[This Transcript is Unedited]
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Agenda Item: Welcome - Letter to Secretary Thompson, HHS - Mr. Rothstein
MR. ROTHSTEIN: This meeting is not being broadcast on the internet as far as I know so we don't need all the formalities including introductions and the like. You all should have a copy of the updated letter that was drafted yesterday afternoon in response to some of the suggestions made at the full committee meeting and just to repeat what I told most of you individually, there are no changes until you get to the second page, beginning with the paragraph - It is not the intent - that paragraph and the one that follows contain all of the changes that were made so I'll give you a few minutes to look over it because you just got it this morning.
DR. ZUBELDIA: Mark, I've stumbled on this twice already on the first paragraph that has changed, the end of the top line there's a period, and maybe it's my eyesight.
MR. ROTHSTEIN: Tell me where you are Kepa.
DR. ZUBELDIA: It is not the intent of the NCVHS to be alarmist or critical of OCR or of the Department. Maybe my glasses need changes or something but twice already I've gone past the period and read - of the Department implementation of the privacy rules - and I said wait a minute. I'm wondering if putting a - The implementation of the privacy rule - on the next line would help.
MS. HORLICK: I actually did the same thing the first time I read it and I don't know why that is.
MR. FANNING: That's a graphics issue.
MR. ROTHSTEIN: We could change the word, we could put - Implementing the privacy rule.
DR. ZUBELDIA: If you miss the period --.
MR. ROTHSTEIN: Did you miss the period, too?
MS. HORLICK: I did the first time I read it and I don't know why that is, it's just weird, I know exactly what you mean.
MR. FANNING: It's an issue, periods are little but that what's conventional in Western writing systems.
MS. HORLICK: I think it's the placement, I don't know why, because it has the capital on Department and --.
DR. ZUBELDIA: The problem is if you don't see the period, like I didn't see it, then it looks like it's talking about the Departments implementation of the privacy rule. That's not what it's talking about.
MS. KAMINSKY: Do you think it would be better instead of saying - the Department - to say - Department of Health and Human Services - or that your expecting more after Department?
MS. HORLICK: I think it would just be easier to say - the - before implementation, everybody, it wouldn't go - Department the -.
DR. ZUBELDIA: Because that makes you break it right there. I don't know, English grammar, would that be proper?
MR. FANNING: Well I have another problem with the next sentence.
MR. ROTHSTEIN: Let's defer to this one, we'll --.
MR. FANNING: You know what I would do if I was printing this out in final, I would change the font, I would raise the size of the period and then return to the standard font. I think the -- period, really, there's sort of no way out of it.
MR. ROTHSTEIN: We can put in parens (period).
MR. FANNING: I guess my question about the next sentence - implementation is undoubtedly a more difficult issue than compliance with typical regulations - I'm not sure what you mean by those, you mean implementation by the Department in terms of putting out guidance and all the rest, if that's what you mean it doesn't make sense.
MR. ROTHSTEIN: No, what we mean is that, this was one of the comments yesterday, because it will affect every consumer in the United States we need a much larger public education program and we need to, it affects virtually every provider and so on, so --.
MR. FANNING: My question is a word issue. Implementation and compliance, compliance usually means someone who is obliged to follow a rule does x, y and z to follow the rule. Implementation can be used in two ways. It may mean the same thing as compliance, carrying out the rule in your own organizations, or it may be installing the whole system and so on by the federal agency. OCR implements this rule by --.
MS. HORLICK: It's almost like in the first part you're meaning to talk about the Department and then in the second part about the providers that have to --.
MR. ROTHSTEIN: What we could do is just change the word compliance to something that is a parallel with implementation. So you could make it, just to be redundant for a minute - a more difficult issue than implementation of typical regulations.
DR. ZUBELDIA: You don't need that word.
MR. ROTHSTEIN: Implementation of the privacy rules are undoubtedly a more difficult issue than with typical regulations?
MR. FANNING: That would work. I don't even know that you need issue, but --.
MR. ROTHSTEIN: Is undoubtedly more difficult than with typical --.
DR. ZUBELDIA: And then you can say either implementation of the privacy rule or compliance with the privacy rule is more difficult than with typical regulations. Either way.
MR. FANNING: Compliance might be better.
MR. ROTHSTEIN: So begin the sentence - Compliance with the privacy rule is undoubtedly more difficult than with typical regulations?
MS. KAMINSKY: I just want to say that the comment yesterday came, the notes that I have from the full committee meeting were harder implementation efforts than usual need multiplier effect. I thought that was a little bit when we were talking about trying to get more resources --.
MS. HORLICK: Back on the Department side as opposed to the provider side.
MS. KAMINSKY: That's what my notes say that are corresponding to this.
MS. HORLICK: Then still with the implementation.
MS. KAMINSKY: It's both actually, they're both true. Implementation outreach efforts will have to be greater and the compliance attempts are right now more difficult because it's a difficult rule.
MS. HORLICK: You could say - Implementation of the privacy rule and compliance with the rule are undoubtedly more difficult.
MR. ROTHSTEIN: The first part of the sentence goes to what the Department is doing and the second part recognizes that it's more than just the Department, that's why I put in - it will require concerted efforts by more than just OCR or even the HHS. Because there are going to be other federal agencies that need to become involved and of course the public and various covered entities.
MS. KAMINSKY: My vote is to keep it implementation and maybe repeat implementation or drop the part that people are suggesting that can be dropped because I think what we're trying to say here is you need to step up your implementation efforts.
MR. ROTHSTEIN: Here's what I currently have and let me know if that's not in line with your thinking - Implementation of the privacy rule is undoubtedly more difficult than with - how about - Implementation - I'll start again - Implementation of the privacy rule is undoubtedly more difficult than with typical regulations and it will require, etc.
MS. HORLICK: Do you want to go sentence by sentence? I have one for the last sentence.
DR. ZUBELDIA: Are you going to start it with - The implementation?
MR. ROTHSTEIN: The implementation - for those who miss the period, we've got - The implementation.
MS. GREENBERG: I like that sentence.
MR. ROTHSTEIN: Well, it's just been changed.
[Laughter.]
MR. FANNING: Marjorie missed the typography discussion.
MR. ROTHSTEIN: Kepa said he kept reading right over this period, and Gail as well, so we made it - The implementation of the privacy rule is undoubtedly more difficult than with typical regulations.
DR. ZUBELDIA: John suggested instead that we could make a big period there.
MS. GREENBERG: Maybe it was just people were out too late last night.
MR. ROTHSTEIN: Ok, if there are not problems, do you have something in the prior sentence?
MS. HORLICK: I was just going to ask you the question, the last sentence in that paragraph, I certainly know what we're referring to but I want to ask you if you think it's implied the reason that we need to forge all these partnerships or if you think if we actually need to spell it out.
MR. ROTHSTEIN: Well, let's see what the, can we hold that and see if, we'll go sentence by sentence. Does anybody have anything in the - Nevertheless - sentence? That was not changed from the prior. The following sentence is new. That was sort of implied in the first version but I wanted to spell it out here.
DR. HARDING: It is a correct sentence. It's our determination that that's, it's stated as a fact, it's our opinion.
MR. ROTHSTEIN: Well everything is our opinion.
DR. HARDING: Ok, that's fine.
MR. ROTHSTEIN: Richard, the prior sentence we say - Nevertheless we believe - . Then the next sentence was changed a little bit so I'll let you read that, the one that begins - A massive - . Then - The providers - that sentence has not been changed. The next sentence begins - OCR needs to - has not changed.
MS. KAMINSKY: This is a general question and maybe it's not the right time so if you want to defer this we can defer it but I do want to bring it up again. You were on providers or OCR?
MR. ROTHSTEIN: Either.
MS. KAMINSKY: Ok, the OCR one - OCR needs to produce and disseminate sample forms, notices and documents in simple language. One of the things Rick said yesterday publicly and again after his presentation to me was he's looking for the concrete suggestions. This letter, Mark and I have discussed, and we've discussed with the entire committee, is meant not just to be about concrete suggestions, more of those will follow, but to make a kind of statement. But they will read this letter and glean whatever concrete suggestions are imbedded in it, so the sentence - needs to produce and disseminate sample forms, notices and documents - to me forms and documents are very vague. Notices, sample notices I know what you're talking about. Forms and documents I'm not as sure. So it may be fine for this letter and we do say we're going to follow it up but I want to kind of revisit that unless you have things in your mind that you were thinking about when you said sample forms and sample documents.
MR. ROTHSTEIN: Well, I have a whole list that I wrote down from the Boston hearing that people said oh we need this, we need this, we need this, we need this, and after Baltimore and Salt Lake City I think our letter should spell out in a fair degree of specificity exactly what we have in mind but I think it might be --.
MS. HORLICK: Should we just say something like - ; we will provide - I don't want to say a comprehensive list -- ; we will provide a list after the conclusion of the hearings - or something? We say we will provide more, well in the beginning I think we say --.
MR. ROTHSTEIN: Well one of these that we could do is if we go back to the second paragraph, the last sentence we could add something. We say - We anticipate sending you additional recommendations - we could say - including more specific suggestions --.
MS. GREENBERG: For documents and --.
MR. ROTHSTEIN: Well, including more specific suggestions in general. Would that help?
MS. KAMINSKY: I'll tell you what I'm concerned about. I'm concerned that we're going to end this meeting, that some form of this letter is going to get voted on, that we're going to get it to the Department and it will make its case, but that we have a lot of good additional information already in our heads and in our notebooks and in our notes that would help the situation, that time is of the essence right now which is why we started these hearings when we did and that if we come out at the end of November, which is when I believe is when the next full committee is with this long, long list, hit them in December when we have all of this right now, I don't know if it will be as effective, I don't know the point of waiting, except I know we're going to get more testimony and we may want to flesh it out more, but I just feel like from my perspective wanting to leverage what's gone on so far with this subcommittee and take back to the Department as much help as I can from all of this effort, I'm very much in favor of concretizing, if that's the word, what our suggestions are.
MS. GREENBERG: I would agree though, if you had specific, had some high priority --.
MR. ROTHSTEIN: Ok, here would be an example. We could change it around - OCR needs to produce and disseminate forms, notices and documents. For example, a sample needs to be translated into several languages, a sample also needs to be drafted with the age and mental capacity of the recipients in mind because we're going to have a lot of people who have --.
MS. HORLICK: Simple language I would think.
MR. ROTHSTEIN: I don't know, if you have someone who has Alzheimer's or some sort of cognitive impairment and you're going to have emancipated minors who are going to have to be signing documents, a single notice form is inadequate and they're going to probably draft 20 versions.
MS. GREENBERG: I think the idea of doing them in different languages is very good because there are actually programs and other types of software that can do that and why should everyone be doing this.
MS. KAMINSKY: In addition, that is such an OCR imperative. The Office of Civil Rights does this -- limited English proficiency guidance.
MS. HORLICK: What it doesn't address and I'm not saying we should address it in this letter is, well if a health department has three primary languages and then one person that comes in, what is their obligation to that person. That's a perennial issue with any health care.
MS. KAMINSKY: OCR handles that in a whole different section of OCR. That's part of their other mission.
DR. ZUBELDIA: In my efforts to keep my ear to the ground lately there's been a movement to draft some industry sample forms for consent, authorizations, they started way back then and now they are writing notices. With the notice, one of the requirements that has been I think taken to the extreme is that the actual rule says you have to disclose every use of the data that you will make and there are some people that are saying they have to disclose every use they will possibly eventually make in simple language, that the notice will be six to ten pages.
MS. HORLICK: The preamble talks about the layered notice and I am clear that no one has read that.
DR. ZUBELDIA: They are starting now a layered notice process. There is, in WETE-SNIP(?) there's a group that has started layered notices.
MS. HORLICK: For the privacy rule.
MR. ROTHSTEIN: I have the proposal. After the sentence that begins, or I'll read the whole sentence - OCR needs to produce and disseminate sample forms, notices and documents in simple language - then add - for example, sample notices and acknowledgments need to be drafted in various languages.
MS. GREENBERG: I would just say - documents in simple and multiple languages - seems that that's redundant.
MS. HORLICK: But I like putting in - acknowledgments - we've already said notice.
MS. KAMINSKY: Instead of saying sample forms or documents say - disseminate --.
MR. ROTHSTEIN: Sample notices and acknowledgments?
MS. KAMINSKY: Well - sample forms such as notices, acknowledgments, and authorizations - I just want --.
MS. HORLICK: In simple language and in as many languages as is possible.
MS. KAMINSKY: There's two different points, one is the simple language and in as many languages as possible and then what? What are the sample, because when you say sample forms and notices that means one thing to me, the sample documents mean something very different to me from the hearings that we heard. The sample documents to me were the request for, can we have the ten point plan for how to make a physicians office compliance.
MS. HORLICK: You know what, we might not, I'm just thinking, it could even be a broader interpretation of notice. That could be a sign in the pharmacy about HIPAA rules so that all those people standing on line waiting to sign up for the first time would know.
MS. KAMINSKY: Well notice is sort of a term of art within the regulation. It usually, for sample forms, meaning, that's like a big piece of this reg, the part that OCR should focus on in my opinion is putting together a sample notice as we describe it in the regulation and if a pharmacy wants to have a big sign --.
MS. HORLICK: I just mean when they prepare there sort of guidance or something. The idea of, goes with the public service announcement and all that. The broad campaign, as much of that detail.
MS. KAMINSKY: I get your point.
MS. GREENBERG: Can I make another suggestion?
MR. ROTHSTEIN: In just a second, I've got some proposed language for that sentence so see what you think of this - OCR needs to produce and disseminate sample forms, including notices, acknowledgements, and authorizations, with simple wording and in multiple languages.
MS. KAMINSKY: And what about your concept of documents? When you said that what did you mean?
MR. ROTHSTEIN: Well, they want a sort of a, we heard the people want a kind of off-the-shelf compliance packet that they wouldn't have to pay three hundred dollars for and that they could go to the web-site and click on the dentist area and just pull down the dentist compliance plan.
MS. KAMINSKY: Is it worth alluding to that, too?
I know it's getting long, and that was your concern, we want it to sort of make a punch and make it succinctly, so I don't mean to be taking away from that, I'm just telling you from my perspective, I'm coming back to OCR after all this.
MS. GREENBERG: How about at the end when you say Mark Rothstein, da da da, and I would be pleased to discuss --.
MR. ROTHSTEIN: That was your suggestion by the way and John is going to string me up. Not this John, John Lumpkin, for volunteering him.
MS. GREENBERG: We'll be glad to discuss more specific suggestions, these matters and specific suggestions with you and your staff. That way it invites them if they really want --.
DR. HARDING: Or also or provide you with lists or --.
MR. ROTHSTEIN: Well we're going to do that as a committee after the last hearing.
MS. HORLICK: That, putting it on the web or something is something that could go in a November letter because here if they get busy working on the forms if they have them just getting them up there or having these different access methods, I don't feel like that's as pressing, the development is more pressing.
MS. KAMINSKY: Where's the web piece? I didn't even see it.
MS. GREENBERG: By saying that at the end they can't say you didn't give us enough specifics.
MR. ROTHSTEIN: How about if we say, jumping to the end - and I would be pleased to discuss these matters, including various specific recommendations, with you or your staff - something like that.
MS. KAMINSKY: Yes, that's lovely.
MS. GREENBERG: Or suggestions, I wouldn't say recommendations because recommendations need to be passed by the committee.
MS. KAMINSKY: No, that's lovely. I think that that's helpful and it will, if they come to me their like what are the other suggestions, I'm like you know what? Call them.
MR. ROTHSTEIN: So we've added after the word matters - including specific suggestions -.
MS. GREENBERG: Can we go back? You picked up on Jim's point that this isn't just the Department and I think that's good. But I would continue that where you say - a substantial increase - I would say - a substantial increase in resources in the Department and covered entities is necessary - or something like that. You're saying no, but the resources are not just needed in the Department.
MR. ROTHSTEIN: Well, we know that but we don't have any control over what the covered entities do. You're right.
MS. KAMINSKY: Our message right now is trying to get to the Department.
MS. GREENBERG: Get to the Department. Ok, fine. I withdraw it, I just thinking, I was thinking what Jim was saying, this needs to be a message not only to the Department so people can say, ok, I'll just wait for the Department to do this.
MS. HORLICK: Let's also look at the last sentence.
MR. ROTHSTEIN: Let's go back to Gail's point on that. The last sentence begins - OCR also needs.
MS. HORLICK: It says - we need to forge these partnerships with the professional organizations - and what I'm asking, with industry and so forth, is it implied why we need to forge these partnerships or do we need to spell it out with a little more emphasis. Because it's clear to us that they can take this active role and not expecting the Department to do everything.
MS. KAMINSKY: My lead yesterday had some suggested additional language at the end of that too because I wanted to make it really clear what it was we were thinking about.
MR. ROTHSTEIN: Do you have any specific language you want to suggest?
MS. HORLICK: I want you to do the language Mark, you're so good at that.
MS. GREENBERG: Help guide their efforts?
MS. KAMINSKY: Here's the deal. There's a couple different things. One, the Department would benefit as well as the industry from the multiplier effect of harnessing the industry efforts that are already out there. Two, to date, OCR in particularly in contrast for example CMS and it's relationship to WETE-SNIP, OCR in particularly has had a very arms length and distant relationship with the industry and has been reluctant to endorse anything that's going on out there because of a fear that they cannot check the quality. Everything needs to be cleared and everything needs to be reviewed, and they have just had this kind of, a very legalistic view and therefore have not taken advantage of this potential additional resource, no cost resource, if only they could work effectively with whether it's regular meetings, whether it was we had talked at the June meeting about tapping into national trade associations and having them be the messengers of the message, whatever it is, so I think that, I'm not sure how to word all that, sorry, but when we say have them take a more active role, it's also for OCR to endorse that process because they are taking an active role already but we need OCR's involvement with that activity to assure consistency, to help OCR get its message out, I guess those are the two major things.
MS. GREENBERG: To sort of leverage and reinforce activities already underway?
MS. KAMINSKY: Beautiful.
MR. ROTHSTEIN: To leverage and reinforce -- Gail does that satisfy your concerns.
MS. HORLICK: Yes, I'm trying to think, yes, I think so.
MR. ROTHSTEIN: Ok, anything else on that paragraph? Everybody ok with it? So now in the next paragraph it was suggested this morning by Gail and I think it's a good suggestion, that we put a period after the date in the second line so it just becomes - The NCVHS very much appreciates OCR Director Campanelli's appearance at our meeting on September 25, 2002. We were pleased to learn - are those first two sentenced ok?
MS. GREENBERG: I have a problem with that second sentence because well I supposed he wasn't around, for months now OCR has communicated their interest in the views of NCVHS, they helped us design, so it shouldn't be news to us.
DR. ZUBELDIA: It's his personal interest.
MS. HORLICK: We could broaden it, but the reason I suggested putting the period there because then I thought we could combine the rest of that sentence with the next sentence so that we also think was less of an afterthought but more of the point of what we wanted to say.
MR. ROTHSTEIN: So the suggestion is - We were pleased to learn of his interest in the views of NCVHS on HIPAA implementation and that new initiatives being developed by OCR in education and technical assistance, and we also think --.
MS. GREENBERG: And we also think that the new initiatives are steps in the right direction. That's good, I think, to combine them.
MR. ROTHSTEIN: So is everybody ok with those two sentences I've modified through right direction?
MS. GREENBERG: So your comfortable, --.
DR. HARDING: I still think that - we were pleased to learn of his interest - is a little bit of a slap.
MS. GREENBERG: I think so too. We appreciate his interest.
DR. HARDING: We were -- confirmed our knowledge that he was interested, that kind of thing.
MS. HORLICK: Well if we just want to talk about him then I think it's ok to say we appreciate his interest, but if we want to talk about the interest of the Department, which has been ongoing, then we need to say that.
MR. ROTHSTEIN: Well, we could just take the whole sentences out if you think it's too sort of gratuitous we could just make it - On September 25, 2002, we think that new initiatives developed by OCR in education and technical assistance are steps in the right directions.
MS. KAMINSKY; And also the next sentence does follow, he came, we heard, and we're telling him we liked what you said, but, however, nevertheless, what have you done for me lately?
MR. ROTHSTEIN: Ok, now we're up to however. Ok, everybody alright with the rest of the paragraph? From your recollections of yesterday's committee discussion, do you think we've included all the areas of concern that were raised? I think we've got Jim's point, Marjorie's point, so everybody is good with this?
DR. HARDING: Is there any change to the last sentence, Mark Rothstein --?
MR. ROTHSTEIN: The sentence we changed was in the second line - and I would be pleased to discuss these matters, including specific suggestions with you or your staff at your - ok?
DR. ZUBELDIA: Does John want you to sign the letter? That's what he said right?
MR. ROTHSTEIN: I don't know what John wants so after he sees the last of --.
MS. HORLICK: He said to add the language - and everything negative in this letter came from --.
MS. GREENBERG: Basically I thought the committee responded very positively.
MS. HORLICK: I did too.
Agenda Item: Discussion of Upcoming Hearings - Ms. Kaminsky
MR. ROTHSTEIN: I think that's great. The next item on our agenda is a discussion of our upcoming hearings.
MS. KAMINSKY: We need Marjorie though, maybe John can help and Gail, too, for the ethics issue that we had from yesterday. I don't have a lot of new information to add since last meeting two weeks ago, I actually needed to catch up on some other work in-between the last hearing and this meeting, so I've only just begun to start in earnest the efforts at contacting individuals and lining up speakers. But I did speak on Monday to Peter Grant who is the man who runs the various HIPAA summits, the bi-annual, biennial, whatever, HIPAA summits, and because we had spoken several months ago about the fact that we were going to be holding this meeting at the same time that he was and that we were contemplating moving it to Baltimore, etc., so we had a follow-up discussion where he wanted to see what was going on and help me identify some potential speakers from his people who are coming to his event as well as maybe even others who weren't when he heard more of what our focus was.
In talking it kind of, he asked where this event was going to be and I made a joke and said well, I'd heard that there were not hotels available in Baltimore, we were late to decide to move it, and you've taken all the good spaces, and he said well I think I have space where I'm holding my meeting if you'd like to hold your meeting where my meeting is, you're welcome to do that. So, I kind of raised it informally yesterday with at least Mark and Mark seemed reception to the idea -- I did say we needed Marjorie before I started, I did say that -- I was just saying that I had a conversation with Peter Grant who is the person who runs the HIPAA summits twice a year and a lot of the other HIPAA events that are going on in the industry and he as offered space at the hotel where his Fifth Annual HIPAA Summit is occurring, in Baltimore, his event is October 30th, November 1st and 2nd, ours is October 29th and 30th but he has space readily available for us on the 29th as well.
We would have to do the first day in one room and the second day in another room but the contractor seemed to think that that was an ok idea and the only reason I said we need Marjorie, we need Marjorie in addition to just keeping you in the loop, is that he also said that he wouldn't charge us for the meeting space, that, I don't know I guess he already has it, I don't know, I don't know his business arrangement.
MR. ROTHSTEIN: Well it might be, what happens is if you guarantee like 800 rooms or whatever he's guaranteeing, the hotel is throwing it in for nothing.
MS. GREENBERG: I don't think we want him to pay for our meeting space but if it's available and he's not paying anything extra then.
MS. KAMINSKY: I don't think he would pay anything extra just to have us come.
MR. ROTHSTEIN: Well, do you think it raises any questions because we are deriving a benefit from some private enterprise meeting? I think having the hearing there makes sense because we've got a 1000 interested bodies.
DR. ZUBELDIA: We will get about 500 people in the audience.
MR. ROTHSTEIN: Right and we'll have lots of public testimony I'm sure in addition to our witnesses. The question is would it have any appearance of impropriety for the committee to be getting this room below market cost because of this meeting taking place?
DR. ZUBELDIA: Peter typically will take an entire hotel, he has somewhere between 1000 and 2000 attendees to his meetings, so he takes the whole hotel, AFFECT(?) is in the same situation, AFFECT wants to have a meeting and now we're talking with Peter are we going to have any room available in Baltimore that week. So he's volunteering to give a room to AFFECT for the meeting. It's another association, an industry association, he's volunteering to give a room for free.
MS. KAMINSKY: I should say one thing though, the one piece that he didn't know that Cheryl, the contractor asked, could he assure us of 12 per diem, not per diem, I'm sorry, 12 government rate rooms in the hotel for the evening. He didn't think that was going to be a problem but he needed to check about the rate issue so it may be that the rate is higher than the government rate in which case I didn't know if there was a way that could be reallocated somehow because we were getting the rooms for free or something like that, we're getting the information so we can make our decisions accordingly, although yesterday Mark also said it might make sense to have the meeting at this spot even if people had to stay at a hotel elsewhere.
DR. ZUBELDIA: It's also a substantial boost for his summit to have NCVHS at the same place at the same time.
MS. KAMINSKY: That's why I wasn't sure if we had an ethical issue here.
MR. ROTHSTEIN: Well, if the going rate is $200 a night for a room, and we are taking 12 rooms, they might be willing to give us the rooms at $150 dollars a night then charge us $600 for the room.
MS. KAMINSKY: Something like that is what I'm suggesting.
MR. ROTHSTEIN: The meeting room which would be the same amount of dollars but then we'd, it seems a little better. John, do you have any feeling on this?
MR. FANNING: No, I don't have any answer. I think there were questions at levels. One is the strict legality level, this off handedly seemed like a gift to the government and specific statutory authority is needed to accept gifts, and such authority may exist, but that needs to be looked into. The second issue is a question of appearance and a kind of reciprocal benefit to the donor that outweighs the contribution to the government. But I have no particular framework or principles for sorting that out. On one hand it is surely in the spirit of the operation of the advisory committee to make it's activities accessible to as many people as possible and why not go where there is interest and attention. At the same time it is -- it would be rather closely involved with what is essentially an industry activity. And of course it would obviously have to made perfectly clear that anyone could come to the meeting, come to our meeting, it does not in any way depend on registration at his.
DR. ZUBELDIA: Maybe to see if there is space in the CMS auditorium?
MS. KAMINSKY: We have space in a hotel that is near the airport apparently. We have a back-up. We were moving forward with a different plan before this came up so we certainly can have our meeting in Baltimore, close to Baltimore, at a very different site if that's what we think is --.
MS. GREENBERG: Where is his meeting?
MS. KAMINSKY: The Marriott City Harbor.
MS. GREENBERG: And we were going to be at the airport?
MR. ROTHSTEIN: Or out near Johns Hopkins or someplace.
MR. FANNING: At the airport or at CMS it might just as well be in Washington or New York because it is not easy to get from the downtown area to those suburban locations. It's probably easier to get to the airport but still, if you do that, your event is not integrated with his in anyway, which may be better.
MS. GREENBERG: We had talked I remember about last year, it might be the same event, which was down in Florida, and either Simon or Jeff was a speaker, well there was a question of them hosting some kind of forum and it got too complicated, but I'm no lawyer like Simon always want to make that clear, but there definitely seem advantages to holding it in the same place.
MS. KAMINSKY: I'll tell you something else. Peter has offered, I know that we would like to make sure that the whole public knows and we would go through the usual federal register process, etc., and it would be posted on our web-site, but he has offered to send out an e-mail, I guess, to anybody who is already registered for his meeting to let them know that this was going to be going on if we wanted to let them know that there were opportunities for public testimony at this event and this was they way that they should go about contacting us if they were interested in giving any public testimony.
MS. GREENBERG: It's good, it's outreach.
DR. ZUBELDIA: Stephanie, it's not just everybody registered. Peter has a mailing list with about 30,000 health care names, very well targeted. It's a fantastic mailing list.
MS. GREENBERG: What is his group, who is he?
DR. ZUBELDIA: HIPAA Summit
MS. GREENBERG: And he's just like a consulting firm or something?
DR. ZUBELDIA: It's a law firm and what they do, they bring these summits together four times a year, two in the East Coast, two in the West Coast. It's a fantastic mailing list, if he sends the announcement of the NCVHS privacy meeting that list, we need to get a big room.
MS. KAMINSKY: He didn't offer us the whole list, he offered to the people who were registered, if I wanted to ask him to send it to the whole list I'm sure that that is something I could ask for or we could ask for.
MS. GREENBERG: Well, I'm not sure we could accommodate them all.
MS. KAMINSKY: The room is supposedly much bigger than our normal size, what he had in mind, what he has available to spare for us is larger than what we typically need or request according to the contractor.
MS. GREENBERG: It would definitely be my preference to have the government rate at the hotel but what was proposed as a possible negotiation with the hotel that they wold give us the government room and we would pay for the room.
MS. KAMINSKY: Do we need any lawyer to look at this at all? And who would be the lawyer?
MR. FANNING: I think you do.
MS. KAMINSKY: And who would be the lawyer? Who typically?
MR. FANNING: Oh, they can be found, it might be the business and law division, it might be the government ethics division.
MS. GREENBERG: Someone at CDC maybe? Since actually --.
MR. FANNING: You might start there with your normal program lawyer.
MS. GREENBERG: Debra Tress(?), is she still around?
MR. FANNING: You might start with your normal program lawyer who can then pursue it with a specialist lawyer if need be.
MS. KAMINSKY: I think it would, because we want a quick answer, if we can get someone that knows the business and administrative law side relatively well and can assess this.
MS. GREENBERG: Do you know Debra Tress?
MS. HORLICK: She knows HIPAA, I'm not sure she knows the business and administrative law.
MS. GREENBERG: Well, I've dealt with her on issues related to the committee on ethics and all that.
MR. FANNING: That's right, it is appropriate to start with your normal program attorney.
MS. GREENBERG: Basically it's CDC funds that are involved in supporting the committee, we also get funds from the Office of the Secretary but once they've transferred them to us it's also our fund.
MR. FANNING: That's right and she wold be familiar with, for example, whatever gift authority is available.
MS. GREENBERG: She has people she contacts, in the past when I've deal with her on issues of, it's been a while because she was on maternity leave, but she has these people in the business and administrative area that she deals with.
MS. KAMINSKY: I hate to get a lawyer involved, but I don't want, but in the back of my mind there's that feeling like I don't know where I'm treading.
MR. ROTHSTEIN: I think you should call them and indicate a sense of urgency.
MS. GREENBERG: Are you comfortable calling her?
MS. KAMINSKY: If you give me the name again.
MS. GREENBERG: Debra Tress-Weimer(?) she uses a hyphenated name.
MS. HORLICK: I have it in my office, I can give it to you tomorrow.
MS. GREENBERG: Gail can tell you. And just tell her --.
MS. HORLICK: I don't know if she even uses --.
MS. GREENBERG: You know more of the details that's why I would appreciate it if you'd call her directly.
MS. KAMINSKY: She's at the CDC?
MS. HORLICK: Yes, I can give you her contact tomorrow, just e-mail me.
DR. HARDING: Do we know if any members of the NCVHS are participating in the program?
DR. ZUBELDIA: I am.
DR. HARDING: You're presenting at the?
DR. ZUBELDIA: I am presenting in that program and possibly in the AFFECT program the same day as we have our meeting.
MS. GREENBERG: Do you plan to put yourself through a Xerox machine prior to the meeting?
MS. HORLICK: It would be good for you if it's in the same building.
DR. ZUBELDIA: Oh, I'd love it if it's in the same hotel.
MR. ROTHSTEIN: Ok, what about on the substantive issue of who we're, not just who are we getting, but what kinds of witnesses do the subcommittee members feel that we haven't heard from yet or need further information from and then we'll find the specific people.
DR. ZUBELDIA: What I'm planning bringing to Utah is some small providers, both small hospitals, small physicians, rural type of providers.
MR. ROTHSTEIN: That would be great as well as --.
MS. HORLICK: Inter-Mountain(?), do you want to go with the big one? I didn't really hear the first day.
DR. ZUBELDIA: We can go to Inter-Mountain, but I think we've already heard from them.
MS. HORLICK: Ok, I didn't know that, I didn't know the first day of the hearing.
DR. ZUBELDIA: From Inter-Mountain Health Care? Not this type, we've heard from Inter-Mountain two or three times in the past, it may be good to bring them in.
MS. GREENBERG: Because they may be able to describe some best practices.
MR. ROTHSTEIN: Didn't you mention some Indians?
DR. ZUBELDIA: There's a group that has one of those trucks that goes through Indian tribes and, a mobile unit, and they are having some problems with the privacy laws, saying they can't do it, there's no possible way they can secure the truck.
MS. KAMINSKY: It's similar to the home health testimony we heard with the mobile work force.
MS. GREENBERG: I would suggest, too, from a public health point, the issues of needs of researchers and concerns, that the National Association of Health Data Organizations, is actually located in Salt Lake. The executive director is Denise Love.
MS. HORLICK: She might even be on your list that you were showing me yesterday.
MS. GREENBERG: She's testified, she just testified to the subcommittee on standards and security, but particularly since she's right there and she's, her membership is very concerned about people understanding.
MS. HORLICK: I talked with Mark and Stephanie yesterday that I should be able to get someone from public health right in Salt Lake so it wouldn't be a travel issue.
MR. ROTHSTEIN: And we can get some people from the University to talk about research issues.
MS. HORLICK: University of Utah.
MS. GREENBERG: She's a good resource.
DR. ZUBELDIA: There's a tele-radiology group at the University that has been dealing with some of these issues.
MS. GREENBERG: At the Baltimore hearing on this same subject I think we should try to get someone from the National Health Care Division of Health Care Statistics at NCHS. They have a lot of concern as to how, I think they did finally get a letter approved by OCR to send to providers, these are the provider surveys. So they are very concerned that the providers are just going to say forget it.
MS. KAMINSKY: These are provider surveys but related to collecting data for the research efforts that go at NCHS?
MS. GREENBERG: These surveys are, we get information, we collect data from hospitals, emergency, the whole range of institutional providers and also individual providers, emergency departments, physician offices, etc., and we've had issues, ongoing issues with in the past before this, where people are saying we don't know if we can provide this information to you, blah, blah, and of course they are voluntary surveys, but nonetheless this has really ratcheted it up now them saying we can't provide this information to you under the privacy rule. They finally got a letter approved for 2002 but basically what it says is don't worry it's not in effect yet, but they are really worried about when they can't say that anymore.
I think they represent, a lot of states have these provider surveys, too, what they want is some kind of sort of like these sample forms or something, they want something that is kind of blessed by OCR but I think they would, particularly since it's right here in Baltimore, I think I could get someone.
MS. KAMINSKY: I have a kind of big picture question/response to that which is a couple of times in my efforts to line up speakers it has been suggested to me to pull in a fed from this division of HHS or that division of HHS, and I have resisted pulling in feds and other -- because I thought originally our goal was to hear from the small providers, small health plans or some health plans if we could find them, and state agencies. I'm concerned that I know that there have been a lot of operating divisions and John can speak to this better than I can because he's in the best contact with them on a regular basis, who has both sought guidance from OCR internally, this is within HHS, and who have wanted OCR to bless their outreach materials, and there have been a lot of concerns in that area all along. My sense is that this is sort of inside of HHS stuff.
MS. GREENBERG: I think John feels the same way and I can withdraw this. I'm just concerned that there is this whole area of anxiety and I think that Denise can certainly express it out in at the Utah hearing.
MR. ROTHSTEIN: What we might be able to do is attack the same problem from the opposite direction by getting somebody from ASTO(?) or NAHCO(?) or some local public health person.
MS. HORLICK: I spoke with, especially I don't know if you want these public health at both, I feel pretty certain I can get somebody from Salt Lake, you might want to just look, you don't want to have the same testimony.
MR. ROTHSTEIN: And we can get Georges Benjamin(?) from Maryland.
MS. KAMINSKY: If you guys can help me identify the right person to talk about this whether it's the state agency that's collecting the information or I don't know who these other organizations are, this is so out of my league.
DR. ZUBELDIA: If we are going to hear from Denise Love in Salt Lake, maybe we don't want to have --.
MS. HORLICK: The guy that I was thinking about was the guy that runs a registry in Salt Lake but he's a vital records person, the registry is under his auspices and maybe the collecting data, he might be able to, he will raise the question and we can help formulate.
MS. GREENBERG: I don't know if vital records, they probably are pretty covered.
MS. HORLICK: You think they're covered, but I could send you the e-mails I'm getting about it. Anything you can think of.
MS. GREENBERG: I predict dramatic drops in response rates.
MR. FANNING: Surely you actually expect dramatic drops in birth registration?
MS. GREENBERG: No, not in vital statistics I don't, I'm not too concerned. The fact is the committee does often hear from other parts of the department as an advisory to the department but I rest my case. I think if we can get Denise to represent some of these concerns related to provider surveys then that might be more in keeping with how you're trying to direct, I can go either way. I'm certainly not looking for NCVHS to get up and say we've trying to get guidance from OCR and we can't get it. That would be inappropriate, that should be handled within, well sometimes the committee does hear that kind of, but I wasn't looking for that.
MS. KAMINSKY: That's why I'm saying it's a broader question. If we want to go there, there's a lot of that out there, not just with NCVHS, there's a lot of that out there. So if we want to bring in the feds and other HHS, it's not like other federal agencies, Labor, Department of Defense--.
MS. HORLICK: This is why those targeted materials are, if they could just address some of that in black and white, that's what people want, they just don't want to do the wrong thing, they say I think we've heard that this is right, can you confirm this, or what does this mean, I think there's such a need for that. I can only speak for the state and local health agency, but I'm sure it's the same. I think there's people where it's not such a need because it's not even on their radar screen, really.
MS. KAMINSKY: That's my point also. I think that the Department has made some kind of an effort to address its own agencies. I think that they've been less forthcoming to the private industry and so given the limited resources, what is our message.
MS. GREENBERG: What about Maryland Public Health?
DR. ZUBELDIA: The Maryland Health Care Commission?
MS. GREENBERG: Who works with them? What?
DR. ZUBELDIA: The Health Care Commission?
MS. KAMINSKY: Do you know what, I think it was -- Anderson, or David Kibbe(?) said I should talk to David Sharpe(?) at the Maryland Health Care Commission and I wrote him an e-mail saying what is the Maryland Health Care Commission. What do they do?
MS. GREENBERG: Are they the ones who collect the cost commission?
DR. ZUBELDIA: They are not called cost commission anymore but it's Health Care Access Commission.
MR. FANNING: I was about to suggest inviting them, too. They have a long history and I've dealt with them, they are attuned to these issues and have dealt with similar issues in the past.
MS. KAMINSKY: What do they do though? Who are they?
MR. FANNING: Collect hospital discharge data and other health data, transaction data, which they analyze to produce statistics about costs and so on. I don't know whether they have any regulatory function. They might. But at any rate they do collect information for these purposes and this is a class of activity, it is really, Denise Love jurisdiction activity. But you have one there that's an active one. The other organization in Maryland is a Health Confidentiality Commission, which has produced some educational material for physicians, for example, and it might be useful to hear from them.
MS. GREENBERG: Are they in Baltimore?
MR. FANNING: The chances are they are, but I don't know.
MS. HORLICK: Is it a state agency?
MR. FANNING: It's a state commission, and I can give you the citation and so on with ease. One of the officials of the Cost Commission is in fact on the Confidentiality Commission.
MS. GREENBERG: I think it would be kind of comparable to the types of people we heard from in Massachusetts.
MR. ROTHSTEIN: Let me ask you a question about your thoughts on having a different kind of panel at one of our hearings that would hear from people who are experts on public education, like PR people, people who've done Y2K compliance, do you think that that's too specific?
MS. GEENBERG: Would that be helpful to OCR?
MR. ROTHSTEIN: That's what I'm saying, would that be helpful to OCR given that you're getting ready to let a contract with somebody to do something?
MS. KAMINSKY: I don't think it would hurt and we're having a lot of redundancy with the provers and this that and the other thing, so it could be neat to have a different angle, I don't think it could hurt.
MR. ROTHSTEIN: Because I think it could help our recommendations if somebody that knew what they were doing said, look, you've got 285 million people you gotta inform about this, and the minimum you need to do, this is what you need to do, sort of print stuff, this is what you need to do in terms of broadcast, announcements, how much should be done through providers, how much should be done point of service, that sort of thing.
MS. GREENBERG: In fact what I would really like some input from people who know is whether these public service announcements would be more effective coming from the government or coming from the professional groups. There are pros and cons I guess of both.
DR. ZUBELDIA: Local groups.
MR. ROTHSTEIN: Local groups. Should it be from the AMA, or?
MS. GREENBERG: Should it be from CVS or, I also agree with Jim, this all can't be done by the government and in fact it gives more the impression of buy-in throughout the industry to have some of it done by the industry, not to mention financially, but also it's a message. There are people who are experts in this who know whether we respond better or they take it more seriously if they hear it from one group than from another. Sometimes it's good from the government other times it's kiss of death.
DR. ZUBELDIA: How about getting the AARP?
MR. ROTHSTEIN: They've got a lot of people, and they are in touch with them.
MR. FANNING: I will also put you in touch with Cynthia Bauer in our Office of Disease Prevention and Health Promotion who has worked more generally on health information and health literacy, communicating with the public about many health matters and indeed as you point out there is a body of knowledge and expertise on how best to do this. Cynthia Bauer.
MS. GREENBERG: She was actually one of the authors of the NHII report, she's worked with this committee.
MR. FANNING: I can provide you with all the contact information.
MS. KAMINSKY: That will be wonderful because I really don't know where to start, I'm thinking PR, Ogilvy(?) Public Relations, where do I go?
MR. ROTHSTEIN: It also might be a very interesting topic for public comment, we're going to have five hundred people in the audience from presumably all over the country and they might say, what seems to work best in our area is.
DR. ZUBELDIA: We may want to have a time of a panel. Normally we have just have 15 minutes for public comments, we may want to have an hour for public comment.
MR. ROTHSTEIN: I was thinking we'd have all afternoon.
DR. ZUBELDIA: And announce it like that and say this is timed specially for public comment.
MS. GREENBERG: You mean in Baltimore.
MR. FANNING: May I also suggest that there's an interest in this more generally in the privacy community and there's an organization called the Privacy Council which has working for it Toby Levin who previously worked at the Federal Trade Commission and who himself worked in the health confidentiality area in the late '70's. They are interested in how you communicate to the public about privacy issues generally, not specifically related to health, but Cynthia and I have talked with them. I think that they're, people understood after the Gramley-Bliley(?) Financial Privacy Act that highly legalistic notices about the respective rights of the bank and of the individual were not helpful or informative. And as a result of that there has been some thinking about technically what is the best way to convey this information. Conceivably we could have someone from that community as well.
DR. ZUBELDIA: Or from the banking community, the American Bankers Association sent a newsletter a couple of weeks ago to the banks telling them that they should all apply for the ASCA extension.
MS. KAMINSKY: Does the privacy rule extend to the banks in terms of --?
DR. ZUBELDIA: As it turns out, the banks when they get an A35(?) transaction to the banking system, converted it into a CTX transaction and that makes them a clearing house.
DR. HARDING: Do we have anything to learn from GLB beside what you're saying?
DR. ZUBELDIA: Yes, and maybe their experience is something that can help us.
MR. ROTHSTEIN: Maybe there's somebody from academia like from the Annanburg(?) School of Communications which is in Philadelphia.
MR. FANNING: The Federal Trade Commission had a workshop on this late last calendar year and that should provide at least a list of names of people who have addressed this in the fashion you've just described.
MR. ROTHSTEIN: So I think if we could, what we want to work toward of course is our November letter to the Secretary. I think it would be very helpful if we could have a fair degree of specificity and outline some of the points that we heard from witnesses in all these areas and here's our recommendations with regard with how to publicize this to the public as well as various professional groups.
I was also thinking that there are many other provider groups that we have not heard from. Chiropractors, physical therapists, various allied health providers, and so on, and we definitely ought to get them involved, many of them have their own offices and now they have an issue of what their going to do with their records.
MS. KAMINSKY: I have coming to me a list of physician specialty societies and active people who are HIPAAites who I was going to contact to kind of broaden the physician horizon, but I don't have a good kind of starting point for allied health professionals.
MR. ROTHSTEIN: We'd need optometrists, podiatrists, all sorts of people.
MS. GREENBERG: They have a lot of professional associations probably located in Washington. Would somebody at HERSA(?) be knowledgeable?
MR. FANNING: Yes, someone in the Bureau of Health Professions and Health Resources and Services Administration would know about some of those.
MS. GEENBERG: Debbie actually did at one point work at HERSA so she might be able to help you with that but I'd say they would know the professional associations and the Baltimore hearing would be a good one. I just looked at my e-mail and I had a notice about this Fifth HIPAA Conference coming up, coincidentally, I did just think of one additional issue when you talked to Debra. We would not want them to try to leverage the fact that we were having this hearing really directly as a way to get people to come to the meeting, because the meeting does include a registration and all that. Now I would think the situation being what it is, is probably they're going to have a lot of people come to this meeting without, but nonetheless, this could be to his advantage, so I think that's something we have to think about.
MR. ROTHSTEIN: Actually from sort of an ethics standpoint, the timing works out well because I think they've just about filled up all the registrant slots so we're coming on at the end so our being there.
MS. GREENBERG: They have a maximum they can take?
MR. ROTHSTEIN: I think so.
MS. KAMINSKY: That was about rooms, I don't know about registrations.
MS. GREENBERG: Ok, that's just an issue that clearly I can --.
MR. ROTHSTEIN: Most of the people who are coming had no idea we were going to be there when we signed up.
MS. GREENBERG: We don't want him saying they are hosting this hearing because also that could set an awful precedent that not everybody would think, you know, you allowed this group to host, we want to host a hearing, and it's a draw.
MS. KAMINSKY: But we wouldn't prohibit him or ask him not to disseminate information at the hearing would be taking place then and there.
MS. GREENBERG: No, I don't think that's a problem.
MS. KAMINSKY: Just in a neutral way.
MS. GREENBERG: Anybody can do that.
MR. ROTHSTEIN: Just ask him to tone down the -- and the band --.
MS. GREENBERG: I was going to say, refreshments, we get into a whole other order of magnitude.
MR. ROTHSTEIN: So I think we've got enough leads to keep you --.
MS. KAMINSKY: My only other concern is in terms of scheduling. When we originally started planning this back in July we had said that maybe on the second day in Utah we would spend substantial time kind of culling our thoughts and pulling together our recommendation list and sort of having a brainstorming kind of wrap up discussion time. One, are we still doing that and two, how much time do you think we are going to want for that kind of a discussion and work?
MR. ROTHSTEIN: I was thinking that the Utah hearing itself might only be a day depending on what we hear in Baltimore but of course it has to be planned in advance, and then a half a day of our subcommittee meeting to go over all the stuff that we heard.
DR. ZUBELDIA: That wouldn't help for those of you who have to fly East.
MS. GREENBERG: I was thinking that too, then you could get out there early.
MR. ROTHSTEIN: If we go until five I'm stuck there.
DR. ZUBELDIA: There's a direct flight at 4:40 from Salt Lake to Washington Dulles and if you don't take that one your stuck until the next day.
MS. GREENBERG: You have a social event planned the first night? Any suggestions? Pay our own way.
DR. ZUBELDIA: Sure we can do something. Go out to dinner.
MS. GREENBERG: I know they have rehearsals that are actually very good, on Thursday night, when are we there? So maybe we can all go out to dinner or something.
MS. KAMINSKY: So one day of testimony in Utah and then a morning of working meeting?
MS. GREENBERG: Will that accommodate everyone?
MR. ROTHSTEIN: I checked my schedule and if I don't get out, I think there's like a four something flight to Cincinnati.
DR. ZUBELDIA: There's flights to Cincinnati on Atlanta, there like every hour, all the time.
MR. ROTHSTEIN: But it stops, whatever.
DR. ZUBELDIA: If you want to come all the way to here, 4:40 flight brings you to Washington Dulles and that's perfect.
MR. ROTHSTEIN: Not that I wouldn't like to spend extra time in Salt Lake City. Ok, is there anything else on our --? Let me just share with you some thoughts that I was reminded of when John yesterday talked about the executive subcommittee meeting in Chicago. I talked at that meeting and since then about the subcommittee's life after HIPAA and obviously HIPAA's the most pressing and immediate thing for us but we need to think long term about getting into other projects and one of the things that I talked about in Chicago that met with some favorable reaction was to take up the issue of the migration of health information beyond clinical settings into other settings, into schools, into banks, credit agencies, insurance files, etc., etc.
So I think what we might do is have a series of hearings and take up some of those issues and I would suggest that a good starting point might be school health records. And there are all sorts of reasons why I think that's a good idea and so I talked to Richard about that, I think he feels that's a viable topic and so maybe after we get this done we can start thinking about that. Would that be to your liking as well Gail?
MS. HORLICK: Yes, I hear an awful lot of not coming into the schools but going out of schools and the carpet issues.
MR. ROTHSTEIN: How it's stored, who gets it, what happens.
MS. HORLICK: Years ago we did the employer issue, what we got was really good best practices from IBM and not a lot of other helpful, I had a hard time getting people to come to that, they did really good things, they were ready to come but they were few and far between.
MR. ROTHSTEIN: That was pre-HIPAA and I think it's sort of a whole new world out there now.
MS. GREENBERG: And given the kind of ambiguity that employers have in relationship to the privacy rule.
MR. ROTHSTEIN: So are there any other matters for the subcommittee to discuss? I will revise this letter and have it copied and distributed for the full committee in time for our meeting.
[Whereupon, at 9:25 a.m., the meeting was adjourned.]