[This Transcript is Unedited]
MARK ROTHSTEIN: Hello?
JOHN DANAHER (ph): Hey, this is John Danaher (ph).
ROTHSTEIN: Hey John, it's Mark Rothstein?
DANAHER (ph): Hey Mark, how are you?
ROTHSTEIN: OK. We're the first.
DANAHER (ph): OK. Great. Great. How have you been?
ROTHSTEIN: I've been well, yourself?
DANAHER (ph): Fine. Thank you.
What is going on in Louisville? Is it warm or cold or …
ROTHSTEIN: It's going to be in the 60s today.
DANAHER (ph): Oh, wow.
ROTHSTEIN: So, it should be nice.
DANAHER (ph): I just wanted to check. Did – you got a copy of the agenda, right?
ROTHSTEIN: Yes.
DANAHER (ph): Did you also get a copy of something like the week after the hearings called “Revised Summary of Hearing on Marketing and Fundraising?”
ROTHSTEIN: Let me walk over here and take a look, I think I did. Hang on a minute.
Let me – yes, they are right here in front of me. “Revised Summary of Hearing on Marketing and Fundraising.”
DANAHER (ph): OK. Great. I just wanted to make sure that everybody got that.
ROTHSTEIN: Yes.
DANAHER (ph): And I'm not sure how many people are going to be on the call.
Hello?
KATHY RANZETTI (ph): Hello.
DANAHER (ph): Hi.
RANZETTI (ph): This is Kathy Ranzetti (ph) from the Association for Healthcare Philanthropy. I was just going to listen in.
DANAHER (ph): OK. That's great. Welcome.
RANZETTI (ph): Thank you.
DANAHER (ph): There's not anyone to listen to yet.
RANZETTI (ph): That's OK.
DANAHER (ph): We are just getting organized here and people should be signing in any minute.
RANZETTI (ph): OK.
DANAHER (ph): Was the agenda for the meeting posted on our Web site?
RANZETTI (ph): Yes, it was with the phone number and everything.
DANAHER (ph): OK. Great.
Hello?
STEPHANIE KAMINSKY (ph): Hello. This is Stephanie (ph).
ROTHSTEIN: Oh, hi Stephanie (ph), it's Mark.
KAMINSKY (ph): Hey, Mark how are you?
ROTHSTEIN: OK. John is with us as well as Kathy Ranzetti (ph) from the Association for Healthcare Philanthropy.
Do you have the list of which members of the subcommittee members were expected on the call?
KAMINSKY (ph): No, I don't have that. I guess I should, but I don't. Do people supposedly RSVP to Marietta (ph)? Is that what you are saying?
ROTHSTEIN: Well, Marietta (ph) usually has an idea.
KAMINSKY (ph): OK.
ROTHSTEIN: So, when she gets on the call or somebody gets on the call then we we'll ...
KAMINSKY (ph): We'll know. Yes.
ROTHSTEIN: Where are you calling from Stephanie (ph)?
KAMINSKY (ph): I'm back in Boston.
ROTHSTEIN: Oh, OK.
KAMINSKY (ph): My workstation in Boston.
ROTHSTEIN: How often are you in Washington?
KAMINSKY (ph): Well, I'm officially sort of stationed in Boston. So, I guess I'll be coming down, you know, for NCVHS matters and possibly other sort of OCR related things, but I'm really here in Boston at this point.
ROTHSTEIN: OK.
DANAHER (ph): Out of my ignorance – this is John. Out of my ignorance, how does that work?
KAMINSKY (ph): It's unique. It doesn't usually get arranged like this.
DANAHER (ph): OK. Say no more.
Where are you?
ROTHSTEIN: There we go? Hello?
MARIETTA (ph): Hi, this is Marietta (ph). I'm signing in.
ROTHSTEIN: Hi, Marietta (ph). Do you know who is going to be on the call?
MARIETTA (ph): Yes. Let's see, Simon (ph), Richard, John Danaher (ph) ...
ROTHSTEIN: Yes, John is already on.
MARIETTA (ph): OK. Brady Augustine (ph), our new member is supposed to be signing on and Stephanie (ph), John Fanning (ph), Gail Horlick (ph) is going to be for awhile, and Mike Fitzmaurice (ph).
ROTHSTEIN: OK. Now is Brady Augustine (ph) a member of this subcommittee as well?
MARIETTA (ph): Yes, he wants to be.
ROTHSTEIN: OK. So, I just need to know, you know, who votes.
MARIETTA (ph): We'll still have a quorum.
RICHARD HARDING (ph): This is Richard. Morning.
Mark?
ROTHSTEIN: Yes. Good morning.
HARDING (ph): Pardon me for being late.
ROTHSTEIN: Well, that's OK. We’re still waiting for – we lack quorum at the moment. It's a slow rising group.
HARDING (ph): That's right, we have some west coasters probably.
ROTHSTEIN: Right.
MARIETTA (ph): I don't think Jeff or Kepa (ph) will be able to take the call.
ROTHSTEIN: OK. So, that means we need four and we've got three at the moment.
DANAHER (ph): Richard, good morning. This is John Danaher (ph).
HARDING (ph): Hello John. How are you?
DANAHER (ph): Good. Thank you.
HARDING (ph): You sound like you are in a well.
DANAHER (ph): As if I'm in a well?
HARDING (ph): Yes.
DANAHER (ph): Oh.
HARDING (ph): Maybe it's my headset.
DANAHER (ph): Yeah, no doubt.
ROTHSTEIN: Richard, did you – you've got the revised summary of the hearing that I sent out?
HARDING (ph): I didn't.
ROTHSTEIN: Really?
HARDING (ph): And then I was – I sent in a note this morning saying that I had the agenda.
ROTHSTEIN: Right.
HARDING (ph): And that's about all that I have.
MARIETTA (ph): Are you near an e-mail? I can e-mail it to you now.
HARDING (ph): Yes.
MARIETTA (ph): OK. I'll e-mail it to you now.
KAMINSKY (ph): This is a revised agenda?
ROTHSTEIN: No, a revised summary of the ...
KAMINSKY (ph): Oh, the revised the summary – the revised summary. OK. Sorry.
MARIETTA (ph): Hi, Stephanie (ph). This is Marietta (ph).
KAMINSKY (ph): Hi, Marietta (ph).
JOHN FANNING (ph): John Fanning (ph) is now listening in.
UNIDENTIFIED PARTICIPANT: Hi, John.
FANNING (ph): Hello.
UNIDENTIFIED PARTICIPANT: Hey, John.
UNIDENTIFIED PARTICIPANT: John.
FANNING (ph): Hello.
ROTHSTEIN: We are one shy of a quorum. We are waiting for either Simon (ph) or Brady Augustine (ph).
And Marietta (ph) we are expecting both of them, is that right?
MARIETTA (ph): Yes.
ROTHSTEIN: OK.
Richard, while I have a minute.
HARDING (ph): Yes.
ROTHSTEIN: At a weak moment, you agreed to do the presentation on the first day of the meeting?
HARDING (ph): Well, you said you weren’t going to be there so I said I'd do it if you asked.
ROTHSTEIN: Well, thank you. So, we can talk offline about getting prepared for that.
HARDING (ph): OK. That's fine.
ROTHSTEIN: Did somebody just join us?
GAIL HORLICK (ph): This is Gail Horlick (ph). Hi, Mark.
ROTHSTEIN: Hi, Gail (ph).
HORLICK (ph): How are you?
ROTHSTEIN: I'm well. Good to hear from you.
We are still waiting for a quorum we need one more. We are waiting for Simon's (ph) alarm clock to go off.
HORLICK (ph): Oh, that's right. It's just 7:00.
ROTHSTEIN: Yes.
HARDING (ph): I still have not received the e-mail.
MARIETTA (ph): I'm trying to find it now.
HARDING (ph): OK.
ROTHSTEIN: Are you close to a fax machine?
HARDING (ph): Yes.
ROTHSTEIN: OK. I mean, I've got a copy in front of me. I can fax it to you. How's that?
HARDING (ph): That would be fine.
How long is it?
ROTHSTEIN: Oh, it's about seven or eight pages.
HARDING (ph): OK. It's 803- ...
ROTHSTEIN: All right ...
HARDING (ph): ... 434-2367.
MARIETTA (ph): Mark, I have it. I'm going to fax it to him.
ROTHSTEIN: Oh, OK.
HARDING (ph): You're faxing it, or you're emailing it?
MARIETTA (ph): I'm going to fax it to you. I have a hard copy.
KAMINSKY (ph): You know what, Marietta (ph)? You sent it to me last week, remember? I have it right here so, Richard, if you want to give me your e-mail address, I can actually try to send it that way, too, and whichever way you think it's the fastest ...
HARDING (ph): OK, rharding@gw.mp.sc.edu.
MARIETTA (ph): OK, I'll try it my way, too.
HARDING (ph): OK. Thank you.
ROTHSTEIN: And Gail's (ph) in Atlanta, that's not too far. She's going to drive you a copy.
UNIDENTIFIED PARTICIPANT: Yeah, that's ...
HARDING (ph): We'll meet in Augusta.
HORLICK (ph): That'll be better weather than here.
HARDING (ph): Yeah, it's about 60 degrees today. Pretty nice.
HORLICK (ph): Yeah.
ROTHSTEIN: Well, I'm not sure what we do if we don't have a quorum.
John, do you have any guidance? We have three of our now seven members of the subcommittee.
HARDING (ph): This is Richard. Does it require a quorum to have discussions ...
ROTHSTEIN: I don't know, that's why ...
HARDING (ph): ... as opposed to a vote?
DEBBIE JACKSON (ph): Hi, this is Debbie (ph).
You can discuss this. There's no problem with starting, especially since we're expecting someone to come on board.
ROTHSTEIN: OK.
JACKSON (ph): The problem comes in when we make action decisions without the quorum.
ROTHSTEIN: OK, well, interestingly, perhaps not so surprisingly, the three of us, who are on the call, are also the three of us who were at the hearing and, so, the first issue that we need to take up in marketing is whether we want to recommend a major change from the current rule.
Under the current rule, as you know, health-related marketing is considered a part of healthcare operations, and subject to the one – time general consent. As long as it is in accordance with the three – one of the three provisions, that is, that it's face-to-face, involves only items of nominal value or complies with the provisions dealing with third – party marketing, such as disclosure and opt-out requirements.
And, so the first question is whether we want to keep that or go to – and you see on the agenda, there are two main options – one would be to go back to the way it was in the NCRM under which marketing would not be considered a part of TPO and, therefore, would require an authorization, or to basically permit marketing the way it is.
And, then, regardless of the decision that we make on this first question, we're going to have a whole series of other decisions to make to go into specific items.
So, John, Richard, do you have any thoughts on the general principle of whether it ought to remain the same. That is, as part of healthcare operations, or whether we should recommend to the full committee that we consider dropping it?
HARDING (ph): Well, that's getting right down to the nub here right away.
ROTHSTEIN: We're not beating around the bush here.
HARDING (ph): This is Richard.
I have, you know, always been a bit uncomfortable with marketing being considered a part of healthcare operations. I mean, that's just something that's – it doesn't ring clear to me.
And, so, in a, I think the face-to-face thing helps it a little bit, but I, you know – my general – and we're not voting here, but my general thought is probably a weighing of all the things that were brought up at the meeting from various people.
I have a tendency to want to return to the position of the MPRM (ph). But, again, I always get tangled up in the definition of marketing ...
ROTHSTEIN: Right.
HARDING (ph): ... and what is marketing and what isn't and that's the aggravation for me.
But I think going outside of healthcare operations is not something that most people feel happens to their own personal identifiable information, and they need to know what's happening with that. But that's my own first thought here, starting out.
ROTHSTEIN: John, do you want to weigh-in?
DANAHER (ph) (?): Sure.
Mark, I would keep operations as part of PTO and then, you know, with the opt-out after first contact or whatever, you know, going to the opt-out.
ROTHSTEIN: OK. Well, I suppose that would – that's in keeping with the sharp division on the issue that we ...
DANAHER (ph) (?): Right. Right.
ROTHSTEIN: Let me give you my sense and I think that we're not going to have a clean black or white on this.
In other words, if we say it goes back to the way it was under the MPRM, I think what we would then do is want to carve out a variety of exceptions. For example, defining notices set by pharmacists about refills is not – not being marketing but, rather, being treatment, or something like that.
So, on the other hand, if we kept it where it is, as something that is in treatment, payment and healthcare operations, then we would perhaps want to also sort of carve out some exceptions to tighten up the rule, setting out specifics for opting in and opting out and saying, you know, perhaps special rules for minors or whatever.
So, as a starting point, I guess the question is, do we want to start with the presumption that it's not appropriate to consider marketing within healthcare operations and then carve the exceptions from that, or start with the way it is now with the presumption that it is OK, and then carve the limitations out from that side.
And, I'm – I agree with Richard, I think, for the following reasons. We are always going to be balancing in privacy the interest in privacy against other interests, which are often quite substantial. And, we've said, for example – and I know I used this example at the hearing – that even in the area of research, where it's obvious that there are many social goods and public health benefits that comes from research, that that wasn't part of treatment or operations or something.
I mean there are many other things for which we are requiring authorization and, in terms of the public interest – we can protect healthcare interest – but in terms of the broader public interest, I just, I don't see the case for marketing, starting with the presumption, even health-related marketing, obviously, that it's OK unless we say otherwise.
And, so, in fact, we may well get to similar points by the time we start, you know, carving out exceptions from one side or the other. But I think that we should start with the assumption that, unless there is an exception, marketing is not a part of healthcare operations.
So, we can't vote, because we don't have a quorum. The – I suppose the question is – not only on this issue, but on all the others that we're going to get to – how should we present it to the full committee, when we do not have a what would be considered to be sort of a binding recommendation of the subcommittee?
HARDING (ph): Well, that's all we – this is Richard. That's always tough, I mean, we could frame up a motion or two as you just said, to have the presumption be that it's OK to use personal health information unless we say otherwise, or the opposite, it's not OK and have some discussions with the full committee about which way they want to go and the fact that we're divided on that.
ROTHSTEIN: OK. Did someone else just join us?
SIMON COHN (ph): Yes, this is Simon Cohn (ph).
ROTHSTEIN: Oh Simon (ph). Good morning.
COHN (ph): Good morning.
ROTHSTEIN: And you are our quorum-maker.
COHN (ph): OK, well, happy to be here. I tried to be – the roads were a little crowded this morning.
ROTHSTEIN (?): Got it.
With us so far are Richard and John from the subcommittee, as well as Gail (ph) and Stephanie (ph) and John Fanning (ph) and Debbie Jackson (ph), and Kathy Ranzetti (ph) from the Association for Healthcare Philanthropy. Did I miss anyone?
OK. We – Simon (ph), to bring you up to where we are, we started discussing – and I gather you have the agenda?
COHN (ph): Yes.
ROTHSTEIN: OK.
We started discussing the, sort of the overarching issue of whether marketing should be considered part of healthcare operations, or not. And I made the observation that I thought, regardless of the decision that we made, we might well come out more or less in the same place, as we had some agreement – this is speculation – on the specifics that we wanted to sort of tack on to that.
In other words, if we kept it the way it is, and have health-related marketing part of healthcare operations, we might want to limit that by saying that certain kinds of things are not appropriate, marketing to children or whatever, that would limit that.
On the other hand, if we took the opposite position, and said we need to return to the NPRN view where health-related marketing requires prior authorization, we may want to add some exceptions to that, such as notices by pharmacists about refills and so forth being not within that general view and that they would be considered, for example, treatment, and make some exceptions that would sort of being us toward the middle from either end.
But, I suppose, that the one decision that we can't escape is the starting point, whether we should start with the presumption that it's healthcare operations or the presumption that it's not.
COHN (ph): Wow. OK.
ROTHSTEIN: As we said, that's getting right down to it.
UNIDENTIFIED PARTICIPANT: Hey, good morning. Have you had your coffee yet there?
COHN (ph): I had coffee. My eyes are still getting big.
ROTHSTEIN: So have you had a chance to give some thought to this?
COHN (ph): Well, I was actually talking to one of our – you know, every state has its own rules on this one and I was – actually I was part of this, because I'm scratching my head about it also and obviously do not have the benefits of the hearings to really inform me a lot and I was actually sort of looking at what California was doing just to sort of see, since, obviously, a lot of people seem to survive with these particular state codes.
And, really, they are more along – I don't know. There was some wording that got pulled out of a civil code section that I was looking at, but they are, you know, more restrictive than the new final rule. I mean, the current privacy final rule, and they don't quite go to the point of aid (ph), but they get a lot closer to where we are now.
So I guess they – and it seems to be everybody seems to be able to survive with that, so I guess I would tend to say that we could sort of go from the position of, I mean, with obviously a bunch of “except for, except for, except for,” maybe the 2A position.
ROTHSTEIN: The 2A position, which is returned to the NPRN, is that correct?
COHN (ph): Yeah, which is, I mean – what I think was your first position – saying from a position, where you're saying, geez, there's no marketing except for ...
ROTHSTEIN: Right.
You know, perhaps it would be not particularly helpful for us four members of the full committee to have a detailed discussion of all the issues related to this point, and I'd be interested in your views on this.
And, maybe what we ought to do, is present it to the full committee as saying, look, here are the two options and the committee has heard – the subcommittee has heard – the testimony, there's an argument that could be made for each side, and it's a decision for the full committee to make anyhow.
If you want to ask individual subcommittee members how they feel, I mean, we'll be happy to share our views at the full meeting, but I'm sort of reluctant to say that, because we voted three to one in the subcommittee where we're missing three of our members, and we're going to be reconsidering the issue anyhow, that this is a “recommendation” of the subcommittee.
And I say that as being someone who's in the majority.
COHN (ph): Which one are you supporting, out of curiosity?
ROTHSTEIN: No, I agree with you.
COHN (ph): Oh, OK.
ROTHSTEIN: So, Richard and I agree with your position and John takes the other position, but I'm concerned about sort of the process of not giving the wrong impression to the full committee that, you know, all seven of us have met and face-to-face and have come up with this. And, it's such a contentious issue that you know that the full committee is going to want to debate this (INAUDIBLE) anyhow.
HARDING (ph): I think that's right, Mark – this is Richard. And the – in reality, if we do vote three to one, in here, that would still not be a majority of the subcommittee ...
ROTHSTEIN: Right.
HARDING (ph): And, so, that it certainly doesn't have a lot of impact, but I worry a little bit that, you know, a number of us have heard a good bit of testimony and the full committee will not have benefited from that and how to bring them up to speed quickly on that is what I was kind of scratching my head about – is to how to lay it out clearly what the choices are and background material and so forth.
DANAHER (ph) (?): Well, maybe this is sort of an odd question, I mean, we were just going to open this up for general discussion and then, let's take four hours and talk about this back and forth which, of course, the full committee could do. Presumably, we’re just asking them for input and thoughts as we make our final recommendations back to them.
ROTHSTEIN: Well, I can, you know, I can draft a letter, you know, a draft letter to the secretary as we usually do and include either position.
Certainly if we – if three of us take that position – and that's the majority view – we can put that in the letter and that will open it up for discussion by the committee anyhow, but what I didn't want to do, and I'd be interested in your view on this, John, is to misrepresent the strength of the vote in favor of making this sort of major change.
DANAHER (ph) (?): I appreciate that, Mark, and so, yeah, however we position it, I just appreciate the fact that, of laying out the argument, the con – argument and so, I appreciate that being put forth.
ROTHSTEIN: Well, what we can do is, how about this – not to make more work for us – we can write a letter to the secretary in which we have, you know, we set things out, but we can put two versions of Paragraph Two.
And – Simon (ph), tell me whether this has ever been done before – where the first version is our justification for recommending that we go back to the position of the NPRN and the second, the alternative, is our justifications for basically keeping it the way it is, subject to both of them, subject to there is exceptions. Has that been done before by the ...
UNIDENTIFIED PARTICIPANT: We can have votes on which paragraph we like?
ROTHSTEIN: Basically, yeah.
Well, I guess it's – one of the questions I have is, at the end of the day, how much difference is there between both positions? If we go from disallowing, but allowing, except for a variety of ...
UNIDENTIFIED PARTICIPANT: Basically, yeah. Well, I guess it's – one of the questions I have is, at the end of the day, how much difference is there between both positions? If we go from disallowing, but allowing, except for a variety of exceptions, which might include a treatment team and healthcare operations ...
ROTHSTEIN: Right.
DANAHER (ph) (?): ... versus that (ph) you can do it except for, you know, a list of 15 things that you can't do, how big of a gap are we talking about?
ROTHSTEIN: You know, that's a very good point, John.
DANAHER (ph) (?): Yeah, I don't know. Because we haven't talked about the specifics.
We also, I think, need to think about what's going to happen with this letter and I think it's important, certainly, symbolically, where we start from, because it's certainly not a given that OCR and the secretary's office will agree with any or all of our exceptions from either direction and they may have other exceptions that they want to put in coming from either direction.
So I think it's important, specifically, because we're not going to be writing the final proposal or revisions that we have a say in telling them what our starting point should be.
UNIDENTIFIED PARTICIPANT: Question. What is – how close are they to the final, you know, the notice of proposal rule at this point?
UNIDENTIFIED PARTICIPANT: Well, my best guess is that they're hoping to have it done by April 1, because they want to have, you know, it out there a year before the compliance dates.
UNIDENTIFIED PARTICIPANT: Yeah, of course that's just the proposed rules ...
UNIDENTIFIED PARTICIPANT: Exactly.
UNIDENTIFIED PARTICIPANT: OK.
HORLICK (ph): Mark, this is Gail (ph).
I saw Kathleen Fife (ph) at a HIPAA training here in Atlanta, and her words were “It's on the verge” – I just thought I'd share that one. But I've heard that the date that they're shooting for is April 1, so I think that “on the verge” and April 1 are kind of the same thing.
UNIDENTIFIED PARTICIPANT: So, the implication is how much weight is our recommendation going to have anyhow – who knows?
It may be that they will take our views into account in the, you know, in the final rule, even if we don't have time to influence the ...
UNIDENTIFIED PARTICIPANT: (INAUDIBLE) I was asking was, is this – the timing is a little awkward except that it was too late to affect the MPRM, maybe you want to time it so it's part of the comments to whatever comes out the next version.
So, basically, the MTVHS comments to the proposed rule.
UNIDENTIFIED PARTICIPANT: Well, I specifically asked at the hearing if we approved at the full committee meeting next week a recommendation and got a letter to the secretary, you know, by early March, whether that would be timely and they said – I think this was – Sue McAndrew said that she thought that they could consider our recommendation.
And, of course, they were at the hearing and heard much of the testimony that we did, although not – I don't think all of it.
ROTHSTEIN: So, let's back up a minute and so the question is – I mean, we've got various options. One option is to, you know, just tell the committee what the issues are and then let the committee sort of decide.
Another option is to write a letter that has the majority support of the people on this call and those who were opposed to that view would have ample time at the meeting to say I don't think that's right. A third option would be to write alternative paragraphs and then tell them they can pick, you know, A or B. Maybe there are others, but we need to pick something.
John, you're in the minority, so I want to protect your interests. Which of those three do you think would be fairest from your point of view?
DANAHER (ph) (?): Say it again – lay out all the options again for me.
ROTHSTEIN: Well, the three that I see, and I'm certainly open to – Revision I is just to tell the committee that we've – here we haven't been able to reach a sort of a clear recommendation by a majority – that a majority of the members of the subcommittee have endorsed on this issue, but it's important and here are the issues.
A second option would be that we write the letter as if we are endorsing to a – which would be a return to the MPRM, the way we have voted three to one and, then, at that point, those who were not in favor of that could raise the issue, well, we don't like Paragraph two of this letter, it's the wrong way to go.
And the third way is to draft, basically, alternative paragraphs explaining why we want to go to the – back to the MPRM or why we think that the basic philosophy is correct now that it's self-care operations and then ask the committee to select one of those two alternatives.
DANAHER (ph) (?): I guess the first one – thank you, Mark. Yeah, I guess the first one would appeal to me the most.
ROTHSTEIN: And, to just say that this is a very important issue and neither position got a majority of the members of the subcommittee support because we had trouble getting, you know, a substantial number of people on the committee to weigh in on the issue and then, sort of, open the floor for further discussion.
DANAHER (ph) (?): And I think that, from – I think, yes.
UNIDENTIFIED PARTICIPANT: Well, you know, the other option, obviously, is to also – I mean, if we talk – we have a couple of hours at the meeting for the full subcommittee, right?
DANAHER (ph) (?): Right.
UNIDENTIFIED PARTICIPANT: And, of course, I'll guess you'll want to talk about this before we go into the subcommittee issues. I guess, you know, as soon as – I mean, we would have a hopefully a quorum and face-to-face meeting in about a week, so we might be able to give them, actually, more substantive recommendations.
ROTHSTEIN: Well, the ...
UNIDENTIFIED PARTICIPANT: I will defer to you however you want to do this when it's – I think nothing seems to work real well.
ROTHSTEIN: OK, looking at the agenda on – Tuesday the 26th at 2:00, it says review privacy letter recommendations on marketing.
And then we have an hour, from five to six, subcommittee on privacy, and then we have some time the following day where we take up the action item, presumably the provisions made previously suggested the day before at the full committee meeting.
UNIDENTIFIED PARTICIPANT: I take back my comments (INAUDIBLE).
UNIDENTIFIED PARTICIPANT: I have that agenda in front of me here ...
UNIDENTIFIED PARTICIPANT: OK.
UNIDENTIFIED PARTICIPANT: ... I actually have a couple of hours ...
UNIDENTIFIED PARTICIPANT: So we don't have a meeting of the subcommittee planned before the time that we have to present our recommendations on marketing.
UNIDENTIFIED PARTICIPANT: OK. I retract my comments.
UNIDENTIFIED PARTICIPANT: That sounds a little bit not helpful.
UNIDENTIFIED PARTICIPANT: Right.
UNIDENTIFIED PARTICIPANT: Would it be possible, you know, to ask John to allow us to have a meeting of the subcommittee?
And, Mark, I would, you know, like the morning, the second morning, and then present that – later that morning or something?
ROTHSTEIN: I think that would be much better from my standpoint.
I will not be at the Tuesday meeting. I will be flying in Tuesday night. Dana Friedman (ph) has an hour-and-a-half presentation scheduled from 8:30 to 10:00 on 21st Century Health Statistics. If we could move that presentation ...
UNIDENTIFIED PARTICIPANT: To 9:00, and we could ...
UNIDENTIFIED PARTICIPANT: No, if we could move that presentation to Tuesday, then we could meet as a subcommittee from 8:00 to 10:00.
UNIDENTIFIED PARTICIPANT: Sure, or earlier even, if we had to.
JACKSON (ph): This is Debbie (ph). Some of the challenges in scheduling all the subcommittees (INAUDIBLE) membership ...
UNIDENTIFIED PARTICIPANT: Yeah.
JACKSON (ph): … and increase the times of an hour-and-a-half to two hours, because we're trying to get that 21st Century report, you know, presented at the next meeting. We're going to be including it in this (INAUDIBLE) mailing.
UNIDENTIFIED PARTICIPANT: No, what I was suggesting, Debbie (ph), was we have an hour on the agendas now from 2:00 to 3:00 that says Review Privacy Letter ...
JACKSON (ph): Right.
UNIDENTIFIED PARTICIPANT: OK? I'd like to take that time and move Dan into that slot.
UNIDENTIFIED PARTICIPANT: ... was we have an hour on the agenda now from 2:00 to 3:00 that says Review Privacy Letter.
JACKSON (ph): Right.
UNIDENTIFIED PARTICIPANT: OK?
I'd like to take that time and move Dan into that slot and now he'll be a half-an-hour shy, but he can pick it up somehow. And, then, on Wednesday morning, February 27, the full committee would not start until 10:00, but the subcommittee could meet from 8:00 to 10:00 that morning.
JACKSON (ph): So you would complete the – the full committee agenda would be completed, in fact, (INAUDIBLE).
MARIETTA (ph): This is Marietta (ph).
UNIDENTIFIED PARTICIPANT: (INAUDIBLE).
UNIDENTIFIED PARTICIPANT: Yes. Marietta (ph) just said something, but I – we're back.
UNIDENTIFIED PARTICIPANT: OK. Well, at any rate, if we can work that out would that – I think that would be better if everyone agrees and then we would have, you know, maybe what we can do is, in advance of the subcommittee meeting, draft the paragraph and let the subcommittee vote on which one to include and then we'll have, like a, real letter.
UNIDENTIFIED PARTICIPANT: Yeah.
That would just make more sense from our standpoint. I understand the bigger picture that everybody is trying to wrestle with of different people's presentations and members of subcommittee's multiple subcommittees and so forth.
But I think that having you there as chair is very important and I think that having us meet at least for an hour or, you know, even if we did it from 8:00 to 9:00 or 8:00 to 9:30, that second morning, that would be preferable than just going in cold.
JACKSON (ph): Hi, this is Debbie (ph) again. Sorry, we were disconnected.
UNIDENTIFIED PARTICIPANT: So, Debbie (ph), did you hear, before we were disconnected, my suggestion?
JACKSON (ph): Yes. I've heard a couple of options. I guess it really is up to you since we don't – you're not talking about an overlap on subcommittee meetings.
UNIDENTIFIED PARTICIPANT: That's right. So, I wonder if you could raise this with ...
UNIDENTIFIED PARTICIPANT: Mark, I'm confused here. I'm with Marjory (ph).
UNIDENTIFIED PARTICIPANT: What you're talking about, about an hour-and-a-half that ...
UNIDENTIFIED PARTICIPANT: OK.
UNIDENTIFIED PARTICIPANT: Maybe I'm looking at an old draft agenda here.
UNIDENTIFIED PARTICIPANT: OK, I'm looking – well, maybe I'm looking at the old – the version I have, I guess, it says 12/26. That may be an old one.
UNIDENTIFIED PARTICIPANT: I just got on to the web and there is the Review Privacy Letter at 2:00 on the first day and it looks like just an hour scheduled for that?
UNIDENTIFIED PARTICIPANT: Correct. And, then, you're talking about the second day? I don't see an hour-and-a-half presentation ...
UNIDENTIFIED PARTICIPANT: What starts at 8:30 in the morning on the 27th?
UNIDENTIFIED PARTICIPANT: Oh, that's work group on the health statistics for the 21st. That's a meeting. That's a work group meeting. You're saying you want to have this ...
UNIDENTIFIED PARTICIPANT: Oh, that's work group meeting? Yeah, I thought that was – I see, that's a work group meeting.
UNIDENTIFIED PARTICIPANT: Which actually would be fine. We could meet then instead of 5:00 to 6:00 or then, in addition.
UNIDENTIFIED PARTICIPANT: Is that – are there any overlaps?
UNIDENTIFIED PARTICIPANT: I don't see any of this moment, unless NHII is ...
JACKSON (ph): NHII is off the record.
UNIDENTIFIED PARTICIPANT: Is off the what?
JACKSON (ph): NHII – they've already completed their report, so we're fine with them.
UNIDENTIFIED PARTICIPANT: You say we don't exist anymore?
JACKSON (ph): No, they don't have a subcommittee breakout session.
UNIDENTIFIED PARTICIPANT: Oh, OK.
So, basically, we would run 8:00 to 10:00, like we usually do ...
UNIDENTIFIED PARTICIPANT: Right.
UNIDENTIFIED PARTICIPANT: On the second day …
UNIDENTIFIED PARTICIPANT: Right now, we're at 5:00 to 6:00 on the first day.
UNIDENTIFIED PARTICIPANT: Do we want to do both?
UNIDENTIFIED PARTICIPANT: Well, I won't be there.
UNIDENTIFIED PARTICIPANT: Oh, you won't be there at all?
UNIDENTIFIED PARTICIPANT: No.
I'm going to be flying in from Minneapolis, so, what – yeah, there is no overlap because the 21st Century is Dan Friedman (ph), Vicky Mays (ph), Paul Nuvochek (ph) and Barbara Starfield (ph), so we could meet at the same time they are and then vote on, you know – take a final vote on the letter.
UNIDENTIFIED PARTICIPANT: Is there, though, time in the agenda after, you know – and on the regular agenda, on the second day, to put us in an hour?
UNIDENTIFIED PARTICIPANT: Well, we are already on the agenda ...
UNIDENTIFIED PARTICIPANT: The first day.
UNIDENTIFIED PARTICIPANT: No, on the second day, too ...
UNIDENTIFIED PARTICIPANT: Oh, OK. I don't have that in front of me. I'm sorry.
UNIDENTIFIED PARTICIPANT: ... at 1:00.
UNIDENTIFIED PARTICIPANT: Yeah, but according to – I think the presumption in here is there's not going to be a big long debate on that.
UNIDENTIFIED PARTICIPANT: Well, the – I mean, usually what happens is that, you know, there's a draft letter – remember the process that we usually go through ...
UNIDENTIFIED PARTICIPANT: Yes.
UNIDENTIFIED PARTICIPANT: Maybe this one isn’t the process we should follow, but usually, you come to the committee, with a draft letter, you sort of go through it with the committee, you hear all their concerns, issues and otherwise, then you go to the subcommittee and you revise it and bring back the finished letter.
What we're obviously assuming here is that somehow, from 8:00 to 10:00, we can do all the word-smithing necessary, as well as conceptually agree, on what's going on here, which is not one of the easier things, based on this conversation, and present to them a final melting of the minds that we can sort of move through without significant modifications at 1:00.
UNIDENTIFIED PARTICIPANT: Yeah, we'll have until 1:00 to do it. What we might be able to do is move the reports from subcommittees and work groups, which is executive subcommittees, etc., and move that to the 2:00 slot so that would give us more time, from 1:00 to 3:00.
UNIDENTIFIED PARTICIPANT: To 2:00 the previous day?
UNIDENTIFIED PARTICIPANT: Yeah.
See, because we don't have the action item from the other subcommittees, Standards and Security, at 1:00. But, if we move the other non-action items and the stuff that we can, to reports at the 2:00 time slot, that will give us, you know, two hours for the two action items and ...
UNIDENTIFIED PARTICIPANT: Yeah.
Well, you know, I certainly am convinced. I don't think that Richard wants to have this discussion with the full committee. Or, Richard, or you volunteering to (INAUDIBLE) this up on Tuesday on your own to …
HARDING (ph): No.
No, I mean, I would volunteer if directed by the chair, but I think it would be much better to have the chair chair and then present it to has done the most work on it.
ROTHSTEIN: Yeah.
Well, I guess the one question I would have in all this stuff – you know, I'm fine with all of this – and it's just a question of talking to John and making sure that he is comfortable with, you know, doing these sorts of changes which, I presume, he would be.
The only question is just, realistically, I think that this is one of those areas where the devil's really into detail ...
HARDING (ph): Right.
ROTHSTEIN: ... and, you know, conceptually, I'm all supportive of, for example, 2A, except that I'd have to see a whole bunch of excepts there ...
HARDING (ph): Right.
ROTHSTEIN: ... and it seemed to me that we could have a fairly long discussion on the subcommittee about what those exceptions are all about.
UNIDENTIFIED PARTICIPANT: How about if we do this? Let's – we know where we're, sort of – I think there's a sort of general consensus on this.
Let's take a look at some of the exceptions and see if we have some consensus and, if we do among the four of us, now, maybe, this plan will be realistic. If we don't, if we're divided two to two on half the issues, then we've got to rethink it.
UNIDENTIFIED PARTICIPANT: OK.
UNIDENTIFIED PARTICIPANT: Is that all right?
UNIDENTIFIED PARTICIPANT: OK.
UNIDENTIFIED PARTICIPANT: OK.
Let's start out with the first one, on the definition of marketing. And, some of the things that we need to think about are – should the rule be further clarified to distinguish treatment communications from health-related marketing, and I think this is a no-brainer.
UNIDENTIFIED PARTICIPANT: Yeah. Yeah, that's the tough one.
UNIDENTIFIED PARTICIPANT: Well, I think ...
UNIDENTIFIED PARTICIPANT: I mean, it's the tough one to figure out the difference, but that's a key question.
UNIDENTIFIED PARTICIPANT: But we're not going to have to actually write the definition, all – I think what our recommendation would be – to OCR, to clarify whatever they come up to.
UNIDENTIFIED PARTICIPANT: Right. Right.
ROTHSTEIN: Then, the next one would be, should the definition of marketing be amended to make all communications by pharmacists treatment and that – see, that was a suggestion that was made by the pharmacists, by Don Bell, the National Association of Chain Drugstores.
And I don't think there would be much support for that, just giving a, sort of a line check to the pharmacists and anyone else that they would – who would be their business partners, although I think there is – would be widespread support for a narrower statement that – about refills and things like that.
And the third one, under the definition, is, should the rule prohibit all disclosures of PHI for health-related marketing that involves any payment or compensation.
Now, that was a suggestion proposal from Bob Gelman (ph) and that we would only have to reach, if we started from the other direction, that is, that we're going to keep the rule essentially as it is. This would – this is Bob's way of keeping the same framework, but having the result as if we didn't have that framework.
Remember? He said that this is sort of a stealth attack on the – and I don't see support for that, frankly, because, either we're going to go with the presumption that it's not, you know, healthcare operations, in which case we would – we won't need this – or, we're going to go with the presumption that it is healthcare operations and, philosophically, people wouldn't support this.
Does that make sense?
UNIDENTIFIED PARTICIPANT: OK.
JACKSON (ph): Say the last piece again. I'm sorry. This is Debbie (ph).
If it is healthcare operations, you think people wouldn't support this?
ROTHSTEIN: If it is healthcare operations ...
JACKSON (ph): Yeah.
ROTHSTEIN: ... then people who would probably not support that, because they're – and John can talk to this better than I can, because I'm trying to summarize his position – would not want to take out anything that involves payment or compensation.
Is that fair, John? John Danaher (ph), are you still on? Oh. Well, I think it's fair. OK, well, I'll just put a question mark next to it.
The next set of issues surround prior authorization. If the present structure is retained, should one or more of the exceptions be deleted? And that would be, you know, the face-to-face nominal value or complies with third-party marketing requirements, should retail reminders and information from pharmacists be permitted without authorizations.
And, I think, I would be inclined to go along with that as one of the exceptions coming from the other side.
HARDING (ph): Can you hit me with that one again?
ROTHSTEIN: Sure.
HARDING (ph): Where are you in this? I can't find where you're going here, Mark.
ROTHSTEIN: OK, in my – did you get the fax?
HARDING (ph): Yes.
ROTHSTEIN: OK, in the fax, skip all the summaries and testimony – “Marketing Issues for the Conference Call” – under B, there are 22 points ...
HARDING (ph): OK.
ROTHSTEIN: ... and, Stephanie (ph), very graciously and helpfully, lumped them together by category for my use, so I don't know what number this is, but it's ...
HARDING: Oh, OK. That's why I was having trouble following ...
ROTHSTEIN: Yeah.
KAMINSKY (ph): Richard, I actually sent that to you early this morning when you said, “Is there any other material?”
So, I don't know if you want to look at that or not, or if you received that. Did you ...
HARDING: That's all right. I'm referring to an email that was sent out. Is there another document that got sent out?
KAMINSKY (ph): It didn't really get sent out to everybody, but if you guys want me to send it along right now I can.
ROTHSTEIN: This was a proposal to the chair for a different agenda that was not sent out, it was summarized in the agenda that you have.
HARDING (ph): Oh, OK. It’s just sitting on this one.
ROTHSTEIN: Right.
It's basically – what it is, is Under B, those 22 points. I put those in – basically in the order that the people testified and that's not a very logical combination of their recommendations.
And what Stephanie (ph) did is to take those 22 and lump them by categories and those categories are the six ones that are listed under B in the agenda.
HARDING (ph): Oh, OK. And the one that you were just on right now had to do with ...
ROTHSTEIN: The one I was on said should refill reminders and information from pharmacists be permitted without authorization.
HARDING (ph): OK. So this is under two prior authorizations?
ROTHSTEIN: Correct.
HARDING (ph): Got it.
ROTHSTEIN: Well, this would be Number 13, under B.
HARDING (ph): Yeah.
COHN (ph): Well, we really – I think that the – yeah. I mean, I guess it's really all a question of specificity. I just sent out by email sort of the California provision on this one, which sort of goes to (INAUDIBLE) if it's treatment, payment, healthcare operations, it should be cut – it's fine but, if it's not, then don't. And, obviously, the question is, does that – I mean, is this part of healthcare services to the patient which, obviously, it is.
ROTHSTEIN: Right.
And, so, if we went back to the MPRM and did not include something such as, “What is Number 13 B,” it certainly would violate HIPAA or the pharmacists, then you would note, saying, “It's time to refill your prescription.”
UNIDENTIFIED PARTICIPANT: Unless there were a prior authorization.
ROTHSTEIN: Yes, thank you.
Unless there were a prior authorization to contact the patient about this, and I think that there would be fairly widespread support for this exception.
UNIDENTIFIED PARTICIPANT: I agree.
ROTHSTEIN: OK. The next one.
Should the rule prohibit marketing by indirect providers, clearinghouses, and employers without prior authorization? So, this would be one of these that would be coming from the other side.
You know, I'm trying to think what – I've got an idea that might be helpful. How about this? We – all these lists, they're going from both directions. What we need is sort of a left-hand column, saying, if we approve a change in the NPR – in the current rule to go back to the NPRN, where the presumption is you need an authorization, here are a list of possible exceptions to that.
And, then, on the right-hand side, there's a different list that says if we keep the basic structure the same, where health-related marketing is considered healthcare operations, here are a list of possible exceptions to that, from that side. The problem that I'm having is we're going back and forth.
KAMINSKY (ph) (?): I think that's correct, except I don't think that's correct for all of the topics that you're talking about. I think that's true for two, which is prior authorizations, which is right at the heart of the debate that you're having.
Three, the opt-out or opt-in provisions because that's also embedded in that debate, and then, probably, four, disclosure of market considerations, but I don't think it's correct for those other three, which are the definitions of marketing, special-case marketing and regulations of methods, because those are sort of outside of whether or not the current structure is kept. Aren't they?
ROTHSTEIN: Well, no, because under special-case marketing – I think those are exceptions if we keep the present rule, which says you can do health-related marketing, but not to minors.
KAMINSKY (ph) (?): I see.
ROTHSTEIN: And, the same thing for regulations of methods, you can do it, but we have to regulate the methods. Although you could regulate the methods from the other side as well, and say, either under an exception to this rule, these – you need to have these methods.
So, maybe that's the only exception, meaning the only one that doesn't come from one side or the other.
KAMINSKY (ph) (?): What about the definition of marketing itself?
ROTHSTEIN: Well, I think that one would be another one where we're going to call for a clarification and I don't think there's any way that we can, as a subcommittee, or even a full committee, come up with a definition.
I think the only thing that, realistically, we can recommend, is that OCR should clarify the definition of marketing and provide examples and the whole thing.
KAMINSKY (ph) (?): But, they have already done that in what's available now.
ROTHSTEIN: Yeah, but we're going to change, I mean – we're going to be under anything that we approve, we're going to be changing that.
See what I am saying? We're going to be recommending exceptions coming from both sides, or from either side, and, then, they're going to have to clarify what those exceptions are all about.
KAMINSKY (ph) (?): Oh, OK. I guess so. I guess maybe – I don't want to take all your time on it right now, but it does seem to me, looking back at the – you know, the existing rule, that they did – when they went from the original to what they have now, they did do a lot of, sort of, clarifying. Or, they tried to do a lot of clarifying.
So I sort of – I was hoping on this phone call we would be a little more specific about what we were going to be requesting them to do. Because it sounds right to try to make the request that they distinguish treatment, communications and health-related marketing, but I think the effort is there in what's already in existence, in the Definition of Marketing section.
ROTHSTEIN: Yeah, but that's based on the assumption that you've got rule – exception three, that is, health-related marketing is considered part of healthcare operations. I mean, the clarification is based on an assumption that we may not share and it's a way ...
KAMINSKY (ph) (?): No, I'm talking about the actual definition section of marketing, not in the part on authorizations.
Do you know what I'm talking about? I'm talking about – oh, I'm trying to find – I'm talking about 164.501, I'm not talking about 164.514.
ROTHSTEIN: OK.
KAMINSKY (ph) (?): I guess, when I was going back over the material and trying to organize it, it seemed to me that the issues around the definition of marketing were kind of separate and apart from the issues around the authorization piece. The authorization piece making an exception for what you guys are calling healthcare marketing.
And that's now being lumped under TPO. Do you see what I'm saying?
ROTHSTEIN: Yes but, even under 501, one of the things that we've spent a lifetime on last – not this most recent hearing, but the hearing before that, was on disease management ...
KAMINSKY (ph) (?): OK. Which was not clear from the way 501 is currently construed ...
ROTHSTEIN: Yeah.
KAMINSKY (ph) (?): ... OK. All right. I'm sorry. I didn't have that.
ROTHSTEIN: Well, that's OK. So, we would want to get them ...
KAMINSKY (ph) (?): … further clarification on that piece.
ROTHSTEIN: Right. Especially as to disease management.
KAMINSKY (ph) (?): OK. I'm sorry. Thanks.
ROTHSTEIN: OK, gang, where are we? We're a sub-quorum now.
KAMINSKY (ph) (?): Well, I guess I was asking all those questions because if you'd like me to help you draft something where you'd sort of have, you know, your left side and your right side coming at it from one angle versus the other angle, I'm happy to do that, if that would help with the debate.
ROTHSTEIN: That would be terrific.
UNIDENTIFIED PARTICIPANT: That would be helpful.
KAMINSKY (ph) (?): I just needed to make sure I understood.
ROTHSTEIN: I think what we need to do is, you know, if we, you know, if we change to the presumption that an authorization is required, here are a range of exceptions to basically soften that.
And, if we keep the current presumption the way it is, that, if you satisfy one of these three exceptions, health-related marketing is part of healthcare operations, here are some potential exceptions to soften that.
And, I suppose, there are some proposals such as the one to amend the definition of marketing to make all communications by pharmacists treatments that could be considered to be sort of strengthening the current view, but I just don't think there's any support for that. Is that fair?
In other words, to recommend that more marketing be permitted pursuant to the third exception, then, currently, is under the rule. I think, if the committee approves anything, it would be to sort of cut back on stuff.
KAMINSKY (ph) (?): So, you're not talking, then, about the (INAUDIBLE), you're talking about something else?
ROTHSTEIN: What I'm talking about is the proposal that was suggested by the pharmaceutical industry that anything they do is OK, which would be benign on the (INAUDIBLE) marketing issues for the conference call.
KAMINSKY (ph) (?): As opposed to the specific carving out of the refill reminders?
ROTHSTEIN: Correct.
KAMINSKY (ph) (?): OK.
ROTHSTEIN: That would go way beyond that, which, I think, that people would not – well, let's go through this list. This will help. Simon (ph), you with me?
COHN (ph): I'm here.
ROTHSTEIN: OK. If this would help Stephanie (ph) and me come up with a proposal of two lists and the ones that would have the most support, I would say.
So far we have, under Marketing, the definition of marketing to clarify, under the prior authorization from one – from whatever side, on the refill reminders. Then we have another proposal, should the rule prohibit marketing by indirect providers, clearinghouses and employers without prior authorization and, I would think, that this would be one that we would consider if we keep the rule the way it is – the presumption the way it is.
So this is a viable proposal. Should covered entities be prohibited from soliciting and authorization from marketing on behalf of the third party the same thing, keeping where it is limitation, should all marketing be limited in instances where there is a prior authorization with a limited duration? That would be, it seems to me, subsumed (ph) within going to – reversing the presumption.
Then we go in the opt-out, opt-in provisions, should opt-out, opt-in provisions be specific or general? And, I suppose, this might be one of those, sort of, from either side, maybe this would be a – on both sides – that we should address, because this would go to can you opt-out of all marketing or just this kind of marketing, or opt-in.
Should other options be considered, such as giving the consumer the opportunity to opt-out before the first contact? That would be only if we kept the rule the way it is now, because that would be – that would not be an issue if we reversed the presumption.
Should the patient, provider, or third party have the burden of establishing whether the individual may be the object of marketing activity and that would depend on where the presumption is, right?
KAMINSKY (ph) (?): OK.
ROTHSTEIN: Should the rule clarify the rights of consumers after they have received a notice of their rights and requests that contact be limited, i.e., that they have to be informed whether their request will be honored. So that will be a consideration if we keep the presumption as it is.
KAMINSKY (ph): Can I – I'm sorry. I don't mean to interrupt again. But ...
ROTHSTEIN: Please.
KAMINSKY (ph): Can you just put into – you're just so articulate, Mark.
I wish you would put into words, what would be the situation where you reverse the presumption, how, then, does the out – opt-in provision even come into play at all? I'm sort of looking ...
ROTHSTEIN: OK. If you reverse the presumption, that means you need an authorization.
KAMINSKY (ph): Oh, OK. And, then ...
ROTHSTEIN: And, then, if you authorize marketing, you might still elect to opt-out of certain kinds of marketing when they – when they contact you.
KAMINSKY (ph): OK.
ROTHSTEIN: Right?
KAMINSKY (ph): Yeah. Yeah. Yeah.
ROTHSTEIN: Yeah. OK.
And that, should there be further regulation or clarification of the role of indirect providers, e.g., how should indirect providers be informed about whether or not a particular patient has opted in or out.
And, I think this is an important issue from either side. I think that was – how do you know whether someone has opted in or out? And that would be an issue, regardless of the presumption.
Should the rule be amended to improve the opt-out system? I think we're talking about that. Should the rule be amended to delete the requirement that consumers be informed about why they were selected for targeted marketing?
This was a proposal that would assume that we are keeping the presumption and this would make it easier, basically, for marketers. We could put that on the list but, as I say, I don't think those kinds of things are likely to get support for the committee.
Forced disclosure of marketing arrangements – “Should the rule require clear, conspicuous and complete disclosure of all marketing arrangements including posting information on the web site of the covered entity?” This was a Gelman (ph) proposal assuming that we keep marketing with the current presumption. So that would be keep the presumption would be a way of cutting back.
KAMINSKY (ph): Sorry to interrupt again. But, you know, yes it would be – you would assume the current presumption. But even if you reversed presumptions, even if somebody authorizes it, isn't there some type – maybe because I'm coming into the whole privacy debate late in the cycle, I'm sort of way behind the curve here.
But I sort of feel at times that even an authorization can be signed kind of blindly. And then somebody may not be completely – I mean – unfortunately. And that maybe somebody is not 100 percent aware of sort of all the little fine print of what they have authorized and to the extent that that may, in fact, be happening in some of these contacts.
Wouldn't it make sense that there sort of be other protections there even if there's a signed authorization.
ROTHSTEIN: And I think that's a good point. It'll just change slightly.
In other words, we would say if there is an authorization required, then “Should it require clear, conspicuous blah, blah, blah.” And the other half of – if an authorization is not required, “Should marketing arrangements require clear, conspicuous blah, blah, blah?”
So I think that's a good suggestion, Stephanie (ph). I think we could put that on both sides.
“Should accounting for disclosures identify all the parties in interest?” And I think that's one of those that would be a both side issue. Now we've got special case marketing, minors and sensitive information. “Should there be special regulations for marketing to minors with marketing involving health information of marketing?” And that would be presumption stays the same. We're going to cut back somehow.
“Should there be special restrictions placed on marketing involving other forms of sensitive information such as psychiatric records?” Again, assuming that it stays the same.
And “Should the rule prohibit any disclosures to third parties such as business associates, about children or any sensitive medical information?” And this might be a both side issue because even if there is an authorization, you might limit the permissible range of authorizations to bar that.
On the regulations of methods we said these were both sides issues, which would include, “Should there be regulations to methods used in marketing such as voice mail, e-mail, et cetera?” “Should telephone solicitors be required to inform individuals of their relationship with the covered entity at the start of the call and that they may opt-out of all future contacts?” And I think that's something that should be considered regardless of the general thing.
So we have now very quickly gone through all of the issues and tried to identify under which presumptions we would consider which. And in some cases they would come under both.
Has that been helpful at all?
COHN (ph): Might be more helpful if we actually had the information in front of us.
ROTHSTEIN: Yes, you are certainly correct, sir. And what I'd like to do is get this to you in advance of the meeting.
In other words, I don't want to hand this piece of paper out 8:00 a.m. on the 27th. We need to have people come into the meeting having read this and having a position on all the various issues that they're prepared to defend or support, or whatever.
So Stephanie (ph) and I will work out some sort of timetable for getting this to you in advance of the meeting, although there's not a whole lot of time.
KAMINSKY (ph): I'm very open to help get it done end of this week. No problem.
ROTHSTEIN: Great.
COHN (ph): Maybe I just need to ask another question, which sounds like sort of the same question I asked about thirty minutes ago.
(INAUDIBLE) from OCR on the phone?
KAMINSKY (ph): This is Stephanie Kaminsky (ph). I'm with OCR now.
COHN (ph): Oh, you're with OCR. OK.
Is the timing – this letter is likely to come out about the 10th of March. Is that timing on marketing going to be helpful or is it just going to be very confusing?
KAMINSKY (ph): I'm too new to OCR to be able to give you an accurate answer on that.
I think that Sue McAndrew word from the subcommittee meeting a few weeks ago is the best information we have on that at this point.
COHN (ph): Unfortunately, I wasn't at the subcommittee meeting, so I have no idea.
DANAHER (ph) (?): Oh, I'm sorry, Simon (ph).
I might have mentioned this before you were on the call. I asked Sue McAndrew this specific question if we did not get a letter out until the 10th of March or so, would that still give time to OCR to consider the recommendations, and she said, “Yes.”
COHN (ph): Oh, OK. Thank you. It sounds like that question is already answered, then. Thank you.
ROTHSTEIN: So are there other things that we need to talk about in terms of marketing?
We're going to have, by the end of this week, a general discussion of I think what we agreed with John was a paragraph that would be available for the full committee. No. I guess that moots that.
If the whole subcommittee is going to meet, we can draft alternate paragraphs for the subcommittee. And they can vote for a changing of presumption or keeping the presumption, and before we take up the issue of which one of these specific ones on our list we want to include. So that kind of moots that, although we'll try to get as much of the letter written as we can just as background.
Is there anything that we need to do on marketing before we distribute all that material to you because we need to take up the issue of fundraising?
Hearing none, or maybe having worn you out already, I'll take up the issue of fundraising. You see on the agenda we have again sort of the main issue whether the current structure of fundraising coverage under the rule should be continued. And under this may be another one of those situations where it's framed basically the same way.
In other words, if we keep the presumption the same, that marketing – sorry – that fundraising should be considered under healthcare operations, then we've got some potential recommendations for either strengthening it from the fundraisers’ perspective.
And we have some proposals on that such as we see in our recommended list that I have some additional things that I see written comments on that will be incorporated. And then on the other side, if we want to reverse the presumption and say that an authorization is required, then there are some suggestions on that.
For example, under B2, if the current system is replaced with one requiring prior authorization for fundraising, should the authorization form be simplified for fundraising?
And then B3 is one of these regardless of the system should there be additional clarification on the transitional rules. There are no transitional rules for fundraising. There are general transitional rules for other matters. But it became clear after the hearing that maybe we need some transitional rules for fundraising as well.
I guess what I'm proposing is that for the fundraising we prepare a document that is similar to the one that we are preparing for the marketing, which would be sent out by the end of the week, which would have the general proposal which would be the presumption stays the same, the presumption is reversed, and then three different sets of recommendations are things to consider. One is if it's to stay the same presumption, here are some possibilities. If the presumption has changed, here are some possibilities. And then a third set, here are some things to consider regardless of whether the presumption is changed or stays the same.
COHN (ph): Mark, I almost understood what you just said.
And I feel really ignorant because on one hand I guess I'm trying to think in my own mind what the current rule on fundraising is as well as my own view is that fundraising for non – profit entities, which is really what we're talking about in research institutions, is a societal good that – I mean I guess in my mind I know it sounds like marketing. I think about it in a separate part of my mind.
ROTHSTEIN: I think that's an excellent point, Simon (ph).
I think there is a much stronger societal case for fundraising for nonprofit institutions than there is in marketing, you know, the latest lift chair to people who have a bad back. And I think our debate or our considerations, individually and collectively, certainly ought to keep that in mind and we don't want to throw the baby out with the bath water.
On the other hand, an argument could also be made that the fundraising rule does not sufficiently protect the privacy of protected health information the way it ought to. So, yeah, I think your point is a good one. Perhaps we do a disservice to all concerned by continually lumping, or seemingly lumping, fundraising with marketing when they are quite different things and social interests are distinct.
COHN (ph): And maybe that needs to be part of the letter.
ROTHSTEIN: Yes. I think that's a good suggestion. And when we prepare the draft letter I think we will make clear to the secretary that even though we consider these issues at the same time because in some respects they're related, they are different in several respects, including the following, and mention them.
COHN (ph): OK. Thank you.
ROTHSTEIN: Richard, anything that I need to ...
HARDING (ph): No, I think we've covered a good bit of ground in a short period of time.
You know I was just sitting here looking out the window with the rain coming down and so forth. And thinking that one of the things that struck me at the last hearings was somebody's statement – and I don't even know who it was – that the burden of protecting the individual's personal health information shouldn't be on the individual.
That is, if it gets out, it shouldn't be the citizen's obligation or expense or hassle factor, but that it should be the people who were using it. And it's just something that keeps ringing true and I keep kind of when I'm listening to these things thinking about where is the burden in these different scenarios? Who has the burden to protect and to recover that information, you know, if it does get out.
That was just a thought I was having.
ROTHSTEIN: And also it's a matter of expertise because even though you or I might view it as a burden to try to opt-out and check on all these possible uses of our PHI, for some people it's just totally out of the question.
They couldn't possibly do it even if they wanted to because they're just – they're not as educated with regard to how the healthcare system works or what their rights might be and so on.
HARDING (ph): Well, that's all. I think the plan that we had set up and hopefully with the change in the time of the meeting and so forth I think that we'll have some good recommendations.
ROTHSTEIN: Is Debbie Jackson (ph) still on?
KAMINSKY (ph): She stepped away. She'll be right back.
JACKSON (ph): I'm here now.
ROTHSTEIN: OK. I want to raise the issue and see if we can get this settled before we're off on how we're going to get the proposed revision of the full committee agenda taken care of.
Does that come through John or Marjory (ph) or ...
JACKSON (ph): We can take care of that. It looks like a switching around. It's not like a major revision.
ROTHSTEIN: Right. So let's just clarify that.
JACKSON (ph): Could I just indicate that it looks like the 2:00 spot we can do the subcommittee working sessions and just move them up earlier. It's really just a move – up. We don't have to consider pulling anything else in that spot.
ROTHSTEIN: Right.
JACKSON (ph): So it looks like your subcommittee working sessions would start 2:00 to 4:00 instead of currently indicated at 3:00 to 5:00. And then the next session would be on quality 4:00 to 5:00 or 5:30.
And they can use that time for the subcommittee working session or that working session.
ROTHSTEIN: That's right.
JACKSON (ph): The next morning then, since the work group on 21st Century and the subcommittee on privacy there is no overlapping membership can occur concurrently. I'm just trying to see about a room arrangement with Jackie (ph). That would be the 8:00 to 10:00 spot. Then starting at 10:10 convening in (INAUDIBLE) for the full committee meeting.
And then keep in mind the morning sessions are pretty well set in stone. So if you're looking at reviewing your material after your subcommittee sessions on that morning, the first time you will review the privacy material for the full committee would be after lunch, 1:00 or so. That sounds to me like something you're going – for the discussion the first time discussion with the full committee – I don't really see you in a position to take an action at that time.
ROTHSTEIN: Well, that's the only problem. And so we would need to work out with John and members of the committee, the full committee, depending on what their view is of our recommendations, some procedure for either authorizing the executive subcommittee to approve this or having a conference call of the full committee, or doing it by e-mail or something so that the committee would have a chance to see the final version.
COHN (ph): Well, Mark, why don't we do this.
I'm listening to this one and I'm concerned – I think, Debbie (ph), you made some very good points there and they're my issues, too, because this is somewhat picky stuff as well as very controversial stuff.
And if, indeed, we're at the point now where we've sort of put some things together and an in and out and we're going to do a draft letter, et cetera, why don't we take the time on the first day and have Richard at least air it with the full committee so we can get some feedback that would help inform our session the next morning.
ROTHSTEIN: You mean keep our 2:00 slot and let Richard distribute maybe our sheet, you know, with the two columns?
COHN (ph): OK. Let's just talk about what we're going to have. If, indeed, what we have the next morning is a sheet about what's in and what's out and we're sitting there discussing from 8:00 to 10:00 what's in and what's out, and then we're suddenly going to magically see somewhere between 10:00 and 1:00 a final letter that we're going to vote on at 1:00, I think you need to rethink that.
I don't think that that – there's no way that the national committee, or I for that matter, would even vote on something with that short a time frame and that sort of period to look at the actual wording.
If, indeed, there can be something put together that's sort of a draft letter, and maybe there are certain sections where we sort of divide out various issues for comments by the full committee or otherwise, that we can then take and sort of look at the next morning, I think that's all very doable. I mean, were you just planning on having a column A and column B for the meeting?
ROTHSTEIN: Well, I was planning to have that for the subcommittee and planning to have sort of a skeleton letter and we would just pop in the – whatever we decided on in particular.
But I think, Simon (ph), your suggestion is a good one, and if Richard is willing what we can do is keep the 2:00 slot on the first day and let Richard lead sort of a general discussion in the full committee of what we heard and what we're thinking about doing and how we are sort of analyzing the problem.
And that would really give us an idea and some guidance for what to do in our 8:00 meeting. And also it would save a lot of time at the 1:00 meeting where we don't have to sort of bring people up to speed on what the issues are.
COHN (ph): Yeah. And then sit there and read it for the first time.
If you're talking about pop-in, pop-out segments, you might structure this in a way where there are introductory paragraphs and then either numbered or bulleted things that come in so that those things can either be taken in or taken out without completely requiring a complete rewrite of the letter.
ROTHSTEIN: Yes. That's what I had in mind.
COHN (ph): OK. I think we can get to that point. I mean, Richard are you comfortable with that?
HARDING (ph): I am with a little bit of help framing it and so forth. I think I could do that.
COHN (ph): As I said I don't think we can realistically be there at 8:00 the second day and I think you'd lose your quorum very quickly.
HARDING (ph): No question about it.
COHN (ph): Now the other question – and I don't mean to jump into another issue, but we do need before the call is over to mull about a little bit about what it is we think we're going to need to do around the notice of proposed rule.
Since likely there will be a notice of proposed rule that comes out whenever. When it comes out when I see it. The person at this point, based on my history with the federal government and these NPRMs, but likely there will be a 30-day turnaround. So we're going to have a long turnaround and it's all going to happen imbetween meetings.
So we're going to have to come to the meeting suggesting a process about how we're going to respond, react, et cetera, and we'd better all be comfortable with it.
ROTHSTEIN: Yeah. That's a good thing to raise even though it's a disturbing thought. We will need to come up with some plan and probably have to arrange a couple of conference calls I would think. One to talk about certainly the issues that we want to weigh-in on. I mean, regardless of what they propose we can't in 30 days and at this late hour revisit every single issue.
We may want to pick out the issues that we have already discussed or have established positions on, or react to any sort of sweeping changes that are proposed. You know, we don't need to weigh-in on every sort of clean-up that they do.
For example, the first contact rule that is obviously going to be changed in the new NPRM is something we've weighed in on already and I don't see any need to …
HARDING (ph): Or we can cut and paste.
ROTHSTEIN: Yeah. So I think you're right, Simon (ph).
What we're going to – I don't know with only three of us on the call now we can establish anything, but we should ...
HARDING (ph): Well, I think this is really the role of the chair to propose a way to approach this and I actually don't' know what it is we're going to be seeing. Probably like everyone else, we're all somewhat in the dark. And I don't know whether it's going to be big or whether it's going to be small.
One of the things you may want to be thinking about – and this is just a thought – is that we may want to begin to block out some times either for conference calls or if we think it's a big enough thing to even have sort of a combination fly – in conference call or something like that where we really can spend a day developing something. If we think it's big enough.
And I'm not suggesting additional trips to Washington if I can avoid, but if it comes to a certain point where at four to six hours on a conference call where you say it just might be easier to get on a plane and do this face-to-face.
And that's something that – I mean, you just need to come up with whatever you think makes the most sense. But it's almost (INAUDIBLE). We'll need to in some way consider it on the second day in the morning to come up with an agreement on how we want to approach all of this.
ROTHSTEIN: Well, we're also going to have to talk with John because we need to have ...
HARDING (ph): … agreement by the full committee.
ROTHSTEIN: Exactly. Even if we reach agreement now we need some mechanism for the full committee to deal with it.
HARDING (ph): That's right. And we'll likely have the same issues for these other NPRMs on new administrative and financial transactions. But those are really going to be minor – that's not a big deal. This may be a bigger – a much bigger deal, anyway, just to confuse you, make things even worse.
UNIDENTIFIED PARTICIPANT: Well, I appreciate you doing that. I was starting to feel like I had a handle on things.
COHN (ph): And I think we've got – it sounds to me like we're getting – we've gotten the process together for dealing with this first letter.
Assuming it can be drafted at the point that Richard can do it. It's just that we'll need a couple of minutes on the agenda for the second morning to talk about how we want to approach this and propose a process, get sort of an agreement from the subcommittee members and then for the full committee about how we're going to deal with it when the NPRM comes out.
ROTHSTEIN: OK.
Stephanie (ph), what I'd like to propose while you're on is that I will draft a sort of a draft letter that we can move the pieces around on. But there are certain things that we need to sort of set out in the letter.
And if you would work on the – you know there are sort of three columns, if we change the presumption, if we keep the presumption, and regardless of what we do – those issues for both sets, marketing and fundraising. And if you can get that to me ...
KAMINSKY (ph): I can shoot for COB if you want.
ROTHSTEIN: That would be terrific. Let me tell you my schedule. I'm going to be out of town tomorrow and I'll be back Friday morning and then I'm flying to Washington. I'll be probably at my hotel by 3:00 on Friday.
How about if I call you Friday afternoon?
KAMINSKY (ph): OK.
ROTHSTEIN: And by then I should have your stuff and you should have my stuff and then we can – oh man, that's probably too late for everybody isn't it to get that in the hands of ...
Simon (ph), Richard, do you need our stuff in advance of the afternoon session that Richard is going to lead?
HARDING (ph): No. I mean if you had it that morning ...
ROTHSTEIN: Oh, clearly yes.
KAMINSKY (ph): I'm sorry. Were the dates of the meeting next that following week or Tuesday and Wednesday?
ROTHSTEIN: Tuesday and Wednesday.
KAMINSKY (ph): So if we finish up our work on Friday evening and I get something out people will have it Monday before they leave. I mean, hopefully.
ROTHSTEIN: OK. Would that be all right?
KAMINSKY (ph): Yeah.
DANAHER (ph) (?): Mark, I just want you to know that I've been back on for a bit. I apologize. I had something unavoidable. I apologize but I'm back on.
ROTHSTEIN: Oh, OK. Well, let me – OK. So that agreement is OK with you Stephanie (ph)? I will call you at 3:00 on Friday?
KAMINSKY (ph): Yeah. That's fine. I just want to make sure what our final products are for next week.
Are we going to just have a sort of letter with all the moveable pieces? Is that our final product? Or are we also going to have a kind of working paper that kind of more roughly kind of lists the issues in a sort of more flowed way?
UNIDENTIFIED PARTICIPANT: Both.
ROTHSTEIN: The draft letter that I'm working on is sort of like a structural letter without any meat on the bones and we need sort of the menu of issues ...
KAMINSKY (ph): OK. I understand.
ROTHSTEIN: ... under the presumptions so that we can actually flush those out. And I think the main thing that we can accomplish at the 2:00 session on Tuesday is to have the full committee aware of sort of what we're up to and to reach sort of a comfort level with the process.
John, I'm not sure when you came in or out so let me just bring you up to date.
DANAHER (ph) (?): Thank you.
ROTHSTEIN: I'm going to be drafting sort of a skeletal letter that I will work with Stephanie (ph) on and you will have it by Monday.
And Stephanie (ph) is going to work on sort of separating out the issues by category. In other words, which ones we need to consider if we keep the presumption the same, which ones we need to consider if we reverse the presumption, and which ones we need to consider in any event.
Richard is going to lead a general discussion of the full committee at 2:00 on Tuesday just to put the issues on the table. Then on Wednesday morning the 27th, the subcommittee will meet from 8:00 to 10:00 when presumably we will actually take a vote on which general presumption we want and which of the specifics we want to recommend to the full committee.
And then we will take those and incorporate them into the framework letter. So we will actually have a draft letter by 1:00 that we can give to the full committee.
The other thing that Simon (ph) raised is that I'm going to need to talk to John about a procedure for reacting to the NPRMs so that we can get comments in a timely manner from the subcommittee and then ultimately from the full committee, depending on whenever it comes out.
Am I leaving out anything?
KAMINSKY (ph): Just one thing. Richard, are you still on the line?
HARDING (ph): Yes, ma'am.
KAMINSKY (ph): OK. I just wanted to make sure you knew you were back on for 2:00 the first day.
HARDING (ph): I am. And what I would ask is some bullets.
KAMINSKY (ph): Yeah. That's what I'm trying to, kind of, glean. And that's sure.
HARDING (ph): If I can have the bullets, I can throw in the – fill in the details for the bullets to make sure that we get across and that they understand that we discussed and so forth, that'd be helpful.
KAMINSKY (ph): OK. I'll try.
HARDING (ph): Thank you.
ROTHSTEIN: OK. Everybody know what they need to do?
COHN (ph): I have a question. Are we going to be able to distribute this by e-mail this draft letter prior to the meeting on Tuesday for the full committee or are we going to basically walk in and hand it out when we start getting ready to talk?
ROTHSTEIN: I don't think that – the draft letter that I'm going to put together is going to be devoid of any substance.
COHN (ph): What?
ROTHSTEIN: Well, I'm going to say that we had the hearings, these were the issues, these were the concerns. But it's not going to have any recommendations because we haven't voted on them yet.
KAMINSKY (ph): But, Mark, will you have something do you think – when do you think you will have your piece completed?
ROTHSTEIN: I will have that completed – I hope to do that tonight.
KAMINSKY (ph): Because there's no – we can distribute everything that we have in the state that it's sent to anybody on the subcommittee in advance of everything.
ROTHSTEIN: Simon’s (ph) question was whether we should distribute that to the full committee.
KAMINSKY (ph): Oh. I'm sorry.
COHN (ph): Maybe I'm really confused about what the deliverables are. If what we're having is a nice paragraph and a nice conclusion – “Thank you very much for considering our recommendations” as a summary.
And then there's nothing in the middle as strawman (ph) proposals for how we might want to go forward to either be accepted or rejected in discussion by the full committee for us to work on further.
And the only thing we're going to list is the 35 issues that we just talked about in bulleted form without any recommendations around any of them. What exactly is the full committee going to react to the first day, what exactly are we going to have the second day? And how are we going to get to the final recommendations on the afternoon of the second day?
I guess I'm confused on that. I had thought we were going to say that you were going to take a stab at sort of taking your current views, the fact that we don't have a quorum – I guess now we have this quorum. We have a three to one vote on a particular direction.
We know it's not a quorum vote but this is like the best we could do. It's a very draft letter. You know something for the full committee to react to. Positions, knowing this is just a draft letter and then we refine it the next morning. Not that we have bullets of 15 items without any recommendations on any of them.
ROTHSTEIN: Well, I guess – I mean maybe I'll go back to an earlier proposal. Should I do two letters? Because what we – what we need to have is the rationale of why we want to recommend that we keep the same framework or change the same framework.
And that I certainly take a stab at putting together. But the specifics – I mean we haven't voted on and we won't be able to vote on until we have a full committee vote on which presumption we want to use.
COHN (ph): Let me just go way, way back. John, are you on the phone?
DANAHER (ph) (?): Yes.
COHN (ph): OK. I guess you were the one who voted against this idea of getting more strict except with a whole bunch of exceptions, is that right?
DANAHER (ph) (?): Say that again. I'm sorry.
COHN (ph): I heard about a three to one vote.
DANAHER (ph) (?): Right.
COHN (ph): And I'm presuming you're the one?
DANAHER (ph) (?): Yes.
COHN (ph): OK.
I guess the question I have is – and I didn't hear your initial issues, but is the issue just a fundamental no matter what we would do in terms of the exclusions that you would be uncomfortable with getting stricter except with a whole bunch of exceptions.
DANAHER (ph) (?): No. That's not the question that I could get comfortable with a whole bunch of exceptions.
Basically, where I sit is a belief that the public good is actually served by what – over the concerns of the public's privacy being violated by a whole host of activities that I believe go on in healthcare organizations that get grouped into the concept of marketing.
So – and I have – I think there's a greater good and it's got to do with all these activities that fall under disease management and other things that kind of they're in this gray area of marketing. And so in educating consumers, et cetera.
That's where I fall. So can I imagine that there's a whole bunch of exceptions and exclusions, et cetera that would get me comfortable? Sure.
KAMINSKY (ph): This is Stephanie (ph) again.
This is the point that I was trying to make earlier which is that it seems like the whole debate around the authorization piece is very different than the debate around the definition piece. And, John, from what you just said, it sounds like you're – the thrust of what you're saying revolved around the definition piece more even than around the authorization piece.
Is that not right?
DANAHER (ph) (?): Right. And that's what during the hearings – the subcommittee hearings that's what – so the answer is yes.
KAMINSKY (ph): So that's why every time we kind of talk about three to one, we've been talking about it around the authorization piece, I think. Haven't we?
DANAHER (ph) (?): Yeah.
ROTHSTEIN: That's right.
DANAHER (ph) (?): And we really didn't talk much about the definition piece.
KAMINSKY (ph): Right. That's what I was trying to raise earlier that I really feel like there are exceptions to the definition of marketing that kind of pull out what OCR tried – or whoever wrote the privacy rule or whatever, that they kind of try to clarify what are sort of treatment or what are part of networks, healthcare networks.
And that there are all these sort of fuzzy areas that are kind of part of day-to-day healthcare operations that are really not considered marketing, that are protected or carved out from sort of the general rules revolving around marketing. So I just want to be really clear about ...
DANAHER (ph) (?): Well, Stephanie (ph), to a point.
You see, I think that the – given the absence of that clarity, then I feel that the public good is better served. I feel very comfortable that the public is served once they're contacted that they have the option of opting out.
And so in the absence of clearly defining what those activities are I don't think that by requiring authorization to do marketing prevents people from getting information that I believe that they can be better served by rather to the possible violation to their privacy.
KAMINSKY (ph): So it does dovetail with the authorization quite well.
DANAHER (ph) (?): Right.
KAMINSKY (ph): All right.
DANAHER (ph) (?): And I think my position is very much – is very much in the minority. It's just having worked in health plans, having worked in environments where I've seen lots of good being done by people getting information and et cetera. Or third parties having access to that information. I just am a believer that it's – that it can serve, in other words ...
COHN (ph): Well, John, as you're talking I'm sort of reflecting on watching TV and the pharmacy act. And sort of laughing, which is nothing that would be precluded by any of these rules.
So, I mean, I guess it gets down to the individual issue. I was just trying to figure out whether or not we had enough of a support to basically try to move forward with a single view of how we craft this thing or whether, as Mark was commenting, we had to come up with two completely separate paradigms to sort of – I mean one being the way it is now, but obviously putting a whole bunch of exceptions on that side versus what we're talking about now which is tightening things but putting a whole bunch of exceptions in.
I guess what I'm hearing is that we probably don't have complete agreement. I am reminded, obviously, about the – what is it? The various testimonies back last year that were prior to the January hearing.
But anyway, Mark, what do you want to do?
ROTHSTEIN: Well, I think here's the problem procedurally.
Obviously, it would sort of move the debate forward if we could draft a proposed letter that would take a position. For example, at least taking a position as we have voted three to one to reverse the presumption subject to all sorts of exceptions we haven't considered. So that suggests doing that.
On the other hand, we don't have a majority vote of the actual members of the committee and I don't want to be in the position of seemingly trying to ram this rather fundamental change down the throats of committee members and I certainly don't want to stand on John's toes as the minority member.
The only thing that I would ask, John, is whether you think if I wrote a letter that recommended the general – in general going back to the NPRM view of requiring authorization subject to various exceptions that we haven't talked about but we obviously would – whether that would somehow prejudice your position or whether you would still be in a position to assert your views at the meeting of the subcommittee as well as the full committee?
DANAHER (ph) (?): Mark, whatever would lead to facilitating this process. I think it's important that our voice be heard and so whatever would be – I'd be comfortable with whatever will facilitate the process so that we can get the position of the subcommittee out there and – you know.
So whatever you choose is fine.
ROTHSTEIN: Well, I appreciate that, so how – without objection I'm going to change sort of the framework of the letter to be a statement that it's the recommendation of the committee that the position originally set forth in the NPRM is the better one for the following reasons, which I will set out, and also include a paragraph which indicates the value of marketing and that these positive values associated with marketing to these management education, et cetera, should not be lost.
And therefore to maintain those within a framework of protecting health information we recommend the following specific measures as well and just leave that blank.
DANAHER (ph) (?): That'd be fine.
COHN (ph): And per our previous conversation – you may have already discussed this – but I'm just sort of waking up now.
You guys got me here to the office at 7:00 a.m. So even with coffee I'm not the brightest in the world. But presuming the definition on previous testimony that we are someone recommending some special treatment for disease management with the definition that we received previously.
ROTHSTEIN: Right. Because remember the testimony we heard in August.
COHN (ph): My point exactly.
KAMINSKY (ph): But, Mark, even if you do write a letter like that, I can't provide for Richard a kind of bulleted format that goes through sort of both sides.
ROTHSTEIN: Absolutely because that will be valuable because somebody at the 2:00 meeting might say, “Well, can't we achieve the same thing without switching the presumption entirely?” And then Richard can say, “Well if you want to do that here are some ways in which we can sort of rein this stuff in.”
KAMINSKY (ph): Just two follow-up points.
One is would that bulleted thing be just for you, Richard, or do you want it for the whole group to look at together, or does that matter? I mean, is this just for your own eyes?
HARDING (ph): No. I think any information that I would had it would be helpful – I mean if it's in a format that is readable and so forth could be helpful to the whole group. I'm not coveting that for my own use.
KAMINSKY (ph): That's my general ...
HARDING (ph): It would have to be a little more detailed for it to be generally helpful. But if you have the time to do that.
KAMINSKY (ph): I'll try. Second follow-up point because I know we're running out of time. What were you going to do, Mark, about fundraising then?
ROTHSTEIN: Well, that's a good question.
We really didn't even talk at this level about fundraising. But I think fundraising is we need to debate the issue of fundraising but the specifics are so – it's a much simpler issue in the sense of all these specific issues about definitions and special rules and the like that we're going to have to consider for marketing we don't need to consider for fundraising.
I mean we've got a couple of important questions to decide and I'd like to decide that in the full committee – subcommittee meeting. So I don't know that we need to make a final decision on fundraising just yet.
COHN (ph): Well, I presume that our general view is that we are supportive of fundraising and supportive of nonprofit institutions doing it in a relatively unfettered fashion.
ROTHSTEIN: Well, we're also in support of privacy and we are also in support of – I mean there's a problem in the details.
There are proposals to allow healthcare fundraising to get access to more diagnostic information including what department they were treated in and that sort of thing that we clearly need to debate as a group.
KAMINSKY (ph): I guess I was wondering if you were going to try to take a similar stance like put together a letter of recommendation to the secretary that sort of took one of the two framework positions, i.e., we like it the way it is or we want to revert back to the way ...
ROTHSTEIN: I don't know that I'm in a position to do that. We haven't really even discussed that on the conference call.
I don't know what everybody's feelings are. Simon (ph) has talked a little bit about it but Richard and John haven't weighed in. So I just don't feel equipped to do that. I can draft some general language about needing to strike a balance, about – of supporting research and indigent care and all the other things that nonprofit hospitals do.
But also protecting the privacy of PHI and the reasonable expectation of patients with regard to whether they would or would not be solicited and how they are solicited.
DANAHER (ph) (?): Well, could we take a minute and find out what the other views of the other subcommittee members on the call are?
ROTHSTEIN: OK.
DANAHER (ph) (?): I would feel very badly if we spent all of our time dealing with marketing and we don't get a chance to in any way reflect on fundraising in this letter.
ROTHSTEIN: OK. Richard?
HARDING (ph): I'm trying to shape the question that you want me to answer and this is in the fundraising thing whether the current structure of fundraising coverage under the rule should be continued or not?
ROTHSTEIN: Right.
HARDING (ph): Again, fundraising does not cause me near the heartburn of marketing.
And I certainly would be the last person to want to decrease the ability of nonprofits to raise money and I think that the request from the large institutions to maybe have one more field available to them like a department is not a concern of mine – a great concern.
So I don't have much trouble with having that list of approved demographic information being amended. And really I've never heard any complaints from anybody about fundraising issues from nonprofits. So I'm reluctant to get in and mess with it much from what is being proposed.
DANAHER (ph) (?): I'm in agreement, also. This is John.
COHN (ph): I would like to see – I'm not sure I agree on the issue of expanding the fields to – to ...
HARDING (ph): Departments?
COHN (ph): ... departments. I mean I don't know that I want some hospital fundraiser to know that I was seen in the psychiatry department or in the oncology department or in whatever.
HARDING (ph): Well, we'd talked about that sensitive information or sensitive departments along those lines would be not included. But anything is sensitive.
KAMINSKY (ph): The question, though, that we were trying to start with, Mark, was whether or not we were going to keep just the general consensus around keeping the structure or recommending the structure remain as is versus revert back regardless of those sort of smaller ...
ROTHSTEIN: I would be comfortable writing a draft letter in which we say that we distinguish between fundraising and marketing in terms of the general approach that ought to be taken and then we can say why and then take up some of the specific issues in the fundraising area that are on both sides.
In terms of giving more demographic information that would be sort of opening it up. But there are proposals as well to make certain disclosures that would maybe narrow it somehow. So we can take up the specifics and there aren't that many as opposed to marketing and agree for the fundraising at least we will not recommend that there be a switch in the presumption. Is that OK?
DANAHER (ph) (?): Great.
HARDING (ph): Yeah.
ROTHSTEIN: And – well – thank you for holding our feet to the fire on that. So we have made I think more progress than it might appear.
And I will get working on that, Stephanie (ph), and in any event we'll send it to you by e-mail as soon as possible. We'll call you at 3:00 on Friday. We will copy the members of the subcommittee on everything and I hope that Jeff and Kepa (ph) and our new member Brady (ph) will read all the stuff and be ready to go by the subcommittee meeting.
Have I left out anything?
HARDING (ph): Hope not.
ROTHSTEIN: OK. Well, thank you Richard and John and Simon (ph), and Anthony and Stephanie (ph) and anybody else who's still left. Debbie (ph).
JACKSON (ph): Yeah. We're here.
COHN (ph): Mark, it sounds like the only change actually to the whole agenda as we've come to it is that we want to move the subcommittee to the next morning?
ROTHSTEIN: Right. So that I can attend. And I appreciate that.
COHN (ph): Yeah.
ROTHSTEIN: I think that's manageable.
HARDING (ph): We appreciate all the hard work you're doing, Mark.
ROTHSTEIN: It's amazing, you know. The more we debated stuff and the more we proposed stuff, we're winding up in the same place.
KAMINSKY (ph): That's a very good process.
ROTHSTEIN: Well, thanks everybody. I'll see you all next week.
END