does serve a specific purpose. But in some sense, too, it is not the same as a clinical code set in the same way that, let's say, a HCPC or an ICD code set is.
In some ways it is also a marriage between a package reimbursement model and a clinical code set. To that extent, it fits an industry need. So, we need to basically identify, is this the way the industry feels comfortable in terms of representing information.
I do think we have an obligation to basically continue taking this on and making some recommendations, perhaps to the NCVHS to consider as part of that process.
MR. SUAREZ: Just a quick comment, too, and this is not a new request for code sets but actually maintenance of existing code sets, Rich pointed out the differences between external code sets that are medical code sets in nature and how they are maintained, and the issue with external code sets that are non-medical, and even some internal code sets through the implementation guide, are non-medical internal code sets.
The confusion and perhaps the issue of maintenance of those external code sets that are non-medical have created some confusion as to how they are maintained, how they are updated, how they are changed, how often they are changed and what kind of process exists to maintain them and update them and provide information back to the industry.
Specifically, examples include -- one is the taxonomy code, which now the NUCC is responsible for maintaining, the place of service codes, for example, and other code sets that are external codes that are maintained by different agencies.
I am raising the issue about the maintenance of non-medical external code sets and perhaps coming up with a more efficient way of doing that.
DR. COHN: That has actually been an issue that we have gone on record before now.
MS. WARD: A suggestion, maybe just in response to that is, maybe we can do a better job of just explaining how they are maintained.
We all know, those of us who are involved in the committees, know how they are maintained, but the public at large doesn't.
It might not be that we need to change the process. It might be that we need to better articulate what the process is for each of those code sets, just to make it more generally known, and I think we can do that.
DR. COHN: I actually want to ask one more question about a code set and then I will go to Kepa, and I see Dave Moertel is also standing up and wants to make a comment also.
Walter, you are sort of bringing up the issue that I wanted to begin to slide into, which is actually a specific question for Richard Landen and probably for George Arges also.
It has to do with the issue of the external code sets versus situational elements. As I have looked through all 75 pages of the recommendations, A,B,C,H, et cetera, it appears that there are some decisions that have to do with the use of situational data elements, other times external code sets which do much the same thing. Sometimes on one guide one is being used, on another, another use is being used for the same element.
I guess the first question I had for X12 is, and knowing that sometimes you use external code sets and sometimes you use situational data elements, what is the philosophy that X12 uses to determine what ought to be in an external code set versus what ought to be a situational data element. I am sure that NUCC has a comment on this also.
MR. LANDEN: There used to be a real simple answer to that. The answer pre-HIPAA used to be that the more volatile the code set, the more frequently it changed, the more likely it was to be set up as an external code set, because the code set was stable and rarely changed, like the U.S. Post Office list of state abbreviations.
You could build that into the standard itself, so the information would be right there in the implementation guide, right there in the standard.
You didn't have to worry about the slowness of changing the standard from one version to the other which, for X12 purposes, is minimally a year and could be longer for debated issues.
HIPAA changed that a little bit. The philosophy is still there, but when you compound the question by introducing the element of situational usage, that gets real interesting.
Then you go into turf issues, what is proper and right to be described in the implementation guide as defining the situation, particularly with reference to HIPAA and the required public comment process there.
If the situation is defined in the guides and the guides go through the NPRM process, then it is real clear that the situation itself and the resolution and the explanation of the situation, when you use A and when you use B, has gone through the public comment process.
When you move that situational question out to an external code set, there is, number one, the control issue. Whose turf is it? Is it the standards organization or is it the external coding committee.
Then there is the question of, does it really go through the proper required public comment period. Many of the code setting organizations operate by their own rules and guidelines.
We have seen a change to a number of them, from more openness, in order to participate in the spirit of HIPAA.
There are some issues there. I am not sure they are unresolvable but, like so many things, this is our first time through it.
Because we are a volunteer process, because we are a consensus process, it is majority rule, but we have got some real interesting minority opinions.
I think what is going to happen is as, over time, we go through this a few times, we will come to a working resolution.
Right now, we are mainly debating based on philosophy, on theory, and less and less, I am happy to say, on turf.
DR. COHN: George, do you have a comment?
MR. ARGES: The other thing I would want to add is, you have to keep in mind, too, the supporting information systems, at least on the institutional side, that lend support to maintaining information.
Code sets have been a convenient way of taking information and simplifying it so that it is machine readable and handled in an easier fashion in terms of communicating it.
The NUBC has, long before X12 health insurance, been involved with codifying many of its data requirements. Part of it was a convenient way of reporting key pieces of information that are part of the service.
Creating it in a way that allows a discrete element to be created within the X12 standard as opposed to referring it to an external code list, has to be evaluated.
I also think they need to understand, too, we are trying to keep consistency, not only in the way things are handled on paper but also the way it is handled electronically.
When output is generated, there are ways where you store information and keep it and you are able to find it sooner and much better, in terms of where it is reported.
To me, we have some elements that are kind of screwed up. It is like taking several, let's say, ICD-9 codes and putting them into a discrete segment, and then keeping all the others in a separate segment.
That, to me, causes more headaches and more problems. You need to either say some of the external code sets are important for that particular sector of the industry, and that that sector of the industry needs to be capable of utilizing it and reporting on it.
I think it is very important, too, as we look toward attachments. A lot of the existing needs for attachments really have come because people weren't willing to work with the existing code sets.
Therefore, they asked for the answer to be spoon fed in a different manner rather than to work with the answer as it was contained in the code set in a codified manner. From the perspective, that adds to the administrative burden and process.
MS. WEIKER: A couple of observations about expressing data in a discrete data element within the standard versus expressing it in an external code set, that I think you need to consider as you are thinking about this process.
As it is right now, those data elements that are expressed in the implementation guides are clearly identified in the HIPAA data dictionary, which people use to see where is this data element used, how is it used, what are its attributes. What does it mean to me.
Some would argue that a point that Rich made, the volatility of some of these code sets that are maintained by external maintainers, the ability to change, remove, add codes, change definitions, et cetera, would be dependent upon that particular code set group versus what, in fact, changing data elements is subject to right now in a guide, which is a much broader, much wider industry consensus through DSMO, through NPRM. So, you need to think about that.
Do we care, are we concerned about the ability to change codes, change definitions, change values without subjecting it. Maybe some of it, it is appropriate, maybe some of it, it is not, but there is a very definite path that the two of those take, and it is a very different path. I think Rich made that point as well.
Thirdly, the data values or the data that is expressed right now with discrete data elements in the implementation guides, those that are situational, have situations. Hence the name, situational.
The situations direct implementers when and how to use them. When that is no longer the case, if those become not used and the data is expressed in an external code set, that situational guidance on when and how to use is no longer there.
So, is there value in having the situational data elements actually provide some kind of guidance on when they are used and how they are used.
All of these are things, frankly, that were discussed at the April meeting with various parties chiming in.
Personally, I think that some of them, it probably is appropriate to go one way, but others, you need to take a step back and say, do we really want to be defining -- basically to be defining all of the content in code sets, rather than defining the content in the guides. Fundamentally, that is the difference.
DR. COHN: Kepa and then David.
DR. ZUBELDIA: Along the same lines, Maria, I think there is a risk in defining all those situations in the code sets.
I think several of you have pointed out the kind of lack of publicly known due process for the development of the code sets.
I think we run the risk that if the code set is not just codes, but it is also situations and business rules, all built into a code set, that code set maintainer, in fact, because a standard development organization that has not been accredited by ANSE.
A question would be, could those code set maintainers go through the ANSE process and become ANSE accredited, and then maintain the code set with rules in them and go through a process similar to the standards themselves. Is that a feasible solution to this?
DR. COHN: Did you want to comment on that specifically?
DR. MC DONALD: I think we want to separate the two or three different things that you were saying. You were saying that code sets are one thing, but when code sets have business rules in them, they are more complicated. That is one thought.
I think another thought is when the code set is sort of just an answer, or whether you are really defining new variables through some complex structure, and you would like more oversight.
I think in general, those who have dealt with big code sets where it is like a dictionary, that is a hard thing to do by consensus and keep up with.
I don't think Samuel Johnson would have ever succeeded if he had to do this by a consensus process.
In the law, the code sets are specifically excluded from the ANSE kind of process, I think because of that insight.
There is sort of a gray zone, though. When you get beyond just codes and there are business rules, there is another issue there. Maybe the business rules should be kept out of code sets. I don't know.
DR. COHN: Dave Moertel?
MR. MOERTEL: My question is directed toward Mr. Arges. He had listed a list of code sets in his testimony and he had made a comment and I almost backed away, based on that comment, because he got to my point. I would just like to carry it a little bit further.
George, the question I have is very relevant to the comment you made about the consistency between the paper and the electronic environment.
Although I am searching for that utopia where everything is being done electronically, I know it is going to take a long time for us to get there.
Based on that comment, could you help outline, from your perspective, the benefits of having the external code sets that you have listed as part of this implementation.
MR .ARGES: Sure, and actually at last week's NUCC meeting, there was a presentation done by someone who is part of the SUSPIR(?) program.
They had indicated that there is still a large quantity of paper claims that are basically converted into electronic format. My guess is that is still a convenient and easy way to basically pull information.
So, if you are looking at information that is logically laid out in a paper document and then scanned, it has to be then logically transferred to another particular area.
You can build all sorts of sophisticated rules to basically map it with little exceptions here and there.
Fundamentally, if you have quadrants within the paper that you know are going to go to a certain area, you know where it needs to go into the electronic and it would make the task much easier.
It is still very much a large part of today's industry. My guess is that it will still be a part of the process down the road.
DR. MC DONALD: Two more questions, both to the last speaker. One of them is, you mentioned the use of ICD-10 CM and ICD-10 PCS. This is just a matter of curiosity. Is the ICD-10 PCS, is that that very large data set on implementing records and it has the very regular definitions that was developed by 3M originally?
MR. ARGES: The procedure classification system?
DR. MC DONALD: ICD-10 PCS, that is how I knew it. I just don't know whether it has gotten new content or new name or that is what we are talking about.
MR. ARGES: It is the procedure classification system that is part of the new I-10, the revised.
DR. MC DONALD: I am just trying to relate it back to something that I knew in my distant past. There was something called ICD-10 PCS that was developed by 3M for HCFA. Is that what you are talking about?
MR. ARGES: Yes.
DR. MC DONALD: You didn't mention CPT. I didn't know if that was left out.
MR. ARGES: The reason I didn't mention CPT is, I understand the structure will be the same. If not, I understand it will still fit the same structure as I-10-PCS.
The key thing in the statement about I10 is that they are significantly different in terms of field size. So, we basically want to accommodate that.
I think the CPT currently is being accommodated in the existing structure.
DR. MC DONALD: I10, at one time, had a very limited space for each axis, which may have been changed, but it seemed like an impossible, two characters for labs, or something like that.
I am not familiar totally with the way it is logically laid out, but I understand it is a vast improvement over the I9 classification system, and it is designed to basically accommodate a number of changes that are occurring.
DR. COHN: Tomorrow we will be talking about plans for hearings in late 2001 and 2002. I think code sets are likely to move up toward the top.
DR. MC DONALD: The second question I had regarded what you call -- you have three different kinds of code sets in NUBC, if I have got it right here.
There are value codes, condition codes, occurrence span and revenue codes. My main question is, what is a value code? Is that a code for a value or is that a code that says what the value is?
MR. ARGES: It is a code that represents a particular measurement of some sort.
DR. MC DONALD: So, it is saying what the value is.
MR. ARGES: Right.
DR. MC DONALD: That could almost be represented as a data element?
MR. ARGES: Right.
DR. MC DONALD: That gets into content definition. Regarding whole data sets -- let me rephrase that. That kind of development might prefer to be more exposed than just adding to a linear dictionary of different kinds of diseases or stones or whatever.
It has all kinds of collisional activities for colliding with other parts of standards and other things. It is a little bit like putting in a new field.
I am not saying it is a bad idea. I am just saying that, when we lump in how to deal with codes, there are some quite different categories of issues that will come up with trying to make a broadly mergible standard, if one sort if just sort of linearly tossing in new variables.
DR. COHN: Maybe I can ask the question a little more precisely. My understanding is that a value code is a code that says, the following is the weight of a child, for example, would be one value code.
MR. ARGES: Newborn birth weight.
DR. COHN: Then you put a number after that. So, that is how the value code works. I did observe, as I looked through this long list, that in some places birth weight is being considered using value code. Other places, it was a field in X12.
It really led me to ask the question about, where is the dividing line on all this stuff and what makes sense.
I know the recommendations in here, for the provider, it is actually a field. For the institutional claim, it is recommended as a value code.
I don't know if these things are up for appeal or whatever, but is this their recommendation of the DSMOs?
MR. ARGES: I think the recommendation changed to a value code.
DR. COHN: In both cases?
MS. WEIKER: No. In the professional claim form, the 837, it doesn't have a field like the institutional does with the specific value code. It is on the paper claim form. It is on the electronic and has been on the UB electronic.
There is no place on a HCFA 1500 that says, put a value code and then put the number that is associated with it. There is no place on a professional claim to do that.
That is why there is a difference with the professional guide and the institutional guide.
In fact, that principle applies. All of these codes that are applicable to institutional claims in UB92 hard copy paper aren't used in the professional world, and value codes, occurrence codes, and the other things you see on there.
That is why there isn't another way to express that. In the professional guide you will see a data element identifying that data.
The question that you just asked is what spurred this entire discussion a month and a half ago.
MR. ARGES: Right, but what has also happened as a result, I think, on the 1500 is that there are growing differences between the paper 1500 and the electronic, significantly more elements on the electronic than there is on the paper.
You can't codify -- let's say, on the paper you are very limited in terms of what you are capable of reporting in terms of the hard copy.
It was discussed, I think, at some point in time at the NUCC committee about revamping the 1500 to basically perhaps codify some of these very elements, rather than to basically constantly redesign the electronic to accommodate a new reporting requirement.
DR. ZUBELDIA: It looks like the demarcation that is being made now is that if the value code or if the codified element is part of the standard flat file format, UB92, or 1500NSF, then it would be codified as it is today and continue that way.
I am wondering if the demarcation might not be more appropriately made if the code or the value belongs in more than one transaction, then it should be an X12, and if it only belongs in one transaction, it would be a value code.
I will give you an example. The total amount of the claim, that is a value that can be expressed either as an X12 data element or as a revenue code in the UB92. There is not an equivalent in the new code in the 1500NSF type.
What we are seeing is that the 837 professional is going to be used as an X12 data element. The 835, when it comes back, will have to have it as an external element.
The 837 institutional has two ways of doing it, either as a revenue code, 0001, or as an external element. I think in cases like that, it seems to me it would be cleaner to make it X12 for everybody, for all the transactions involved, even though it would break with the traditional revenue code system that we have today.
It will create the system that George was talking about, where you go to revenue codes and they all appear as revenue codes, except for this one, that appears somewhere else.
I think that kind of environment needs to be looked at to see what would be easier for the processors of these transactions to deal with, rather than necessarily continuing with the tradition.
Also there may be some balancing rules associated with it, where the service lines and the claim number and some of these other numbers have to be balanced against the total amount or things like that. That may not be a good example, what I am using.
MS. WARD: Oh, yes, it is. In fact, that was a change request, Kepa, change request 126. X12 and NUBC and the NUCC, which all opted in, basically said, for consistency usage, we are going to leave it like it is.
The request was to remove the data element in the institutional guide, to mark it not used. Then that would require a separate 835 guide or specific segments to almost be totally rewritten to support that in the 835.
So, it was agreed to by the DSMOs and in a consensus-building process, to leave it as it is.
DR. ZUBELDIA: I was talking more about the general principle in that one example. I didn't even know there was that request.
MR. ARGES: That principle was raised to me the other day, or last week, at the NUBC meeting by Larry Watkins from X12.
Fundamentally, I don't think I have a problem with that. I think that probably would be fairly workable. There are, in the revenue codes, those little overlaps where you have those quirky little total ones that would have to be pulled out and handled separately. That could be done.
I would say the value codes, the condition codes, the occurrence codes are pretty much discrete as they are.
DR. ZUBELDIA: Are those only applicable to the claim? If they are only applicable to the claim, there is no reason to take them out of the value code list.
MR. ARGES: They are applicable to the claim. I don't think they come back on the remittance at that level.
DR. ZUBELDIA: So, the principle would still apply. The code reflects in more than one transaction. It would be more appropriate, if it only applies to the claim, you can just leave it on the list.
MS. GREENBERG: I just wanted to ask about something that Maria mentioned about the data dictionary. I think it really is important that users be able to go to a data dictionary to find out what the content is, rather than having to go in a lot of different places.
When, for example, I know that the decision was made for newborn birth weight in the institutional guide, to do a value code, rather than retain the element or use the element that was currently in the guide, you are saying that that piece of information is not in the data dictionary.
MS. WARD: That is correct.
MS. GREENBERG: George, do you see any solution to this? This is around what we are talking about, that certain value codes are being used in lieu of a data element.
MR. ARGES: I would say that the only caveat to that is who would be reading the data dictionary. These implementation guides are mostly being read, I think, by many of the systems information people who have to carry this forward.
They are not really being read by the business office people who have to collect this information and routinely understand it.
From that perspective, there is a gap here. I think that is one of the problems we have had with the DSMO process in terms of trying to clean up some of the things that are currently out there, because the industry really hasn't had the time to take a close look at them.
MS. GREENBERG: I know the meta data registry, the X12 and HL7 are putting their data into that. Is NUBC and NUCC, are they also putting their data elements, or the code sets into the meta data registry?
MR. ARGES: No.
MS. GREENBERG: I am just trying to think there could be some place, which the meta data registry might be it, where you could actually find out what is the content here.
DR. MC DONALD: There is an intrinsic and impossible problem. That is, you can define these structures in abstract form as you would a drug file, a pharmacy file.
You won't find a single field for ampicillin ever in a pharmacy system. You are not going to find probably a single field for a body weight -- you might -- in a medical record system.
You are not going to find a field for glucose. You have got 50,000 of these variables. So, the model that you have is a simple research data base and it doesn't work in this other model.
You can't fit them as fields. So, you are going to end up with this value kind of thing in any system. The issue really is, there is no regularity or rules about when they go where.
I mean, the real problem it is being done sort of -- you know, simple codes, diagnosis codes, that is a gimme. They are really simple to think about because they are in line with all the other things like them.
When you mix them up, and we have to store the patient's big toe size, because that is just a code, then you get screwed up.
I think the problem is that you are never going to see a data dictionary with all that you want in it, I will bet you a million bucks, because you are going to have to put all knowledge into the dictionary, and that is not how they model things in big systems.
I mean, you just can't do it. I can show you a hundred example models to show you why you can't do that. The problem we have is, we don't know where to look.
There should be a data dictionary and vocabulary specifications of various kinds, with some categorizations such that you can guess where to look.
You can say, this is a value vocabulary and then you would look in that. It comes out the same, but just to focus on the field definitions doesn't get you where you want to get, if you don't get closer.
MS. GREENBERG: That is fine. I am just saying that there should be some way that people can tell.
DR. MC DONALD: One of the problems, it is sort of a way to sneak in data structure by making them codes. Although that isn't necessarily bad, it is just that it is done ad hoc, I think is the problem.
MR. MOERTEL: I came up because I chair the task group in NCX12N that produced the HIPAA data dictionary. Indeed, it contains some of the codes associated with the HIPAA transactions.
The HIPAA data dictionary, though, was developed to contain the data elements that are listed separately in the implementation guides. It does not contain the codes.
It does not contain either internal code sets of external code sets. The only time it does, and the reason things like baby birthweights show up is because these guides were originally condensed, and then they were flattened.
Whenever there was a segment with multiple codes, they took the iterations of the loop so that each loop had the code set identifying what the loop was.
Before, when the baby birth weight used to be a code, now there was actually a loop identified as a patient weight or a baby birth weight.
That is how some of those codes got into the data dictionary. At that point, they became discrete data elements.
I completely agree with Dr. McDonald, to try to define all the codes within the HIPAA data dictionary won't happen any time soon. It is a very complicated process and you have illustrated why, and I fully agree.
The other issue with some of the value codes and things that we discussed, these are not new codes. These are not codes that were created for HIPAA.
They have a 20-year history that hospitals have been using these codes, these value codes, these occurrence codes. These are something that is in our system today.
If we are looking toward administrative simplification, trying to reinvent a wheel that has been working successfully for 20 years really isn't what we should be about.
If you look at the hospital environment versus the professional environment, because of that codified information, you will find that the percentage of electronic claims being submitted in the hospital environment is extremely higher than in the professional environment. Why? Because of those code sets.
The NUBC has been very responsible and diligent in maintaining those code sets. So, before we throw out the baby with the bath water, so to speak, we need to be very cautious about eliminating some of that information.
DR. BRAITHWAITE: Walter, this one is for you. In the last bullet of your testimony you say that the NUCC indicated that we should make sure that any proposed standard is out in the community and preferred to be in national use before it is adopted as a national standard.
This sounds like we are going back to pre-HIPAA, which is, it is not a standard unless it is already in use by everybody, which of course, never happened and never will happened. Clearly, that is not quite what you meant.
MR. MOERTEL: No, the point that we discussed at the NUCC and there was consensus was the fact that when you look at the standard that was named into the rules, 4010 October or May of 2000, that has never been put into place in the industry.
The previous version, 3050 or 437 was being used. The actual standard that is being used and offered as the new national standard was never really put into place in the industry and being used.
It had been tested by the standard development organization. In fact, the point was made, in the development of those standards, X12N actually released them as DSTUs, draft standard for trial use, and that stayed in that mode for a while, for about three years, and they become then official standards.
The point that was being made was more a generic statement of saying, if we are going to recommend national standards -- and it doesn't relate really to transaction standards but it goes into OSHA standards and other standards, that we have a responsibility of making sure that those standards have been tested in the industry and have been at least used, so that we don't face some of the issues that we are facing, of not knowing what the standard is going to look like, or knowing what it is going to look like but not how it is going to be actually implemented and tested.
That is the point that was being made, really, by the statement. It was the expectation that any future standard that is named into new rules is tested and is put into the industry for test before it is actually adopted as a standard, rather than the reverse, developing a standard, naming it as a new national standard, then having the industry test it.
DR. COHN: Maria and then Kepa has a final question and then hopefully we will break for lunch.
MS. WARD: I can't resist. Bill hit the nail right on the head. We have been able to do this now for many, many years now, and we have elected not to. Hence, HIPAA.
Now, even with the final rule, we have a sector of our industry saying, give us maybe two or three or five more years, because we don't have enough time.
So, everything that Walter points out is incredibly well taken. In a perfect world, if we could do that, perhaps we could avoid a lot of post-implementation trauma.
Let's face it, if we have people who don't even want to implement what is put in front of them with the final rule, there is no way they are going to step up and say, let's test a new one before we issue a rule. It is just not going to happen.
DR. ZUBELDIA: Maria was a perfect segue for my next question, which is, Rich Landen mentioned that compromise -- these are my notes, it wasn't your oral testimony but my notes say, compromise by consensus means that there will be a dissenting minority.
We will continue to hear from the minority about why they do not agree with the industry position. The question I have is, as NCVHS, what would be your recommendation, so that we pay due attention to the minority but giving the corresponding weight, that it is a minority position, rather than a very noisy vocal minority.
MR. LANDEN: That is the trillion dollar question. Health care is the largest single component of the US GDP. Yet, we are, to a large extent, a cottage industry that has never embraced standards.
What we have found in many forums, be it the NUBC, the NUCC, is no matter how many experts you gather in a room, no matter which experts, the field itself is so diverse and each segment of the field has its own business needs and idiosyncratic requirements in the way that field actually works, day to day, implementing out there, real world, that there is never at one time in one place all the perfect information that you need to make a decision that works well for everybody.
So, when we go from the atmosphere that we have been with the NUBCs and NUCCs of the world, when you look at the pre-HIPAA standard, you have to remember that was all taken in a voluntary sense.
NSF, most people refer to as national similar format. You have got a core that is standard. Around that core, trading partners deviate when you look at the federal or state programs, the Medicares, the Medicaids, the Department of Labor, the Department of Defense.
These are all programs that have their foundation in legislation and then the rules by regulation, for the most part.
When you look at the private sector, all their rules are based on contract law. When you look at the equivalent in implementation guides for the UBs and the NUCCs, the 1500s, you find a lot of references like, as required by Medicare, as required by Medicaid, as defined by your state SUBC, as required by contract.
Then, on top of that, which is kind of a lubricant, a fluid level to allow the standard to be tailored for particular industry sub-segment use, you will find a lot of leeway for trading partners to create their own ways of codifying special information that normally it is the payer, the health plan, that requires in order to adjudicate that claim pursuant to its contract, generally with an employer.
So, those whole lubricant layers of allowing this local flexibility and this trading partner-specific flexibility has gone away.
For that reason, even some of the comments we have made about how well NUBC and its codes have served the industry and NUCC and the 1500 have served the industry, we can't necessarily take that for granted.
We are now in an environment where we don't have that voluntary compliance and we don't have that ability to deviate from the black and white norm any longer. That is an issue that this industry will really have to toddle through in its learning curve as we implement these HIPAA mandates. Did that get to your question?
DR. ZUBELDIA: No. How can we -- NCVHS -- know that when we hear somebody, that they are part of the majority or the minority or they are a very vocal and very small minority.
MS. WARD: We can categorize them.
DR. BRAITHWAITE: We can get the experts in the room and take a best guess.
DR. COHN: With that, Kepa, I don't sense that you have been satisfied with that comment, but I doubt that there is one.
I want to thank this panel. First of all, I really appreciate all your hard work in terms of coming to consensus although, as Richard commented, not complete agreement.
We will obviously be talking about this more this afternoon, but you have given us some tremendous guidance and we really want to thank you. We will now adjourn. I think we are running a bit late.
[Whereupon, at 12:35 p.m., the meeting was recessed, to reconvene at 1:30 p.m., that same day.]
DR. COHN: This afternoon we are going to be having an industry roundtable discussion for further discussions on the DSMO process and results, as well as some more general discussions about the implementation readiness of the transactions.
We want to lead off with Dave Moertel. Thank you for coming. We know you were part of the beginning of this whole effort to expedite changes to the standards and I am curious about what your thoughts are at this point.
MR. MOERTEL: Thank you for inviting me today. I am the manager of electronic commerce for the Mayo Foundation. I have also had involvement in other areas of the industry that I have listed on the front slide.
These are the issues that I plan on addressing today in my brief discussion. As you recall, I spoke on February 1 on the topic if the industry's early experiences with HIPAA implementation.
In that testimony, I explained how Mayo created a HIPAA compliance effort that focused on reviewing HIPAA implementation guides.
The team also created a gap analysis, comparing data available electronically with data contained in the HIPAA transactions.
They found that there was a large number of new data requirements and had determined that infrastructure changes required to be in compliance were going to be expensive.
Based on that analysis, we had a meeting of provider organizations, provider associations and representatives from HCFA, that convened to review this list of elements.
In addition to the Mayo Foundation, the group here, various provider organizations, joined us in this discussion, and I have listed those out in your handouts; likewise, these different associations, the American Medical Association, Hospital Association, Dental, the National Uniform Claim Committee and the Health Care Financing Administration.
The group evaluated the Mayo analysis and determined that the gaps identified were common issues for the provider industry.
My February testimony also discussed the issue of universal business need. In our provider group discussions, a common question was whether or not the new required data elements reflected a need for the health care industry, or were the requirements expressed by a single or small number of payers or state agencies.
A major issue that arises from that universal transaction philosophy is that the burden often falls on the provider for reporting all the required elements in a claim transaction.
If a given provider is now obligated to provide those required data elements on all claims to all payers, even though none of the provider's business partners may need those data elements, that issue is now further complicated because those payers who don't need the element for processing the claim will need to maintain that data element so they can pass it back on a remittance advice, or pass it on to a secondary payer as part of the COB process. So, these issues aren't just specific to the provider community.
Our provider group believed that if the elements in question were not currently necessary for billing services, the element should not be required for the HIPAA implementation. We were looking for administrative simplification.
It appears that some of these data elements do not reflect a universal business need for the health care industry or that they are requirements expressed by a small number of payers or state agencies.
The HIPAA 837 implementation guides were developed for the purpose of reporting claims services from providers to payers.
If the inclusion of some of these elements was to fulfill other needs -- i.e., state public health reporting -- they should not be required elements to be reported on the claims transaction.
In fact, our provider group supported the position that the 837 standard should be utilized as the transaction to report data for public health purposes. However, we believed a separate implementation guide should be developed to fulfill those needs. There is wide support in the industry to do that.
The group believed that in order for administrative simplification in health data standards addressed by the HIPAA act to be successful, some of the data elements in question were going to require some compromise.
Oftentimes, there were other more widely accepted methods for capturing the same information, and we talked about that a little bit this morning.
While the law provides the framework for administrative simplification, significant work still lies ahead for all those involved in these transactions, the modification of the standards and the implementation guides, the review process needed to establish uniformity in the use of the standard transactions, and overseeing and updating the process as needed.
I provided an appendix to all of you in February that listed all of the claim issues for the provider work group.
The recommendation from NCVHS was to utilize the DSMO process for bringing these issues forward, and I followed that advice and entered the 46 issues plus an additional six issues on remittance and eligibility on the DSMO site, prior to the last ANSE X12N meeting.
I will have to tell you that these issues were not warmly received by my X12N colleagues, but they did agree to work with the DSMO group on a fast track process for the review of the issues. X12N opted in on all of the 52 issues that I brought forward for the group of provider organizations.
At the present time, only two of the requests that I brought forward have been honored. One did result in a change and three more are under appeal at this time.
I have been told that up to five more will be handled as maintenance, but I have no way of confirming this.
Now, I seem to have seen a list floating around that actually had the final results of the DSMO process at the table.
DR. COHN: That 75-page document. We had the testimony from Margaret, I think, that we had a list of the As and the Es or the Cs -- A, E and H.
MR. MOERTEL: Not the Cs, though?
MS. WEIKER: Not in the list.
MR. MOERTEL: Okay. At any rate, at this point I had no way of confirming the final outcome. I am hoping for that to happen soon.
If you think that having two out of 52 issues resolved for the provider community is a poor batting average, I would strongly agree.
The provider community is one of the most under-represented groups at NCX12N, and this is not an uncommon result.
Instead of being categorized as a minority, I guess I would prefer to look at us as sort of the silent majority, but that is another issue.
In point of fact, this is why a number of providers and provider organizations have been driven away from the process. I think the results of this process showed a very clear issue, but that isn't the most important issue that I want to share with you today.
The process for handling the DSMO changes involved having the industry work together in the X12N work groups to come up with an appropriate solution and/or recommendations for data maintenance requests.
Most of the issues that I brought forward were relevant to the claims transaction, so I focus most of my efforts with that group.
Twenty-six of the 46 claim issues were accepted by the work group for changes to the current guides. Thirteen others resulted in a change that partially resolved the issue. This represented better than half the requests. So, why weren't these changes made?
Well, you would think they were voted down at the DSMO meeting. In actuality, they were changed prior to that meeting by a group of the X12N management team before they got there.
It is too bad there wasn't any provider representation in that small group that made these changes. I don't know how these changes could be made without the work group authorization and, you know, I don't know -- I don't know the answer to that question.
At the very least, you would think there would be an opportunity for the work group to appeal these changes. Well, at this point, we haven't heard back from the DSMO process on all the issues, but we do know which issues were accepted as additions to an addendum to the guide.
These issues have gone out for a 30-day comment period which ends either today or tomorrow. I heard tomorrow in an earlier testimony.
This sounds like a great time to appeal the issues that the management team altered, but this appeal process has also been restricted.
If you go out to the web site, a note reads: X12N asks that you please keep this discussion relative to the implementation guide changes proposed in the attached PDF file.
Only the pages that contain changes are included. Please do not post new topics to this discussion. Any new topics will be resolved.
Well, that includes other issues that went into the DSMO process that were not accepted. Those are not issues that can be discussed during this forum.
It is interesting that, if you go to the page, it lists five issues that are under appeal. Well, the appeal process for the DSMO group hasn't been opened yet. So, how can these issues be up for appeal?
They were appealed by one of the three people that I indicated above as part of the management team. The right to appeal was supposed to be open to the original submitter of the issue, but I guess that right will only avail after the close of the X12N comment period. I find that interesting, how that worked out.
I followed the advice of this group in February and have found that there was a substantial breakdown in the process that was recommended.
I realize that I wouldn't be getting a favorable response to all the requests that I was making on behalf of the provider organizations, but I did expect a better result than I have shown you today.
So, at this point, I again ask for your recommendations on how to proceed with these issues.
DR. COHN: Dave, thank you very much. Sally Klein?
MS. KLEIN: Good afternoon. I am Sally Klein and I am the HIPAA coordinator for the state of Montana and the Medicaid agency, and I am here representing the National Association of State Medicaid Directors.
I also sit on what you all might know as the NEMI work group, which is the National Medicaid EDI HIPAA work group.
Perhaps few health plans will be as challenged by the transition to HIPAA as Medicaid agencies. Many of the services we perform or fund are unique to Medicaid and are not the function of any other payer.
To comply with our requirement for federal reporting, and due to our obligation to be stewards of tax payer dollars, we have created a large number of proprietary reporting mechanisms.
Our challenge has been to cross walk data elements such as type of service, provider specialty, provider type and thousands of local codes and unique provider identifiers into the standards available in the 4010 transactions without impacting client services or compromising our relationship with Medicaid providers.
We were progressing in these challenging tasks prior to the fast track DSMO process. We had originally believed that the DSMO process would provide an opportunity to continually improve the work done years ago in creation of the 4010 transactions, but we were certainly not prepared for the full scale assault on significant data elements within those transactions.
The fast track process impacted Medicaid agencies in several ways. First of all, while impact assessments and gap analyses continued, any programming for conversion was place on hold.
Several critical DSMO requests remain in the appeal process and may not be decided until later this year. Some decisions of the steering committee remain unclear. So, it is not possible to understand whether a change request has been approved, is under appeal, or should be appealed.
Thirdly, Medicaid agencies took advantage of the DSMO fast track process to request a change that will allow us post-payment recovery from third party payers who are actually liable for the claim.
Medicaid is mandated to conduct this pay and chase and, without this change, we stand to lose approximately $500 million of tax payer money every year.
The decision of the steering committee seemed to favor this request, and was in fact posted to the WPC web site. Unfortunately, that decision is now reversed, and it is necessary to file an appeal.
Since the steering committee seemed to support the request, it is not clear how, or with whom, an appeal should be filed.
Fourthly, the fast track DSMO process seems to run counter to the MOU as originally signed. The original MOU calls for timely review and a commitment to open public access.
The details of the 90-day business analysis with opportunities for a 45-day extension are clearly detailed in the MOU.
Further, the appeals process is confusing. While any person or entity has the right to appeal the outcome of a standard change request at the SDO or DCC level, appeals beyond that level are restricted only to the collaborating organizations under this MOU, and to the requester of the HIPAA standard change request.
This would seem to imply that a change request that completely altered the standard data set, and was approved by an SDO, could not be appealed at the DSMO level by an entity that was drastically affected by the change.
Five, we have been told that the data standards modifications cannot take place without another rule making process.
There is no way to determine when that process will begin or to guess what the final outcome will be. The 4010 versions could all be modified or a more recent version could be adopted.
If that were the case, it seems possible that another extensive DSMO process could begin all over again with the newer versions.
Finally, the fast track process kept all Medicaid agencies at a frenzied pace for three months. We frantically gathered data to support positions on data elements we felt were critical to support our business needs.
Much of our business is unique but critical. We continually encountered the argument that, unless all payers needed a particular data element, it was not necessary in the transaction.
We found ourselves at odds with health care providers and found ourselves resisting change, simply because we did not have adequate time to research the profound implications of such drastic data changes.
Under calmer circumstances, we might have been able to develop perfectly viable solutions, had we had the time and opportunity to work collaboratively.
It is hard to elaborate on very many positive points of the fast track DSMO process. It did require us to rapidly assess our systems and business operations, which may have jump started our HIPAA activities.
Few processes have served as well to unify Medicaid agencies, solidify partnerships at a federal level and build alliances with other agencies, both public and private, whose mission it is to improve the health of the country.
The old philosophy behind some ancient medical treatments is, that which does not kill you will make you stronger.
It is with that philosophy in mind that we would like to offer a few recommendations to improve the DSMO process.
It is clear that, without a firm base, progress toward HIPAA will be chaotic and ineffectual. In light of that, it seems that all of the rules for administrative simplification should be finalized before implementation can begin.
All states have limited budgets to invest in systems changes, and will find it impossible to continue to request funding for reprogramming.
We anticipate, for instance, that we could program our systems to accept the national provider identifier as the NPRM currently details it, only to discover that the final rule is significantly different and we would need to reprogram the changes.
The fast track process has taught us that we cannot even assume that standards are final.
Likewise, of what value is the privacy final rule without security rules to ensure that privacy is maintained.
We suggest that all significant rules for administrative simplification be finalized before covered entities are expected to begin compliance.
Compliance would likely take two years once the rules have become final, and there is a solid foundation upon which to base our transition efforts.
Secondly, it is our belief that the organizations that comprise the DSMO MOU are well suited to advise NCVHS and ultimately the Secretary when it is time to move forward into a new HIPAA standard.
They are will positioned to keep their finger on the pulse of the health care industry and to know what new standards would better serve our health care mission.
We would like to propose that the DSMO process be used as a conduit to inform various standards development organizations that some changes are necessary to improve the quality of the data that is transmitted.
We believe, however, that each individual SDO has processes in place to continue to evolve and improve the standards and create new versions.
Since that process is public, collaborative and progressive, it would seem well suited to the development of quality standards.
Once a standard is developed by the industry, its data content should be final until another standard is named.
Standard data content should not be eroded, particularly before implementation has demonstrated the value of the complete data content.
Finally, we suggest that new standards should not be named in rule until pilot projects have confirmed that those standards improve health care processes and can be implemented without enormous system changes for either provider or payer.
This may, in some ways, slow the progress that could occur with HIPAA, but would assure that each change would be built on a solid base with concurrence and user acceptance by both payer and provider communities.
State Medicaid agencies would like to underscore our commitment to making administrative simplification work for our clients, our providers, and our taxpayer constituents.
We believe strongly that there are distinct advantages to be gained with HIPAA implementation and hope that our comments here will help improve the process of health care delivery.
DR. COHN: Sally, thank you very much. Richard Landen, I understand this session you are wearing a Blue Cross Blue Shield hat; is that correct?
MR. LANDEN: I am wearing a different hat this session.
MR. LANDEN: I am Rich Landen. I am with the Blue Cross Blue Shield Association. I was invited to be on this afternoon's panel as a spokesperson for some individual Blue Cross Blue Shield plan employees who, individually or on behalf of their plan or on behalf of another organization, had submitted change requests through the DSMO process.
There were about a half a dozen individuals from various Blue Cross Blue Shield plans and I was asked to elicit their view of what their experience was, submitting a DSMO change request.
Unfortunately, because these are all volunteer things and the nature of trying to write a report and get it through channels, I only got one official response, and I will read that to you.
It is from Joanne Weingarth of the Empire Blue Cross Blue Shield Plan. Joanne had submitted 10 change requests through the DSMO process.
In a letter to the subcommittee that you all have, she says, based on her experience as participants in the DSMO process, here is the following testimonials.
Then she lists the specific requests that she had submitted. There were 10 of them. I won't read through those. Her experience can be summed up in a few paragraphs here.
Once the change requests were submitted, there is nowhere on the DSMO web site that provides a status of the request, nor were we, the submitters, asked to participate in the DSMO discussions of our request.
Please note, however, that Empire Blue Cross Blue Shield participates on several list serves, and has received some information on the status of our requests as noted above.
We are not sure if these are final decisions and probably won't know until the Federal Register is issued, by which she means the final rule.
DSMO process and recommended improvements. Entry of change requests was simple enough via the DSMO web site. As an aside, speaking for the DSMOs, I do believe that the simplicity in having one specific place to submit the requests could probably be described as our number one priority when we were building this system to handle the change requests for HIPAA. People would know where to go to submit their requests. I am very please to see in this letter that apparently we accomplished that key objective. Back to Joanne's letter.
Originally, I do not think the requests were assigned a number, and that was quickly changed as the number began to increase.
It was good to be able to see the requests the industry is submitting. We are knowledgeable of the change request process due to participation at X12 and Health Level 7, and knew the time frames involved for submission of change requests.
The industry as a whole may not understand this process. The DSMO web site should be made more user friendly. The search feature should be enhanced to search by a specific change number.
You should be able to print all requests without having to select each one. The resolution of each request should be added, possibly all those requests that will be included in a specific implementation, for example, all the requests that have been accepted for the fast track.
HIPAA implementation. With the number of requests submitted for consideration for the fast track, the number of changes actually considered for the version 4010 X12 implementation guides seems very small.
Just for your reference, I think there were, what, 231 change requests, and how many became category As, about 10 percent -- 30-some, so about 15 percent.
There is concern about the fast track and the amount of thought and investigation that was put into each request.
Some of the changes made may have an even greater ramification than the original guide had. Change requests that will be considered for the next round of HIPAA could take a considerable time to implement, and would they still be required.
Based on our requests, and which ones were considered, they will have minimal impact on improving our implementation.
The number of service lines supported and the maximum field sizes are a major concern and were not changed.
As I mentioned, I did not get written responses from any of the other half a dozen individuals I talked to, but when I preliminarily talked to them on the phone about submitting testimony to the subcommittee, I got the feeling that Joanne Weingarth's letter that I just read was fairly typical of their experience.
They knew where to go to submit their requests, but once the request got out there, there was not the responsiveness that they had expected. As one of the architects of the DSMO process, I agree with that.
When we were working on the memorandum of understanding, we had talked about a lot more feedback to the requestors. For several reasons, not the least of which being the fast track process and the intense time demands, the other major factor was the cost of a web site.
Had we included all the bells and whistles, the feedback loops and the automatic whooshing of information out to the submitters, it would have cost substantially more money than it did, and the web site was funded by the six DSMO organizations with some ongoing maintenance dollars contributed by WEDI, I believe.
The web site that we built was the one that we could afford within our very minimal budget. Again, I do think that, on behalf of the six Blue request submitters that I polled, that Joanne's responses are typical of the user experience. Thank you.
DR. COHN: Richard, thank you very much. Catherine Schulten?
MS. SCHULTEN: I am absolutely not going to talk about the DSMO process. I am going to talk about a completely different topic. Just put all your DSMO questions aside. Think about something else.
My name is Catherine Schulten. I am here representing AFEHCT, for a project that I am working on called ASPIRE.
I am also here representing WEDI SNIP. WEDI SNIP has taken on this project and is writing a white paper on it as well. I work for Sybase, who is a vendor.
Many of you have seen this presentation before. It is a beautiful presentation, actually, so I am going to run through some of this stuff kind of quickly, because I know many of you have already seen it before, and I am going to focus on a couple new key points on this presentation that are new to it, some findings, and where we are with this project.
For those of you who don't know, the ASPIRE was the Administrative Simplification Print Imagery Research Effort project.
It is a transaction gap analysis and demonstration project. It was requested by the NUCC and they asked assistance from AFEHCT for this project.
The goal of this project was, does a HCFA 1500 paper claim form contain all the necessary and required data needed to create the HIPAA compliance version 4010 837 professional claim.
We got together some demonstration project participants from the provider payer clearinghouse and, I should also say, the vendor community.
This is the HCFA 1500 paper claim form. It contains a subset of data that is present in the 837 professional. It contains some data that is not present in the 837 professional, and it is a paper form that can be turned into an electronic print image, and I am going to talk about that a little bit more in detail.
This is the UB form. It is also called the HCFA 1450. That is really I think its more official name, the HCFA 1450, but we sometimes call it the UB.
Once again, it contains a subset of data that is present in the 837-I and it contains some data that is not present in the 837-I.
This is the new part of the presentation. There have been some questions about, well, how do you go from a paper form to an electronic form.
First of all, this is how forms are created in a provider's office. This seems very elementary, but it is important that we sort of level set.
These paper claim forms can either be filled in by hand, they can be typed or they can be generated from data entry, from a practice management system.
You can't see this real well, but what this is supposed to be an example of is a flat file that is produced from the data entry process.
Really, it is just some data. It has no -- there is no way to really know what that X means when you just look at that flat file.
The only way you know what that X indicates is that it has to be then overlaid on top of the actual claim form itself. That is how it gets some intelligence. That X then indicates that this patient relationship, the insured, for example, is self, because it happens to be in that box.
Now, another way you can get from paper to electronic is that paper claim forms are turned into electronic data through this process called scanning.
Scanning takes this paper form and runs it through a scanner and it picks off the data that is actually physically on this form.
I think I have an example here of what scanned data is. It is difficult to see here, but what I tried to show was that it is able to count the spaces between the different data elements, and that is how it understands what that X is.
It has counted so many spaces between, for example, the state, and it goes all the way over about 15 spaces and now it is able to figure out that this person is employed, a full-time student or a part-time student, by the number of spaces over to the right.
DR. FITZMAURICE: Is that a scanned in optical character recognized document, or just scanned?
MS. SCHULTEN: It is actually a made-up document that I put up here for this presentation. I was trying to show that, in a scanned image, it is really just counting spaces over to the next letter, and that is how it gets some intelligence. I am going to get a real picture of a scanned piece of data, but I just haven't yet.
DR. FITZMAURICE: When you type it in on a computer, then you have to print it out and then scan it?
MS. SCHULTEN: Yes, you print it out.
DR. FITZMAURICE: That seems like a waste.
MS. SCHULTEN: Actually, the way it works is that the provider would print it and he sends it to the payer. The payer gets it and says, well, I don't want to sit here and have to re-key all this information. So, they scan it and now all of that information is now available to them.
If they have a mapping process, then that data, like the first name can then be mapped into the first name space in their adjudication system. That is how the scanned data gets into their system without having to re-key it.
Another way that that same data can get into the payer's system is the actual flat file. The flat file can be translated by a clearinghouse into a format that can be accepted by the payer.
For example, it could be translated into an NSF or a UB or an 837 or some other proprietary format that that payer uses.
It is important to understand that a clearinghouse can be just a clearinghouse, or it can be a payer who is acting as a clearinghouse. So, sometimes payers act like clearinghouses and do that mapping translation process.
This is just an example of a UB claim that was translated into a HCFA 1450. What started off as being on a piece of paper now looks something like this.
Once again, can we go from a HCFA 1500 or 1450 form and translate that successfully into a HIPAA-compliant 837 transaction?
When we did this process, we tried to identify what the gaps were between the data. I categorized the issues into four separate categories.
There is the category of gaps between mandatory data content, meaning it is not physically on the form, but it needs to be in the electronic version. So, how do you get there. It just doesn't exist.
There are data specificity gaps. There is ambiguity within data element cross walks and then there is the non-standard use of the paper claim format. I can go over each one of these very quickly.
In the gap analysis, also, once we have determined what these categories of gaps were, we also, through this process, through this ASPIRE project, came up with some work arounds and some different solutions that can be used.
So, we have categories of four different solutions. One is the development of precise implementation guides for the paper claims, an industry-wide-accepted cross walks to be published, trading partner agreements and data enrichment, are all work arounds or other solutions that can help with this issue.
These are examples of the gaps between the mandatory data elements. One is the provider taxonomy code. Another is the payer responsibility sequence codes. These are examples of pieces of data that do not reside on the paper claim form, but are required on the electronic version.
This slide shows what I mean by a provider taxonomy code for those who aren't real familiar with it. The billing pay to provider, specialty information, aka the taxonomy code, is required if the rendering provider is the same entity as the billing provider and/or the pay to provider.
A taxonomy code is another name for provider specialty code. These are examples of taxonomy codes. They do not exist, for example, on this HCFA 1500. There is no place to really put that. There is no box that says, put your taxonomy code here.
There is also a gap with payer responsibility sequence. There is nothing on this form that indicates that this is a primary claim, a secondary claim or a tertiary claim. So, these are examples of data element gaps.
This is a new piece of information that I wanted to share with you. I put in here, the magnitude of missing data elements. I put missing in quotes, because it is not that it is necessarily missing. It is just a different format.
Some of it is missing. I don't think that, just by looking at numbers, you sort of lose sight of the bigger picture.
The HCFA 1500 claim form has 33 numbered boxes on it. I sat down yesterday and I counted. What do these 33 boxes represent?
In my count -- and I could be off here by may 10 or so -- is about 150 discrete data elements. So, patient's last name is an element, patient's first name is an element.
Then I looked at the NSF 2.0 electronic claim. That has 25 different records, starting with the AAO to the ZAO. I know that not all of you are familiar with an NSF, but if you are, there are 25 different records.
I counted them, and these represent 582 discrete data elements. So, already, going from paper to electronic, we see a huge gap of information. There are only 150 pieces of data that we can put on here, but we can put 582 on an NSF.
Then I went and looked at the 837 professional. I had lots of time last night when I was working on this. The 837 professional institutional has 244 segments from the ISA to the IEA.
That represents -- I sort of had to guess here because I didn't want to count all of these, but I took a full claim and it counts the number of elements in that claim.
I counted about 1,054 elements in a fully completed 837 claim, which means that all of the stuff about home health, all the stuff about coordination of benefits, every single thing was filled in. That is your maximum size. Now, we are getting even larger.
Now, what we have to understand is that a large percentage -- and I don't have the exact count here, and I will find that out later -- but a large percentage of those elements are what we call qualifiers.
These are not discrete data elements. An example here, this is a patient's name and how it is represented in X12.
It is telling you here three things or four things, NM1, QC, the number one, and the letter MI, those things that are up there in red. Those are qualifiers.
You don't see qualifiers in NSF or UB. You certainly don't see it here on a paper claim. The way we know what that data is, is either by virtue of its placement on the form, that is how we know that that is a patient's name versus, you know, your school name.
The same thing with the NSF and UB. We know that it is the patient's name because it is 27 characters to the right of this particular record, and that is how it is qualified. It is sort of its position within the transaction.
In X12, it is a little different. You actually have to qualify that data. So, a lot of these things are preceded by codes.
If we took out those qualifiers, I think we would see a much smaller number here. I am not saying that we would see 582, but it certainly isn't 1,054.
Another issue, another data content gap is the ambiguity within data content, the cross walks. This is an example that I usually use, that the HCFA 1500 provides a check box to indicate self, spouse, child and other, while the 837 professional lists 25 different relationships to insured.
This is a big one here for child. Then there are like six different types of children on an 837. So, you have this one-to-many cross walk issue. It is not that it can't be overcome. It is just an area that needs to be considered.
I used to have this slide up here about the NDC and the J codes. Obviously, I will need to change this one. I am sure I can find some other examples of ambiguity within data content.
The use of revenue codes and the HCPC codes and the J code and the NDC code was an issue. Hopefully that one is going to be resolved.
There are also issues with data specificity. The 837 professional makes clear distinctions between bill to, pay to and rendering. The HCFA 1500 does not. If you look at the HCFA 1500, in box 33, it just says, physician/supplier name. So, it doesn't break it down into bill to, pay to or rendering.
NM1 segments, the 837 requires the distinction between individual and organizational data types. For example, a billing provider can be John Smith, MD, or it can be Best Billing Service, Inc. So, they are different.
There is also this conference of the non-standard use of the paper claim format. The HCFA 1500 and 1450 paper claim formats contain fields which can be used for a variety of purposes.
The example that I like to give is, it even says, on the back of the HCFA 1500 form, the very first line, it says, because this form is used by various government and private health programs, see separate instructions issued by applicable programs. So, the form itself doesn't even try to be a one form fits all instruction.
The HCFA 1500, for example, in box 19, has a statement, reserve for local use. The UB92 field two, this is an untitled field. It is assigned for use by each individual state.
There is also a variety of data that can reside in these sort of all purpose boxes. For example, number 19, reserve for local use. I always like to say, this was my favorite box when I used to fill out claim forms. You could put whatever you want in here, really.
You could put CLIA numbers, mammography numbers, procedure descriptors, explanation of what type of drug was administered, reform tax, you could just write whatever you wanted. You could go on and on in that box. These fields are state and payer driven.
These are some of the solutions or work arounds that we discussed when we were doing this project. One example is the development of a precise implementation guide for the form.
If you make the instructions for the form very specific, then you won't have issues in trying to map from the form to the electronic version, because you know exactly how this form was filled out.
UHEN is working on this and they are, for example, putting in instructions that say that box 25 of the HCFA 1500 can only contain the pay-to-provide tax ID. If you know that is what is in that box, it is going to make it very easy for you to do your mapping.
Another work around or solution that we are developing is industry-accepted gap analyses and transaction cross walks.
That is something that WEDI SNIP, the translation work group, is working on. The SNIP translations in business issues work group is also writing a white paper.
I am co-chairing that effort and we are sort of in a draft format right now of the white paper, but it is coming out. We have some effort done toward it. Hopefully within the next few months we should have a white paper on this issue.
This is really an opportunity for the industry to share their cross walks with one another and aid in their development.
Another possible solution is the use of trading partner agreements. By this I mean that a provider can tell their clearinghouse or their payer that if they put on this form some information maybe outside the margin or in a box that doesn't really have an indication of what that data element is, they would tell their trading partner, this is what I put in that box, so you know what that means. So, your trading partner agreement goes down to the specific level of saying, well, any data that is in box 19 is the CLIA number, for example, and they know how to map that.
Data enrichment is another possibility. Practice management vendors could assist providers by augmenting the data present on the paper claim form.
This is an example that I have seen done in the past where, instead of just placing an X in box one of the HCFA form to indicate the claim type, instead, you put a one, two or three in that box to indicate primary, secondary, tertiary. So, there are ways of augmenting the data.
This is just where we are with the ASPIRE project. If you go out to the AFEHCT web site, AFEHCT.org, you will see the work sheets that we have done, the gap analysis that has been done.
I know a lot of people take these work sheets and they use them then as a starting point. This is not the definitive answer.
Like I said, everyone fills out these forms differently. You can go and take that work sheet and then, from that, you can model your own transaction gap analysis.
These were some of the organizations that participated in this project. As you can see, we had a good cross representation, not too many on the provider side. It was mostly payers.
Our next step in this process really is the publication of the white paper and the determination of best practices. If you have any questions, I would be happy to answer them, but not on the DSMO process.
DR. COHN: Catherine, thank you. For the subcommittee members, I asked Catherine to come because, when I heard her last week, she did a nice job talking about approaches to data gaps and all that sort of thing, so thank you very much.
Obviously, I think there have been some issues brought up by a couple of the testifiers. I was actually hoping that maybe we could start off by asking the DSMO representatives to perhaps clarify a couple of, I think, concerns expressed by the testifiers.
MS. WEIKER: We were going to ask you if we could.
DR. COHN: I hope you don't mind me asking you in that case.
MS. WEIKER: No, Simon, that is why we are here. I will start with Dave's testimony. Dave mentions -- it is second page, third paragraph -- that two of his requests have been honored.
All of his requests were reviewed by the DSMO in a consensus-building fashion. We all agreed on the categorization of those requests.
I guess I am a little -- maybe the word honored is a little bit of a misnomer, because they were all done in a consensus. They were all categorized in an agreement by all of those organizations.
It is not like we dismissed his requests. We did look at them and did categorize them.
DR. MC DONALD: Could I just get a clarification? When you say you categorized them, does that mean you didn't reject any of them, you just said, some we deal with now, some later?
MS. WEIKER: Right.
DR. MC DONALD: So, the categorization really means that you give them a priority of when you get to them.
MS. WEIKER: Yes, in the testimony this morning, I am not sure if you read all of that testimony, but basically we said, modifications necessary to permit compliance --
DR. MC DONALD: I read that.
MS. WEIKER: That is what we did.
MS. GREENBERG: Either A or B.
MS. WEIKER: There were some that there were no changes.
DR. MC DONALD: I am trying to get it clarified. Did you say no to any of his requests? I think that number would be worth saying, that you said, we are not going to do those.
MS. WEIKER: We did categorize, I believe, some of Dave's requests as no changes were necessary.
DR. MC DONALD: I just want to know that. What he is saying is two out of 43. You are saying that there is another number that maybe gives balance to them. You rejected N of them, you accepted Y of them, and there is a bunch in between that is still up in the air because they may not be done in this round.
MR. MOERTEL: Exactly. Clem, let me clarify, two of them made it to the addendum as A items at this point. There are some that are being reviewed. There are some that may make it as a maintenance item. I haven't seen that list is so I don't know what the final verdict is.
DR. MC DONALD: I just wondered how many got rejected.
MS. WEIKER: I would have to go count his personally. I have no idea. There are 231.
MR. LANDEN: The category B simply says, this item, this requested change, was not critical enough to fit into category A. It is thrown back into the hopper for the standard development process for the next version of the HIPAA guide.
So, if it is in B, all they are saying is, it is guaranteed to be considered for the next round. It is neither an approval nor a disapproval.
MS. WEIKER: I think our point in bringing this up is to say that what is being expressed here is that two out of 52 issues have been resolved for the provider community and that is a poor batting average.
The point is to say none of them are dismissed at hand. None of them were excluded from a fairly lengthy debate. In fact, most of Dave's were the ones that we spent a considerable amount of time on.
Now, the result might not be something that is necessarily deemed acceptable by the requester, but the point is, all of the requests were handled, were considered, were categorized.
If there is a need to know what the actual outcome of each of those requests was, we can go back and do that for you, but we didn't do that specifically for those requests.
DR. COHN: I think we are counting them up here as you are talking, but continue.
DR. WEIKER: Also, in that third paragraph, there is a comment about the provider community and under-represented at X12. That is a fair statement.
However, we must all remember that there are six groups that make up the DSMO. The NUBC and the NUCC represent a lot of the provider community. They have representatives, and the dental contact committee as well.
So, there were provider community representatives. They may just not have been in the X12 organization when those were being categorized.
MR. LANDEN: May I interrupt you? Your observation that the provider community is under-represented, I would not categorize that as a fair statement. I would categorize that as an accurate statement.
MS. WEIKER: We will have to make a new category for that, Rich. The next paragraph, in regard to what happened at the X12 and then, if management changed those, that is not my issue, that is an X12N issue.
There was some give and take made by the representatives of X12N management during the discussions with the other DSMOs.
As part of a consensus building process, there is going to have to be some give and take when we all sit down and work together. What happened prior to that, I do not know, but I know there was some give and take in order to reach the consensus when we all met.
Also, I think there is some confusion, and it is not just Dave, I hear this theme throughout the testimony, between the DSMO web site and the Washington Publishing addenda web site, or the X12N web site.
The X12N web site contains the technical analysis of the category As. There are also those items that the X12N management team has said they will appeal.
The fact that they are labeled appeal on the addenda web site may be not quite the right verbiage to use because they have not been officially appealed, but Gary Beatty, who is the X12N chair, did state, when we were going through, that he was going to file an appeal. One of the things that he did was to gather further industry input and put those out on the web site.
In regard to the DSMO web site, I received a voice mail that the appeals or the right to appeal is now available on the web site.
The categories have been updated. There is a place that lists the categories on the DSMO web site. All of the categorizations and the final comment from the DSMO have been posted.
There will be a notification sent to each of the requesters that the DSMO business analysis has been posted. It will tell them where they need to go to look at it, as well as if they want to file an appeal, it will give them the time line that they need to do that.
There will be a button to say, file an appeal, and you can either enter your documentation to substantiate your appeal at that point, or you can come back within seven days and enter it at that time as well. That is now available on the production DSMO web site.
X12N, in regard to posting no new topics, that was an effort to keep the discussion to what was germane. So, I think there is some confusion about the two different sites. But the DSMO site is now fully functional, so you can go out and look at the results of all of the requests. If you are a requester, or a collaborative DSMO organization, you may file an appeal. So, it is open.
MS. WARD: If you are reading this later, just to clarify what you are reading in the last page of this testimony, the statement that precedes the italicized copy of what is put out on the addenda web site, that restricts adding new issues, et cetera, the statement that precedes that alludes to that being DSMO appeal related.
That verbiage that is out on the X12 addenda web site has nothing to do with the DSMO process or the DSMO appeal process. That is why Margaret is saying the two web sites and their functions are being confused. What is on the X12N web site doesn't have anything to do with the appeals process.
DR. COHN: Maybe I should break in. We actually counted up the numbers here.
MS. WEIKER: For Dave's request?
DR. COHN: I hope you don't mind, but Karen was actually doing some counting. It turns out, of the numbers here, we have the A category, which is priority changes for the NPRM or change process, there were four accepted.
Bs, maybe we need to talk about that to see what Bs really are. I thought Bs were accepted but just were not critical at this time, as opposed to Richard's characterization, which is that they go back for further discussion. They had eight.
Cs, which are maintenance, had 13 acceptances. Ds, which were rejections, no changes, I notice reading through some of these there was mention that there were other -- Ds were 24.
Fs were withdrawns, are two, and Hs, which are sort of for further evaluation, are two. I don't know what one considers to be Bs, but certainly 17 appear to make it through this initial process.
Eight, depending on what you are going to do with Bs, then there are a number that are up for appeal. It isn't quite as bad as it sounds.
MR. MOERTEL: Numbers can be gotten in various directions. If you actually count those items that match the initial requests, there were changes, there were things that went to the addendum, but only two matched the initial request.
There were two additional addenda items that made it into the addendum, that were modifications of the requests, partial resolution. I am aware of those, but only two of the original requests went through as requested.
DR. MC DONALD: If you take the best case, you got knocked out by 50 percent, in the worst case you got knocked out by 90 percent. I think you are not counting the maintenance ones just because you haven't seen them. In fairness they are probably going to be there.
I really wanted to get into a slightly different thread here, and there are two parts of it. One of them is, this is a tremendous amount of work and these are all volunteer people doing it.
I was thinking how I would not like to be between you two, because you want exactly the opposite stuff. There are going to be either unhappy people or crazy adjudicators, or both.
Secondly, I think the expectations may be way too high for this DSMO process at this stage. I think what people are using it for is to say, gee, what I really wanted is, I wanted a Cadillac, so I am going to put in for my Cadillac.
I mean, everybody who just wants anything is just putting it in. It was sort of a short cut, not having to go to the standards group.
I think maybe this first phase, you may have been better off labeling it, these are reasonable modifications of the current accepted standards, rather than anything anyone ever wanted. I think you can't manage it that way.
The last thing, and I think I said this in other contexts, I think it is going to be very, very hard to do this without faces talking to each other.
That is, I think the expectation -- and I saw what some of these requests looked like, and if I read them, I wouldn't know what the hell they wanted or why. You really expect an awful lot from a requester, to give some justification and explanation.
You can get that with some face to face, but to assume you can do that as an automated process at this level of complexity without people dialoguing face to face or voice to voice, in the long run, I am pessimistic. I don't know of any example of things that have succeeded at this level of complexity without that.
MR. MOERTEL: Dr. McDonald, in response to that, what I was trying to emphasize in my testimony was not that I felt the DSMO process was broken.
I was trying to make it very clear that I felt there was an issue with the X12N and representation. The process that you talked about did occur.
Once these issues go to this site, there is industry discussion and, quite frankly, Sally Klein and I got to know each other very well over telephone conference calls as well as other members of the NEMI groups. There were long debates over a number of these issues.
I would say the first half started as a debate. The second half turned into dialogue. I think we were very successful as an industry coming to a solution that required compromise on my side, compromise on Sally's side. We came to agreement.
Those issues that came out of the work group were the result of an industry agreement. The change took place after the work group, after the industry consensus, by the management team, and they changed the outcome before it went to the DSMO group.
Not only did the outcome change, the discussions at the DSMO group were not representing the constituents of X12. That is the issue.
DR. MC DONALD: I am confused. I withdraw my comments, then, and wait to understand.
DR. COHN: I guess we should ask, Richard, I guess you are wearing many hats today. Do you want to in any way speak to that? Don't feel you have to, since you are right now wearing a Blue Cross Blue Shield hat. If you want to put on a different hat, you certainly are able to do that.
MR. LANDEN: I take off my Blue Cross Blue Shield hat and put on my X12N health care task group co-chair hat.
One of the unending joys of working with an all-volunteer organization of very bright, very dedicated people, is you have got disagreements among the process. You have got a lot of conflicting goals.
I don't want to get into, with this committee, a discussion of what was right, what was wrong with the process.
I will make two statements that I, as one of the management, and speaking for the other X12N management people, number one, feel very comfortable with our decisions that Dave is alluding to, in modifying, changing some of the recommendations coming out from some of the work group.
Number two, the other side of that coin, is to have acted any other way would, I think, have been a greater disservice in representing X12N and the DSMO process.
That being said, just so you know there is another side of the story, Dave's concerns are of concern to us. We have, within the insurance subcommittee, used one of the work groups to do a little survey of the co-chairs who were involved with this DSMO fast track process, to get some more opinions. Do people agree with Dave, are there problems, are there things we can fix, are there not. We will be having a very interesting meeting next week.
As I said in earlier testimony, you have always got a consensus. You have always got a minority. In this particular process, we also had changing parameters that we, as managers, were a little bit more in tune with.
We had some of the directives that were coming from HHS and HCFA, and what is the objective of the exercise here, what is the category A and what is category B and what are the rest of the categories.
We felt very strongly that it was appropriate management behavior to do the changes that we did. That was our judgement at the time.
We are going through a process. If our judgement and hindsight turn out to be wrong, we will change it. We will change the process.
I think there are just an awful lot of very complex factors coming to a head here, one of which Clem McDonald raised earlier. A lot of the requests were just a sentence or two, at most a paragraph.
When we collectively, the six organizations, were negotiating the memorandum of understanding, one of the exercises we went through -- and I think, George, you are the one that had done that -- was to draft a kind of a questionnaire, a screen for the change request. What is your change, why do you need it, why is this a national compelling interest as opposed to just a need of your organization.
As I mentioned earlier, that level of detail we haven't gotten to on the web site yet because of time, because of budget constraints. I think that would have helped in this process as well.
So, a combination of those factors -- lack of information, the rushed time period, the changing external demands on here -- created a series where management had to act, and we acted.
If we acted improperly, we will find that out next week, and I am looking forward to that discussion because it is part of the quality improvement process. I guess that is it.
MS. WARD: Just a quick response to Rich's last statement regarding the need for detailed information and clarity on his requests so that, when they are considered by the steering committee, we can understand really what the requester wants.
X12 hasn't yet gotten down to that level of detail in the questionnaire on the web site, but HL7 and NCPDP have.
We anticipated this kind of confusion, especially with our particular subject matter with claims attachments, and anticipated the need to really hold our requesters responsible for what it is they are asking for.
We have even had people go out to the web site, start to fill out our questionnaire, realize they don't have the answers and withdraw, do their homework, and say they will come back when they have it done.
That was sort of the whole point. I think that would just be a tremendous value for the X12 implementation guides as well.
HL7 has offered that questionnaire to X12 and I do that now for you, to take it, modify it, change it as it fits your need.
Before we adjourn, I think Margaret and I, with respect to Sally's testimony, want to talk a little bit about a couple of points that were made there, and just provide DSMO perspective on a couple of things.
If George is still on track here, however you want to do that, but I would like to just make a few statements about the other testimony as well.
DR. COHN: George, do you want to make a comment and then I will let Maria?
MR. ARGES: Yes, I did want to make a comment. Actually, I want to kind of piggy back a little bit on what Dave was talking about.
I, too, experienced the frustration that Dave experienced because I participated in some of these provider calls as well as some of the X12 calls.
We went into the San Diego meeting, the final DSMO meeting, with the assumption of looking at where everybody's position was.
As an NUBC representative, we carry forward the recommendations of our respective committees. It was somewhat surprising, I think, at the last minute to see some of the X12 positions change from what was actually given to us beforehand.
It seemed to be made unilaterally. Maybe the reasons were that the other X12 participants who were involved didn't have the full instructions from the management team or whatever, but shame on the management team for not communicating that to the X12 participants.
It does create a level of frustration and it creates a sense of who is it that is speaking on behalf of X12. As an organization, I am not quite sure who it is that has the authority at this point in time.
DR. COHN: Maria would you like to finish up and then we will take a brief break?
MS. WARD: Yes, just a couple of points. On the first page, the third item that talks about a particular request having been approved and moved forward by the steering committee related to the pay and chase, the Medicaid encounter data that the Medicaids are involved with.
There is a statement here that says, it had been improved and, unfortunately, the decision has been reversed and it will now have to be appealed.
I don't want to put words in your mouth, Karen, but it wasn't the DSMO steering committee that made a determination that this was not appropriate. It was HCFA.
Truly, the reversal there has nothing to do with the DSMO. Is that fair to say? I don't know if you are aware of that, but just so the committee is aware of that, it is not necessarily germane to the DSMO process.
MS. TRUDELL: Right, the assessment was based on a definition of the various transactions that were involved and we were trying to make a decision as to whether this particular business functionality actually fell into the purview of a claim and remittance advice CCOB. That was the advent of that decision.
MS. KLEIN: Perhaps that one might have been more accurately referred to as a policy, whatever category?
MS. WEIKER: We have recategorized that. Gary Beatty, of X12N, posted that information when we were not quite done going through all the change requests.
Then Karen, that last Friday, came on and said, we have clarification on this. So, we have recategorized it and the web site has since been updated.
MS. KLEIN: It was just very confusing for us because the only web site we had to access was the WPC web site which said, on one day, yes, this is approved, go ahead and do it, and a day later it is pulled and the DSMO site wasn't up and available.
It is just to reiterate that the process has been a bit confusing for all of us.
MS. WARD: Then, number four on the second page, I would take you back to the opening statement of HL7's testimony that was, right up front, very clear to say, don't confuse the DSMO MOU process with the fast track process, and I think a lot of people have been doing that.
Take into consideration that if folks are saying that the fast track process, for example, runs counter to the MOU, remember, that process wasn't what we set forth to do in the MOU.
It was some flavor of that because we had to come up with something, so we modeled it on the existing process, but definitely don't confuse the two.
What we don't want is the industry saying this MOU and this DSMO process doesn't work. It is not fair to say that and we need to keep fast track in the context of fast track and not apply that to the others.
Then lastly, this is probably more than anything just a personal observation, the number one down at the bottom under sort of the category of recommendations to improve the process, really starts to talk about, it seems as though all the rules for administrative simplification should be finalized before implementation.
I don't really see that that has anything to do with the DSMO process. I think that that might be an expression of how people in the industry feel, but I am not sure that there is the tie in to the DSMO process, talking about issuing all the rules at the same time.
DR. COHN: That will be the next session, I think. I was actually going to give everybody a break, but would you like to make a comment?
DR. MC DONALD: It is on this subject, and there are a couple of things. One of them is that originally, from the last testimony, I had the impression that the fast track was almost solely dedicated to getting rid of stuff.
I may have just hallucinated at the last testimony, but that was still my impression, that it was an attempt to make it simpler in this first past and more like the old one. Maybe I was wrong about that.
The second thing is, if one adds things or takes things off there may be a need for anyone to be able to complain.
If the person asks for something and didn't get it, then they are the only ones that complain. If someone asked for something and did get it, then everyone else can complain.
It seems like we may be leaving out a complainant in the process, unless I am misunderstanding it.
MS. WEIKER: We have plenty of complainants.
DR. MC DONALD: Is it true, though, that Joe Blow who didn't ask for it, and now it is changed, can't appeal a change?
MS. WEIKER: At this point, only the requester or a collaborating organization can appeal. The MOU was written specifically that way.
Let's say that Joe Blow is sitting out in Timbuctu and was counting on that data element and now, all of a sudden, it has been removed.
DR. MC DONALD: Let me rephrase that. I can see that, if someone asked for something extra, or asked for a change, and didn't get it, that is the only person who could complain. That seems fair.
If someone asked for a change and got it, then other people could get to complain, because they may not want it.
MS. WEIKER: That would be done in the NPRM process, and I think it would also be done before that, because the expectation is that when each of these six DMSOs, representing everybody who is a member of it, et cetera, when we come and we have that conversation about do it or don't, the intent is that we are bringing our constituent's position to that discussion. The idea is that you are representing a whole lot of people, not just the requester.
DR. MC DONALD: Since there will be an NPRM, and there wasn't in my original concept of it. The third thing, regarding the Medicaid, at least off line, there is an activity underway to try to figure out Medicaid, some of the data -- I don't want to say this wrong -- but as a sort of attachment, or whatever. Am I saying that wrong?
MS. WEIKER: Yes, a little bit. The Medicaid group is presenting specific attachment needs to HL7 to say, for this kind of attachment, we would like a standard. They are very active in doing that right now.
DR. MC DONALD: Never mind.
DR. COHN: I would actually like to complete this panel. I actually wanted to thank you all. We are going to break now for 10 minutes. We are running late.
I do want to warn the subcommittee that they should plan that we will be here after 5:00 and others can join us, if they would like to, for the discussion.
I want to thank everyone. I think as we have looked at the process, I actually want to thank, again, the DSMOs for being willing to take on this fast track.
I know it was not perfect, but my own view, as I have listened to the testimony, is that most of the problems that we are seeing and sort of debugging would be common to almost any first-time process.
In a sense, we probably put it under a little pressure, but I am not hearing that it is a whole lot different than if we had taken a whole year to do this one.
Instead, now, we are in late May or early June with the knowledge that otherwise it would have been into January or February of next year that we would be reflecting on, well, next time we will do it better.
I think you should congratulate yourselves. It has been a wonderful activity. We obviously need to move forward and figure out what it is we need to do in terms of advising the Secretary.
So, thank you. We will take a 10-minute break and then move on to our last panel.
[Brief recess.]
DR. COHN: I want to get started on our final panel. I first of all want to thank all of our panelists for joining us.
I know some of you sat through the conversations today and have hopefully found it interesting. Others, I know, have just arrived.
The topics that we are going to be talking about over the next while and we are interested in your guidance about has to do with, first of all, the DSMO process and results.
For those of you who know about that, we obviously look forward to whatever comments about that, that you can provide us.
On a larger level, we are also interested in the overall implementation of readiness of the transactions, specifically, the financial and administrative transactions and finally, any comments you might have about general readiness issues, recognizing that it is our responsibility to try to advise the Secretary on how best to have a successful or early implementation of the HIPAA regs.
With that, Tom Gilligan, if you would like to start with your comments?
MR. GILLIGAN: Good morning. I am Tom Gilligan. I represent the Association for Electronic Health Care Transactions, and I would like to thank the national committee for the opportunity to be with you today.
The Association for Electronic Health Care Transactions -- AFEHCT -- is an industry action group that focuses on federal health care legislation, particularly HIPAA and administrative simplification.
Member companies all are actively involved in the electronic transmission processing and maintenance of the financial and administrative transactions such as those listed in the 1173 A-2 of the Social Security Act.
All these companies are also actively involved in other electronic health care activities. In essence, these companies provide the EDI, e-commerce, internet infrastructure to the health care industry.
AFEHCT member companies fully support administrative simplification provisions, all of them including the privacy reg as is.
We were strongly involved in the legislation from its genesis through its enactment. We are firmly committed.
What I would like to do today is offer some perspectives on the overall readiness, provide some examples of the magnitude of savings, discuss the legislative proposals, S-836 and HR-1975, and basically go from there and, at the end, offer some thoughts about how to deal with this situation.
What I have done in the written material before you is to offer some parenthetics or praecies of readiness studies that have been done in the past -- since the beginning of the year anyway.
The first one is the Tillinghast-Towers Perrin study commissioned by Blue Cross, that claims that, as of November, a couple of weeks after the regs became effective, that virtually no hospitals had carefully prepared or considered the implications of HIPAA.
However, a study released by Moody's in March, indicated that a majority of providers were ahead of the curve and had minimum adequate budget plans in place and Moody's study was done on hospitals with publicly rated bonds.
Phoenix Health System has done a study in the last two weeks of April. There are the statistics there. They are more encouraging.
On May 2nd, the Gartner Group performed a study. The results offered were encouraging and discouraging. At that point in time, they were saying that health care organizations remained far behind in preparing for HIPAA.
They concluded that unless health care organizations substantially boost their compliance, most will fair to meet the October deadline.
On May 9, the AHA News reported some more encouraging news, that nearly 60 percent of all the hospitals responding said they were increasingly ready to meet the deadlines.
Of all of the studies done, only the Gartner study was done using a statistically valid, ratified, random sample of providers.
Gartner paints the bleakest picture of provider readiness. However, Gartner executives recommended that only an effective one-year delay, not necessarily a change in the dates, but an effective one-year delay could be achieved through flexibility in enforcement.
The health care community has exhibited a wait and see approach through much of the HIPAA experience. Gartner associates that with a clause in the preamble to the final rule, which says that if the privacy regs went out within a specific period of time, that perhaps the department would pull a regulation.
I think the Blue Cross Blue Shield may have created a somewhat self-fulfilling prophecy, as many health care providers were waiting and seeing if the Blue Cross campaign was successful before committing resources to becoming compliant with the transaction standards.
Vendors are going to be ready. We maintain that some of the clearinghouses are ready now to support the transactions such as claims and remittance advice that are part of their core business.
This contention is corroborated by the Phoenix Health System study. The last remark there was, all clearinghouse respondents indicated their firm would be ready to transmit all HIPAA compliant transactions within 12 to 18 months before the transaction compliance deadline.
There are savings, a little bit about savings. I have included some slides at the back of the presentation here from Allina Health Systems and the New England Health Care EDI Network, and Care Tech Solutions, made a presentation at a recent TEPR meeting that was held in Boston about savings to be achieved in the state of Michigan. They are all rather substantial and the savings is impressive.
With respect to the legislative proposals, Blue Cross Blue Shield Association has been a prime mover for these proposals.
Given the Blue's history of support for administrative simplification, many of the people in the health care community are puzzled as to why the Blues are promoting proposals to delay the implementation of administrative simplification so forcefully.
Just to cover a few points of that history, Barney Tesnowski, the then-president of the Blue Cross Blue Shield Association, had co-chaired the original WEDI effort in 1992 and then 1993 and the WEDI reports of 1992 and 1993 bear his imprimatur.
The Blue Cross Association participated in the working group that met on a regular basis here in D.C. that worked with Senator Bond and Congressman Hobson and Sawyer, that helped to shape the original legislation.
The association has played a very strong role in the private sector ANSE process that has developed the standards later to be adopted by the Secretary.
In their response to the post-transaction standards rule, this quote appears in their response: The Confederation of Blue Cross and Blue Shield plans support the various implementation provisions and time tables set forth in the NPRM.
Lastly, the Blue Cross Association initiated the WEDI SNIP effort, which is basically providing a coordination to identify problems associated with implementing the transaction standards and providing a coordinated consensus effort in arriving at solutions to those problems.
However, about the time the transaction standards were published as a final rule in August of 2000, the association decided to seek a delay in the implementation date of HIPAA. The Tillinghast-Towers Perrin paper doesn't shed any light on why the Blues were seeking this delay.
I have laid out for you the operating paragraph of S836, which is the proposal to delay that is in the Senate. It basically says that they want to delay the beginning of implementation until 24 months after the date on which the Secretary determines that all the standards are out minus the standard for the unique patient identifier minus the privacy standard and the regulations for enforcement are in final form and the plan identifier and the other identifiers are ready and available.
My sense is that, I have read also HR1975. The language is not identical, but the intent and the effect are.
AFEHCT opposes tying all the regs together. Proponents of this proposal say they need to see everything before they need to comply with it, in the one package, so they don't have to perform multiple systems upgrades.
You know, this proposal makes a lot of sense if you are operating in a vacuum. However, providers and payers will have to implement the transactions and other administrative simplification standards, in an environment of constant change.
Medicare is about to change its prospective payment system. That is going to require some changes to the hospital systems.
HHS will modify the transaction standards later this year. There will be changes to the implementation guides and also, during this same period of time, state programs, the states will legislate changes in security and privacy laws. It will also have an effect on this.
Even administrative simplification, the statute itself, provides for changes taking place on a rather frequent basis.
At no time within this environment that we are going to implement HIPAA will there ever be a time that you will have all the data that you would like to have sitting in front of you as a package that you can assess and say, okay, now I have however many months to implement this in one shot. It is just not going to happen.
I want to separate my characterization of the proposal as being insidious from the people who are offering it.
It is insidious because it is so attractive, but it is an all or nothing approach. If we don't get all the regs out, if we can't come to agreement on the attachments proposal, if somebody wants to argue about the security final rule, if somebody wants to take issue with the enforcement standards, the enforcement rules -- and it is my understanding that people have not yet put them to paper, writing those rules -- that the department's efforts to get all the remaining rules out in perhaps two, three, four or more years down the line with a two-year additional implementation period behind that, at that point in time, the current standards are going to be stale, and my gut feeling is that, at that point in time, this is effectively killing administrative simplification.
My sense of the situation is, if you believe administrative simplification is a good thing, then we need to go and set the standards on a staggered basis, as it is.
Some things to keep in mind is, nothing dire is going to happen in late October when the deadline comes and goes.
A swarm of federal agents, HIPAA agents, is not going to go out across America looking for people who are not in compliance. There are no monies in HIPAA to authorize that. In all likelihood, the transactions final rules will not be published by then. So, nothing is going to happen.
MR. BLAIR: I thought there was a special swarming provision in the law.
MR. GILLIGAN: In terms of talking to the folks up on Capitol Hill now, there is not a consensus yet, but there is sort of a sensitivity that people are not going to be able to make the October deadline.
Compromise is probably going to happen. That is how we arrive at an equitable compromise.
With respect to the timing of compliance, I think we need to create sort of a soft landing approach. We need to not penalize those who have kept faith by deploying resources to implement HIPAA. We need to give the wait and seers an opportunity to comply. We need to also be flexible enough that if somebody wants to do more than just comply and wants to leverage their system, lever their remediation to really upgrade their system, we ought to be sensitive to that, too.
I think the operative words are good faith effort or, as they appear in section 1176, reasonable cause and not to willful neglect.
I think that kind of a flexibility could be achieved by changing one word. Instead of the Secretary shall impose a penalty, the Secretary may impose a penalty. If somebody doesn't want to give that an open ended deadline, we could put in a time frame of, let's say, 18 months after the deadline the Secretary can exercise his judgement on the imposition of penalties.
I think we are going to have to be sensitive to other aspects that may need to go into this compromise. I don't think they necessarily have to do with deadlines as much as they have to do with, how do you treat specific subject matter and resolve problems that are out there. I think that concludes my remarks.
DR. COHN: Tom, thank you very much. Harry Reynolds from Blue Cross Blue Shield.
MR. REYNOLDS: First, I want to thank the committee for inviting me to the Tom Gilligan roast. I appreciate the order that you so nicely selected.
I do want to thank you for this morning. I have been running the efforts of the North Carolina plan for the last two years on HIPAA.
I have co-chaired the NCHICA process in North Carolina, which all of you have touted as a national leader. Also, I have been with the Blues 24 years. I started EDI of North Carolina and have run a major business unit within a plan as well as LOIS.
I am totally comfortable to go to whatever length anybody wants to go, as to the readiness of anybody in or out of our environment.
I have met with most of our key vendors. We have most of our key players at the table at our NCHICA meetings on a regular basis.
My comments will be threefold. They will be related to the Blue Cross stance as a group, as they are related to Tom's comments on our legislation. They will be discussed as Blue Cross of North Carolina, which is coordinating very closely with the entire North Carolina environment and NCHICA, which as people have mentioned things, NCHICA is out there helping them coordinate how things should be done within a state.
MR. BLAIR: Just one thing. Harry, as somebody whose background tends to be from the provider side, as you go through -- and you are kind of doing it right now -- could I ask you to continue doing that as you go through?
The letter that Tom Gilligan commented on, that appeared to me to represent the views of the Blue Cross Blue Shield Association of America, if I am not mistaken, and I understand there are many other Blue Cross Blue Shield entities and associations.
For my benefit, and maybe for others on the committee, could you clarify when your comments represent Blue Cross Blue Shield Association of America versus other Blue Cross Blue Shield entities.
MR. REYNOLDS: In my text, they are clearly identified. However, due to some of Tom's comments, I have added some things, so that I cover some things that are put out there.
MR. BLAIR: Great.
MR. REYNOLDS: I am vice president of Blue Cross of North Carolina, HIPAA oversight officer. I am speaking on behalf of Blue Cross and Blue Shield of North Carolina and Blue Cross and Blue Shield Association. I am not speaking on behalf of NCHICA. Although I am co-chair, Holby Anderson is the executive vice president of NCHICA. I can talk about our efforts, but I am not speaking for NCHICA.
Blue Cross Association represents 45 independent Blue Cross and Blue Shield plans throughout the nation that provide health coverage to 80 million, or one in four, Americans.
Our plans have been leaders in the use of electronic data interchange transactions in both our roles as private insurers and government contractors.
Over the last 24 years, Blue Cross of North Carolina has instituted electronic transaction standards that have resulted in 90 percent automation of hospital plans, 67 percent of our physician claims, including cross overs from Medicare Part B and others.
Blue Cross and Blue Shield of North Carolina plans nationwide have a similar percentage of claims automation. So, we truly understand the whole idea of simplification.
We are automated. We cannot afford to go to paper. It would not be a situation we could deal with.
In August of 2000, the Department of Health and Human Services finalized the first in a series of regulations implementing administrative simplification, provisions for HIPAA.
We met the portability requirements immediately and as needed, as we do for all the requirements. Being a government contractor, none of us in the Blues are new to the whole government process and what it means to deal with the government and their continuing changes.
These rules set out complex technical requirements to standardize electronic transactions, and virtually all codes used by providers, health plans and drug stores by October of 2002.
It also increased the already significant activity for those of us affected. As you heard, we have been at it 24 months in NCHICO alone. So, I somewhat disagree very much with the attitude that anybody has been taking, at least in the environments that we are familiar with.
The Blues held a session with over 300 attendees in early March, going through all the details of HIPAA. When you look at the hotels and add everything up, you are probably looking at over $500,000. If that is waiting, we are going to wait a little more. We are going to continue to spend the money we need to.
One thing I would like you to remember about today is, as you think about it as a committee, and those of you who were here for most of the day, you heard a lot of activity and you heard a lot of people working very hard.
One thing you heard consistently was volunteer. We are driving a health industry with volunteers. They are doing a wonderful job, but that is not the normal regulation process that you have seen.
If you don't remember anything else but Dave's face when he walked out of here, right, wrong or indifferent, whether he agreed or disagreed with the opinions that went about it, he now has to go back to the entities that he met with, and they have to figure out from a business standpoint what they have to do with the answers.
That is the one piece that continually gets missed in this. It is not the answer. It is what we have to do with the answer.
Nobody wants to listen to that or talk about that to any of us. Whatever those things that they requested that they felt would help things become simpler, you have to go back and work on them.
We have to all work on them, for example, in North Carolina with 15,000 providers. We all have to work on them. Otherwise, we don't get there together.
The Blue Cross Association and Blue Cross of North Carolina have long supported simplifying. I have already covered that.
It is important to fully appreciate the scope of the work ahead of us. HIPAA touches every aspect of our business and every partner with which we trade.
Nationally, there are 2.6 million health plans, 5,134 hospitals, 701,000 physicians, 353,000 other providers, and employers required to implement these changes if we want to transfer data electronically.
Take that number and multiply it by eight transactions, and now you start getting your states of readiness that you are dealing with as you take care of it.
In addition, the new rules call for elimination of all local codes. I would like you to look at the first attachment that I have in my package. If you look down the numbers on the right hand side, I was in a plan meeting the other day talking about HIPAA implementation, and the issue of that is, if you just look down the non-standard codes, it is really immaterial what you decide.
It is really immaterial whether we get those put in national codes or not. It is the fact that we get an answer. It is the fact of whether we can or can't cross walk it, whether we are using a clearinghouse or whatever, and then what does that mean to the business rules that those local codes included.
Remember, all of us that set up local codes, it was more than likely that it was because there was not a national code that met that, especially if you look at the home health agencies.
We are anxious to get rid of the non-standard codes because we are using 30,000 standard codes if you look at the center. We are very excited about that.
In our case, when you have the Dukes and the University of North Carolinas and others doing different things on a continuing basis, to continue to take care of the customers we have in North Carolina, and the health industry situations that are going on, we have to continually deal with things that are outside the norm, and we have to do that in a way that makes everybody satisfied.
So, we are very anxious. I am very excited about the DSMO process, because the DSMO, in my opinion, will get all of these or some portion of these, and I am sure, as you heard this testimony earlier, Medicaid is dealing with the same thing.
So, DSMO needs to get more volunteers and they need to get readier, because it is going to come and it is going to come hard. I won't spend any more time on those codes.
Every day we uncover more and more issues which need to be addressed. If you look at exhibit B, again, this is just individual things. I am not making these out to be paramount situations, but they are situations, for those of us who are truly doing this project, it is the reality of our daily lives.
If you look at where it talks about, on the left-hand side, the HIPAA code values or the employee status, if you look at the right-hand side, our customers want four levels of status four retirees.
Especially as you think of the unions that deal a lot in certain things for salary and certain things for hourly and so on, these are the things that you will really start seeing hit more and more in the DSMO process.
When we get an answer, we can do business. When we get an answer and have it clearly defined, then I will be more than happy to go out to the customers in North Carolina and make it clear to them, they will have one level of retiree or multiple levels, or somebody will teach us better what fields we could use in that 834 that will allow us to manufacture this.
This is from our customers. So, a lot of people couldn't get over the idea that this is the health care fight.
The GMs, the Fords, the University of North Carolina, the people that are covering their employees, want this thing.
We are going to have to figure a way to do them. We are going to have to figure a way to let them cover their people the way they want to. That is not a situation that has to do with ANSE or anything else. That has to do with the reality of people trying to figure ways to offer health care to their employees, which is a huge situation that continues to grow.
At Blue Cross, we realize that successful HIPAA alignment, in concert with all of our other partners including physicians, hospitals, other payers and suppliers of software and services, and we hope that AFEHCT steps up even more in the NCHICA effort, that is why we co-founded the NCHICA situation.
Myself and Dave Kirby from Duke are the co-chairs of that, and we have six subcommittees right now that are going through everything that was covered here today, the transaction code sets, the privacy, the security.
So, if anybody thinks they are going slow in North Carolina, I will tell you exactly when the meeting is, and you can come down and have a break.
HIPAA is an unusually complicated issue and there are no simple answers. Blue Cross Blue Shield of North Carolina conducts business with over 15,000 entities in North Carolina.
Our business partners and we have struggled with the current piecemeal approach to implementing HIPAA. You are absolutely right. Some people have waited. That is absolutely a fact.
I can tell you right now, there are still people waiting, and we are struggling as NCHICA and we are struggling as Blue Cross of North Carolina, and we are struggling as a Blue Cross system to get them going.
You all know who they are and you all know what that means. I am not going to spend a lot of time on it.
Regulations have been released slowly and independently. HIPAA will become people's business plan. Anybody in any sector has a problem when there is a government regulation the size of this one.
The end result, if people continue to wait and we continue to keep this date, it could be chaos and reduce quality of health care administration.
I love some of the comments that I have heard people make about that the Blues don't want to pay, that one of the reasons we don't want more automation is that we don't want to pay.
Most every Blue now uses a pharmacy benefits management company, which means you walk into the pharmacy, you hand them your card, you pay your co-pay and we immediately get the charge.
Fifteen years ago -- and having been with Blues 25, I can say this -- 15 years ago, you are absolutely right, but those are old, old comments. Those are not about the way we do business today.
Those are the kinds of things that, if we are going to argue, let's argue on today's standards. If we are going to argue, let's argue on today's business practices.
Also, in North Carolina, we have a prompt pay legislation that is going into effect, that is going to put significant penalty on us if we don't pay faster.
One of the things we are actually trying to do with that legislation is, we are trying to add to that legislation, put the prompt payment on HIPAA, ready transactions.
I don't want a prompt payment on crappy paper and I don't want it on the old format. Put it on HIPAA. Now, if that is not supporting HIPAA, I don't know what is.
Rush to implementation, I have already talked enough about that. Compliance costs, let's say, as I go through, we talked about the Towers-Perrin and there has been a lot of written and verbal banter about that.
Let's take the hospital costs of $775,000. I was reading an article in the Raleigh paper the other day. Eleven hospitals in North Carolina will go out of business this year.
I don't care if it is $25,000. If you know your rural hospitals of your state and of your country, because of the balance budget act that HCFA enacted on them, their margin is gone.
Their ability to generate revenue to do large projects is very limited. Come to the NCHICA meetings and they will tell you.
Those are the things that we are facing as far as people we are dealing with. In addition, the Medicaid was spoken enough about, and I would rather not spend a lot of time going into that.
For health plans, it was estimated about a million dollars. That was grossly underestimated. We spent $750,000 last year, and I have got an approved budget through our board of $6 million this year, and I am well into it.
To give you an example, I will be writing a check tomorrow, which this morning's issue, I don't know what to do with it. Honest to God, I don't.
I have contracted for $90,000 worth of education on the transactions which will start June 15. That is the nine transactions. They will be videotaped.
One of the things we are doing in North Carolina is, we have met with the vendor. That vendor does not market to small hospitals or providers, because of the cost of their services.
We will donate that education through NCHICA. That education, the videotape of all that education on all the transactions and all the code sets will be given to the small providers for their use.
Now, we know what cooperation is. We know all the things, and the DSMO and everything is going on. That is what we are doing.
We are not slowing down. I don't care what is in the legislature or what is talked about. We have got to go until there is some reason put behind some of this stuff that allows us to continue in an appropriate way.
Unfortunately, a lot of providers and health plans are unaware of the sizeable costs associated with administrative simplification and have failed to adequately budget.
I made a presentation to the North Carolina Hospital Association in which there were 73 hospitals in attendance.
I asked how many had a budget in 2001. One hand went up. I asked the question again, assuming they didn't understand. One hand went up.
These were small hospitals, but a lot of the small rural providers in this country are not awake, and the doctors are also in that situation.
Now, we can talk in here all we want to. Seventy-two out of 73 that don't have a budget for this year, that is a sit back and wait.
It doesn't matter what anybody says, they are not going to be ready for October of next year, and we don't want to run those systems into a process.
Band aid solutions exacerbate costs. I mentioned in here that one of our plans is spending over $60 million worth of wrap-around.
I can tell you, our legacy system -- and we have said this publicly -- our legacy system right now cannot take the 837 and map it to the 835. It brings in 10 line items, it cuts it to six, and gives six out of the back end. For every payment we have made over the last 15 years, we will be retiring that system, and moving to our new system.
Our new vendor is going to take 90,000 programming hours -- just programming hours -- to change that system and that software will be available next April.
When the vendors say they are ready, ask them what ready means and ask them when they can truly deliver and what testing has been done.
In addition, the health care industry has undergone massive consolidation in the last five years. To deal with one of Tom's comments about why the Blue's haven't changed, the Blues have changed.
Any of you that knew a CEO of the blues 10 years ago, tell me they are still a CEO of the Blues right now, other than Ed Sellers in South Carolina. There aren't many more. Tell me there are executive staffs that are the same. Tell me there are systems that are the same. They have changed dramatically.
What Barney started is not what came out in the law. What Barney started is not what the Blues are now, whether it is systems, processes, and the same with all the hospitals.
If organizations were given more time, they could spend the money smarter. This equates to premium dollar savings for health plan customers and tax payer savings from public programs.
I truly don't believe that providers are going to be ready by 2002. I absolutely don't believe it. I can absolutely say that for North Carolina.
We may have a handful, but most of them have no chance. That is one of the reasons we are donating a lot of this training to the small providers.
We want them to understand. We want them to do it and we want them to get quality education, not just somebody coming in the door, knocking on the door, asking them for $10,000 apiece and saying, let's go.
In addition to cost, many providers are unaware of the significant new data requirements. You have heard enough about that today, those of you who have been here.
There are significant new data elements and the young lady that just spoke a bit ago, that it was 150 and it went to 1,054, but let's say it is between the 580 and the 1,054, that is still a dramatic amount of information that needs to be dealt with.
Success depends on universal compliance. We all have to get there together. That is why we started NCHICA. That is why the Blues are working together. That is why we are trying to deal with the AMAs. We all have to be there.
This is not something that you get an award for being ready, running dual systems, handling dual processes. If you think about it, let's take the manual process for a second.
You are going to force me to run one system that takes in paper with old codes, old identifiers and old fields and process those, if the provider wants to. That is a continual reminder, they don't have to go to electric.
You are going to require me to be compliant electronically. That is two different sets of codes, two different sets of identifiers. That is bizarre. Make the paper and the electronic the same, if you want to simplify it, the last time I checked.
I would love the same identifier, I would love the same fields, I would love the same information.
Vendor products, I have personally met with -- we have 285 vendors that we use. Two hundred of them will be affected by HIPAA.
I have picked the top 15. I have met with 12 of the 15. They are not ready. They can give me the plan for their plan. They are not ready.
I commend Tom and some of the clearinghouses, but I don't commend most of the people that we are dealing with that are national vendors that are not there.
Staggered release, I have already talked about that. Support for the extension is broad based. I take Tom's words, that it was pushed by the association. Well, maybe we were the ones that understood it, the fastest, the best and the over-reaching. Sometimes if you are first in line, you get shot at. That is fine.
I think you can see by the list here, of the people that are behind this, it is no a ploy to kill administrative simplification. It is a ploy to make sure we don't blow up the health care industry and put ourselves in a position where we weren't going to end up.
In conclusion, the association and North Carolina strongly support administrative simplification and are dedicated to its implementation.
I will spend the $6 million regardless of the decisions this year. I don't like to go to my board for $6 million where, if this bill passes, they are going to wonder why I spent quite that much.
On the other hand, I have already explained to them that, no matter what happens, we need to spend the $6 million, because we have got to know. We have got to know clearly and we have got to know that our vendors are ready and everything else, and then we have an orderly thing.
Take our 15,000 people we work with. If you just gave me 12 months to implement those, that is 1,000 people converting everything you heard this morning a month, 50 a day. That is big.
There are a lot of plans that have a lot more providers and deals than we do, but that is big, when you start adding it up.
I thank you. We look forward to any questions that come up and continued debate over what is the right approach.
I don't envy you, but more important, I don't envy us, after you decide that we have to do it. So, thank you very much.
DR. COHN: Thank you very much. Robert Tennant, MGMA. Thank you for coming.
MR. TENNANT: First of all, thank you very much, Mr. Chairman, and thank the subcommittee for inviting MGMA to speak here today.
My name is Robert Tennant. I am the government affairs manager for MGMA. I am one of these volunteers that we have been hearing so much about.
I serve on the WEDI board, the NUCC board, and I co-chair, along with Chris Stallaker and Larry Watkins, WEDI's strategic national implementation process. They are known as SNIP.
We are obviously very pleased to testify. Obviously this is a critical issue in health care today and this hearing couldn't be more timely in light of the recent legislative activity and its potential impact on HIPAA implementation.
In my testimony today, I will focus on general readiness issues revolving, of course, around the transaction code set standards.
Of critical importance, of course, is the issue of setting the time table for implementation of the transaction and code sets.
Well, 24 months for implementation of this rule seems like an ample time. For those medical practices that have limited resources or for those who have yet to begin testing their electronic claims system, there is probably not sufficient time to be ready for October 2002.
Therefore, MGMA supports a compliance extension of a minimum of 12 months. One of the reasons why MGMA supports additional time for implementation is that there has been a great level of uncertainty in the private community regarding when these regulations will be finalized and when group practices will be required to submit HIPAA compliant electronic claims.
As we have heard, many medical practice administrators have adopted a wait and see attitude, not confident that they should be moving forward with adopting the HIPAA standards.
We are also very concerned that there is little incentive for group practices to expeditiously upgrade their billing and patient records software to comply with the new standards, since a health plan can refuse to accept and adjudicate a claim submitted using the standard format until the compliance date.
MGMA is encouraging health plans to enter into trading partner agreements with their provider clients, establishing testing schedules and timetables for when health plans will be able to begin accepting these standard claims.
While MGMA supports providing additional time for compliance, it is our contention that a delay with no fixed compliance date is counterproductive to the overall goal of administrative simplification.
Anticipating, like so many others, that HIPAA regulations would be released promptly and as a package, MGMA believed compliance for all the administrative simplification standards should not be required until all the final rules had been published.
However, things have changed. It is now quite apparent that the rules will be released in a staggered manner.
We suggest that the industry should look at it in terms of four stages. Stage one would have the transaction and code set standards fully implemented by October 2003, thus, allowing an additional year for covered entities to prepare their systems.
Stage two would be the identifiers two years after each of the final rules.
We also believe a third stage should be the coordination of privacy and security. We do not believe that you can have privacy without security, and we believe that the two should be synchronized.
The final implementation stage would sort of be a clean-up stage for all of those outstanding provisions such as claim attachments, potentially for support of injury, enforcement, rather than wait around for these to be finalized. There is no need to wait for all of the rules until those are published.
As Tom alluded to earlier, the nature of the standards developing process dictates that there is never a fixed starting line, when all standards are in place and static for a lengthy period of time.
We also believe it is not necessary for the standards to be static in order to upgrade practice management systems to handle the HIPAA standards.
The standards can be successfully implemented in a staggered fashion. In addition, we believe that a substantial delay in the implementation of HIPAA would delay the many benefits of HIPAA stemming from the transaction standard.
It is important to remember that the transaction standard is more than just claims. Obviously, that is going to save practices considerable time and resources, but also we have to think about automated remittance, advice, standardized referral and, of course, health plan eligibility verification.
As well, the move toward standardization in general will also provide benefits far in excess of what was anticipated in the 1996 legislation.
HIPAA is clearly the first step toward a comprehensive reconstruction of the administration of health care, obviously a critical pathway to reduced cost and improved patient care.
Finally, I would like to raise what we believe are three critical implementation concerns for group practices. Obviously, cost to transition to the new standards is going to be an issue for group practices.
It is going to vary from group practice to group practice depending on their complexity, on how far they have moved toward e health, and on what standards they decide to adopt.
That is an important issue because a lot of group practices have already begun the process of migrating to the new 837 and 835 standards.
They are finding that those are the ones that are providing the most efficiency, cost savings. There is absolutely no reason to delay moving in that direction.
We are also concerned -- and Catherine did an excellent job of discussing the HCFA 1500 form. There is a concern that the paper forms haven't kept up with the electronic forms.
The NUCC has been looking at standardizing the HCFA 1500 form, by mapping the 837 data elements. We have not been successful yet in coming up with a prototype that everyone is happy with.
As we have seen, there are some cross walks, but there is still a concern in the provider community that their paper forms will not match their electronic forms and that, again, produces more burdens.
Finally -- and I am greatly encouraged from Tom's suggestion that there will not be a swarm of agents come down on group practice administrators -- we are concerned that there will be fines levied before the industry is really ready.
We are concerned that testing will not have taken place and we are concerned, of course, about the potential fines.
In conclusion, MGMA is highly supportive of the development and use of national standards in the health care industry.
We are confident that HIPAA is going to be a tremendous asset to group practices, lowering administrative costs. However, there are clearly a lot of problems -- we have talked about the DSMO process -- but these can be solved and our belief is that we need to move forward as quickly as possible with the standardization.
DR. COHN: Robert, thank you very much. Don Moran?
MR. MORAN: Thank you very much. My appearance today is in an odd guise, in that I don't have a prepared statement to submit to you because I don't have an opinion on the matters before you officially, because I am not an organization.
I am a consultant who, over the past 15 years, has probably had relationships on all six sides of this particular Mexican border dispute.
In today's guise, I am here as a consultant to AFEHCT, and I am working with them on a white paper to help policy makers potentially sort out some of the complexities here.
In that spirit, rather than giving you a lot of detailed position stuff, I thought it might be useful to try to make three or four points that we will be trying to provide, because ultimately these are the issues that policy makers are going to have to be grappling with.
First, I guess I would start by taking off on a point that Harry made a moment ago. It is impossible to judge readiness until you have a standard by which readiness can be judged.
When we deal with matters of complex claims transaction transmission, adjudication processes, there are no really meaningful standards to say, when is the world ready.
Now, in Y 2K, we had a special case because we had a particular date and either the lights were on or the lights were off when the clock struck midnight and we knew readiness when we saw it. Parenthetically, we didn't know it until then.
In this particular case, I guess I would suggest to you one observation, and to make that observation, I have to posit a standard.
Let's suppose we were to erect a standard which said, we would like to find a point in time when 75 percent of the organizations, as organizations, were subject to these regulations, would be sufficiently compliant with the regulations such that they would properly adjudicate about 95 percent of the dollar value of all the claims passed in between them.
I guess I would assert to you that, no matter what the standards are, and no matter what date you set, whether now or whenever in this next thousand years, that you will achieve that standard of readiness and compliance probably two to three years after the final implementation date for whatever regulations are actually put in place.
Simply the whole process of bringing something up and debugging it really can't be finalized and completed until it is applied, and there is really no way in which the great majority of entities, particularly some of the smaller entities to which Harry referred, are really going to be ready until the acid test is met, which in this business is where money changes hands as a result of the accuracy of the determinations made.
One of the challenges you will face in advising the Secretary and the administration on all of this is that readiness, defined in some hard and firm way, is impossible to achieve prospectively.
As a result of that, you are going to have to balance out the immediate compliance plus the prospect of front end crashes with the prospect of doing the whole schmeer endlessly the farther back you bow into it.
The second point I will make here, I think this is more of a policy observation than a technical observation, although it has some technical implications, again, as Harry said, I don't mean to be picking on you, but I think the Blue Cross and Blue Shield position represents probably the height of all the complexities of all of this.
Many of the reasons why this whole set of issues is both promising and difficult is not because of the EDI transaction interfaces and what it takes to make all of those compliant and having people passing the standard claims back and forth.
Both the promise and the challenge lies in the business processes that sit behind that. The reference was made a moment ago to the fact that the character of customer contracts in particular are a major impediment to working into a standardized world, simply because, in the world of operational benefits management, most of this is RFP business, where at least the marketing side of the house explains to the operational side of the house why the customer is always right and they get whatever they want.
Now, in the particular reference, we heard passage to Ford and GM, and I happen to have worked in and around that environment a fair amount.
I guess I will suggest to you that most of the details that we are discussing here that are down to the level of code sets are actually embedded in the triennial collective bargaining agreements between the United Auto Workers and the three large manufacturers, and implemented nationwide.
I just observe to you that the next round of that is, in my rough recollection, up to 2002. So, what they will negotiate for and what they will ask Blue Cross and Blue Shield of Michigan, their national control, to implement will be determined by whatever the live requirements are on the ground during the calendar year 2002.
What people will say yes to or no to is not the prospect that some new standard may loom on the horizon 18 months from now, but will come live with the fact of whatever the law is at that point in time, as implemented in regulation, will be what the customers will ask for and what the marketing side of the house will tell you to deliver.
If anything, I am trying to explain the complexity of the Blue Cross and Blue Shield position in this world, simply because, as long as these things are uncertain, it is correct that you are going to have tremendous cross pressures.
The only way you are going to get through uncertainty is some finality, at least as to some pieces of all of this.
I guess the third thing I would say in conclusion to all of that is, given that combination of those two states of affairs, I am tremendously sympathetic to the fact that policy makers may well have underestimated many of the implications of what administrative simplification is all about.
I guess I would say to you, having spent many years in and around the policy environment, both on this side of the mall and up on the other side of the Hill, is that if you really wanted to build a kind of retrospective legislative history of administrative simplification, you are going to face a very serious challenge.
Many of the things that policy makers are really concerned about in the worlds of operations to go things like, what do you mean you are getting rid of local codes? I have just spent the last four years, on the behalf of all the device manufacturers in my district, trying to ram their various products through the carriers and local codes are the only way I have to do that.
There are a thousand different stories there. At the end of the day, what we may discover is that the best arguments for an indeterminant delay in many of these things are really arguments for repeal, rather than arguments for delay in and of themselves.
It is possible to make the case that the business practice implications of much of this is so substantial as to cause people to call into question what it is we are all about here.
If that is, in fact, the case, then we ought to look at it objectively and cleanly and understand that if there really are substantive areas into which administrative simplification is now, or will, intrude, that ultimately run counter to what the interested policy makers think there is in all of this stuff, that maybe we ought to sort that out, cut that cleanly, and decide how much administrative simplification we can have.
At the end of the day, I think one part of the statement that I inferred from the Blue Cross and Blue Shield position is actually correct. There is no such thing as partial standardization.
Until we can get to the point where we can get this whole thing so that we can understand that we are moving forward to do something together, we aren't going to do much of anything in concert, and that is going to be a major challenge. Thank you.
DR. COHN: Thank you. Sally Klein?
MS. KLEIN: Good afternoon again. We are pleased to have the opportunity to participate in this discussion of HIPAA readiness for the implementation of the administrative simplification title of the Health Insurance Portability and Accountability Act.
It will have significant impact on state human service programs, especially Medicaid. While we are looking forward to a standardized, HIPAA compliant world, there are grave concerns in the public and private sectors that the current time frame for implementation is insufficient, particularly in light of the fact that not all of the regulations have been finalized.
While state Medicaid agencies are working diligently and moving toward HIPAA compliance, it is a time-consuming and resource-intensive process.
I would also mention that we have also the constraints that deal with legislatures that meet in our respective states.
In my particular state, the legislature met in January of 2001, when we had no idea what to ask for. They will not meet again until January 2003. So, we can't ask for money between now and then.
The complexities of the final rule on standards for electronic standards and the related implementation guides first had to be carefully reviewed and understood in the context of Medicaid's unique business needs and processes.
Only after addressing this huge learning curve have states begun to move forward with assessments, putting out RFPs and securing vendor contracts.
Major issues for Medicaid programs include local codes. State Medicaid programs have relied heavily on local procedure codes to support coverage of many services. Areas such as home and community-based services, mental health and non-traditional supports are built almost exclusively with local codes.
Nationally, over 30,000 local codes currently used by Medicaid will have to be reengineered. We are in the process of cross walking the codes and getting new ones added by the HCPCS committee, but it will take a substantial amount of time to complete.
To date, seven of the 34 categories of local codes being cross walked are complete. An additional four categories will be left to each individual state for review and subsequent code requests.
Prior authorization is another problem for Medicaids. The 278 health care service review, request for review in response transactions, lacks a great many of the data requirements used by Medicaid agencies to pre-authorize certain medical services.
The transaction lacks clinical data elements that are used to determine the medical necessity of the service being requested.
Medicaid agencies are struggling with how this transaction can be useful for preauthorization purposes with its present lack of clinical data elements.
The current transaction would not serve the business needs of either the Medicaid agencies or their providers, but we will be forced to implement it.
There are certain solutions. We could either make this transaction not one that was mandatory for Medicaid agencies or a new standard could be named. In any case, the current one will not meet our needs.
Third party liability and coordination of benefits, we mentioned this earlier. Current regulations do not clearly include Medicaid post-payment recovery as a HIPAA required transaction, and the code sets do not support such activities.
While we have sought clarity on this issue, a ruling has not been received from HHS. Under federal Medicaid rules, states are required to pay and chase claims from other payers.
States stand to lose millions of dollars in recoveries if they are not able to bill claims electronically to major carriers.
The HIPAA regulations require massive changes to systems, processes and business practices. In Medicaid, partially as a result of HIPAA, at least 14 states are choosing to totally replace their Medicaid management information systems.
However, the short implementation period will not prove adequate time for most states to complete a re-procurement.
These states will have to purchase temporary solutions to support their old system until the new one becomes operational. From our viewpoint, this is not a prudent use of taxpayer dollars.
To ensure a smooth implementation of the transaction and code sets, significant time must be allocated toward all phases of HIPAA projects' life cycle and implementation period.
For a few states that have been working on implementing these standards, even before the final rule was published, the current date may be feasible.
Unfortunately, this scenario does not apply to most states. There are also no assurances that there will be enough qualified vendors to meet demand in such a short amount of time.
States have serious concerns about budgetary implications. Costs of HIPAA implementation are coming in much higher than initially projected.
While state assessments are ongoing, current estimates from submitted and approved advanced planning documents suggest that the cost of bringing state Medicaid agencies into compliance, only with the standards for electronic transactions, could exceed $1 billion.
While states will receive 90 percent or 75 percent federal financial participation for the majority of systems changes and training activities, coming up with state funding will be difficult in a time when Medicaid budgets are rapidly rising.
The funding issue is further exacerbated by the fact that such dollars are tied to state budgetary cycles. There are still states completing gap analyses and assessments that will not have a good cost estimate in time to receive adequate funding for the upcoming fiscal year.
In addition, a few state legislatures meet biannually and have already finalized budgets for fiscal years 2001 and 2002.
A longer implementation period would enable costs to be spread out over several years and would substantially reduce unnecessary spending on temporary solutions.
The American Public Human Services Association, APHSA, which is the parent to NASMID, has been part of the coalition with the Blue Cross Blue Shield Association and American Medical Association, to actively seek a legislative solution that would extend the implementation period and create a single date for compliance with the administrative simplification requirements of HIPAA.
As each administrative simplification regulation is related to the others, it is difficult for states to begin complying until all sets of regulations are finalized, when their impact can be assessed as a whole.
At this point, many questions are unanswered, with final rules still pending on security, national employer identifiers and national provider identifiers.
Proposed rules are forthcoming on claims attachments, national health plan identifiers and enforcement.
The staggered release of rules means that states replacing their MMIS, or even making substantial changes, will have to make critical system design decisions based on incomplete information and guesswork. If the rules differ, states will have to pay to reengineer.
Finally, a longer implementation period will eliminate unnecessary spending on temporary solutions, enable costs to be spread over several years, and provide needed time to develop national code sets and security safeguards that will support the unique needs of public programs.
The proposals introduced in Senate Bill 836 and House Bill 1975 address these concerns, and we hope that they are passed.
While Medicaid has long been supportive of the goals of administrative simplification, we feel strongly that more time is necessary for proper implementation.
We look forward to being able to advise the NCVHS and the administration, as we continue to meet the challenges of HIPAA administrative simplification.
DR. COHN: Sally, thank you very much. Our next speaker is Lou Saccoccio from AAHP. Thank you for coming.
MR. SACCOCCIO: Thank you very much. My name is Lou Saccoccio. I am general counsel at the American Association of Health Plans. I want to thank the subcommittee for inviting AAHP to participate in this roundtable this afternoon.
I also want to calm your worst fears. As the lawyer on the panel, I certainly will not be long winded and will try to get right to the point.
AAHP is a principle national organization representing HMOs, PPOs and other network health plans. Our member organizations provide or arrange health care services for over 150 million Americans nationwide, and of course, AAHP are covered entities for the purposes of HIPAA administrative simplification.
I have been involved in a number of discussions with member health plans regarding this issue, both at the operational level and at the CEO level.
A couple of things come out as being very clear. First of all, AAHP member plans are committed to implementing the electronic transaction standards and the rest of HIPAA administrative simplification, and are taking the steps necessary to comply with the final rule, and will certainly take the steps necessary to comply with the other rules as they become final, or at least come out in proposed form.
However, it was also clear, from our discussion with our member plans when we went out and asked them the question, that the overwhelming majority of them felt that additional time was required in order to come into compliance with the electronic transactions and code sets.
The reasons that were the most often cited were to avoid conflicts with other information system modifications, to allow HHS an opportunity to clarify the regulations requirements, and to develop related requirements such as those dealing with security, medical records, privacy and plan identifiers.
It would allow plans to coordinate their implementation members with their business associates and other covered entities, and to spread the cost of compliance over a longer time period, thus reducing the financial burden in any one given year.
Of these reasons, the two most common, the two that seem to have stood out most strongly, were the question of coordination of implementation.
You have already heard this afternoon a number of speakers talk about the need to try to coordinate the implementation of administrative simplification with some of the security rules still in proposed form, the health plan unique identifier is not even out in a proposed form at this time.
Also, you have the privacy rule that is now final and being implemented. Although implementing electronic transaction standards and code sets does not prevent you from necessarily implementing privacy or vice versa, the fact of the matter is, as a health plan, when you are trying to come into compliance with these regulatory requirements, it puts an administrative burden on your plan overall, and there are certain costs that are involved with that entire process.
When you try to push it all into a single time frame when there are still question marks with respect to other regulations, it becomes a very difficult thing to do.
The other major issue that arose in a significant way was the issue of cost. HHS estimated the average cost of compliance for an HMO or PPO would be only $250,000. Based on our discussions with our plans, we believe that estimate to be grossly underestimated.
Harry Reynolds gave you some indication with respect to the Blue Cross Blue Shield plan, where there the estimated cost of HHS was $1 million. For some reason, the estimated cost for the HMO or PPO is one fourth of that. Why that is, is not entirely clear.
We can tell you that our plans certainly believe that that estimated cost is grossly underestimated.
As a result of our discussions with member plans and a number of our committees, our board of directors, in February of this year, adopted a resolution calling on AAHP to advocate for an extension of the compliance period, that there be a coordination of the rules, and that a compliance period begin to run after the last final rule is out.
AAHP has also taken a number of steps to help educate its members in this area. Back in February of this year, we had a HIPAA conference that followed a policy conference, where we had over 200 attendees.
In June of this year, that was in Washington, D.C.. Then, in Los Angeles, a couple of weeks from now, we have another conference that will again address a number of these issues.
We have been trying our best, as the association, to lead an educational effort for our plans in this area.
AAHP supports the principles of administrative simplification. As the health care system becomes more dependent on data automation, the need for clear uniform standards is readily apparent.
Today, the lack of uniformity for electronic transactions and code sets across health plans make exchanging data both expensive and difficult.
The implementation of the HIPAA administrative simplification requirements is a costly and complex undertaking for all covered entities.
It is important that all the entities that are impacted by these new requirements be given enough time to implement the changes set out in this final regulation, as well as the other administrative simplification standards. Thank you very much.
DR. COHN: Lou, thank you very much. Jack Emory, from the American Medical Association, would like to speak?
DR. EMORY: Thank you, Dr. Cohn and members of the committee. My name is Jack Emory. I am with the American Medical Association.
We appreciate the opportunity to participate in your committee's discussion today on HIPAA implementation and transition problems.
I think everybody is sort of claiming fatherhood for WEDI. Certainly, the American Medical Association was involved from the outset.
Our former executive vice president was chair of the WEDI group following Barney Tesnowski, and we obviously and strongly support the principles and goals of administrative simplification.
However, having said that, we urge the department to promptly and fairly promulgate final transaction standards as quickly as possible.
I was disturbed this morning, in part, by some of the discussion I heard from the committee about publishing rules without going through a notice of proposed rule making.
I think Dr. Braithwaite's reference to, I believe, the General Counsel's discussion that there should be an open comment period to allow people to comment on the best efforts of the DSMO organizations is entirely appropriate and should be pursued.
I am concerned, and I would suggest to you that, if you don't do that, it would be legally challenged very quickly by any number of organizations.
I am not saying that the AMA will do it, but it is clearly an opportunity for organizations to become familiar with the many changes that we expect to see in this October rule that is coming down.
A comment period, even if that takes more time, is going to be necessary in order to help people understand what is being changed.
We thank the DSMOs for all of their work. We have been involved, organizationally, with any number of them, and we know the amount of work that goes on in this.
From our own personal experience, if I can give you an example of documentation guidelines that the medical profession has been involved with for a long, long time with the department in trying to promulgate or issue documentation guidelines to help physicians, the CPT editorial panel spent years -- Dr. Cohn knows in part because he was there for a part of that time -- trying to develop documentation guidelines, and made their best effort and best proposal to both the department and to the physician community about what should constitute good documentation guidelines.
When the physician community as a whole -- and if the parallel here to the country has a whole -- had an opportunity to look at proposed standards on the transaction standard coming out relatively soon, our house and the physician community rejected the CPT editorial committee's recommendations saying, that is not good policy, that is not good documentation guidelines.
I would encourage you, go through that process. I think it is the right way to go.
We have heard reference to the Gartner study that demonstrates that many health care providers are woefully behind. I am also taken by some of the comments that Dave Moertel talked about this morning with the Mayo Foundation and how many organizations still have problems with standards as they exist today.
If we step back -- and I think this committee should step back and ask any provider in the health care community today to come to this meeting and try to understand what you all have been saying -- I think there would be a very large question mark over your head.
They wouldn't know what you are talking about. Most people don't understand what HIPAA is or what its implication is for them.
I looked at the implementation standard for the professional 1500 guide. It is a big document that size. It chokes the physician.
It is almost impossible to understand how they are going to be able to sit down and absorb that and make the changes that are required as a result of that implementation guide.
A majority of our 300,000 members of the AMA are practices and small businesses. The magnitude of changes associated with HIPAA will require significant expenditures of resources and time.
We have consistently advised the department that compliance with HIPAA should be coordinated. We have also suggested that it should be deferred until two years, until all the pertinent rules had been published and final.
If there is a better way to do it, if we could somehow find a way to push the department to get the rules out faster, we would do it.
We never, ever will walk away from our support for administrative simplification. Make no mistake about that, we support it, but we have got to know what the rules are. What are the requirements.
How can you tell a physician to go out and start implementing HIPAA when they don't know what the final standards are?
We are hearing today that there are 230 standards that may be included for modification coming out in September. What are you going to tell them to do? What is out? What is going to change? We don't know at this point.
The AMA and a number of other prominent organizations who are WEDI members support S836 and 1975, and we will continue to support that, or look for any other way to provide additional time in order to know what the final package will be for a physician to be able to orderly implement the changes that are going to be required as part of their practice.
We are not and do not support legislation for any other purpose, other than to make certain that we know what systems need to be changed, and that we can cost effectively and efficiently come promptly into compliance with the HIPAA rules.
With some of the questions that our specialty societies have, our dilemma is, what do we tell them to do? A gap analysis is fine, but if you don't know what you are ultimately going to be held responsible for, how do we instruct them and what guidance can we provide to them.
I also regrettably can't tell you that I know whether or not physicians are taking steps, efforts, to come into compliance.
My guess is, from my experience with Y2K, is they are not, most of them are not and, as small physicians, find themselves more overwhelmed with trying to stay up with current practice rules and requirements of payers than trying to devote time and effort to trying to come into compliance with CLIA.
We still need help. We need your help to understand that physicians in small practices are going to be the last people, probably, to take the action to implement the HIPAA provisions.
We are willing to work with you. We want you to hear our voice and take this into consideration as you advise the Secretary. I thank you very much for the time to talk to you today.
DR. COHN: Thank you very much. Jim Schuping, I believe you are our final presenter, from WEDI.
MR. SCHUPING: Mr. Chairman, I thank you for having us on this panel today. I know that we are running a little bit late here, and I will try to focus my comments briefly on the letter which you have in front of you.
The first position statement I would take is that we certainly join our colleagues at AFEHCT and MGMA as being unequivocally opposed to any kind of swarming.
WEDI, as I think all the members on the panel are familiar with WEDI's role as delineated in the HIPAA legislation, is to serve as an advisor to the Secretary of Health and Human Services.
In that role, we have taken on a number of functions over the years. There are three particular elements that we have pursued here, that have led us up to many of the recommendations that we have included in this letter that we sent to the Secretary in March.
Probably the most widely recognized is the system of policy advisory forums, that we have conducted throughout the industry over the past few years.
WEDI represents slightly over 180 organizations at this point in time. Those organizations represent a pretty broad-based cross section of the key stakeholders in our industry today.
We have providers, payers, mixed payer providers. We have standards organizations involved. We have vendors and clearinghouses, and we have a small smattering of consumer interests.
Collectively, they bring a lot of issues and a lot of concerns to the table. WEDI's advisory group process is a process of identifying those issues and concerns and, through interactive discussion and the sharing of case studies and various other pieces of information, to find solutions, and to make recommendations that we can then forward to HHS for consideration as they shape these standards.
We also, in April of 2000, created a national initiative which you have heard referred to as SNIP, strategic national implementation process.
SNIP, we currently have, in the letter that we had sent to Secretary Thompson, we were over 2,000. We are now nearly 3,000 organizations that are represented through the list serves and the various communication vehicles that we are using within the framework of SNIP.
SNIP's responsibility and the reason it was formed, was really to step back and assess the readiness of this industry for the implementation of the HIPAA standards and, in the process, to try to identify solid data, case studies, best practices, where there are information gaps, and to pull this all together, again, through a coordinated system of forums and consensus building, so that we can kind of get a handle on exactly what the magnitude is, of the problems that we have before us.
SNIP has its own web site, which is a sub-web site of the WEDI web site. It is getting tremendous traffic and tremendous volume of activity and interest, which shows that there is just a tremendous, ever-increasing number of organizations out there, that are trying to prepare themselves and position themselves to take on the issues and challenges of implementation.
We also, in February of this year, to complement the work that we were already doing, we conducted an industry/public hearing in Chicago over a two-day period.
The purpose of the hearing was to invite organizations to come forward and to share with us what their experiences were to date with HIPAA preparations, and also to make any recommendations or to share any problems or concerns that they might have.
We had some 57 organizations that submitted either written or verbal testimony in that process and, again, it was a very, very good cross section of industry organizations that were represented.
The bottom line, I think, on that testimony was -- and this repeats some of the comments that you have heard already here this afternoon -- we didn't have a single organization that expressed any opposition whatsoever to administrative simplification.
It was obvious, from some of the testimony, that there was a significant number of organizations, and most of them fell within the provider area, that simply had not begun preparations and, from where we were sitting and listening, were not going to be able to make at least the initial target deadlines.
Some were awaiting release of the final regulations. Some were stalled on key unresolved issues, and others were just deeply concerned that this whole thing was going to happen, because they could see that there were not adequate resources for everything to move forward in a timely fashion.
The letter that we have prepared and sent in mid-March to Secretary Thompson -- and you have it in front of you and I am just going to hit a couple of the highlights -- were, number one, WEDI felt very strongly that the health care industry must maintain an aggressive and realistic schedule toward administrative simplification.
One of our biggest fears -- and I think it was shared widely across our board with some differences of opinion -- was if we had some lengthy extended target dates placed before the industry, that this would cause a number of organizations to back off, to possibly reallocate resources and otherwise slow down their movement in pursuit of the implementation of these regulations.
Secondly, we felt that it was very, very important, based on our discussions and interactions with the department, as well as other industry dialogue that we had had, that there simply were not sufficient resources being given to the department to deal with the tremendous volume of comments and work load that they had there.
Our recommendation was that these resources be found and identified and somehow allocated to move this whole process forward as quickly as possible.
We also shared, in points four and five and six there, you can see, we are looking at a packaging concept. I know this has mixed reactions.
What we were saying here, and what we were hearing from the forums that we were conducting, was that it made a lot of sense, it made a lot of business sense to be able to view security along with privacy.
I think you have heard that comment made here this afternoon, and also to be able to view the transactions and code sets in concert with the identifiers, the provider identifier and the employer identifier.
We are recommending here that, for example, that the same enforcement dates for both privacy and security regulations be established, based on the resolution of any outstanding issues.
We are recommending that a two-year time frame from the time these issues are resolved would be reasonable, assuming that there are no hidden surprises or anything coming out in the security document.
More important, that all of these be synchronized, so that organizations can look at them in packages, see the linkages that are important to their tooling operations and be able to move forward with some confidence that they have the full picture in front of them.
Health plans should be ready to exchange the standard transactions with any requesting trading partner, beginning October 16, 2002.
Health plans and their trading partners then would be permitted one additional year to complete the implementation of the transactions and code sets.
From an enforcement standpoint, this would mean that there would be no significant financial penalty for health plans, providers or clearinghouses who are demonstrating a good faith effort toward completing full implementation of transactions by October 16, 2003, which involves roughly a one-year extension.
Some folks have asked why WEDI is recommending or modifying its initial recommendations as were stated in the 1993 report.
In part, it is because of the feedback that we are seeing in the industry. It is also because, when we wrote that initial report back in 1993, there were two basic premises that were a part of that.
One was that the initial regulations would be, in fact, issued as a package down the road and, number two, there would be adequate government and private sector resources to make all of this happen.
I want to stress that WEDI is solidly behind moving forward with administrative simplification. We think that whatever resources are necessary need to be marshalled and put forward on this.
We don't want to see unreasonable delays because of my previous comment, that we are terribly afraid that a number of organizations will begin to downshift and delay, or reallocate resources that are needed for them to comply.
We need to resolve the key issues. SNIP, we think, is having tremendous success in gathering input across the industry. We want to see that process continue.
Where we have problems with issues, we need to resolve them. We need to assure that there is an adequate infrastructure in force, particularly at the department, to assure the success of the HIPAA implementation.
Lastly, we need to have a realistic and achievable schedule all of us can move forward on collectively.
That is the sum and substance of the letter, Mr. Chairman. I thank you for the opportunity and would welcome any questions.
DR. COHN: I want to thank you all for some very interesting discussion. I do want to observe, in my introduction this morning I sort of commented that obviously our role here is to help identify barriers and issues. Of course, we have been hearing those all day.
Also, to try to come up with some recommendations to the Secretary and ways to mitigate those issues. Certainly, once again, you have heard a whole day's worth of issues.
I just want to start off the discussion by sort of asking -- maybe we can just go around very quickly asking for input.
As I look at some of the options that we have in terms of addressing some of the issues you have presented, I see sort of a spectrum of issues around, I guess, delay or regulatory flexibility.
On the one hand, I see this issue of regulatory flexibility as being one tool that potentially could be used to soften the implementation, and it goes from low to some sort of a fixed delay for some length of time, and then sort of at the extreme I see sort of this issue of what I described as a sort of indefinite delay, where the delay is postponed, but is dependent upon four or five other things happening that could be stopped, or have other lives of their own.
I guess I am just sort of curious of everybody's view. Can you very quickly and very succinctly describe really what your views are in terms of what you would prefer, from your organizational view as well as personal view, of what you think the industry really needs. Jack, do you want to start out?
MR. EMORY: I am a little bit concerned, because at least in some of the meetings we have had with representatives of the Secretary's office about privacy administrative simplification, we are hearing, we can't do anything within the department and it is really up to the administration.
If you don't like the fact that you don't know what all the rules and regulations are and you want more time, we can't do anything about that, within the department.
Tom raised some compromise possibilities today and, frankly, that would be encouraging, but I don't think it would move us off our concern that we want to know what the package is, so that we can implement a package and we need to know what is going to be required.
What I would ask for from the administration is if there is a willingness to consider options that would give us the time, an adequate amount of time, after a package is developed. We would be happy to hear that.
Going to the Hill is a tough way to go. You have got to convince 535 people, basically, or a majority of them, to support a legislative effort.
With sort of the feedback we are getting so far, it appears that the only way we are going to get that, is to go to the Hill and get the Congress to tell the administration, give us more time.
MR. SACCOCCIO: The position Al Gore took was that they would like to see all the administrative simplification regulations come out in final form, and then have a 24-month compliance clock begin from that point.
One thing, though, that has been mentioned a couple of times is this issue of coordination between privacy and security.
The fact of the matter is that you have a privacy regulation now that the compliance clock is running on, but you have a security regulation that is in proposed form.
That is a recurring theme with a lot of our plans as well, that we need to have this coordination between security and privacy, but you are up and running on privacy right now without being able to do so with security, which is another reason for the position that our board took.
MR. GILLIGAN: I am unalterably opposed to tying one regulation to another one. I think you have, on the administrative programmatic considerations, it makes eminent good sense. On the political side of the situation, it makes no sense whatsoever.
If you buy into tying all the regs together, I think best case scenario, three, four years out, you have all these regulations.
People are asking for more staff for HCFA and HHS. I don't know that that is going to happen. We are assuming good faith participation on not trying to stop any one of these regs down the line. I do not know that that is going to happen. So, we are buying a pig in a poke when we tie the regulations together.
MR. MORAN: Let me just amplify Tom's point briefly with another practical political situation. We are now in the reality that we are having endless annual clean-up, fix-up legislation in Title XVIII if not elsewhere, starting with BDRA 1998, 1999, now we have HIPAA.
So, every year there is a bite at the apple, and a significant bite of the apple is shots at whatever regulatory status quo actions people don't happen to like at a particular time.
If you, in effect, have a statutory change that links the enforcement of administrative simplification to two years after the finalization of a set of regs that will be endlessly in play in an annual cycle and subject to pushes and shoves from a whole host of different places, it is just an invitation to chaos at that point in time.
I guess, as between arguments of time certain delay versus enforcement forbearance, you might find that there are actually some technical issues you want to consider if you want to go in the direction of enforcement forbearance, because that has some problems as well.
As a practical matter, a time uncertain delay linked to a bunch of regulatory actions that are subject to the whims of back and forth political action is no standard at all.
MR. TENNANT: I, of course, agree with that. I think the one thing we can agree around the table is, we are all in favor of administrative simplification, and the faster we move forward on that, the better.
Without a specific compliance date, for example, for the transaction standard, there is little incentive for providers to move forward.
I think if you tie it to some nebulous standard that is not even out yet, again, you are looking at five, six, seven years down the road, and the problem is the momentum is lost.
The momentum is not just for submitting an electronic claim. The momentum is to streamline the administration of health care.
We all agree we spend far too much money administering health care instead of delivering health care. I think the faster we can save money, the better. Certainly we would be in favor of a strict date that we could all shoot for.
MR. REYNOLDS: Speaking for the Association, I think we are already on the Hill with our position. However, as an implementer, when you look at what WEDI put forward, the packages -- I am speaking strictly as an implementer of this large project -- the transactions code sets and the identifier, especially the NPI, there is not much discussion about the NPI, but depending upon how providers, especially hospitals, select the NPIs, they can change the structure as to how we deal with it.
Duke University has 20 provider numbers now. When they go to 10, they are no longer broken in 20 pieces, our contracts, our payments, everything we deal with.
That is a real quiet monster. If you let the doctor pick one or two or multiples, that is still hard to really get a good sense of. That changes things.
I like the idea of the transactions code sets and identifier, at least NPI, as an implementer. Those really, all three, dramatically change the way we administratively deal with things.
Privacy and security, I am still really troubled over the fact, how can you commit to privacy when you haven't committed to how you are going to secure.
That means that -- all of us deal with privacy and security right now. This isn't a new theory to any of us in the health care industry or we would be in court every day.
The data is no more private -- we process the claims for our Governor. He is no more private when you do HIPAA than he is now. We sure can't have that data floating around. So, we are all worried about that every day anyhow.
If you are going to give us a regulation, then put the security with it, too, so that we know that when we make it private, it is secure under your guidelines.
As an implementer, those are packages that allow me, when I think through the whole operation, all the way from the provider all the way to the clearinghouses, to us and COB and everything else, those are reasonable packages.
The final rule, people may be misreading it. Maybe that is an initial rule, when it initially comes out. There is no final rule in HIPAA.
That is one thing that we tell our board all the time. Welcome HIPAA into your life. It is going to be here. So, it is going to change, but it is getting it out once so that we have got a framework.
As an implementer, give me a framework. Give me wish lists, give me a framework. Then I can go implement it.
That is one of the troubling things that we all have, those of us that actually have to do this. There aren't many people in the room who are actually going to have to do it.
They are going to have to recommend to people, but they are not always going to have to do it. We need a lot of them around.
MS. KLEIN: I think from our perspective, we need to have a stable base to start with. The NPRM came out and named the 4010 transaction. We all kind of thought everything was fine, we can start.
That is now subject to a process which I know is intended to make it better, but it has made it very rocky for us.
It has eroded to the point where we don't know where to start. Now there needs to be another NPRM process, more public comment.
It begins to feel like an endless cycle before you can start, before you get a base to start on. So, we would like to see a stable base, knowing it is not perfect, knowing that the needs of everybody are not met in it. Certainly ours aren't, as well as providers and what not. But once we get it in place, we can make those corrections through the ongoing process with a future look, so that it gets better and better as we work it through.
Some of those problems will weed themselves out as it settles and we go, yes, this really is a problem, or maybe it wasn't and we thought it was.
Give us a base, tell us where we can start. Give us all of the rules so that we know what we are playing with, what the whole field is going to look like. Then I think we are all ready to move forward.
We aren't asking for an extended deadline or extended compliance time for no good reason. We just need to know where to start, and then we can move forward with it.
MR. SCHUPING: Well, it is hard not to be redundant. I guess I would simply refer to Harry's comments as one of the types of input that we got that led us to our recommendation that we look -- if it is possible, that we look at a little bit of packaging where it makes business sense to do that.
Again, our bottom line is to get these regulations out as quickly as possible. We had asked in our letter -- we wrote this in mid-March and we were looking for April 30, and maybe we were whistling in the wind, but we were trying to set something as a target date to move toward.
Based on our discussions that we have had with department personnel over recent months, we know that getting those regs out is going to require additional resources.
There is only so much fire power, only so much horse power that they can throw at it. That becomes a critical issue.
I think the third piece is the entire process, they need to step back and set a realistic, doable, achievable schedule that we can all kind of hang our hats on and believe in and move forward on.
We have gone through a long, long period of delays here, moving targets. I think you need to step back once, take a look at what is doable with resources, what can we accomplished, set the schedule and then get the industry behind it to move forward, so that we don't have too much of a delay.
I think we all know we are looking at some delay, but let's make it something realistic.
MS. WARD: Thank you, Simon. My name is Maria Ward. I am with First Consulting Group. I would like to make just a couple of observations based on this dialogue.
A few things, and just comments. The concept of a package deal -- and the gentleman over here, I think, articulated it very well -- that implies that there is a point when all this stuff is static and it is clean and it is great and now we can move forward and we can proceed.
I would submit to you that that is not ever going to be the case. This morning's discussion, I think, is perfect evidence of that.
We thought we had something that we called final, and now we see that there are reasons to change it. If we wait for every one of what we are considering the initial proposed regs to be in final form, be published, I know all too well the circumstances around claims attachments, from my own personal experience.
I would suggest to you that there is not going to be a final rule for claims attachments probably before 2003, and to extend two years beyond that puts us into 2005, an implementation date for all, because that might be the last of the finals of this first round.
I don't think there is anyone who is aggressively moving forward, implementing right now, that wants to wait until 2005 for a deadline. I would caution you from that aspect.
Secondly, I would suggest that the committee, when they do make a recommendation, clearly there is an underlying theme here that suggests some sort of a delay, however that is defined.
Be very careful about requesting a delay and thinking about the impact that that will have on the industry.
Jim shared that with us in terms of the discussion, the dialogue, that the WEDI HIPAA success task force had.
I would remind you that really the vast majority of this industry, certainly NCHICO being an exception and some of the other early implementers, the vast majority of this industry waited for a final rule. That is the way it is. They waited for a final rule to start moving on this.
If we are suggesting that we are going to push out that what is final date, I would suggest to you that those people who waited will turn around and re-wait until that time.
MR. GILLIGAN: And you will make wait and see out of the people who are now pushing forward, which will compound our problem.
MS. WARD: Personal experience, I am working with a number of different entities in the industry right now. One person with whom I spoke about a week ago, I was at HL7 when the Senate Bill 836 was introduced, and we had some dialogue about that there in our work group.
I talked to some folks at Health Claim who said, oh, there is going to be a delay. I said, I have no idea why you drew that conclusion from an introduction of a bill that is proposing a delay, but their interpretation of that is, well, there will be a delay. Then, does that color their decision-making process as they go forward.
The point that is actually in WEDI's testimony is, well, if we are going to talk about pushing dates out here, don't just push a date out. I strongly disagree with waiting until all the finals are published and then adding on however many months.
If you are going to do that, even if it is a year, as WEDI suggests, be very clear about milestones and deliverables and requirements in that interim period.
If you don't do that, I think the response you are going to get is the general approach that we have seen with the industry that has caused us all to be here in the first place, which is that people were not doing this on their own.
Lastly, I think to some degree I would challenge this concept of, transactions can't be implemented without the identifiers. I have a little bit of trouble with that.
I understand that both implementing the transactions and the identifiers, both of those tasks, will require significant system modifications.
I would again suggest to you that you don't have to wait for the identifiers to be published before we can move forward with these transactions.
There is absolutely nothing in the development and the exchange of these transactions that requires the identifiers to be in final form. Thank you.
DR. COHN: Did you have a comment or a question or otherwise?
DR. MC DONALD: A bunch of thoughts come to mind. If one has said we are not going to have an internet until it is all done, we never would have had anything.
I think that logic doesn't hold up in a changing world, in a systems world. I want to get the biggest machine, wait one more year. Whatever you do, you always have a good reason to wait.
On the other hand, regulations can get crazy. So, if you want to just kill regulations, I think the good plan is to bind them all together. I think that is probably the best approach.
I am a provider, but I see patients. I hate some of the stuff that is happening to me. It is crazy. It is absolutely insane and it started, probably, with good ideas.
What I thought I still heard the last time, the only changes to make to the current regs are to cut stuff out, period, and get on with it.
You are saying no, but see, you are my enemy in some respects as a practitioner, because you want me to fill out forms and they are just games to cut down the money. Just cut my salary and get it done with. Then we can save time and see patients.
It drives me nuts to have to figure out, geez, I spend 45 minutes with patients but I write enough about their history -- geez, I was trying to get them just that they wouldn't kill themselves on the 12 drugs they are taking.
My thought about this was just videotape me and I will send you the tape and you have it all down.
I think the thing was kind of okay and now we are opening up the whole Pandora's box. The only choice you have got is to chop stuff out to make it simpler and then get the darned thing out, or just get it out.
I don't think anyone is going to be happy, even though those who want it. There is a side that wants more and they want to have all the future research ideas they ever had.
They want to have free form -- get this thing simple, like we say the law is supposed to be, and forget all that data collection. Just cut our salaries, if you want to save money. Don't do the games.
MS. WEIKER: I am going to make this short and sweet like me. Margaret Weiker with EDS, and I am representing that opinion at this point. We are opposed to any delay at all. I want to say, go, Tom, go.
MS. KLEIN: I am not sure I would disagree with your statements. However, then, as a taxpayer, please don't ask me where I spent the money.
DR. MC DONALD: That is the old story. They would just cut, cut, cut. Don't do the games. Just cut it and say, you get 10 percent less next year and then we are all better off instead of saying, we will chuck on this, and six hours, don't pass go, don't collect $200 and all these other games.
It comes out and I don't want to call and wait 20 minutes for an approval. Just cut the salaries and let us figure out the best way to live with it, instead of playing the game with the taxpayer and this and that, because we are going to make sure you are not cheating. It is just killing us.
MR. EMORY: I have heard physicians at the AMA say that, I think. [Laughter.]
DR. FITZMAURICE: Just a couple of words. What I am hearing is, I didn't hear anybody say HIPAA should go away, that we should not have HIPAA.
I think I heard unanimous agreement that, if we had all the package today, all the standards in place, give us some time to implement it because then we will know what it is, and give us some time to spread out the capital costs and we will do it.
I didn't hear anybody say that we don't need it, we don't want uniform implementation of it.
I heard some say -- and I am not sure if this is shared generally -- that resources are needed by HHS so that we can get the standards done in a reasonable length of time.
Frankly, I have been at this from the beginning. I look around the table and I see the same faces at a lot of the different standards meetings inside the department, working on these standards.
At some point it is, let's drop this and let's do privacy. You look around the table and you see the same lawyers, you see the same people working on it and you know darned well that attachments isn't being done, that the identifiers are not being done because they are sitting at this table, and not sitting at that table, and myself included.
I think the department has done a tremendous job at listening to the industry, finding out what you want, trying to give it to you and then coming back and making changes.
Bill has been the leader in that. Karen has been out there, Stan Knockhamson. I can't give enough credit to the people who are really working hard at this and getting the job done.
It is a very large job. We set priorities and we went for those priorities. We set the priorities for transactions and codes.
Get something out there people can build on and can save money on, and then let's protect the data that is going to be electronic. That was our next priority.
Now it is time for some more priority setting. With the resources that will be devoted to this, we will set priorities.
Whether we get it done in the time frame that you would like depends on what is devoted to it. HIPAA isn't the only thing the department is working on. There are a lot of priorities within the department. That is why there are some good political people up above us making these choices.
When you see what you get, know that there has been a lot of good effort put into it, and that priorities were set.
MR. BLAIR: Could I build on Michael's comments and come at it from a little different standpoint? By the way, I sit here and I listen to both sides or all five sides and I find myself acknowledging the validity that everybody is expressing.
On the one hand, people want lists to go forward, have HIPAA implementation go forward as quickly as possible because people see the benefits.
On the other hand, there are struggles and there are concerns about having flawed implementation either discredit or impair the credibility of HIPAA or do damage to further implementations in the future, which I think also has validity.
So, I am prefacing my comment because I want to try going at this from a slightly different perspective. My question would be, to each of our testifiers, if Health and Human Services was to put priorities on the national provider identifier, on data security, on the health plan identifier, I think those are probably the top priority ones, but if you have a different one, that is fine -- I don't think your top priority one is likely to be the enforcement one, but whatever they are -- I would like to ask that, if the dates are not delayed, because Congress doesn't get its 500 folks together to delay them, and if the administration does not further delay things, but the administration, Health and Human Services puts priorities on getting final rules out, could you please tell me, each of you, what is your number one priority for the next final rule and what is your number two priority for the next final rule. Which would help you the most.
DR. ZUBELDIA: Jeff, may I add something to that? They say they would like to see the enforcement final rule as the last final rule or they want to see it before the last final rule?
MR. EMORY: For the AMA, I don't think we could answer that. My guess would be -- and I don't think it was an option you asked, and that is privacy. I would like to see privacy first.
MR. BLAIR: Well, privacy we have is a final rule.
MR. EMORY: There are changes in the works for that as well, and I would like to see that agreed to, so that the data that is going to be made more readily available through administrative simplification --
MR. BLAIR: Let me refine my question. I will make it more explicit. We are waiting for a final rule for the national provider identifier, the health plan identifier, health claim attachments and security and enforcement. So, there are five things we don't have final rules.
If you had to pick which ones would help you the most, what would be your number one choice and number two choice?
MR. EMORY: I would put security first.
MR. BLAIR: Security is number one?
MR. EMORY: And attachments number two.
MR. SACCOCCIO: This is Louis Saccoccio for AAHP. Based on what I have just heard, I would think because you now have a final privacy reg, that security would probably be up there as number one.
Number two would be a tough choice. Representing health plans, I would think the health plan identifier would be important. That is not a documented proposal at this point.
I guess those would be the one and two, based on what I have heard from our member plans.
MR. GILLIGAN: I am Tom Gilligan. To answer this question, I am going to defer to Kepa.
MR. MORAN: Don Moran. I have no institutional view, but from a technical standpoint, you almost certainly want to do security first. That has the most high level architectural implications.
I guess I will violate the premise of your question and say probably you want to do attachments last. The only reason for that is, that is going to take forever. If you queue everything else in behind it, you are going to bog the whole thing down.
MR. TENNANT: Rob Tennant with MGMA. Assuming that you get claims attachments out, when I think of our members, they are on the front lines of HIPAA. They are dealing day to day with billing issues and things like that.
When they get a request for additional documentation, even if they send an electronic claim, they are forced to send everything on paper.
They are salivating at the thought of being able to send electronic claims attachments. I would put that right up near the top.
Second would be the NPI. If you are dealing with traditionally 60, 70, 80 payers in your group practice, you are dealing with 80 different numbers. That is a hassle, that is a burden, it wastes money and there is no need for it. The quicker providers get the NPI, the better we will all be.
MR. REYNOLDS: Harry Reynolds. I am not interested in pulling our bill off the floor, so we have already said we want them all. If you want to make me put them in order, I am comfortable with Jack's comments. Security is obviously very important and privacy, those have to go together.
I would echo a couple of comments on attachments. Just in North Carolina, we are at 67 percent physician, 90 percent hospital, and most of that is with attachments. You can't get those electronically.
If you are looking to simplify it, those attachments are a big deal to increasing our volume, which is actually the thing that will start giving us savings, other than inquiries. Until we raise that 90 and 67, we are not saving any money.
MS. KLEIN: I don't know if I can speak for all the Medicaid agencies because I think they are all at a different place.
I think the NPI is very important to us. We need to recognize who that provider is that is sending us the bill, and there are a lot of things attached to that.
Security is certainly a big issue to go along with privacy. Then I would echo the attachments. There are a number of things to be sorted out with attachments.
We have to look internally to see how many attachments we really need and then we have to find a good way to get them.
MR. SCHUPING: I have got some of my board members in the room here, so if I call this wrong, jump. I would have to say, also based on the discussions that I have been a part of, that security would be a number one choice for us. That is very critical to all of them.
Claim attachments we don't even have the NPRM for. I don't even know that that is a fair response. If I had to go from beyond security, I would say get the identifiers, and I don't know that I would pick one or the other, but let's get them out, the NPI and the employer. The attachments, we don't even have an NPRM out yet.
DR. COHN: Clem, and then I have another question.
DR. MC DONALD: This is sort of a comment. Firstly, I think attachments, if one doesn't assume one does them at once, you may be surprised, there is stuff cooking and it may come a lot easier with the use of both scanning and some other things.
I think the focus on security, that privacy doesn't do anything without security I think is not correctly analyzing it.
Right now, we have no laws in most states to prevent someone, for a big bribe, giving away medical records.
That is the biggest and the major and maybe the only way practically that privacy stuff goes out. So, every actress or actor is at risk, if they are in the right state.
With the privacy law, overnight it will stop that, because there are legal remedies for that. There are security regs that cover parts of things right now.
HCFA has requirements about putting stuff on the internet. I don't think we are in such desperate shape in the security area as it has been described.
I kind of like attachments myself and I would love an NPI if it is done right. So, everybody is dealing with doctor numbers in every single darned hospital and they are a big huge hassle.
If they came in with one stamped on their head, they came in with one they knew, and it was good, how it is implemented really counts. That would be a wonderful contribution.
MR. REYNOLDS: You know, the internet, with the right security, will get a lot of us out of the excessive costs we have on private networks.
DR. MC DONALD: You have just got to follow certain rules. I read some regs. Maybe they were proposed regs.
DR. COHN: I think Jeff brought up a good issue, which is obviously there may be a lot of legislative things that happen which are clearly beyond the scope of this subcommittee or the full NCVHS.
We do have some input, or at least are able to provide some advice to the Secretary, that if things don't happen, as you have been advocating, things that might help improve implementation, make the implementation go better.
The question is, putting delays and other things like this out of your mind, if Congress does not act, if things go along as scheduled, what can the Secretary do, from your view, to help ease the burden, deal with the implementation barriers that you have all been describing.
You know, what would you like the Secretary to do? Anybody want to respond to that one?
MR. GILLIGAN: I think the Secretary has -- if my reading of Section 1176 is correct, the Secretary could find justification for being flexible with the enforcement in there.
However, if you were to just sort of issue a letter to the file kind of thing for circulation, or make a public comment about how he was going to implement enforcement of this in the first few months after October 2002, he could go a long way to resolving some concerns there.
I would like to see that dealt with in a way that keeps those who have committed the resources to move forward with HIPAA still committed.
I don't want to see it extended so far that they start to lose faith in the program, and then we turn them into wait and seers.
DR. COHN: Other comments?
MR. MORAN: I think it all boils down to resources. When we look at HIPAA, we are looking at a multi-billion-dollar change to the health care industry, potentially multi-billion-dollar savings.
You get a situation where the DSMOs are fighting to try to come up with $30,000 to produce a web site that the public can comment to.
We are losing sight of the big picture in terms of resources. You have mentioned folks like Dr. Braithwaite and Karen and Stanley and Mary and those folks.
They are absolutely wonderful individuals working very hard, but there are too few of them. We need a lot more folks active in this process, and we need to educate them.
We have also heard today that providers are way behind the eight ball. Partially, that is due to they don't know about the eight ball.
When you think about Y2K, you see a tremendous outpouring of information to the providers, through 800 numbers, town hall meetings, letters going out from the administration.
There is nothing like that on HIPAA. I think we can educate, via the government. If it comes from HCFA, the providers listen. I think we have to recognize that.
MR. BLAIR: Simon, can I respond to that a little bit?
DR. COHN: Sure.
MR. BLAIR: I think that is an additional, very helpful thought, is where are the bottlenecks, what could be done to ease the bottlenecks.
I think maybe that can be part of either our discussion tomorrow morning or maybe, if somebody else has some other ideas as to the most constraining bottlenecks we have to being able to get those regs final, maybe that would help us.
DR. COHN: Other comments; Sally?
MS. KLEIN: At the risk of being unhumorous, there is a joke that goes around about, the beatings will stop when the morale improves.
I think that the movement to compliance is going to come when people realize that there is something in it for them, that there is a benefit to be gained by doing it.
I am not sure how much you can punish people for not doing it. It has got to come from the other side. There has got to be a reason why they want to. Then you won't be able to keep them down. They will be pushing you ahead faster than you can manage.
I don't know where you come up with the answers for that, but I am not sure enforcement is the right word.
DR. COHN: Other comments from the panelists?
MS. DOYLE: Hi, I am Theresa Doyle and I am a consultant to the Blue Cross and Blue Shield administration. I just want to make a point that when we have looked at this issue and tried to consider, well, if the enforcement was delayed, in essence, that the Secretary wouldn't penalize you if you were not in compliance on the date that it came forward, practically every plan said that didn't mean anything.
If the law said they had to be compliant by October 16, 2002, they needed to be compliant. They couldn't just say, well, we may not get penalized, we may not find that to be a problem.
We felt that there are too many -- there is too much oversight, even at the state level, on what it is that we do.
If there is a law in place, we are going to be compliant. That is why what we have taken as a position is to say that we need an extension. We need an extension into the future.
I just want to offer to you, we did look at that at one point and we just don't think that that is really an option.
DR. ZUBELDIA: I would like to make a comment to what Clem said on the attachments. You are saying that the final rule is going to come out in a few years and everybody wants that.
I hope they don't want a final, final, final rule on attachments. Right now, there are many decisions that need to be made.
So, we know there will be further final rules on attachments. We will never finish the process. There will never be a final on anything.
I am also encouraged to see that, in this informal survey we did, the enforcement final rule was not mentioned as any priority for anybody.
They put the enforcement with the least priority, which means it will come out last, which effectively gives a delay in implementation for everybody. If there is no enforcement, you get an effective delay.
MR. EMORY: Can I interrupt just for a second, just for an observation? The physician community has had a lot of negative experiences with the Federal Government about penalties, about sanctions.
They have been beaten about by the Office of the Inspector General, by the Justice Department, by Medicare carriers, by Medicare intermediaries, by the AARP, worried about sanctions and penalties.
Knowing that the enforcement rule has not been issued isn't going to leave many physicians feeling comfortable that we have got more time.
It is still a concern for us, very much of a concern for us, that there are going to be sizeable penalties possibly imposed.
It is one of the things that is going to keep physicians moving forward to implement this, because they don't want to incur those penalties.
MR. SACCOCCIO: One other point on that from the health plan point of view, even if you had some sort of statement from HHS regarding enforcement or delay in enforcement regulation, where there would be some flexibility with respect to good faith compliance, in the health plan environment, you have employers that you are contracting with that may require, as part of contracting with you, that they see a compliance date that is still part of the law, whether or not you are, in fact, in compliance with that.
You have state entities that, as part of the licensing process, may ask whether or not you are in compliance with all HIPAA requirements, and whether or not that is going to affect your licensure and your operation in that particular state.
It is not just the federal government. The fact that there is a law and a requirement with a certain date also affects other aspects of your operations.
DR. ZUBELDIA: I find that comment ironic when you just said a few minutes ago that physicians are not taking steps to become compliant.
So, they are not taking steps, but on the other hand, delaying the enforcement rule doesn't help them either. I am not sure what they want. I am a physician, too. I am a member of the AMA, too. I am not sure. There is something that doesn't fit there.
One theme that I have heard throughout all the testimony is that everybody wants to know what the rules are going to be. Everybody wants to have some sense of finality on the rules.
I have heard two different versions. They want finality in the rules before starting to implement. Another group is saying, we want finality in the rules before they are enforced.
Finality in the rules before you start to implement is a very risky proposition. I don't think you can do that and still be in compliance with any reasonable time frame.
From what I heard from Harry, I think there are some very important things that he said. He mentioned that he has 15,000 providers in North Carolina to implement.
Probably most of those, if not all of them, are already doing some sort of electronic transactions with current identifiers today.
If they wanted to migrate to the new standards, maybe even using the new identifiers, even though that might be heresy to somebody, maybe using the current identifiers and not migrate the identifiers, they could do something that has been talked about, is staged implementation.
Implement some things now, some things later, and some things next year, which is typical in systems implementation.
You don't want to implement everything at once, unless you want to change systems or go down for an extended period of time.
You want to stage your implementation and do things a little bit at a time, so you can do some testing and not disrupt production too much.
With 15,000 submitters that are doing electronic transactions today, you are saying it will take maybe a year to implement those, because nobody is ready yet and you would have to do between 50 and 100 a day.
The reason for that is because you would have to have all 15,000 of them converted by the deadline. If they are not converted by the deadline, they would have to stop sending transactions electronically to you. That is extremely disruptive and I can see the concern there. That is very disruptive.
What if you were to become compliant with some sort of magic wand today. Then, allow for two years for the providers to implement, for the providers to transition.
I think the providers are looking at the vendors and the vendors are saying, I cannot start deploying this with the payers because none of them are ready.
The payers are looking at the vendors and saying, I have no prize for doing this first, because you guys are not ready either. Nobody is ready.
If the payers were to be ready first, and I know there is no prize for being ready first, if you were to be ready first and then give some time for the vendors and providers to, in a non-disruptive way, to become compliant without stopping their production stream after October 16 of next year, if they cannot become compliant in 12 months, give them two years, would that help the payers.
The question here is, is it worth providing a non-disruptive method of implementation as opposed to running two systems in parallel, that you would have to run for an extended period of time. Where is the balance.
MR. REYNOLDS: That is something we can only answer individually. I mean, you don't know anybody else's processes.
The point is, if everybody is not ready at a reasonable time, in reasonable proximity, we can't afford dual systems.
You can't afford dual sets of codes. You can't afford to do that. You can't afford equipment to do that, if you are having to do that.
DR. ZUBELDIA: You are running dual sets of codes now. Every year from October to January of March, you have two sets of ICD-9s and two sets of CPTs, and you have to keep those for several years.
MR. REYNOLDS: But I am running the same business process against both of those. I can't run the same business process against the old and the new in HIPAA. That is the difference. It is a different business process.
You are changing the way we do business inside our entities. The whole thing you heard this morning, when you pulled back the NDC code, that would have completely changed the way hospitals dealt with pharmacy.
So, a lot of stuff is coming out that is changing, philosophically, the way we do business. That is why you can't afford to run two businesses for a significant period of time.
MR. MORAN: Let's segment that a little bit, just to make sure that that point is clear, because it is an excellent point.
Passing claims is one thing. Accurately adjudicating them against whatever business rules are supposed to apply under the terms of all your contracts is quite a separate distinction.
My guess would be that virtually everybody in the country would probably be in a position to pass compliant claims by October 16, 2002, if all you wanted to do was have standard claims being generated in one place, standard claims received in another place, and standard remittance advices and everything else come back.
If the interface is all we are worried about, we are not worried about much. What we are worried about is that inside the back office of the payer's side, there is a whole pile of stuff in terms of -- I don't even want to get into the question of history conversion, because we will be here all afternoon.
There is a whole pile of back end business processes that run on a set of rules for which standard claims don't necessarily provide the data, or won't provide the data going forward, unless the underlying business processes are simplified down in certain circumstances.
Local codes are only one simple illustration of that. There are dozens of other different kinds of things having to do with ways in which accounts are characterized, customer contract features and that whole kind of thing.
The key to this is to understand that one of the reasons why we all have to march forward as fast as we can toward something that gets us up is that ultimately those business processes are going to have to be redesigned.
Until they are, the idea of enforcement forbearance, while an interesting idea, what are you going to be forbearant on, the ability to pass the claims or the ability to pay them accurately.
From that standpoint, we are never going to get to that second standpoint faster than we are going to get there. So, we have got to get there as fast as possible.
DR. ZUBELDIA: Would it help to have the standard transactions and still maintain local codes, or local codes don't go away, and still maintain the current identifiers?
So, all you have to do now is the EDI front end. Once the EDI front ends are in place, then we can look at maybe identifiers.
Then, once the identifiers are in place, then look at the code sets, rather than trying to gulp everything at once. Is that a more reasonable approach?
MR. MORAN: That is a real hard question. Ultimately, there is no standardization without standardization.
So, the faster you get toward standard claims passing back and forth, the better. The challenge is that ultimately a lot of people who have business processes that are more complicated than what standard claims are going to support, are going to have to drop those businesses processes or modify them, in order to adjudicate claims accurately in a standardized environment.
The faster we get to that point, the better the reality is. That is one subtle point in that regard. That is why it may not make sense to rush forward madly on attachments, because attachments are, to a certain extent, the potential for a work around on some of those kinds of standardization problems.
Now, obviously that would drive a certain number of people nuts. As a practical matter, if you can pick up non-standard data elements through attachments, you can live in an environment where you might not be able to do it if you had to go to a whole new code and standardization.
MR. REYNOLDS: You know, we keep kind of answering hypothetical questions. All of us are facing these no matter what you decide.
I guess, rather than a single question and a single answer and all of us trying to represent a lot of entities -- and that is really difficult -- you need to get the right people in the room and go at this.
These are questions that can't be answered with a quip or they can't be answered with one statement. I can tell you right now, no matter what date you set -- I will just talk about North Carolina -- no matter what date you set, I still have a 12-month transition period, minimum, with my providers.
I have got to back up or go forward, or I don't know what to do with that yet. I can't tell you anybody in the room that can answer that question.
Fifteen thousand people in North Carolina have to get together and decide which transactions we are putting in first by what date, start testing them, and I am working with your company on trying to get everybody to test the same way so that I don't have to test with 15,000, and do it in a way faster.
I still have 15,000 entities to implement. It doesn't matter what date you pick, from that standpoint. I still have to work that out as an implementation period.
So, to pick a date or say, does that make it easier or different, it is more complicated than that. You have got to take a lot of things into consideration.
MR. BLAIR: Let me clarify what you are saying. What you are just saying sounds to me very much like what Kepa was asking.
Does it make more sense for there to be a separate implementation date, an earlier one, for the payers, and then allow a 12-month period for the rest of the providers, so that it could be spaced out. That was my understanding.
MR. REYNOLDS: Let me phrase it this way. We all need to be ready in some kind of reasonable proximity and then we have X amount of time to transition.
If you tell the payers to get ready, let's say, at day one, whatever that day is, and then you say, everybody else, you have to transition within 12 months, my God, how many are going to wait for month nine, month ten and month eleven. If I divided them up equally, I still have 50 a day that I have to do.
DR. ZUBELDIA: One of the premises of HIPAA in the law is that the payers have to receive the transactions. It doesn't say the payers can't receive non-standard transactions. They have to receive standard transactions.
Then it says, the providers can only send standard transactions. So the payers, in theory, could receive one standard transaction without penalties, but there would be no way to send them, because the providers can only send standard transactions.
If we change that view and say the providers can only send standard transactions, but if they don't send standard transactions for a year, there may be no penalty, the payers are still in compliance, the providers still have the requirement, but it would provide a non-disruptive transition time when you can send the old or the new standard.
MR. REYNOLDS: What is the jurisdiction that I have to make those 15,000 line up in any kind of way to give me an orderly transition? There is none.
DR. MC DONALD: There are a bunch of things that I think are distractants. Firstly, to say we are changing it away from NDC, that is disrupting hospitals, is nuts. They don't use it. What they went back to is what they are using now. I just want to clarify that.
The thing about the non-standard codes -- and I think maybe Maria can represent this better -- I think someone has looked at 20,000 of these, and it turns out there are only 600 or 800 new codes needed. I don't know how long it will take to get that out, but it isn't such a huge burden.
The third thing is, unless you are in North Carolina, I know it has advanced, but we just heard talk earlier about how they take the printed copy to the insurance company and then scan it to get the results in, and that ain't rare.
My understanding is, it is less than half of docs are sending electronic now. So, there aren't all 15,000 of them, unless you have got 15,000 hospitals.
MR. REYNOLDS: We are scanning those now.
DR. MC DONALD: You don't have to be synchronized. You just have to get the electronic guys synchronized.
MR. REYNOLDS: That is a nice try, but I vehemently disagree with it.
DR. MC DONALD: I am not suggesting what you must do. I just want to clarify the truth of the state of the world right now.
We don't have physicians offices sending electronic messages to all their payers. There is some smaller percent that are doing it. That is what I want to clarify.
DR. COHN: Maria, it looks like you have a comment.
MS. WARD: A couple of comments that you might find interesting. Some of the payers that I am talking to now are saying that they are going to continue -- to ride piggy back on what you are saying, Kepa -- payers are going to continue to accept non-standard from their providers after October 2002, if that is, in fact, what their provider sends.
The payer's viewpoint of that is they are not out of compliance and if, in fact, their provider would technically out of compliance, well, that is not the payer's problem.
So, some of the payers that I am hearing talk about implementation are saying they are going to do it anyway, not all of them, not necessarily the majority, but that is something that is being discussed out there.
I would also like to point out this whole thing of dual submitting, dual formats, X12 formats, and let's just say the UB92 flat file format.
Medicare contractors have been doing that for years. That was my life when I was a payer. I had 835s and proprietary formats and 837s and UB92s and NSFs. So, we have been doing that as payers for a long time.
Now, I think the distinction would be that we had the latitude in the old world to maybe not have to have all of that as standard as that is now, and dealing with codes would be an exception to that.
Dealing with codes would be definitely an exception to that. From a format perspective, payers have been accepting and dealing with both of those for a long time.
Just to put your mind at ease about attachments and slipping it all in there, I promise you, that won't happen.
The attachment process going forward, I co-chair the attachment work group, and I also co-chair a work group in X12 that deals with attachments.
Going forward, anything that makes itself into what we are calling the HIPAA attachment is subject to the DSMO process.
So, there is a very public, very open, very consensus-based process that sits behind all of that, and we are very clear, in the attachment group, because we have faced so much frustration, really, with the industry in general in developing attachments.
We are very clear that that does not become a vehicle for people to have work arounds and things that can't come in, in the regular transactions. That is just not going to happen.
MR. MORAN: I understand that completely and I know where you are going. All I am saying is that, between now and whatever date in which these regs are final, that is a different set of stories.
MS. DOYLE: A couple of points. One is, there have been those suggestions that the payers would be ready and then the providers come back, I guess, a year later, given an extension of time.
We feel strongly that the importance of this is a universal compliance. I think there is a great fear about running several systems and having potentially the electronic and the paper and then, on the paper, you may have some new numbers, you may have some old numbers, and the whole reconciliation process will be very, very complex and very costly.
They are very concerned about the disruption that that would cause. Having said that, there is a point that I would like to emphasize that really hasn't come out here, and that is the amount of money that is going to be wasted in doing wrap arounds to meet a 2002 deadline, when new systems are slated to be up and running just a year or two later.
We mentioned it in our testimony and I have talked with the Medicaid directors. I can tell you that there are numerous states that have new systems that are on the horizon that they reprocure, but that will not be available in time.
It is not just a private plan problem. This is also something that is happening in the Medicaid program, and I think that that is an important issue that we have to take into consideration, is to what extent is money being wasted on these temporary band-aid solutions that really, we would be saving a lot of money if we had this extension so that people can really get up to speed smartly.
DR. COHN: Kepa, do you have a final comment, and then we can wrap up this panel.
DR. ZUBELDIA: I see several themes. One is a disruption theme and nobody wants to have the disruption of this required implementation date.
I see also the theme that we want to have everything in place at once, so we know what the rules are, so we know what we have to do and we do it once. We don't have to do it two or three times.
I also see the theme that, having everything at once, it is going to cause me to change all my business processes, because of all these new identifiers, code sets, everything at once is a lot to swallow all at once.
The MGMA has presented the option of implementing things in phases. I am trying to find what the balance is. Is it too much to have everything at once?
It may be that we are looking at having everything at once so I only have to do it once, but since it is such a big project that I only want to do it once, it may take me five years to do that once implementation.
I am not sure that is feasible, to go to implementing once in five years, when we know that this is an ongoing process. We are not going to have final rules of anything that will not change ever.
Where is the balance? Is the balance better toward implementing stepwise, and using the identifiers we have today for another few years, and then using the code sets we have today for a few years?
Is that a better balance than trying to have everything at once and getting an extra five years to implement this big gulp?
MR. GILLIGAN: I have a question in response to that question for somebody on the HHS staff. Supposing we did wait until all the regs came out and it was a nice, tidy little package.
Does the HHS staff then visualize, a year or two later, coming out with one set of regs that covers the full spectrum of HIPAA and all the changes in those regs in one document? Could you disgorge that thing?
DR. BRAITHWAITE: Followed immediately by a swarm of enforcers. Realistically, Tom, given the current resources, there is no way that HHS could put out an omnibus, here is everything that will ever be for this year. It is just not possible.
MR. EMORY: Has the administration made -- we are all eager to get this quickly. Has anybody in the new administration, at this point, said to you, get this done or asked you how long it is going to take to get it done?
MS. TRUDELL: No.
MR. EMORY: I am not saying that we are going to say you ought to have more resources, but clearly, you need some help and we would like to see these rules published and we would like to see them published quickly.
I am worried that, you know, if we only end up with the handful of you sitting around this table from the department -- I think Michael put his finger on it -- you work security today, tomorrow you work on something else, and everything stops while the process sort of inches forward.
I think if there was some assistance that the administration could provide, it would be sort of a firm commitment on when we are going to have these. That would be very helpful, and that there are resources behind it to help you do that, and to help you achieve that.
MR. MORAN: In that regard, it may be that the nature of the commitment required is a commitment not to do too soon the ones that are not yet done.
As a practical matter, all of this is systems integration work. There is no off the shelf process that you can buy that does any of this stuff or any of the back end systems that you plug in.
So, everybody is building out different components of this. In certain instances, it may be that knowing that certain aspects wouldn't have to be converted for another two years would give some head room to people out in the field to prioritize that stuff.
Now, that would be a controversial point and I am not sure everybody would agree with it, but from a real world standpoint, if you just think about this from the HCFA perspective of what the carriers and intermediaries are going to do, I didn't see a huge bolus of new money going down the contract pipe to pay for all this stuff the last time I looked.
It is going to be an incremental game of inches out there in the real world, and some orderly schedule may actually be superior to anything else.
MS. TRUDELL: I would like to follow up on Jack's point, and turn it around and ask a question. We have been talking all afternoon about not wanting to start the clock any sooner than some date in time. Is there a start the clock no later than date?
Your point was, we would like to see these regulations quickly, and at some point after the last one is published, then the clock starts. What point is that really? Can you put a time on the calendar? You would like the clock to start no later than?
MR. EMORY: If you could do it tomorrow, great. Is that the answer you are looking for?
MS. TRUDELL: Yes.
MR. EMORY: I know it is not universally felt that way, but from the AMA standpoint, we would like to see you move forward expeditiously. If you could get it done tomorrow, with two years later being the compliance date that people are going to be expected to be in compliance, that is reasonable.
MS. TRUDELL: Does everyone around the room agree with that?
MR. REYNOLDS: Every Blue has substantial resources working on it now. We would love to turn it up.
MR. TENNANT: That is clearly not what the House and Senate bill says, though. It is fine to say it is 24 months and if we get them out tomorrow, but the bill says the later of.
I think you have got to look into your crystal ball and you have got to say to yourself, especially with 1975, it says that the provider identifier will be out to every provider, not every Medicare and Medicaid provider, but every possible provider, including potentially medical students.
Now, how long is that going to take, before we have those individuals having the number and being able to use them.
We can only estimate years and years from now. If the one word was changed in those bills to the earlier of, then you can make that argument, but you can't make it the way the bill says now.
MR. GILLIGAN: Karen, I will ask your question back to you. If 1975 and 836 were changed to read, the Secretary shall have all these regs out no later than such and such a date or what have you, would that change the resources available to you all?
DR. ZUBELDIA: It is already in the Act. The date was 1998.
DR. BRAITHWAITE: There was no money, so that is what happened. Tom, there is only one example we can use, and that is, when there was an administrative priority on getting out a privacy rule, they got it out in about twice as long as they said they would get it out. That is a lot faster than we have been able to do with anything else because the resources were there to make it move.
MR. GILLIGAN: All of which is why I don't want to tie one reg to the other.
DR. ZUBELDIA: Could I ask you how much of an extra effort or less effort would it be for your plan to implement things one step at a time as opposed to doing it all at once? What would be your preference, if you had a choice?
MR. REYNOLDS: I am speaking as an implementer. I am not speaking as an executive of my company. I am speaking as somebody who is day to day designing this system. I gave you may packages earlier. I still differ very much about the comment about the NPI.
The NPI could dramatically, unless you make some changes to it, could dramatically change. If you made the provider take it within 90 days after you issued it, so we would know what numbers they took, and then you would say they had to use it on paper and/or electronic, that makes it real nice, because we are using one number.
If you are going to standard, go standard. Go one number, use that number, Duke is Duke is Duke, no matter who in the room is using it.
Then you start getting into some kind of order. Transactions, code sets and then identifiers are the things that are administratively run through our world.
Privacy is the most obvious thing to all consumers and everybody that is related to it. They don't know a thing about HIPAA but they know about privacy. We want to know that we are not going to implement two security mechanisms across our telecommunication systems, one, because you don't have the current one out, and then one when you put the new one out.
The sooner you get that security out, we are going to know -- and I will go back to something Tom had in one of his comments -- about the Blues protecting their private networks.
My God, it is very, very expensive for us to have private networks, and that is the last thing we can do. We want to cut our costs, too.
Getting onto the internet or getting onto other means other than private networks is absolutely a plus, but the way you have got them set up now, can we or can't we.
To me, those are the kinds of things that the reality of what we have to do are based on those things.
DR. ZUBELDIA: Would you do it all at once or one package at a time?
MR. REYNOLDs: If you gave it to me all at once, I separate privacy and security and they don't basically change what I do.
We have done a continuum on all the privacy regs. We picked 25 major things that it affects. We have got a privacy officer who is going through those.
We picked one through five on each one of those. Who is going to do it. What does it mean. We are moving on that, but how do I protect it.
That is kind of a project going over here. They are not running over each other big time. Then the other is, how do I get this done. Then, is everybody going to be ready at a reasonable time with me.
You could have four options: new codes and stuff on paper, old codes on paper; new codes on electronic and old codes on electronic; I could be dealing with four distinct inputs into my company at one time, and that is not normal.
In the past, with clearinghouses or anybody else, if you had a different format with the same data, you could translate it.
If you get into what we are into now, it doesn't translate quite as easily without additional data, and that is what we heard in the presentation this morning.
DR. MC DONALD: I thought the problem now is there were hundreds of different codes. Everybody had different codes.
If you are dealing with three different Medicaids, you are getting three different codes. Is that wrong? I keep hearing that it is really horrible now, but it is going to not be as horrible in the future, so we shouldn't go there.
DR. COHN: He only has one set of codes.
DR. MC DONALD: You design your own codes? You have control over your own codes?
MR. REYNOLDS: There is one Medicaid in North Carolina.
DR. MC DONALD: You never get Medicaid to pay across the border?
MR. REYNOLDS: We don't deal with it. EDS deals with Medicaid. We have Medicare Part A and we have Blue Cross.
The providers in North Carolina, we have agreed with them what the codes are. We have been using the codes. We have got 90 percent of our hospital claims automated under those codes, and we have got 67 percent of our physician claims under those codes.
It doesn't really matter what you say. Those are going to change. So, I have got to go out with all them. Until we get more than 67 percent physician, it doesn't really help us a lot, and until we get more than 90 percent hospital.
My administrative cost actually goes up for the whole time of the interim, and it doesn't drop until I get above those. Yet, I am spending $6 million this year.
Trust me, we are on it, we are after it. We are trying to look for some order. We are trying to look for some structure, and we are trying to look for something that gives us the package to do it.
If I was up here not spending any money, it would be a little different. We are all moving and we are spending big money on this thing and we are going to try to help everybody else to get ready, too.
Dr. ZUBELDIA: Would it make your life easier if everybody was to implement the transactions now with the code sets that you have today, with the identifiers you have today and, once you are done with that, you could concentrate the limited resources in doing the code set transition only.
Once they are done with that, concentrate their limited resources in doing the identifier transition only.
MR. REYNOLDS: That is a big answer to a small question and I want to be real careful not to overstate that. I wouldn't want to answer that right now.
Philosophically, I understand your question. Reality-wise, I am a little nervous.
DR. COHN: Could you do me a favor, and think about it, and if you can get us back an answer, that would be appreciated.
MR. REYNOLDS: I think that is a good question. It is a good question for anybody.
MS. WEIKER: I have a comment to Kepa. If you take the implementation guides, Kepa, as they exist now and you say, let's implement them in that format, then we will worry about the code sets, there are certain data elements that don't exist in those implementation guides today that I would use in my back office business process type of service, and Medicaid is a perfect example.
In your suggestion, I would have to take this claim that would not have type of service on it. I am still going to have to go in and make some major back office changes to accommodate no longer having type of service. So, that wouldn't do me any good.
MR. REYNOLDS: We have that same situation.
DR. ZUBELDIA: Every Medicaid and some commercial plants are going to have to make that accommodation, with new code sets or without new code sets, with new identifiers or without new identifiers.
That is an accommodation you have to make because of the standard format, not having type of service. I agree with that.
If we disaggregate the changes we have to make with the standard format from the code sets and the identifiers, and we can center the resources in one thing at a time, the total implementation time may be the same.
It may be 50 years. I don't know. From what I am hearing today, it could be. We could do that over a 50-year period with diluted resources, because we are working on multiple fronts in parallel, or we could have an implementation time of two years for the transactions, we have two years for the identifiers. We will have those identifier final rules one day, and maybe then we can center the resources on different topics, the entire industry working on those reduced topics at once, and achieve a shorter transition time for each one of the topics. Is that an advantage?
MS. WEIKER: When you say code sets, are you talking about the external code sets?
DR. ZUBELDIA: I am talking about specifically local codes and NDC issues that may be left over. That is what I am talking about.
MS. WEIKER: I think, even though the local code issue is a huge issue, I know in the Medicaid, they are actively working on it and trying to get that through.
There will be some that they just won't quite get all the way through. Yet, when they go in and they look and they say, I am going to get rid of this local code, then I am going to take these data elements in this transaction to find out or to supplement the removal of the local code.
They almost have to go together. You have got to be real careful when you start saying, I am just going to get these transactions and then I am going to go in and then I am going to look at my local code issues and then I am going to do this and then I am going to do that.
Back to the point of I need all the rules at once, then you are really piece mealing me, Kepa, with going in and making a change and making a change and making a change.
DR. ZUBELDIA: Is there an advantage to having the transactions first and having the data elements first, before you remove the local codes and then you remove the local codes, knowing what you have in the transactions.
MR. REYNOLDS: The new format eliminates -- if you remember the presentation this morning, it showed things that are currently on the HCFA 1500 and other things that go away with the new format.
For example, type of service goes away, which is a big effect to us. I haven't looked at the record long enough to know if you could recreate type of service from X amount of other fields that would come in. Again, I am not that close to the actual detail.
MS. WEIKER: You can.
DR. ZUBELDIA: I am not saying implement the code sets before the transactions. I am saying, do the transaction formats first, then code sets, then identifiers. Would that help.
MS. WEIKER: Instead of doing the transactions, then I am going to have a start date and an end date. Then I am going to start looking at code sets.
DR. MC DONALD: One other slight variant on that, what about separating the provider out. I have heard there is a problem with the size of that as well for payers.
There is this one to one. There is a provider ID and that is not out yet either.
DR. ZUBELDIA: The provider ID, we have heard from Harry that it changes the contract situations. Each university has 20 different IDs because they have 20 different contracts.
DR. MC DONALD: What I am saying is, delay that. Leave it as it is. That is really what I wanted to ask, is that possible.
If I was a provider, you just delayed the benefit to me for that many years, because they want to get to the one set of codes, the one set of IDs, the one set of other things. That is the benefit to you guys, back to your comment earlier.
DR. REYNOLDS: It depends how long it is. There are a lot of ifs. The DA number is nice. Some of these other numbers are not as nice.
DR. COHN: I think we will need to have a discussion. We obviously want to thank the panelists. I think we are exhausted.
We have really appreciated having you here. We know we are about an hour over. I do think we need to stay as a subcommittee for a couple of minutes, just because I know Clem is not going to be here tomorrow, but he is here until 8:00 tonight.
We really want to thank you for coming and giving us the fruits of your thought and we will take that into consideration as we try to figure out what to recommend to the Secretary. So, thank you.
DR. COHN: Clem, first of all, are you available on phone tomorrow? We have got about three minutes and then we are going to have to adjourn.
DR. MC DONALD: I have got an 8:00 o'clock flight tonight, so I have got some time.
DR. COHN: The people who are doing the transmission have to turn it off at 6:00.
MR. BLAIR: Would you be available tomorrow morning over the internet?
DR. MC DONALD: I have got two half hour slots, 9:00 to 9:30 and 10:30 to 11:30. Shift those an hour.
DR. COHN: We start at 9:00 tomorrow, which would be 8:00.
I would like to ask, then, would you like to give us any reflections or thoughts on today.
DR. MC DONALD: I think I probably said it. I think that there are sentiments in the world that want a fairly complicated set of things which I think would be more than a couple years delayed, like maybe after I died, and I have got a long-lived family. So, that is one set of issues.
I think the concerns that might be valid is, this could give a mechanism to add a lot more data collection into everybody's life and make life miserable.
I guess we have got to go back to our basics. I like your idea, Kepa, and I don't think -- that wasn't selling too well and maybe in the real world that wouldn't work when you break it out, trying to find some simple way.
We really have nine transactions approved and the question is whether we should try to shut down the modifications or make it very, very, very small so that we can let things go on.
Once we open that up, I think we open up a can of worms. I still like my idea that we say, the only thing you can do is take stuff out. There was a strong sentiment -- and we might get more provider support.
DR. COHN: Most of, I think, what we are seeing is things being either taken out or not removed. I don't think that there is anything that I can think of other than a couple of code items that I think are being added. I may be mistaken about that.
MR. BLAIR: Taking things out that weren't necessary.
DR. MC DONALD: I think the goal should be avoiding having too many little holes that people can crawl in, and it is going to be painful, and try to get on with it.
I think the idea of tying them all together is only informative for internet delay. These things are not going to -- they are going to continue to change. We have to have a mechanism for continued change.
All standards require continued change. You have got to throw a standard out if you don't get it reviewed and rechanged in five years or something like that.
It seems to me that I would still argue for trying to remember the provider's sad state and don't let this be a mechanism for adding data gathering.
I know from my own research side, it is just a different task. If they are not funded for data gathering, we shouldn't make it a mechanism for making life harder.
DR. COHN: Any other comments or thoughts?
DR. MC DONALD: The MDA, it almost seems like it was done four years ago and I don't know what really happened to that.
That actually, again, if done right -- that has to do with having a big enough character set, that you have fewer characters and people can remember them and use them as a routine sort of thing.
DR. ZUBELDIA: One point that I think has been, for me, the highlight of the day has been the letter from the Secretary to NCVHS saying, I am accepting your recommendations to keep the NDC out of the requirements.
That is not a final rule. That is just a letter saying what the action would be, a statement of direction.
I think that something like that, or the NPI, in line with the white paper we have for attachments, that is not a final rule, it is a statement of direction, this is where the NPI will go after the 5,000 comments that we have on this topic. This is the way we are thinking. This is the way we are going.
I think that we can do a lot of good for the industry that is now saying, how am I going to prepare for an NDI. Is it eight digits, is it 10 digits? Is it numeric? How do I need to make my changes in my system.
Once they know what changes they need to make, then it is a step-wise implementation. I don't think anybody is going to implement the whole thing at once and test it all at once. They can move one step at a time.
DR. MC DONALD: Actually, that would be an enormous value to the community, a tremendous value, because whatever the next generation is, they will just make it that many characters. They will just be ready for it. It won't be that painful.
Secondly, there will always be a story about -- this is in the 1960s and 1970s -- that the best way to automate a lab system was to prepare for it and call the designer and then cancel the contract, because they were reorganizing.
By the same token, if there is a lot of work done on the standardization and really some good solutions that come up and say, this is the direction we are going, people are going to do it anyway.
It will work toward that end with less pain and complaints because they are not holding a gun to their heads.
We can actually prestandardize by such an approach where people will pick it up. They are looking for a solution. The next generation is going to be built that way. Then when it is regulated in, it will be less painful.
DR. ZUBELDIA: Then we have the other mystery, which is the payer ID. People are saying, well, we don't even have a proposed rule. How do we prepare for this when we don't have anything.
Something like that white paper on attachments, I think that is fantastic, because it tells people where we are going, what is going to happen, what they need to do today to get ready for that. So, if they want, they can start working on it.
MR. BLAIR: This is a question, really. What I am hearing is that, if we give the industry confidence that the NPRMS are a good predictor of what the final rule will be, then they are more likely to begin the implementation process.
I don't know that anybody can answer this now, and I think we will want to continue to discuss this tomorrow. What this makes me think of is that, if it is possible for the final rule on security regs, to be as close as possible to the NPRM, that may be a very positive thing for how the industry would interpret what will happen with the national provider identifier, with the employer plan identifier, and with health claim attachments.
DR. MC DONALD: You picked a tough one, though.
DR. ZUBELDIA: I think the tough one has a potential solution. I think if the department publishes a summary of the comments, not a final rule, but something that says, this is a general summary of the comments we received during the comment period, indicating the direction in which the comments are going, that will give people an indication of the direction in which the final rule will be going. That will do a lot more than just being silent.
DR. MC DONALD: The NPI, there is a draft that has been around for a while and why not publish that.
DR. BRAITHWAITE: The fact is that it is quite different from what was proposed in the NPRM. It is a 10-digit --
DR. MC DONALD: But that is stupid. I can see why it is not in the final NPRM. The DEA number has been alpha numeric for 100 years.
DR. ZUBELDIA: That is where the confidence of the industry, between the NPRM and the final rule breaks down, because those two are very different.
DR. COHN: Of course, that is why you have an NPRM is to get comments. If they knew all the answers and they didn't want any extra input, they would just put a final rule out.
I think we are going to have to wrap up today. We are going to meet together at 9:00 o'clock. I think the question is what, if anything, do we feel we need to communicate to the Secretary at this point, reflecting both on the first sessions in relationship to the recommendations coming in from the DSMOs, and I think some reflection on exactly what we will be able to comment on by the end of June, will be useful at that point.
I think we just need to sort of look through our notes. Now, we are sort of in a situation right now where a lot of what we have been describing this afternoon, everything is becoming very politicized.
So, it attempts to sort of solve everybody's problems, to make everybody feel good, to address all concerns, and it is likely not to be successful at this point.
I think we have heard a fair amount of counsel. I think we need to try to put it together, along with, I think, a healthy dose of our own views and sort of see what we could make sense of, in terms of recommending to the Secretary, knowing that we have probably the Secretary's ear probably much more than we have Congress or the legislative process.
We just sort of need to think about it tonight and sort of see what we can come up with.
Recognizing that this would be a draft, would obviously need to go to the full committee, whatever we decide to come up with to the full committee for further comment, modification, hopefully we can come up with something that sort of puts together what we have heard today. With that, it is almost 6:00 o'clock.
DR. MC DONALD: What you could tell them is, keep at least 10 character spaces available for their provider ID.
DR. COHN: Dr. McDonald, if by chance you happen to be available tomorrow, during any of the time in the morning, we would love to have you on a conference call. If you are available, please let us know.
Otherwise, we will adjourn until 9:00 o'clock tomorrow morning. Thank you all very much.
[Whereupon, at 6:00 p.m., the meeting was recessed, to reconvene the following day, May 1, 2001.]