[This Transcript is Unedited]
National Center for Health Statistics
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Agenda Item: Introductions and Opening Remarks
MR. REYNOLDS: Good morning, everyone. I would like to welcome you to the Standards and Security Subcommittee of the National Committee on Vital and Health Statistics. NCVHS is the statutory public advisory body to the Secretary of Health and Human Services.
I would like to remind everybody to turn your cell phones off and if you would, realize that this is being recorded and it is on the Internet. So, if you will keep that in mind as we go through today.
I will ask members of the committee and everyone in the room to introduce themselves and I would like members of the committee to bring forth whether or not they have any conflicts of interest that they are aware of.
So, I am Harry Reynolds, co-chair, from Blue Cross and Blue Shield of North Carolina and I have no conflicts.
MR. BLAIR: This is Jeff Blair. I am co-chair with Harry and I am director of health informatics for Lovelace Medical Foundation and I am not aware of any conflicts.
DR. STEINDEL: Steve Steindel, Centers for Disease Control and Prevention, staff to the subcommittee and liaison to the full committee.
DR. CARR: Justine Carr, Beth Israel Deaconess Medical Center, member of the committee and the subcommittee. No conflicts.
MS. GILBERTSON: Lynne Gilbertson, National Council for Prescription Drug Programs.
MS. WEIKER: Margaret Weiker, EDS.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to the full committee, staff to the Subcommittee on Standards and Security.
MS. GREENBERG: I am Marjorie Greenberg from the National Center for Health Statistics, CDC, and executive secretary to the committee.
DR. WARREN: Judy Warren from the University of Kansas School of Nursing, member of the committee. No conflicts.
DR. COHN: Simon Cohn with Kaiser Permanente, member of the committee and chair of the committee and member of the subcommittee. No conflicts.
MS. BUENNING: Denise Buenning, Centers for Medicare and Medicaid Services, lead staff to the subcommittee.
MS. KUHN: Kathryn Kuhn, National Community Pharmacists Association.
MR. KYLE: Frank Kyle, American Dental Association.
MS. SPECTOR: Nancy Spector, American Medical Association.
MR. ESHRIC: Mark Eshric(?), Siemens Medical.
MS. SPIRO: Shelly Spiro, representing the American Society of Consultant Pharmacists.
MS. VILARET: Michelle Vilaret, representing the National Association Chain Drug Stores.
MR. ARGES: George Arges with the American Hospital Association.
MR. OFANO: Bill Ofano, Blue Cross/Blue Shield Association.
MR. WILDER: Tom Wilder with America's Health Insurance Plans.
MR. REYNOLDS: Okay. This morning our agenda is that we are going to start off talking about the DO Proposal Review that they have on streamlining standards. So, we look forward to that.
Then we will have a panel that will -- we call it a reactor panel to what is recommended, to hear what they have to say. Then we will have some discussion after that, basically on what we have heard this morning and we will have some further discussion before we adjourn, on yesterday, which seems like it had to be three days ago -- yesterday's discussion that we had on NPI.
So, with that, I would like to -- I will just go down the order. Margaret, so if you would go ahead and start, please.
Agenda Item: SDO Proposal Review
MS. WEIKER: As I mentioned earlier, I am Margaret Weiker with EDS, but I am representing ASC X12 this morning. I am the vice chair of the Insurance Subcommittee. I am also a board of trustee member for NCPDP and serve as the lead standardization co-chair for the Standardization Committee. I am also a member of HL7. They are unable to attend today.
I think they sent a letter to the subcommittee in regard to their absence. They are fully supportive of the process that we have outlined before. So, if there are questions in regard to HL7 procedures, et cetera, I may be able to answer them. Otherwise, we just may have to go back and ask them if there is something very specific that I may not know.
So, Lynne will actually read. So, I will turn this over to Lynne.
MS. GILBERTSON: Good morning.
The testimony delivered today on behalf of ASC X12, HL7 and NCPDP is a continuation of the December 2005 testimony, where each SDO provided information on this topic. In November 2006, the SDOs came back with a final unified testimony on this subject.
In that October session, we provided you with a document entitled "Proposal for the Modification of the HIPAA Transaction Standards Adoption Process." The document represents the SDO unified approach to streamlining the HIPAA standards adoption process. This joint SDO prepared document examines the current process, summarizes findings and proposes ways to improve the adoption process for increased efficiency.
The joint SDO proposal was approved by all three SDOs and the approaches we recommend can and will be implemented by each organization should HHS elect to adopt this streamlined approach. Minor modifications during the testimony were requested by the committee. We made those changes and submitted the final document back to the committee soon after the October meeting.
The current process right now, the ability of the Standards Development Organizations to be responsive to industry need is greatly impaired, resulting in stakeholders waiting a minimum of five years to be able to implement new specifications adopted under HIPAA. Please refer to Section 4.
Most concerning with the current process are some underlying assumptions; that it is okay to wait until the NPRM process to review and provide input on these final implementation specifications, which could be years after the actual approval of the implementation specs. Based on public comments received through this NPRM process, the approved published version of the implementation guide is expected to be reopened and modified, republished, reballoted, the whole process gone through over again, which could be years later than the work that was done originally.
The regulatory process is not predictable, when it starts or when it ends. It is potentially very lengthy and it compromises the ability of the SDO to be responsive to the industry's business requirements.
The proposed is included in this document as well. It retains many of the existing processes. It offers a more efficient approach to several of the key areas where current problems exist. Opportunities for input and participation are not eliminated. Rather, efficiency is achieved by consolidating public participation and input at appropriate times. Additionally, we propose adding steps that are critical to the process, such as the development of a benefit analysis report, which has been requested by OESS.
Some of the highlights, the Federal Register, the HHS list serves, the SDO processes, industry notifications, they alert the industry to the development of an implementation specification. The industry is made aware and encouraged to participate. Refer to Section 5.
The industry involvement in these steps is critical to the successful development of consensus-based standards that represent the widest, most diverse collection of industry stakeholders. The most effective use of industry volunteer time is during the development of these specs. Individuals that don't wish to participate at the development level, can participate during the public comment or ballot timeframe, however the approval process works.
The valuable input occurs during this public comment or ballot timeframe as well. This involvement results in the collection of all technical public comments at one time, while it is being developed, while it is being approved and thus eliminates the need to reopen a published standard years later.
The collection of comments at one time improves the timeline for adoption. The industry knows that their comments are discussed during this development and during the ballot or approval process. Then another process involvement is the Federal Register, the HHS list serves, the SDO processes, the industry notifications. Alert the industry that there is a ballot approval process and the critical dates and timelines so the industry is made aware and urged to participate.
Then while the DSMO process that we currently have is underway, the benefit analysis survey is conducted by WEDI. This is another opportunity for the industry to be aware of the activities going on and to provide much needed valuable feedback. The resulting report is provided to the SDO, the DSMO Steering Committee and to NCVHS for their review. NCVHS receives public testimony, which includes the recommendation of a change request from the DSMO, a report of the survey findings from WEDI and public testimony.
Finally, the final rule is published in the Federal Register, based on recommendations from the SDO, the DSMO Steering Committee and NCVHS. This includes the adoption and implementation timeframe from the industry.
With these process improvements, important benefits are reached. The timeliness and the length of time for adoption are optimized. The volunteer industry participation is at the beginning of the process, yielding more efficient use of limited volunteer resources.
The stakeholders have input during both the development and the approval of the implementation specifications and they are notified of all the timelines. Beyond the increased quality perspectives, timeframe estimates prepared for both the current and the proposed process indicate potential time savings of up to three years. We eliminate the possibility of an endless loop of NPRM change requests that never move to a final rule. Please refer to Section 5.2.
ASC X12, HL7 and NCPDP thank you for the opportunity to discuss this again. We have spent considerable time understanding the process, assessing impacts and building recommendations. We firmly believe that action needs to be taken at the federal or congressional level for changes to occur that will allow us to be responsive and supportive of industry business needs in a predictable and timely manner.
Thank you very much.
MR. REYNOLDS: Before I open it for questions, just let me -- what would you like this committee to do? I will let you finish your letter.
MS. WEIKER: Well, Lynne and I discussed that this morning because we knew you were going to ask that question, Harry. I didn't know if you wanted -- basically, what we would like is for this committee to write a recommendation to the Secretary to make any necessary changes, legislation, rules, whatever, in order to allow us to implement the process that we have outlined in our paper.
MR. REYNOLDS: I am writing that down with your names under it.
A couple other quick questions. The last three days -- this is Simon's and my third full day of hearings here -- I have heard the word, the term of art, "the industry," used many times. I think what yesterday pointed out was that through everything that is going on, a portion of the industry or portions of the industry are continually being missed through the communication processes we use now. So, you used it a number of times. So, how with this new process, which obviously if people -- if there are a number of people who don't know they should have an NPI, then the fact that there would be an SDO, that they are working on a standard or that that would be their point of input or they should get involved is a gap that I think we are all struggling with, just period, you know, is how does everybody talk to the industry, if we are going to talk to the industry, you know, if we are going to use that term, you know, magically.
So, speeding up this process a little bit, you know, because anything the government says people tend to listen to a little more than maybe something that is outside of that. So, help me construct how -- you know, what else is going to happen with what you are talking about doing that is going to raise that level of involvement because, you know, it -- sometimes the actual standards development is not as visible as some other things.
MS. GILBERTSON: Okay. Quite a few things in that wisdom of Solomon and patience of Job.
The concern is that we need to become predictable and timely with NPI, for example. Everyone that -- you can't say everyone, but those who wish to implement and keeping up with events knew the May 23rd, 2007 date and worked steps to accomplish that.
One of those major steps was having a database to bank up against, to support accurate information that would have to be shared. When you miss a major step like that, you throw off all timeliness and predictability because now you are building a project plan based on secondary or tertiary events that you are going to try to buffer yourself. How can we get along with this when we miss this step.
I think it is very important that if you are going to have milestones and deadlines, you make them. Now, you know, the industry as a whole are -- human beings as a whole want change, but they don't want to change. So, how do you balance that? I want something because I want it, but I don't necessarily want to implement because you want it or I don't want to implement what you asked for.
So, we don't use the term "the industry" lightly when we are talking about it because there is a misconception that someone, perhaps, like someone in an SDO determines what we are going to do moving forward with standards, just to make everybody's lives miserable and the SDOs do not determine their schedules.
The SDOs consist of volunteer members from the industry, who say we want, we need, we want to move forward and when they agree as a consensus body they want to move forward, we come forward with the next specs and we bring them forward. So, in that regard, the industry is who we are speaking on behalf of because they have said we want to file a DSMO change request. We want to move forward. But guess what? Our patience runs out when we will see you in seven years before we can start implementing.
How do I build a project plan when I have no idea when an NPRM would be issued or no idea when there would be an implementation timeframe I have to be ready for? So, we are kind of giving mixed signals. You need to be moving, you need to go forward, but we are our own worst enemies sometimes with why are we still waiting.
Things that we have asked for in previous years, recommendations from the committee, still have not seen the light of day. Now, there are various reasons. We are human, whatever. But we keep giving the message of, well, sometime it will happen. Meanwhile, how can I build a project plan when I can't implement that? If I do, I will be out of compliance. Now what?
MS. WEIKER: In regard to outreach, we all probably get 20 e-mails from list serves or associations or organizations that we belong to in regard to education. This is happening or this meeting is happening. We also realize that a single doc sitting across the street is not going to come to an X12 meeting or to an NCPDP meeting. They are just not going to do that.
I know in instances where we have actually practicing pharmacies, our pharmacists come to the meeting, but yet he had to hire somebody to go behind the counter so he could attend the meeting. You know, he is like what is my cost benefit of doing this? So, more and more, our providers are relying on the associations they belong to represent them in these arenas. I know at X12, we have several that come in and represent and are very active and I think those that were missing, as we heard yesterday, there were providers that didn't realize they even had to get an NPI, et cetera. Are there groups, associations that these providers belong to or, you know, how do you reach those that are not in the main stream.
I think we do have to look at where do they belong. What do they read? Those kind of things, put an article in a magazine. So, I think the industry as a whole needs to look at how do we encompass everybody and how can we figure out to get the few that are sitting out here that aren't in the know. But I know from an organization, an SDO point of view, more and more relying on those organizations and associations to represent them in that arena and we welcome that.
MR. REYNOLDS: I am going to continue along a train of thought now and then I will turn it over to everybody else.
So, the word "hurry," "hurry this up," not hurry unreasonably -- make it more expeditious, make it -- okay. I am good with that. But we continue to see that the other things that are getting implemented are taking longer than we all wish.
So, using your term, you said it is volunteers. So, at a time where you are going to take a process and make it tighter, in an environment where even when we make it long, we miss people, are there are any -- do you have any plans -- I didn't see them in the record -- do you have any plans, back to this idea -- there is a difference between volunteers because, obviously, you tend to get the volunteers from the big people that can group up and take staff and send them somewhere.
But maybe -- you know, at least I would like to hear your words on the fact that, you know -- and everybody, you know, pays to be part of these and so on, some dues or something -- is whether or not there should be some standing people making sure that some of these other things get recommended because if we are going to shorten the timeframe, then if we are missing them in the long term, we are going to miss them in the short term and then when it comes here or any of the reviews that you are having, it puts a dramatic burden, a more increased burden -- not dramatic, I will be careful -- an increased burden on us and anybody else that you have set up as the public forum, to make sure that those people are included, having those types of people that were discussed yesterday, the smaller providers, the this, the this, the this or this in your process in some way, to make sure that there is a complete look is a thought.
I am not recommending it. It is a thought. It is a question that I have because as soon as you shorten it, you know you may run right by a whole lot of people and that is going to then -- somebody at some point is going to have to go time out, we have got to talk and we have to make sure we get everybody. Because the volunteer thing is still, you know -- well, all of us struggle with that at times as to who could volunteer for what.
If you could help me with that.
MS. GILBERTSON: One of the recommendations we did put in the paper was that we use some of the existing processes to be more informational, the Federal Register, the HHS list serves, to notify that work is even starting. Now, granted, an SDO continues to constantly work on the new requests from the industry, but here is a banner message. I think it would be very helpful to also see how far reaching those list serves might be within organizations. NCPDP notices are shared with X12, HL7, our organization and association contacts, things like that.
So, I think we have a lot of far reaching. How far down we get I can only guess. But we seem to have a lot of information going out, but adding all those different features of the actual steps, here you were doing this now. Here you were doing this now will help. I think if we are trying to get to the actual provider level, we are probably fooling ourselves because what we need is association organizational assistance. They perhaps don't want to worry about is this a data field or 6 bytes or 25 codes or whatever. They want to know what is the practical implementation. How is this going to affect me?
So whether we notch up the EMP(?) guides a bit so there is more business examples in there, that might be helpful, whether there is more expansion on -- NCPDP is doing web casts right now on Version D.0 to say here are the business cases we are bringing into this new version, please join us. We will talk about what your questions are, things like that. But once again, that is more of a technical perspective because we are not going to tell people how to do their business. We are just going to say here is what the specifications mean based on your business needs.
So, perhaps some more joint WEDI sessions, association sessions, things like that, where people can pop in, listen if they want. At that level, we might get a percentage of less than the null.
DR. FITZMAURICE: As I listened to this, I am really in favor of speeding up the process, but I also read something in the paper yesterday or the day before about habeas corpus, which relates to due process and applied to us it means getting public comment and public influence and doing our own due diligence consideration. So, as I see the process, you would have a federal registered notice of the process of the development of the standard or modification of the standard. Everybody come and join in and bring your considerations.
You then have the SDO development of the modification or of the standard and an SDO ballot. Let's say a Federal Register notice of the ballot and the way to get every member of the public into that ballot may be paying a small postage fee for having the ballots mailed if they are mailed in. That is up to the SDO.
So, we are getting notices out there. We are trying to alert the public about this. Then it goes to the DSMO. The DSMO does its thing and says, all right, we are ready to go. We agree with it and we got good public comment. We send it to NCVHS. NCVHS looks at it and says, yes, a little tweaking here or there after the tweaking. We say, yes, it really looks good and where do we send it.
We can't send it for a final rule. So, we have to send it to the Secretary. The Secretary receives it, says who is responsible for this, sends it to CMS and it goes through the regulatory process that will lead to HHS approval and OMB clearance and then to Federal Register publication, assuming it all goes through smoothly, publication of final rule with comments and a compliance date.
Now the public can then write in and comment but if the comments aren't substantial, then it holds. I don't know that it speeds up what goes on with our due diligence, with what goes on within the agencies, within the Department, even within OMB. If we could pinpoint more closely where the holdups are and the reasons for the holdups, then we might be able to attack those.
I am for this process. I am for making it work with the Administrative Procedures Act, but once it gets inside of HHS, I don't know how we can do our job faster. I think maybe we can do our job faster. I think having the public looking at this and saying we did it in this time period, the clock is ticking for you, not that something is going to go off, but the public will be watching more closely. I would hope that that would also speak up the process and get more cogent comments in more quickly.
MS. GILBERTSON: One of the things to consider, I don't want to use the term "speed" because that is not what this is about. If the industry wants six years to implement a standard, the industry will recommend that and that should be what goes forward. If the industry wants 18 months for something else, that is the industry recommendation. So, we are not talking about speed of how fast we are shoving things out to the industry. It is when the industry asks and gives a timeframe that we try our best to adhere to those kind of time frames.
You know, I am accused of living on Planet Utopia a little bit and I know there have been extensions and things like that, but I also think that if you have a plan and you know what you are expecting and things fall within that project plan, you are not going to deviate that much. What I am more afraid of is if the industry asks for it, they are still waiting for it six years later. To begin the process of the NPRM, they are still waiting for it years later. Nobody believes it.
MS. WEIKER: A perfect example of that, putting on my NCPDP hat, is a recommendation this committee made in regard to the billing of supplies. That is basically just fallen into a black hole and contingency rules, plans, are still in place and will be in place until we have some final resolutions.
So, you know, as Mike said, you get to a point and then it just kind of sits there and it falls into this nebulous, you know, worm hole, as Lynne might say, that says, okay, now what? Now we sit and wait. We have all done our due diligence. We have all done our work, but now it sits and what do I do?
DR. COHN: I am really not going to ask a question. I am just going to give a very brief comment and I will apologize if my facial look sort of telegraphs my thoughts. I just want to way I am very sympathetic to the issue of identifying -- you know, having the process be predictable and I think that is really what we are all seeking.
Obviously, from my perspective, having heard -- I mean, this presentation you are giving today is not all that different than what we saw three or four months ago or was reflected in one point proposed federal legislation, which obviously, didn't go far last year or didn't make it completely through the process last year.
Obviously, I think our intent today was to not just hear from you but also hear from others in the industry to get wider thoughts on all of this stuff. But regardless of exactly how everything looks, I think we are all very committed to the increased predictability of the process. I guess I should also comment that -- this is obviously maybe not as brief as I had thought -- I had the opportunity to give a presentation recently about HIPAA after ten years.
Certainly, one of the things I observed in the -- at least from my view is that the industry doesn't appear to be able to tolerate lots of change and, indeed, we are at this point from my view only really moving from implementation to optimization. I am only really now beginning to hear from people in the industry about the desire to sort of move to new standards, at least in a couple of the areas. I mean, NCPDP may be different. We need to somehow have a conversation about why you are different, but I certainly am just observing at this point that people as we are beginning to optimize CAQH, WEDI and all this, that there is suddenly beginning to bubble up actual genuine needs for now modifications to the standards. So, that is just another reflection that obviously the conversation is timely but that the industry really wasn't ready for it, seemingly, up until very recently, in my observation.
So, anyway, it is not a question. It is just a comment. I am looking forward to the other industry comments on the proposal.
MS. GREENBERG: Two things. One, on the issue of outreach. I think those of us who were here yesterday, the first speaker was from the National Minority Quality Forum and it struck me that one -- I thank Denise for bringing them in, for bringing that organization in. I am not sure we have heard from them before, but -- they may be a group that you are well aware of. But given your comment and I think it is true, that associations, consortia, you have it, are really the ones who have to do the heavy lifting of trying to find out what their constituencies want and then representing them in the standards environment, which is getting increasingly busy.
I mean, as we meet here today, I don't know there are about three other meetings that each of us could probably easily be at and another ten we don't know about. So, I think that is a realistic approach. But I am thinking that the associations also -- and maybe you already do this, but need to partner with groups like this and other groups, who are -- who represent members of the profession, but who are not as commonly seen certainly in these meetings and probably in your meetings as well.
So, I just wanted to mention that because I know you weren't able to be here yesterday. It strikes me that that would be a useful collaboration.
The other thing is I was really taken -- not that I am sure it is the first time it was said, but what Lynne was saying about being predictable and timely and, of course, being the opposite of predictable and timely, which is the process seems to be now. As you said, this is partly the real world and we don't really live in a predictable and timely world, it seems, but we can strive for it.
I was thinking the original report by WEDI about the potential for savings, administrative savings, with administrative simplification, which I know we haven't realized yet, but I think there are still -- we all kind of still ascribe to that potential -- was very effective because it really focused on the business case and the real savings potentially in dollars, as well as improvement hopefully in quality and somebody yesterday referred to quality driven efficiency or something, which was something I thought was nice also.
I wonder if it would be helpful to make this case to try to do something like that again about the actual business case for predictability and timeliness in light of what, as you were describing, what members of the industry can do in that kind of environment and what all the costs are of unpredictability and lack of timeliness. I mean, I think we all agree that these are good goals, but if you could actually do some of that kind of benefit analysis, like was done in those original WEDI reports that might get some attention, from policy makers. Maybe you have already done this, but I don't know that I have seen it because there are real specific costs here, staff costs, research costs, planning costs, false implementation costs, all of that.
MS. WEIKER: I agree and I know there have been organizations that have looked at other transaction because everybody talks about claims, claims, claims. Well, there is a whole bunch of other HIPAA mandated transactions. Eligibility, and that is getting some traction now with the CAQH initiative and the cost savings, they are trying to, you know, put dollars to some of that. Then you start looking at like prior authorizations and what has happened is once people start opening some of these guides and these guides we have to remember are ten years old now and they are like, oh, wait a minute, the business is now this and how do I do it in this guide that was written long ago that maybe I didn't pay a lot of attention to because I was looking at claims, which does affect your cash flow, but in the long term to truly get those savings and to move away from the paper based environment is you have to implement those other transactions.
As an example, I saw recently where it cost like $4.70 to do one prior authorization and if you could automate that to where I don't send in all this paper, then, obviously, anytime you start doing that, you start reducing your costs. You reduce your clerical, mailing, posting, et cetera.
So, I agree, some of those studies are kind of just now being done, but they are being done very silo-ish, so to speak. Maybe that is something WEDI should do is go back and say, okay, we wrote these papers X years ago. Let's go update them. We know so much more now than we did then and add the process and the timeliness and the challenges we all have and had.
MR. BLAIR: I want to sincerely commend the work effort that the DMSOs have made in trying to see if you could come up with a useful way to streamline the process. I mean, this is not your first draft. You wound up doing a first attempt, listening to the response you got when you came to us before, improving it, there are certain things that to be honest with you, you probably would have liked to have streamlined further. On the other hand, there is the balance because you still have to have a diversity of constituency groups that are heard. It still has to be a deliberative process.
So, within the constraints of a consensus-based process and diversity, I think you have made a major step forward. I strongly support the recommendations that you have given us. I think you have given us the recommendations within the context that history has played out so far, which has been HIPAA. HIPAA is still going to be with us, but we are trying real hard to move beyond HIPAA. There is the Consolidated Health Informatics Initiative Standards, which I would like to be considered as part of this streamlining process.
I don't know if that means that we have to revisit these. I hope not. I would really like for the thoughtfulness, the benefits of this process to be examined by an array of other SDOs that have been beyond the scope of the DSMOs.
My wish is that a lot of them would look at this process and say this is a helpful process. They will sign on. Maybe you have other ways of looking at that. But clearly where we have national goals to try to implement electronic health record systems as quickly as possible, e-prescribing as quickly as possible, to try to move towards a nationwide health information network as quickly as possible. RIOs are struggling against areas that haven't been defined.
I think the issue of trying to streamline the process has gotten even more urgent and at the same time, the diversity has gotten broader. The challenge has gotten greater. So, anyway, I will summarize my comments by saying -- by maybe asking you both a question is have you thought about saying that the streamlining process would be broader than HIPAA, would include the Consolidated Health Informatics Initiative, maybe HISPE(?) and whether you have reached out to those entities to see if they would also concur. Maybe that would broaden and strengthen the constituencies to support the acceptance of these recommendations and if you haven't, if you have some good approaches to try to do that so that there is not further delays and we could take advantage of the streamlining process as soon as possible.
So, that is my question to you.
MS. GREENBERG: I cheered when you mentioned CHI, by the way.
MR. BLAIR: You cheered or --
MS. GREENBERG: Marjorie cheered.
DR. STEINDEL: Marjorie, Steve turned in chagrin when it was mentioned.
MS. WEIKER: Yes, we were watching the different faces.
MR. BLAIR: All right. Then, obviously, I don't get to see all of the faces. So, I welcome all comments and views.
MS. WEIKER: Jeff, what the three SDOs looked at was we looked at the process, was the HIPAA process that we are bound by into through legislation, through regulation and he said here is the HIPAA process here at the APA. This is what we are tasked to do, so to speak. That is the process we looked at and involved people with.
We did not go into CIH, HISPE, the SDOs are involved in the HISPE effort because they are looking at their use cases and saying what standard fits this particular use case, what data set, et cetera -- did go to the SDO, but that is outside of a different process versus what we have been mandated and regulated to do in regard to HIPAA. So, we just looked at the HIPAA process because right now that is what is legislated and regulated for the SDOs at this point.
MS. GILBERTSON: And I would not recommend other SDOs having to be under HIPAA if they were to ask.
MR. BLAIR: I never would have thought of it as being under HIPAA. I was thinking of it as good work that you have recommended as a process to try to streamline building consensus among SDOs and having it go through the regulatory process, to federal adoption of standards. That is the way I was viewing it.
So, do you still feel as if -- that we have to look at this as, quote, under a HIPAA process?
MS. GILBERTSON: Well, one of the things that is going to happen since we are all very involved in HISPE, for example, is if the use cases ask for modification, we are stuck. They have to wait until the next version of HIPAA is adopted because we can't change the standards we are being asked to enhance because of the use cases.
So, as part of the standards readiness that we worked on in HISPE, we recognized that one of the criteria that have to be looked at when they are evaluating standards, code sets -- "standards" is a very broad term under HISPE -- we have to pay attention to whether or not there are federal regulatory legislative constraints that a particular standard might be under or need to be used because of.
Now, another Tier 2 criteria is that it is represented in NCVHS recommendations and HHS recommendations, in CHI recommendations. So, we do use that as Tier 2 criteria under HISPE. So, there is very definite collaboration going on in that respect, but what we have a concern with is, okay, let's move the industry forward, based on what the business need or what the use case is or whatever, but you can't use it. That is not a very favorable environment. So, I am not sure if we completely answered all your questions, Jeff, because we are collaborating. We are trying to move things forward. But the regulatory process as it exists for the HIPAA transactions right now because I can't address everybody else's regulations, tie your hands instead of moving you forward.
Did we miss any other points, questions?
MR. BLAIR: Maybe what you are saying is that -- and this is not clear to me and maybe this is why Steve winced. I don't know. Maybe he could explain. Are you saying that other standards, for example, I am just throwing some out as examples, not from an advocacy standpoint, all right? We have ANSI accredited standards like SNOMED International. We have other entities that are promoting standards like IHE, where the STM standards that have created CCR, that is ANSI accredited. We have -- and you can start to go down the list in terms of other ANSI accredited and ISO standards, a whole bunch that are a part of CHI, that we would love to be able to move forward as quickly as possible.
I don't know whether or not we move them forward by leaving them out of this process or having them join the process. Maybe if somebody could answer that question, that would also help.
MS. GILBERTSON: Could you explain what you mean by move them forward?
MR. BLAIR: Let's take RX-Norm. I will just throw in another one. All right. We are going to wind up wanting RX-Norm to be available for e-prescribing. Is it going to have to go through the NPRM process analogous, the HIPAA process and then the next time we have a version upgrade of RX-Norm, we are going to have to wait four to six years for a version upgrade? Or is the fact that it is not a HIPAA standard, does that mean it could move faster?
MS. GILBERTSON: Yes.
MS. WEIKER: Yes. The industry wishes.
DR. COHN: I just want to clarify, Jeff. I sort of hear where you are going, though. Under HIPAA code sets can be updated at least yearly and more often than that once they are identified as a standard. You may have other examples you want to give, but, remember, ICD-9, CPT, NDC, et cetera, all are named as code sets through any of these methodologies, don't require the process you are describing. So, this is an issue of clarification. You may have other examples.
MR. BLAIR: So, SNOMED, RX-Norm and LOINC, for example, they could move faster. They are not limited is what you are saying? We can have version upgrades in those more quickly.
MS. WEIKER: Well, there are two kinds of things when you talk about a code set. You have I am implementing ICD-9 and that is in HIPAA and that is what must be done. But let's say I want to move to ICD-10, for example. First, because you want that code set used in your claim, in your eligibility, in your whatever, whatever, that now has to go through the DSMO process because the DSMO is responsible for those code sets that are part of HIPAA.
So, if I want to go from 9 to 10, you have to submit a DSMO change request and it goes through this process. Also, the SDOs would have to make sure that the qualifiers are in the transactions and those type of things as well before you could use it. But let's say once I named ICD-10 or I have named ICD-9 it is currently named, I can add codes to that code set monthly, yearly, daily, whatever, the process of who maintains that code set has, like for NDCs, you could do that weekly and it is done weekly.
MR. BLAIR: It sounds like the thesis of what I was proposing was wrong. I just heard an "uh huh" from Steve. In other words, the -- it sounds like the HIPAA transactions and code sets are constrained by federal laws. The CHIs are not. They could move forward more quickly and we ought to leave the CHI standards out of this and just do what we can to move the HIPAA standards process forward with what you have proposed and keep them separate.
MR. REYNOLDS: What I would like to do now is thank you very much for presenting because I think I agree with Simon. We are going to have a discussion after our break on this. First, we are going to have the reactor panel. So, you guys, as you know, we think you have done a great job the couple times you have been here. So, we are anxious to now hear from others as to what they think about it, other than just us. So, if we could go ahead and get that panel up and get started right away.
Then after they are done, we will take a break and then we will discuss it. Thank you.
[Pause.]
MR. REYNOLDS: Let's get started. Our next panel called the reactor panel -- that is an interesting headline -- so we look forward to it and I will just go down the order of the presenters here. So, Tom, we will have you go first, please.
Agenda Item: SDO Reactor Panel
MR. WILDER: Thank you very much. Good morning.
My name is Tom Wilder and I am the senior regulatory counsel for America's Health Insurance Plans. I want to thank the committee for the opportunity to join you today to talk about the process that is used to adopt, modify and implement HIPAA standards.
AHIP is a trade association. We represent about 1,300 health insurers and our members literally on any given day process millions of HIPAA transactions for a variety of business operations. I think the paper that is presented to you and the recommendations from the three SDOs does a very good job of outlining some of the concerns and frustrations with the current HIPAA process. I think there is pretty widespread agreement among the industry if you will that the process that is used now not only to modify existing standards, but to adopt standards at the front end and to implement them at the back end is dysfunctional.
Again, the paper, I think, provides yu with a good sense of what some of those concerns are. I think that the paper is good as well in that it really kind of forces us to have a discussion that the industry has needed to have for some time about how to get that process fixed and I have some suggestions and recommendations in my testimony. It is by no means I think all of the things that I think need to be considered but they are just some things that I would lay out for you.
First of all, I think that for most of the industry, the process that is used to adopt and modify standards is a black box. Most of our members really don't understand who the SDOs are, what they do, why they do it and why it is important to them. So, I think it would be very helpful for the SDOs to actually sit down and perhaps in cooperation with CMS to actually put down in paper, in a white paper or other documents a clear outline of who they are, what they do, how they do it and most importantly why the industry should care.
The SDOs are correct. There is industry involvement. There obviously needs to be more industry involvement, but typically those are the folks who are really kind of standards experts. They get really excited about what a loop segment is. There is not a broader understanding amongst -- and I am not saying that to be pejorative. There is just not a broader understanding amongst the CIOs and the CFOs and the others about, you know, why this process is important.
Secondly, I think it would be very helpful for the SDOs to reach some kind of common agreement on a standard process that they can all use together in conjunction so that there is a -- and, again, I would put this in this paper, a clear explanation of here is how you submit a change request. Here is how it is considered. Here is the deadlines for those considerations. Here is the balloting process that we are going to use for that balloting process.
As you know in any business organization, you have got to have predictability. So, if the deadlines were sinked up amongst the three organizations, at least there would be some common process at the front end that everybody follows to get change requests considered.
Thirdly, I think it is important for everybody to have a better understanding of pilot testing. I know pilot testing has been very valuable in some of the recent HIPAA standards considerations but there is not a very good understanding of what pilot testing is and when it is needed and when it is not needed and how best to incorporate it into the process.
Right now, it is done typically after the NPRM comes out. Maybe it should be done earlier. I don't really have a clear answer to that, but I think if the standards organizations and CMS, again, could sit down and kind of talk through with the industry the value of pilot testing, who needs to be involved in pilot testing and when it could be plugged into the process, I think that would be very helpful.
Finally, in terms of at least the recommendations I have in my testimony, I think the opportunity for public comment at the agency level must be preserved. That is comments after the NPRM comes out. I would agree with the recommendations in the white paper that earlier public notice would be very helpful, earlier opportunity for the industry to comment at the standards level is critical and I think that will resolve most of the issues.
But first of all from a strict legal perspective because this is a regulatory process, from the standpoint of the Administrative Procedures Act, I don't think you can actually do away with public input at the rulemaking process. I think it is very important to preserve that public input because again when a standard is being considered, those folks who are intimately involved in the process, they are members of the standards organizations. In some cases they have paid a fee to below to that organization and when you get to the rulemaking, it is then when the wider public at large, if they choose to, can actually write into the agency and say, you know, yes or no, this concerns me because of X, Y and Z.
In the earlier panel, they actually talked about the billing for supplies issue, without going into the detail of that. I was involved in some of those discussions and recommendations to the NCVHS and it wasn't until the rule was actually published and some of the folks actually started to look at it, that is when the red lights went off.
So, sometimes, regrettably it is not until the very end that people actually start to kind of recognize where there are problems.
Finally, I would like to just take a step back and just make a general comment about, again, the process from beginning to end. This is something actually that Blue Cross and Blue Shield Association, I think, made in some earlier testimony, either to this group or to another forum. But they actually suggested that there be what they called a critical path analysis of the HIPAA process.
I think that is a great idea. I think in some forum, either here at NCVHS or perhaps WEDI or another group someone needs to actually sit down with everybody in a room and just think about the process that is used from beginning to end and how we can do a better job of improving that process.
To Jeff's point, I think some of the other standards organizations need to be involved in this discussion. I would not want to bring everything under HIPAA. HIPAA is good because it actually sets some firm deadlines and has an enforcement so everybody knows they need to follow those standards. But because it is embedded in the regulatory process, that is where I think a lot of the delay and slow down comes. So, I think the industry through some form really needs to kind of take a step back and say, okay, we know we need these standards. We know we need to have predictability. We know that we need to have a deadline upon which everybody can rely.
We know that we need to have some kind of mechanism that forces everybody to follow that deadline. How can we do it in a way that is a lot more rational than what we have now?
I thank you again for the opportunity and at the end, I would be glad to answer questions.
MR. REYNOLDS: Tom, thank you.
George, we will go with you next.
MR. ARGES: All right. Chairman and members of the subcommittee, I want to thank you for the opportunity to be here today and talk about the proposed modification to the HIPAA transaction process.
We know that the SDOs follow the American National Standards Institute process, which unfortunately does not always have the benefit of full provider participation. I have often heard that providers need to become more involved and engaged, but the realities are that it is difficult for providers to basically send someone to these meetings and will likely remain so in the future.
In many respects, the purpose for the creation of the Designated Standards Maintenance Organizations was to give providers a voice in the review and approval of changes to the implementation specifications as outlined in the HIPAA standards. As you know, the DSMOs include each of the ANSI SDOs, as well as the three data content committees, the Dental Content, the National Uniform Billing Committee and the National Uniform Claim committee.
Each of these content committees really strives to bring forward the provider viewpoint on important decisions that can influence the HIPAA transactions. The content committees look at the policy implications of a change and how it would affect the operations of the provider and the health plan.
The DSMO focus is not so much on the technical side of how a segment within the electronic transaction carries information, but rather on the policy and implication that a change will have on the day to day business routines of each constituency represented on these committees. This includes instructional narrative to help users better understand when and how a particular data element should be used.
The DSMO was created after the final rule on the HIPAA transaction standards was published. One of their first tasks, obviously, was to conduct a fast track review of how these transactions would apply and that in essence led to the Addenda versions of the current standards. Once the initial effort was complete, the DSMOs turned their attention to reviewing suggested changes for future transactions.
A number of these changes have been incorporated in subsequent versions of the standards. Generally, all of the DSMO have worked hard and worked well together to basically include some of these change requests. The volume, however, of the DSMO review has decreased substantially in the last several years, but in examining the 005010 version of the claim standard, we also noted that 85 percent of the changes were not brought before the DSMO for review. Fortunately most of these changes are not substantive and include many improvements in the structure and the instructional material that make up the standard.
We want to emphasize we want to commend the X12 group for a lot of these improvements. The question of whether the AHA is prepared to support the next version of the existing standard can be answered as a simple and strong "yes." The 005010 version includes many changes that the NUBC brought forward such as diagnosis indicator reporting and future changes to support ICD-10 coding.
In addition the NUBC and X12 have worked closely to make improvements to the claim transaction, for instance, in the interpretation of the inpatient and outpatient applications of the transaction standard. This version contains significant improvements that should be adopted as a replacement to the existing standards and we wholeheartedly support moving that as quickly as possible.
But there are more questions that remain unanswered and require attention, questions as to whether the current process is working at its best and whether there are opportunities or areas where the process could be made better. These are some of the issues hat I believe require immediate attention.
We know that the current process takes too long and presents us with a take it or leave it dilemma. As a whole we need to establish a process that relies on incremental stages for earlier input and review. The process must include all affected parties and must involve DSMO input throughout the development process.
Over the years X12 has made improvements in how they manage requests for changes, but the establishment of a more rigorous outreach program is imperative. This includes adopting a public mechanism that logs and posts all change requests. In addition, it should actively seek the review from the other DSMO members as they are looking at changes that are brought to their SDO work activity.
Additionally, it would be beneficial to publish an advance notice of change items up for review in advance of the trimester meetings. This would help alert affected organizations of upcoming issues and provide them with an opportunity to comment. We realize that X12 is composed of volunteers and that this would impose an even more burdensome work activity on this individuals. But initially this may be difficult to apply, but in the long run, I believe, it will make their job easier.
We would expect that minutes to the workgroup meetings and discussions be made available and accessible through a single central portal that would first serve as a central point of reference and provide a better understanding of the issues before the SDOs.
Formalizing this process would improve the outcome and increase the awareness of the upcoming changes under consideration. While many of the X12 workgroup leaders strive to apply these goals informally, communication vehicles are often not formalized and vary from workgroup to workgroup. Some workgroups utilize list serves and different web boards. Others rely on periodic conference calls. This makes it difficult for individuals, especially those who are unable to attend the trimester meetings, to find, review and provide input on various workgroup activities.
As I noted earlier, 85 percent of the changes in the implementation guide were made without prior DSMO review. Greater communication and involvement earlier on is the key. Last year, Congress worked on a bill, HR4157. It included provisions to expedite the change process for the HIPAA transactions. It relied on notice and publication during three distinct points in the standard setting process. The first would be a notice that ANSI will begin work on the development of the new version of the implementation guide. The second notice would occur when a draft of the guide was available for review and comment and then third a notice would be posted to indicate that a final implementation guide was available for review.
By the way, I believe it included a final opportunity for input through the NCVHS hearings on whether appropriate outreach and input had occurred and to entertain any other final comments from any interested individuals or organizations. We would expect that the DSMO organizations would be engaged throughout this process, particularly during the first two phases. This will allow us to help correct any areas where there may be some egregious element that may have been added or changed, that would adversely affect health care, but fundamentally the AHA is supportive of the stages that have been outlined in that proposed piece of legislation. We do believe that improvements and better communication throughout the development process is essential and that the DSMOs must play a more active role throughout that development cycle within the X12, as well as other SDOs.
In conclusion, we want to reiterate our support for the adoption of the next version of the X12 standards and we would urge NCVHS to encourage change to the existing process, hopefully, one were X12 and the DSMOs can increase their communication and review of future changes under consideration.
Again, thank you for this opportunity to present today.
MR. REYNOLDS: Nancy.
MS. SPECTOR: Good morning. I am Nancy Spector, director of Electronic Medical Systems of the American Medical Association.
As some of you may be aware, I am also chair of the National Uniform Claim Committee, which is a member of the Designated Standards Maintenance Organization and I also served as the 2006 chair of the DSMO Steering Committee.
The AMA would like to thank the National Committee on Vital and Health Statistics, Subcommittee on Standards and Security for inviting our input on the proposal for modification of the HIPAA Transaction Implementation Specifications Adoption Process as put forward by the Standards Development Organizations of the DSMO.
The AMA's comments on the modification proposal that I am presenting here today are based on policies that have been developed by our House of Delegates at various times over the last several years. They are part of larger policies that do not necessarily speak just to HIPAA modification, but they provide an overview of the physicians' view on this topic.
To begin, the AMA supports the ongoing development and use of standards for electronic data interchange. Policy adopted in 2000 asks in part that our AMA continues to facilitate the rapid development of uniform, industry-wide, easy-to-use, low cost means for physicians to exchange electronically claims and eligibility information and remittance advice with payers and others in a manner that protects confidentiality of medical information and to assist physicians in a transition to electronic data interchange.
A second policy reaffirmed in 2004 calls in part for our AMA to advocate the use of standards that are continually modified and uniformly implemented. The business needs of health care are continually evolving and, therefore, the standards through which data exchange occurs need to continually be modified and updated. Without ongoing modifications, the standards and implementation guides become outdated and may no longer support the administrative needs of the physicians or the industry as a whole.
Technical changes to match new health care needs are not the only reason for modifying the standards and implementation guides. Clarifications in the instructions of the guides themselves are needed to improve the processes the guides support. For example, since widespread usage of the X12 version 4010 implementation guides began after they were named in 2000, the industry has learned much about the instructions of the transactions.
In some cases, instructions were found to be unclear and ambiguous or business needs changed since the original writing of the guides, which led to various interpretations. This created an added layer of burden to physicians and the industry when various interpretations were implemented.
The AMA is aware that the X12 5010 Technical Report 3s are being brought forward through the DSMO process for consideration for adoption. We understand that many of the overall improvements in these guides are clarifications to instructions, which make the requirements for the transactions clear and less burdensome for physicians. Specifically, the situational notes in the transactions have been restructured and rewritten. The Situational notes are used to clarify the business content, clarify the format of the data content or indicate relationships in data content between different transaction sets. The improved situational notes provide very clear rules as to when each element is to be sent and when it is not to be sent with a focus on data requirements when they are known to impact adjudication. This will result in improved standardization and clarity among the guides and in the industry's use of the guides.
The many improvements that have been made in the newer versions of the X12 TR3s emphasize the need to continually modify and update adopted standards. Improved standards and implementation guides will assist the industry in continuing to move forward with better business processes and may also entice those in the industry that have not yet implemented electronic systems to do so.
Next, the AMA supports the proposal's call for industry input at the development stage of the standards and implementation guides. AMA policy reaffirmed in 2002 asks in part that our AMA encourages physician participation in the appropriate national organizations involved in the implementation of HIPAA regulations.
The SDO's proposal is for more industry involvement to occur at the standards development stage and calls for notification through the Federal Register of SDO work beginning on new versions of standards. The intention would be to reach the widest range of interested parties and encouraging them to participate in the work. In addition, the proposal calls for the Department to announce the approval process for a new version through their far-reaching federal list serves, again, encouraging participation at this stage in the development of the standards.
The AMA supports the proposal for early notification of the SDO work and encouragement of more participation at this level. Currently, the AMA participates and contributes in X12's work developing standards and implementation guides and will continue to do so.
Overall, the AMA does have concerns about the current level of participation by providers in standards development compared to other segments of the industry. For standards and implementation guides to be well-received and widely adopted by the industry, there must be equal participation in their development. The AMA will be happy to work with X12 to further explore possible ways to improve not just physician involvement but provider involvement as a whole.
I just want to address Margaret's comment from earlier that there are many associations that are involved with X12 specifically and, yes, they do represent a wider range or broader number of providers, their members, but when it comes to business matters, the associations have one vote as a member of X12 and even though they represent hundreds of thousands of providers, they still have one vote compared with the other members that are there participating.
Finally, the AMA would like to voice our concerns about the frequency of the adoption of modified standards and implementation guides. AMA policy adopted in 2000 calls in part for our AMA to study strategies on implementation of the HIPAA regulations, such a limit on the frequency of modifications, which will lessen the financial impact on physicians. A second policy adopted in 2001 calls in part for our AMA to continue to aggressively advocate to Congress and the Administration, physician's concerns with the administrative simplification provision of HIPAA and that the AMA seek changes, including legislative relief if necessary to reduce the administrative and cost burdens on physicians.
The AMA recognizes there is a balance between too few updates, resulting in outdated standards and guides and too frequent updates, resulting in administrative and financial burdens for physicians. Clearly, there are costs and benefits of upgrading to newer version of a standard. The benefits are in having better transactions that more closely meet the physician's business needs, which I spoke of earlier. The costs are literally the financial costs for the physicians for the necessary system upgrades or costs that are passed onto them by their vendors. In addition, there are other administrative costs, including staff training, possible interruptions in the processing of transactions and the general overall time spent on the implementation.
The question of how often to upgrade to newer versions of standards and guides is really a double-edged sword. If modifications are not made often enough, the work necessary to complete the modification will presumably be more extensive and costly, which we are currently facing with the X12 4010 version to the 5010 version. One could argue that more frequent modifications involving a smaller number of changes would be easier to implement and cause less widespread disruption and upheaval in the industry. Unfortunately, there is no evidence at this time as to which is more costly, the smaller, more frequent modifications versus the more extensive, fewer modifications.
The SDO's proposal addresses the lack of predictability in the current process and a lack of agreement on how often the industry wants to move to a new version of a standard. The AMA agrees with their comments that knowing the process and associated timelines will enable physicians to manage and allocate resources for competing initiatives. Also, the industry needs to reach consensus on when to proceed to the next version and this is an industry decision, not an SDO decision.
Perhaps these are questions that could be answered separate from the proposal in terms of the step-by-step modification process and the AMA would be willing to work with NCVHS and other interested organizations in addressing these questions.
In summary, the AMA supports the use of continually modified and uniformly implemented standards and early involvement by physicians and the industry in the standards development work but has concerns about the frequency of modifications because of the potential financial impact and administrative burden that will be placed on the physicians.
The SDO's proposal raises many good questions about not just the steps for modifying the standards, but about the overall process of which it is a part. Now that the transactions and code set regulation has been in place for several years, it seems appropriate that we as an industry review the process and take necessary steps to improve it so that we can achieve the administrative simplification we are all looking for and the AMA would be more than willing to participate in this work.
The AMA hopes that you have found this information to be helpful and we look forward to working further with the subcommittee, the full committee and the Department as this proposal continues to be evaluated. Thank you again for the opportunity to testify today.
MR. REYNOLDS: Thank you, Nancy.
Kathryn.
MS. KUHN: Hello. My name is Kathryn Kuhn and I am representing the National Community Pharmacists Association. Thank you for allowing us to testify on behalf of this important topic. I would like to point out that NCPA does represent independent pharmacy marketplace. I did share these specifics with you yesterday. So, I won't review them again with you today.
What we would like to do is point out a couple of things that we see as problems with the current HIPAA standard modifications process and then point out a few recommendations for how we would like to see that process change moving forward.
First of all, the one major problem that we see with the current process is the DSMO process. In our experience when a change request enters the change request system, the SDOs collectively evaluate and ultimately vote on the change request. But typically the SDOs in general don't lack the expertise to evaluate a change request if it is outside of their domain. So, they must defer to the SDO with the relevant expertise.
So, what results is you have all these SDOs that can't deal with a topic or change request because of their lack of expertise outside their domain. So, they end up abstaining in the voting process. So, we feel like this aspect of the HIPAA modification process is very ineffective and needs to be reevaluated.
Secondly, we would agree that there needs to be more timely adoption of new implementation specification standards. For example, if you look at the regional pharmacy transaction standards today that we are using, which is the NCPDP version 5.1, NCPDP actually since that version has been implemented has developed another version that currently exists and it is more than 20 versions advanced from 5.1, which is currently in draft form and that would be version D.0.
Some recommendations that we would like to see incorporated moving forward as part of the HIPAA modifications adoptions process is support for an abbreviated process and we would encourage this so that more timely adoption of standards could occur. We also support what was being proposed by the SDOs, continued use of the WEDI cost benefit analysis surveys to study the impact on materially affected parties, particularly including the provider community. In developing the WEDI surveys, we think that substantive quality survey questions should also be developed by a broad cross section of the industry and not just limited to the SDOs.
The survey questions should address impact on technology, implementation costs and requisition of additional patient data. They should also address impact on provider work flow and potential diversion from patient care and also should include an assessment of the administrative burden on the industry.
We would like to further comment about the WEDI surveys. We feel that these surveys should also include samples that represent a broad cross section of the industry and it must include providers in the survey pools. For pharmacy providers we recommend working with the Pharmacists Services Technical Advisory Coalition, which is called PSTAC. This is comprised of seven national pharmacy organizations and they all represent provider communities.
Just to give you a rundown of who belongs -- which provider or pharmacy provider organizations belong to PSTAC, they include the Academy of Managed Care Pharmacy, the American College of Clinical Pharmacists, the American Pharmaceutical Association, the American Society of Consultant Pharmacists, the American Society of Health System Pharmacists, the National Association of Chain Drug Stores and the National Community Pharmacists Association.
These are all provider groups belonging to this one organization that are focusing on improving the EDI Health Care Claims Infrastructure specifically as it relates to pharmacy providers and just as an FYI, PSTAC is also a member of the AMA CPT Editorial Panel. So, it is a credible group. I do serve as executive secretary of that group.
Another recommendation that is part of the HIPAA modifications process moving forward is that we would like to see a creation of what we refer to as a holistic process that allows for systematic review by the health care industry and one that establishes a scheduled review process and includes associated timetables. So, for example, a review of the need to change to a new HIPAA transaction standard might occur every two years or five years, but there should be some sort of timetable or schedule where that would occur.
Also, this process would be one that utilizes the federal rulemaking process that provides for public comment regarding the industry readiness for change. With this process we feel it is still very important to maintain as opposed to limiting such a process to an SDO process only because the SDO processes lack broad dissemination that is characteristic of a federal rulemaking process and typically the SDO processes involve decision making at the workgroup levels and they also could have limited representation of the materially affected parties.
So, for example, in the case of the NCPDP SDO, that retail pharmacy is affected by in terms of our claim transactions, pharmacy providers are exceeded three to one by payers, processors and vendors in the NCPDP organizations. So, they are underrepresented and I think we have heard some of that from the other SDO membership organizations.
As part of the federal rulemaking process, we think it should also include specific timeframes or milestones for decision making to alleviate this protracted adoption process and we would agree with that aspect of the SDO proposal, but we feel like the process should only focus on industry readiness in terms of readiness to move to -- a transition to a new version of an implementation specification and not focus any further on changes to the implementation specification because we feel that that -- at that point it would have been through a vetted process. We would just like to focus on a transition to industry readiness.
What we don't to see occur again is -- as part of any sort of standards modification process -- is a repeat of retail pharmacies experience when HIPAA was first implemented. At the time prior to HIPAA implementation, retail pharmacy was already using an electronic health care claim transaction, which was NCPDP version 3.2 and it was widely accepted by the -- 3 at that time. However, with HIPAA, implementation of HIPAA, it mandated a higher version, which was movement to 5.1 and at the time it had not been fully vetted by the pharmacy industry. So, many considered it an unnecessary transition at that time and it cost a major expense for the industry to implement. We don't want to see that occurring again.
We would agree that there are benefits that have been proposed by the SDOs and with the inclusion of our recommendations we feel that they would establish a schedule for upgrading the HIPAA adopted implementation specifications that lagged behind existing implementation standards and they would also establish a reasonable predictable maintenance cycle for HIPAA adopted standards that have not been feasible to date. However, it would provide for the necessary checks and balances via a federal rulemaking process.
That concludes our comments and I thank the committee again for the opportunity to provide this testimony and our feedback.
MR. REYNOLDS: Thank you, Kathryn.
What I would like to do is, Lynne, would you and Margaret mind joining us at the table since we heard from you and now we have a reactor panel. Let's discuss it. If we could do that, I think it would be good and I will now open it to the committee for questions.
Judy.
DR. WARREN: This was a question that came out of Nancy's testimony. You were talking about -- it is on page 2 -- the business needs are continually updating and may actually outstrip some of the standards. How would you suggest we go about this keeping up with the business needs because you were saying that some of the old specification guidelines were concerned about business practices that are in the past. So, this is causing problems.
MS. SPECTOR: I don't know if I have the answer for that in terms of keeping up with the business needs. I think that that is something that the SDOs in their work in looking to are we ready to move to a new standard, a new start, writing a new guide, I think that is part of what their work is and, again, that is representative -- you have got participants from the various sectors of the industry there, who are recognizing what are the newer business needs and do the current -- does the current transaction guide accommodate that work or do we need, you know, new loop segments, elements that will accommodate that?
The one issue -- and I am not well-versed, I admit, in the transaction guides, but you have got the health savings accounts that are becoming more and more popular and do the 4010 guides accommodate all of the needs in terms of the data that needs to be, you know, exchanged for those transactions. So, that was one of the new developments that I was thinking about that may need to be met. I am sure there are other examples that others could give.
DR. WARREN: To follow up on that, I think everyone of you has made the comment that your particular sector is not well represented in the SDOs. It is like the SDOs are over here and the work you want done is over here and you are not participating.
From my own discipline, you know, I go around trying to get everybody in nursing involved in the SDOs and my involvement, I mean, there is a big need and the SDOs are trying to get the providers there so they can do that and they are not able to bring them there. So, do you have any suggestions about how to encourage your own particular sector and this is for everybody to participate in the SDO process so that we can be more appreciative of business.
MR. ARGES: I think one of the things I had commented on was if the SDOs themselves could lay out the issues that they are discussing ahead of time in a way that is easy to find, the time slot that it will be available and making certain that they can communicate it. I mean, I think the associations would be happy to be able to go to the web site, identify the particular item up for discussion, tag that item and contact our members to say this is coming up. We believe this is important. You need to be there as part of that discussion.
I think that is one way around it, but right now, I think it is very much a byzantine process. It is a lot of who you know, going behind the scenes and kind of figuring out after the fact about what is going on. Again, there are different levels of workgroup documentation. Some do a better job than others. It would be nice if there could be some pushback really on the workgroup to focus more on formalizing their actions and their work activity in a way that lays out more of a here is the agenda. We are logging it in. We are making it available for the public to see.
This will be up for the next trimester meeting as part of a discussion item. This is what we have considered today. Here are the minutes from that and this is the type of outreach that we have had.
MR. REYNOLDS: Before I recognize anyone else, Jeff has a comment for you, George.
MR. BLAIR: I am a little surprised by -- I think the comments, the things that you are asking for are all appropriate and I am a little confused by them because the standard development organizations that we have been working with in health care that are part of the HIPAA process and almost all of them that are part of the other standards that will be CHI are accredited by the American National Standards Institute, ANSI. The criteria to be accredited is that the agendas need to be posted in advance, typically on web sites and that they have to be open meetings, consensus meetings and virtually everything that you just articulated are required processes to be accredited by a standard development organization that is recognized by the American National Standards Institute. Am I missing something or were you just not aware that these requirements were in place?
MR. ARGES: No, I am aware of the ANSI requirements and it is an open process and it is consensus driven. The question is are you getting people to attend as the process develops, where the discussion takes place, where the workgroup issues take place. All too often a lot of that discussion is really who you know, rather than laying it out formally in a way that can get people to go to a particular meeting.
I would wager if you were to go to the X12 web site today and say, okay, there is a trimester meeting coming up in a week, what are the top three issues for discussion on each of the workgroup activities and my guess is you will not be able to find it easily or find the top issues that will be up for discussion.
MS. TRUDEL: I am recalling my first foray into an X12 trimester meeting and it is very daunting, the structure, the number of workers that are meeting concurrently, the fact that the issues tend to be couched in technical terms so that you don't get the business notion of what is behind a change to a loop or a segment.
I think there is always room for improvement there. But I would follow up on Kathryn's point also and say that the regulatory process isn't perfect either. In the proposed rule for the first HIPAA regulation, we specifically proposed 5.1 and we got no comments saying that 3.2 would be better.
So, there are always ways to, you know, improve either one of those processes.
MS. KUHN: I would like to point out, recognize that this SDOs have to adhere to the ANSI standard. However, if you look at each one of their structures, they all operate differently. Some may encourage or discourage more provider involvement based on say their membership fees, for example. I think if you look at their balloting process, each one of them operates a little differently, too, may also affect provider involvement and provider input into the decision making process. So, those are our concerns.
MR. REYNOLDS: Judy had a question and then Marjorie and, Lynne, did I see your hand? Is this on the same -- what I want to do is I want to finish any comments on this because we have got another list going on with other people's questions.
DR. WARREN: My comment is -- and now I am speaking from my own experience of working in an SDO, specifically in HL7 and one of the biggest challenges we had was trying to get providers to attend the meetings. I realize it is daunting because people are looking at specifications but without the providers there to help us with the use cases, it was very difficult to do those things.
When we made outreach, we got no response back and I think that is very frustrating when the SDO knows that they need the providers there. They contact the various organizations or people they know and there is no response. So, I guess I am suggesting back since everybody here feels that they are kind of outside, that maybe somebody within your organization needs to reach out to the SDOs to their formal central offices and say I am here. I am your main contact with AMA or AHA or, you know, whoever. When you need help in these areas, we will provide somebody.
All the meetings are open. You don't need to be a member to attend any of them and you can show up. Although I will tell you I agree with Karen. My first meeting at HL7 was daunting. You know, it is kind of like -- I don't even know what room to go to. You need to find someone that is willing to go at least to a second meeting because the first one is just figuring out, you know, what is happening and how the agendas work. But think most of the SDOs have people that if you say, you know, I need some help in figuring out how to attend, they will assign someone to you and connect you up and make sure that you could participate.
So, I am just arguing for it. This needs to be a bi-directional street between the providers and the SDOs so that they can inform each other.
MR. WILDER: If I could respond real quickly. I think the industry first of all is becoming more aware of the importance of the process. I think early on we just were clueless and so we are getting smarter about it. We have all talked about some things that can be done in terms of better transparency, better uniformity among the organizations.
Again, my cautionary note is the SDO process is not always the place where the right decisions need to be made. Again, they focus on more of the technical aspects of a standard and sometimes there are policy issues that need to be dealt with elsewhere. So, we need more inclusion in the SDO process. We need more participation but we also need to recognize that that is unfortunately not the end all or be all of all of these changes.
MS. WEIKER: When we talk about the SDO and the industry and I look around the table, we are the SDO and we are the industry. So, when comments are made about, oh, the SDO needs to do this and the SDO needs to do that, we are the SDO. We are the change agents that need to take charge and propose those changes.
I agree, communication in some of the SDOs could be better, more uniformity. I don't disagree with that at all, George, and we are trying to do that. These are volunteers that co-chair these groups, that write these guides. They have got another full time job. So, we need to be careful. We agree we need more outreach and how to do that. We are very open to that and, yes, we know it can be very daunting to go to an HL7 meeting and to go to an X12 meeting. I mean, I have been there where it was my first meeting, too. We are trying to put together more of an educational, like how to get around kind of thing.
As mentioned, the SDOs are now saying, you know, we need to assign somebody to the new members or the new attendees to help them through the process because we want to keep those people coming and get them there, to keep them coming versus they come once and like, oh, my heavens, what the heck is all of this about and never come back because then we have lost and we have lost as an industry.
So, I guess my comment is we are them and we need to be the ones to make these changes.
And in regard to the ANSI accreditation, each organization is ANSI accredited and ANSI says you have to have -- you must follow an open process. It doesn't say how you do that process. It just says you must do, you know, X, Y, Z. Having agendas is not part of any of the accreditation.
But each SDO through the years developed their processes based upon their membership and the rules at that time and how they operated, some prior to ANSI accreditation and made changes. So, yes, we all do it a little bit differently, but yet we all still follow those same principles.
MR. ARGES: Just a comment. I agree with Margaret. In essence the entire community is part of the SDO and what I was trying to convey is can we do better and the answer is yes. We should be able to do better. If we are looking to basically adopt an expedited process that really puts different faces of look and see and touch and feel and review, we want one that can basically do the type of communication a lot earlier and is inclusive so that we don't have to necessarily go through a PA process that waits after the fact to get public opinion. You are really reaching out to try and get that as soon as you can and try to be inclusive as early on as possible. That is my point.
If we can formalize it in a way that everybody feels comfortable with, then I think it really bodes well for the industry. I mean, I think a lot of the SDOs have done a terrific job. I am not trying to say that they haven't. What I am trying to say is we can do a better job.
MS. GREENBERG: Tom was, I think, quite explicit that -- in his caution against eliminating the notice of proposed rulemaking that allows the public broadly to comment on a regulation. But I didn't hear and maybe I missed it, but an explicit position from the other three presenters on that. Maybe that is because the organizations, you know, don't have one or I missed it. I wondered from each of you, Nancy and George and Kathryn, whether your organizations are supportive of that aspect of the WEDI proposal or feel that you still need the opportunity for public comment to a proposed rule issued by the Department.
DR. STEINDEL: Excuse me. I want to add to Marjorie's comment because I was going to ask something very similar. What I would like to hear from each one of you is where your proposal differs or how you would augment what was proposed in the opening session, the six bullet items. That goes along with what Marjorie is asking because one change I heard was keeping the NPRM process.
So, Marjorie, do you forgive me for adding on?
MS. GREENBERG: That is okay.
MR. ARGES: My viewpoint is the initial phase for significant NPRM process really is when a standard has not been identified in name as a standard prior to that time period. When you are going from one version to another version and you are looking at this expedited process and you are trying to engage people early on, in essence you are modifying what has been an NPRM process at the back end and the way it is now, it is take it or leave it. You basically designed the standard and here it is, you accept it or you reject it. That, to me, doesn't seem acceptable. What you want is public input at the earliest stages so that everybody has no surprises, that when the final product is there, you can pretty much embrace it and move on with it.
The idea of having it predictable is one that is important and we need to be, I think, on a regular cycle in terms of new versioning only because you are probably not going to get it right to begin with anyway. What you want is the opportunity to change it. The problems that we have is that you don't have that opportunity to change it. You want to process that says it is not necessarily perfect, but here is what we have done. Here is what we have reviewed. This is how it will look and feel. It will be in place for, I don't know, two years, three years after it has been laid out, but if it doesn't work well, then we need to then change it.
The problem we have today is it is out there and good, bad or whatever, it is out there for a long period of time and people are just out of compliance or it is not working for them.
MR. REYNOLDS: I would like to take a break now. Come back and hear the other two responses. We will take a 15 minute break.
[Brief recess.]
MR. REYNOLDS: Point of order. We are going to spend the next 15 minutes on this because we obviously have a -- we need to have a little discussion of our own, based on other than the questions and then we need to make sure that we get two or three other items we have to take a quick look at.
So, George, you had commented. Steve had asked for -- and Marjorie had asked for a couple more comments.
MS. SPECTOR: I can go ahead and comment for the AMA. In terms of Marjorie's question about elimination of the NPRM specifically. As I read through the proposal the pieces I picked up on are the call for early involvement of the development stage and I do think there is an opportunity within that development stage to expand it beyond just the technical writing of the guide, but also try and pull in those conversations about, you know, what is this impact going to mean in the settings. Is this -- you know, just talk more about this policy kind of issues as the development takes place.
Then the other piece I focused in on was still the call for NCVHS testimony before, you know, a letter would go forward to the Secretary, supporting or making a recommendation about the change request and so I look at that NCVHS testimony as the opportunity to hear from people in the industry, representatives of the industry on is the industry ready for this. Is this the right time to do this? Hear about that cost benefit analysis work that WEDI is going to be doing and then also to have discussions about the implementation timeframe, how best can this be rolled out, looking at what other competing initiatives and priority are going on and trying to coordinate among those so that everybody is not trying to do everything at one particular time.
So, I think that if those concerns can be addressed through that NCVHS testimony and then maybe shift some policy questions into the development stage, I believe the AMA would be fine with removing the NPRM process.
MR. REYNOLDS: I forget which one of the other two of you were supposed to comment.
MS. KUHN: Well, I think I addressed this in my comments that that was part of our recommendations is that we do retain the NPRM part of the process as a way to allow for public comment of the need to transition to a new transaction standard.
MR. REYNOLDS: Mike, you had a question and then Simon, you have got the last one.
DR. FITZMAURICE: We have heard a lot of good features about the proposal and some things that you would like, one of them being a chance for public comment and following the Administrative Procedures Act. So, I ask you if the SDO proposal as we have heard it today were consistent or modified slightly to be consistent with the APA, would your organization support it. If not, where would you go to modify it to make it acceptable?
MR. ARGES: Can I ask a question? I am not quite sure I understand what you would modify to be as part of the APA. There are like three distinct phases that have been proposed. Each of those has a notice for the public. So, what modification would you make there?
DR. FITZMAURICE: The modification might be when it reaches the Department is there -- that the APA require an NPRM, a notice of proposed rule making with public comment or can it be put out as a final rule with comment and if comments aren't great, then it becomes the final rule. It may be that the -- knows much more than I do about the APA and I think probably Karen knows more than I do about the APA -- would say you have got to insert something, insert more than just public hearings, maybe NCVHS has to take all written comment, take the written comments, too.
I am not sure, but those are things that I had in mind when I said some slight modifications to be consistent with APA. So, what I say is if the SDO were consistent or modified to be consistent with the APA, would your organization support it, the SDO proposal and if you wouldn't, if you still have problems with it, where would you go to modify it to make it acceptable.
MR. WILDER: I think what I would look at in terms of modifying what they have put forth is some process to designate what is a what I would call a minor modification, which I think 99 percent of them are versus the 1 percent, where -- while you are modifying existing standards, it actually has a major impact on a business process and you need to have more and lengthier input.
For those minor modifications, because of the requirements of the APA, HHS may decide we are going to fast track this and we are going to issue it as an interim final rule with opportunity for comment, with a short 30 day comment period. For those modifications that are significant, you might want to have a more robust process with a longer comment period or have pilot testing or what have you. But, again, I think most of the modifications actually are not a big deal. They get fully vetted at the SDO level. I just again caution you. There are some things where you actually need to have more in depth discussion.
DR. FITZMAURICE: So, basically for minor modification you would support the SDO process. For something more than minor, you would like to see more industry, maybe public comment.
DR. WILLIAMS: Yes, again, with one caveat. I am by no means an APA expert. I think you are going to have to have some opportunity for public comment at the rule making level. I don't know where that dividing line falls. I would defer to others, but you may need to actually -- maybe it is a shortened period or what have you, but you may need to actually publish it in the Federal Register or have comments of some kind.
MR. ARGES: I think I would agree with Tom. There should still be an opportunity for public comment as a final analysis but I would hope that earlier on, there could be really no surprises. I mean, hopefully the communication is occurring the way it is supposed to occur and if perhaps a change law could be developed early on to kind of summarize the type -- nature of changes and who all might have been involved in the approval, there really should be no surprises. I think you can kind of cut down on the time at a later date, for one final opportunity or comment to basically approve up or down the rule.
MS. SPECTOR: I agree, again, with the idea that there needs to be public comment in the process and I guess the question is what -- how do you define public comment? Does it have to be an NPRM, an interim, final rule, final rule with comments or -- and I am by no means an expert with APA, could NCVHS hearings and maybe -- and an opening for written testimony to be submitted, does that constitute public comment?
I guess the other question I would raise is in that public comment, is there going to be any definition as to what those comments are about because what we currently are facing is if those are technical comments and it is deemed that a change needs to be made in the guide, it can't be made in that version of the guide. It has to be made in the next version of the guide, which is not the guide that is named in the NPRM. So, you have to issue another NPRM. So, I mean, that is that loop that you get caught in. So, are those public comments going to be limited to only policy type questions? Are they going to allow for technical changes? Because that gets you back into that same loop that we are in right now.
DR. FITZMAURICE: So, but if that were handled then, then you would support the SDO proposal?
MS. SPECTOR: Yes, because I think without it, we have got what we have now.
DR. FITZMAURICE: Yes. Exactly right.
MS. KUHN: I don't have anything to add.
MR. REYNOLDS: Simon, you have got the last one.
DR. COHN: First of all, I want to thank this panel. I think it has been -- especially the last couple of minutes have been tremendously interesting. I wasn't sure we would actually get to a place of substance as opposed to, you know, just sort of talking about issues. So, some of these last few comments have been very helpful.
Now, let me drill down even maybe a little further into substance. I expect that probably sometime in this coming year, we will probably start talking about modifications to standards. One could imagine even though we haven't talked about priorities, that my understanding is is that there is an NCPDP modification coming forward, D.0, and X12 is I think -- 5010 coming forward. Exactly.
My question is with all of this discussion, what advice would you give to all of us as we think about embarking on this one. How does all of this conversation affect how the NCVHS should approach this, how all of you should approach this? And you can certainly follow up with written comments if you would like to afterwards, but it is just -- we are drilling down from a hundred thousand feet to 50 to 5 and now we are down to about a hundred feet in terms of -- what do you think? You know how we function. You know the current processes. What are your recommendations for this -- for these modifications that are upcoming?
MR. ARGES: To me, the process that has just been outlined in terms of the SDOs, No. 1, I think, would be an improvement because the way -- what we are confronted with today is either you take the 5010 or you reject the 5010. So, you are then faced with having to look at another four or five years of development time to get a modification of an existing standard out there.
So, to me, it is important to keep that in mind, but I think what we have learned as part of the DSMO discussions is I think the DSMOs can work together fairly well. We have a change law. Can we make improvements? Sure. And I think we would like to see that. I would like to see an X12 log that is created as they look at changes so that we can move them forward. It would be easy to kind of have them piggy back what I think Steve Bass in Washington Publishing ably provided to the DSMOs as part of their process.
Maybe there might be some issues of funding within the X12 process or the other SDOs in terms of trying to apply some of those communication rules is what I view them as.
MS. GILBERTSON: It is a pretty concerning environment right now, Simon, because I think there was a lot of industry activity working toward HR4157 in the timeframes that were suggested there, along with the modification process. The status of where any of that stands -- I mean, there was a lot of activity getting to that point. So, to consider the X12 versions moving forward or the 5010, the NCPDP standards coming forward is extremely concerning in the current environment because people are being asked to review the implementation guide, to make comments, to go through the formal ballot process in 2007 and we have no guidance for them as to how to build their project plans or when they can even consider this.
From the pharmacy industry perspective, we have made over -- an amazing amount of modifications that are nasty for the industry to support Medicare Part B and the industry has said we know D.0 is going to be a lot of work, but we are tired of shoving things in and what is our project plan for D.0 and we can't give them any kind of guidance. The NCPDP standard guidance is after adoption, trading partners should not -- or after approval of a standard, trading partners should not consider implementation before 180 days, but now they have regulatory processes that say you cannot implement this without being out of compliance, asking for some kind of waiver, something like that to move forward.
So, that is extremely concerning unless there are bills coming forward or modifications coming forward somewhere from the industry. As an SDO, we cannot lobby. So, we just -- we say here is the standard. The industry wants us to move forward, but as for implementation timeframe, it is anyone's guess.
MR. REYNOLDS: Very quickly --
MS. GREENBERG: I know we are talking about 5010, but my understanding that X12 is working on 5050 now?
MS. WEIKER: 5040.
MS. GREENBERG: 5040. So, let's say we go through a two year process here to adopt 5010, do we even want 5010? I mean, and I guess that is what you are saying, just getting 5010, without changing the process kind of puts us where -- instead of ten years behind, maybe four years behind or something.
MS. SPECTOR: I was just going to say one question we could ask, though, is do we want to keep 4010 because that is what we are faced with, keeping 4010 indefinitely for something that maybe better --
MS. GREENBERG: 4010, I realize, but I wondered if 5010 is really what you are talking about or 5040.
DR. COHN: Once again, I am going back to the HIPAA law, which I am going to have to look at Karen to make sure I have got this one right. I don't believe that the modification provisions are the same as the actual new standards for adoption. Can you remind me on this one?
MS. TRUDEL: Very different --
DR. COHN: The two year --
MS. TRUDEL: They are very different in terms of the Secretary's discretion to -- that the compliance date. Within initial standards the Secretary is constrained by the legislation to have it be two years after adoption for everybody except small plans. Whereas, for modification, he has a great deal of discretion, as long as the implementation date is more than 180 days after adoption.
DR. COHN: Okay. Thank you.
MS. TRUDEL: There is no limit on how long it could be either.
DR. COHN: So that would be obviously something else that one would want to ask the industry. I just wanted to -- since that comment about two years had been brought up, I did want to set the testimony straight on that.
MS. GREENBERG: -- the rule making process.
MR. REYNOLDS: Jeff, you wanted the last comment on this one?
MR. BLAIR: Yes. And Karen, are you saying that we are not even in a position to accept the proposal from the DSMOs because of what you just said?
MS. TRUDEL: No. The only initial standard that is in play at this point is claims attachment. We have adopted standards for all of the other transactions. So, theoretically, 5010 over 4010 is a modification. It is not new.
MR. BLAIR: I am going to make a motion and I want to preface the motion by indicating that it asks for an accommodation on the parts of those folks, who had said that they especially want the opportunity to make public comment during notice of proposed rule makings and while this doesn't totally shut this off, the standards development process does involve a certain amount of investment on the part of those folks that want to have more business issues and business practices represented in that and I think it should be. It should be as diverse as possible, as inclusive as possible.
So, the fact that an investment needs to be made in greater participation in the standards development process doesn't -- I did not find that a compelling argument to wind up saying that we should keep things the way they are, and, therefore, it is something I respect, but I feel as if we make that investment in getting business practices and business requirements into the standards development process, that we could streamline the process and frankly I think we might even have better ideas included in the final standards if the business practices are integrated with the rest of the standard development process at that time, than if it is included separately in an NPRM process.
So, my motion is to accept the recommendation from the DSMOs for the streamlined process.
MR. REYNOLDS: Is there a second?
[There was no response.]
Motion dies for lack of second, Jeff.
Thank you, all of you, very much. We really appreciate you coming forward and your testimony was very, very helpful. Thank you.
Agenda Item: Subcommittee Discussion
Okay. We have got three things to touch base on and I am going to move quickly through two and then we will spend some time on the letter and what we need to --
DR. COHN: Can I make a comment?
MR. REYNOLDS: Yes.
DR. COHN: That last motion, I think from my view, the lack of a second does not prejudice for the conversation about that issue.
MR. REYNOLDS: That is correct.
DR. COHN: About that issue, which I think is probably a very germane issue for writing of a letter.
MR. REYNOLDS: No. And I would say personally the reason I did not move to second it was that I think we need further discussion and I think we heard differing views. For example, if I were to say something -- I would like to hear a little more from Michael. He was talking about the APA and other things, which I am not as astute in as he is. So, accepting that motion and then adding some of the things he said may make a letter.
That is why I didn't move.
DR. COHN: I just wanted to make sure that those who had testified are brought forward --
MR. REYNOLDS: That is correct. It is not about the motion. It is about all the discussion that went on and we haven't put that together to agree or disagree.
MR. BLAIR: Would the motion be more appropriate and more likely to be accepted if the motion was for us to craft a letter with appropriate exceptions to --
DR. COHN: Jeff, I think this is a process question. I think we need to talk about it first and then let's figure out the next steps and then we will see if a motion is appropriate.
MR. REYNOLDS: Proper procedure says you can submit any motion that you want. So, I am not in any way keeping you from doing that.
MR. BLAIR: Okay.
MR. REYNOLDS: So, do you want to or not, submit another motion?
MR. BLAIR: It is fine. I think we can just simply go through the process.
MR. REYNOLDS: That is fine. I am just making sure we go through appropriate process. Okay.
The first thing is the future agenda items and I passed it out to everybody yesterday and you saw what it is. I have spent some time with Marjorie this morning. We are usually budgeted for two hearings a year and I think with the number of things that we have listed there, we are probably going to plan to do -- we are going to do three. What we are looking at right now and I am not going to go through that chart because I think this letter is far more important against the full committee soon.
So, I am asking each of you, you have seen what we have put together as a structure. You have seen what we have put together as possibilities. I would love to hear from each of you if you have problems with what those subjects are, problems with what we are thinking going forward, that you get those to me by next Wednesday.
Hearing none, then Jeff and I will make a proposal to Simon as to what we -- what our next hearing would be. Now, I am looking at some timeframes and probably if we are only going to have two others maybe the end of April and early May because one of the things we have in our next hearing is hearing from the e-prescribing and then in early April they are giving their update to Congress. So, that would be a good reason to move that further into April and May. So, we could pick that up in our next sweep through.
Then, obviously, you are looking at September or October and the reason you are looking there is we have to do the HIPAA annual report and we have got to do some other things like that that we are required to do, plus it would be a good time to maybe check back on the NPI after our letter that would go out, if we do one now. So, those two hearings might fall into a good spot to be able to do that.
Plus the other subjects, but I am just kind of laying it against things we know are going to have to probably be involved in. So, I would like your comments by Wednesday.
Yes, Marjorie.
MS. GREENBERG: You could think in terms of a half day after a national committee meeting. In this case we -- the Privacy and the Standards and Security met sequentially and there was quite a lot of overlap. So, there are ways that --
MR. REYNOLDS: I agree and I think -- but I think the important thing and as you see on there, remember, we had some a consideration column because there are some synergies that we may have with others. So, I am just talking about the business that we know this committee has to do as its charge. Then there may be other things that will come up from others that add to our charge and then whether those need to be separate hearings or we would do the kind of things you are talking about is what we are -- that is where I think we are going.
So, right now, we could really know what we need to do and that is probably going to be two more sessions and then anything else that comes up from anyone else, we will do that.
Yes, Simon.
DR. COHN: I appreciate you bringing up all the issues but based on our previous conversation, I do think we need to put exclamation on the 5010 and the D.0, which I recognize is in there and you will need to work closely with the --
MR. REYNOLDS: Absolutely. No question. One of our subjects in there is standards and I just paraphrased why never on time. All this plays together. So, how do we work the whole process. 5010 would be a great example of the next one. What do we do for the next one that makes us do it as an industry than we did this last one.
Any issues with that, approaching it that way? I please ask you to take a look at it. As a matter of fact, I -- go ahead.
DR. WARREN: You are going to send out a notice for us for dates for these?
MR. REYNOLDS: Yes.
DR. WARREN: So, we don't need to give you dates.
MR. REYNOLDS: We will work with Marietta and go ahead and start pulling for dates. I was trying to give
you --
MS. GREENBERG: Remember that the Executive Subcommittee is meeting on May 3rd with a dinner on May 2nd.
MR. REYNOLDS: That is what I am saying. We will work through with -- I will work with Marietta on the other schedules that are out there and then we will look at what we are doing.
The next thing is the NCVHS annual report and we covered this the other day in the privacy session. I have already submitted all my comments.
MS. GREENBERG: You are talking about the HIPAA report.
MR. REYNOLDS: Yes, the HIPAA report. What I would like to do and I have talked to Denise, if any of you have specific changes that you want to submit, if you would please submit them directly to Denise and again by the middle of next week because remember we have all been asked to kind of look at this by December anyhow, last December.
MS. GREENBERG: Right. Well, I am assuming that Jim Scanlon and staff are working on the revision as we speak.
MR. REYNOLDS: That is correct. So, I am just saying to you if you have comments -- in other words we were supposed to have done it earlier. If you haven't done it, you might want to get involved. Some of us have and so I don't need -- see a reason to take the whole committee's time to go through something that everybody can read and can comment on.
All right. So, having covered the two of those, let's talk about yesterday's letter or yesterday's hearing and possibility of where we stand and we obviously spent a little time talking about it last night and trying to get our thoughts together as to what we thought. So, I would like to paraphrase what we said and then what is going to happen is that Denise and I and Jeff will work together on a draft. We will probably have to schedule, obviously, conference call or something else, because we need to have this to the full committee, which is February 12th. So, this is not a --
MS. GREENBERG: The process is that the subcommittee has to agree on the letter and then it is supposed to go to the Executive Subcommittee before it goes to the full committee.
MR. REYNOLDS: I understand, yes. I agree and that is what I am saying. So, the time frame is short and we need to move.
Here is what we had kind of -- trying to talk about and pick apart the structure not the words because, again, I haven't rewritten anything and don't plan to. I am paraphrasing what we heard last night. So, by May 23rd, we feel that the covered entity should be able to individually have themselves ready, which means providers ought to be able to get their numbers and we will spell these out as sub-bullets under their providers, should be able to get their numbers. Payers should be able to process. Clearinghouses should be able to process NPIs. So, that is what we would say would happen.
MS. GREENBERG: Can I ask a question?
MR. REYNOLDS: And that outreach would continue.
Yes, you may.
MS. GREENBERG: Is that assuming that the dissemination notice --
MR. REYNOLDS: That will be the next thing.
MS. GREENBERG: That is what was unclear to me yesterday, though, whether payers can be ready without that.
MR. REYNOLDS: They can be ready to process. They may not have all the numbers and they may not have all the cross walks but they could be ready internally to process. Remember, because we are not saying implement. We are saying ready to process because, obviously, if we are going to recommend anything after May 23rd, it is called working together to make it production ready.
DR. COHN: Harry, can I just ask a question?
MR. REYNOLDS: Please do.
DR. COHN: Maybe it is the very first sentence. I am presuming that what you are discussing is recommendations that involve a contingency. Is that correct?
MR. REYNOLDS: That is correct.
DR. COHN: I just wanted to clarify that he was talking about recommendations that involved the contingency, you know, implementation.
MR. REYNOLDS: The next is as we said in our letter in November, the NPPES and the data dissemination must come out to allow full implementation. Now, further our discussion last night and again as a framework was that the industry be given once the NPPES and the data dissemination are put out and available, that the industry be given six months after that to complete its readiness.
Now, during that six months we had numerous discussions about what should occur. You know, we heard all the way from WEDI, where you got every claim has to have things or it could be that we basically are -- just say that they are six months and that the industry needs to work together and do whatever they need to do and do their cross walks and do everything else and I think we settled on the fact that by stating that there should be six months, that we basically -- that is as far as we go. We don't -- we are not prescriptive on what people should or shouldn't be doing with each other or how they should or shouldn't do it or who they are or aren't during that six months time frame. But basically we are saying we are saying by May they should have what they need. They should be able to do it themselves and then when they get this data dissemination and the NPPES, they ought to be able to begin processing.
The one thing that we still haven't completely settled on, which we will do some more looking at is whether or not because of the fact with drug claims, as we heard from that discussion yesterday, whether or not since they pretty much don't have a relationship with the people, with the prescribers necessarily, don't have a -- whether or not that would take anymore time to make sure that they were able to get those numbers so the prescriptions could start
-- could work.
So, that is the only question that was still on our mind.
Yes, Karen.
MS. TRUDEL: I don't think that is an issue that is limited to pharmacy. I would say that is a -- there is a similar construct in terms of laboratory and diagnostic services where the referring physician very often does not have any business relationship with the lab at all.
MR. REYNOLDS: I think that is a great addition and that is why we are talking about it in open forum today. I didn't say we had all the answers last night. No, but I think that is perfect. That is the kind of thing we got to make sure. So, basically then what you are saying is there are -- we were wondering whether there were two distinct legs and I think you are making it clear there is one leg.
Yes, please.
MS. TRUDEL: I think there would have been two distinct legs if there had been more prescriptive discussion about whether you are talking about dual processing or not. If you take that off the table, then I think they become very much more similar.
MS. GREENBERG: [Comment off microphone.]
MR. REYNOLDS: Yes. That is where we decided to go, again, not necessarily to define for anybody what they need to do because you are basically saying that that is where it is. Now, that is the structure of what we heard. Obviously, yesterday we had a lot of information. We had a lot of approaches. We have a situation that we are dealing with and so that is the construct.
Yes, Simon, please.
DR. COHN: I guess I would make a couple of maybe just clarifications to what you are describing. I guess I just wanted to bring them up just to make sure that we are sort of in agreement.
First of all, I think when you talk about six months, you are talking about six months from the May implementation date or the date of the -- not the date of the release, the date of dissemination -- data is available, whichever is later.
MR. REYNOLDS: That is correct.
DR. COHN: So, I just want to make sure that we understand that.
MR. REYNOLDS: That is correct.
DR. COHN: I also want to make clear -- and once again this is just looking around to see if there is an understanding that the NCVHS intends to have ongoing hearings to monitor this and will provide further advice to CMS and the industry as it is perceived about whether there needs to be any additional adjustments made to any of the --
MR. REYNOLDS: That is why as I looked at the end of April and the September/October, those would be two possible good times to basically have those check-ins also.
MR. BLAIR: The second point that you made was that the payers would be ready by May 23rd to begin processing. Is that what you said? Or to begin testing? What was the statement you said about the payers being ready by May 23rd?
MR. REYNOLDS: What we are saying and I want -- whether it is payers -- well, we use payers and clearinghouses, will have their systems modified to handle NPI. I did not say in production.
MR. BLAIR: Then the question I have for clarification is for clearinghouses and payers to be ready, are you including the fact that they would have had to have received NPI numbers from providers in order to do that?
MR. REYNOLDS: No, they would not. They can test. Anybody can test prior to that with made up numbers and other things. That is why -- that is the only reason for the transition that we are talking about is since everybody has it, you can't do it. I would say that enough of these people have relationships that they should be able to get some validated to be able to test prior to May.
DR. FITZMAURICE: I am looking at the incentives for working hard, spending money and being able on May 23rd, not only to have your system tested, but to begin real time processing of actual claims for those providers who can give them sufficient number of NPIs. Should there be an incentive to do this as fast as possible or maybe the mirror image, a disincentive for those people who don't make it possible for this to be done?
MR. REYNOLDS: I think the whole reason that we have said need to be in the position that we said, which is providers having a number. Payers being ready to process and clearinghouses being ready to process, which are the only covered entities we really can chat about. I mean, I could go on with another whole list, but it doesn't make any difference, is that we can enforce it and we enforcing it but it is still a May date for them to do certain things. If you aren't by then, we are not even alluding to what kind of jurisdiction anybody would have over that, what kind of follow-up anybody would have on that or what kind of anything else would happen. We are saying that people should be able to be ready.
Now, obviously, when that gets to the Department, they can read that anyway they choose to as to what they would want to do at that point.
DR. FITZMAURICE: Yes. You hit it right on the button. Do we want to make any references to -- in a contingency plan that we might recommend that they consider in centers to reward those who make it happen even faster?
MR. REYNOLDS: Well, remember, and I will play off a number of Karen's comments and a number of other people's comments yesterday. The date is May 23rd. I mean, we can't change that. We cannot change that. Nobody can change that. So, all we are saying is that there is a certain place, hearing the testimony we heard, there is a certain place we feel everybody should be and we haven't seen any road blocks for them to get to that point. Remember, we heard what we heard. We discussed what we discussed and we are giving a status of the industry. We are not necessarily -- and we don't have the jurisdiction over this. So that is kind of where we are.
DR. FITZMAURICE: But we can make recommendations. We don't have the jurisdiction and if we want to be silent on it, that is fine, too.
MR. REYNOLDS: I guess I would say it differently. As part of this process of preparing a letter, if anyone has recommendations, like yours, that could clearly be articulated and discussed in a draft, I mean, that is part of this whole process that we go through. But as a group last night, we did not discuss or go into any further --
MS. GREENBERG: [Comment off microphone.]
MR. REYNOLDS: Everything we heard yesterday, which includes that we have no jurisdiction over the dates. They are in law. So, we are just making a point as to what we think the industry should be able to do by May 23rd not what should happen in a case that somebody does or doesn't. You are asking whether we should go further and we -- I haven't heard anything from the committee different than that or positive than that.
MS. TRUDEL: Just again kind of to remind people what the regulations give us the ability to do and not do, the compliance date is what it is. We don't have any ability to reward people for making it. We have the enforcement ability to penalize people for not making it and the contingency process allows us to give covered entities, who are making a good faith effort to not be immediately subject to enforcement. So, essentially that is kind of our construct that we are operating inside.
MR. REYNOLDS: Wouldn't you also agree that this really is a complaint driven process?
MS. TRUDEL: All of HIPAA is a complaint driven process.
MR. REYNOLDS: I understand. So, what I am saying is we recommended where we think people could and should and would be on May 23rd. If a complaint were to come in, then that -- you know, it is a complaint. It is going to be a complaint whether or not there is any transition period. It is going to be anything else and the status of that particular entity that was complained against at that point would come under discussion, whether we ever write a letter or not.
DR. COHN: Obviously this brings up the issue of compliance versus enforcement. So, I think that is potentially a piece that needs to be reflected in the letter. I think we also generally need to be -- err on the side of being less prescriptive rather than more prescriptive in terms of the details, knowing that the industry is diverse and I think we heard that -- because anybody can complain at any point. That is clearly in the process.
Marjorie.
MS. GREENBERG: Is the committee suggesting or recommending that CMS should implement a contingency plan here or -- I guess what I don't understand is can someone be out -- even if CMS -- does CMS have the ability to implement a contingency plan without any change in the regulations?
MS. TRUDEL: It is the Secretary's authority to publish contingency guidance and that was done in 2003. I would say we have the same authority now or the Secretary does --
MS. GREENBERG: So, if someone then complains that some business partner wasn't in production, would they have grounds? I mean -
MR. REYNOLDS: If you were to read --
MS. TRUDEL: Can I explain how the process would work? The complaint would come in and because it would be an NPI complaint, it would come to CMS and in the course of looking into the complaint and doing our fact finding, if we had contingency guidance in place for the industry, we would look to see whether the complained against entity was otherwise compliant in making a good faith effort to work with their trading partners. If that were the case, then we may make decisions not to impose penalties.
MR. REYNOLDS: The reason we have been very focused on that date is that if somebody hasn't spent any effort, we have heard that there aren't any major road blocks as to why they shouldn't be able to spend the effort to get to a certain point by May 23rd. If they don't and a complaint comes in, that may be looked on a lot -- that has got a whole different flavor whereas the last time there was a contingency, it really didn't have -- it wasn't requiring anybody to be anywhere.
MS. GREENBERG: I thought there was a plan.
MR. REYNOLDS: Yes, but this is a little further along than that.
That is the thought. That is the structure. I mean, it is going to take some work to get it to a point that it sounds like something good.
Steve.
DR. STEINDEL: This last part of this discussion has confused me because in the first part of the discussion what I was hearing was, okay, there is a certain set of things that can be done by May 23rd and we have outlined those. Then I thought we were going to note, too, HHS that there are going to be difficulty in complying with the NPI regulation due to the lack of the NPPES and that we were going to recommend some contingency response because of the lack of NPPES and that would be the contingency guidance that we would recommend that CMS uses when they are looking at a complaint.
MR. REYNOLDS: Correct.
DR. STEINDEL: So, we are in sync. It was just a matter of a little bit of phrasing.
MR. REYNOLDS: Yes.
Okay. Any other comments on structure, the thought that we need to do?
We will begin to put out a draft. We will obviously post the calls because I am sure industry people know we will be very interesting in what this says, especially we had so much interest yesterday and I think very helpful. I think that it was absolutely outstanding input. People were incredibly professional in presenting it. The emotion was limited. It was really good. I really appreciated it.
MS. GREENBERG: You are considering an open conference call?
MR. REYNOLDS: Well, we may. I don't know. I mean, that is what we have to decide what we are going to do.
Any other issues -- well, questions? Jeff, back to your earlier -- is it the desire of the committee that some type of a letter or recommendation or something start being put together on the SDO proposal, any other discussion that we heard earlier? If so, then we will need to decide on a time frame. It may or may not need to be ready for February, but it may be for the next full committee, whenever that is, but I am just throwing that out on the table so that we make sure when we walk out of here we understand clearly our assignments and the timeframes of those assignments.
So, Jeff, you might want to jump in on that since you had previously made a motion on it as to what you would like to see happen.
MR. BLAIR: I guess I would submit for consideration to the subcommittee the drafting of a letter that would support possibly with amendments or, you know, contingencies or wordsmithing, but would support the basic concept of a streamlining of the process, I mean, the SDO and the NPRM process.
DR. COHN: I presume we can discuss this without having to second it?
MR. REYNOLDS: This is a chat.
DR. COHN: Thank you. Because I would like to chat about it.
I thought the discussion today was very, very helpful and I think we, at least from my view, it felt to me that the fundamental elements of the SDO proposal appeared to be very sound. I did hear, I think, what I thought were some very welcome additions from other panelists. Then I think the other piece was the issue of public comment, which I think we need to think about. I was particularly intrigued with some comments made by one of our lead staff in relationship to the variety of options that the Secretary might have in terms of the actual rule making, which might help expedite the process.
I personally don't know enough about that and I don't know whether we can get information in written form to help educate us and allow us to make a determination or whether we need testimony. I mean, I am a little concerned. I think the last time we had testimony from a lawyer on this issue. I don't think we came away any smarter -- that is a bad -- let me reframe that.
I thought that the many issues were brought up of value by the attorney, but I didn't come away with a conclusion or a way of really being able to put it together. So, I think whatever we come forward with potentially needs to consider that because I was -- it would seem to me that there maybe some ways that there may be some ways that we can incorporate public comment into all of this stuff in a way that doesn't necessarily slow the process. I think that -- whether we need to explore that in open hearings, get written information, I don't know.
But that was the part that I am -- in terms of trying to put it together.
DR. STEINDEL: Simon, I think we need a little clarification on from the process that they put together was in the last two steps because it seemed to occur after the SDOs had finalized their process and is there a feedback loop because what happens if NCVHS holds public hearings in this area. We uncover some new information. Is the intent to actually use that as a feedback loop and then it also occurs at the next step at the final regulation stage. You know, do we anticipate the Secretary having any discretion at that final regulation stage on what can be done, final reg with comments. As was pointed out, what is the nature of those comments.
I think those two areas need to be clarified.
MR. REYNOLDS: Michael.
DR. FITZMAURICE: We may need a lawyer to comment authoritatively on it. One of the things that we could do is recommend to the Secretary that there is merit in this proposal and the industry has by and large looked upon it favorably in our hearings and that we recommended the Secretary consider it and also consider obtaining legal advice as to how it could work within the construct of the Administrative Procedures Act.
MS. TRUDEL: I actually absolutely agree with that and actually have suggested that before. I think there would be very long protracted dialogues and discussions to assess how a proposal would fit with the APA. I don't think you could get someone to come in here and provide testimony that would say, yes, no. But I do think that it would be easier to get that kind of assessment done with care if there is a specific proposal on the table for people to look at as opposed to looking at something theoretical.
I would suggest sending it forward with that caveat.
DR. STEINDEL: I think we just got our letter.
MR. REYNOLDS: Is everybody comfortable that that type of a letter, taking what we have heard and what we want to add that way would be the appropriate thing to begin? I see heads nodding. Anybody disagree with that?
MR. BLAIR: You don't need a motion for that either?
DR. WARREN: We are going to write a letter and then we are going to send it to have one of the lawyers look at it to see if it is within --
MR. REYNOLDS: No. Asking the Secretary to have lawyers look at it.
DR. WARREN: Got it.
MR. REYNOLDS: Now, the thing is now let's talk about timeframes. Is this in -- does this come before us in the late April, early May timeframe or is this something we are trying to get in position to give to the full committee in February?
MR. BLAIR: If it is possible for us to get it to the full committee in February, I would like to see that happen. If it turns out that it is not possible, then, you know, we have to accept reality, but, you know, this is a process of trying to streamline the -- we have tried the streamline process for more than a year and I certainly would like to have it move forward as quickly as possible.
MR. REYNOLDS: I am sure everybody would agree that you have just designated yourself as a drafter, along with whoever else you might want to help you.
MR. BLAIR: How did that happen?
MR. REYNOLDS: And you know the timeframe between now and the meeting. I took the other one. You got this one. Would you like to adjust your thinking on the timeframe?
MR. BLAIR: I will do my best.
MR. REYNOLDS: Okay. Are there any other items that need to come before the committee?
MS. GREENBERG: In other words there is a possibility you will have a second letter?
MR. REYNOLDS: There is a possibility.
MR. BLAIR: And, Michael, maybe you could assist me since you offered some wording that I think --
DR. FITZMAURICE: Yes, I will, Jeff.
MR. REYNOLDS: My letter has priority. So, if I need Michael, he is in line --
DR. FITZMAURICE: And maybe have Denise pulled in to help do the boilerplate of here is why we are involved in this.
MR. REYNOLDS: Denise is helping me first.
MS. GREENBERG: But at a minimum you would have something maybe to review among yourselves in February.
MR. REYNOLDS: We might have, yes, in our breakout session.
Any other -- yes, Simon?
DR. COHN: Before you adjourn, I was obviously just trying to figure out what exactly are the next steps of the subcommittee between now and our full committee meeting in the middle of February?
MR. REYNOLDS: Denise and I will draft a letter. I will try to have it out by the middle of next week, which is about what we need to do, get it to the full committee and make sure we get calls scheduled or whatever.
We will expect involvement. We will expect help because this is going to be --obviously, the last two days have been complicated set of hearings. So, this isn't one that is going to dash off -- dash quickly off your pen.
We are about to recommend a significant thing. So, I ask that all of you please engage. Okay?
Hearing no other business, consider us adjourned. Thanks for everybody's attention. Everybody stayed really focused.
[Whereupon, at 12:10 p.m., the meeting was concluded.]