[This Transcritp is Unedited]
The National Committee on Vital and Health Statistics Full Committee was convened via telephone conference call on February 2, 2000. The conference call was open to the public.
Participants in the NCVHS Full Committee Conference Call on February 2, from 1:30 p.m. till 3:30 p.m.
Operator: Hello, this is AT&T Teleconference, your recorder is now on the line.
Kathleen Frawley(?): Hi, this is Kathleen Frawley.
Diane Schnidman(?): Hi, this is Diane Schnidman at the American College of Surgeons.
Kathleen Frawley: Hi. Is there anyone else on the call?
Diane Thomas(?): Diane Thomas with Delta Dental Plan of California.
Kathy Bookham(?): Kathy Bookham, LM Chevelier(?).
Richard Harding(?): Good afternoon, this is Richard Harding.
Kathleen Frawley: Hi Richard, it is Kathleen Frawley. How are you?
Richard Harding: Hi Kathleen, just fine.
Kathleen Frawley: Good.
Bob Gellman(?): Hi, this is Bob Gellman.
Richard Harding: Hi Bob.
Kathleen Frawley: Hi Bob.
Dan Friedman(?): Hi, this is Dan Friedman.
Kathleen Frawley: Hi Dan.
Richard Harding: Richard Harding. Let me get something while we are waiting. I will be right back.
Jim Scanlon(?): Hi this is Jim Scanlon.
Kathleen Frawley: Hi Jim, it is Kathleen Frawley.
Jim Scanlon: Hi Kathleen, how are you doing?
Kathleen Frawley: Good.
Jim Scanlon: Are you up in New York?
Kathleen Frawley: No, I am in Florida.
Jim Scanlon: Oh my goodness! Much nicer, let me put the speakerphone on here.
Kathleen Frawley: It is very pleasant.
Jim Scanlon: I bet! Well Kathleen, the temperature is going up a bit today, maybe melting some of the snow.
Kathleen Frawley: Yes, I have been watching and getting reports from people up North.
Man: Closed on Monday.
Man: Yes, we were.
Man: I was in last week, and oh what a mess!
Man: I know. Is John Lumpkin on the line?
Kathleen Frawley: I don’t think he came on yet.
Man: Oh okay. I think snow scares him but – (laughs) we were actually closed for two days last week.
Man: Well I was in Wednesday, Thursday, and Friday and the city was still pretty debilitated.
Man: Yes. Well Dan, that’s because of Boston doesn’t have hills. You are used to the Boston area.
Man: Dan, did you go to the 2010 meeting?
Dan Friedman: I did Paul. Well actually I should have said meaning in as so far as I went to the two sessions were we had presentations.
Man: Was there good attendance?
Man: …….. at NCHS.
Man: did you have good attendance at your session?
Man: Yes we did! I felt the attendance was good and I thought people were really interested. I was very glad about it especially the one on the National Health Information Infrastructure. I thought we had got some really good feedback.
Man: Great! Yes, I did a presentation the day before and then had to go back, but it was very spotty attendance that day, but that was in the middle of the blizzard.
Man: So you got out okay!
Man: Well I got out the next morning.
Man: Our flight paths probably crossed.
Man: Yes, probably so.
Jeff Blair(?): This is Jeff Blair, I will join the call.
Kathleen Frawley: Hi Jeff.
Gail Horlick(?): This is Gail Horlick.
Kathleen Frawley: Hi Gail.
Gail Horlick: Hi.
Andy Kramer(?): This is Andy Kramer.
Kathleen Frawley: Hi Andy.
Man: Hi Andy.
Larry Schwartz(?): This is Larry Schwartz.
Woman: Hello?
Woman: Yes?
Woman: This is NCHS. Sorry we are a little late. The room that we had reserved was taken. …… so we figured we should –
Woman: It is hard to move clutter.
Man: That’s right. This was taken, too, up until then.
Woman: Who do we have at this point?
Man: We have got the Asby(?) contingents, Scanlon, Breakways(?), and Sanchez(?).
Woman: Breakways, we missed you at the last conference.
Barbara Starfield(?): Hello, Barbara Starfield here.
Man: I got a message saying you were trying to reach me, but then nothing happened.
Woman: This was a miscommunication.
Dan: Hi Marjorie(?), it’s Dan.
Woman: Oh Hi Dan. Is John on?
Woman: No.
Woman: Which members do we have at this point?
Woman: Call a role and we will say here or not.
Man: That’s good.
Woman: Okay. Do I have it with me here?
Man: Hello?
Man: Is that John?
Clem: It is Clem.
Man: Oh, Clem, okay.
Marjorie: Hi Clem.
Man: How are we doing? Do we have enough people?
Marjorie: Not yet. Jeff Blair?
Jeff Blair: Yes.
Marjorie: Simon Cohn(?). Kathy Kootan? Kathleen Frawley?
Kathleen Frawley: Here.
Marjorie: Dan Friedman is here.
Dan Friedman: Yes.
Marjorie: Kathleen Fyffe(?)? Bob Gellman?
Bob Gellman: Here.
Marjorie: Richard Harding?
Richard Harding: Yes, I am here.
Marjorie: Lisa Iezzoni(?)?
Lisa Iezzoni: Yes, I am here.
Marjorie: Thank you. Andy Kramer?
Andy Kramer: I am here.
Marjorie: Andy, how are you doing?
Andy Kramer: Recovering slowly. Much slower than I would like.
Marjorie: Yes. We are really sorry to hear about it.
Andy Kramer: Yes, I was sorry that I could not have been there. I would have not done well in the snow with my –
Marjorie: Oh, yes, no we are not doing well who aren’t in casts. John Lumpkin? Clem McDonald(?)?
Clem McDonald: Here.
Marjorie: Mark Rosstein(?)? I think he was not available. Barbara Starfield(?)?
Barbara Starfield: Here.
Marjorie: Okay. Elizabeth Ward? Kappa Zobeius(?)? So right now we have –
Paul Newcheck(?): Marjorie, you left off my name, Paul Newcheck.
Marjorie: Paul, why aren’t you on this? I am just reading off – I didn’t have my roster. I hope you got the email. I didn’t see your name here, Paul Newcheck.
Woman: Marjorie, I count ten.
Jeff Blair: Marjorie, can you hear me?
Marjorie: Yes, that is Jeff, right?
Jeff Blair: Yes, I just wanted to make sure that I didn’t have it on mute.
Marjorie: I also have ten. I am sorry, Paul. I don’t know why your name wasn’t on this list.
Paul Newcheck: That’s okay.
Marjorie: Anyway, you got the number so that is good. My reluctance on starting is that John isn’t here. I guess we could ask Kathleen to chair in that she is the chair of the subcommittee on Privacy and Confidentiality, until John joins us. Maybe I can have someone call his office, John Lumpkin’s office to see what is holding him up.
Man: Marjorie, before we do, why don’t we - this is an open national telephone conference. Why don’t we ask all the others to identify themselves?
Marjorie: We haven’t had staff actually identify themselves by name either, so why don’t we do that and maybe John will join us by then. Asby do you –
Man: Yes, we will start here. Jim Scanlon from Asby.
Joe Breakways: Joe Breakways from Asby.
Linda Sanchez: Linda Sanchez from Asby.
Larry Schwartz: Larry Schwartz from American College of Surgeons.
Gail Horlick: Gail Horlick from CDC.
Marjorie Greenberg: …… chapter, Marjorie Greenberg.
Debbie Jackson(?): Debbie Jackson.
Marjorie: Anybody else?
Roberta Dean(?): Roberta Dean, National Wholesale Druggists Association.
Lisa Greenleaf(?): Lisa Greenleaf, Crow and Mooring(?).
Doug Atacourt(?): Doug Atacourt from Washington Health Advocates.
Kathy Brucker(?): Kathy Brucker from Miller and Chevelier(?).
Phoebe Bruen(?): Phoebe Bruen from the American Insurance(?) Association.
Dave Schultz(?): Dave Schultz from the National Wholesale Druggists Association.
Alex Brittain(?): Alex Brittain, McKenna and Cunio(?).
Diane Thomas(?): Diane Thomas, Delta Dental Plan of California.
Marjorie: Anyone else that we haven’t heard form?
Don Rusho(?): Don Rusho, Delta Dental Plan Association.
Man: Anybody from Blue Cross Blue Shield Association?
Woman: Was that a question?
Man: That is a question.
Woman: Everyone has had an opportunity to identify themselves?
Man: Everyone who wants to.
Man: We don’t have a quorum, is that what I understand?
Marjorie: No we do have a quorum. We don’t have our chair. Dr. Lumpkin is not on yet.
Clem McDonald: Well I was just going to suggest a discussion of the point that Bill Breaf(?) had made in his comments about basically staying the scope of the HCFA in a letter about HCFA. It seems to me that the appropriate thing to do is to get that out. At least get a discussion whether we should get that out of there because I think it is just going to confound the utility of this document. Did anyone else read that?
Woman: What are you referring to, Clem?
Clem McDonald: Well Bill Breaf had said some pragmatic comments about our letter.
Woman: It was circulated to the members and staff, but the people who have called in from the public don’t have them probably.
Clem McDonald: Well I wasn’t really trying to discuss them. I was just trying to discuss the issue that was raised, which I think – I understand that there has been like 40,000 comments delivered. So this has not been a low comment issue. What we did was by saying you should also do some other things for privacy, all which are good, and we can argue about them separately and probably right,. But the fact that we have tangled them up with our mission of the HCFA(?), probably makes us much less – our message gets really hard to accept. I think from how I have read his interpretation, because the focus in the logic and the justification is now based on HCFA. It seemed to me, and I wonder if everyone else had thought the same, that we should just try to remove that extended goals in this letter and do that in some different fashion?
Bob Gellman: This is Bob Gellman. I disagree with what Bill had wrote on this regard. I think we need to take a broader view of this thing. I think that the department took a very narrow view of its authority under HCFA and its other authority. I think that the department could have done a much broader job and created a set rules that would actually be much easier for everybody to implement. I don’t see any reason why we should back away from that general point of view and if the department doesn’t agree with us, they are welcome not to do it. But I think it is a perfectly fair point. I don’t think that it adds to the complexity of the task. I actually think that it takes away from the complexity because, ultimately, it will be easier if everybody were subject to the same rules and we didn’t have people ducking into and out of coverage of the rules throughout the health care system.
Man: Now Bob and I disagree about this, but let me make it clear what it is that we disagree about. I don’t disagree with a comment that suggests that the secretary apply other authorities to increase the scope of these privacy rules. What I disagreed with was the statement in the comment that said that this was being done in the interest of presenting a uniform regulation. My comment was that the authorities of HSF are extremely varied. The ability of HSF to reach various aspects of various organizations varies across the different programs that we run. Our authority to enforce these things varies greatly and that the result would be a broader scope of applicability as a rule, but it would not be uniform. I was just objecting to the stance that this would provide a uniform coverage of health care from the public’s perspective.
Man: Well, Bill, it really is the word “uniform” and literally the word “uniform.”
Marjorie: I know I heard some people join us. Can anyone who was not on at the role call, who would like to identify themselves, please do so.
Michael Fitzmaurice (?): Michael Fitzmaurice is here.
Christina Nyquist(?): This is Christina Nyquist. I am with the Blue Cross Blue Shield Association.
Marjorie: John Lumpkin, have we heard from you yet?
Man: I am sure he will let us know if ………
Marjorie: We have just called his office and they expect him to be calling in.
Jim: I’m sorry this is Jim. Clem, you have already sort of gotten into the letter itself, which is the issue of applicability, which may be as good of point as any to start. The issue that we just had started discussing was on the first page of the letter under the applicability of the proposed regulation. You have before you, if you flip over to the second page on some as well.
(Simultaneous discussion)
Marjorie: Is there any objection to Kathleen Frawley steering this conference call until John Lumpkin joins us?
Man: No.
Man: Good idea.
Kathleen Frawley: What I would like to do is just to try to go in order of the documents, just so we can – it will be easier for me to get your comments and to be able to make the revisions. I would just like to go back to the first page and there are three paragraphs, which are introductory paragraphs before applicability. I would just like to find out if anyone has any changes to the first three paragraphs.
Marjorie: And I guess we’d agreed that little words missing can just be sent to Kathleen, but more substance of things.
Man: Could I just ask an operation question?
Kathleen Frawley: Yes.
Man: I had sent you some comments after your deadline, the day after your deadline.
Kathleen Frawley: Yes, I have got them.
Man: Okay, well I didn’t know if you could accept them because it was after the deadline.
Kathleen Frawley: Yes, I did and I looked at them and I tried to make the changes before I came.
Man: Okay.
Man: So the document that we should be looking at is dated when?
Kathleen Frawley: January 24th.
Woman: January 24th?
Kathleen Frawley: January 24th.
Man: Yes, that is the one.
Kathleen: So were there any changes to the first three paragraphs?
Man: No.
Kathleen: Okay, hearing none, then we are going to go to applicability and we’re back to this discussion that Bob Gellman and Bill Breaf raised regarding the issue in the second paragraph on the uniform regulations across medical records, type the records, and types of covered entities. Bob is arguing that we should go obviously for the recommendation that the secretary use all available authority to achieve uniform regulations. Bill is indicating that we can argue for a broader scope. ……….
Man: I think you can decide to go for the request for a broader scope by getting HHF(?) to apply to ____ authority. But I don’t think you should use the rational that it would provide uniform regulation across all medical records, which is what is implied as I had read those two paragraphs.
Kathleen: In the second paragraph.
Man: Yes, first and second actually.
Man: Come up with some other rationale besides that one, because that just doesn’t make ….
Man: Well I disagree with that ____. It seems to me that unless we have looked at all of the secretary’s authority, we don’t know whether the secretary could prescribe uniform rules or not. In some respects the rules from the perspective of the record keeper could be very much be uniform. Some enforcement element, administrative elements on the part of HHS would clearly be different and I think that is a matter of lesser concern.
Man: Well I guess I had took it that Bill’s did have some sense of the authorities, the various authorities, from what he had said.
Man: I can’t say that we or I have looked at them all to see. We have discussed them and have decided earlier on in this process that it would be something that we would put out for comment. We did that in the ______, so it is open for comment and we welcome that comment. I was just saying that the language that you are using to promote that comment that it implies to the public who reads this, that if we did that it would produce a uniform regulation across all records that HHS has any control over. I think, although I can’t prove it to you, that that’s going to mislead people.
Marjorie: By the way, I have asked, and I know we won’t always be able to do this. But this is Marjorie, that if the speaker could identify him or herself whenever possible it would be helpful. We are going to have a written transcript so that is helpful.
Kathleen: Okay, what we need to do as a committee is we need to vote on whether we make a change into the document here. The one is to leave it as it is currently written or the other is to revise it based on the recommendations that Bill Breaf has made. So I am going to have to ask for the committee members to vote so we know whether we make a change to the document. So if you want to go ahead and let us know, yes or no.
Man: Well are we suggesting leave it as is or discussing changes?
Kathleen: Or changing it as Bill has suggested.
Man: Well what was the exact wording? We take out the word –
Kathleen: The idea was to take out the wording to try to achieve uniform regulations. Instead of that –
Man: We take out the whole sentence?
Kathleen: What we had tried to do is to achieve a broader scope.
Man: Right.
Man: Yes.
Man: I am just not clear. I am reading the words here but I can’t picture what exactly is changing in the last sentence.
Man: Somebody make a motion as to what the change would be?
Man: Yes.
Man: Or did you already Bill, in your –
Bill: No, I can’t make a motion.
Man: Oh, right.
Jim: This is Jim again. I wonder before we do that, I think that the initial draft was attempting to answer two questions that were asked or commented in the proposed rule. One was that should HHS expend the applicability to include paper records within the covered entity? I think earlier the NTVHS(?) had wording to the effect that they would recommend that it do so. That could be in fact be somewhat uniform. But the second question, should HHS use other authorities available to it to cover other entities and other holders of health information, which is the second point. We seem to have lost the first comment as well. I think we would really like to hear from you on the idea of should the covered entity, should the scope of the regulation include the paper records as well as the electronic records of the covered entities under HCFA. We seemed to have lost that.
Man: Well it says, Jim, in the first sentence under applicability that the NTVHS agrees the scope should be extended including purely paper records..
Kathleen: Right.
Jim: Okay.
Woman: Then the second one –
Man: Is it clear?
Man: Yes.
Kathleen: Yes, I think we have answered that question, Jim, and agree with that the department should do that. I think it is the whole issue of the available authority of the secretary and what the secretary can do to achieve uniformity.
Man: Well I would propose that we remove the sentence beginning with “Having uniform regulations.” If you read the next paragraph, we really don’t lose anything, I don’t think, if we do that and can avoid the possible confusion.
Woman: But the first paragraph is not talking about using additional authorities. It is talking about covering paper records as well as electronics.
Man: But it still stands, I mean what we are doing is interpreting our statement. We’re suggesting that this is how the world would think of it in this last sentence. I don’t know if that it is necessary to fuss over it when you think about it. What we have said is that we want it uniform. We had said to even get additional authority to do it. So what are we losing here? Help me, bob?
Bob: What are we losing?
Man: I take it that sentence is out. We really interpreting the world’s view of this rather than saying what they should do.
Bob: Well, I don’t want to play too many games with this, but if we take the sentence out the headline is “NCVHS decides it is against uniform regulation.” I think we’re looking – I think Bill has raised what is not an unreasonable issue but from the perspective of these broad comments. For us to say we’re in favor of uniform regulations that apply across the board, I don’t see what is so terrible about that.
Man: Well we said it in the sentence before. They should be uniform across forms of identifying information. All we are saying know is that this uniform records make the regulations, I mean we are saying a step further which if you read the two paragraphs, I don’t think we are losing anything. If it is a confusing sentence we don’t have a confusing sentence.
Bob: I don’t fine the sentence confusing. I don’t think it is a big deal, either way, to tell you the truth. I am not concern about the internal bureaucratic problems with HHS and trying to implement the recommendations that we are making especially since they are not likely to do so. For us to simply say that we think we ought to have uniform regulations that apply across the board and the secretary should use all of her authority is a very nice goal and a very nice statement. The rest of it is details that don’t belong in this letter and aren’t particularly relevant.
Man: Well I would move that we strike that sentence because I don’t think we are losing any thoughts that are desired, when you look at the two sentences in total.
Kathleen: Okay, so there has been a motion made to strike those two sentences.
Man: No, no, just one.
Kathleen: Well we can’t keep – the second sentence says for example, “Conditions of participation.”
Man: No, no, I am talking about the last sentence under the applicability. There are three sentences. The second one says, “Privatization should be uniform across all forms.” That’s fine.
Man: Which paragraph.
Man: It’s the last sentence it says, “Having uniform regulations apply to all medical records would simply the burden for covered entities to comply with.” I think that is the one that was raised as the trouble.
Man: You think that sentence is untrue?
Kathleen: Maybe it’s the problem, I don’t think that is the problem sentence. The problem is in the next paragraph and it is the actually phrase in the second line “to achieve uniform regulations.” That’s the only problem that phrase. It is the second paragraph that we are looking at.
Man: Oh, then never mind. Sorry.
Kathleen: So that is the question and whether we want to make a change in the second paragraph in concert with some of Bill’s discussion or if we wanted to leave it as it is currently written.
Jeff: This is Jeff. It sounds like there really is not a difference in our will or intent, …… it is just the semantics of the wording. There may be other issues that are in this report during the time we have to review it, which really deal with substance. So I would suggest that if it’s not a substantive(?) change that we go on to something that is.
Man: Well since I brought it up, I can accept that.
Kathleen: Okay then, I think we should take a vote as the committee to make sure that we have this on record. Can we just have everybody’s vote as to whether …….leaving it as.
Woman: You want votes from the subcommittee members?
Kathleen: No, all committee members.
Woman: Okay.
Woman: You want me to call the role?
Kathleen: Yes.
Woman: Jeff Blair?
Jeff Blair: I vote to retain it as is.
Woman: Kathleen Frawley.
Kathleen Frawley: Retain.
Woman: Dan Freeman?
Dan Friedman: Retain.
Woman: Bob Gellman?
Bob Gellman: Retain.
Woman: Richard Harding?
Richard Harding: Pardon me. I’m sorry, I am not clear on what we are voting on so for the time being I am going to abstain.
Woman: I think the vote is just to leave the language the way it is.
Richard Harding: Or what? Or remove that sentence?
Man: Yes.
Richard Harding: I vote to remove the sentence.
Woman: Lisa Iezzoni?
Lisa Iezzoni: Retain it.
Woman: Paul Newcheck?
Paul Newcheck: Retain.
Woman: Andy Kramer?
Andy Kramer: ______
Woman: Clem McDonald?
Clem McDonald: I am going to abstain.
Woman: Barbara Starfield?
Barbara Starfield: Retain.
Man: Marjorie, do you vote too?
Marjorie: No I can’t vote, this is just members. Someone is trying to take this room away from us; that is what I was doing.
Kathleen: Marjorie, according to what I am showing, it passes that we leave it as is.
Marjorie: Okay. So I think that is what we had got too. So you might just want to move along then.
Kathleen: Okay, the next section of the letter is definitions. There are –
Linda Sanchez: This is Linda Sanchez from Asby. I just had a clarification suggestion. The first paragraph discusses health information and reading it, I think you are actually referring to individual(?) identifiable health information, which is the information covered by this regulation. Health information is a defined term, but it is broader than what is actually covered in this reg. I am wondering if you want to clarify which term you are actually commenting on?
Jeff Blair: This is Jeff, I agree.
Man: So we should call that protective health information?
Man: I think patient identifiable health care information.
Man: Individually identifiable or –
Man: Well we have definitions, the regs have definitions in them.
Woman: Right, right. The protected information in the reg is defined as protected health information, which is the subset as individual identifiable health information held by the entities covered by _____ basically.
Jeff: This is Jeff. Kathleen, I think is probably more familiar with this document then anyone else and to be consistent with wording that may be used elsewhere, Kathleen, what would you suggest to include this concept?
Kathleen: We should probably be using protected health information.
Jeff: Okay, could I move that we add that like that phrase to this sentence?
Kathleen: Does somebody want to second that?
Man: I’ll second that.
Kathleen: Marjorie, do you want to take the role so we can vote on that?
Man: Do we have to do it by role or can we just ask?
Marjorie: If there is anybody who is opposed.
Woman: All right, why don’t we do it that way. I just want to make sure that we are formal enough. Are we voting on putting it in only in one place or every place?
Woman: Into this definition.
Woman: Just in that first paragraph, the one place in the second sentence.
Man: Well there is more places where it would apply, I think.
Woman: Start off with the definition or protected health information raises serious problems outside the treatment of payment process, and then it goes in again in that first paragraph there are several references to health information. We would be using the word “protected” in front of it.
Woman: It also comes up on the second paragraph.
Woman: Okay, thank you.
Man: Could we phrase the motion then to, the phrase should be added in the definition and all other places where the subcommittee chair, Kathleen Frawley, feels that it should be appropriately added for consistency.
Man: Could I make a slightly different suggestion here, that if we agree to a change in this thing that we give Kathleen Frawley the authority to make technical and conforming changes to make it all consistent instead of piece by piece?
Replies: Absolutely.
Man: I second your motion.
Man: So now lets call the question.
Kathleen: Yes, I guess that the easiest thing to do. Is there anyone opposed to that?
Man: No.
Man: I just want to say that I am not sure that it is right. But I can’t argue at the moment why it is not, because there is so many different definitions of different flavors of health information, all of which are nested on the previous one, that it probably doesn’t make any difference where you start.
Man: So that passed.
Kathleen: Okay, the next definition on that page is the definition of health plan. Any comments there?
Man: Well are we finished with paragraph or are we going to go back over any of it?
Linda: I actually had another clarifying question.
Kathleen: Okay, fine, Linda.
Linda: In the first paragraph the question, which is a good one in the second half of the paragraph, it sort of implies that they would actually – these life insurers or employers would be covered by these rules. I just wanted to point out that only health plans, specific providers, and clearinghouses create health information. These other organizations could only be subject to the rules if they were a business partner or business partner of these groups or were themselves, for instance, a provider or a health plan.
Man: Well what does this effect the contents of?
Linda: Well in the first paragraph and the second paragraph it is not clear to me what the point is. For instance, how can they tell one’s personal health information? I mean if they got it from a doctor - if they got it from a covered provider then it might in fact be protected health information. If they didn’t get it from a covered provider, a covered entity, and they are not a covered entity, then by definition they are outside the rule.
Man: Yes, except that is not what the regs say. It gives you a very broad definition of what constitutes health information.
Linda: Right, but health information isn’t actually covered by the rule, it is protected health information.
Man: Right, but when you get information that is protected health information and you already have the information in another context and in another way, you can tell what’s what. An employer may have information that pertains broadly to the health to somebody. The definitions don’t necessarily work in the real world because an employer may have a file that contains information collected during an application for employment and during other activities at work. Then a health plan comes in, gets put in the same file, does this flow upstream? Does all this information now get covered?
Linda: I was letting you know that I actually read that in that paragraph. I didn’t get that point in that paragraph, so you might want to clarify that, if that is what you are trying to suggest.
Man: And then the last thing again, in that paragraph it is used as general issue that again cam from Bill Breaf’s comments which we have some of these editorial comments about what the rules should do and maybe they couldn’t. Are we comfortable? Those who read his comments and I thought they were persuasive, but maybe no one else did. We just going to tangle this all up if have these side issues coming up when they didn’t have the authority in the rules to do other things.
Man: I want to make a couple of comments on that. First of all the secretary has plenty authority to do plenty of things. Just because she hasn’t exercised it in these regs doesn’t mean doesn’t mean that she doesn’t have more authority than the ______. Second of all, however, on this whole point of definition of information, Bill and I have had a couple of rounds on this. We haven’t quite satisfied one another about what exactly what we’re saying here. This is an extremely confusing delicate difficult issue to try and deal with. We’re never going to be able to beat it out over the phone in this kind of a call. I am not sure we could do it if we spent a couple of hours at it in a room. Anyway, this is just inherently very complicated. There is at least some confusion about what the language means or what the proposed comment means. It maybe that this is a point that is too messy and not well enough articulated to be included here. So if people are uncomfortable with it and it is not as clear as it ought to be, we aren’t going to fix it. I think the only practically alternative at this point is to leave it out. I am not necessarily saying I would prefer to leave it, but I don’t think it is an irrational choice.
Man: Well what are our choices? Can a subcommittee go back and kind of make it clearer or is it just that we leave it out or we keep it in?
Man: What is “it?”
Man: …………. I mean I agree with Bob, there is a lot of confusing parts in the regulation that it is hard to even to make clear comments about it because it is hard to pick a target. So if this is a deep confusion of the regulations then it would be important to clarify the confusion, to ask for clarification. Do we have a mechanism besides just deciding today to deal with some of the paragraphs?
Woman: Well actually the purpose of the call today is try and resolve as many things as we can so that I can make the final revisions because this letter is due by February 17, 2000. So we are really under the wire at this point.
Man: Then I think what Bob had suggested or hinted, we should take it out.
Woman: How many paragraphs are you talking about removing, I guess that is what is unclear to me.
Man: An alternative might be if you can define what it is that you find difficult to understand in a phrase and just ask to have it more clearly expressed, perhaps. If we can’t get to the bottom of the confusion in the allotted amount of time, at least find a way to express that confusion and suggest that it would be clarified.
Bob Gellman: This is Bob Gellman. I don’t this that is a terrible idea. If Kathleen would be willing, maybe she could take - I think the paragraph that we’re tripping ver is the second paragraph under definitions we talked about earlier. Maybe just do something along the lines like Bill said. There is a lot of confusion in the definitions and they need to be clarified in some fashion and leave it go at that.
Woman: Okay.
Man: I support that.
Man: I support it, too.
Kathleen: Is everybody happy with that?
Man: Yes.
Kathleen: Okay. Can we move to the definition of health plan?
Woman: I do want to clarify on the question at the body, the definition of health plan paragraph, you read through an interesting question here from the perspective of the provider who has information and doesn’t know who is going to pay for it in the end. The information that they have is still protected no matter who ends up paying for it. The question is, when they send the information to a payer, does the information the payer have protection. From the providers’ end, if they are a covered entity, it is in fact protected.
Man: So what is the bottom line?
Woman: Well the answer is will information be subject to the privacy on the interim? Well the answer would be yes when it is held by a covered entity.
Man: Of if it is passed from a covered entity. Are both of those true?
Woman: It depends who it passes to.
Man: We don’t know if someone is necessarily a covered entity or not until we figure out what policy is paying for the health care.
Woman: Right, so if covered entity has the information it is covered, in terms of that interim statement. If you were talking about their provider of health care, the information the provider has is covered. If it is hanging around in an insurance company, it depends upon what site of insurance company it is in.
Man: That’s the point of this comment, I think that it should be.
Man: Right, that is the point.
Woman: Well the last part is a little confusing, how will covered entities or others know?
Man: I think this identifies a problem that we should keep in. No?
Man: Well let me try and clarify and see if that fits the bill for anyone. If you send the information to anyone for the purposes other than treatment and payment, then you have got to have essentially a contract that says that you will protect the information. If you send it to a payer who is not a covered entity, such as an automobile insurance company, then you are allowed to do that without the patient’s permission under the way the rule is written, but the organization that gets it is not a covered entity. So they are not under the rule to protect it.
Man: Wait a minute. If you are sending something for payment to someone who isn’t a covered entity, that can be done without patient consent?
Woman: It is a regulatory consent concept. If the individual gives you a card saying this is my auto insurance, send the bill here. The implication is, somewhat the same way you all described in your credit card financial comments, the implication is that there are providing consent for you to send the information for payment. They had provided the insurance to you for payment, there is an implied consent.
Man: Well it seemed to me that – and I am not sure about this. This requires reading entrails of the draft regs, but the assumption that you can disclose information without expressed consent for treatment and payment is based on the assumption that people who are providing treatment and payment are covered entities and so that the patient is really not significantly losing rights, because the information remains under the scope of the bill. Now you are arguing that if you are giving the information to some third party to pay that that’s okay without expressed patient consent. That seems to me to be another matter and a rather complex one to deal with. There may be other circumstances like this where someone may come forward, being willing to pay a bill, just to get a copy of a record.
Man: I think as a committee member, I think there is a problem identified in this paragraph that the regs have to wrestle with. I would suggest that we move on, and leave this as is, unless someone has some great ideas about to make it just perfect in a fast time frame.
Kathleen: Clem has made a motion to keep it as is. Somebody wants to second it?
Man: I’ll second it.
Kathleen: Okay. Marjorie, do you want to take just the role so we can vote?
Marjorie: Okay. Jeff Blair?
Jeff Blair: Yes.
Marjorie: Kathleen Frawley?
Kathleen Frawley: Yes.
Marjorie: Dan Friedman?
Dan Friedman: Yes.
Marjorie: Bob Gellman?
Bob Gellman: Yes.
Marjorie: Richard Harding?
Richard Harding: Yes.
Marjorie: Lisa Iezzoni?
Lisa Iezzoni: Yes.
Marjorie: Andy Kramer?
Andy Kramer: Yes.
Marjorie: Clem McDonald?
Clem McDonald: Yes.
Marjorie: Paul Newcheck?
Paul Newcheck: Yes.
Marjorie: Barbara Starfield?
Barbara Starfield: Yes.
Kathleen Frawley: Okay, thank you. So that passes unanimously. Okay, the next term is worker’s compensation. I don’t know if anyone has any changes to that?
Man: No.
Kathleen Frawley: Okay, hearing none, then the next one is the Definition Of Designated Record Set. Hearing none, I am going to move on to the next one.
Man: Well actually I am not against it. I am not in any opposition. I don’t quite understand it. Does anyone else understand it. We’re referring to acts and things that I don’t have any idea what they say.
Man: what is the retrieved in fact?
Bob Gellman: This is Bob Gellman. Under the Privacy Act, records that are of federal government records are only covered by the law if they are in fact retrieved by individual identifier. An agency can have two identical files that contain the same information, organized in the same way. If the agency actually, factually retrieves information by individual identifier from one file, it is covered by the privacy act. If the agency does not retrieve information from the other file, even though it is identical, it is not covered. The distinction is a remnant of the era of purely paper records. It doesn’t make any sense anymore. What happened I believe here, is that the department was scratching to solve a different kind of a problem and they couldn’t see beyond this discredited(?) idea in the privacy act to deal with it. So they stuck it in here. I think the point of the comment is that this is the long way to go about it. We shouldn’t take a failed idea from the Privacy Act that has been criticized for 20 years as unworkable and stick it in these new regs. That is the basic point here. Does that help?
Woman: I will be having suggestions on how to define it differently.
Man: Well let me comment. For a different reason, I had problems with the definitions of the data set to be causing a …………, but the problem I had was that I don’t know how to take it out without breaking the whole thing. So I didn’t comment on that as strongly. It seems to have some rationale, but maybe the thing to do is to say that it should be reviewed or revisited.
Man: I think the real problems here is that if you look at a hospital, it has got a lot of records, many of which are duplicative of other records. Some of which may be things like backup tapes. So if I come along as a patient and say that I want access to all my records and I want every copy of the same record that appears everywhere including on the backup tapes. In theory that could present a real significant administrative problem. The solution here is not to use this crazy concept which doesn’t work but to say that certain kinds of records that are duplicative or backup copies of records or something are simply not covered and to leave them out in certain ways. But to do it this way in this notion of retrieved in fact is absolutely meaningless in a computerized view. It simply doesn’t work. It will just sow confusion. If you want to rewrite this to simply say the concept is troubled and leave out some of the detail, it doesn’t matter, because that is in fact the point here.
Man: Well I agree with you. The concept is troubled.
Woman: It would be helpful if you provided an alternative approach.
Man: Bob actually did provide an alternative in some of his comments, but they weren’t included in the committee’s document(?).
Woman: But we have them on-
Man: We have.
Man: We have it.
Woman: Great, okay.
John Lumpkin: Hi this is John. I am finally here. What’s up?
Kathleen Frawley: We’re under the definition section.
John Lumpkin: I was afraid of that.
Kathleen Frawley: We’re discussing the definition of designated record sets, which would be on your third page of your document and that is where we are right now. So do we want to make any changes to this paragraph?
Man: I thought we were going to make it simple and say some of it us has problems and it should be revisited. The definition is hard to operationalize. There is no question about it. I don’t know if it is operationalizable. But you need some distinction and I guess that is the issue.
Man: Well Clem, one of Bob’s suggestions was to allow the covered entity to make their own decisions and to exempt duplicate records not directly used to make decisions about individuals.
Man: I like that!
Man: Actually, that is correct with one amendment, that it is not the covered entity that decides that, the rule decides that. The rule should exclude those from certain provisions of – you can’t just exclude those records entirely from the scope of the act, because then those records could be sold on the street. But they can be exempted for example if the concern is that those records would be the subject of access requests by individuals, you can exempt those from not accessing correction rights. If there are other provisions, you have to go through all the regs piece by piece and see. You can’t just do something very broadly.
Man: Yes, I think that is the essence of the issue and the reason this designated record set concept even came up.
Man: Yes. I mean there is –
Man: Saying for that thing.
Man: Yes, there is a problem here and the point is that the solution that you have is not a good solution. That’s really the point.
Man: Well I think it sounds like we agree that there should be a discrimination between two categories of records and are having trouble naming the distinctions or listing them exhaustively.
Man: Is this something where Bob could work with Kathleen to modify the wording?
Woman: But we don’t have a recommendation in this paragraph which is I think the problem we are having trying to deal with it. We say something is wrong but we don’t say what should be done about it.
Woman: Well I think what we are saying is that this definition needs to be revisited.
Man: Why don’t we just say that?
Woman: That’s right.
Woman: I think that is what I had heard from the discussion and that’s the notes that I have made here.
Man: Bob, could you live with that?
Bob: Yes, sure.
Man: Okay.
Kathleen Frawley: Okay, hearing no objection from anyone, we’re going to move on to the definition of individual.
Man: Good.
Kathleen Frawley: And this has to do with foreign military and foreign diplomatic personnel and their dependents who are excluded from the rule.
Man: This is put in with some deliberateness and granted it wasn’t explained. There is probably a reason.
Man: Yes, I will tell you what the reason is, but of course I don’t know this for a fact. The state department doesn’t want to be bothered, DAD doesn’t want to be bothered with having to comply with these rules with respect to this class of people. The result is that they are totally unprotected and if you are a provider who happen to be treating a diplomat, you can publish his damn records in the New York Times and you don’t violate rules. That absolutely makes no sense whatsoever. If there are problems in implementing these rules, for these kinds of personnel, whoever wants to exempt them needs to come forward and explain exactly what they are. But these flood brush exemptions for anything that any other agency in town who want to be exempt from the rules that the secretary rolled over and played dead for, are mistakes. This is number one on the list.
Man: Well we really are asking, what is the corrective action? To take it out or to ask them to give specific justification ______?
Man: ____ said the answer would be to either to take it out or narrow it to a specific problem that needs to be addressed.
Man: Okay, should we say that?
Kathleen Frawley: Why don’t I put that it is a specific problem that needs to be addressed?
Man: Are you all right with that, Bob?
Bob: Yes. I will speak up if I hear something that I don’t like.
Man: I had thought so.
Woman: He is not shy.
Kathleen Frawley: Okay, the next term is Research Information Unrelated To Treatment. This is the one that we on several conference calls that we have had concerns about that the term is not clear.
Man: Well I forget what this is used for but I thought there were a couple distinctions made that were unnecessary. They are fully defined and unnecessary about research information.
Andy: This is Andy. I think this is an unnecessary distinction and I think we could stop to the point of saying that the recognition of two separate categories of research information is confusing and troublesome. I don’t even think that the idea that this category of research that they have made it doesn’t …….. oversighted seems strange to me as well because …….. going to. So I think the recommendation ought to be more clearly just stopped at the distinction. I mean I realize that we have given the out of qualifying.
Kathleen Frawley: So what you are recommending, Andy, is that they drop the term?
Andy: Yes, just to have research.
Kathleen Frawley: Except that they have a separate section in the Federal Register, Bill or Linda or Jim, isn’t there a separate section on research information unrelated to treatment.
Linda: Yes, the intent of the provision, and I in no way disagree that it is, it could be much more clearer. But the idea here was that there is certain information that can be gained in the research context, but actually could be very harmful to the individual if it got back to the payer for instance. There could be some sort of diagnostic test or genetic test run on them that has absolutely no validity, but could end up in the hands of the payer, both of which could end up having to be redlined. The idea was that there needed to be a way to distinguish this from regular information in the medical record that might be appropriate for a payer to know.
Man: Well if you wanted to say the payer –
Linda: For protection for this particular information.
Man: That’s an issue of the type of information, not the issue of the type of research. That same information could be collecting a very valid IRB approved study that was ultimately going to lead to great…….. I understand the point that you are making that research is some kind of information that is collected that is non-threatening and non-problematic and other types that is a much bigger risk and that might be worth …….making. I just don’t know –
Woman: I think there is actually some confusion as to – it is interesting to hear that people think that this information would not have to be gleaned under an IRB or some other approach. This is information that is created as a result of research, whether the research was approved through an IRB or was selected through an individuals consent, was not seen as being at issue.
Man: Well you were making a distinction not just for paying, but across the board. I thought it would be extremely burdensome to have to decide under regulatory threat about whether a particular item of information was highly reliable was research and experimental, was good or bad, because it changes by day as the papers come in. It is sort of off recommended FDA treatment. I don’t think that it is doable. I think don’t think there is a current problem. People don't put in 500 page questionnaires into the chart just to stuff them in there. I would say that the organization should be cognizant of what information should go on a chart. Use their own usually good judgement.
Man: And I wonder if the requirements for the disclosure of the minimum amount necessary wouldn’t address or solve this problem in a sense that if you have information that the payer doesn’t need to see, then you shouldn’t disclose it to the payer.
Man: And it might be worth making that point very, very clearly …… research information.
Man: But this is the distinction, the distinction was between really routine data that everyone uses routinely and stuff that may be kind of new and leading edge. I think the border there is going to be impossible to manage. I think we should leave something to the good judgements of our organizations and people who care about these things.
Man: Well I would agree with you that that provision needs to be in there with respect to research information that is past on in any way after meet those minimum and necessary criteria. I just don’t there is any reason to distinguish categories of research for that purpose, because all research is up at those …….
Man: I agree.
Man: I don’t disagree with that at all.
Man: I would move that remove – we argued to remove this distinction about research categories from the regulations.
Kathleen Frawley: So Clem, you are suggestion is to remove this paragraph.
Clem: No our paragraph. The distinction they make in the regulations and the consequences of those distinctions.
Man: We’re strengthening our paragraph so that it says unequivocally this is a distinction that is not useful, can not be made, and that all research ought to be …………
Man: And that would come under, instead of their need for more explanation, we would make a positive statement that we should eliminate –
Man: That distinction.
Man: And treat it all the same.
Man: I second your motion, Clem.
Kathleen Frawley: Okay. All in favor?
Kathy: Aye, this is Kathy by the way, I am on.
Kathleen Frawley: Okay great.
Man: Marjorie, are you calling the names?
Marjorie: Okay, do you want to repeat what you are voting on here?
Man: Clem, why don’t you repeat the motion.
Clem: Well actually I am not sure I am the one that said it best, I don’t know how to do the words missing, so Kathy you got the words message.
Kathleen Frawley: I am not concerned about that. I have got a few notes down.
Man: We basically want to suggest that they remove the distinctions made in category research and the consequent behaviors related to those distinctions that they are requiring.
Man: If I could facilitate the process, is there anyone opposed? Let’s put that in and then we take the main motion, we can do a role call.
Man: Okay.
Andy: This is Andy. I had one more issue on the research definition. Later in the document they ask for any help we can give clarifying the distinction between research and health operations. It comes up as an aside later on, those are two definitions in there. It seems to me, I don’t know where we would want to do it, but it seems to me that we may want to give them at least a line of clarification as to what that distinction might be. In particular I could even suggest that wording but it’s where they talk about health care operations. It is under definition thirteen(?) they have conducting quality assessment and improvement activities. I think that definition could say something like “for the purpose of reviewing your individual for specific providers, there is evidence that it is individual and specific providers is part of health care operations as opposed to hypothesis testing research under the research area. Because it seems like they do struggle with that. I don’t know where you would want to bring that up. That is an earlier definition, that definition being that it is a distinction between that and research that they had wanted help with.
Man: Well I think we best hold that to the place where it sits, because Kathy will – unless it fits here.
Andy: Well yes, I didn’t know where it went. I didn’t know if would also go in this paragraph under the research definition. That is why. If another definition that occurred before all these others, but I don’t know that there is enough to say about it other than that is a clarification.
Kathleen Frawley: Okay. John Lumpkin?
John Lumpkin: Yes.
Kathleen Frawley: John, I am going to turn it over to you to chair now, because we had voted that I would chair until you came on the call. So we are at disease management, now.
John Lumpkin: Okay. Thank you. The governor gave a wonderful speech, if I were to say so myself. Anything under disease management and I just want to point out that we’re and hour into the scheduled call and hour into our document, so we will need to try to focus our discussion.
Woman: Another clarification, is this definition in the proposed rule, I can not recall?
Man: No it is not. This is somebody else’s definition.
Woman: Okay, well then why do we want to address it here?
Linda Sanchez: This is Linda Sanchez from Asby. As the person who is actually going to have to come up with the definition of disease management, I want to put in a special breed(?) that people give me suggested definitions. Because we do say at the end of the definition of treatment that it includes disease management. It is clear we’re going to be ____ define that term. I know what people don’t like. I have yet to figure out what people do like.
Man: Well let me give you the suggestion that you do not want to define disease management. You want to define certain kind of activities that should be prohibited as disease management. That would be much easier to do.
Woman: I agree completely with that.
Woman: Yes.
Man: So we’re all happy with this? We can go on to page four?
Woman: No, no, that does require some change. We should recommend that we do not adopt a definition of disease management. We need to say that.
Woman: We say in the last sentence that we do not recommend the adoption of this definition in the regulations.
Woman: Well, but that suggests that it is –
Man: That is weaker than what Bob is saying. Why don’t we say what Bob had said? Will you repeat that Bob?
Man: Do we need to identify disease management functions?
Bob: You should identify activities that might be called disease management that should be prohibited. But I don’t think we are going to have time to start listing them, but just to make a suggestion that rather than defining disease management, to prohibit certain kinds of offensive uses and disclosures of information.
Kathleen Frawley: Okay, I have it. Are we ready to move?
Man: Okay.
Man: Okay, we’re moving into the next section, which is Treatment, Payment, And Health Care Operations.
Woman: Okay, I have a suggestion. In the third paragraph the first two sentences in the third paragraph really belong with the second paragraph. I had a hard time understanding it until I realized that would clarify it.
Man: Can you say that once more?
Woman: Okay. The first two sentences of the third paragraph which starts, “Some and CVHS members” should be part of the second paragraph because it relates specifically to what’s in the second paragraph.
Man: Well I have a stronger suggestion. This came from one of our members. I thought that we had voted that this wasn’t – it confounds what we are trying to say here. I thought that the consensus was that everyone – well the issue really is tying whether we want to have statutory or not statutory. There is a variant in that and whether we could still allow them to get consent even if there was statutory authority. But this paragraph is just one argument for one of the positions rather than being the position.
Woman: Which paragraph, the third one?
Man: The middle one.
Woman: The third one.
Man: No, I am sorry. The second one.
Woman: Additionally.
Man: Yes, that is a specific item that was of concern to one our members, and it was and it is, but I think it distracts from what the theme was. Almost all the members were in favor of statutory authorization when we voted on a smaller committee meeting. Some members were concerned about the prohibition of getting consent as well. There are other things that have been done and I know other members were concerned about not having someone have escapes where they could do something differently. So it is a complex subject, but I don’t think this particular paragraph is focusing on what the issues were.
Man: Well you are proposing just eliminating the second paragraph.
Man: Yes, not that it is not a correct point, but just –
Man: Right.
Man: Is the individual that suggested this point available on the call? Does anyone want to speak up for paragraph two?
Woman: I know Simon was concerned.
Man: Simon didn’t bring it up though.
Man: Was he concerned about the wording in paragraph two or was he more concerned about the discussion that starts off paragraph three?
Woman: He actually gave me some language for this section.
Man: This didn’t come from him. It came from one of the members that is not on the call. He had spoke it up.
Woman: Actually Simon had sent me an email for this section and I am trying to – I don’t have it in front of me.
Man: Well I think the bigger efforts in those disagreement then we should get them clear on the bigger thematic things, not the specific example.
Man: Okay, so anybody going to speak up for it?
Woman: Does this mean eliminating the first two sentences in the third paragraph.
Man: No, no, I think they are different themes. The middle paragraph is just an argument for having a formal consent.
Man: Okay, going, going, gone. Anything else on this section minus the middle paragraph.
Man: Well I almost think we should vote on the numbers who think statutory authorization should be supported to get a better sense of what the weighting was.
Man: Okay.
Man: Now there is a complication because the specs say two things. They say you have statutory authorization and they also say you may not obtain a signature.
Man: Anyone who is – call out your name if you are for – if you want to not – I am trying to understand it so I can put this clearly. We have got the two issues. The issue of statutory authorization versus conform(?) consent.
Man: Yes.
Man: Okay, do we want to weigh in on one of the others or leave the language the way it is. Is there anyone who wants to change the language other than Clem?
Woman: Are we talking about the first paragraph or the second?
Man: First.
Man: First.
Man: Second is gone.
Man: Anybody want to change that language just to note that there may be some difference of opinion. Anybody else jumping in on that? So if it is okay, we will just leave it the way it is.
Man: Okay.
Man: Anything else on this section?
Man: Well the last part of the second paragraph or the third paragraph really is the same argument about research data. It doesn’t relate to informed consent. It doesn’t refer to this big thing. The line between clinical, meaning experimental data, I wrote that, or I had submitted a comment on that. It falls under the issue of distinguishing the levels of experiments and research data.
Man: Are you proposing deleting that?
Man: Yes.
Man: Yes.
Man: Deleting what?
Man: Where it starts with – the section on special handling of information collected for research purposes is heavy handed. It really is to the question of the distinction of research data. It isn’t to this question.
Man: You would delete everything following that section.
Man: It is great prose, but yes, I would.
Man: Then I think for stylistic things, we’ll just move those two sentences above in to the first paragraph.
Man: Okay.
Man: Anybody opposed to doing that? Okay. Minimum necessary?
Bob Gellman: This is Bob Gellman. I have a problem with the second paragraph saying public health requests should be exempted from this requirement. The notion of public health requests could cover a multitude of activities. I think that if there is an issue here, just because you are a public health person, doesn’t mean that you should have a right to get access to records that you don’t need. If we need to say, and this may not be a relevant point, that public health requests have to be judged in light of the purpose. If you are doing some kind broad based tracking down of an epidemic or something and you don’t know what you are looking for and you need to have access to a lot of records until you figure it out, that is perfectly reasonable. But to simply say that anyone who has got the name public health in their function can get any record that they want without regard to this is much too broad of an exemption.
Man: Well I kind of pushed on some this. The push comes not from being exempted from paying attention to the _____, it is the specific and very intense requirements of the minimum necessary specified by the regs which does apply to public health. This means that every – it says that you can not do it as broad policy. You have got to do it case by case. Well how do you deal with the daily positive results that you have to send out for regulatory reasons about communicable disease? It just didn’t make sense that could be intended to be true.
Man: Well I think there are clearly are some problems with the minimum necessary principle in operation. I think that the department has to do a better job in explaining on how this will work in a variety of circumstances and in some circumstances, a minimum necessary may be defined fairly narrowly and in other circumstances it may be defined broadly. But I think to simply say “public health” which is not –
Man: Well the words that I had used in my letter was to be exempted from the flow of the intense minimum necessary requirements as specified in the –
Man: Maybe if I could suggest a language that would embody both which is that public health requests sometimes require a broad range information to enable epidemiological investigation.
Man: Well it is the ongoing requirements that –
Man: In addition there are ongoing requirements, therefore this rule should allow these requests to be performed.
Man: What if they should not unduly interfere with these requests?
Linda Sanchez: This is Linda Sanchez again. It sounds like your concern is the requirement for individual review of every –
Man: Yes, yes.
Linda Sanchez: You may want to explicitly say that that is the problem that you are trying to fix.
Man: That is the problem I am trying to fix.
Linda Sanchez: That would be helpful to us to know what is the problem.
Man: Well the form(?) and necessary now with that one set of paragraph that says, “each and every instance of a request must be applied some twelve or fifteen criteria.” This is impossible! It is death! So I don’t think we just need to push on the edges on it for a lot of things. The last paragraph would satisfy some of these, a lot, if it is acceptable.
Man: But if we can go back to that, then what we should say, instead of saying that they should be exempted –
Man: Well they would be exempted from that specific – yes, okay, say what you – yes go ahead.
Man: All data needs are often – what is a good word to use –“routine.”
Man: Recurring or routine.
Man: And may require a broader amount of information to facilitate the epidemiological investigation, therefore rules should not unduly hamper investigation like in a positive statement what we don’t want to occur.
Man: But it would be easier to kill that one part of minimum necessary because it applies across all kinds of things like this, including patient care as it is currently written. So every time you want to do a computer lookup, you got to go through this process.
Man: I agree that there are a lot of practical problems here, but I don’t wasn’t to walk away from the concept. I want to find a better way of implement it.
Man: But in terms of every instance reoccurring(?), that could be applied to certain categories of one time requests but it just is not feasible. I think that should be changed and then the whole thing becomes much more manageable.
Man: I am a little bit confused just by the terminology, “public health requests.” Are we talking to the mandated recording?
Man: Yes.
Man: I wonder who had spoke up from the government side about the “H”(?) instance. Could you restate that? Maybe we could get an agreement to soften that?
Woman: My interpretation of what you all were talking about was that you are responding to not only the fact that there are a lot of assessments to be made, but the specific requirement discussed on page 599.45. That requirement says, “In addition, the procedures would provide that the covered entity will review each request for disclosure, individually on its own merit and for research the documentation if required are IRB or other approval. Covered entities should not have general policies approving of all requests or all requests of a particular type. These disclosures are used that carefully considering the factors identified above as well as other information specific to the request that the entity(?) finds important to the decision.”
Man: Yes, that thing makes sense for individual research requests but it doesn’t make sense for the public health weekly – you know, the twenty-four hour delivery requirements to send out communicable disease information or patient care or operations or any of them. See that is –
Man: I agree. It certainly doesn’t make sense for mandating public health reporting work. It is not a request. It is a requirement.
Man: Right, but I think that Gellman’s point, which I think is legitimate is that while there is a public health purpose to get a report, or a registry form completed, there should be some review for everything.
Man: Each time is the requirement, each time they ask for it.
Man: But really we’re saying that hones(?) in public health to get off loaded to their responsibility should be on the public health entity, that it undergoes a minimum necessary review before the reporting requirements apply upon reporting entity.
Man: But the regs can’t cover that.
Man: If you are right, if you are disclosing on a regular basis communicable diseases to the public health department, there is going to be a standardized, there already is, to be sure, a standardized methodology on the scope of information. But the rule says is that you can’t send 500 pages of medical records when all you have to do is say this person has STD.
Man: Well the rule doesn’t say that. I would like it if the rule said that.
Man: Well I agree that ___ just needs to do a better job in clarifying how this should be done. But I can tell you that from the experience under the privacy act which has a whole variety of disclosure requirements, not exactly like this, but vaguely comparable. They all get subsumed in the great bureaucratic process. And all of the things that have gone on in the past that are at least practically reasonable continue to go on without everyone looking case by case at each specific report when it is identical to the ones that they just had sent 500 of earlier this year.
Man: I know, but we shouldn’t have regulations say stuff that is nutty.
Man: Well I agree with that.
Man: Do we want to then say that public health reports should be exempted from the case by case review?
Man: Yes.
Man: I am against that. I don’t think there should be any – I don’t know what a public health report is.
Man: Mandated public health reporting.
Man: I don’t know what a mandated public health report is. You have got to be a lot more specific.
Man: …..mandated.
Man: And if you say that it is exempted from the minimum that means that if someone has to report a STD to the state, they can send the entire medical record.
Man: No, no, no, no one is arguing for diminishing the principle of minimum necessary, …… if you can’t do it by a policy or you can do it at once for all the kinds of requests I am objecting to it.
Man: Oh, okay, I don’t disagree with that but to say, I think for this committee which is composed of public health people and researchers, to say that public health should be exempted from something –
Man: Well why don’t we say be exempted from the each instance.
Man: what I had said, and I want you to listen carefully what I was saying. That statutorily mandated public health requests should be exempted from the case by case review. Meaning the minimum is necessary provision. So that means that the first time you get a request from a public health agency, you do the minimum necessary review and then after that, every single other request does not have to go under the case-by-case review.
Man: Well the language you have suggested says the first one is exempted, too.
Man: John?
John: Yes.
Man: The way that I understand what you are saying, you would leave it up to the data providers to decide whether or not a statutory mandated reporting requirement is reasonable.
Man: Well they don’t have any choices.
Man: Well I think that is questionable, I mean I would agree Clem that they don’t have any choice if it is statutorily mandated.
Man: Bob?
Bob: Yes.
Man: Would you have a problem with the language that was there if it said statutorily mandated self requests?
Woman: I hate to throw in another problem, but one comment we have gotten from a lot of public health people is that a lot of times they are used to general authority to request information and public health reporting. They don’t actually have a specific statutory authority to request specific data items. For instance they don’t have statutory that says that you can ask for name, STD diagnosis and one other thing. ….. authority saying that they can get reporting that they use, so if you require a specific statutory authority that may be useful for most public health authorities.
Man: Well I am not sure that their legal – If I authorize(?) and I promulgate rules, the rules carry the weight the statute.
Man: Yes, but if the regulations are statutorily mandated as opposed to legally mandated; that is a difference.
Man: Okay.
Man: Anyway, my objection here is the concept of an exemption. If you have to interpret the minimum necessary rule to facilitate this, I don’t have a problem with that. You know, to talk about facilitating the rule should be interpreted to facilitate the routine reporting of mandatory disclosures, I don’t have a problem with that.
Man: Let us stop there. Anybody have a problem with what Bob had just said?
Man: That is a lot better.
Man: That’s good.
Woman: That’s fine.
Man: But that means they would change that part that says every single one somehow.
Man: That’s fine. That is assumed with what I had just said, whatever it was. But I just don’t want to see “exemption.” That word sets me off.
Man: Okay.
Man: We got it. I think we have language we can live with?
Woman: Yes.
Man: Yes.
Man: Well there is another piece here about the research ones, and I wondered whether they had to do redo the minimum necessary on the RIB(?), when the RIB has to do minimum necessary.
Jeff: This is Jeff. I need to excuse myself from the call.
Man: Whether we couldn’t just require the organizations to verify that they had IRB approval.
Man: I actually object to that last sentence there, further research requests will be deemed and the problem is that the minimum necessary rule applies, even if the IRB has approved the research request, their hospital could say, “Here is an entire file. Go have a good time.” Because the rule doesn’t apply, because an IRB has said something.
Man: But the IRB is supposed to apply minimum necessary, why are we doing it twice?
Man: I know, I understand that. They are but because we’re not applying it twice. The minimum necessary rule applies to the record keeper. The record keeper is not subject to the IRB’s regulatory control. When a researcher walks in and says, “I need these records under this protocol.” They could just say, “Here’s a copy of an entire record,” when they only need one piece of information.
Man: Well they do.
Man: Well I don’t think that is appropriate. Well at least I think an accommodation has to be made but to simply say that the IRB approval means that a record keeper is no longer subject to the notion of at all, minimum necessary concept or some kind of procedure, seems to be going too far.
Man: Well you ask him to set up a privacy board, you ask him to do all these kind of things, and then you saying redo it yourself after you have set it up. I don’t get it. I think this is going to be tremendously burdensome. I think _____ is not going to be equipped to do it. There is going to be a huge amount of work. They are just going to say to forget the research, why screw with it?
Man: But wait a second. Who is the keeper of the record in that hospital setting?
Man: It is the hospital.
Man: Okay. So what you are saying and what Bob is saying is both correct. If they are doing research in an entity where the record keeper itself under IRB review, as opposed to research where you go out in the individual physicians’ offices and have them participate in the research. So I go through and IRB at the University of Chicago and I am collecting cases from people who are working at Little Company of Mary Hospital. That clinicians and their record keeper really have not been under the IRB review and that clinician, even though the people who are doing the research want to have the operative report because they are doing a study on operative cases, yet to simplify things they just give them the whole chart.
Man: John, to tell you the truth, I don’t object to that procedure for research. I object to the notion however of simply saying an IRB review by itself means that the minimum necessary rule applies. If you write a separate rule for researchers and not circumstance to say that it is okay for researcher to get the whole record, as long as they only walk away with the piece they need, that doesn’t bother me. That facilitates the problem of people not being willing to cooperate because the researcher takes on the burden of doing that. That doesn’t bother me.
Man: Okay, so what we need to do is we should just make a statement that the rule should not mandate multiple views of minimum necessary.
Man: I don’t think you can avoid multiple views of minimum necessary.
Man: Well if anyone here has worked on a hospital committee, it is the most conservative, overworked, and busy. The current rules just do nothing because it is too hard. I mean, where is the problem that we are trying to solve here? What horrors have occurred in this context where you have a standing IRB, you got additional requirements from the IRB to assert minimum necessary. The hospital doesn’t know what is necessary for the research. The little office will never know what is necessary for the research. All you are doing is insuring that there is no research on this stuff.
Man: Well I think you have to keep the possibility that the record keeper simply says, “Here is an entire copy of the record. You can go away with the entire record.”
Man: Well I wouldn’t mind saying that, with all thought, you know, they always get over interpreted. There is further deeper interpretation. I am opposed to this doubleness.
Man: I think that – I am not hearing you disagree with Bob and I am not hearing Bob disagree with you. …….. is that the rule needs to be able to enable both.
Woman: John, we’re going to have to wrap up this discussion because it is almost 3:00.
John: Right, that is what I am trying to do.
Woman: Okay.
John: What we should do is to state the problem and that the revised rules should address it.
Man: Okay.
Man: All right, I buy it.
John: Okay, we will add in language if it is agreeable, that says, “The problem is full reviews get in the way.” Something along those lines, we’ll let everybody have a chance to take a look at that, ___ language, and sign off. It has to be done quickly. “Right to restrict,” was there anything else on Minimum Necessary?
Man: There is another paragraph there and I think it at least ought to be exposed.
Man: Can you be more?
Man: No, I like it, but I don’t know if everybody likes it?
Man: We’re not going paragraph by paragraph.
Man: Okay.
John: Okay, right to restrict, anything under that section? Okay. Creation Of The Identified Data? Any problems with that section? Okay. Business Partners?
Man: I have a problem here with the beginning. It says on the one hand, treatment payment and operations are already exempted from many of these requirements. I don’t think that is really true. They are not exempted from the Business Partner Provision. What they are, they are exempted from a requirement for Lotus(?) but they are not – if you are making payment disclosures or operations disclosures, or whatever, to third parties, you need to be subject to the Business Partners.
Man: Okay that is fine. That was my comment.
Woman: So we will take this sentence out.
Man: You can take it out.
Man: Okay?
Woman: It’s two sentences isn’t it?
Man: Yes.
Man: Yes.
Man: Yes.
Man: Any objections to taking out those two sentences? Good. Anything else under Business Partners?
Man: Can non-committee members comment on this?
John: What we are going to do is that after we get done with this, we’ll let you comment. Who was that?
Alex: This is Alex Brittain(?), I had a comment on this section. But I will hold it till the end if that is the protocol.
John: Okay. Is there anything else under this section? Okay. Individual Authorization?
Linda Sanchez: I’m sorry. This is Linda Sanchez on business partners. The very beginning of this discussion, it is actually not true that treatment payment operations are exempted from –
Man: We have already struck those two sentences.
Linda Sanchez: Okay good. Sorry I had missed that.
John: Okay, anything else under that. Okay. Individual –
Linda Sanchez: One more thing. Are you all going to provide some standard language or suggest any? Last paragraph, suggest that the department creates standard language for standard disclosures.
Man: That is a very complex task that this committee isn’t capable of doing.
Linda Sanchez: Okay.
John: Okay, Individual Authorization?
Linda Sanchez: Actually yes, the third paragraph, or actually the second paragraph where you discuss clearinghouse seeking patient authorization. It would be helpful – we’re not aware of that happening at all. It would be helpful to provide an example. This comes from someone’s experience. We’re not aware of a clearinghouse ever seeking patient-
Man: Good, then it will be easy to prohibit it.
Linda Sanchez: But we don’t know what we are prohibiting.
Man: Just what it says, prohibitive clearinghouse from getting patient authorization for marketing disclosures.
Linda Sanchez: But if we don’t know what problem we are trying to fix, we need some justification for it.
Man: You are trying to keep clearinghouses from using patient records for marketing. I think that is perfectly clear.
Linda Sanchez: But clearinghouses do not normally ever interact with an individual.
Man: Well maybe they will just change their mind if they decide they can find a way to sell patient records.
Linda Sanchez: Okay, so there is not an existing problem that you all have samples of ? That was what I was trying to find.
Man: I don’t know of anyone who is doing this, so let’s prohibit it while no one is doing it and no one will object.
Linda Sanchez: All right, that is what I was trying to figure out.
John: Okay, anything else under this? Okay, Health Oversight.
Woman: I guess I have a question on the bottom, the last two sentences. “An exception should be allowed if the action arises out”
Man: I’m sorry –
Woman: I’m sorry, the last paragraph under Health Oversight.
Man: Okay.
Woman: The third sentence from the last, from the end of the paragraph. It says, “An exception should be allowed if the action or an investigation arises out of and relates to a receipt of or payment for health care.” I guess I sort of don’t know what health care is in this context.
Man: Well can I explain the concept here. Basically the idea here is to say if we are giving records over for criminal or for an abuse(?) investigations, we’re basically going to allow that to occur and not withstanding the impact on patient privacy. The protection for patients is that the records that are turned over will not be used against them. However, if there is some kind of activity that the patient is involved with, for example, if the patient is a party to the health care fraud, then it is perfectly okay to use the record against the patient for that purpose, because that is why you have got it. Does that make sense?
Woman: If the patient is part of what?
Man: A health care fraud scheme.
Woman: Fraud scheme.
Man: I mean I have dealt with the prosecutors on this issue for twenty years and they always bring up this example, “Well what if the patient is part of the fraud scheme?” Well the answer is here is your exception. Now you don’t have a problem.
Woman: Well I don’t have any problem with reclamation part of it. It is not clear to me that is what it says. So maybe you could suggest some rewording for it.
Man: Okay.
John: Okay, so we are going to do some minor clarification there?
Man: Yes, I will come up with something.
John: Okay. Is there anything else under Health Oversight? ____ Administrative Proceedings. Okay. Law Enforcement? Okay. _______ Health Data System? Rectory Information? Banking and Payment Process? Research?
Man: I have a problem under Research. The second paragraph says that the justification for the additional requirements beyond existing IRB requirements is hard to understand. I don’t find anything all that unusual, difficult, complicated, or hard to understand about the additional requirements for IRBs. And indeed, this paragraph later on says, “that these new and additional requirements are contained in or implicit to the existing IRB requirements.” If that is true, and I don’t know that it is, but if it is true, then what’s the problem with making it is explicit so that everybody knows what the requirements are and they all comply. There is no great additional burden imposed by the additional specificity here.
Man: I had brought this one up. Maybe the question should be, could we have a reinvestigation of it? It just seems like, it is like I have this strong sense that someone thinks that everybody is the bad guys and we got to just beat them up a couple more times to make sure they are good. That is how it feels. The committees that I am involved with are very, very meticulous about confidentiality and I don’t understand where the problem is that this is coming from. But we have to have new stuff that will have to be reinterpreted and refigured. And almost sounds like you have a political commissar assigned to every one of them. I didn’t go into that because there must be a privacy expert. I don’t know how we identify them on every committee.
Man: Well I mean I don’t have the same perception. I think the IRBs get out of this whole thing pretty much unscathed. Although there are a couple of additional boxes for them to check and issues specified for them to look at, but none of them, as you have said here, none of them are necessarily all that new and they are sort of implicit.
Man: No.
Man: So this isn’t some horrible new requirement and not a great additional burden.
Man: No it is probably not. I won’t push for it if no one else is worried about it. Any other researchers on board?
Woman: Well why don’t some of the proposals be made so that we can react to the proposals.
Woman: Bob, you are recommending that what be deleted?
Bob: Well, I don’t know. I would probably want to delete the second paragraph.
Man: Okay, the whole second paragraph? There is a proposal to delete that. Does anybody have a problem, besides Clem?
Man: Who submitted it.
Man: Right.
Woman: Yes, Clem, why don’t you just basically say why you think the whole thing should be kept or modified?
Clem: Well I have to go through the regs a little more deeply. But they added two or three more recommendations about the items that had to be covered in the IRB thing, in which I really do think they are duplicative in general. In English writing, and in scientific writing, you don’t want duplicates of things because it just creates confusion. Now I don’t know if that is true and would require more investigation. The idea that you had to have an explicitly labeled privacy expert on it, seemed foreign to me in America. The closest thing I came to that was the Russian political commissars in the army. We have these requirements, and personally I don’t know how you identify them. In just seemed a power push rather than a real necessity.
Bob: Well if I can comment on that, there are already requirements for various communities to be represented.
Clem: Yes, and they are all easily distinguishable.
Bob: And there are requirements for example, for different communities to be represented on the membership of NCDHS, too. This is not exactly some new concept. You find this all the time in statutory at least, requirements for establishing committees with various points of view, often specifically denominated in very broad terms, civil liberties, health research, whatever. That these communities be represented. I don’t think it is that hard a thing for somebody to figure out.
Clem: Well if we were working against a problem that we are trying to solve, I could deal with it. But I don’t know what the problem is that we are trying to solve and I think we are creating additional regulatory structure, which only creates problems and pain at the end.
Bob: Well I think that there are problems with IRBs and I think there have been some reviews by Inspector General at HHS and by AGAO that have shown that the confidentiality isn’t that well protected by IRBs. So if there is some additional requirements here of a modest nature to try and push IRBs to do a better job, I think there is justification for it.
Woman: Well I sort of agree with both of you. But I come down, I think on the side of Clem because I have been on IRBs and have seen how they work. Putting new requirements on them isn’t going to make their job any better. I think it is the whole structure – I mean the idea is good, but the structure is flawed.
Bob: Is there somebody there on the staff who could speak to what the new requirements are?
Man: Actually these are requirements that are not now in the common rule. I am trying to find them in the regulatory –
Man: It is three bullets, I think.
Man: Yes, I am trying to find them in ours. Linda, can you …………additional requirements for the IRB.
Linda Sanchez: I have it. Okay, in the regulatory text itself, I will just go over them quickly. The privacy board has to have members with varying background. Have at least one member not affiliated with the entity conducting research, or related to a person who is affiliated with the entity. Some of the conflict issues and the privacy board needs to approve it, i.e. wave informed consent requirements if the following criteria are met, which is that these in disclosure health information involve no more than minimum risk to the subjects. The waiver will not adversely effect the rights and welfare of the subjects. Research …….. be conducted without the waiver. Whenever appropriate the subjects would be provided with additional pertinent information after participation.
Man: That is a new one.
Linda Sanchez: The research could not practicably be conducted without access to and use of the protected health information. The research is of sufficient importance so as to out weight the intrusion of the privacy of the individual whose information is subject to the disclosure.
Man: But those you are not distinguishing the new ones from the old ones.
Linda Sanchez: No, I am just going through them. There is an adequate plan to protect the identifiers from improper use and disclosure. There is an adequate plan to destroy the identifiers at the earliest opportunity, consistent with the conduct of the research, unless there is a health or research justification for retaining the identifiers.
Man: I haven’t heard anything new that strikes me as the least bit –
Clem: No, well there is a place in the document that identifies the new ones that aren’t part of the common rule.
Man: Well Clem, do you have a problem with the rule as she just read it?
Clem: I don’t know if she is reading the parts that have the extra ones.
Nancy Sanchez: I just read all the requirements in the rule.
Clem: You hadn’t mentioned the one about having to have a political, I mean have a person who is identified as a privacy expert on the committee.
Nancy Sanchez: Well that is part of the members of varying backgrounds and appropriate professional competency.
Clem: But that is in addition to the current IRB rules. It is.
Nancy Sanchez: I don’t know.
Bob: Well was the part that you had just read, was that the requirement for the membership, varying backgrounds?
Nancy Sanchez: Privacy board requirements from the rule itself are that it has to have members of varying backgrounds, professional competency as necessary to review the ____ protocol. Include at least one member who is not affiliated with the entity in their research or related to a person who is affiliated with that entity. And does not have any member participating in a review of any project in which the member has a specific interest. Now the preamble language explicates that. It will take me a moment to find that.
Bob: I don’t hear anything in there that says that there has to be a privacy commissar on the committee.
Clem: Right, and we’re not –well I think maybe – what would anyone agree to? I think this can’t be done quickly. We have to find the parts.
Bob: Can I make a suggestion, Clem?
Clem: Yes.
Bob: Do you think you could write a slightly milder mannered version that says that we are concerned without necessarily saying to drop any language or whatever. Just to say, “We’re concerned about overloading IRBs.” Something to that effect and if it is a very general statement, I won’t object to it.
Clem: Okay.
John Lumpkin: Okay? Anybody else? Okay. Anything else under Research? How about Next of Kin? How about Application in Special Classes? Notice of Information Practices? Access for Inspection or Copying?
Man: Well I had some objections to the original letter.
John Lumpkin: Okay.
Clem: Well I am the Lone Ranger in a lot of these things, so maybe I should just quit. I’m too worried about these things. But I think that the regulation that was presented was not like most of the state regulations. I had read some of them. The exception in the California regulation that made it much easier to live with was the fact that you could summarize. You could dictate and summarize the contents at the choice of the place. That is number one. We don’t have any out. The physician doesn’t have any outs. The second thing I am worry about is the thirty day limit, which says you got to rush those data out, even if you worried and you are not sure who the person is who is asking for them.
John Lumpkin: Okay, is there something you want to add or change in the current language?
Clem: No, I can’t – I am sure there is but I can’t do it.
John Lumpkin: Okay. Clem, I think if you come up with something, it would probably be good for you to send it on under separate cover.
Clem: Okay.
John Lumpkin: Okay. Anything else under Access for Inspection of Copy? Accounting of Disclosures? Amendment or Correction? Relationship to State Laws?
Gail Horlick: This is Gail. That should be exempt in the first sentence and the only sentence.
John Lumpkin: Oh, okay.
Kathleen Frawley: This is Kathleen. It is actually the language from the Federal Register and was except.
John Lumpkin: Except? It should be exempt but the Federal Register says “except.”
Kathleen Frawley: Okay. So that’s why I have that language. I was following what they had.
Gail Horlick: Yes, because I was wondering. Okay.
John Lumpkin: Okay, anything else under that? Definition of Protected Health Information?
Woman: I’m sorry. I didn’t realize I had the mute button on. Can we just go back to the Accounting of Disclosures for a minute. Because I think there may be an inconsistency in what we’re saying. I am not sure. But in the second paragraph, we’re basically saying that if you have audit trails that are used for all types of transactions including those that would normally be under Health Care Operations, then you should disclose to the patient who is accessed. When you get to the paragraph at the top of the next paragraph, it is basically saying that the rules should require audit trails for treatment payment and oversight, in the middle of that paragraph. Is that what we are saying? Or are we just saying that if they exist they should be disclosed or that they should be maintained? We have looked at that here and said that if we put in audit trails for every internal access of a record as part of payment, treatment, or otherwise, it unbelievably degrades response time on our systems. It would also make the treatment process far more expensive than it is now, because every time a provider wants to get on to the computerized patient record to make an inquiry, it is going to slow it down.
Bob: Well can I make a couple of comments? First of all, get a faster computer. But more seriously I think that the comment here, and not that it couldn’t be adjusted here and there. But the comment here is rather ambiguous or luke warm in support of audit trails and recognizes some of the problems. What it says in the second paragraph is that this should be applied prospectively if you’re going to do it as opposed to retrospectively, which would be enormously difficult and expensive and cumbersome. That’s why I think the comment is that it shouldn’t be applied to paper records at all, because that would be an incredible unbelievable burden that no one would take up. So I think the point of burden is at least reflected there and if you think it should be reflected more strongly, I certainly wouldn’t object to that. But I think there already is – it is not strong overwhelming support in these paragraphs for audit trails.
Woman: No I was ……….the sentence in the middle of the third paragraph which reads, “ We recommend that the rule require audit trails for treatment, payment, and oversight for computer systems.”
Bob: Well if you want to suggest weakening that a little bit, I wouldn’t object. Do you want to say “consider” or “evaluate.” I don’t know. Whatever or what have you.
Man: Well Chris, I have two minds on this. I mean I think all the medical records reviews, and suggestions, or privacies that for real time access, you need to keep something on a trail. Now there is an issue of how detailed it is. It can make it more expensive/less expensive. These batch runs are another story because it is just a different set of issues. You know all at once who is getting it. So I think we got to encourage these audit trails for real time looks at the patient’s record in computer systems I wouldn’t require it.
Man: But don’t we already recommend? I mean that is part of our security recommendations. We have already recommended that.
Man: Yes. It has a lot to do with what people mean, what they are looking at on the screen, versus whether they have actually probed the patient’s record. There are all kinds of levels that make it harder or worse.
Bob: Well what if we just threw into that sentence the concept of say a practical and cost effective audit trails.
Man: Okay.
Man: All right.
Bob: As a way of recognizing that it is not.
Man: Kathy, does that work for you?
Kathy: If we changed “required” to “encourage.”
Man: I like “encourage” too.
Bob: Okay, I don’t object to that.
John Lumpkin: Okay.
Kathy: And then add the cost effective and practical.
Man: Yes.
Man: So we encourage cost effective and practical audit trails for treatment and so forth.
Bob: Yes.
John Lumpkin: Okay. Anything else under Disclosures? Let’s get back to the definition of Protected Health Information. Any comments under Sincerely?
Man: Well they amended the correction is when it also – I thought the rule was fairly practical in its initial approach to that.
Man: Okay, where are you?
Man: I am back on page 17, now that we have looked at it again.
Man: Where at on 17?
Man: The amendment for correction, in general, we’re recommending that all corrections have to be adopted more or less, and I think that the rules as proposed were more practical as a first pass for what you need to do on these things.
Bob: It doesn’t say that the amended corrections have to be adopted. It says that they have to be considered in good faith.
Man: Okay.
Bob: I mean even I wouldn’t support something that …………
Man: I don’t know how strong of a sentence that is as a legal statement.
Bob: Well the problem here – there is always a problem with corrections, and basically the rule has such a broad exemption for stuff that doesn’t have to be corrected that it makes it a joke. I mean the reg is just a joke on correction. Yes, you can’t really deal with this in some very specific exact way. All you can do is say “good faith.” I mean some phrase like that – if someone has a problem, you have got to make some reasonable effort to consider it. When somebody comes in and says, “No, no, I don’t really have cancer” because they want the record to change for some reason, and the physician says, “That is wrong.” Then that is it. On the other hand if somebody comes in and says, “You have the wrong year in which I was born” and the record keeper says, “We don’t have to fix that because we got it from somebody else.” That’s a little silly. So you have to find something in between. I don’t know another way to do it other than to say consider their request in good faith.
Man: Okay.
John Lumpkin: Okay?
Man: Yes.
John Lumpkin: Okay. Now we have an amended document with a couple of things that will be clarified. We have some people of the public who want to talk about certain issues. Alex, you had identified yourself earlier.
Alex Brittain(?): Okay, thank you very much. My name is Alex Brittain. I am with McKenna and Cuneo(?). I wanted to comment on the Business Partners provision, which at least on the set I have is page five of fourteen, in particular, the last two paragraphs of that section. I just wanted a clarification because I wasn’t quite sure I understood what the committee was referring to. There is a discussion that begins on the second to the last paragraph, beginning “Covered entity ____ second information, many ways to Business Partners.”
Man: Okay, it now reads “covered entities disclosed protected health information to many different business partners” that paragraph?
Alex Brittain: Right and then I wasn’t sure, it appears at one point in time, the committee is suggesting that it is not appropriate to have a business partner agreements, rather there should be exemptions for things such as consultation referral. However, my understanding of the proposed rules is thus far that prior to consultation a referral with regards to transfer among covered entities and not from a covered entity to a business partner. Then there is further discussion in the last paragraph with regard to the suggestion that there should be as many standard disclosures as possible. Again it is hard to make a distinction between disclosures between covered entities and disclosures between covered entities and business partners. From that, I think some confusion can be read into the document by the reader.
Bob: Disclosures between covered entities may be a business partner and it may not be. It depends on what is going on.
Alex Brittain: Well they give an example of a covered entity disclosing to a clearinghouse. That would be a situation where arguably it would be between covered entities provided that it is for or on behalf of the covered entity. Then theoretically I guess two covered entities would have to enter into a business partner agreement. But when you start speaking in terms of let’s identify as many standard disclosures as possible, it raises a couple of questions in my mind such as are we really talking about disclosures between covered entities that we could identify all the disclosures that are possible? Secondly, the recommendation appears to be let’s not have the business partner agreements, but rather let’s have the simple disclosures which would exempt you out of the requirements of business partner agreements. Which then leads to the ultimate question of, do you lose enforcement mechanisms with regard to letting patients be third party beneficiaries?
Bob: Well the point of this language and I come to spend more time reading it over to see if it is clear enough than we have right now, is essentially there are lots of business partner activities that are quite standardized. To expect every person in the health care industry to go to the post office or the Federal Express and negotiate some kind of deal before they throw and envelope into the mail, makes no sense. And as many of these things that can be dealt with in some standardized fashion so that this doesn’t have to happen, then that will simplify the implementation process for everybody. That is the basic point here.
Alex Brittain: Okay, but if I am a provider ……….
John Lumpkin: I think we are not going to have time to get into a debate over this. An issue is raised, if there is a member of committee who would like to propose some change in the language and if not, I would suggest that you would submit your own comments directly to HHS about trying to clarify that section.
Alex Brittain: Fair enough.
John Lumpkin: Okay, other comments by anyone else on the call.
Kathleen Frawley: This is Kathleen. We just need to make arrangements for logistics for the letter in terms of how we are we’re going to proceed now.
John Lumpkin: What’s our deadline now?
Kathleen Frawley: The letter needs to be at HHS February 17. Both Bob and Clem have volunteered to give me some revisions.
John Lumpkin: Well what I would like to do is if we can get those revisions to you, we will consider the letter as you do it as passed. It will be submitted to the committee members and unless – maybe we could do that within four or five days. The committee members will have four or five days to get back to me and unless there is an issue, we will just send it on.
Kathleen Frawley: Okay, well if Bob and Clem could get their material to me by Friday.
Man: I will get it to you today.
Kathleen Frawley: Okay. Clem, if you could get it to me by Friday.
Clem: Sure, Kathy.
Kathleen Frawley: Then that will give me a chance and then I can turn it around over the weekend and Marjorie will have it on Monday.
John Lumpkin: ……. By Kathleen, and second it by Bob that we move to send the letter as modified, as agreed to be modified on to the secretary. Are you willing to second, Bob?
Bob: Yes.
John Lumpkin: Okay, is there any more discussion?
Marjorie: This is Marjorie. John, were you suggesting – on this schedule I would get the letter from Kathleen on the seventh.
John Lumpkin: Right.
Marjorie: Then you want me to send it out to all the members with an opportunity for some to object.
John Lumpkin: Object.
Marjorie: By when, the eleventh?
John Lumpkin: Sure.
Marjorie: And hearing no objections, it will be sent. Right?
Kathleen Frawley: Right.
Marjorie: And if there is any objection, then obviously you will have to deal with how that is dealt with.
John Lumpkin: I will have to make a call and then you can “dis-elect” me or something.
Man: John, you did a good job. We wouldn’t do that. You got us through by 3:30.
John Lumpkin: Okay, all those in favor of sending this _____ signify by saying aye.
Replies: Aye.
John Lumpkin: All those opposed say nay. Are there any extensions? Hearing none, we will do as we have agreed.
Christina Nyquist: John, this is Christina Nyquist. Is there an opportunity for one more public comment.
John Lumpkin: Sure.
Barbara Starfield: I have to get off. This is Barbara. Bye-bye.
Man: Me too, John. Bye.
Christina Nyquist: John, this is Christina Nyquist with the Blue Cross Blue Shield Association. I would just urge your committee to consider that every day an additional implementation issue is raised with me; I am sure with your members as well; to encourage HHS to perhaps build something into the regulations so that when it is issued, it is issued as an interim plan or rule, or in a format so that it can be modified as implementation issues continue to be discovered once people start trying to implement it.
John: Okay. I think that is a fair statement and I hope that you do make that as part of your comments to HHS.
Christina Nyquist: Yes, we will.
Man: John, before we go off. Actually with or without and interim final rule, I think we would could revise the rule.
Kathleen Frawley: Every year.
Man: Every year actually, so either way we would be open to any improvements in the rule, whether it is interim or final.
Christina Nyquist: Great.
John Lumpkin: Great. Do we have any other business? Thank you everyone. This is a very difficult process and I appreciate everyone.
Replies: See you, John. Bye. Thanks!