[This Transcript is Unedited]
Hubert H. Humphrey Building, Room 705A
200 Independence Avenue, NW
Washington, D.C. 20020
DR. COHN: Would everyone please be seated? Good morning. I want to call this meeting to order. This is the second day of two days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The committee as you all know is the main public advisory committee to the U.S. Department of Health and Human Services on national health information policy. I am Simon Cohn, Chairman of the subcommittee. I am the National Director for Health Information Policy for Kaiser Permanente. I want to welcome you. I want to welcome fellow subcommittee members, those listening in on the Internet, and I want to thank those who are coming and joining us today for taking time from busy schedules.
I just want to remind everyone, given that this is being broadcast over the Internet, that when we are talking we should try to speak slowly and into the microphone, so that they can be taped and those on the Internet can hear.
Today the main focus -- and we will start now and adjourn by about 12:00 to 12:30, but our focus today is on continuing an investigation into ways to improve the HIPAA process, and to my view, stabilize it.
We have two major concerns. One is, we are interested in soliciting from industry and other experts what are good ways of improving the process, and the other piece is recognizing that we are a little less than ten months from implementation of the administrative and financial transactions; are there some major show stoppers or issues that we should be aware of at this point, so that we can begin to do some things to deal with that.
I also want to thank Jim Schuping for his help in terms of putting this meeting together, as well as Karen Trudel, our wonderful staff, and support from HHS and CMMS.
With that, let's have introductions around the table and then around the room. For those on the National Committee, I do want to remind you that if there are any issues coming before us today for which you need to publicly recuse yourself, please note in your introduction.
With that, Kepa, would you like to start with the introductions?
DR. ZUBELDIA: Sure. Kepa Zubeldia with Claredi Corporation, member of the committee and the subcommittee. As far as potential conflicts, I am a personal friend of four of the testifiers, and I am a member of WEDI, and one of them is a client of ours.
DR. COHN: Are you going to be able to say anything this morning?
DR. ZUBELDIA: Probably not. I should go home.
MS. BEEBE: Susie Beebe. I am staff to the subcommittee, I am with NCHS and CDC.
DR. GREENBERG: Marjorie Greenberg, National Center for Health Statistics, CDC and executive secretary to the committee.
DR. PICKETT: Donna Pickett, National Center for Health Statistics, CDC, and staff to the subcommittee.
MS. MC ANDREW: Susan McAndrew, Office for Civil Rights, Senior Policy Advisor for the privacy rule.
DR. MC ELROY: Patsy McElroy, National Council for Prescription Drug Programs.
DR. TATE: Michael Tate, staff on the Washington office of the American Dental Association.
DR. SCHUPING: Jim Schuping, Executive Vice President with the WEDI organization.
DR. REYNOLDS: Harry Reynolds, Vice President of Blue Cross and Blue Shield of North Carolina and a member of the NCHICO board.
DR. JONES: Ed Jones. I am Chairman of the Board of Directors for WEDI for electronic data interchange and a private health care consultant.
PARTICIPANT: Medical office to Center for Medicaid and Medicare Services, staff to the subcommittee.
DR. FITZMAURICE: Michael Fitzmaurice, senior staff advisor for information technology to the director of the Agency for Health Care Research and Quality, lead staff to the Secretary's Council on Private Sector Initiatives to Improve Security, Safety, Quality of Health Care, liaison to the National Committee and staff to the Subcommittee on Standards and Security.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, senior advisor for data standards and vocabulary, liaison to the full committee and staff to the subcommittee.
DR. HUFF: Stan Huff, Intermountain Health Care and the University of Utah. I work with standard terminologies and with the HL-7 group. I have been involved in LOINC and previously a member of the SNOMED editorial board.
MR. BLAIR: Jeff Blair, Medical Records Institute, member of the committee, vice chair of the subcommittee, nothing to recuse myself of, but my affiliations include AMIA, ASTM, HL-7 and HMSIS.
MS. TRUDEL: Karen Trudel, Center for Medicaid and Medicare Services, staff to the subcommittee.
DR. COHN: I think Dr. Zubeldia has additional things he needs to disclose.
DR. ZUBELDIA: Yes, additional conflict. I am also a member of NCPAP. I understand that Barry Watkins will be coming and representing X-12 sometime in the morning, and Barry works for me.
DR. SQUIRE: I am Marietta Squire. I am with NCHS, CDC and staff to the subcommittee.
MS. CURRY: I am Leeann Curry. I'm a doctoral student in nursing informatics at Columbia University.
DR. COHN: With that, Dr. Zubeldia, you don't have anything else, do you?
DR. ZUBELDIA: That's it.
DR. COHN: With that, I think we have an opening statement from Ed Jones, representing WEDI. I just want to say, thank you all for being here and joining us.
DR. JONES: Thank you for inviting us. We just finished a WEDI board meeting in San Antonio the last several days.
About a week and a half ago, in preparing for this meeting, we had a telephone discussion with a variety of our members, both members and board members, to come up with a context for our discussion. Yesterday prior to adjournment of our meeting, I went through the statement that I will go through with you to get concurrence from board members and additional input. It does not represent an official WEDI board policy or recommendation. It is really to provide context for our discussion this morning.
With that, I'll go through this. I believe you have copies.
In May 2002, WEDI testified in Denver, Colorado before the Secretary's Advisory Committee on Regulatory Reform. WEDI's recommendations in that testimony, which focused on improving the HIPAA administrative simplification standards implementation process, included the following.
First, create a predictable process such as tying new HIPAA regulations and/or major version changes to HIPAA regulations to the type of predictable process that Medicare uses.
Second, take minor maintenance processes out of the federal regulatory mode. For instance, with ANSE X-12N and other consensus-based standards organizations agree to maintenance changes in the standards, could they not become effective 180 days after publication of the revised implementation guides, and an accompanying notice in the Federal Register.
Next, identify a high-level HHS official with the responsibility and authority to assure that all HIPAA regulations are processed in a timely fashion. We are glad that that designation has been made.
Convene a joint WEDI-government task force to review the options available which can improve the process. WEDI is examining government-private sector relationships in other industries with similar responsibilities. These HIPAA administrative simplification regulations that affect all health plans, not just Medicare and Medicaid, and therefore the delays and lack of clarity have a much larger negative impact on the entire industry than might be the case if just governmental programs were involved.
Lastly, WEDI also believes that it is well positioned through its regional organizations and the intellectual property resources that have been developed through its strategic national implementation process to help the industry implement HIPAA on a more comprehensive basis than has been previously undertaken with WEDI's limited resources.
Several months ago, WEDI submitted a grant application
through the WEDI Foundation to HHS and CMMS in order to obtain funding for HIPAA education. WEDI is well positioned with content, faculty and regional special interests and delivery infrastructure to reach an extensive audience, including minorities, rural areas and non-traditional audiences such as employees and local governments. I might add here that we have undertaken several of those efforts to date.
At WEDI's board meeting this week in San Antonio, one of our board members asked the following questions. If HIPAA administrative simplification were to be enacted today, what would we do differently? What have we learned from the process in the more than six years since enactment?
Our purpose in meeting with you today is to try to provide some context to those questions by identifying weaknesses and challenges in the present HIPAA administrative simplification process, and to identify and discuss areas of concern that need to be rectified if compliance with HIPAA administrative simplification standards is going to be timely, successful, and such to realize the cost and efficiency benefits of HIPAA administrative simplification.
There are three major areas that we believe provide context for our discussion this morning, and that encompass WEDI's earlier recommendations.
The first, Congress and the Department of Health and Human Services have not allocated sufficient financial and personnel resources for a timely, predicable and successful implementation. This has had consequences to date.
These include: The set of standards comprising HIPAA administrative simplification have been released in a haphazard manner, creating confusion, frustration and skepticism in the health care marketplace. A significant number of affected parties, just months before compliance deadlines with several of the standards continue to believe that HIPAA administrative simplification will not occur or does not affect them.
This issue came up yesterday in our discussion and across the spectrum represented on the WEDI board. They are hearing this increasingly.
Next, a significant number of affected parties are still unaware of HIPAA administrative simplification standards requirements, reflecting in part insufficient resources allocated to education and outreach efforts, and in part the delivery of messages that are inconsistent.
On behalf of the WEDI board of directors, I want to emphasize to you that CMMS and OCR have stretched scarce resources to make best efforts with regard to education and outreach, but that the size of the health care industry and diversity of its stakeholders dwarfs the federal government's commitment of resources.
Significant levels of noncompliance at times of HIPAA administrative simplification compliance deadlines also have future consequences. These include -- and these were brought up yesterday by our board members -- a potential for cessation of Medicare payments for noncompliance providers, the potential for disruption of current electronic transmission by providers and payors. This was a big concern, particularly of the larger players at the table, and potential for disruption of cash flow to health care providers.
We raise these as concerns, as contingencies that should be addressed not as inevitabilities. Nevertheless, we believe that greater care on compliance, timing and deadlines is necessary when education and outreach efforts are insufficiently funded.
The second major area of context is, the current federal regulatory process that underpins HIPAA administrative simplification standards is too slow and impedes compliance and innovation in a dynamic health care marketplace. The failure of timely publication of transaction and code set addenda is impeding testing.
I got a voice mail last night from the head of one of the largest networks, saying that if the addenda were not out by Friday, they were going to have a problem with compliance, and asked me for advice, and I didn't know what to tell him.
Going forward at a minimum, the federal government and industry must design alternative innovative methods and processes that will expedite modifications to HIPAA administrative simplification standards that are not structural -- I want to stress that word structural -- in nature.
One example would be to present non-structural issues in public hearings scheduled at regular intervals, findings from which would be forwarded as recommendations to NCVHS for review and consideration within a specified time schedule, followed by a 30-day public comment period. Within a specified time period thereafter, say 60 days, HHS would have the opportunity to consider public comments and issue modifications.
The third area we would like to discuss as context -- and perhaps this is the most important, looking to the future -- going beyond HIPAA administrative simplification standards, a new collaborative process drive by the health care industry with government participation as a payor and not as a regulator is necessary to foster innovation in health care and realize efficiency benefits.
This approach recognizes that regulatory processes involving the application of technology lag market deployment in a competitive business environment. This approach also recognizes that return on investment or ROI as it is commonly known is the catalyst for business to embrace new cost effective and efficient tools. The federal government as a payor benefits as a free rider when it does not impede, but fosters innovation driven by ROI determinants.
This approach recognizes that current regulatory efforts have focused on transactions to the detriment of encouraging the health care industry to redesign its business models to innovate and attain more efficient and cost effective interchanges of the information. This approach acknowledges that the federal government has a regulatory role in administrative matters such as privacy and security, but also acknowledges that the federal government's regulatory process relating to health care industry developed transactions standards has stifled innovation, and has the potential for disrupting business operations around compliance deadlines.
Finally, this approach recognizes that in an era of unfunded federal mandates, the only way to insure predictable, timely and successful deployment of technology is when businesses are willing to make investments in technology that have a positive return on investment.
My colleagues today will discuss these issues further with you, and how the consequences of existing processes have affected their organizations, and how changes to these processes going forward may lead to a more efficacious implementation of HIPAA administrative simplification standards. We also want to discuss how a new collaboration between private industry and the federal government might begin to alleviate impediments to innovation in health care in the future.
With that, I thank you.
DR. COHN: Thank you.
DR. JONES: Simon, I don't know where you want to go with that. These are just some basic thoughts that we wanted to get out in front of everybody to, number one, generate some discussion, get some feedback. There may be some spinoff conversations that might come out of these, but these are three things that were very much in the front of our minds.
DR. COHN: Well, Jim, help me with this one, because we haven't scripted this one very tightly. But do others have comments that we want to make, or would you rather just have us go into general conversation?
DR. JONES: I would encourage the rest of our panelists here to share any thoughts they might have, not only on the basic focus paper, but any thoughts that they might want to bring to the discussion, too. Then somehow we can weed this all out.
DR. REYNOLDS: Do you want me to go now?
DR. COHN: Yes, please.
DR. REYNOLDS: Again, I'm Harry Reynolds from Blue Cross Blue Shield in North Carolina, and today I am representing Blue Cross Blue Shield of North Carolina, not the Blue Cross Association, and not all the Blues.
I think by looking at the panel, I am probably the only one that is on the ground all day every day implementing HIPAA. If you look at the transactions, when the providers, the practice management systems, the clearinghouses, the payors and all the business associates become HIPAA compliant, then we are all HIPAA compliant.
There is no competitive advantage to any one of us becoming HIPAA compliant, because HIPAA is really re-engineering the way the industry does its business. We have to minimally get there on October of '03. Then we can move on with whatever improvements we have either gathered through our implementation, or we hope to get going forward. But that has to be our minimum value of success.
So it doesn't behoove the payors to get way ahead, or the providers to be in position or the practice management. We all have to get there.
If you look at the privacy, it is exactly the same thing. I have spent a lot of time actually educating our customers who are our employers on how privacy is going to affect them. Employer is a bad word in the privacy legislation, but when you try to walk into an employer of 100 people and tell them about plan sponsors and group health plans, and you look at their eyes and you look at how they will deal with the protected health information for their employees, the reality of the size of HIPAA on the privacy side does it.
For example, just touching base briefly on privacy, the exciting thing is, some of the innovations that we are for example being able to put into our system, so as soon as anybody keys in a number of one of our members, up would pop up whether or not there is already a confidential communication situation sitting out there, or an authorization, which would then allow our customer service people -- because we administer $2.8 million North Carolinians.
So when you are talking about privacy, every time we ouch them, we alone have 340 different letters that we send out to our customers. Every one of those letters has to be adjusted to deal with the privacy situations, especially as you get to things like confidential communications. But that all has to work. So our public has to understand it, our providers have to understand it. We have actually gotten calls from some of our providers saying we cannot give you as a payor more information again. We can't give you this information we used to give you. Well, that is not a fact, but education is going to be key.
So in privacy, we all have to win, in transactions we all have to win. Again, some of us just saw the WEDI thing this morning, but some of the things I do firmly agree with is that there has to be a clear and precise decision making process. We love the frequently asked questions. We would also like to go further to clear final decisions.
Some of the significant issues that we are facing right now. Interpretations of the IGs. Kepa wants to excuse himself from a number of things here, but he can't excuse himself from the discussion that we have to have with him on a regular basis. He believes it says this and I believe it says this. Who is right, and who gets to win? I don't care, but we have got to pick one.
If that discussion is going on with all the providers, and we have 5500 submitters of electronic transaction stuff. Those 5500 have to interpret it a certain way, and we have to interpret it a certain way. If you don't remember anything else I say today, think of a ping-pong table with one side of it up. If you have ever done that when you were a kid, you put the one side up, the ball always comes back.
If the interpretations are not clear, and somebody doesn't say this is the interpretation period, as payors we will have decided one thing, the providers will decide another, and every time it comes in, it will fail those IG edits.
That is not the business we are in now. We have prompt pay laws in North Carolina which require us to get those claims in and get those claims out, otherwise we have to pay interest. That is the reality of the situation. That is not complaining, that is not whining, that is the reality.
I have sent thousands of transactions through three different vendors, and I get three different answers. They group up in groups of two on different answers. So these decisions -- this is not a drill for us, this is not practice. Ninety percent of our hospital claims come in automated now, and 75 percent of our physicians. That must be maintained, period, for us to be where we are now.
So as they mention some of these things -- and I've got a list here, but I'm not going to belabor you with a list, but there are many of these, and the players in the industry know that, and the players in the industry are watching the listserves. You almost have to have a couple of fulltime equivalents watching the listserves, because that is where the scuttlebutt is.
I gave an education class to 50 physicians about two months ago, 8:00 in the morning on a Saturday morning. They all attended. They brought 25 of their office staff. I asked them if any of them had either talked to their vendors, or their vendors had talked to them. It was 8:00 in the morning, on a Saturday. Nobody's hand went up. I asked it again. Nobody's hand went up.
We are facing on a daily basis the eyes of the people who are implementing HIPAA. Give us clear direction. Give us these decisions that we all want. For example, the addenda has got to come out, period. It has got to come out. If it doesn't, you already have people in the industry, and you can watch the heads of the rest of the group. We have people that we are dealing with that say, I am going to implement 4010, thank you. Well, all of us that are in the front row that 4010A is what is going to fix 4010, and it is also what everybody expects to have happen in October, right? You can't do both of them at once. You can't have an industry doing both of them at once.
So this is not about who is crossing the T's and dotting the I's. This is talking about myself and 5500 entities that I receive claims from. Where are we?
I will tell you straight up: We have decided we are working on 4010A. Please get it out. I don't want to be that stupid, but please get it out.
So each of these things come up. We have got the same kind of issues riding on things like DDE. There is a lot of discussion going on in WEDI and I appreciate WEDI stepping on them, but that is an issue around that.
So as you look at it and as you listen to us today -- the dimension of staffing, I have 75 fulltime equivalents in my Blue Cross alone, working on HIPAA. I would like to hear the number the federal government has full time, all day every day, working on it to get this thing out. Remember, they are the keepers of the light. If they don't give us the answers, what do we say?
I am very anxious, and we are spending a lot of money and a lot of time. For example, here is our latest document that we sent out to all of our providers, three major HIPAA stories. We are not shying away from making everybody successful, the providers, the practice management systems, the clearinghouses and us. That is the deal.
I don't win a thing. I waste the money that I am spending from my board if I don't get all of them compliant, and I spend probably 40 to 50 percent of my time not dealing with my own industry, because I have got to get my providers ready, I've got to get the clearinghouses and practice management systems -- and we done that.
So this is the kind of stuff that as you hear us today, it is not about who has got what, it is about getting HIPAA compliant. You all started the clock on us, and I hear that clock ticking like Captain Hook did. There is a big alligator sitting on top of my office right now, and I can hear the clock going.
We do not misfit on mandates, we do not take lightly our responsibility, and we do not rest until we know we can say that. Our board has again given us a multi-million dollar approval for 2003 to continue working on HIPAA. Two-digit multi-million. I can't fail them, I can't fail our customers. We can't not be private, and we can't not have the same automation that we have.
So when you hear my answers today, or you hear questions or anything else, understand where we are coming from. I'll be happy to go the distance with what is going on with the providers and with what is going on with everybody else, and we'll go wherever you want to go. But I hope you hear the passion. There is nobody sitting here not wanting to do this. There is nobody sitting here and not wanting to get there. Help us get there. Please listen to what we say, and please listen to what WEDI is saying. We are all grouping up with WEDI in many ways, because they are kind of a point. CMMS is stepping up in the cases, and OCR.
So that would be my introductory comments that I would like to make, because this is really something we need to see happen. We are anxious to be whatever kind of player we all of us can be in doing this.
DR. COHN: Mike, did you want to make a comment?
DR. TATE: Yes. Simon, you asked yesterday if there were any issues still outstanding. Frank McCorney will be here at about 11 o'clock or so to answer any questions you might have. I was listening online.
I'm Michael Tate with the American Dental Association, from the Washington office. By the time April 2003 gets here, Bob Lapp and some of the other staff in the Chicago office will have conducted probably over 60 seminars on HIPAA on specifically the privacy rule at the state level. We also provide information constantly in ADA News, as well as online at ada.org, our website. But it never fails. A couple of times a week, I get a call from a dentist who says, what is this HIPAA stuff? I know he has got three minutes, because he just numbed somebody, and as soon as that takes effect he gets off the phone, and he is going to go back to work. So I get three minutes to explain HIPAA. I've gotten pretty good at it.
The downside is, when I tell him that HIPAA pertains to practitioners who transmit transactions electronically, or who have someone do that for them, and only those practitioners, if he is not doing it electronically, it is a 30-second phone call. He has told the staff, turn off that damn computer, because if we don't do anything electronically we don't have to comply with HIPAA.
Now, a year or so ago, Dr. Scott Trapp was here and testified as to what the ADA was doing to encourage dentists to submit claims electronically, it saves them money and they can save a couple of hundred dollars weekly by doing things electronically. HIPAA has put us back two steps in that process. So there is a concern for us at that point, when we are trying to get more dentists to submit claims electronically.
We are also doing a lot, as I mentioned, with outreach and education for our dentists. Every time a date changes or a rule changes or something changes, Bob Lapp has got to go back to number one, two, three, four and five seminars and say, something changed. If any of my dentists ever receive 334 letters on HIPAA, they probably read the first five, and the next 329 would go in the trash.
Dentists have a staff of about five people. Eighty percent of dentists are general dentists and they are sole practitioners. They have a staff of about 4.3 on average. I'm not going to tell the dentist to form a HIPAA committee. They would look at me like I'm nuts -- anymore than an optometrist would form a HIPAA committee, because there are about five of them. So basically, what dentists want me to do is to put HIPAA on two pieces of paper and put it in their hand; tell me what I have to do to comply. Not what I should do, not what I might want to do; what do I need to do to comply with this regulation, period. Those guys and gals are chair side. They want to do their work, and they want to get reimbursed for it. Everything else should be invisible to them. How it happens, they don't care. They just want to do the work and get paid for it.
So from that perspective, we have to keep the small practitioner in mind. A lot of them are not hospital based, they are not subject to some HIPAA committee going on in a large provider facility. They are on their own. They really don't have time for a lot of this.
We like to frequently ask questions. We would appreciate it if the answers came back a little faster, because they get asked, and it came up at a seminar, and a month goes by before Bob can incorporate it into the next seminar on HIPAA that he is doing. So we are constantly putting out addendas.
We developed our own privacy kit in house. We have a staff group of about six or seven people in Chicago and me down here. We developed our own privacy kit for our members, just the basics. This is what you need to do. During the seminar you get a copy of the privacy kit. So we try to minimize the addenda and the errata sheets that have to go in that kit, just to keep it simple, so they will comply. So whenever we see a guidance or a memorandum or a new final rule, those six people have to go through those 200 pages and find out what changed, just so that when a dentist gets his three-pager, it doesn't change too much.
So I guess what we would ask is, let's keep these people in mind when we are doing rules. They are where the rubber meets the road in the health care system, not only dentists, but the optometrists and the PTs and the chiros and all the rest. But they have to implement the rules, so let's keep them in mind.
Thank you.
DR. ZUBELDIA: Mike, you started with one page, went to two pages and ended with three pages.
DR. TATE: I know. I have been in Washington since 1989, so if I kept talking it would be 20 pages.
DR. MC ELROY: Patsy McElroy with the National Council of Prescription Drug Programs. I agree with everything that has been said so far.
I think primarily, the Council would like to say, we feel the need for speed. We have got -- right now we are balloting version 8.2 of the standard; 5.1 of the standard was named in HIPAA. So the industry is moving forward. The need in the industry is there, but we are trying to accommodate.
Right now, we are working with Medicare on their implementation and issues with 5.1. Medicare was not at the table when 5.1 was developed. Our concern is, if we move forward, let's let the industry itself name the versions. We have got -- Medicare is dealing with issues that we are trying to retrofit while still into the standard, but still maintaining the standard's integrity. That is a big issue. You are going to see some other points coming out like that. The FAQs we agree with, too. It is a timeliness issue, again, if we could get responses in a more timely manner.
Basically that is all we needed to say. We agree with all the things that have been said so far.
PARTICIPANT: Sue, do you have any comments you want to make at all from OCR's perspective?
MS. MC ANDREW: No. Mostly I am just here to listen. I am going to have to excuse myself in a few minutes.
DR. COHN: I think Karen also wants to make a comment.
MS. TRUDEL: I can't disagree with most of what has been said, either, especially with respect to, wouldn't it be nice if the addenda were published.
I just want to raise a couple of minority views that I have heard from people that I think need to be balanced against the needs and proposals that have already been put on the table. These are not necessarily things that -- these are things that I have heard from other industry players.
We do have in the fact that we use the administrative procedure act regulatory process some guaranteed checks and balances for people who may feel that they are not full players at the table in some of the standards developing organizations, who may not feel that the DSMO process is -- they may not feel comfortable that the DSMO process is going to represent them necessarily exactly the way they would like to see it happen.
Some people do feel that the regulatory process guarantees everybody openness to the process, the ability to comment and to be able to do it in a public way, and to insure that that comment must be addressed in some manner, that there is a certain amount of fairness in that. We have tried really, really hard at CMMS and at HHS to be divorcing the needs of any programs that we run as covered entities, so that there are people who feel that we bring a very balanced and judicious view to things, and that we don't have a vested interest in the outcome.
So there are some balances that we have there that I think we have to think hard about before we remove them from the process.
The other things is -- and I know this has been talked about a lot -- I think it is very difficult to define what is a change that is not significant. I'm not sure that I agree with Ed that a change that is not structural is not significant, in a business sense. I think there are some organizations who might say, I don't care about the structure. If you change the number of possible codes that you can put in a particular data element and you take one of them away or you add one and you make me use it, to me that is significant to my business process, and I don't feel like I was represented in the discussion there. So those are some things that I think we need to be aware of as we balance these issues.
DR. COHN: Jim?
DR. SCHUPING: I was wondering, Simon, in the amount of time that we have to deal with this, would it make some sense to take the two or three major issues and spend a little bit of time on each? Like, let's talk a little bit about resources, maybe talk a little bit about process, what can and can't be done, and then maybe the collaborative effort going forward.
I would gather in that process there would be some residual issues that come out we can also go to.
DR. COHN: Sure. I guess one question I had as I was listening to some of the testimony, was everything here that you were commenting on focused on the administrative and financial transactions? Or was there also -- we did hearings on the privacy during the fall and winter, actually during the fall period, and we heard a lot of issues around timeliness of FAQ responses and all of this stuff. It is sounding to me like some of the same issues, so I wasn't sure whether they were related to privacy or whatever.
Can you comment, or can others? My sense from you was that you were talking a lot about privacy.
DR. TATE: I was. Frank will be here to discuss any concerns with coding and standards and all that. He has pretty much handled that up in Chicago.
But it is the same kind of general -- we get a call, what are the rules, what do I have to do. What do we tell them? They want to know then what are the rules, what do I have to do to comply. We don't want to tell them, there is an addendum coming out, something coming out, call me back in six months, because they won't call back. So it is a sense of finality, do this, especially when this has to be done just around the corner, and you will be in compliance, because that is what they want to hear: will I be in compliance if I do this. That is what we struggle with, the this, in ADA.
DR. COHN: And giving a quick response about, this is okay. That is a good point.
DR. REYNOLDS: Simon, the only reason I mention privacy is, a lot of us are implementing both of them at the same time.
DR. COHN: Understandable.
DR. REYNOLDS: I think -- and I know OCR is stepping this up, but I know we have offered through CMMS, since we have done so much training of our employers -- and I'll tell you, the employers are a lost entity in the privacy. Every phone call that is going to come in from us from an employer will change dramatically under the privacy law, and we will look like we are an ugly checkpoint. We will look like we are interrogating people, and they are not going to understand some of these things. So we are also anxious to help OCR and others in taking some of the documents that we have produced on the ground for our face-to-faces with people, give them to OCR for use in discussing that.
Again, the word employer is kind of an ugly word in there, because it is broken into two things, plan sponsor and group health plan. All employers turn their head. But every single employer that does anything for their employees related to their health care including helping them fix claims is going to get it right in the mouth here soon. It is going to look like, all of a sudden the big insurance companies and all the others are stepping up to do it. So we are anxious to help.
So I'm glad somebody here is from OCR. I'm going to try to get Sue to give me a card before she leaves, because a lot of us would like to give them some collateral that they can use, that we have been using, because once these small employers and other employers understand this -- we spent three hours with the state of North Carolina, the state employees association, yesterday, with their health plan, 450,000 covered lives. They were in yesterday for three hours. We were teaching them how they need to deal with their own protected health information.
So on the ground, there is some action going on, and I agree completely with Mike. So that was the only reason I mentioned that. It is also a good opportunity to get hold of somebody and try to offer some of the collateral that we are all using on the ground, and they can use it, and then can get it out to the people, and it is going to carry a lot more weight when it comes out from OCR than some of us.
DR. COHN: And I think Sue actually has some cards that she is getting ready to pass out.
DR. JONES: I think from WEDI's perspective, there are three issues. The first is the lack of consistency with the regulations across the board, because they all are interrelated; coming out in a timely manner so that investments by business can be more efficacious.
The second relates to the transactions for which there is enormous effort and investment going on, yet there is tremendous uncertainty as to what the final outcome is going to be.
I think the third, in terms of our discussions relating to this, I think it is less focused on privacy. It is more focused on the lack of having the security rule out, which is with security safeguards required by privacy, having ambiguity as to what that means. So again, it is investments being made in those areas, but there is really no framework. A framework may come out that could change or alter the course of those investments that have been made.
So looking at it from a business standpoint, it is really from an ROI perspective that we have taken this.
DR. COHN: Sure. Now, Jim, you had tried to pull us back into the one, two and three here, which in my view makes a lot of sense. I know Karen was commenting. I think one of the questions we have is obviously -- I think we are all in favor of predictable process. The question is, how do we do it and what does it mean.
Now, unfortunately Karen just walked out, but I was going to comment. She had made a point about the issues of code set changes. I agree with her that code set changes are sometimes a major issue for plans. One would observe that if you are an external code set, you can pretty much change your code set at will, but if you are an X-12 code set that is external to the standard, then obviously right now you are mired in the regulatory process.
So in a sense, the way things are working right now has been to really force a lot of the decisions around X-12 to be done through external code sets. You see that -- and I'm trying to think of what it is called, it is what MUCC has in their UB.
DR. ZUBELDIA: Bill type?
DR. COHN: No, it is not bill type, but it is various codes.
DR. GREENBERG: Condition codes?
DR. COHN: Condition codes, thank you, condition codes, that appear to be a direction that the standards may go, because among other things it provides flexibility to respond to a lot of business needs, that they actually had to be in the standard, and had to become structural. You couldn't do it in a timely fashion.
I don't have an answer to this one, but I am aware that this is -- we want predictability, we would like less regulatory overhead; where is the balance here?
DR. SCHUPING: I have a question, and maybe there is someone here in the room that has the knowledge and the legal background that can answer this.
We are not certain how much latitude within the laws that govern the regulatory processes, how much latitude there is really for implementing change and taking certain types of innovation and putting it through a fast-track process, if you will, such as Ed described.
I don't know whether anyone in the room here is that familiar with the regulatory aspects of that, but it would be interesting to know what can be changed without Congressional action, for example, how much latitude do you have to make little tweaks in the process to speed things up.
DR. ZUBELDIA: Let me see if I understand what you are saying. Expanding on what Simon said on code sets, the external code sets today are maintained by external entities, UBC, CMMS, HHS. When any of those code sets change, there is no need for a regulation change.
The external transactions are maintained by an external entity, not by the government, by X-12, and the external implementation guides are maintained by X-12. The HIPAA implementation guides are maintained by X-12.
So if I hear correctly what you are saying, you are saying that perhaps those implementation guide changes should follow the same path as the code set changes, and be maintained externally outside of the process. Is that what you are saying?
DR. SCHUPING: If that is an acceptable way to go, it might be an option. It might be an option. I just don't know if there are any land mines to doing that, or any kind of problems that we would run into.
I'm kind of stepping back and just trying to take a fresh look at this, kind of like what Ed posed in his comment. If we were starting HIPAA today, how would we do it, and can we make any changes.
DR. COHN: Unfortunately, Karen is not here to tell us that everything we know is wrong, but when we talk about minor maintenance changes, which of course I don't know what that means exactly, but it sounds good. We have no idea what it exactly means. Is the suggestion here that in a very pragmatic way we consider all X-12 code sets to be external code sets, and suggest that the Secretary consider them as such? Is that really what we are talking about?
DR. ZUBELDIA: I'm not sure there is much difference between minor maintenance and major maintenance.
DR. COHN: That was my question.
DR. ZUBELDIA: The HCPCS does are undergoing major maintenance right now, by removing all the local codes and putting them as national codes. That is a very substantial change. However, there is no regulatory notices. There is no M, there is no final rule that says the HCPCS codes now will be this HCPCS table.
I think that that distinction between minor and major maintenance is probably irrelevant. I think if the Secretary adopts a code set or a transaction set, the NCPVP transaction and NCPVP maintains that transaction set, what is the problem with that? The same as the AMA maintains the CPT codes. If there is a change there going from CPT-4 to CPT-5, that would be something that may be adopted by the Secretary, but changes within CPT-4 from year to year is just routine maintenance. Perhaps the standard transactions could go the same process.
Even if that routine maintenance changes something structurally, such as the way of handling the MPC codes, that has happened in the addenda. That is a structural change. However, it is a structural change decided within X-12 with an open process, where everybody can participate.
DR. COHN: Actually, I thought Dr. Zubeldia was going to recuse himself from the entire conversation. I'm giving you a hard time.
Let me ask the others, what is minor and what is major?
DR. JONES: We have no definition of structural, non-structural, minor or major. What we were really focusing on was coming up with a process -- someone would have to make those definitions. But coming up with a process that was more expeditious in the M process, which has a certain set of guidelines, but the end game is always uncertain in terms of when the publication date of the final version is going to be. If there were more predictability to that process, then I think the definition need fades away.
DR. COHN: So your main issue is, if we can get HHS to do a predictable yearly update process, that really solves most of your concerns?
DR. JONES: I think it would solve a number of the concerns in this area. It also relates to, there is an enormous amount of innovation going on in the industry now. I am looking at it from my own perspective, but I think many of the people involved in this area three or four years ago would look at the payment requirements and the remittance advice and the premium payment as, the banks have been involved with that, they have the payment clearinghouses and so forth.
Less emphasis has been put on that, but all of a sudden the banks are taking a key role in this area, financial institutions; how do we now make a more cost effective payment mechanism, and how do we integrate health care clearinghouse type functions with payment clearinghouse type functions.
There is a concern in that community in terms of making fairly substantial investments to try and resolve that. If we make those investments, are we going to be mired in a regulatory process that is unpredictable. That is one of the concerns on innovation that has popped up both in conversations with IMAC but also within WEDI as well.
DR. COHN: Ed, can I ask you about this one? Yesterday we received notice of the first approval of the exception to the use of HIPAA standards to test proposed modifications to those standards, which as you remember is part of the HIPAA rule.
Now, is that a process that you are -- to me, the question of innovation is how do you test innovation, as well as how do you implement change. Is your view of innovation that suddenly you come up with a new standard and everybody adopts it, and that is the way we innovate? Or where does this testing fall into all of this stuff? Is there a need to test any of this? Is there a multi-state need to test modifications before they go nationally? Or if they are good ideas, do they just go forward?
DR. JONES: No, I think there needs to be a melding of those processes. Obviously within X-12 you have a vehicle for doing that.
I think at this particular point in time -- and when I mentioned if this were enacted today, we are in a totally different environment. The Internet is much more dominant. We are dealing with new payment mechanisms that weren't even considered six, seven years ago. These processes outside of health care are moving on one track, health care is moving on another track, a different regulatory track. It is how do you meld the two so that they have some commonality, some efficiency in the processes.
I am getting this response from the financial institutions, who are on the verge of making billions of dollars of investments, new types of payment mechanisms, not only for health care, but mainly plastic, to eliminate paper and the check processes that are very costly. They see the bumps in the road with HIPAA.
How do we pull these two together so we have a more smooth track to move forward? I don't know how we are gong to solve the innovation and the regulatory process, but I think we have to come up with some way to meld those.
DR. REYNOLDS: I'd like to make a comment on that. When you mention X-12 and all the others, right now in any of the legislation, X-12 has no authority, correct? When we have all gone to HIPAA, we have gone to HIPAA to standardize.
Our implementation that we are going through right now is trying to standardize. Remember the hospitals, remember the doctors, who are dealing with many, many payors, many, many entities in many, many ways. I know the issues are somewhat of an answer for them on that, but that is one of the reasons that you all headed that way, was to make it easier, so that we did it one way in one structure.
So if we start saying that X-12 is the answer or this is the answer, then have to somehow when they have that authority to make that decision. I can tell you that there is an emphasis in North Carolina right now where there is a large payor in North Carolina that is looking to use other than the standard codes for EMS standards, because they can't get the codes they need.
I don't care if that is right or wrong. The whole legislation that you put down is for us to be together. So we have to be careful. I agree in speeding up the process, but if you come up with a whole new process, you have got to be sure that you pull these people that you allow in the process in. Otherwise, most of us right now have gotten where we are in -- in my case, 24 years of one provider at a time to get to 90 percent hospital and 75 percent physician. If you now make all these other committees and it is not mandatory for us to follow some of these things, we are going right back there.
So I think we have got to be careful. We have got to speed up what we are doing. I am comfortable with that, because I think we can't wait for all these things to come out quite as slow as they are. I know it is good to get everybody involved, but I can tell you right now, there are people who are still lost. You can have any process you want to; they are not waking up. We are seeing them every day. We are seeing them all day every day.
So you are going to lose some of them in the process anyhow, but if you turn it into that X-12 gets to make this decision and somebody else gets to make this decision and so on, back in my own world, how do I implement that so that I can tell Duke Hospital and I can tell the University of North Carolina hospital, here is how we are going to do business, and it is going to be compliant based on the federal regulation that somebody is going to check us on. We have got to be real careful.
So I am not interested in blowing it up. The minute you start eroding it, then you are getting rid of what you have asked us all to implement and be in place by. So we have got to be real careful with that.
DR. COHN: Since Karen has been out of the room, we are all trying to figure out -- we all know what predictable means. I think we are all in agreement that we would like to see a predictable process. But now we are talking about, are there things that we can offload from HHS, regulation.
Karen, for your benefit, we were talking about this issue of code sets, that external code sets are somehow handled by external entities and can be changed at will, whereas things that are part of the standard somehow fall into the process.
So I was throwing out, do we recommend that all code sets be considered external for the purposes of the rule. That is one option Harry is evidencing concern, which I do understand; suddenly if everybody can start changing these code sets at will and you have 150 different code sets that everybody is changing at will, how do you deal with implementation, and does that create chaos in the name of innovation.
Is that what I am hearing from you?
DR. JONES: Let me give you an example from the banking community. Anyone in this room can go to an ATM and the rules governing that, whether it is in this country or elsewhere on the network, are very explicit and standardized. I don't think we are getting close to that.
One of the comments that came up in the WEDI meeting was, as a result of the processes we have gone to to create standards, we have got to put everything in that everyone wanted, and leave some things out. But we haven't created a set of standards that are efficient in the process, in moving information in order to -- I don't have the exact quote with me that someone said yesterday, but it is really focusing on the business returns to moving information efficiently.
For the self-funded industry and a work group that I co-chaired years ago, we came up with all of the types of products that we were talking about using in that industry, and then had an external group that would maintain that list. So it would be not changing any of the structure or the format of the transaction, but the content as new products came out.
There is a feeling that because of the process we go through today, it takes too long to do that. It stifles innovation. So if we could expedite the process, -- it is the unpredictability at the end of the M process that is a concern.
DR. SCHUPING: Karen, in your comments you made reference to checks and balances as being an important part of the review process. What is involved with that? Is that part of the delaying things that we see in the overall review process, these checks and balances that are built in to make sure that all the various interests are considered? I guess I am just asking for your personal opinion.
MS. TRUDEL: Actually, I meant that in a general sense. The publication in the Federal Register and the solicitation of public comments and then the process that we go through internally to review, analyze and respond to all the comments, does have the effect of providing some sense of confidence for people that they are being listened to, who may not derive that sense of confidence from the ANSE consensus groups.
DR. COHN: Dr. McDonald? Do you want to introduce yourself?
DR. MC DONALD: Clem McDonald from Indiana University. This is a really interesting discussion, and I don't know if I can make anything better. But it sounds like there is at least one thread that I would like to label stronger. There may be a rationale for at least picking some fields that are in some of the standards, and saying that those code sets could change without going through the regulatory process. That could help some things. That is in fact what has happened with external codes like diagnoses and things. To say that you would like them all change would be a little radical, because some of the fields are actually equivalent to structural changes when you change codes.
So I think that is maybe something we should think about. It wouldn't solve the problem of a whole new technology, but the good part about having a regulated standard is that at least in theory, everybody has got to use it. The bad part is that it is regulated.
The ATMs, nobody has to use an ATM, so there isn't the same thing, like this privacy standard, where everybody is bound to it no matter what. They are interlocking in some very, very complicated ways, which have never happened before.
The regulatory process, one of the bad things about it is that it actually gives voice to teeny voices that may not be relevant. It gives loud strength to those voices. I don't mean relevant in the sense that they are not good people; it is just that in the big force of economics and all that, it is just not -- and it wouldn't happen in any other circumstance.
The ANSE process as I know it and have been participated in in various standards, it invites everybody in. So you hear people say, I don't want to go to that meeting or whatever. So it is a tough issue. They react by sending letters, then it is really hard to get the dialogue going.
So I don't know if we can do anything about it, but it does create some really heavy burdens. I think we are talking about the clinical message standards; many people who talk about it think it shouldn't be regulated, they should be stimulated and encouraged. That may in the long run be a better way to go for lots of things, because then there are consenting adults that decide to do things or not, rather than being forced to do it.
DR. COHN: Your last comment, I thought about it a fair amount, and I know Kepa will probably speak to it. I guess I was a little concerned about trying to run the voluntary model for financial transactions. I think I would worry about that being the direction we were advocating.
Kepa?
DR. ZUBELDIA: I am going to be a little bit critical here, but I would like to take a look at the ROI of the regulatory process and the value added of the regulatory process.
There is certainly no question about the value added in making a comment period, where those tiny little voices that would otherwise not be heard can be heard. But specifically for the EDI transactions, X-12-1 CAPT transactions, many of those voices raise a big issue, a big concern. Those transactions cannot be changed through the regulatory process. They have to be sent back to X-12, which is an open consensus process.
Then there is an additional level of checks and balances with the DSMO process, where you have other standard development associations and WEDI and ADA, and an industry group of referees that approve finally the implementation guide for adoption, essentially.
What the regulatory process brings as value added is the finality, the opportunity for little voices to be heard and finality to that process. I think there is opportunity for the voices to be heard throughout the whole process. And of course, some people won't voice their opinion until the very last minute, and that is an opportunity. If your opportunity to voice your opinion at the last minute is with the DSMO process, then if the finality could be with the DSMO process, we would avoid all of these additional regulatory steps that could be perhaps done with a simple notice that says the DSMO have come up with this new version. It is a good place for adopting whatever DSMOs adopt.
I don't know if that is feasible in the regulatory scheme or not. That is for us to address. But I think the value added of finality is very important. Perhaps what you are looking for is putting the finality point closer to the developers rather than closer to the regulators.
MS. TRUDEL: Again, I don't disagree. But I want to be clear on what we are hearing. I'm not saying it is from a majority of people. It may be from some of those tiny, tiny voices.
It seems that not everyone is comfortable with this process. It is essentially untried. It is in its infancy. We have done one round of fast-track changes. There has never been a complete run-through of the entire DSMO process, hearings before NCVHS. There has never been one full regular normal cycle of modification. It may be that one full round of that cycle will make peoples' comfort level increase.
What I am sensing is, those of us who are involved in it and active in it I think do have that comfort level. People who are seeing it from the outside may not yet, because it is still untried, relatively.
DR. COHN: We have two new people at the table here. Would you both like to introduce yourselves, and do you have any comments that you would like to make? I recognize that you have no idea what we have been discussing.
DR. WARD: I'll just agree with everything that everybody has said so far. Maria Ward with Price Waterhouse Coopers, here representing Health Level 7. I imagine as we get through discussions, probably also my experience is with PWC and our clients.
MR. POKORNY: I am Frank Pokorny with the American Dental Association, representing the DSMO steering committee and the dental content committee.
DR. COHN: Just to tell you both where we are because I think is relatively simple, everyone probably around the table and probably everyone listening over the Internet all agree that there is a need for greater predictability to the HIPAA process. I don't think that is an issue that we need to argue about.
I think the issue that we are mulling about, are there ways to streamline the regulatory process in addition to making it more predictable. I think that is what we have been looking at mulling about, are there some things that can be done to all of that, and would that also contribute to greater predictability.
I think we are all hearing the pluses and minuses, and is this really the time to do things or not, are there ways to maybe take some steps. There are obviously radical revisions. There are also steps in that direction.
I don't have the answer to that one. I'm just trying to frame the issues as best we can. But I think that is the issue that we are struggling with now. Recognize that the National Committee, or at least the subcommittee, would like to come up with some sort of a letter for the full committee in February, recommending whatever it is that makes sense, so we can send to the Secretary something that is a thoughtful view that has your input and hopefully the consensus of a fair amount of the industry.
DR. JONES: May I comment?
DR. COHN: Ed.
DR. JONES: I'd like to go back to what Kepa was saying. I think the relatively ROI of these processes is a very good way of looking at this. There is a very positive value add for finality predictability. But you can't look at this in a vacuum. You have to look at it in context.
If we were dealing with this issue four years ago in a relatively stable cost health care environment, four to five years ago, it would be very different from today, where everyone is concerned about rapidly escalating costs. All the health care stakeholders are experiencing that.
If I may use Harry's example of 75 fulltime equivalents working on HIPAA, yet we have this uncertainty as to whether we are talking about 4010 or 4010A. This was believe me a big issue in our board meeting yesterday. We are talking about enormous costs that diminish the value of return on investment, and in fact may turn that into a negative.
So I think that becomes a very important issue in trying to look at how we can enhance predictability, in that context of an escalating environment. No one that I am aware of sees any alleviation there in the near future. Yet we have these costs beginning to escalate because of the regulation. I think we need to focus on that.
DR. REYNOLDS: I would also add that every time a decision is made -- let's take a 4010 and a 4010A. Once a decision is made, the whole industry has to line up to it. So the timeliness and the preciseness of the decision adds to the quality of whether we can line up.
You have got people right now, a lot of people are done with 4010. Those numbers people are done with that. They are testing it and going full speed, most people are that are the players. We have got to go against it. There has been stuff on the wires lately, it is illegal to go to 4010A. Well, but from a business standpoint, from an ROI standpoint, I can't spend any more with those 75, and I can't spend money with consultants, and I can't spend money on anything else when I know my only way to become compliant in October, based on what the reality is, is 4010A, and we'll get smacked if we're not.
So where are we? It is like having an aircraft carrier. You've got plenty of fuel, you've got plenty of planes, you've got plenty of everything else, I don't have a motor running. I can't turn it anywhere. So I am sititng there all ready to go, but I can't get there.
So those are the kind of things that, when the process has to be more precise, more clear, and it has to understand the real industry you are driving. If you have decided to standardize, then you are in front of the industry. So standardize and get in front of it, or figure out another process that is going to move a little faster. That is all I think we're talking about.
This industry is sitting there, come on, come on. Everybody is in the starting blocks. Some people actually ran around a few times, but that is practice, 4010. We have got two or three people that have posted great times in 4010, but that is not the race. The race is 4010A. That is where the trophies are going to be.
DR. ZUBELDIA: I'd like to ask Patsy, what is the race in NCPAP? You said you are retrofitting NCPAP 5.1 to fit some of the Medicare requirements into 5.1. Are you going to release a new version of the implementation guides for 5.1 that includes retrofits?
DR. MC ELROY: No. We are just having to look at the fields, Kepa. The needs for Medicare were not -- Medicare was not at the table when 5.1 was developed, as were some other players. That is not new within the other X-12; I'm sure there were some people that weren't there and have to implement that standard.
So what we are doing is, we are looking at the needs and requirements of Medicare, and we are seeing where we can put some of those needs in the existing standard and still maintaining the standard integrity. It is things like facility IDs and very small minutiae sort of things that we have to go in and say, is this a prior segment. It gets down to the nitty-gritty detail, but we are having to address those needs right now.
It is difficult at best, but it is like, we have named a standard or we have named a version, and now we are having to go back and fit needs into those versions. That is our concern about the future; if versions are named, is everyone going to be there to say this is what I need.
Did that help you?
DR. ZUBELDIA: So when you address those needs, there is not going to be a new implementation guide issue for 5.1. They are just going to --
DR. MC ELROY: No. What we could address is in the editorial document. We have an editorial document that says, here are clarifications to implementations. There would be some clarifications in the editorial document.
DR. ZUBELDIA: Okay. Does that compare with the companion guides in X-12?
DR. MC ELROY: Yes.
DR. ZUBELDIA: Except that NCPAP has one for the entire industry.
DR. MC ELROY: Right.
DR. ZUBELDIA: And X-12 has one per payor, right?
DR. WARD: X-12 doesn't have any. Payors who think that it will be helpful and meaningful to their providers to create something that hones in on any specific needs for that payor are creating companion guides. That is creating a lot of frustration I think for the provider community.
I agree with the intent. The intent is sort of like testing, but not knowing what you are supposed to be testing. They are trying to tell them before they start testing, here is the stuff we need as a particular payor. But I wouldn't compare that to any standard produced document. I think it is different.
DR. COHN: Jeff?
MR. BLAIR: Maria, help me understand the companion guides a little bit more. Are you saying that if a payor offers a companion guide, it is clarification and guidance? Or are you saying that it begins to offer unique requirements, which tends to degrade the standardization of the X-12 message to the payors?
DR. WARD: What individual payors are going to do obviously I can't attest to. But it is intended to be the former. Within the implementation you still have some degree of flexibility, and that only makes sense. For particular data elements within an implementation guide, you can have some set of valid values, one through seven, let's say, even if it is a qualifier that identifies what type of payor you are.
So some payors are taking the step to say, one through seven is valid, but for me, each and every time you and I do business, provider, it is always going to be three. It is always going to be the code that identifies me as Blue Cross.
So they are trying to -- it is not intended to go above and beyond anything that is defined in the standards. It is not intended to change anything that is defined in the standards. It is intended to almost be a reflection of what are their edits, what are their specific requirements for certain things, so that the provider doesn't have to try to figure that out. The only way they actually get to a point where they have clean transmissions is through many iterations of testing. It is intended to --
MR. BLAIR: Okay, that is the intent. When the providers see these companion guides, do they find them helpful, or do they find them frustrating, because each one is different?
DR. WARD: It is interesting. I don't know to what extent you all might have talked about something before I came here, but I think I mentioned in the last hearing in December that there was a joint initiative undertaken between WEDI and CAQH, Council for Affordable Quality Health Care. It was in response to this idea that each payor that does create a companion guide might have at a minimum a different look and feel to that guide. So every time a provider got one, they would have to figure out all over again, how do I navigate my way through this and how do I understand this.
So WEDI and CAQH through outreach to the industry, broad industry representation, payors, providers, lenders, I was part of that with PWC, created a standard template, or a standard look and feel for a companion guide. They are encouraging right now through marketing and some other efforts, encouraging all payors to at a minimum take a look at it and consider whether they could live with that standard.
So you can't specify the data content from payor to payor to payor, but at least you can make it all look the same, so that the provider receiving it can have a little bit easier of a time of it. And providers that I have talked to about this are very supportive of that concept. The challenge will be getting them out there.
Some payors have had them already distributed, created and out on the streets for the better part of a year even. Some payors were doing this long before HIPAA. So we are trying to encourage those payors to see if they can take their data needs and transport them in this standard.
But generally, the providers are receptive to the idea, as long as they are not trying to figure out how to read 300 different kinds of companion guides.
DR. REYNOLDS: Let me give you some specific examples of what we would put in a companion guide as a payor. A lot of the things that are in the HIPAA standard -- for example, you can have a date of admission in the date of service. There is no edit in HIPAA that says that they have to -- you would like your date of service to be after your date of admission. There is no edit out of the X-12 that does things like that right now.
We put that in the companion guide, because I promise you, if you do the service before you admit the patient, we will not pay that claim. That is a fact. I know we are accused of a lot of things as payors; we are not going there. If it is not when they are in the hospital, they are not going to get it done.
There are many situational elements under the HIPAA regulations. The situational elements are there to take care of situations, by definition. We have to define those situations based on the procedures that that provider does, and what our agreements, whether it is contractual or by other means to process that. If we are doing electronic transactions, it has to be clearly stated in a way that we do that.
Now, that is in the regulation. That is part of your standard. We set it up so that we can do business. We are doing business. We are electronically agreeing to format.
MR. BLAIR: So these are edits and clarifications, and they are not inconsistent.
DR. REYNOLDS: They could be inconsistent between payors, because one payor could decide this is a situation and another payor can decide this. But guess what? Those hospitals have contracts with those payors based on what procedures they are or aren't doing, based on what has been the contract.
So again, this is a conduit for us doing business. It does not tell us that we can't have special agreements. We can't do special things with special providers. If we do it, we have to have this information.
So that is why they were put in, that is part of the reason. We were staunch supporters, and sent in our format of our companion guide to Maria's group to do that, because we firmly believe you can't have providers trying to find somebody's situational items in section six and somebody's in section ten, and we are writing in all different styles. It has got to look reasonable. Otherwise it is a free-for-all again.
MR. BLAIR: But they are not inconsistent with X-12 or the implementation guide for X-12, though.
MS. RAY: Say that again?
DR. ZUBELDIA: Jeff, let me answer that. Jeff wants to know if they are consistent or inconsistent with an implementation guide or with X-12.
Just in the last week, I have seen e-mails come in to me through the mailing list on companion documents that are clearly contradictory with X-12 or the implementation guide. This is something that is becoming a tsunami. It was a little ripple at first, and now it seems like every payor finds the freedom to do things their way.
I am going to refer only to things that I have seen in the last week, but I have seen companion guides that require the use of a payor specific identifier, even though it is qualified as an NPI or a social security number. They say they don't want social security number or the NPI, they want a payor specific ID.
There was another one that said they want the dollar amounts with two zeros, such as 5.00. Well, health syntax requires the dollar amounts to have trading zeroes suppressed. So it is against health syntax to send 5.00 for dollar amounts.
Another one said that they wanted 250 service lines in the professional claim, because their system cannot handle more than that, although the HIPAA implementation guide says you can go up to 999 service lines.
I saw another one that said they were only going to accept four diagnoses, where the implementation guide allows for nine. If you send nine, they are going to reject the claim. They only want four because their system can only handle four.
These are the things that are happening. I agree with Maria that they shouldn't happen. All implementation guides should be what you need and the companion documents should be consistent with the implementation guides. But the reality is that what started as a minor change is growing to be where every payor is asking for whatever they please through companion documents.
In talking with a HIPAA expert lawyer here in D.C. the other day, I brought this up and I said, how is this possible? He said, what are companion documents? Are those defined in the regulations anywhere? Is anybody allowed to have companion documents? We couldn't find anywhere in the regs that it talks about companion documents.
It talks about trading partner agreements and how the trading partner agreements cannot go against the implementation guides or X-12, but nowhere it talks about companion documents. Everybody is using companion documents to twist the implementation guide their own way.
DR. COHN: Kepa, I am hearing your concern, and I think it is certainly a valid concern, and Maria may have other comments.
To me, the issue here is that I think the intent of companion guides sound like they are useful to assist providers with implementation. You only have to look at one of these implementation guides, especially if you are a provider, to know that you don't want to do that very much. You have got to be a pretty large provider to take the unadorned implementation guide and do anything with it. So that is reality.
The big issue you are bringing up, which I think is very valid, is if the implementation guides start modifying or changing the implementation guide or the standard. I think that is something the HHS needs to monitor.
DR. REYNOLDS: I would also like to challenge the word every. You used the word every.
DR. ZUBELDIA: I'm sorry, I didn't mean to.
DR. REYNOLDS: You used the word every. This is an open discussion. The point is, most of the payors understand what the X-12 means and what those requirements are. We also know that we can be audited by CMMS, we can be audited by anybody. If found not in line with this federal standard, we can have plenty of issues related to this. We don't need any of those. We are an industry that doesn't need any of those things.
So I think that there needs to be some kind of -- as we have talked on other things, there already is a responsibility through CMMS to monitor how people are or are not doing the transactions to take care of those situations. But I can comfortably tell you, it behooves none of us to get outside that standard. It behooves none of us that are the players to start trying to jerk this around, because it is not going to work in the end. It is easily found out, and it is easily managed in dealing with it.
You mentioned trading partner agreements. I'm not going to pay a claim. I am also not going to deny a claim if those dates I used as examples don't match, because then I bring the person, who is already under enough emotion of going into the health care industry, may have somebody in the hospital, and I am sending them a denial and I am sending the hospital a denial. The next thing you know, if the process doesn't work in the hospital, they get called if their health care company is not going to pay the claim. Don't act like that doesn't happen. That happens all the time.
So we have got to be careful that we make sure we are dealing with valid information, and where it is not in the IGs, that is good business. I'll face any of you on good business. That is where we have got to get to.
DR. COHN: Maria, you were going to have a comment, and then Clem.
DR. WARD: Just a quick comment. To crystallize, Kepa brings up a good point. Unless now that you have companion guide police to se what everybody is doing with their flavors of companion guides, you are never going to know. The intent behind WEDI CQH -- and we actually had a very long discussion about it; we put some sort of verbiage in the implementation guide to say, look, the intent of this thing is to A, not exceed or go beyond or violate, or all of those things. So we created the intent that you stay within the boundaries.
I would just make a general comment. The whole point of this in the first place is that without a provider knowing what the edits are from the payor, they could be selecting any one of many different options in many different segments, in many different data elements. The only way they are ever going to find out whether they are appropriate is by having claims rejected.
So this was intended -- it is not mentioned in the law, it is not mentioned in the regulation; I think we just came up with the name as de facto in the industry. Payors were doing it long before HIPAA. We came up with this idea to try and prevent that back and forth and back and forth and back and forth in testing, and just get down to, what do I need to pay my claim. If payors could tell providers what they need to pay their claim, providers would be a whole lot happier.
DR. MC DONALD: Kepa's comments were actually quite alarming, but it sounds like we don't have to police companion guides. All we need are test messages, if these are limits sorts of things. That seems pretty horrendous, that someone sends eight diagnoses and they get rejected when the spec says you can send ten. It seems like that should be just flat-out wrong.
It would be fairly technically east to have a fully blown out set of messages you run through them, that HCFA could run through them. But you don't have to read the guides. You just send messages and see if it gets rejected, based on something that is different than what the standard says.
I almost wonder, if there is a lot of that going on, that is the way to solve that. That is where the HCFA or CMMS police would -- they wouldn't have to read the guides.
DR. WARD: There is a transaction, Clem, that was not named in the original. We have a couple of different flavors on the X-12, which is an acknowledgement for the receipt of that. It gives some of them in a very detailed manner, the specifics about licensing. But that is not required to be used under HIPAA.
DR. MC DONALD: You could still send the message, and if it gets rejected, sample these places where there are really egregious differences with the size and the dimensions and the format specs of the standard. It seems like a limit being less than what the standard says would be pretty egregious.
DR. REYNOLDS: Karen, you also have a process on the website that, if anybody is doing that, somebody can go out there and report them. That would make it easier yet.
DR. ZUBELDIA: I saw an e-mail last night from a vendor that is dealing with a payor. I won't name names. The payor has asked them to put the payor-specific provider ID qualified as NPI in the billing provider ID, with the qualifier as if it was the NPI. Since there is no NPI, you might as well use the payor-specific ID in that field, right?
I saw the whole thread of correspondence. The vendor answered back, saying this is an improper use, but I will do whatever you want me to do, because I want my transactions to get through and get paid.
DR. COHN: Frank?
MR. POKORNY: Thank you, Simon. I have been listening to several different comments over the past 15 or 20 minutes. I'd like to work backwards from the most recent discussion of the companion guides.
When I first heard the comment on the companion guide and the discussion of these as being a tool to aid the provider in preparing a transaction that would be accepted and ran through the system, my first reaction was, wait a second, isn't this an imposition of payor-specific requirements to the transaction, in a way? Yes, it is, but is that necessarily bad?
Now I am trying to look at what I think is the big picture, the overall intent of HIPAA, which was to remove some of the waste in the administrative processes, to speed the administrative processes. Aren't we all trying to find a way to insure that information is exchanged in the most efficient manner possible, so that claims can be processed in the most efficient manner possible, and the reimbursement take place in the most efficient manner possible.
I know i am just talking about claims. There are other transactions that are made. Let's talk about money, because that is another theme that has been going around here, too, is money.
So in some respects, I see the intent of these companion guides, for lack of a better terms, as looking towards the higher overarching objective of HIPAA, which is to make it better, make it more efficient, make it more achiever. It does however contradict another aspect of HIPAA, which is, you send the same thing to everybody. If you don't use that piece of information, you throw it in the BIT box. That is a horrible dynamic here, or a little bit of a contradiction.
I'd like to add one more comment on this point before I go to another point. Maria, I think you touched on something very, very important, as we look ahead. Do we want to have the providers, who are all users of the HIPAA standard transaction, learn by rejection? Or do we want to try and help the overall education of every sector of the health care community who have been using these transactions to use them in the most effective way possible.
Now, maybe that suggests a much more significant educational effort that goes beyond individual peer-provider relationships. But it seems to me, what I am hearing over the past couple of minutes is an attempt to try and achieve the overarching objective.
I'd like to go back though to one of the earlier comments that I heard about being ready to implement 4010 or accept transactions of 4010, I am ready to accept transactions -- or it looks like I'll have to be ready to accept transactions using 4010A.
The word that kept on going through my mind was stability. What I am hearing here, what I have heard in some other conversations is, we haven't even had mass implementation of the transactions. How do I know what is right and what is wrong? Companion guides may be the first piece of feedback on mass implementation to help guide the evolution of all the standard transactions.
I go to X-12 meetings, and there is continual work on tweaking transactions. I recognize this as a nobel effort, but it is tweaking transactions on hypothetical what-ifs, or perhaps in some cases a very vocal part of X-12 is saying, I need this for my particular needs, and wouldn't it be good if everybody else adopted that. I am saying, that may be a fair argument, but we are still not refining the transactions based on mass implementation.
There could be a lot of effort being undertaken on the development side that more properly represents dollars that should go towards the implementation side. Just get out there, get them in place, get some real-world feedback.
Is it going to be rough? Hell, yes, it's going to be rough the first six months, and even the first year. But I think we have to look at this as a real transition period, and then make decisions based on that; where do we want to go.
One thing that terrifies me, frankly, is any recommendation to the Secretary within the next couple of years saying, I think it is time to move to a next version of the transaction sets. I am saying, wait a second, on what basis? We haven't even started a real implementation of any of the HIPAA standard transactions, industry wide.
DR. COHN: Frank, you bring up some good points. Kepa I know wants to make a comment. I am going to take one of my discretions as the chair, and after his comment we are going to give everybody a break. Then we'll go back to the conversation after that.
DR. ZUBELDIA: Frank, you bring an excellent point. I think that something that has not been addressed is that perhaps the companion guides are the best feedback mechanism to know what should be changed in the implementation guides for the next version.
Perhaps the DSMO and even HHS ought to monitor the content of the companion guides to identify what is it that is being asked by the payors to do different, so the next version can be improved. It is an excellent feedback mechanism.
DR. COHN: Well, of course sometimes the reason they are in the guides have to do with limitations of the systems, but that is another issue.
I am going to give everybody a 15-minute break. We will get back together at 11:10, and we will continue the conversation. I want to refocus us on trying to move forward in what is it we need to do to make this predictable.
(Brief recess.)
DR. COHN: Can we please have everyone sit down, and we'll get started here?
Before the break we had a number of discussions around these companion documents. I think we have seen good and bad sides to them. Concerns were expressed, as well as, Frank did a very good job of expressing it. Maybe there are some learnings from all of that.
I think one of the questions that we were all mulling about -- and Jim, I'm putting it back in your court a little bit -- is there something that can be done to look at these companion guides to identify if indeed there are some major issues, either variances with the standard implementation or if there are some learnings that ought to be being expressed?
DR. SCHUPING: Yes. I think whether it would be the task group that is currently pulling these together, or an extension of that. Some of the discussions today would certainly merit some kind of a complementary study and a review of some of these issues to see exactly what the ramifications are.
DR. COHN: Okay.
DR. SCHUPING: And I think we have the volunteer capability to do that.
DR. COHN: Do you think that would be something we need to see in a paper, or do you want to come back sometime in the future and share the findings?
DR. SCHUPING: We would certainly be willing to come back and do that.
DR. COHN: Okay.
DR. SCHUPING: If this is the first of a series of discussions on these particular issues, we certainly could incorporate them in that format, too. Whatever would be best for this committee.
DR. COHN: We are obviously exploring. My question when we started off the day was, do we have some very obvious recommendations to make to the Secretary. We may decide by 12:30 that we have some, or we may decide that this is the first of a couple of conversations, where we need to come to a common understanding.
I don't know what the answer is at this point. It is hard to send a letter to the Secretary saying do good things and at a high level, make this stable and predictable. But we can't agree how. So I don't know where we're going to go.
DR. SCHUPING: Yes. The mission of the task group obviously was to get these templates and these companion guides as a project out there so people could learn from it. But I think in the process, we are learning some things, too. I think there were some really good points raised here earlier.
So it seems to me it would just be logical and good business for us to circle back, gather the data that we can gather, and then make a report on that at the earliest possible time.
DR. COHN: Okay. Clem, you had a comment?
DR. MC DONALD: You go ahead, because this is a slightly different thread.
DR. REYNOLDS: You could ask Karen a frequently asked question that she could put on her websites, which is about this; can anybody stray from the IGs as part of their companion guides, put out the answer. I think even while Jim is getting the results, you would send an alert to the industry, because again, most of the players are watching those frequently asked questions pretty significantly.
So I think that would be an immediate way to make an impact, and then let Jim continue to get information from others as to what the inherent problems are.
DR. COHN: Great.
DR. MC DONALD: Along the same thread, I would like to at least keep open the idea of a test set or some mechanism by which the mechanical parts can be challenged, if they are limiting the fields.
I heard at the break that there actually is an outfit that provides a system that actually checks messages, so it is definitely doable. That would save everybody a lot of time, if you are doing seven and you are supposed to be doing eight, or whatever the dimension is that is not working right.
DR. COHN: Are you looking at one of our committee members in this discussion?
DR. MC DONALD: I don't know.
DR. COHN: You work on this, Clem. I'm sure you understand this probably better than most, that the reason that there may be some deviation from the implementation guides is not typically because it is an issue of not understanding the implementation guides. There is obviously fundamental system issues.
DR. MC DONALD: Yes, but the problem that is going to create doesn't matter. It is going to make it such that people can't expect a valid message to get accepted.
DR. COHN: Right.
DR. MC DONALD: And that is the worst sin in all of this. I agree there are a lot of subtleties about what you need in one message. I'm not talking about that. I am talking about the basic syntax and the number of repeats and those kind of things that aren't accepted. That is going to be a big problem.
DR. COHN: Yes, I think I understand what you are saying. Usually the owners of the systems know.
DR. MC DONALD: Oh, sure.
DR. COHN: It isn't like, oh my gosh, I didn't know, and based on my test set I have suddenly discovered that there is an issue. It is usually, I know I can only take four, and that is why I put this into that. That was really my comment.
Who are you suggesting do what with these?
DR. MC DONALD: I don't know what I'm suggesting, but in terms of something that an agency or an organization could do would be to probe them, or to caution them they might be probed with a given test set at some intervals or at unpredictable intervals, and send a message in that looked like from a physician and see what happened.
Or at least to be thinking about how one could -- again, there is no interest in having to read 5,000 companion guides, but the full range of the messages it should take. That would be the question. Hearing about the companion guides, we heard a couple of series that they may actually say we are really doing less than what the standard says, and we will reject the message if you do as much as --
DR. COHN: I think what you are describing is an interesting issue. I do know that at least from things that I have seen from the CMMS HIPAA national office is that they were not doing proactive enforcement, which is what you are beginning to describe, I think.
DR. MC DONALD: I wouldn't like to call them enforcement. I think it is not a matter of the issue about, are they doing this or that yet, but that they can't -- the thing that is unfair about this is, the game here is that both sides, the providers and the payors, are playing by the same rules. If you have payors cutting back, you want to send a lot of diagnoses to make these matches work. So that is a particularly sensitive one.
If you have got ten diagnoses, you send four and you thought you were sending ten, even if they just strip them off, you may find you have got medical necessity breaking, because one of those diagnoses covered the medical necessity. Then you go to jail.
So I think it would be very destructive to the process to have those kinds of differences occur and have messages rejected on those bases. I think maybe FUA would be the answer, that you cannot do that kind of thing and expect to be in a happy world.
DR. COHN: Karen, any comments?
MS. TRUDEL: No.
DR. COHN: Okay. Anything else on this issue? Going back and asking about this issue about predictable and stable processes or whatever, is there -- we have thrown out a number of various things.
I guess my own view on this one is that I think that suggestions that require legislative changes are less likely to happen than things that require regulatory changes. I think things that tweak things or that require Secretarial redefinition are probably more likely to happen than things that require more work. Are there other things that need to happen, or are we at this moment wanting to -- other than saying, let's get things predictable, let's make it look like the Medicare payment yearly changes and all of this, are there things more that we want? Maria?
DR. WARD: Jim and I have had this conversation as well,and I don't know if you have already said this in my absence, but part of what would help us is to understand what can we do. We don't know what is so hard fast, whether it is about a regulation or a legislation, that it can't be changed. So therefore, we wouldn't even consider perhaps changing some part of a process.
In other words, what can we do from the Department's perspective? What might be able to be changed that can work through industry versus through either the regulatory process or some other process? Does that make sense?
DR. COHN: Sure.
DR. WARD: We are just not sure what our options are, because we don't know what is so hard fast that it is never going to change, so don't even consider that, because we have to always do that, whatever that might be.
DR. COHN: Jim, and then I have a couple of comments.
DR. SCHUPING: I am wondering if it would even be possible to lay out a schematic of the different kinds of regulatory processes we go through, and examples of what can be done a certain way as opposed to another way.
Maybe if we could look at that in a continuum in the end, and who are the entities that have to interact with that process, it might help us to visualize where the problems are, where the delays are being generated from, and then perhaps that might lead to some realistic solutions, given the framework of what can we do and what can't we do.
I don't know if anyone here around this table, and we have all been dealing with this for several years, has a clear understanding of exactly what the parameters are of implementing innovation to the regulatory process.
DR. COHN: Jeff and then Karen. Jeff, is it on this point?
MR. BLAIR: Yes.
DR. COHN: Okay, good.
MR. BLAIR: In one form or another, many of the issues that we have heard today have been voiced before, in May and at other times.
In the past, NCVHS has included wording in specific recommendations or attached to other recommendations with respect to the need for Ms or for final regs to be on time, or for the process to be improved in some way or other. I have no doubt at all that CMMS and HHS have done everything that they could, but I would like to hear from maybe some of the representatives of HHS that could give us some guidance of how could we craft a recommendation in a way that might have a better chance of being successful than we have been during this last year and a half.
MS. TRUDEL: I think I would like to collect my thoughts for a moment.
DR. COHN: I think Karen wants to mull over things a little bit. Maybe I will fill the void here for a moment or two.
I think, Jim, you have asked a very good question about what sort of regulatory process options are there. Truthfully, I know primarily the M process. I do observe that when we see Medicare, the 45D notices and all of that, there appears to be somewhat of a different process going on, though I have to admit I don't truly understand all of the ramifications of that, and how that differs from an .
I think to me, part of the question gets to be, are there particular pieces or slivers of things, but parts of things that buy re-interpretation of currently existing laws. We know that laws are difficult to change. Once Congress opens something up, you never know how it is going to come back together again. But it really becomes an issue of interpretation; are there other things that can be streamlined or made easier.
Do we for example need to be thinking about recommending -- we recommend primarily to the Secretary. Maybe the Secretary needs to advise standards development organizations that they should consider making more of their code sets external code sets, for example.
I don't know if that is the right answer or now. I certainly was observing that in the whole world of condition codes which we were talking about earlier and all of that, and that is -- at the end of the day, and I am not very happy about this one, but the difference between a code set and a structural change begins to meld into one another. Clem knows this almost better than anyone. But that is a way to create additional flexibility in a system.
That doesn't require regulation, that doesn't require legislation. Obviously it requires very great thought, because I agree with Harry that you don't want to have -- there are a lot of code sets out there already, and you don't want to have anywhere 80 code sets for each individual field maintained by yet different entities on different schedules with different levels of quality.
So I think there is an issue here.
MR. BLAIR: But it is something to think about. Clem?
DR. MC DONALD: I think you accomplish the same thing, or you might accomplish the same thing. First, it had to be restricted by fields, and so it is those things that have very large catalogs that typically are the most useful to make external. But they could also perhaps declare that they would be treated like an external code set within the body of it. There are two ways.
DR. COHN: That is where I was going. I don't even know if this helps. I was just thinking of a thing where there is some flexibility already inherent in the regulation.
DR. MC DONALD: But let's say if somehow UPC became the codes for labelling everything in an institution. You wouldn't want to have to go through a regulatory process every time someone made a new product. So it is things like that.
DR. COHN: And certainly ICD and CPT or all of this stuff are already handled separately. Maria, did you have a thought on this one?
DR. WARD: Yes. There is another side to that. You mentioned that this was something that would have to be thought through very carefully.
DR. COHN: Yes.
DR. WARD: We established the DSMO steering committee for the purpose of having the broadest and appropriate input to changes that go forward in these implementation guides. If you begin to express any significant amount of this data using external code sets, versus through the actual discrete data within the implementation guides, the process for changing those code sets is not subject to that bigger broader DSMO procedure that is in place.
So I would caution that none of us would have any control over the definitions, the definition changes, the subtractions to the condition codes, the revenue codes, et cetera. Right now, the controls we put in place were that it does hit a bigger, broader group. So when we go forward, we are more confident that there was more industry involvement.
So that is just something to consider when you are talking about or considering to express any of these data using code sets versus actual discrete data within the standards.
DR. COHN: Very good point. Frank and then Kepa.
MR. POKORNY: If I could take a slightly contrary perspective to what you just mentioned, Maria, it would still to my mind -- if many of these code sets become external code sets, if we look at the DSMO role in review of the implementation guides as they are put forward as new standards, the usage could be information within the guide itself, that clearly limits use of an external code set, just a subset of that external code set to be appropriate for HIPAA standards transactions.
We could have an external code set with the implementation of that in the HIPAA environment be limited by virtue of the instructions in the implementation guide.
I think we have done that to a degree in some of the change requests that have come forward, looking towards later versions of the transaction sets. I wish I could remember the one from the last couple of months in the 700 series.
But my point is that even if we do have code sets that are external, they could be managed from a HIPAA perspective by instructions in the implementation guide.
DR. COHN: Kepa, did you have a comment?
DR. ZUBELDIA: Yes. I don't think that the code sets being internal or external is going to make that much difference. But Maria, perhaps this is something that you are going to kill me over, but I am going to suggest that the addenda guides could be an experiment for this sort of environment, where the finality to the addenda can still be in the publication in the Federal Register, could be the adoption of the addenda or whatever addenda version is adopted by the DSMOs.
If the DSMOs choose to have a booklet changed, or choose to have some other changes to the addenda, it doesn't need to go to a Federal Register publication, and the DSMOs become the end point of the addenda standard. Then HHS could adopt the addenda without specifying a chapter and verse like is being specified today and say, the addenda as published by the DSMO become the HIPAA standard for these six attachments.
Perhaps when there is something as big as having a new attachment, there could be another rule that says there is a new attachment. But those six attachments are adopted by HHS as the HIPAA standard could be maintained through HL-7 and X-12, and have the DSMO approval process be the end point, and once it is approved by the DSMO, that is the new version of the standard.
Perhaps we could do that without having to mess with the code sets being internal or external. If that experiment with the addenda works, then it could be expanded to the other standards.
DR. WARD: Just for clarification, you are using the term addenda and then you are jumping to attachments.
DR. ZUBELDIA: I'm sorry; attachments. Not addenda, attachments.
DR. WARD: Okay.
DR. ZUBELDIA: Whenever I said addenda, replace the word attachment. I was thinking of the attachment every time. That is where the transcriber is -- I was thinking of the attachments. That is why I said you may want to kill me over this one, because you chair that work group. But the attachments are a great experiment, and the rule hasn't come out yet. Perhaps this is a way where we can experiment with this and see if it works or doesn't work.
DR. WARD: Are you suggesting that the rule not come out, and that the DSMO just make the decision?
DR. ZUBELDIA: I am suggesting that the rule should come out in a much abrogated manner, maybe a one-page rule that says the attachments are whatever the DSMOs decide the attachments are.
DR. WARD: That principle would apply, I assume, going forward to any of the subsequent --
DR. ZUBELDIA: If the experiment works.
DR. WARD: I'm not sure I want to be the experiment.
MR. BLAIR: Could I just ask about this? Eliminating a layer in the process I think could be beneficial. On the other hand, it could be that that means the DSMOs are just assuming the same responsibilities that HHS has without having the funding to be able -- have the resources to be able to do that job, in which case, if we don't provide funding to the DSMOs to do that job, then they are in the same position.
DR. ZUBELDIA: But they have the responsibility today.
MR. BLAIR: They have the responsibility, but do they have the resources to be able to do that?
DR. ZUBELDIA: Well, they have the same funding today, and they are doing it.
DR. WARD: At least as I see it, one of the significant differences is, as I have always been told from the perspective of the Department, is that to have that NPRM, you have this 30, 60, whatever-day public comment period, where the whole world knows and they have an opportunity to say something about that. I suspect many people would not be happy with the idea of not having that, and just having it go through the DSMO.
We talked about this as a group about a week ago. We talked about something like this. It is possible perhaps that there could be some sort of a public comment period that precedes a final DSMO decision or something, where maybe everything didn't have to go through that more formal NRPM process.
We obviously didn't nail down anything, but the idea that maybe there is some public comment that precedes the DSMO, but what then comes out of the DSMO does not go through NRPM. It in fact becomes as you suggest the thing that ends up getting offered to the Secretary.
DR. COHN: Harry, Frank, and then Jim.
DR. REYNOLDS: I ask everybody to keep in mind, we are the HIPAA players in this room, but there is a mass implementation out there that doesn't have a clue what a DSMO is, and doesn't have a clue with some of the others. So whatever we do, if it is not driven back through a process where somebody makes the decision and the decision has to stick, if these decisions look like they are being made somewhere and then they don't have some kind of kick behind them when they go out there, then standardization doesn't follow that.
That is called, I do what I want to do, because I don't know whether I agree with it, or it didn't come from the federal government, it didn't come from regulation. It is not in the Federal Register.
So the point we have got to be careful of, I think flexibility is important, but any of us that work in this all day, you are driving the standardization, and you just had a long talk about the companion guide, where people are trying to sneak away from it. If we let all these people make all these decisions, and in the end we still don't have it, where you have to do it, and there is some kind of situation where if you don't do it, you are going to get dealt with.
Now, we talked about resources earlier. These committees to me can be extensions of the resources that aren't available right now through the Department and others. Their recommendations can come straight in after the industry deals with them, and whether you reduce the period of review or whatever it is. But the point is, it still comes in and it still goes through something that we have to deal with.
Again, just because somebody makes a code change somewhere, and some committee -- we still don't have a clear interpretation out of anybody as to what the IGs say. I'll give you six vendor names, and they all disagree on what the IG says and what they are putting in their software. That is implementation.
We have got to be careful what we are doing in just passing this out around again, because that is how we got where we were before everybody decided to go to HIPAA. So let's keep that in mind. Mass implementation has to be our goal. Otherwise we don't have a standard, and we just go back to doing what we are doing and go back to whatever else is doing. That is what worries me about where we are headed.
DR. COHN: Frank and then Jim.
MR. POKORNY: The idea perhaps of using Kepa's idea of the attachments guide as a DSMO product, and going through some sort of process that yields a HIPAA standard as a result of that, I hear Maria talking about, that sounds like a possibility, but shouldn't there be a public review period as part of that, a couple of bells went off in my mind.
The first bell was, where is the net saving in time, first of all, if instead of having a public comment period administered by the Secretary in the federal government, if it is administered by the DSMOs.
The second bell that went off is, what legal liability arises by pursuing this path? All of a sudden a series of designated standards maintenance organizations, granted, named by the Secretary, taking on a responsibility that results in potential changes to the way all sectors of the health care community work, is there a liability that the participating members and/or organizations would have that we don't have right now, at least we believe we don't have right now. If we go down this path, is there some sort of protection that has to be extended from the federal government?
I don't know. I am raising this as a question and a concern.
DR. COHN: Jim and then Karen.
DR. SCHUPING: Just sitting here listening to the questions that are being raised, I think we are raising more issues and questions than we are answered, which I guess is not unexpected.
DR. COHN: It may be okay.
DR. SCHUPING: But I am wondering if there is sufficient interest to this, if the committee would support some kind of an industry-government -- just an informal task group that would take a look at, be charged with reviewing the current regulatory process that we have right now, perhaps taking a couple of case examples like the one that Kepa suggested, just walking through it and looking at the pros and cons, looking at the impact on the various parties that would be involved, the stakeholders, and coming back within a reasonable period of time with some recommendations. We have viewed this regulatory process and the various options that we have, and here is where we think we can make some changes that might work, and here are some other things that we simply can't touch.
But I think if we are going to move to any action on this, it seems to me someone has got to be charged with -- unless there is someone already doing this, some group within the industry and/or the government or both has to be charged with taking this on and looking at it, and coming back to the committee with some recommendations.
I think we could probably have this kind of discussion repeatedly over a period of time, and we are not going to resolve it unless we specifically take the charge and run with it.
DR. COHN: I was going to respond.
DR. SCHUPING: I didn't mean to go off the conversation.
DR. COHN: I am listening to you, and I am thinking of priorities as well as people power. I am acutely concerned about -- the HIPAA office focused on the initial implementation, so I don't want to suggest that we start devoting resources from them.
Now, obviously this can become a forum for increased understanding of the options. I think we were all saying, there may be alternatives, we may need to understand thoughts and processes better, and we can certainly put together a session where we get some greater education.
I guess in terms of moving from there to kicking around some options or whatever, maybe at that point there is a group that gets off and talks, but I think it would have to probably be sponsored by WEDI and coming back here with some thoughtful recommendations. But maybe that is the process we may consider, which is looking as we go forward what sort of choices are there.
I personally am not real optimistic about the process of getting rid of the government completely. We have already tried this self standardization process, and I am old enough to remember the 300 implementation guides of the UB-92 that I saw back in 1996, so I don't really want us to go back there.
There may be something very interesting around claims and attachments, recognizing that we do expect to see an NPRM. I certainly do not want to avoid the process of an NRPM for claims attachments, but maybe there are some ways to recommend innovative ways for the upkeep and maintenance for those claims attachments that we may want to consider in whatever recommendation.
DR. SCHUPING: I was just raising the issue, that if there is sufficient interest on the part of the committee, this is something that I am sure WEDI would be happy to try to facilitate, try to indicate people that would be interested in participating in the process that would represent key stakeholders, and then come back with recommendations, if that would be helpful.
MR. BLAIR: Simon?
DR. COHN: Please, Jeff.
MR. BLAIR: I think that would be helpful. There are a lot of interdependent and interrelated health care information standards initiatives that are going on. I think that if the recommendations are focused exclusively on the experience of the financial administrative transactions, the HIPAA financial administrative transactions and the privacy regs, that that may prove to be a little too narrow.
The NCVHS has also recommended that funding be provided to support a national health information infrastructure. Part of those things include HIPAA, part of them include the other standards that we have set forward that are part of a national health information infrastructure and that would work with HIPAA, which are the PMRI standards. We are going to be getting into terminologies, there are issues on Capitol Hill with respect to standards for patient safety.
You have a whole host of information standards initiatives that we are hoping the government will facilitate and enable and encourage and accelerate, that are interdependent. CHI initiatives. I sort of feel like if the recommendations are just HIPAA, then we will only be halfway there. So we may need a little bit broader group than just exclusively the focus on the financial administrative and the privacy transactions.
DR. COHN: Karen, would you like to say something?
MS. TRUDEL: We have a lot of laws in the federal government that we have to work within. One of them is the administrative procedure act, another is the federal advisory committee act, which affects how we work with external organizations to make sure that one group doesn't have inappropriate access into the decision making process.
I think it would be very difficult to sit down and try to establish a structure of, you could do this and you couldn't do this. What we find works best when we go to our general counsel is to say, can I do this, this one thing. Here is this thing, I can explain to you exactly what it is, I want to go and work with this organization, I want to do this, I want to develop this, this is the outcome, this is how I want to publicize it, this is what I want it to be. Can I do it or not.
So I think in terms of having something that we can take back and look at all the various implications of various laws, having something fairly specific would be really helpful.
If there are some ways that you feel we could address not having the due process of the DSMO process and then the due process of regulations, specific, that we can go back and look at, that would be really, really helpful. If there is a concern -- and I think I am sensing one; you have got industry experts, you've got the DSMOs that are specified by regulation. You have got the SDOs who essentially own the standards. How do you then get any kind of guidance made official, short of adopting it as a regulation, what are the other alternatives, how can we develop or bless guidance.
So I think these are some of the things that I am hearing that are things we should be thinking about. It also would be very helpful to know if there is a consensus about the difference between a new standard, a change in code sets, a change in the structure or the business purposes for a transaction. Have we gotten to the point where we shouldn't adopt specific versions anymore? Should we just adopt a version and then every version that comes along after that is just automatically going to be implemented? But no more than one a year.
These are some of the things that I think I would want you to think about and tell us where you think we could make some changes, get some specific proposals, and then take it back to legal counsel and say, within all of the various laws that affect us, can we do any of these things.
DR. COHN: Ed and then Maria.
DR. WARD: I want to bring us back to Kepa's example. I am thinking more and more about whether or not I want to kill him for the claims attachment example.
I just want to be clear that I didn't think that it was a good idea to have claims attachments be the test bed for this. I said that in principle it might be something that we want to look at, and when I heard Frank talk, it sounded like perhaps people understood me to say, yes, I am going to offer up the work we have done to see if this works or not. So I want to be clear about that.
I am also thinking about something you thought of, Karen, in your statement regarding naming versions versus -- I don't know what the alternative is. I know that this discussion had taken place ten or so years ago, before we came out with -- and I wasn't part of those discussions. So I don't know what went into that, but I can tell you, from our perspective in our committee right now, I think you probably know, Karen, we are dealing with that right now.
I in a very general sense brought this up to the committee in December. We have a version that is seven, five, six, I don't know how many years old. We have a recommendation that we started creating in 1997 for claims attachments, and we would be I think remiss if we didn't take a step back and start to think, is there a better way to do this, given the point in time, not just today, but the point in time when people are actually going to be implementing this three years from now, four years, I don't know how many years from now, and being held to that version versus being held to something that is looser, to say what is most appropriate at the time that the rule comes out, or whatever, would have allowed us some more flexibility.
Now we are trying to figure out what to do about this within HL-7.
DR. COHN: Ed and then Clem.
DR. JONES: I want to go to Karen's point, but also reflect on something Frank said. That was, we are looking at mass standardization over a period of two or three years, or whatever that term is.
On the one hand, we are dealing with a legal structure for compliance. On the other hand, we are dealing with a set of rules that have come out piecemeal, and we are coming up on deadlines three or four months from now that are requiring compliance. There is a tremendous degree of worry about those who were investing considerable resources, to try and achieve that.
There is another group that is just hearing about HIPAA, and there is another group that is not going to be compliant, and how do we resolve those two. So when we are trying to look at alternative procedures, we are really looking into the future to try and get away from these problems in future instances.
DR. COHN: Clem and then Kepa.
DR. MC DONALD: I want to return to the attachment thing just a bit. For those of you who don't know, basically all it is is a structure for sending out a questionnaire, more or less, with a few complexities to it.
We explored the extent to which one could make a new attachment and not have to go to the full procedure. It didn't look very feasible, except for those attachments which already say, send me any lab tests. Then if a new lab test comes along, that wouldn't require it.
But if we use this in a way to define effectively fields or new content in something like the AMIS attachment, any changes to that, it was decided from the advice we had in many conference calls that that would require the same NPRM process.
So just to say that the attachment is not necessarily going to be an easy way to get around the issues in general.
DR. COHN: Thank you for bringing some reality back into that discussion.
DR. MC DONALD: Many of us thought you shouldn't have to do it, just to assign a structure to analyze. But when we analyzed it closer and the federal questions came in, it seemed like that may not really work.
DR. COHN: Kepa and then Harry.
DR. ZUBELDIA: Good, because I have a question for Harry. Harry, the HIPAA law requires that the changes not be more frequently than once per year. It also requires that the changes be implemented in -- that there be a time frame for implementation of the changes of no less than 180 days. That is what we are facing with the addenda this time. Addenda, addenda, addenda.
DR. MC DONALD: You mean addenda?
DR. ZUBELDIA: I mean addenda. So the minimum time frame is 180 days. What is a reasonable time frame in your eyes? The feedback I am getting out there is that 180 days, six months, is not enough to make one of these changes.
So whenever there are changes, what is the time frame for implementation? Are we talking from -- does it take a year to make these changes, does it take two years to make these changes, does it take six months? What is the recommendation? What should be the implementation time frame for changes?
DR. REYNOLDS: I guess I would say this. You could use Medicare as an example of how they have done it, only from the fact that there are an awful lot of the industry that has to respond to what Medicare does. It usually affects the doctors, it usually affects the hospitals, it usually affects some key intermediaries. I know those intermediaries are shrinking, and it is not quite as significant of an impact as it used to be.
But if you are changing structure, we are driving an entire industry. So if you ask the big players to be federally complaint, we can move as we need to move, because that is not somewhere where we want to live, not compliant with the federal mandate.
But how does it affect -- and that is maybe one of your criteria -- how much does the change really affect the doctor that you go to, the small hospitals that right now with the balanced budget act and everything don't have the capital sitting around like the big players do to make these things go. So we can hire consultants, we can bring in additional staff. It is the players in this industry that don't have the resources that you have got to look right in the eye as to how that change happens.
Six months to us, if we are pushed, we can probably make that happen. But again, with HIPAA and especially this standardization process, it doesn't matter if the big players win. It matters that we all get there. Whatever we have standardized and made this industry get better at, -- remember, that is the whole goal here: get better, leaner, faster and smarter.
If your change isn't going to do that, or it is not going to do it to where that one doctor office or that five doctor office or that small hospital with 100 beds doesn't say, this is a top priority for me to do because this makes a difference, I don't know what the time frame is.
But Medicare has always been what, you put them out once a year and you have how long to do it, Karen?
MS. TRUDEL: We do system changes four times a year.
DR. REYNOLDS: But you pretty much have a standard system that you made everybody conform to. That is why the number of people that are doing it now is less.
MS. TRUDEL: Even with respect to those changes, we have to have our instructions on the street five months before the effective date.
DR. REYNOLDS: So there's eight months right there. So minimally, something that is currently working, and again, under a system that is pretty much dictated. That is why you see the intermediaries shrinking, because the dictation of that system -- the way everybody is going to be successful in this, less people doing more transactions through that structured system is success, if you are in the ROI from the business world.
So even that alone, you are looking at an eight-month period. So rather than act like I would be a representative to say what that number should be, that is what it --
DR. ZUBELDIA: So knowing that the providers don't have to send the HIPAA transactions, they can send paper, if everybody in North Carolina was to implement the addenda and the addenda was published tomorrow, and everybody was going to start implementing the addenda on Monday, when do you think that would be done? Just a guess. Six months?
DR. REYNOLDS: You're not going to put me in a position to say that we would be ready by October '03.
DR. ZUBELDIA: Not you, no.
DR. REYNOLDS: You might do a lot of stuff to me today, but you'll never get --
DR. ZUBELDIA: The providers.
DR. REYNOLDS: Just let me tell you where they are. I'll just flat tell you where they are. We still do not have a provider in North Carolina that can send us a clean 837, period, under 4010, 4010A or anything else. We lost all of our early adopters that were supposed to start sending us stuff last year.
You have a situation where the vendors and clearinghouses are starting to work with our providers. So I would say that you would be in a situation where I'd say probably in the July time frame -- and I was quoted in a magazine yesterday talking about that, in the July time frame is when the heat is going to come up for people to really start testing.
We are trying to come up with an automated way to help providers be able to test with us and get the answers back right away and so on, because we cannot manually handle 5500 -- if you remember my testimony which you can go back to almost two years ago, I used that same calculation; 5500, and I needed 12 months. If I had 12 months, it was still 40 a day. Now it is down to, if I go July, August, September and part of October, that is 1,000 a month; you start getting 50 to 75 a day.
We would have to agree, so like I said earlier, I don't turn the end of that ping-pong table up and say your transaction doesn't pass, your transaction doesn't pass, your transaction doesn't pass, because their interpretation and/or their vendor's interpretation doesn't agree with my vendor's interpretation.
So giving a date is suicide, because I'm not responsible for all the players. I can tell you right now that the answer was, I decided to go to 4010A three weeks ago. I stopped all work on 4010, game over. I've got providers in North Carolina that are still going full speed on 4010, but guess what? For me to be over here where I have got to be ready in a reasonable time to start testing with them, I have already made a decision which is illegal, because there is no 4010A out, right? So how can I start talking to people about testing 4010A when there is no 4010A out?
So what has happened with this whole thing is the reality of becoming compliant changes regularly. The reality of how to get there and what we each have to decide changes. So I was telling you that for us to get everything ready, it has been about eight months. That is why I made the decision two weeks ago to have everything up, everything ready and everybody tested.
Again, you didn't allow me in the law to be ready in October. You allowed me to be ready in enough time that I can be converted over, the mass implementation with all of the people that I receive transactions from. You have also put a hammer down in October that says I can't do anything other.
So my date can't be October. It has got to be backed up a lot further, so we can get these 5500 entities over with us. So that would be my answer to that, and I would like to make another comment, if I could.
DR. COHN: Please.
DR. REYNOLDS: You hear about new transactions coming out you hear about some of these things. Since I am the only implementer in the room right now, I please ask you to take very seriously -- you are asking all of us to implement privacy, which we have got a lot of money and a lot of time spent on. We will train all 3,000 people in our company on privacy to make sure they understand how to deal with the right things.
We are implementing eight transactions. We are awaiting an addenda. At the same time, we don't have the answers on those, and I have already talked about those, the IG interpretations, the 4010A. We still are in some arguments about whether the 997 or the 824 is the appropriate thing to send back, because the 824 is kind of an optional thing and the 997 doesn't give you everything you need.
That has to happen by October. Please don't put out anything new, because what is going to happen is, if you put out anything new prior to finding out whether or not this industry can at a quality level implement what we have got, my gosh, we're in trouble.
When you put it out, we are going to have to immediately assign resources, because the minute you put it out and the minute you start asking questions and the minute you start the clock, back to your point, how long is it going to take, what does it look like. How long is it going to take? Are we up to the level of the 837s, to where the attachments really matter?
So please, and I say that for all the Blues, please let this implementation happen. Debrief from this implementation as to what is going on. Understand the process, but I find it almost unrealistic, almost unbelievable to me, that I have outstanding questions in an industry about an October date, and we have got momentum. Momentum can either be your best friend or your worst enemy, and I'm telling you, right now momentum if we don't get these answers is our worst enemy, because putting out new stuff at a time where we need answers to the current stuff -- help us get done for October before you start deciding what we are going to do next.
We understand attachments, and we are all excited about them, too. But man, let's get this other stuff going.
DR. COHN: Remember, the attachments discussion is for a notice of proposed rulemaking. It is not a final rule.
I guess I should ask, are you publicly stating that you are against having the security rule come out in a timely fashion?
DR. REYNOLDS: No.
DR. COHN: Okay, good. I just wanted to make sure. That is what I was beginning to wonder.
DR. REYNOLDS: The other thing to remember, all of us that are implementing by October --
DR. COHN: Have to have security.
DR. REYNOLDS: I can comfortably tell you, it is going to be secure. It might not be to the I and the T of what your security regs are actually going to look like, but I'll guarantee you, I don't need to be in the paper because I didn't secure it.
So we spend hundreds of thousands, almost millions of dollars, getting ourselves updated to a total industry standard on security. That is not really a new one. We have all banged that one around enough, and we have seen the final rule, and we are just waiting for your final process to happen.
DR. COHN: Sure.
DR. REYNOLDS: I'm just talking about new stuff that is going to change the way we are doing things.
DR. COHN: Okay. Maria, did you have a comment?
DR. WARD: I have been making a list of several issues that have surfaced in the last couple of minutes, and I want to make a couple of comments.
Kepa, to your question, I don't think there is an answer either about when can people be ready. I am speaking now on behalf of my day job, which is sitting primarily in the last six to eight months with providers, large provider health systems, trying to help them figure it all out around transactions.
DR. ZUBELDIA: How long does it take them to figure it out, to the point where they can actually send a production transaction?
DR. WARD: I spent Monday and Tuesday with a very large provider health system. They have a regional pharmacy component, they have ambulance home health, acute care, physician groups, who have not had dialogue with their vendors yet about what they are doing to need and when they are going to need it, to begin testing in April.
Now, some of their bigger vendors have initiated that, and have given them crosswalks and gap analyses and said to them, here is what we think and here is how it is going to look. But they may have 22 or 23 different systems and different vendors for different types of products and things that they support.
Some of them are never going to get anything from their vendors. They are saying to us, is it reasonable to go through all of our DDE screens, our terminal screens, and just figure out what all the data are in those little boxes on those screens and make a big list of that, and compare that to the implementation guide, because we don't think we are ever going to get anything from this particular vendor.
So that is a state of readiness that is a real example. It is not a small hospital, it is not a small health system. So that is the real world, part of the real world. I'm not saying everybody is there, but as it relates to implementing the versions and is 180 days enough, I think you have to put all that in context.
If at a point where we are rolling with claims attachments, Clem explained it. In large part, implementing it and having the structure behind it, once you do that and you roll in two new attachments or three new attachments or whatever each year, that is not a significant thing. That is some set of questions that will have some set of answers. So I would think that people could do that in six months or in eight months.
The basic structure of that thing, the vehicle that transports it, once it is in, new attachments aren't going to be like new versions in the implementation guides and X-12.
So the point there is, I guess there is not an easy answer. There is not one answer. I needed to put some of that in context.
Harry brought up a couple of points that now that Harry brought them up, I'm going to make a comment on. They were things that I have been thinking about, coming into this meeting as well.
You mentioned, Harry, I think you said interpretations of clean claims, clean transactions and how that varies, and that ties into our companion guide discussion. This particular provider that I was with on Monday said, you know what? If you have an opportunity, we would like you to express something when you talk with these folks on Thursday.
That is, we think that it is time to face the music. On October 17 of this year, this is not all going to work the way we think or we hope it is going to work. Their suggestions as a provider, and the example they were giving was, some payors are going to make the choice to reject flat out any claim that is not HIPAA complaint, from a content perspective, from a syntax perspective.
Some payors are going to say in the vein of, as a service to our provider we are not going to reject their claim, even though we should, technically. We are going to accept it, because we don't want to stop business. We are going to maybe give them an acknowledgement and tell them what was wrong, maybe not, maybe we are just going to accept it.
Now the provider, who is creating these transactions, has something that one payor is going to respond to and another payor is going to respond to differently. I'm not sure that actually helps the provider in the long run.
What these folks suggested was, and I suspect that this isn't even something that is achievable, but that there be some kind of a grace period for payors to not be penalized after October 16 if they do continue to accept transactions that are to some degree not compliant, and if there is a grace period that it be defined, and that we actually allow people once they start exchanging those transactions, to figure out what is wrong with them, to fix them, and to get it right.
Realistically, to think that is all going to happen before October, I just don't think that is the reality. That is something that these folks shared with me. It is also something that a number of my colleagues within PWC have been hearing from payors, and they have been hearing it from providers, and actually starting to frame that issue and saying it is time for us to start -- we all hear it, and most of us probably think about it, but I'm not sure anyone is actually articulating it and bringing it up and talking about it.
DR. COHN: I think I will respond to that, and others may have comments.
I think your comment that we need to be thinking about it is probably a very good comment. My concern, if we start beginning to proclaim grace periods or transaction periods is that people in the industry will go, I've got a four-month grace period now, that means I don't really have to implement until February 15, 2003. I think that would be how it would be interpreted.
I do agree with you, I think this is an important issue that we need to be cracking very carefully. But I would be curious about your thoughts. Do you think beginning to announce grace periods would send the wrong message?
DR. WARD: I agree with your wholeheartedly about the way we have as an industry tended to respond to these kinds of things, and that would be the last thing I would want to see happen as well.
But short of actually maybe trying to figure out what we are really going to do on October 17, if this doesn't all come together, then October 17 we are going to have to be trying to figure it out, and everybody is going to be -- God only knows what everybody is going to have to deal with.
So I don't know. Maybe there is a way to talk about a grace period that isn't so open-ended, just like we talked about ASCA. I had this conversation with you guys a year and a half ago, two years ago. To find deliverables, to find milestones, requirements. One of their requirements, they thought, would be that if you are going to accept my transaction and it is not HIPAA compliant, you must give me an acknowledgement. You have got to tell me what is wrong with it. You can't just take it in and not let me know what the problems are with that, which right now under HIPAA they don't have to do that. They can just accept it, reject it and say we didn't like it. There is no requirement for any detail in an acknowledgement under HIPAA.
One more comment, and this is giving a flip side view of something that you said, Harry. As I go out and I talk about claims attachments at national-level kinds of forums, what I am hearing from the provider community is, it really does matter to them more.
What I heard from someone at the Illinois Hospital Association about two months ago, she raised her hand and she said, this 837, that's great, but guess what? Some percentage of all of my providers' claims in the state of Illinois are going to suspend for medical review. At that point, the 837 bought them nothing, because they have to turn around and send in paper, supporting documentation.
So she was saying to me, what can we do, the hospital side of the world, to get this thing moving, because to them, the claim isn't all that great until you have the ability to send the attachment. That is one provider view of that.
MR. POKORNY: Thank you, Simon. I was just thinking about the how-long question. To my mind, in many respects, how long it takes to implement a new standard or any regulation is so dependent on the individual circumstances of the entity facing that decision. I think they have a series of questions that help the organization decide how long it is going to take.
Is this something completely new? Or are we building on something that already exists? Can I do this just within house staff? Do I have to go outside and get some vendors and become vendor dependent? Is there any clear benefit to this change to my business? Or is the benefit somewhat ambiguous?
Then we get into, must I do this at all costs? Or is it worth facing the risk of a penalty for noncompliance for some period of time? It is a carrot and a stick. Some people may respond just with a carrot and some people may ignore sticks. I think there is no one hard and fast rule.
The one thing I am hearing is, longer is better. How long is long? I don't know how long is long. It sure as heck isn't three months. Six months, maybe. Eight months sounds a lot better.
The grace period issue. I think we have already had a grace period if we start looking at this one-year extension. We are still coming up against the end of that. So grace period isn't the answer.
I think part of any implementation in adopting a new or a modified standard requires both sides to try and do their best, and if something isn't working, give adequate feedback so the sender knows what is wrong with the transaction, as Maria has suggested, not just say it is not any good.
DR. COHN: Clem?
DR. MC DONALD: I was going to support Maria's statement. I would like to not have your statement about the most important thing is just to meet a deadline because otherwise this just gets delayed.
We are dealing with something that could kill the whole system. Think about the Cedars Sinai event. That can happen nationwide, where you are going to have riots in the street, because this could change -- there are practices that are teetering, there are hospitals that are teetering. If you get them in a situation where they go bankrupt because of this, it is going to put back standards for 100 years.
So I think we should be very aware of these kinds of things. You already mentioned, Harry, you're going to accept them.
DR. REYNOLDS: No, I'll tell you where we stand.
DR. MC DONALD: But it would allow the payors to engage in some fashion that we wouldn't run into high risk events like the whole system grinding to a halt. It could very well be that no one would get paid for six months, and then we -- and whether you could ever get Humpty Dumpty back together again would be a good question, certainly regarding standards.
What will happen is, there will be a political backlash against standards. That is what will happen. So I think if we take the position, those crummy guys, let's beat on them and not give them a break, I think that wouldn't be the right attitude.
DR. COHN: No, I actually did not mean that. What I meant was that I think it is very, very premature for any sort of a conversation about this issue. A lot of people haven't even started implementation.
DR. MC DONALD: Well, some of the issues that Maria brought up, such as giving notice of what the problem was, might be very appropriate to be thinking about now, because that would help with the engagement over some period of time.
DR. REYNOLDS: A couple of things. I don't want any of my comments misconstrued. I am all for the attachments. However, the timing of it is what I am talking about. We clearly understand. When Blues across the country have over 80 million people that they -- we want it automated and we would like the whole thing automated. We don't like paper coming in, and we are having to image it.
Remember, every piece of paper that comes into our shop, we have to image it, we have to find it and so on. So that is not the discussion. It is the timing. How can we on one hand in North Carolina know that there is a practice management system that has a thousand clients -- I said the same thing to Holden Anderson yesterday that Maria heard; they haven't met with any of their clients. Maria talks about large hospitals, and we talk about other people that aren't doing that. At the same time, we talk about putting out new stuff and moving faster. So we have got an industry.
The second thing is, we had a structure. Personally, it really upsets me. I spent a huge amount of time filing for the extension, huge amount of time. We actually did it for 70 of our large clients, who are ASO accounts, who are covered entities. The results that came out on that are dismal, not DSMO, dismal, as far as who filed for an extension. Nothing happened. That was in the law. Nothing happened to anybody.
So there are people right now who are outside the law. That should have been our first signal, because if you are willing to be outside the HIPAA law right now, you are. If you are filing noncompliant transactions and you did not get the extension, you should be in big trouble.
So we let the first little episode go right by. Everybody went, we'll work with them. Now we've got October coming up. What you are talking about today is -- and I'll speak for North Carolina, my business -- if you are saying let's just forget it, let's do whatever we're doing, I can tell you, no payor in their right mind is not going to tell their hospital if they submit a claim what is wrong with it. You ought to be talking to them about a different issue.
All of our testing and everything we are going to be doing with our testing is going to clearly tell them what is wrong, because if I don't stay at 90 percent hospital and 75 percent physician, my cost of doing business, my cost to my customers, and then you want the real sick part of it, the provider who does not become compliant, goes to paper, does not get penalized in North Carolina.
I have a prompt payment law. If I don't pay it fast enough, I have to pay them interest. That is sick. When you add this all up, that would be a sick situation. To where we become compliant, they are able to not become compliant and go back to paper, and I have to pay them if I can't hire enough people or do enough things.
That is were we are headed, gang. That is the serious, serious side of this. So as you are looking at whatever you are looking at, you need to understand we are talking about an industry that is coming upon a deadline. We are talking about an industry that is spending billions of dollars a year trying to get this ready, whether some are or aren't. So don't take lightly whatever that next step is. Remember, I was one of the ones that came up here and asked for the year extension.
But the point is, we assumed that with the steps that were put in place, anybody who was not coming along is going to get popped. They should have been popped when they had to file for the extension and nothing happened.
We blinked once. The industry and the law blinked once. Now that is the scary part. So now we are getting into the real, real serious portion of the program, and the next blink is going to be interesting.
I feel this like a pressure that is insurmountable. The contingency we would have to put in place if it goes more to paper is to pay an outside vendor to take the paper, key the paper, image the paper, because I happen to be in a low unemployment environment, and I have automated everything I can as much as I can. That 90 percent hospital, ten percent of that is the attachments, so I totally understand that that is my only way to go above 90 in most cases.
That is the real deal. When I walk out of here, if you don't help me now come up with a process, and you don't understand the ramifications, then I will go back tomorrow and I will be in exactly the same place that I left yesterday, which is out there trying to do everything we are doing, to get these people to come along. But I can't drive their business plan.
So everything we are talking about today, that is really the bottom line of this. It is not about the law anymore, it is about industry. It should not be a plus for anybody to be able to ignore that law now and not be talking to their vendors and not be getting ready, and not have filed the extension and not be getting this done. You shouldn't be able to win that way, but there is an element of victory in that position right now.
DR. COHN: Ed, why don't you make a comment? I think we need to begin to wrap up here, because we are running out of time.
DR. JONES: I'd like to second that heartily. I have heard for years, and I am still hearing it now, that there are no teeth to this, it is not going to happen, it is going to be delayed, et cetera. So I think if even a hint of talking about a grace period got out into the public, you are going to be reinforcing that notion, and probably accelerating it.
But I do think it is very important that we had this discussion yesterday at the WEDI board of talking about contingencies and a contingency plan, and from the perspective of the board members, it was talking about what -- because of these interrelationships and trading partners, each of them is doing everything they can to be compliant. But if they are a payor and their providers aren't ready, what is the contingency, and vice versa.
So I think the contingency of dealing with these events needs to be considered at a variety of levels.
DR. COHN: Michael?
DR. FITZMAURICE: I want to talk about a positive note that has been fairly quiet. We all got here together, and I don't mean just those of us in this room, and we all are the solution. But the resolutions of the issues don't spring out in front of us. It is not a matter of having a tremendous insight, that is what we should do. It takes a lot of hard work.
I want to address the three issues raised in the letter. The first one, Congressional and HHS funding. I walk into my house as a teenager and I've got a ragged shirt on. Mom and Dad say, buy a new shirt. I say, I don't have any money. Well, take it from your shoe money, or maybe an unfunded mandate, or Dad gives you the money, Congress gives you the money to do it, which hasn't happened, or you ask for the money and then Dad gives it to you. But if none of the above happened, you would continue to wear the shirt or you would wear ragged shoes.
So it is not a matter of, HHS should spend more money. We have to set priorities. It is not a matter of, Congress should give us more money. The industry has to decide what it wants the government to do and what it wants to do for itself. If you want the government to do it, somehow resources have to be found.
The government is too slow. But we heard a good defense from Karen that the APA provides checks and balances. This is the regulatory process that brings uniformity and time certain compliance. Time certain is in quotes. But that is what you bought. But if you think it is too slow, monitor the progress as best you can.
FDA, for example. Look at how many New Drug Applications are approved by FDA each year. How long does it take on average for each year's approved NDAs? Apply the same kind of criteria to us and the regulations for health care data standards.
High level priorities are subject to change, depending upon old versus new Administrations. But fortunately, HIPAA is still a good idea. Yes, it is. But there is continual education, new concerns for the public and reflected new concerns of decision makers. It is us that also has to be educated, not just the public. Again, monitor the situation.
Thirdly, you asked for a collaborative process. At the highest levels, the government is both a payor and a regulator, two arms. You can't always send one arm to a meeting and speak with one voice. At lower levels, the government can speak of its own implementation issues without violating the regulatory process. At lower levels, the system can speak of regulatory issues without messing up its own implementation.
So the recommendation that I offer is, provide good forums. Part of the success is that the industry has provided good forums where people can get out and talk about the issues and learn about the issues. I hear Maria talking about getting out, I hear Karen, I hear Stan Nockenson talking about getting out. There have been some very good forums, and we learn from that.
We can improve the process by understanding the issues and the health system that drives these issues. Again, kudos to NCVHS. It provides a very good forum. There is no other place that I know of where you can come in and talk about your issues, and we can address and respond to those issues and carry it back. I'm not sure this was envisioned 50 years ago when NCVHS was formed, but it is a place to go. People look upon NCVHS as the place where issues will come out, where what is coming down the road will be discussed here first, and that provides good advance notice and good thinking.
So the positive note is that we have NCVHS as a good forum. More positive is, there are steps to take to continue the process. Monitor us, and continue to provide good forums. We couldn't have done this without your advice. We have the knowledge of the industry that you supply us, and we have been responsive to you in the past. We want to continue to be responsive to you.
DR. COHN: Wasn't that wonderful? Michael, thank you. I was trying to figure out how I would put this session together.
Truthfully, I don't know that I can put this session together. I think we have heard a lot. I think I came in hoping that we would be able to take a long look at what was going on and look beyond the initial implementation. Part of NCVHS' role is to try to look out there a bit to try to solve the upcoming issues that we are dealing with.
Obviously, what I am hearing a lot is that there is so much angst going on with the implementation, it is really hard to see out much beyond October, which I think is very reasonable.
I certainly don't think we have a letter to send to the Secretary at this point, though I am reminded by this conversation, not that we have to have hearings over these issues over the next while, but I think we need to provide time for conversations about what is going on and the issues on a regular basis as we go forward, just because I think there are a number of things that were brought up, some of which at least to my view are probably a little premature to seriously discuss now. But some of the things may become more appropriate as we move forward.
There are some of these issues during the summer or late spring or whatever, depending on where we are with the implementation, some of the ideas may have a lot more validity at that point. We will have to see and monitor the situation.
Do others from the subcommittee have a view? I'm sure we need at some point to get somebody in to talk to all of us about the various ways of simplifying and streamlining the process. I think we have asked you, Jim, if you want to put together a think group to come back with some ideas or things. I think we are all in favor of making this more predictable, more stable. It is hard looking towards an October implementation to take the long view at this point, but we do need to be thinking about it.
Jim, do you have thoughts on this one? I want to thank you for putting together this. I think this is going to be the first of a number of discussions.
DR. SCHUPING: And I think we would like to return the appreciation for your creating the opportunity for the forum, because I think there has been an awful lot of good thoughts shared here today.
I guess the one take-away for us is that you are comfortable with us going ahead and trying to develop some kind of a dialogue and a task group review of this current process. We will certainly draw, Karen, upon your offices to help us in that and give us what intelligence you can. We will come back just as quickly as we can with some recommendations. But I think the overall discussion has been very, very helpful to us.
It does need to go on. I don't think we touched all the bases today. But it has been a good start.
DR. COHN: Kepa?
DR. ZUBELDIA: Jim, how often should these be repeated? You say it needs to go on.
DR. SCHUPING: How often can you tolerate us? However it would work into your schedule. I think it would be helpful to do it three or four times a year at least, to get in here maybe in concert with a couple of your meetings, and just try to have a little bit of time set aside. I know you are all pressed for time and you have a heavy agenda in most of the meetings. But to the extent that you can carve out a piece of time for this kind of discussion, we would try to get those scheduled.
DR. ZUBELDIA: Let me probe something. Would it be helpful to have this in a different forum rather than here? Rather than having WEDI and DSMO representatives coming to NCVHS, perhaps having NCVHS going to one of the WEDI meetings? Or will that be too disruptive?
DR. SCHUPING: Not at all. As long as we have time to plan it and build it in, we can do that.
DR. ZUBELDIA: I have seen some of those meetings, and they can end up in a war with nitpicking about specific issues. So sometimes it can be really disruptive, so I am really concerned about that.
DR. SCHUPING: What we could do, Kepa, if we created some kind of a roundtable forum for discussion with a very clear agenda, this is what we are going to be talking about, and have representation from NCVHS, whether it would be a whole committee or just a couple of people coming in and participating. I think that is what we tend to do with these kind of industry discussions, is to have representatives from the different groups, CMMS, OCR, the various stakeholders that we have within our membership.
DR. COHN: Marjorie, you are raising your hand. Do you have a concern?
DR. GREENBERG: I just want to caution, we have had individual members meet and present at WEDI, and that is fine. But I think if it is going to be the National Committee or the subcommittee having discussions with an outside group, I think it is probably -- we have meetings outside of Washington; it is not that we have to meet in Washington, but we do have to follow the federal advisory committee act. They have to be open meetings and they should be -- we have tried to broadcast our meetings and make them as open and available to people as possible. So I think in that sense we are probably best controlling the venue, if it is a National Committee meeting.
DR. FITZMAURICE: So it could be a set of hearings in connection with a WEDI meeting, where we have a separate room and maybe a separate hotel, but a large enough auditorium that a lot of people can come.
DR. GREENBERG: I have no objection to holding a meeting in Chicago or wherever, but I think we have to keep in mind once you have met several members of the National Committee as a subcommittee or as a full committee, that there are certain regulations.
DR. REYNOLDS: Even if you picked some cross section of the industry and got some kind of a monthly written report, whether it is coordinated by Karen or WEDI or somebody else, we are down to eight months in this deal. When you start talking a couple of times a quarter or once a quarter, or we will meet again in July, there is a whole industry out there that is going full speed.
So since you are going to be such key players in this, you may want some kind of a something coming to you, even if it is not in a formal meeting, but something coming back to you from the industry for your reading, that keeps you aware.
You heard a lot of different situations here that have to be dealt with. I promise you, when we go out of here, we are all going to deal with them, with or without help, because we have got to get ready. So keeping track of what is going on and how people are getting there may be something that keeps you in the loop, so that when you come back in two months or whenever you meet again, you don't get flooded again, you are keeping up to date. That may be something to think about. That is just a recommendation.
DR. COHN: Maria?
DR. WARD: I was thinking, based on your comment about having ongoing discussions, along the same lines as Harry. I am going to stop short of offering this, but what I would offer is to find out if it is something we could actually do.
Every day the folks in our HIPAA practice and other practices that are out there, we are with providers, we are with small doctors' offices, we are with vendors, we are with everybody who is implementing. We are trying to help them get through their implementations. It might be helpful to you, and it might be something we can do, to try and pull those experiences from our clients and consolidate that somehow, naming them, all of that, and providing that to you in some kind of a summary. Say, look, here is what is going on at this place and that place and the other place, and these are the issues.
So that is something I would offer to take back if I could get support in pulling something like that together to support what you are trying to do. I think that would help.
DR. COHN: We certainly would appreciate that. I think that is the sort of thing -- part of the issue of keeping tabs on the industry is, as we know, this is a very complex industry. I think of various consulting houses that produce reports. There is no single all-pervasive source.
DR. WARD: I'm not even suggesting anything subjective on our part, just literally relaying back to you what our clients are telling us. We are all over the place. I think you know, a number of folks in our practice really know this stuff inside and out. Clem just said, do it.
DR. MC DONALD: We welcome all outside work, and we read it.
DR. COHN: I think I'll also ask Jim, is WEDI going to be producing any sort of a regular update on the industry as the implementation moves forward?
DR. SCHUPING: Oh, yes. We have got a lot of stuff going on.
DR. COHN: I know you have got a lot of stuff going on, but what I meant was --
DR. SCHUPING: We can share whatever we have that would be of value to you.
DR. COHN: Okay. As I said, to me it is a very valuable conversation. I know we are going to be having a discussion like this in February, but as we look at the March schedule and then the may schedule and whatever -- and once again, I don't want to make it too structured, because I don't think that helps. Plus, I also don't want to take staff away from their main job, which is implementing HIPAA. But it may be some ways for us to continue the discussion and focus it down more as some of these other issues become pertinent.
Final comments before we adjourn?
DR. ZUBELDIA: Jeff had a comment.
DR. COHN: No? Okay. I want to thank all of you. This has been very useful and very interesting, so thank you. We will continue the conversation.
(Whereupon, the meeting was adjourned at 12:42 p.m.)