[This Transcript is Unedited]
Hubert H Humphrey Building
Room 705A
330 Independence Avenue, SW
Washington, DC
DR. COHN: This is the session for the subcommittee on Standards and Security. We introduced ourselves this morning. There's no need to go around the table and reintroduce. I want to indicate that our agenda is going to be somewhat different than what we had indicated.
The intent was that we would start with a discussion of PRMI recommendations. Jeff, I think that there may be an opportunity in case you want to reflect on any of the comment that had been made in case any of them requires any other wordsmith changes. I want to provide you that opportunity.
You were surprised by the rest of us when the PRMI letter was passed today. We do want to allow you the opportunity to do that. The presentation on codes at issue that was scheduled to be delivered is being deferred until April. I guess they're in the process getting approval for their white paper and don't want to make a presentation to us without that information.
Instead of that, we're going to spend a little time talking about the issues around ASCA, both the issue of publishing reports and how we mobilize to do that. The second issue is this issue of statistical analysis. Brady began the discussion earlier today.
We want to give him a little more time to throw around ideas about how we might approach that. The other piece is we've asked Vivian to join us to talk about the plans for the April hearing. Is that about right? Is there anything anybody needs to be discussing or presenting today?
MR. BLAIR: We have comments that were sent to us in relationship to the letter. Are there any comments that you want to bring out in terms of discussion that in any way needs to relate to modifications to our letter?
There are three comments that responded back. I looked them through and thought they useful and thoughtful. I feel like the main one that needed to be addressed was by Dan Rodie of AHIMA. We did that by attaching the original PRMI document to this letter for clarification.
I give an opportunity to anybody else in the subcommittee who has read those comments. We sent them out last Thursday. If anybody else has any thoughts about those that they think needs to be reflected in the letter, this would be the opportunity to do so.
DR. COHN: I don't see anybody raising their hands. This is the final opportunity. Other than that, we'll let Mike do whatever wordsmithing he wants. Did you have a comment?
DR. FITZMAURICE: I looked over the comments and I think many of Dan Rodie's comments are good ones, and things we want to visit after we send the letter to the Secretary. Jeff mentioned early in the meeting about revisiting things in a year and a half to see what action has been taken, what kinds of incentives work and what kinds don't. Maybe there needs to be a stick involved.
There are some questions for clarification. Part of it is background that the Secretary can come back and ask us additional questions on. By and large, the letter is self-contained. It tells the Secretary what standards are important and leaves it to him to determine how to respond to that importance.
There are a lot of different avenues. You can encourage the agencies to use it. You can sternly encourage the agencies to use it. You can develop incentives in terms of your grants or contracts that you let out, making a condition for contracts that particular standards be used.
Then you can evaluate the benefits and the costs of using those standards. There are a range of opportunities open to the Secretary. The letter is good as it stands.
DR. MC DONALD: You were going to add that editing thing about marketing and Jim's suggestion.
DR. FITZMAURICE: I have two edits.
DR. COHN: As long as we're all comfortable with it. With that, Jeff, I want to thank you for shepherding the effort and moving us to the completion of this letter. There will be additional letters and topics, but at least we've completed this one. You have my thanks and I'm sure the thanks of the committee.
With that, shall we move on to talk about the ASCA issues? If you all remember, under the Act, we've had three responsibilities. One was to advise HHS and CMS on the development of the model form for compliance extension. We actually did that at our last set of hearings.
That is moving along pretty well at this point. There are two other tasks we need to talk about and figure out what sort of action plans we want to get involved. One, publishing reports on best practices and solutions in relationship to issues we identify regarding HIPAA implementation.
The other is the statistical analysis of a sample, whatever a sample means. We asked Brady to begin to think about a little bit. The other one has to do with publishing and we haven't even begun to talk about it, but we should all be aware that there is no requirement that we get the statistical sample in prior to us beginning to publish best practices or solutions. The question is: How do we want to approach this? I would open up the floor to thoughts.
MS. TRUDEL: Karen, do you have some thoughts that you would like? Comments? Where is Kepa when we need him? I would throw out that I would, in April if we have time or at the end of May at the hearings then, have an opportunity to engage in a discussion with WEELE about their reports on solutions and best practices to see if there are any of their documents that might be publishable by the NCVHS or identified by us.
The other question would be to get an idea of what other solutions exist out there that we may want to indicate or identify as worthy of publication. Karen, is that something we can get help in terms of identifying people that may want to have their efforts or documents published?
MS. TRUDEL: I definitely think that that's a step that we could start fairly soon.
DR. COHN: Does anybody else have any other groups that they think have published or developed best practice documents around HIPAA implementation?
MS. TRUDEL: I'm assuming we're talking about non-marketing, non-proprietary solutions?
DR. COHN: Yes, I believe we are talking about non-proprietary solutions. Does anybody else have any other additions? I guess it was pretty obvious that it needed to be non-proprietary, but any other requirements that we should be discussing with anyone who is interested?
We'll probably try to find some time at least for a couple of minutes in April to have that discussion to get it going. It's something that we can do long before we start getting the sample.
MS. TRUDEL: One last question, would you like me to start the ball rolling on that and send out some e-mails and start the process of getting people to tell us that they think they might like to be involved in supplying solutions? Then I could come with a list of potential candidates and candidate organizations that would be similar to some of the ones that Jeff has already put together on candidate standards in some of the past deliberations. Is that an idea?
MR. AUGUSTINE: Just to talk about the analysis portion. Do you want me to start on that?
DR. COHN: I wanted to see if there was anything else on this point.
MS. BURKE-BEBEE: I was just going to offer to Karen, there is the X12 trimesters. There has been a new development of early adopters and formal presentations that are being made that sound very helpful to have witnesses or testimony on these panels that we're talking about.
DR. COHN: So we could ask them to be included. We probably ought to check these creative arts provider groups and health plan groups to see if they have anything that they want to share or bring forward also. Anything else? Anyone else we should be querying?
MR. BRADY: The analysis portion, I don't envision being too difficult. If I remember the form we discussed at the last subcommittee meeting, it wasn't very complex and there weren't a lot of categories with regard to the questions that had numerous selections.
Most of the information would be electronic, entered over the Web as opposed to paper form. I envision that we would just try some stratified sampling method where we account for and maximize the information we have in the administrative database and sample a minimum number of records in the paper side and weight those accordingly.
That's probably what we're going to end up doing. The extension form is due March 31. We would envision doing this during April and May. Is there a time line that we have here?
DR. COHN: It's an interesting question. They have to be sent in to HHS by mid-October, by October 15 of this year. The question will be whether we start sampling them as people begin to submit them or whether we wait. Karen is in charge of develop this form. Brady you're thinking about the analysis. What are both of your thoughts about when we'll be getting this in?
MS. TRUDEL: We're expecting to get a very large initial volume of people downloading the sample form and the instructions to see what it looks like. We're expecting that there will be an initial rush, but I don't think that people will be in a rush to actually submit the form.
That will probably go on a fairly even keel until we hit September and then we'll get a really sharp spike. The question is, how frequently do you want to do that and could we possibly just provide the subcommittee with ongoing statistics monthly or every two weeks of how many we've received? We could do that.
MR. AUGUSTINE: It depends on really if you want to analyze on a month-to-month or cumulative basis or if you just want one sample at the end that takes everyone into account. It's going to add in value to look at it month-to-month because you're going to multiply the times you're going to sample records.
Let's say the sample size is 30-100. If you want to look at getting an inference based on each month, you're going to have to do 100 each month or 30 each month. If we just want one sample at the end, we could wait until October or whenever and then do one sample at that time.
DR. COHN: I'm missing a cumulative monthly report at least for the electronic responses and it would be useful. It doesn't sound like it's very hard to do. Some idea on a monthly basis of how many paper or non-standard electronic submissions we're getting might also be useful, but once again, I don't expect that we should send 3-4 people out to start counting paper submissions if we can avoid it, but some sort of a sense of that would be useful so we can identify trends.
MR. AUGUSTINE: If you can deal with what somebody would term unacceptable standard errors, once you get to 30, that's a viable sample size that's accepted in industry. There is a magical thing about 30 in statistics which means your monthly sample on the paper side could be 30 or larger depending on what you're trying to do, but 30 is the minimum that I would recommend on any sampling strategy.
MR. BLAIR: I thought that in order to determine our sampling method, we needed to know what questions we wanted answered by sampling first and then we would determine who important it was to have accuracy or to do that on a frequent basis or not. Do I have things mixed up or do you already feel like you know what you're looking for?
MR. AUGUSTINE: We already know the questions will be based in the form. What proportion of respondents could not meet the deadline because of this reason. It's basically a sample trying to determine an estimate of proportions. Every question is going to be that way, yes or no, what category. They all have the same type of structure. The sampling strategy will be the same for each and every question on the form.
MS. TRUDEL: The question that's being raised here may be does the subcommittee want to break down the analysis into cohorts and look at providers separately from plan, separately from clearinghouses. Maybe that's something we need to discuss.
MR. BLAIR: I know that Congress indicated that we are to set value since we have to go through this process, what value does it have to us? My thought is that if we could look for the sampling to help us identify some segment out there that's having a problem, then maybe that will help us with either education or we need to target that group for additional support or it could help us to identify a recommendation to HHS on something else that needs to be done. In short, what we want to look for in the samples are who's having a problem and why are they having a problem?
MR AUGUSTINE: You have to weigh that against the other end. We looked at the extension forms a few weeks ago. They had pretty much stripped them down to where there wasn't a lot of added value on those forms. If we want to stratify, to try to add some value by looking at different types of providers, then your sample size will double or triple depending on how many different groups you stratify by.
DR. COHN: For the electronic submissions, we really don't even need to do a sample. We could analyze the whole database.
MR AUGUSTINE: That's the tough thing though because is that representative of all your providers?
DR. COHN: No, I agree with you. Through the electronic, we could divide it up and there are divisions by various providers. The question gets to be how do we handle the paper pieces? We're going to have to look at how many paper requests for extension come in. I would start small rather than large.
MR AUGUSTINE: It would be interesting to look at each separately, the paper and electronic. I would argue that it's hard to separate those two because any number that you represent with just the electronic is going to be a little bit misleading.
The clinics and physicians that are doing it on paper are characteristically different than the ones doing it electronically. Any inference you base on the electronic records are going to be a little bit misleading possibly. You really need to put those together before you make any real inferences. You can track one and look at it, but making inferences based on it, I wouldn't recommend.
DR. FITZMAURICE: Where would we put our resources? If it's cheap to handle the electronic ones, do we then sample more of the paper ones and how much proportionately more? We've got $10,000 and put $2,000 in the electronics because they're cheaper to analyze and $8,000 on the paper ones? It's a question of where to put the resources in analyzing it. You have to do a lot of abstracting, key punching.
MR. AUGUSTINE: I recommend electronic because you get the entire population. There is no standard error. In this case, you go with the minimum sample on the paper side and try to minimize the cost of performing the analysis.
You have a little more standard error, but some of that will be nullified or muted because of the full population that you're getting on the electronic side. It won't be as bad as it seems. We'll know more when I get a chance to do a study design and we can look at that.
DR. COHN: We'll do a monthly review basis of what we've got starting at the end of April or some period after this is actually up on the Web with the idea that you're saying electronically review all electronic summations because those easy. Then you're saying in samples of about 30 to start with and we'll see what we have.
MR AUGUSTINE: I'll do a sample size calculation. I don't want it put too much burden. I understand that resources are limited. We want to have the minimum size that we can make valid inferences off of and I'll look into that and bring that back to our next subcommittee meeting.
DR. COHN: Okay. This is something that as we begin to get results, we can always modify the methodology. Jeff, are you okay with that approach? You brought up a really good issue there. It's just a question of how to deal with it in a way that recognizes that the staff doesn't have a lot of additional time on their hands or a lot of staff support for this activity.
Any other comments about the analysis at this point? Brady, we'll put you on for a couple of minutes at the next meeting for a little more in-depth discussion minutes. I don't have any other ASCA issues. Is there any other ASCA items that anyone has?
It's moving along pretty reasonably. If we can get some time and begin to get some best practices published, we will be moving forward very well. Now, shall we spend a couple of minutes talking about the April hearings?
As I understand the focus of the April 9-10 hearings, they're on possible gaps in the HIPAA code set and the issues of concerns to possible expansions to a list of codes or needs for placement.
MR. BLAIR: I'm missing some of your words.
DR. COHN: The April 9-10 hearings are really meant to focus on issues around possible gaps in the current HIPAA code sets as well as issues of concern related to possible expansions to the list of those codes or the needs for replacements of some the older code sets, a la ICD9CM Vol.3 moving to ICD10)CS.
Vivian, do you want to talk about more high-level thoughts at this point.
MS. ALT: There are three that we know of for sure, ALTLINK, HIHS, and DSM. Vision is possibly going to want some time as well, but that's something that they wanted to go off on their own and decide how they want to approach it and come back. We're not sure if they need time or not.
DR. FITZMAURICE: What was the first one you mentioned?
MS. ALT: ALTLINK.
MR. BLAIR: Weren't there two different developers that had come up with code sets for complementary and alternative medicine? I thought Alternative Link was one and there was another one.
DR. COHN: I only know about Alternative Link, but I am looking at Vivian to see if I missed something.
MS. ALT: That's the only one that I know of.
MS. TRUDEL: It's the only one that I'm aware of also.
MS. ALT: We were thinking that we wanted to get their opinion the representative from each of these groups to give an overview of why they think their area is a gap. We'd also like to talk with some of the insurance companies and get them to tell us whether they are covering any of these areas, have someone from CMS talk about their viewpoint whether or not they also see this as a gap, get the state representatives in, get their viewpoint on this. Just try and get different angles so we're not just hearing from the one group saying we definitely need this, but getting other angles also to confirm or verify whether or not it truly is a gap. That's the part that I know. ICD10 PCS, I don't know as much about. I don't know enough to expound on that.
MS. TRUDEL: The CMS representative will be talking about ICD10 PCS not from a content point of view about what the structure is, but some of the comments that they received at the ICD9 CM coordination and maintenance committee meeting urging CMS to move forward with some type of plan for implementation of PCS and there would be a greater discussion about if that's feasible, how that would be accomplished, and so on.
DR. COHN: We should also expect to see industry groups that might comment on some of the others, might also have some feelings about desirability and what type of assistance they might need in terms of considering a move to ICD10 PCS. It might be that the industry representatives might be able to do some double duty.
MR. BLAIR: We would have alternative medicine, optical, and what was the third?
DR. COHN: HEIC, home infusion, and then we had DSM4 which is the mental health diagnosis codes.
MR. BLAIR: What about nursing codes? They're coming up with a new nursing code system which uses methological principles. Is that a candidate for us?
MS. TRUDEL: Basically, the ones that we are aware were ones that wrote in during the comment period to the NPRM and when we had announced what our potential candidates were, what we thought we would be the de facto standards that should be named.
Both the alternative link group and the home infusion group wrote in to indicate that they were not covered as part of those standards that were being considered under the initial adoption. Subsequently, during other meetings, there was a discussion by the vision group. But they're not coming forward we don't think at this next meeting although it's possible if they have a proposal worked out. There seemed to have been competing opinions about which way to go and they were going to go back and take a look at that.
MR. BLAIR: Do you know what would be nice? Even if they have a resolution, it might be nice to hear from then the experience they went through. Maybe we could learn something from the experience they went through to give guidance to others so that they could either avoid pitfalls or expedite the process of finding the right place.
MS. TRUDEL: We can do that. One of the reasons that we especially wanted to talk to the home infusion community is that we had suggested that they work with CPT editorial panel to try to get their identified gaps accounted for. They have actually been doing that. They have been working within the process. We want to get a sense of how that's doing and whether their experience is something that could be of use to some of the other groups that have identified their gaps also.
MR. PICKETT: Just a comment and some clarification. Are we talking about PRMI codes or administrative codes or both?
MR. BLAIR: Administrative.
DR. COHN: These are codes meant to be administrative and financial transactions, used for billing, and other sorts of purposes.
DR. MC DONALD: We are going to plan some PRMI code discussions?
DR. COHN: Yes, we haven't structured a date. We're trying to make it through these three first and then we'll be querying people for dates for hearings during the last half of the year, hopefully, in the next week or two.
MR. BLAIR: One other consideration, when I was at the last HL7 meeting and I sat in, do you think that it would be appropriate to hear from Steve Brown who is heading up this project on coming up with the drug reference terminology on the part of the VA and as part of the GCPR project?
Does that fit in the domain or does that veer too much towards the code sets for PRMI? This would be the work effort by the VA and HL7 and a consortium of other groups to come up with a drug reference terminology to compliment the NDC codes?
MS. ALT: Actually, we were planning to have Stuart Nelson talk at the April meeting. It would have been more appropriate to have him talk at the May meeting, but he's not available at that time and he's been chosen to represent it to this committee. That will be on the agenda for April.
DR. COHN: Other comments or thoughts?
MS. PICKETT: As one of the follow ups to the February meeting, there was a discussion by the subcommittee that some of the comments that were raised and some of the testimonies that were provided during the February meeting, that we would synthesize some of those issues and bring them back for discussion.
I know that there were a couple of groups that had raised some very interesting points in their testimony that we were not able to follow up on as part of the discussions of the February meeting. That would probably be something that we might want to keep in mind for the April hearing as well.
DR. COHN: At this point, we have not heard from the American Dental Association in response to our letter and hopefully, we will hear by April or provide time for further discussions with them potentially.
MS. PICKETT: Definitely.
DR. COHN: As I'm listening to the items in April, my bet is that it's going to be a relatively full, we'll be getting close to two days. There may be a little bit of time for Brady who will be looking at statistical issues and other ASCA issues.
It's going to take most of that 1.5 days to handle the issues that we've described. I would urge members of the subcommittee to not plan an early departure on April 10. This is an early warning on that one. Are there other things for April?
On top of everything else, we'll probably ask WEELY assuming that they have their white paper approved by the board by that time to come and present. I'm sorry we didn't have them this time. I think they would provide a useful framework and perspective on the issues we're trying to deal with, but we also do understand that they need to get approval from the board before they start publicly disseminating a white paper.
We'll certainly find some time for that. Other things that need to go before the subcommittee at that point? As I commented, the agenda for this session has gotten changed around pretty significantly and I don't have a whole lot to discuss.
I'm going to indicate to all of you that you will receive information over the next week or two looking at availability for the June-December time frame so that we can schedule another three two-day hearings to deal with issues as they begin to come up.
I think we've already seen today that digital signature needs a little more work to e done and in my own view, we're not going to come away recommending the standard at this next set of hearings, but maybe there are some things that the Secretary can do to help move things forward and move everyone together that are beyond just asking the SDOs to start meting about it.
I'm hearing there is a lot of action occurring in this area. We are all concerned that they all meet at the end of the day. It's probably worthy of a letter for us to draft for the full committee.
Beyond that, I don't have any other words. We passed our PRMI letter. These other things are in process. Are there any questions or comments from the committee? Well, in that case, this is just to make up for all the many times we've gone to 5:30 or 6:00. The fact is, we're adjourning early. I want to thank you all very much and see you in the morning.
(The meeting adjourned at 4:45pm.)