[This Transcript is Unedited]
Room 705-A
Hubert H. Humphrey Building
200 Independence Avenue, S.W.
Washington, D.C. 20201
MR. ROTHSTEIN: Good morning. My name is Mark Rothstein. I am chair of the Subcommittee on Privacy and Confidentiality of the National Committee on Vital and Health Statistics. I want to welcome those of you on the Internet as well as those of you in person to our subcommittee hearing this morning, which follows on the heels of yesterday's full day of public testimony on issues related to marketing and fundraising under HIPAA.
Before we get started, as is customary, we will begin with introductions of those of us here who are live sort of, as well as disclosures.
So, I will begin. My name is Mark Rothstein. I am the director of the Institute for Bioethics Health Policy and Law at the University of Louisville School of Medicine and like all medical institutions, my institution does fundraising activities, although I have no idea how and I am not sure what effect anything that we would have to say would directly affect my institution, but I wanted to disclose that.
Richard.
DR. HARDING: I am Richard Harding, M.D. I am a child psychiatrist and professor of psychiatry and pediatrics at the University of South Carolina School of Medicine and, in addition, I am the president of the American Psychiatric Association and serve in that position until May of 2002.
DR. FITZMAURICE: I am Michael Fitzmaurice, senior science advisor for information technology in the Agency for Healthcare Research and Quality and government liaison to the National Committee on Vital and Health Statistics and staff to the Subcommittee on Standards and Security.
MS. KAMINSKY: I am Stephanie Kaminsky currently a health insurance specialist at the Centers for Medicare and Medicaid Services, soon to be a privacy program and policy specialist at the Office for Civil Rights at the Department of Health and Human Services.
MS. GREENBERG: I am Marjorie Greenberg, the National Center for Health Statistics, CDC and I am executive secretary to the committee.
DR. DANAHER: My name is John Danaher and I am a member of the advisory committee to NCVHS and a member of the subcommittee and I am also the CEO of a health care e-learning company that does provide HIPAA learning. I have made the appropriate disclosures and do not believe that my presence represents any conflict of interest.
MR. FANNING: I am John Fanning. I work in the Office of the Assistant Secretary for Planning and Evaluation of the Department of Health and Human Services and I am interim staff to the subcommittee.
MR. METTERS: I am Tom Metters, associate vice president at Lab Corps, a clinical laboratory company and an indirect provider. Just here to listen and learn about how these things might affect us.
MS. LUSTER: Hi. I am Kathy Luster with Patton Boggs.
MR. DANA: Good morning. Matt Dana(?) from Capital Associates.
MR. GOBEL: Paul Gobel with Chesapeake Research Review, an independent IRB and consulting company.
MS. FRIEBERG: Elizabeth Frieberg with Price Waterhouse Coopers as health care consulting practice.
MS. CASE: Kirsten Case at Olsen, Frank and Rudolph(?).
MR. ROTHSTEIN: Thank you and good morning to everyone.
Let me propose a schedule for this morning. As you know, we heard testimony in four different panels on two main topics. That is marketing and fundraising. At the moment, we are having copied the notes that I made yesterday or just last evening, based on yesterday's hearing, as well as the discussion of the recommendations that were made by each of the witnesses and some other issues that arose in our question and answer session.
What I proposed to do inasmuch as we only have three of the six subcommittee members is to see if we can frame the issues that we need to discuss with the full subcommittee, which we will do, I propose, as well by conference call to be set up as early as possible and a conference call that, of course, would be open to the public to dial in and listen to our discussions.
It is my expectation that we will have a recommendation to present to the full committee at the full committee meeting next month. If we fail to do that, then we will just have, I think, totally missed the necessary cycle, given the likely publication of the NPRM that everyone anticipates.
So, if there are no objections to that schedule, let me also add that given the nature of that schedule, it seems to me that we can eliminate the break that was scheduled on the agenda and proceed directly through our material and then it is my anticipation that we should be able to conclude our business by approximately 10:30 this morning. We will not need to go much beyond that.
So, are there any comments by subcommittee members on that outline of the agenda or proposed agenda?
DR. FITZMAURICE: It seems reasonable.
MR. ROTHSTEIN: Let me just very briefly go over
-- and I apologize. We don't have the paper copy yet and Michael takes much better notes than I do, so, please feel free to chime in.
What we have before us are basically three sets of proposals, two of which are very easy. We had a group of witnesses who said that the present HIPAA regulations dealing with the issue of marketing and fundraising is the right balance and that it basically should be retained.
We had another group of witnesses who said that it was the wrong balance, that it was irremediable and, therefore, should be just wiped out completely and we should recommend to the Secretary that the rule go back to the way it was proposed originally, which would mean that authorization would be required for all marketing and fundraising activity.
Those, I think, are pretty easy to summarize. Then there are a series of proposals that are in between, which would save some of the elements of the current rule and yet make various changes, some which we could characterize as minor and others which are pretty fundamental.
I think that it is probably -- I mean, we can spend time if you want talking about -- well, maybe we ought to talk about all of them. I think that is probably the fairest way to do it. So, let me characterize the witnesses -- thank you -- while you are reviewing the summary. What I also proposed to do is to take the panels, and that is reflected in your handout, slightly out of order in the sense that we go from Panel 1, Panel 2, Panel 4, then followed by the public witness and then separately Panel 3, which took up the issue primarily of fundraising. So, we will take up the marketing issues altogether as reflected in Panels 1, 2 and 4 and then separately Panel 3.
Then you will see at the end I listed as other issues and that is certainly not an all-inclusive list, just some other things that I noted and we can work on that and add to that as necessary.
So, let me give you all a couple of minutes to just digest this and then we can discuss some of the specifics. So, for those of you on the Internet, you can run to the refrigerator or wherever you need to run to and we will be back in a couple of minutes.
[Brief recess.]
I think the first thing that I would like to do or open the floor for before we get you the document is amendments to the working document in front of us, things that I misstated or omissions that --
DR. FITZMAURICE: Just a small touch on the No. 1 under Don Bell. That would make all communications by pharmacists not marketing. I guess a question, did he mean that would make all communications by pharmacists to be treatment?
MR. ROTHSTEIN: Yes, I believe --
DR. FITZMAURICE: I think that was the repositive way that he wanted it to come out.
MR. ROTHSTEIN: Sure. We can amend that. Everyone see where we are? We are under Don Bell, point No. 1, instead not marketing, we should make that treatment. So, I mean, his intent, I believe, was to say that anything that they did would not require a prior authorization because it was for the benefit of patients.
Marjorie.
MS. GREENBERG: What I recall especially is that he explicitly said that if it was clear that pharmacists could remind people about having to refill their prescriptions and tell them about alternative therapies, then it would be okay with him to, you know, get rid of the marketing.
MR. ROTHSTEIN: Was that in his written testimony or do you think that was in his --
MS. GREENBERG: It may have been spoken, but he said that a few times. His main concern seemed to be that the rule not prevent or require prior authorization or consider marketing, pharmacists reminding people about -- you know, sending refill reminders and being able to tell them about alternatives. But I think you are right. That was more in the question --
MR. ROTHSTEIN: I think it is an important point because that may be something that the committee wants to consider recommending.
MS. GREENBERG: If the rule isn't clear about that, it needs to be.
MR. ROTHSTEIN: How about if we add as a point 6 under Don Bell's recommendations, that refill reminders and notices about new products or --
MS. GREENBERG: Information on alternative therapies or something, but from the pharmacist.
MR. ROTHSTEIN: Right. And information from pharmacists.
DR. FITZMAURICE: That they are getting paid to do?
MR. ROTHSTEIN: Well, yes. Then we would have to debate that point. We might want to say that -- I mean, we might want to attach all sorts of conditions to that because those of us who have phoned in refill orders often get a phone message, you know, your refill is ready to be picked up, which I think is fine without a prior authorization. I wouldn't be happy if they called and said your Prozac, your, you know, AZT is here, et cetera.
So, we may want to attach certain conditions to that and the full committee may consider notice of it is time to refill your prescription to be akin to the kind of your prescription is ready to be picked up. We want to protect or not overly burden, let's put it that way. So, No. 6 would be refill reminders and information from pharmacists. Let's just leave it that and then we can attach conditions if w want to adopt that.
Other points to add? Stephanie?
MS. KAMINSKY: I just remember being struck by his introductory remarks about the sort of market-based health care system that we are all sort of a part of and that to some extent to reduce some of that marketing freedom might have some adverse impacts on prices and costs and competition. So, I don't know if that is --
MR. ROTHSTEIN: I think that is a good point and maybe before we get to the listed items, we can put that information promotes competition and benefits consumers. Would everyone be okay with that? So, that was a point that he did stress.
DR. HARDING: Mr. Chairman, in the first panel, you didn't have anything down that was said by Mr. Cividanes. Oh, okay, you did. You just had that he felt things were pretty good.
MR. ROTHSTEIN: Yes. He had no specific recommendations in either his written testimony or as I recollected from his oral testimony. I would be certainly happy to add stuff if I missed it.
DR. HARDING: The only thing that I wrote down that he mentioned was that marketing should be included in the PTO.
MR. ROTHSTEIN: Okay. Which it is.
DR. HARDING: At the present time.
MR. ROTHSTEIN: Yes.
DR. HARDING: Right. He just had that affirmative -- well --
MS. GREENBERG: I think also it was Mr. Cividanes who noted that privacy notice that is required will have disclosures about -- and tell people what is disclosed and what isn't and that they can opt out or ask for restrictions at that point, although it was then further noted that the provider doesn't have to agree.
MR. ROTHSTEIN: I think that is something worth adding. So, can we add under his testimony that the privacy notice will advise individuals of their right to request an opt out.
MS. GREENBERG: And will tell them if their personal health information is going to be used for any marketing purposes.
I know that the -- John, maybe you can help with this -- John Fanning -- the two Johns sitting next to each other there -- I know that the rule -- the provider doesn't have to do what is asked, but do they have to at least tell the person whether or not they are going to? Bob suggested that they don't even have to pay any attention to it.
MR. FANNING: Well, they certainly don't have to pay any attention to it.
MS. GREENBERG: I mean from the point of view of abiding. They don't have to abide by it.
MR. FANNING: No.
MS. GREENBERG: But does a person have to know that they didn't abide by it?
MR. FANNING: We can look at the text. I don't think it addresses that specifically, frankly.
MS. GREENBERG: I mean, if you say please do not leave do not leave any telephone messages for me -- you know, the provider says, well, you know, I haven't got any other way to communicate with you so I am going to, but doesn't tell you, you might be under the impression then that there are not going to be any telephone messages.
That seems a bit much if you aren't even informed.
MR. ROTHSTEIN: May I suggest that we add that because that was -- it is not clear where that came from in terms of the witnesses, that we add that to the end as under other issues as a No. 5, which would be clarify the rights of consumers following notice, et cetera. Would that be acceptable, Marjorie?
MR. FANNING: Well, Marjorie, there are two elements to allowed or specifically provided for patient requests. One is to request restrictions of uses and disclosures. The other is a request to be communicated with in a certain way. In neither case does it say that the organization has to indicate its willingness to do it or its rejection.
MR. ROTHSTEIN: Other comments or additions to the statements?
DR. DANAHER: I am not sure that this is the right time to bring it up, but thinking through this, I think all of the arguments, all of the different positions trace back to one fundamental point that you made yesterday. I think the fundamental question you asked yesterday is should it be PTOM or should it not be PTOM. I think fundamentally what happened yesterday was people shook out either on one side or the other of that issue.
So, on the "no" side, it was the College. It was Lambda. It was NAIC. It was APA. It was Gellman. On the "yes" side was Hopkins and it was NACDS and it was DMA and on the "yes" side, there were just some minor -- in my mind, some minor concessions that they would like putting in the, you know, department for fundraising, which I don't think in my mind would severely -- so, I think that -- and then on the people who don't believe that marketing should be part of PTOM -- and I think we are at this seminal question in the way you put it because we have chosen -- we think probably it is the right decision not to go down the slippery slope of trying to define out, figure out what is case management, what is disease management, you know, what represents -- in the absence of doing that, what we have done is kind of lumped in as part of PTOM.
So, I think for me at least, in thinking through all these different positions, we really have to -- if we go back to affirming that it should be PTOM, then I think we can deal with the people who are in favor of that, their issues, quite easily. I think the people who are against PTOM, that other group, then they just have one -- then they have a seminal fallback position for them.
That seminal fallback position is that they keep on -- they want, it seems, prior authorization. That seems to be kind of what they all -- as I was going back through.
MR. ROTHSTEIN: Well, if it is not part of PTO, then marketing and fundraising activities would require a prior authorization. So, it is not a method of implementing PTO/M, right?
DR. DANAHER: No. And I agree with you . If it is not -- but what they are saying, okay, it seems to me the people on the nay side are saying, okay, if you insist upon making it part of PTOM, then I want prior auth. The way to protect ourselves is to have prior auth.
MR. ROTHSTEIN: No, I think what they are -- I don't want to characterize it because their testimony speaks for itself and they are not, you know, monolithic. But I think what their position was is that it is inappropriate to consider marketing along with or treat it the same way as treatment payment or health care operations. Therefore, it needs to be separately dealt with and the way we deal separately with other things, like research, is to require prior authorization and then there are some other steps that they would like to see in addition to that in terms of how marketing ought to be regulated, even if there were authorization -- prior authorization.
I think their fallback position is, well, if there is no prior authorization required, in other words the framework stays the same, then they still have a series of proposals, some the same, some different, to regulate the circumstances under which marketing activities can take place as part of treatment, payment and health care operations.
DR. DANAHER: I agree with your characterization of that. That characterization is very helpful for me because I think as we go along these decisions, there are some very real branch point, you know, decisions that we make. What I am just trying to do is trying to aggregate and create some kind of order in terms of how we can make logical decisions based upon what we heard.
MR. ROTHSTEIN: Well, I think that is very helpful and, of course, as I said earlier and I think the subcommittee members agreed with, with only three of the six members, we can't make a substantive call today on what we are going to recommend to the full committee. But I think your point is a very good one and that is to the extent that we can frame the issues for our colleagues, who were unable to be here, that will help us streamline our conference call and focus our debate on these specific branch points, as you say.
What we will do is we will supply our absent colleagues with copies of the written testimony, as well as the summary in its revised form and so that they can prepare for our conference call. In addition, maybe we can come up with some sort of structured agenda for the conference call in which we sort of go through this branching tree or however we want to characterize it.
DR. DANAHER: Thank you. Thank you very much.
MR. ROTHSTEIN: Are there other comments, amendments to the draft document?
Marjorie.
MS. GREENBERG: I don't know if you have anything in this draft about the Gramm something Bliley.
MR. ROTHSTEIN: Gramm-Leach-Bliley?
MS. GREENBERG: Yes, because that was raised several times as actually at least on the opt out, I think, provisions being more consumer friendly, although I think a few people also said, well, at least, I know the last -- the public testimony said it wasn't working, but there did seem to be a number of suggestions that from the point of view if you are going to have an opt out, look at that, that it offered something better or at least offered some precedent.
MR. ROTHSTEIN: Your recollection is in accord with mine. I didn't mention it here, although I did try to characterize which witnesses said that they were opposed to opting in or opting out. We can --
MS. GREENBERG: -- that looked like a new alternative.
MR. ROTHSTEIN: What we can do is add as a point No. 6 on other issues, consideration of other opting models, including Gramm-Leach-Bliley.
DR. FITZMAURICE: Mark, there wasn't an awful lot that I found applicable in Gramm-Leach-Bliley, except the difference is that it permits an opt out before you get contacted for a purpose as opposed to the privacy rule lets you opt out only after the first contact. It did give notices out to everybody. So, that may be a second difference from the privacy rule. You have to mail them out to a given address that your financial institution has.
I didn't find the scope to be very overlapping. It overlapped with insurance companies, financial institutions, not particularly providers or clearinghouses. So, it may be a model to look at, but we need to look at it for lessons to be applied to the privacy rule as opposed to let's follow something in the Gramm-Leach-Bliley.
MR. ROTHSTEIN: Exactly. I think that is a very good point. So, we could make point No. 6 something like consideration of other opting models, for example, under Gramm-Leach-Bliley opt out can occur before the first contact.
MS. GREENBERG: It seemed especially galling to people that someone had to be contacted before they could -- to those who were against the current law, rule.
MR. ROTHSTEIN: Richard.
DR. HARDING: I have a series of questions that I just wrote down about that I don't know if we should take a stand on or what, but then just see if these fit into anything. Seven of them right now. I have gotten that far.
Should PTOM be modified in some way? That is a question.
Two, should indirect providers, that is, labs, radiologists and so forth, indirect providers, be further regulated? Should minors be marketed? Should voice mail and e-mail solicitation be restricted? These are things that are in here in some ways.
I am just trying to see what the issue is. Should opt out and opt in be specific or general? That is, can you get out of everything by opting in or out or is it all one thing at a time throughout?
Should sensitive information, quote, sensitive information, be further restricted? Should the burden of all this be on the patient, provider or marketer?
Those are just questions that I think are in here, but seemed to me things that keep coming up that -- and there are many more, too, that somebody needs to make a decision on and wonder if that is the duty of the full subcommittee to come up with recommendations to the committee on some of those things and maybe not all of them are our venue, but I just kind of wondered what to do with those kind of questions eventually.
MR. ROTHSTEIN: I think that is an excellent starting point. Let me suggest how we might use that information that you have listed.
Suppose we took up at our conference call as a first issue. Whether we want to recommend that the structure remain the same, in other words, that marketing be covered under certain circumstances, under the rules applicable to treatment, payment and health care operations or we want to recommend that the marketing provisions be deleted from their existing structure and be replaced with something else.
Then it seems to me that irrespective of our decision at that first point, we will still need to address the issues that you set out and perhaps others that we could list as well because we could, for example, decide that marketing should still be within treatment, payment and health care operations, but yet recommend that marketing to minors, there would be a special provision for that.
So, would that be in accord with your thinking, John?
DR. DANAHER: I think that is the place we have to start. I agree.
MR. ROTHSTEIN: Okay. So, let's assume that is our -- the first question is for our discussion on our conference call, should it be -- you know, should the basic structure remain the same, marketing -- we are going to talk about fundraising separately. So, we are just talking about marketing now. Should marketing be within the definition of health care operations or should it not?
Then regardless of the answer, we can now tailor our responses on these specific issues to the framework that we decide upon. I think the advantage of that also in framing the issue is when we go to the full committee, we can explain our rationale more clearly. Let's say hypothetically, the full committee wants to go a different route. Let's say we decide we want to keep it under health care operations and they don't. Well, then it would be less traumatic to just go back up the tree and be now on the side of, all right, how are we going to regulate, given the fact that it is not under health care operations because then we would still need to face the same issue of whether we would want to regulate the methods of marketing, et cetera.
So, maybe we can go through your list again
more --
DR. HARDING: Do Margie and John and, you know, Mike and so forth feel that that is a reasonable way to go, I mean, from the standpoint of the Department?
MR. FANNING: I don't know that there is any -- the Department doesn't have a standpoint.
MS. GREENBERG: It is a question of sort of which comes first, the chicken or the egg, to some degree. I mean, you could start off that way and I think it would certainly be good to get a sense of how each member feels. Of course, the people who aren't here have to have done their homework because we want their opinion to be informed by what you heard yesterday.
I can see you kind of coming out one place and then once you work through all the issues maybe revisiting.
MR. ROTHSTEIN: Yes. You certainly could make an argument that we ought to do it exactly the opposite way, that we ought to go through the list of all the things that we are concerned about and once we figure out how we want to deal with them, it will become self-evident which major decision we should make.
On the other hand, there is nothing to stop us from doing both at the same time, starting from the general proposition and working to the narrow proposition and then reconsidering the general proposition.
MS. GREENBERG: Conductive and inductive.
MR. ROTHSTEIN: Absolutely.
Yes, please.
MS. FRIEBERG: Elizabeth Frieberg, Price, Waterhouse Coopers.
Just for a point of clarification as you have this discussion that might be helpful, my understanding about what piece of marketing is currently addressed in the TPO area is the marketing exceptions versus other types of marketing. When you are discussing it here, you are referring to marketing and I think that may be confusing for those of us who are listening because I think the exceptions do address a lot of the concerns that we have heard in yesterday's testimony about places and times and processes in which it is appropriate or falls under a treatment category.
So, I was just hoping that you might try to speak to those two things as separate issues.
MR. ROTHSTEIN: I appreciate that clarification. We are talking about the three exceptions in the rule. Sometimes we get sort of in our own little world. We are talking about face-to-face contact. We are talking about the nominal value exception and we are talking about the third party uses exception and all the various things that come under that.
Certainly if you -- we want to make it clear to those listening who aren't -- who don't have copies of the regs in front of them that under no consideration, I believe, is the idea that medical information is going to be auctioned on the Internet somehow and that would qualify as marketing under, you know, treatment, payment and anything else you wanted to do.
So, thank you for that clarification. We will try to be more precise in our discussion.
MR. FANNING: Mr. Chairman, back to your first question, I don't think it makes a whole lot of difference what order you take it up in, as long as you set it out precisely one way or another. So, then when you are going through, let's say, the first question, if that -- if some answer there becomes dependent on the substance that we have in the second category, we would at least know where it fits and it doesn't get fuzzed up.
As you point out, it could be done in either direction.
MR. ROTHSTEIN: So, let's just start out with the general proposition and then work to the specific. At least for our purpose today of framing the issues for our conference call, it may well be easier for our colleagues. That is our main concern because under no set of circumstances are we going to be drafting anything of the specificity that HHS will do.
So, the first big question is, of course, should some marketing exceptions be within treatment, payment, health care operations? If not, then marketing and its exceptions would both be requiring prior authorization. Then we have the series of more specific questions.
I wonder if we could go through your list, Richard, slowly, so that everybody can get that and then we can perhaps add other things that --
DR. HARDING: It was just a start of -- I just started writing them down.
There was the issue of indirect providers, such as laboratories and radiology. Should there be further regulation there or control of information that they receive?
MR. ROTHSTEIN: Further regulation or clarification of the role of indirect providers.
DR. HARDING: Right.
And then should minors have special status, I guess, in some way or should they be regulated some way different than adults?
Should voice mail, e-mail, solicitation be restricted or regulated in some way?
MR. ROTHSTEIN: A third is should there be special restrictions on voice mail, e-mail and other methods?
DR. HARDING: Yes.
MS. GREENBERG: It is related to marketing?
MR. ROTHSTEIN: Yes.
DR. HARDING: That is the -- you know, sending out a voice mail to phones and people picking up and so forth.
Should the opt out or opt in be specific or generalized to all, quote, marketing? That was the issue of having a bunch of different things to opt out. Somebody said they had 30 different things that they were trying to opt out on.
The issue of sensitive information, should that be defined, further restricted? What should we do with sensitive -- is there a definition or is it just a morass?
Then a fundamental issue of the burden, should the burden be on patients, providers or using the word "marketers." I don't know what the word would be there.
MR. ROTHSTEIN: Third parties?
DR. HARDING: Third parties.
MR. ROTHSTEIN: I have six.
DR. HARDING: That is all I wrote down. I was just starting out. I will try to do some more here, but that is what I wrote.
MR. ROTHSTEIN: Well, perhaps we should at this point go to the end of the document and see how many of the other issues we have captured.
I think this does go to the issue of No. 3, the special restrictions on voice mail, e-mail, et cetera, at least No. 1. Although No. 2 goes beyond that, in other words requiring a more specific script for telemarketing, where they identify up front who they are, as opposed to right before you hang up, after you have made the sale. So, I would like to, if there is no objection, retain No. 2.
No. 3, okay, we have talked about that. No. 4, this really is a fundraising issue that came from Hopkins. I would like to defer on that. No. 5 is one we added this morning. Clarify the rights of consumers following notice and request by a consumer to opt out. So, I would like to add that without objection.
DR. FITZMAURICE: State it again. Should we --
MR. ROTHSTEIN: Should HHS clarify the rights of consumers following receipt of notice -- now, this is, of course, based upon the current framework -- at a request by consumers to opt out and the question was, well, do they have to be informed that they are not going to be -- that it is not going to be followed, et cetera. Isn't that --
MR. FANNING: Yes. That was Marjorie's point.
MS. GREENBERG: Well, it was somebody else's before --
MR. ROTHSTEIN: No. 6 on the list is consideration of other opting models, such as used under GLB, where the consumer is allowed to opt out before the first contact.
Now, have we -- I think what we need to do is go back -- maybe the members of the committee have done it while I have been talking -- and make sure that we have captured all of the other issues that were in the testimony from the witnesses.
So, for example, under the Gellman proposals, there are a whole series of them, such as prohibiting any disclosures involving any payment or compensation. What we could do, rather than go through all of these, is in a separate document that I will prepare with staff, list all of the other specific proposals that we have received. Then we can, you know, deal with them on the conference call, rather than go through each one of them because we can read what they are. Is that agreeable?
Have I missed anything from the testimony? Of course, the commend period is open for another week and we may get other things that will come in, in which case we would have to add them to our list.
Michael, did I do better than usual this time?
DR. FITZMAURICE: You are doing fine.
DR. HARDING: Is everybody clear about what the difference is between marketing and treatment?
MR. ROTHSTEIN: Is this a quiz?
DR. HARDING: I am sorry. I just still -- you know, the definition that Don Bell suggested there in No. 1, should be -- the definition of "marketing" should be changed to a principal purpose of a communication is to sell a product or service that is not related to the health of the patient. Well, you know, you can sell a product that is related to the health or that seems to me is marketing. If I go in and ask for my Lipitor and the pharmacist says, hey, we have got something even better than that and wants me to switch over, that is related to my health and that is marketing.
MR. ROTHSTEIN: Well, I think his point was that by adding the principal purpose as opposed to a purpose, that somehow tightens it up, although "principal" is a word that can be construed in a variety of ways. You will recall that when we had our August hearings, the Disease Management Association had a definition where they wanted to say the primary purpose of the communication and it is debatable whether those sorts of modifications would be of much help.
DR. DANAHER: We are going to have to tease you, Mark, that "principal" can have a number of connotations, especially if it is spelled a-l instead of p-l-e.
MS. GREENBERG: But even more important than the principal or the primary, they added this thing it is not related to the health of the patient. Well, that is --
MR. FANNING: Exactly.
MS. GREENBERG: -- out of scope, obviously.
MR. FANNING: Exactly. The result of this is that I think everything that we are talking about would be clearly allowed with no further requirements or fuss.
MS. GREENBERG: I mean, because we are not talking about things that aren't related to the health of the patient. If the pharmacist tried to sell you his used car, I mean, you know, this -- I suppose you could even relate that to the health of the patient.
MR. ROTHSTEIN: I think we should make no mistake about the fact that for -- and this is not an editorial comment that Mr. Bell was recommending not the status quo but actually an expansion of the leeway given to pharmacists in the area of marketing. One more general issue that we might want to consider is instead of trying to regulate what is going on, we might want to recommend that the department regulate by who is doing it.
So, in other words, we have basically taken that position with regards to physicians and we have said that when physicians have communications with their patients, even if it involves a product, you know, you need to get off Zocor and onto Lipitor or whatever, that is okay. We haven't done that expressly with other health professionals or with any indirect providers. That may not work either.
But all I am suggesting is it represents, I think, a slightly different approach to this situation that arguably gets away from the principal purpose dilemma that we have identified.
Marjorie?
MS. GREENBERG: Is it the case that the rule only makes that clear for physicians or is it for any health care provider? Is a pharmacist a health care provider?
MR. FANNING: I don't think the regulation distinguishes among providers.
MR. ROTHSTEIN: But it says patients, okay -- a communication with a patient now is a -- someone who uses a pharmacy, their relationship with a pharmacist, I don't think, would be characterized as a pharmacist/patient relationship; whereas, it would be with a nurse or a doctor or -- I may be wrong.
MR. FANNING: No. I think the regulation envisions that patient is used for all of these relationships.
MS. GREENBERG: Although I did think that he indicated that that wasn't clear, that if it were -- I mean, that is why I got back to what I said were kind of like his bottom lines seemed to be. I didn't write down his exact words, but the very last thing he said sort of was if it is clarified that pharmacists can, you know, remind people, send refill notices and tell people about alternative treatments, then it is okay -- then the marketing exceptions aren't necessary, that the concern of his organization was that pharmacists perhaps did not have that same clear right to do that without prior authorization, that other types of health care providers did.
MR. ROTHSTEIN: Well, certainly, that would be something we might want to clarify, but there are a whole range of health care products and services offered by pharmacies today. They are more like department stores in many regards than the old-fashioned corner drug store. Not to get to the merits, but that may well be an overly broad way of viewing things. Okay.
MS. GREENBERG: Since we are making disclaimers, whatever, I probably should acknowledge that both my father and my brother-in-law are pharmacists. Just trying to be completely open here.
But that is what I heard him say and you are right, I mean, this pharmacist has a lot of medical supplies that pharmacists or pharmacies make available. So, I don't know.
DR. DANAHER: See, that is what I think he was trying to capture. I don't think it says this well, but I think Mark's point is what he -- Don Bell was trying to capture and that is if the pharmacist is in a therapeutic relationship with a patient, i.e., he is dispensing medications that --
MS. GREENBERG: Supplies --
DR. DANAHER: Right. Exactly. You know, that there is a prescription or whatever. But when in kind of the Wal-Mart definition of pharmacist, they have a whole bunch of other things. They are not directly related to health and, again, the health, I think, is a wide definition than that is -- you know, so I think he was just trying to get more latitude.
MS. KAMINSKY: But I also kind of want to come back to a point that was raised earlier that I think there may be a slight nuance there about whether there is remuneration going on to the pharmacist by some third party or not and how that sort of shifts the treatment marketing paradigm.
MS. GREENBERG: Even with physicians, I mean, I know this came up, although a physician should be -- the rule does not want to prevent a physician from any kind of communication with his or her patient, does there have to be some disclosure if actually the physician has a third party -- has, you know, some kind of fiduciary relationship like I think really should go to this nursing home, which by the way I own or this medication, which I actually have a, you know, an interest in. Does the rule speak to that? I mean, that gets back to maybe it is not -- well, you were starting to say it is not so much what you say but who says it and also and what caveats maybe you have to provide or what disclosures you have to provide.
MR. ROTHSTEIN: I think that is exactly right and one of the things that I was trying to pursue with a couple of the witnesses yesterday, you may recall, is whether there were in place active investigations and active self-regulation in the professions, where inappropriate marketing by the health professionals would be dealt with, the assumption being if that were the case, then you could make a stronger argument that let's just list whole categories of individuals who can engage in these health-related contacts with patients and assume that if they sort of crossed the line, that they will be dealt with by their, you know, professional bodies and that might be the easiest way of doing it.
Of course, I was not convinced of that yesterday because nobody seemed to say that that was either going on or likely to go on. If that were the case, I think it would make regulation a little easier from the HIPAA standpoint.
MS. GREENBERG: You have got two pieces there. One is whether there is a code of ethics that the professional subscribes to. The other is whether anybody monitors it or polices it.
MR. ROTHSTEIN: Right. So, let's get back to sort of an assessment of where we are. On the first issue of marketing, we are in our pre-conference call document. We will have as the first issue to consider whether it should be -- the exceptions should remain as exceptions and, therefore, allow health-related marketing under the three exceptions or whether we should recommend that those be wiped out and even the exception circumstances be related to areas where we need authorizations.
Then regardless of how we come down on that, we then still need to consider a range of specific issues and those are the issues, the six that Richard gave us, Nos. 2, 5 and 6 from the additional issues list at the end of your written document, plus others that I will add based on the testimony that are already incorporated into the document in front of us.
Is that agreeable to the members?
DR. FITZMAURICE: Yes.
MR. ROTHSTEIN: Is there anything else that we need to do with respect to the issue of marketing?
DR. DANAHER: Mark, do you feel that the subcommittee should take a position in regard to these issues in -- you know, or should we work through them on the conference call?
MR. ROTHSTEIN: Oh, in other words, should the three of us basically take a position before we get to the conference call? Well, I don't want to give my view. Give me your view.
DR. DANAHER: From a process point of view, I think it would go more smoothly. The call would go more quickly and be wrapped up quicker. I think for us to walk in there and not have figured out what our own position is, having -- it will only turn it into a, you know -- so, my recommendation is it would facilitate the decision-making process.
MR. ROTHSTEIN: Thank you for that position. Now I will give you my rationale for a contrary position. The subcommittee and to a lesser extent, the full committee tends to review issues de novo and I think, given that there are only three of us, they may well feel that they are being steamrollered. I don't know what we are going to decide, but I just -- I think as a process question and maybe even as a matter of expediting the thing, if we can frame the issues clearly and expect that we will re-read the documents and that the other members will read them in advance, maybe we can make up our own minds and have an informed discussion, but I don't know how valuable it would be, John, to -- where we vote 2 to 1 to do something and then bring it to the rest of the committee.
Marjorie.
MS. GREENBERG: Slightly a side issue to that, but I think it would be good to hear from the three of you as to whether you feel you received adequate testimony to at least, you know, make some recommendations. I mean, I know in the past you did not.
I thought that it was very informative, but -- and whether you feel like you have heard from enough people or that there weren't any real, you know, gaping holes there that you feel you can now proceed because I think you are going to have to tell the rest of them that because they weren't really here and --
MR. ROTHSTEIN: I think there is no comparison between what we heard yesterday and what we heard in August in terms of the depth and breadth of the testimony and the discussion. I feel confident that I have a fair appreciation for the views of the parties and the interests and issues on both topics, that I didn't have before.
So, speaking for myself, I think that we are ready to proceed.
Richard?
DR. HARDING: What I would, I think, appreciate for the phone conference call would be that for us to have these type of questions and then have from the testimony kind of both sides. Should minors be marketed? On the positive, you know, it is a burden to pull out all the ages and -- or, you know, whatever the statement would be as to the positives of having uniformity and so forth and then the positives of why that might be a problem for somebody in a different developmental level than an adult.
Then let us recommend -- if they would like those present to say they came out at at the end of the hearing, I would be glad to give my straw poll hand up, but I think that I would tend to agree with you, that understanding the sensitivities of committees here and other places, that if we have strong opinions about things, I think, a few will get through and then we will argue them to death after that. I think having a little bit of open-endedness for the -- with the facts there on both sides to look at, I think, would be probably the ideal way to go.
If they want to know what we think, tell them.
MR. ROTHSTEIN: I have no doubt that we will be forthcoming with our opinions. The only concern I have with that suggestion, which sounds really good in theory, is that on many of these issues, they were not specifically addressed by more than one person. Some of them are issues that basically we developed ourselves as a result of hearing the testimony. So, it is not like we can go back to the transcript and say, you know, quote whole passages from page 35 for the pro side and page 42 for the con side.
That is the reservation I would have. For example, just the issue of minors, I mean, we talked about it, but I don't know that we had the full discussion that -- and also I am not sure if some of these issues require the expertise of the witnesses. I mean, the witnesses provided us with important information about sort of how things work in their industry, what their concerns are, what their viewpoints are.
Now we are more at a sort of a policy level, having received that factual input and now we know what the issue is with sensitive information, but as a policy matter, is it practical to pull that out? Do the advantages of trying to do that outweigh the risks of whatever?
Michael, did you want to comment?
DR. FITZMAURICE: I would just say that you may not want to make recommendations to the subcommittee but just like I would ask my doctor, after giving me all the facts, doc, if this were a member of your family, what would you do. They are going to say you three were here. What do you think?
To the degree that you can look at each other now in the eye and say, yes, yes, I think we agree on this, then you form a sense --
MR. ROTHSTEIN: Michael, which member of the subcommittee who is not here is going to ask --
DR. FITZMAURICE: They are all going to want to know what -- you were here. What do you think? And you can't see each other on the phone, but here you have a face-to-face ability to get a sense of -- this is an important issue, this is not an important issue. Yes, I think we agree that this ought to be included or this ought to modified or this ought to be clarified.
MR. FANNING: Michael, do you think that the bearing and demeanor of the witnesses are relevant to those determinations?
DR. FITZMAURICE: I think the interpretations of the people with first hand evidence and the ability to ask questions to pursue the problems or to get additional information is very important.
MR. ROTHSTEIN: I think to the extent that we can claim some degree of deference based on having heard the testimony first hand, we will attempt to do so.
Marjorie.
MS. GREENBERG: Just from historical point of view and John certainly recalls this, John Fanning, but for those of you who weren't around with this committee back when HIPAA first came around -- and it is certainly -- just as it is a woman's prerogative to change her mind, it is certainly a committee's prerogative to change its mind. But it probably just might be worth noting that on the issue of sensitive issues and sensitive information, when the committee made its report to Congress back in, I don't know, 1997, was it, or so, a report that was required -- actually when Bob Gellman was chair of the subcommittee -- I think the committee came out against treating some issues as sensitive and others not, but basically saying kind of what you said yesterday, Richard, that what is sensitive to one person may not be to another and vice-versa and that probably information should be given the same level.
I don't know if the committee commented on psychotherapy notes. I mean, that is the exception, isn't it, in the notes, not psychiatric, all psychiatric information, but the notes. But I mean that was the -- it is on the web site, but that was a position the committee took at that time. So, it is just worth knowing.
I mean, trying to change your mind but it is good to know if you did.
MR. FANNING: As I recall, the committee did say that. That was the position of the administration in its recommendations to Congress in the regulation. Now, Professor Rothstein has done a lot of work in the area of genetics and is familiar in detail with the issues of distinguishing types of information.
We have come to the conclusion around here that there is no way of saying it effectively for this type of regulation. Let's just set aside the business of genetic discrimination laws and things like that. I don't mean to address that, but for a general data control enactment, it is very difficult to specify what is sensitive.
MR. ROTHSTEIN: And it may well be that the issue will go away based on some of the other things that we decide. So, for example, if we as a subcommittee decided that we wanted to recommend a series of restrictions placed on the method of contact, no voice mail, no e-mail unless specifically authorized, et cetera, et cetera, et cetera, then it may well be the case that you need to worry less about sensitive information because you are -- or making distinctions amongst sensitive information because all information will be communicated in an appropriate manner. So, the issue may go away depending on what we do with some of the other recommendations.
MR. FANNING: Another thing that helps it go away is giving people individual choice about particular uses. If you see an occasional article suggesting a great computer scheme where people could identify bits of their record as requiring more care and confidentiality than others. Now, as a practical matter, designing a system like that of a present set up of records is -- you know, it is a curious fantasy. But the concept is there of letting people decide, but the business of saying don't contact me at home, a person might do that with respect to a particular practitioner who provides services with respect to a service that that person perceives as sensitive.
MS. GREENBERG: I still can't believe that that man's wife didn't know that he wore dentures.
MR. FANNING: Each person gets to decide and arrange his life the way he wants and we should set up a system that enables people to carry that out.
MR. ROTHSTEIN: Any other comments? I think we are relatively comfortable with the marketing outline so far.
MR. FANNING: Mr. Chairman, your last item here is called "Other Issues." Is it really other issues or is it some different type of categorization?
MR. ROTHSTEIN: It is issues that did not come specifically from the witnesses in their written testimony. They are issues generated by the subcommittee or that arose through the questioning. So, perhaps I should -- well, they are going to be integrated into a new list. So, it won't even appear that way.
MR. FANNING: That is right. It is not a serious issue.
MR. ROTHSTEIN: Okay. Let's move then to the issue of fundraising and you will note, of course, that we skipped our discussion so far on the Panel 3. So, let me give each of you a minute to refresh your recollection of the brief summary I have from the two witnesses on fundraising and also note for you that a couple of the other witnesses also made statements with regard to fundraising. For example, Mr. Adams yesterday said the same provisions that he advocated for marketing should also apply to fundraising and I think some other witnesses did as well.
Ms. Serkes also made that same comment. In a method similar to the one that we have embraced for marketing, in other words, take up as our initial question for the conference call the issue of whether fundraising should be within treatment, payment, health care operations or whether it should be removed. Regardless of the answer to that question, then consider some of the specific issues that were raised by the witnesses and some of our questioning.
Is that agreeable? Okay. So, let me see if I can clarify or ask for additional information. On Ms. Pollak's testimony, the three points here are based on all different assumptions. The first one, if the fundraising remains within health care operations, she would like -- and this would be her top pick, of course -- that the list of demographic information that can be used should be expanded to include the name of the doctor and/or the department that the individual was seen in.
Now, I characterized No. 2 as her backup position is -- and please correct me if I am misstating this, that if authorization is required, in other words, if we make the major decision to move fundraising out of health care operations and an authorization is required, that some special simplified authorization form be authorized in the regulations.
The third one, I think, the third point is notwithstanding what we do on the big issue, there are transitional problems that have not yet been addressed. The regs dealing with transitional issues mostly go to consent type issues and not these non-medical uses.
So, those are the three sort of specific issues that were presented to us. I suppose an additional one, borrowing from the other issues category would be should the regulations put any procedural restrictions on fundraising efforts; in other words, disclosures made on the telephone or method of contact, et cetera.
So, let me open the floor for refinements of that or additions, amendments.
DR. HARDING: Ms. Pollak also brought up the issue of sensitive information and, you know, the -- should there be different marketing rules for the department or division of psychiatry or some other area, which gets back to the sensitive issue. That was brought up in this.
Also, the statement by Mr. McGinley about there haven't been many complaints. I tend to agree with that. I have not heard many complaints about fundraising. I would like to hear if others have because it seems to be -- you know, I have looked around for some example and apocryphal or real and really have not found a lot of clear abuses of this and just wonder if others have had -- have heard of a number of abuses of the hospital, a not-for-profit, abusing that privilege or is it something that happens but people don't talk about it. They just shut up and don't give them any money and drop out because of the -- I don't want to spend a lot of time on that, but it really is -- I just haven't heard many stories.
MR. FANNING: It may be that the program and operational necessities of that activity mean that it is always -- that it is very frequently done in a good way and does not create resistance and hostility.
DR. DANAHER: Dr. McGinley may -- I am speaking from absolutely no basis, but this is an impression that I have. What we have heard is testimonies from very august organizations that have very polished fundraising operations. I think it is not inconceivable that for smaller hospitals that are less august that do not have in-house fundraising operations to hire, you know, less scrupulous third party -- "scrupulous" may not be the right word, but third party kind of marketing things, where the average sophistication of the people doing the direct marketing may not be as good. I mean, that certainly is a conceivable situation.
DR. HARDING: In a small community it would be --
MR. ROTHSTEIN: Well, and we also know of abuses that have taken place with solicitations for specific disease organizations, where you hire a contractor to do your fundraising and then you learn that they engage in practices that really sort of make you blanch. So, I think there have been some abuses in -- obviously in philanthropic fundraising and marketing. I share Richard's view that I -- it is not something that I get calls and e-mails about what can we do about this.
Marjorie.
MS. GREENBERG: One question I had and I don't know whether it is really that relevant, but Ms. Pollak, she emphasized the research aspects of, you know, fundraising for research, particularly related to specific conditions, et cetera, and that was, you know, why the department was important to know at a minimum.
Was she making a distinction or is there any distinction between, say fundraising for medical or biomedical research versus like fundraising to build, you know, new buildings, add on to the hospital, to -- you
know --
DR. FITZMAURICE: She didn't make that distinction, but she focused all of her discussion on fundraising for research at Johns Hopkins.
MS. GREENBERG: Was her request related just to fundraising for research or any fundraising?
MR. ROTHSTEIN: I think it was broader.
MR. FANNING: Broader. I don't recall her making the distinction either, although there may be some -- maybe as a practical matter most of it is that because you don't have to build a new building terribly often. But I don't think she made the distinction.
MS. GREENBERG: It seems people are always building new wings and things like that.
MR. ROTHSTEIN: I would be appreciative of anyone who could answer this. The FTC does not regulate fundraising activities. I mean, do they regulate them under any circumstances, John, are you aware?
MR. FANNING: As far as I know, their basic legislation involves people engaged in commerce and I don't think it goes to this. I don't think, but I can't speak authoritatively.
MR. ROTHSTEIN: So, even a for-profit company that was hired to raise funds for a hospital or medical institution, they would not be regulated by the FTC, only by state people or --
MR. FANNING: I don't know.
MR. ROTHSTEIN: Anyone know that?
DR. FITZMAURICE: I tried to get the answer to that question. I didn't state it as directly as you just did. I had given the opportunity for someone to say, well, we are also regulated by the states and that didn't come forth. I believe they are regulated by the states; that is, fundraisers. I think you have to get a license. They have to make public their overhead rates, what percentage of the funds go to a particular use.
But I am sure that varies across states.
MR. ROTHSTEIN: Can you help us with that?
DR. MC GINLEY: I can from the standpoint of the professional fundraisers that are consultants, that they must report to the state. They must file with the state for the individuals that are employed by the health care provider. They really don't have a license, per se. They may be certified by a separate certifying body.
MR. ROTHSTEIN: Am I correct that the FTC does not regulate any of --
DR. MC GINLEY: No. In the things that we have done they have an impact on us, for instance, there are a number of organizations that oppose percentage base compensation for professional fundraisers ethically, but legally the FTC will rule on that and they would come down on the other way. You cannot preclude how somebody earns their living. Consequently, they have an impact on us, but they don't regulate to that extent.
MR. ROTHSTEIN: Thank you, Dr. McGinley. The reason I bring that up is one of our options might be some specific guidelines for fundraising in either category as an exception or as in the non-exempt category -- I certainly wouldn't feel comfortable, it would be improper if the FTC had jurisdiction over that and apparently they don't.
So, let me recap where we are at the moment on our discussion of fundraising. The initial question that the subcommittee will consider is should fundraising remain within TPO and then we will get to the issues of the three specific points that Ms. Pollak raised in her testimony. Then we will also consider the issue of whether we should have special rules for sensitive information in fundraising and whether there should be specific regulations for the procedures used in fundraising.
Are there other issues that we have overlooked? Okay. So, that will be our plan of attack on fundraising. In terms of our timetable, we will try to get a revised document to you and all the members of the subcommittee, which will sketch out sort of the plan of attack for these two issues as soon as practical. I will have the staff contact all the members to try to line up a time that is appropriate for a subcommittee conference call.
MS. GREENBERG: I would think two hours.
MR. ROTHSTEIN: Yes, I think that is an excellent suggestion, a two hour conference call.
Do we need to publish that in the Federal Register or on our web site or --
MS. GREENBERG: Ideally, I would publish it in the -- I mean, since this is all going to go to the full committee, probably this doesn't have to be, you know, open to the public according to the actual regulations, but I think it would be a good idea for it to be and I think there will be people who would want to participate. Obviously, this is kind of in lieu of a meeting because you weren't able to get the other people here.
But I think because of that, it probably would be adequate if we put this on our -- put the phone number and the call-in directions on the web site because given the fact that the committee is meeting a month from now, I don't think that -- and you have got to get this done before then, et cetera, there probably isn't time to do a Federal Registry notice. I think that is okay.
But for those who are listening in or whatever, we will put on the web site, on the NCVHS web site, WWW.NCVHS.HHS.GOV, when the call is and how to call in or how to ask to call in.
MR. ROTHSTEIN: Is there any other business that we need to attend to this morning?
Marjorie.
MS. GREENBERG: I hate to revisit what you have already -- but, unfortunately, yesterday I took my notes kind of all over the place and I was just relooking at Bob Gellman's slides and there are just a few points that I would suggest you make sure we get into this document.
One is he often used "consent" in his document but said "authorization" and I think he meant "authorization" -- I mean, he meant "authorization" because I believe "consent" is only that initial thing and then any other things are authorization.
So, when it is summarized and I think here when you -- consent is used sometimes here under "Proposal," it probably should always be "authorization." He, actually, when he presented it, he said authorization and I kept crossing out consent and putting authorization.
MR. ROTHSTEIN: So, in Nos. 6 and 7 --
MS. GREENBERG: Yes. Soliciting and authorization, as opposed to a consent.
The other point that I think he made and I think probably belongs -- it was maybe a no-brainer, but it did stick with me and probably belongs up here with that global question is he pointed out that any disclosure to a third party is a breach of confidentiality, I mean that you provided information to a third party.
The real question is whether there is a societal good or just as is decided on some other issues, whether it be public health or whatever by the rule and I don't know, I found that useful because, I mean, first of all, it makes a distinction between the provider, him or herself and what information is being provided in that regard and then between that and providing information to a third party, which right off the bat is in some way a breach -- is it a breach of privacy or of confidentiality?
MR. ROTHSTEIN: Confidentiality.
MS. GREENBERG: I guess confidentiality. Then it is just -- you know, can it be justified.
MR. ROTHSTEIN: I think that is a
MS. GREENBERG: Maybe it can and maybe it can't.
MR. ROTHSTEIN: That is a wonderful observation and without getting too philosophical, there is both an intrinsic and a consequential value to privacy and confidentiality. In many instances we have tended to focus on the consequential harms.
What are the horror stories? How have people lost their jobs or been, you know, embarrassed and so forth, but there is also an intrinsic value to health care privacy and confidentiality irrespective of whether there are any tangible harms. Certainly, the degree to which it undermines the confidence in the physician/patient relationship and the health care system generally is extraordinarily important. So, I think we need to never forget that in our considerations and I hope that the subcommittee and the full committee will do so. so, I thank you for reminding --
DR. DANAHER: May I just bring up an add-on to that point because what I heard Bob Gellman say yesterday was that if there is PTOM and here are a couple of remedies, that would make it more palatable. I actually frankly -- I am a big proponent of perfect information, giving the consumer perfect information and let them make their -- you know, have their own choice.
MR. ROTHSTEIN: If they want it.
DR. DANAHER: I thought that there was something to be said -- and I don't know whether it was called out enough in your points, but if we -- I thought that there was something to be said for covered entities -- you know, he said -- he said if they don't have a web site, tell them to get one. Everybody has a web site these days. I think that there was something to be said for organizations, third party entities and covered entities stating clearly and specifically the types of marketing arrangements that -- this is for the third exception.
MR. ROTHSTEIN: Of course, there is that notice requirement.
DR. DANAHER: Right. I think his point is -- I think what he is stressing is is the web site piece. It is almost analogous to the cigarette package that basically says that, you know, if you want to smoke, fine, you can't say you didn't know, whatever. Just kind of think that if the covered entity is going to engage in activities with third parties that -- and they believe it truly is in the best interest of their members or of their patients, they should be pretty upfront about it and people should be able to access that information.
MR. ROTHSTEIN: I will add to the Gellman remarks, without objection, indicating that he advocates full disclosure of all marketing arrangements, especially with third parties. Would that be okay?
DR. DANAHER: I would appreciate that. I thought it was a thoughtful thing, which I don't think should be --
MR. FANNING: Well, it is No. 8. It is on the next page there.
DR. DANAHER: No, no, you have it there, but I just didn't think it -- I guess what I was pushing for was the web site kind of thing.
MR. ROTHSTEIN: I will add including a web site.
DR. DANAHER: And I don't mean to be a -- I just thought it was one of the more -- it is not tucked away on a piece of paper somewhere. It is not -- I don't mean to make too much of it.
MR. ROTHSTEIN: I can't even read my own document.
MS. GREENBERG: He will appreciate your overall summary here of his comments.
MR. ROTHSTEIN: I think I understated his views.
You should hear what he said off the record.
Are there any other comments or business for the subcommittee?
Let me thank John Fanning for his yeoman work in getting the witnesses yesterday. I want to thank the witnesses themselves for their thoughtful, helpful testimony. I want to thank the staff for facilitating this and our cracker jack AV folks for keeping us on the air.
This meeting is adjourned.
[Whereupon, at 10:23 a.m., the meeting was concluded.]