[This Transcript is Unedited]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
SUBCOMMITTEE ON PRIVACY AND CONFIDENTIALITY
July 15 2004
Hubert H. Humphrey Building
200 Independence Avenue, SW
CASET Associates, Ltd.
10201 Lee Highway
Fairfax, Virginia 22030
P R O C E E D I N G S [8:40 a.m.]
Agenda Item: Call to Order, Introductions, Opening Remarks – Mr. Rothstein
MR. ROTHSTEIN: Good morning, I’m Mark Rothstein and I am chair of the Subcommittee on Privacy and Confidentiality of the National Committee on Vital and Health Statistics and I want to welcome you to day two of our hearings and today’s agenda will consist of a discussion of yesterday’s hearing and further plans for the subcommittee. Before we get to the agenda items for today it’s customary for us to introduce the members of the subcommittee and staff present at the hearing for purposes of identification and particularly for those of you who may be listening to us on the internet. And I’ll begin, I’m as I said Mark Rothstein, not only chair of the subcommittee but a member of the committee of course and I’m director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine. Richard?
DR. HARDING: I’m Richard Harding and I’m a member of the subcommittee and committee, I’m chair of neuropsychiatry at the University of South Caroline School of Medicine and have only the conflicts that that would entail as well as being a member of a board of a foundation and a medical school board.
MR. REYNOLDS: I’m Harry Reynolds, member of the subcommittee, member of the full committee, and vice president of Blue Cross and Blue Shield of North Carolina.
DR. COHN: Simon Cohn, national director for health information policy for Kaiser Permanente and member of the subcommittee and full committee.
MS. FRIEDMAN: Maria Friedman, Centers for Medicare and Medicaid Services.
MR. FANNING: I’m John Fanning from the Office of the Assistant Secretary for Planning and Evaluation in HHS and lead staff to the committee for this meeting.
MR. HOUSTON: I’m John Houston from the University of Pittsburgh Medical Center, a member of the NCVHS committee as well as the subcommittee.
DR. FITZMAURICE: Michael Fitzmaurice, Agency for Healthcare Research and Quality, liaison to the national committee, staff to the Subcommittee on Standards and Security, liaison to this committee.
MS. WATTENBERG: Sarah Wattenberg from the Substance Abuse Mental Health Services Administration, I’m on the Privacy Subcommittee.
MR. ROTHSTEIN: I’m sure the members of the subcommittee would agree with me that yesterday’s hearing was very stimulating and interesting even though we covered some topics we’ve discussed before I found the discussion to be illuminating and then yesterday afternoon’s discussion about the media access to PHI was very challenging intellectually and should give us some food for thought for today.
I want to thank the staff for putting together such an excellent program and especially Sarah Wattenberg and also while I’m handing out staff kudos this will probably be the last subcommittee meeting that we have John Fanning as lead staff for and as most of you certainly in this room know that John is retiring at the end of this month after a very distinguished career at HHS as the primary person in charge of all the privacy within the agency and he is a legend, irreplaceable, and was very helpful to me and all of us and we wish him well and thank him for his years of service to the subcommittee and committee.
Today’s agenda is rather vague in terms of the outline, I would propose the following. We have two blocks of time for subcommittee discussion, that is the block of time between now and our break, which is scheduled for 10:00, and then after that another discussion period. What I’d like to do with the consent of the subcommittee members is to start by going through the three panel discussions that we had yesterday, that is the panel discussions on marketing, fundraising, and then the media, to decide if we want to make recommendations to the full committee in terms of a letter to the Secretary and if so what that should entail. And then in the second chunk, assuming that we can finish in a reasonable period of time, then discuss the issues that were raised at the first presentation yesterday which dealt with the security rule and will take up the issue of what the roles should be of this subcommittee with regard to security, as well as planning additional topics for consideration in the future. We heard a very interesting presentation yesterday for example on medical archives and we may want to discuss whether that should be a topic and I know from discussions with individual members there are a variety of other issues that are percolating. Simon?
DR. COHN: While I generally have no argument or concern about your ordering I would observe that we actually have our staff support from the Subcommittee on Standards and Security who is here specifically to talk about issues related to e-prescribing and possible subcommittee hearings on that topic. I don’t think either of us have an objection to holding it until later on in the morning but having it as a to follow item without a definite time may cause some significant inconvenience. Can we amend the schedule and discuss that right after the break?
MR. ROTHSTEIN: Absolutely. So should the initial session run over where we can’t decide on what we want to include in our recommendations we’ll just sort of table that for a while and take up the issues that you described.
So other suggestions of changing of the agenda or order for the discussion? Hearing none then we’ll begin with our discussion of the marketing issue and of course you’ll recall yesterday that we had two witnesses, Don Bell and Joy Pritts on the issue of marketing, who took somewhat different views on the current language and whether any additional protections are needed in the privacy rule or changes and interpretations, etc. So let me open the floor to members of the subcommittee to make recommendations as to whether this is an issue that we should include in a letter to the Secretary, or a separate letter which is another issue we’ll worry about later, and if so what items from yesterday’s discussion do you think are appropriate for recommendations.
MR. HOUSTON: The concern that I sort of heard out of the testimony yesterday, I’m not sure how to describe it other then that it sounds like what’s happening with the privacy rule, and it’s not necessarily directly related to marketing, but in a general sense it seems like there’s a non-level playing field related to, and that may be the wrong way to describe it, a non-level, there’s non-uniform treatment of communication of PHI or artifacts of PHI depending on what part of the privacy rule applies.
And what I mean by that, by example if a provider wants to send an appointment reminder to a patient’s home, they leave a message on their answering machine, there’s clear guidance as you can do that but you really need to take care to ensure that you leave as little information as necessary, that you don’t add information that might identify what the person’s condition is or problem.
And then you look at what’s happening in marketing on the pharmacy side, they’re sending brochures and things to the patient’s home describing alternative therapies and clearly in that case, the example of Prozac, it’s very clear from receiving the information, or there’s a probability that somebody could determine from somebody receiving that information that maybe they’re on some type of antidepressant. So on the marketing side I think there’s a lot of good communication that need to occur, I’m just afraid that what we’re hearing is is in the privacy rule we’re getting this sort of varied permission to provide communications to patients.
I wish I could say that more eloquently and succinctly but does that make sense?
MR. ROTHSTEIN: I understand what you’re saying I think and there is seeming inconsistency in the treatment of similarly situated covered entities in the rule that certainly will be an issue when we get to fundraising for sure. And I think that’s a role that we should play in trying to point out to the department where we think there are inconsistencies that are not defensible and where covered entities are treated differently in the rule for no legitimate reason, then we should I think feel free to make recommendations about what needs to be done to even things out and sort of standardized the burdens and the benefits of the privacy rule.
So that’s a good general sentiment to keep in mind and I appreciate the comments, do you have any specific recommendations?
MR. HOUSTON: I do think that we did hear testimony yesterday regarding almost some type of disclosure on materials that indicate who’s paying for the communication and I think it would be appropriate to have some type of opt out language, especially where these types of communications are clearly being underwritten by a third party.
MR. ROTHSTEIN: What I’d like to do if it’s okay with you is to take, to split those recommendations because I think they’re actually separate things, and if it’s okay with you take up the first one that you mentioned and that is should there be a requirement that a communication to a patient that a third party is paying for the communication, should that be required. And you could even make it more specific, you’d have to identify the provider who gave the name to the third party. So in other words if a retail pharmacy makes an arrangement with a pharmaceutical manufacturer that the pharmacy will send to its customers who are receiving a certain class of prescriptions information about an alternative medication there should be a requirement possibly, I mean this is a thing to discuss, that the source of the communication was the pharmacy. In other words XYZ pharmaceutical is contacting you or in a brochure and we got your name from your pharmacy because you had prescriptions filled in this area or something like that, to identify where that came from. Is that —
MR. HOUSTON: Well, I think what was happening was that the pharmacy was sending out the communication —
MR. ROTHSTEIN: Well of course but I mean, I’m sorry, I got it backwards, it’s still early in the morning, you’re right. They can’t do that without an authorization. What happens then is the pharmacy sends it out but it doesn’t indicate that it was sent by the pharmacy, it looks like it was sent by the manufacturer and the recommendation was that the pharmacy identify that they are the source of the —
MR. HOUSTON: Was that, I didn’t hear that in the testimony.
MR. ROTHSTEIN: Well see the testimony was that they were being compensated and we talked about the issue of how hard it is to put compensation in there because they could get around it by having sort of promotional deals, they give the money for advertising, they give them a discount on the drugs and make more profit, so to get away from putting that they were getting money from it we were thinking and still searching for some way in which the communication should identify that there is some sort of arrangement between the manufacturer and the pharmacy.
MR. HOUSTON: But you also said that it’s not clear that the communication is coming from the pharmacy, I didn’t think we’d heard yesterday that the communications were ever, the communications ever didn’t identify the source of the information, I don’t remember hearing anything —
MR. ROTHSTEIN: I don’t think the rule would prohibit the following arrangement, the pharmaceutical company approaches the retail chain let’s say and says we’d like you to promote such and such drug and now the drugstore says fine, we’ll send it to the 10,000 people who are taking such and such class of medications. They could hire a business associate to do that and to mail these mailings, I don’t think at the moment, I could be wrong, the privacy rule requires that there be any sort of identification on the mailer that has a return address or anything that says it came from the pharmaceutical company.
MR. HOUSTON: And I agree with you in that regard, what I was responding to was there wasn’t anything yesterday that I recollect any testimony that said these mailings were anonymous in terms of, or they didn’t recognize the source of the mailing being the pharmacy.
MR. ROTHSTEIN: The suggestion as I read it is that there should be disclosure to patients that the provider is receiving compensation which we talked about so this is sort of an alternative. Michael?
DR. FITZMAURICE: By and large the way they go around at meetings and identify conflicts of interest, I think because of the tine arrangements that you described maybe four drug companies have promotional things going on with the drugstore and the drugstore has picked one and sent a mailing out. It would seem to me that if you’re going to go that route you pretty much have to say list all your promotional activities in this conflict of interest page and post it, or attach the page with the letter, it would be pretty difficult to single out one versus another. If you can’t tie in that the reason I’m telling you about this particular drug it’s because the maker of that drug has a promotional arrangement with me and maybe four or five others have similar promotional arrangements, it’s just this one was the one that was picked to send out the drug, maybe the promotional arrangement is more lucrative, maybe for some other reason, but it’s hard to get the cause and effect when you’ve got the same causes from a lot of other drug companies. So you might want to say list all of your promotional arrangements, we own stock in the following companies and I’m recommending this one particular stock and I own part of it.
MR. FANNING: But doesn’t the letter recommend one particular drug?
DR. FITZMAURICE: Yes.
MR. FANNING: Well what difference does it make to the recipient what other arrangement the pharmacy has?
DR. FITZMAURICE: Well let’s suppose the pharmacy has arrangements with all the drug companies so any drug that they mail out for whatever particular illness they would have to disclose that this is the manufacturer of the drug we have tie-ins with it. But if you have it with all drug companies, you’re sending out that one particular one for every mailing you’re making on that particular drug. So you’re saying, it becomes meaningless if you have arrangements with all drug companies.
MR. ROTHSTEIN: But I think we need to focus back on the PHI involved and if you have arrangements with all the drug companies and run an ad or send a circular with coupons or something to all your customers, if it’s not based on the PHI that an individual has a prescription for a certain medication then I’m really not, I don’t see where you’d have to disclose that sort of stuff.
DR. FITZMAURICE: Let me amend what I said. If I’m recommending a stock then I should let you know if I own that stock and you don’t have to know about all the other stocks that I own, alright.
MR. ROTHSTEIN: Before we continue on our discussion I want to give the rest of the staff who arrived a chance to identify themselves for the record. Marjorie?
MS. GREENBERG: I had to take care of another matter, I’m Marjorie Greenberg, NCHS, CDC, and executive secretary to the committee.
MS. KAPPELER: I’m Evelyn Kappeler with the Office of Public Health and Science.
MS. KUTKAT: I’m Lora Kutkat with the National Institutes of Health.
MR. ROTHSTEIN: Thank you and welcome. So any sense of how we can capture this? We’re all sort of troubled by the idea I think. Simon?
DR. COHN: I think this is a very important conversation, obviously as you know I was sort of sitting transfixed through the testimony yesterday before I had to leave. One would observe that, I mean this is sometimes something we say about various areas we go into, certainly one doesn’t feel like there was a real full representation of testifiers, I mean we heard from the chain drugstores, we heard from privacy advocates, we actually didn’t hear from pharma and I think we’re all indicating that the pharmacy companies are part of this equation and it might be useful to investigate or hear from them what their part of all this is. I just know out of many organizational activities how the pharmacies relate to the chain drugstores or just pharmacies in general is typically a very complex arrangement. I mean sometimes they get paid for promotional activities, sometimes there’s discounts, sometimes there’s future considerations, I mean it’s a relatively complex financial arrangement.
Beyond that I think that what I’m sort of listening to, as I was listening to it yesterday, I almost felt like we were having an introduction to the world of e-prescribing and issues related to e-prescribing, the sense that what we’re seeing, I mean pharmacies are marketing directly to the consumers via TV and other things, they’re partnering or however you want to describe it with pharmacies to impact the consumer. They’re going to trying to be figuring out probably ways to partner to impact physician choice at the point of care for the prescription, I mean what more effective way would a manufacturer of pharmaceuticals have to influence decision making. And I guess the question is, I think we need to have the conversation and we need to figure out what it is we’re tentatively coming forward with. But the question is is are there principles that we can broaden out that might have applicability beyond the small issue, or not the small issue but the relatively segmented issue of communications between pharmacies and consumer related to direct mailings, and that would be really the question I would put on the table.
MR. ROTHSTEIN: Well, I think your point is a good one and when we come up to the second of John Houston’s recommendations, or discussion points, on the opt out we’re going to have to be careful if we go that route in talking about how it might apply to other covered entities clearly, so I think your point is a good one because the privacy rule does not make separate categories for different types of covered entities in terms of marketing and so forth and I don’t think we want to go that route, I doubt OCR wants to go that route, and therefore we’d have to be careful in phrasing whatever we recommend, how is it going to apply to such and such group and how is it going to apply to other groups as well. John?
MR. FANNING: Mr. Chairman, I have a question. I wonder whether the committee might want to discuss whether payment makes any difference for the kind of things we’re concerned about here. Ms. Pritts yesterday suggested that it did but I think that is worth discussion, after all the communication is coming to your home as allowed by the regulation from an organization that does have information about you properly and that you know has information about you. Does it make any difference that the communication is stimulated by someone else financially or otherwise?
MR. ROTHSTEIN: Well, I think it’s a good point and we discussed that yesterday, at some level I’m troubled by the idea that a company is making profit based on the information. If they think that drug B is better then drug A and want to tell me about that, whether it’s my physician or my pharmacy or my managed care organization or whatever, I think that’s fine. But when they have separate motivations that strikes me as being closer to marketing then health communication. But for the reasons that we talked about earlier I don’t know that we’re going to be able to get a handle on that payment issue unless we’ve got some new ideas about doing that because there are so many ways of indirectly compensating pharmacies or other providers that what I don’t want to do is create a system that encouraged people to sort of go around it and to do the same thing that they’re doing now. So what’s the sense of the subcommittee on that, Harry?
MR. REYNOLDS: I have a couple comments, I wish we had the NCL Best Practices Guide that they mentioned because obviously we had one consumer view yesterday, we had a pharmaceutical view, and now we’ve got a consumer group that has come out with best practices that’s going to follow quickly upon any letter that we do, which could be used positively or negatively against our recommendation, where a group of consumers have come out, we may say this, they come out stronger, weaker, or something else that kind of puts us in a situation.
The second, I still feel in having implemented this privacy rule, I still feel that it’s very important that the protected health information, if you took the example of a pharmacy sending out information, if they send it out to all of their customers, not just the customers using that drug, then that is I believe permitted by law regardless who pays for it. And I still think that’s the place to be because when you get into using that protected health information for directed marketing for the purpose of somebody benefiting and it’s paid by someone else, I don’t think there’s a lot of gray in that. I think that’s where the law is now and I think that’s where the law ought to stay because if it’s worth sending it out it’s worth, because tomorrow somebody that doesn’t have that condition may get it.
MR. ROTHSTEIN: The out on that is in the privacy rules current definition of marketing, it says marketing means to make a communication about a product or service that encourages recipients to purchase or use the product or service unless the communication is made to describe a health related product or service that is provided by or included in the plan of benefits of the covered entity making the communication including communications about the entities participating health care provider network, replacement of or enhancements to a health plan and health related products or services available only to a health plan enrollee but not apart, then it says for case management or care coordination for the individual or to direct or recommend alternative treatments, therapies, health care providers, or settings of care to the individual. It doesn’t have any tie to payment so in other words whether you’re covered under marketing the unless provision has no reference to whether the covered entity is receiving any compensation directly or indirectly.
MR. HOUSTON: I remember reading that yesterday and I think that section was actually read back to the panelists and I’m not sure whether that particular section was drafted broadly or was imprecisely drafted and what the intent was. When I read that language it doesn’t speak of health plans specifically but when I read that section my first reaction is that must relate to health plans because they’re the ones that would be doing those types of communications, but it doesn’t say health plans.
MR. ROTHSTEIN: There are three separate things and I probably should have said, unless the communication is made, I. to describe a health related product of the health plan basically, II. for treatment of the individual, or III. for case management or care coordination or to direct or recommend alternative treatments, therapies, health care providers, or settings of care, so I think I. does apply to health plan issues —
MR. HOUSTON: But it doesn’t say that but I. is what I think the pharmacies are relying upon to provide these types of communications. And I guess my question is is it appropriate to look into the intent behind Roman Numeral lower i. to determine whether it was intended to be specific to health plans or whether it was intended to be general to all covered entities. I guess that’s my point because if it was really intended to apply to health plans then what this would say is that pharmacies should not be providing these types of communications.
MR. ROTHSTEIN: Let me just put that aside for a second and I think we need to deal with the issue that Simon raised earlier first and that is do you think we have sufficient information base on which to make recommendations regarding this issue of marketing, for example if you think that we need to hear from pharma let’s say on this issue then I think we’ve got no alternative but to table this issue, schedule additional hearings, request pharma and maybe some specific companies and other points of view on this issue, or if you think well we’ve got enough, then we can proceed but I’d like to take up Simon’s question first. Any thoughts?
DR. COHN: I guess I would just sort of comment, Harry did comment about the NCL, I don’t know what the NCL is but certainly it would be nice to know what they just released in terms of their documents and their perspective on all this for example. I mean but I would defer to the rest of the subcommittee, I guess I worry when we start trying to write letters on the basis of two testifiers just because it just doesn’t feel to me that it’s a particularly informed stance especially in an area that’s as complex, I mean we’ve been to marketing before, we know it, we know how complex the whole thing is as well as how many tradeoffs occurred in the development of the regulation.
MR. ROTHSTEIN: One thing that we don’t need to do of course is to recommend the specifics of how OCR would deal with the issue, what we could say is we have these concerns and we think that consideration should be given to redrafting the rule or issuing interpretations or whatever to accommodate these concerns. One of the concerns that I think, from what I hear there’s relative agreement on is the issue that any communication under this unless clause should not be in a form that indicates to other recipients information indirectly about the health condition of the individual. In other words you can’t mail out mailers for specific medications not wrapped in any envelope and delivered just to individual people, here’s the latest, the new generation of anti-virals for HIV treatment and come in and see us about that. I think we could make a recommendation like that where I don’t know that we need to hear from anybody else.
MR. HOUSTON: John Fanning, we’re obviously losing your expertise here very shortly, and again you seem to understand, again I’m really interested in understand what the intent was behind this Roman Number I, was it intended to be health plan specific or was it intended to be general and maybe —
MR. FANNING: I do not know.
MR. HOUSTON: Okay, is there a way we can try to dig into this because I think it does make, this is key to my understanding of whether we need to do more testimony as Simon has indicated or whether what we need to do is try to correct, recommend a correction of a misunderstanding of this particular section. It just, I think it’s very important overall to our assessment of this issue.
MR. FANNING: There is of course the record of the rule making which includes a preamble explaining the original proposal, a preamble in response to comment explaining the regulation, and then if this one was amended as I think it was a similar set of transactions for the amendment and that would certainly be a starting point for figuring out what was intended.
MR. HOUSTON: As we go through this, I mean I have those preambles online, I could probably look at them quickly —
MR. ROTHSTEIN: I think you can go back and start with the amendment because the original proposal was quite different. If you remember it considered marketing within health care operations and would have allowed sort of many things to occur and the committee specifically raised rather strong concerns about that and the amendment made major changes in this. Richard, any views on how to proceed?
DR. HARDING: Well, I think I like your idea of any specifics that we come up with aren’t going to be very good, they aren’t going to be fail safe, right at this point I don’t think we have enough knowledge. I think we can as you said kind of review that there continues to be a problem in this area, there continues to be problem with the definition of marketing versus disease management versus treatment and those kinds of things and that continues to be a murky area that requires clarification by the department and others. And then if that’s something that they would ask us to do and to come up with specific recommendations I think then we’d have our work cut out because I personally think that just about anything you came up with in regards to yesterday’s comments about the sending out the letters could be, somebody could figure out how to get around that pretty easily. I think we have to stay on the policy and definition end of the thing as opposed to getting into the on the ground working out of these things.
MR. ROTHSTEIN: We could say something like we heard testimony that there are problems surrounding, continuing problems surrounding marketing and the committee has concerns in three areas, that is the definition of marketing and its exception under blah, blah, blah, blah, blah, including whether the covered entity that disclosed, or the covered entity has an arrangement with some third party or something like that —
DR. HARDING: Proper notice —
MR. ROTHSTEIN: Yes, and notification provision, second concerning the methods by which these communications take place in that sometimes diagnoses and other information are disclosed to other individuals, and the lack of individuals to opt out of these kinds of disclosures. And not say hardly anything else besides that, I mean we’re raising a red flag, we think this is a problem, we’ve heard testimony about issues here, we agree with these concerns, and we would like the department to try to figure out how to address these concerns within the framework of the rule. Now is that insufficiently specific to be valuable to the department? Simon, or Marjorie?
DR. COHN: Marjorie first and then I’ll comment.
MS. GREENBERG: Well, yeah, I mean I think that, it may be insufficient to give clear guidance on what the solution is but if you don’t feel you have clear, are able to give that kind of guidance it’s unwise to try to do so. But I think it’s apparent over the years that not only the department but also the broader health industry and community takes seriously what the national committee reports and I think if you feel sufficiently comfortable with making those comments I think there’s value in doing so. Now the real issue is whether you do see benefit in continuing to try to work on this and getting other testimony, etc., I mean you could offer to do that.
MR. ROTHSTEIN: We can offer to do that, of course we don’t have the resources that the department has —
MS. GREENBERG: To work with them, to work with the department.
MR. ROTHSTEIN: I don’t know how many complaints have been filed about marketing, we could look it up but they know already, and they may have all sorts of information that we’re not privy to and the other thing that any rulemaking would have to consider is for example if we recommend some sort of opt out, what are we asking covered entities to do, so if we view it, it’s easy to see in the context of a retail pharmacy, now let’s take a look at a physician. Are we asking physicians to allow patients to opt out of communications that the physician might make about changes in drug regimens? I mean we can’t be doing that —
DR. HARDING: That’s treatment.
MR. ROTHSTEIN: Well it is treatment, so what I’m saying is it has to be addressed very carefully and I don’t’ know that we’ve got the time and resources to weigh all those things other then calling attention to the fact that we see a problem here and we think they ought to address it. Simon?
DR. COHN: I think we’re having it seems like three or four conversations at once and I’m getting a little confused. There is a piece of like what did we learn from the hearings yesterday and sort of where are we with that, what were our learnings from it, and then sort of what are we going to do with it. And I’m very comfortable having a conversation about what did we learn and what are the next steps, what did we sort of learn from all this and what I’m hearing is that we’ve concluded there are some high level concerns that we don’t have much flesh on, we certainly heard from Harry that geez, one of the two testifiers referenced a document that none of us have seen or briefed on that might inform some of this, and certainly that might be something we might want to hear from. I had sort of commented well geez, there’s other players in this, we might want to hear from them. I think that there’s sort of like geez, we heard this much, we need to investigate further is sort of the conclusion I’m coming to on all of this stuff but I guess as I listen and us trying to come up with, once again we haven’t even heard from OCR in terms of their perspective on this which might be a useful thing, actually ask them to testify, tell them our concerns and ask them to tell us about their perspective on all this.
I think my bigger concern as I listen to all of this stuff and Marjorie you weren’t in the room when I sort of brought up the first issue around e-prescribing, this particular piece either takes the form of either a paragraph in a letter with three disjointed items on it, once again just thinking of the packaging, or this becomes part of something that is maybe more of an integrated whole. And as I said I realize on the one hand we’re talking about marketing but really when we start talking about in this month, in this world, in this country, when we’re talking about these particular issues we quickly merge into a conversation related to the overall issue of how we’re handling prescriptions, how we’re handling prescribing, how we’re handling communications and all of that stuff. And I guess I would be more comfortable if we figured out what we learned from this, what the next steps are for us to learn more, and then envelope it into a larger conversation related to all of that as it relates to privacy and confidentiality.
MS. GREENBERG: And I’m sorry that I missed the testimony yesterday because I was at the NCHS Data Users Conference but I assume this marketing issue, although very heavily involved with medication issues, is broader then that, it could be marketing devices or —
DR. COHN: Well, we didn’t have any testimony on that.
MS. GREENBERG: But I mean the provision itself is for more then just medications or drugs or whatever. I guess my, maybe I’m not understanding exactly what you’re proposing here, I would not mix up the two, I mean I wouldn’t combine these issues with the e-prescribing standards issues.
DR. COHN: No, but I think I’ve been thinking that there’s probably an issue of investigating privacy and confidentiality concerns related to that broader issue of e-prescribing, in fact we’re talking about that after the break and it just seemed to me that this was sort of consistent and a piece of that larger conversation.
MS. GREENBERG: Well I would agree there are privacy issues I’m sure related to the prescribing. I just had one question, maybe I’m sort of coming in the middle here but you mentioned about you don’t want to be preventing clinicians from treatment, offering treatment options, whatever, but then there’s also, I know the issue has come up before about if the clinician is actually receiving some monetary compensation or some clear compensation. I’ll just ask the physicians here, aren’t there sort of professional ethics, are there professional ethics or guidelines related to that type of issue that would cover this?
DR. HARDING: Marking? Using your patient population to market, using an individuals patient population for money to market a product.
MS. GREENBERG: Yeah, are there?
DR. HARDING: That’s an ethical issue, I don’t know if there’s a legal issue.
DR. COHN: Well if I can comment —
MS. GREENBERG: Code of conduct or whatever.
DR. COHN: The issue is is that, and I think we’ve all recognized this in previous testimony, that there’s a very thin line between health promotion and things that you do related to health promotion versus marketing, and I think that the rule had a difficult time finding the right place there, I mean John help me with this one if I’m wrong, on one hand obviously everyone wants to make sure that the patient has the right medication to take, that its optimal for them, if there’s something new or something that needs to happen that that happens. But obviously we all sort of get a little funny when people are out there frankly marketing and the distinction between trying to be reminded of your yearly flu vaccine or coming in for a recheck or a physical exam versus marketing, that’s a gray line. John, I’m sure you’re familiar with this one.
MR. FANNING: Well, all I can attest to is the complexity and difficulty and fuzziness of the whole thing. I looked into this in some detail after the great giant CVS/Lenses(?) marketing deal and it is very hard to get a handle on. Those pharmacies are in business to make money, if they recommend something they often benefit from the patient taking up the recommendation, but that is true of most health professionals, they recommend their own services —
MS. GREENBERG: Whether it be surgery or —
MR. FANNING: Exactly. So the point you just made about sorting among those things I think is a correct one, it is very difficult to write down in a legal enactment a distinction between them. I am not familiar with the regulation and did not have anything to do with its preparation but it is not really surprising that there is still confusion and doubt both as to the effect of the regulation and among the people of this table about how it ought to turn out, I’m sorry.
MR. ROTHSTEIN: Before we go further I want to let everyone know that Gail Horlick is on line, Gail? Well, she was, and may again. Gail are you there?
MS. HORLICK: Sorry, yes I am.
MR. ROTHSTEIN: So if you have comment just feel free to chime in.
MS. HORLICK: Now I’m just listening, thanks.
DR. FITZMAURICE: As we think through this I’m thinking that here I’m in my house opening up a letter from a pharmacy and it’s recommending a particular drug, maybe about a particular condition that I have, so there is supposedly some benefit from them contacting me about the condition and telling me about a particular drug. There’s some harm that somebody else could see the letter, open the letter up and find out something about my condition. And we’re talking about should the person who opens up the letter be reading that.
It was also spurred not just by the pharmacy’s concern over my condition but because a pharmaceutical company paid them to send out the letter. That might be useful information for me to help me assess the quality of the information I’m getting in the letter. And so from the consumer’s perspective, getting that information might be a good practice, whether I would make it a matter of law or not is something for maybe the committee to consider, OCR to consider, but it is an issue nevertheless that is beneficial to the consumer to know what are the factors that led to me getting this letter.
MR. ROTHSTEIN: Well I think that’s certainly true but there are various ways of doing it and some might be communications from let’s say the drugstore, others might be communications from the manufacturer that just mailed by the drugstore to the list that they provide —
DR. FITZMAURICE: There’s another thought too and that is that we’re looking upon it, is this marketing by the pharmaceutical company or is it not, is it marketing by the pharmacy or is it not, they’re getting their name in front of my eyes too.
DR. HARDING: But isn’t the recommendation just they should improve notice in those activities —
MR. HOUSTON: That’s one level, I think that is one level or one possible way to mitigate the apparent concerns or harm that we heard yesterday, what level of notice or what level of documentation within these mailings would be appropriate to allow the patient to understand what they are, why they are, and what to do if I don’t want to get them anymore but I think that’s just one possible solution and I have to say, I have to agree with Simon, we didn’t hear enough information yesterday to make an informed decision about anything.
I think what we heard yesterday was anecdotal evidence on one side as to some of the abuses, and we heard testimony on the other side that described some self policing that the pharmacy industry was attempting to do and sort of the motherhood and apple pie, but we really didn’t get the range, obviously there was nobody from a health plan to talk about the importance of these types of communications that they might conduct, or from providers discussing, especially people with chronic conditions, why they want to engage in these types of communications with them.
I think it really does, I think we heard enough information yesterday in my mind to lead me to conclude that there is an issue, that there is a certain percentage of the population that is offended by some of the communications that are occurring, I think that simply makes me conclude that we need to delve deeper into the issue and to get a more balanced view from every constituent and maybe try to develop a more comprehensive recommendation.
MR. ROTHSTEIN: Harry?
MR. REYNOLDS: I could take two different positions, one is I could agree with what John just said, different approaches I think we’re talking about. The first, obviously what John had to say is if we’re going to make specific recommendations and I’ll play off the same thing Richard said earlier, we didn’t hear enough yesterday to even begin to make specific recommendations.
On the other hand, with an industry that’s going, and I will speak briefly as a member of a health plan, as disease management becomes kind of the number one billboard issue that’s out there as far as directing people’s health, this becomes grayer and grayer and grayer and it needs to be evaluated so Mark the letter you were talking about could raise that now that we have seen this law for a period of time, now that the industry continues to focus on directing people with certain situations to certain modes of treatments and alternatives to those treatments, the grayness of this really is an issue. The misunderstanding of this is a huge issue because everybody you talk to in the entire industry and a lot of us face it everyday you keep looking at it and you keep trying to understand what it means and you keep trying to do it but you’re always running on the edge because you really can’t get a handle on right or wrong.
And I don’t think the brief testimony we had yesterday is right or wrong because you felt people, play off John’s comment, you felt people pushing the edge and saying trust me I’ll take care of them. On the other hand you hear the consumer saying don’t give up anything but on the other hand there they’re saying people that if you go out and work with them through a disease management program you can in fact improve their life.
That’s where this thing, so I could either agree to a general letter that you were talking about, or, if we’re going to get more specific then I think we need to hear a whole lot more from a whole lot more people —
MR. HOUSTON: I think we’re being asked, is this committee, my understanding of this committee’s charge really is to help identify with clarity what some of the solutions need to be, I think a general letter I mean raising the issue doesn’t do much to try and resolve the issue though I think this is an extremely complex matter that could frankly you could probably listen to 20 people and end up, hopefully you end up further along then we are in our understanding of it but maybe not and I think the other problem too I think here is that we may not be able to work around this with guidance, and that’s another problem, I know Mark has been very clear on is that what we can do that doesn’t require us to actually ask for changes to the rule and is this going to be one of those matters unfortunately that rises to the level of you almost need to make a change to the rule or a clear, some type of clarification to the rule to capture the intent or the issue.
MR. ROTHSTEIN: Well, to move the discussion forward in the interest of reaching the other issues let me see if I can reduce our discussion to two alternatives that we’ve talked about. The first alternative would be to say that we need more information and therefore we will schedule additional hearings on marketing. Now the timing would have to be such that we probably would not be able to have them until the fall and then include it for a letter in January, I think that would be the probable timing, because we have a September meeting and then a January meeting.
MS. GREENBERG: January, who has a January meeting?
MR. ROTHSTEIN: The full committee.
MS. GREENBERG: November, September, November, very beginning of November, early November, and March —
MR. ROTHSTEIN: So we could conceivably have a letter approved at the November meeting. We might further try to focus the discussion at a subsequent hearing on the three areas that we’ve talked about today, whether there should be some sort of a disclosure requirement, some sort of control over the methods so that information isn’t disclosed in the marketing to others, and some system involving an opt out for individual patients.
The other option is to have a general letter in which we raise these three issues as concerns noting that perhaps additional viewpoints need to be considered such as physicians, health plans, manufacturers, other industries doing marketing, etc., just point out perhaps the obvious to the department. But we’re concerned, we have concerns in these three areas. So I think those are the options that we have.
I’d like to take a vote on which one of those two we go to but I can’t resist saying that we’ve had at least three or four marketing hearings that I’ve been involved in so far and there is, and I’d like to have more information, I’d like to see this document, I’d like to hear from all these other people, but there’s also an opportunity cost to us as a committee in doing that because we’ve got a big long stack of other issues that we want to get to and if we have marketing and conceivably fundraising, and just revisiting these other issues until we reach a point of now we’ve got it, we’re going to be sort of pushing off all the other things that we might want to consider. So I just wanted to raise that.
So are we ready to vote on a plan? I mean which one of these two we want to pursue or do we need more discussion?
DR. HARDING: Do we have any idea as to what the department or OCR would benefit from our doing?
MR. ROTHSTEIN: We don’t, as you know we do not have OCR staff to the subcommittee anymore and they have not been attending our hearings either so we do not have any input from OCR.
DR. FITZMAURICE: There’s a thought, you could say, if you send a letter you could say in the letter here’s what we found so far, you could ask the Secretary is there anything more we can do to give you information, do you want us to have more hearings, I mean in a short sentence that doesn’t say all of that but a way that says here’s as far as we’ve done, would more be of help.
MR. ROTHSTEIN: That’s another, I think that’s a good sort of amendment to option one or two, whatever that is, sort of the general letter but with a we’re prepared to have additional hearings to flesh out these issues more if you think that would be valuable. What do you think, Simon?
DR. COHN: Well, I’m just sort of sitting trying to imagine this letter that goes well we heard from two testifiers and they said X, we don’t know about A, B, C, D, or E, but we thought we’d send you this information and do you want us to look at this more, sincerely yours, John Lumpkin. I guess as I’m listening to you I do understand the frustration and wanting to move forward, I guess part of the issue that I have in all of this stuff is that there is actually a need for triage and prioritization of all of this stuff and I guess I’m, the issue that I heard yesterday and I guess that I would just ask the committee, and we at some point need to do some prioritization, this has been, this is not a new issue, this is an ongoing issue that we’ve admittedly is very complex, we’re sitting here without, I mean I’m, we don’t necessarily have all the right people around the room to make a decision about what course we ought to be taking.
And I’m almost feeling that we need to, I mean there’s a bigger issue of making sure that we have all the right people around the table because that really does prevent us from moving forward in a way that utilize our time optimally. Now that’s obviously a whole different conversation but it does underlie the issue that we’re sort of facing right now.
I don’t know that I’m, I have a strong feeling about how we go on this one but it’s just, there are just some sort of fundamental issues that we do need to be aware of that do get in the way of the functioning of the subcommittee and are making it very difficult for us to figure out what the right next step is on this one.
MS. HORLICK: Mark, this is Gail. I don’t know if this would impact a decision but since we haven’t discussed the fundraising and the media we don’t know whether or not we’d have specific recommendations or whether we would be having the same discussion and whether or not we would be sending a separate letter on fundraising and a separate letter on the media the way we did the last time. So it’s possible that after discussing those two that that might impact our decision on how to handle the marketing issue.
MR. ROTHSTEIN: Well that’s another option, we could table a decision on marketing until after we have some sort of substantive discussion of fundraising and the media. Harry?
MR. REYNOLDS: Let me, I want to speak for a minute from somebody who receives guidance since I’m implementing transactions and code sets and privacy and I think a lot of the frustration for everyone and this committee is feeling the same thing is that if you, and I will make factual statement, I am not judging anyone, I am making factual statements, there have been less then 100 complaints on transactions and code sets but a voluminous number of frequently asked questions and guidance coming out that you can find, you can look, and it’s continually communicating to you what this means, whereas you can take 7,000 privacy complaints and the number of frequently asked questions and the amount of communication that’s coming out is very, very limited.
So the guidance that’s out there is dramatically different in this which is a much grayer area in my opinion then transactions and code sets as far as exactly how it works and so what we’re feeling in here, we can have more hearings and do that frequently asked questions stuff but we’re all going to end up at the same point at some point where there’s going to be a judgment made by someone, so I’m watching it, I’m administering both of these programs and I am seeing like a total 180 degree different approach to communication about what it means and that’s facts, those are real numbers and those are real facts and we’ve discussed this a number of times in other hearings about what data is being put up. So it keeps coming back as a frustration because there’s no real significant two way communication.
MR. ROTHSTEIN: Okay. Marjorie?
MS. GREENBERG: This discussion starting with Mike’s suggestion and I had been thinking the same thing and now what Harry said, etc., makes me think that maybe what the committee, the subcommittee and the committee should do is write a letter to OCR, not send a letter to the Secretary but write a letter to OCR, I mean the Populations Subcommittee recently wrote a letter to NIH about the longitudinal study for children, letters have been written to NCHS and so they are somewhat lower on the radar screen in the sense of they’re not recommendations to the department but they’re letters expressing issues, concerns, asking for information back, maybe recommendations, it all depends on what you want to say. I’m hearing that you don’t feel there’s enough information out there and that you are having some difficulty as a subcommittee engaging OCR in your work and such a letter would go up on the website and be discussed in the public meeting, it would be passed if it were by the full committee and I think it would require some kind of a response.
I think partly when you see, we’re dealing with two very different kind of arenas here with the transactions I think versus the privacy and confidentiality and a different culture also from the point of view of legal issues and all of that. So I think there’s a reluctance to be on the record I think probably understandably on certain things which may be why we’re not able to engage as well. But it seems to me that at a minimum a letter to OCR, an official letter to OCR about your concerns asking for specific feedback on what they’re hearing or how many complaints they’ve gotten on this issue, trying to engage them, would seem very reasonable to me.
MR. ROTHSTEIN: I think that’s a very interesting suggestion, I’d like to ask John and Simon for their opinions on that given that they felt that the record did not support a recommendation to the Secretary, do you think that the record would support a letter to OCR as Marjorie described. John?
MR. HOUSTON: I think it’s an excellent suggestion, as long as the letter asks for input or maybe not input but assistance, feedback, so it clarifies our understanding of the issue, potentially either to make recommendation or to hold additional hearings. I think it’s an excellent recommendation and to sort of weigh in on the other options, I’m concerned if we make a limited recommendation for fear that if we did in fact go back and do other testimony and find out that one of our recommendations maybe wasn’t the right thing, one of our initial recommendations wasn’t something that after further testimony makes sense to recommend then we have to sort of rescind or retract a prior recommendation, I think either you’ve got to make your recommendation or get more testimony or do what Marjorie says which is just try to glean additional information in order to make an informed decision. So I like her suggestion.
MR. ROTHSTEIN: Simon?
DR. COHN: I think I’m comfortable with that though I am trying to figure out what the letter is, is the letter a request for more information, the letter is not saying what we found from the testimony but is more of a letter saying we started initiating into this area, we realized we hadn’t received any comment from OCR, we need to understand the nature of the complaints so far, I mean is that the type of letter —
MS. GREENBERG: Well, and some of the issues that have come before you, I mean it’s not like you’ve initiated this, as Mark said there has been a variety of hearings on it, testimony, I think I’ve participated in at least three.
MR. ROTHSTEIN: At least.
MS. WATTENBERG: Is it an invitation to come testify?
MR. ROTHSTEIN: Well, as one model would be to say we’ve had hearings, this is a topic that we’ve addressed many times in the past, these three additional concerns and spell them out were raised not only by the witnesses but shared by the committee. We don’t have a sufficiently broad range of opinions in terms of witnesses to come forward with a recommendation to the Secretary at this time and in particular we have not, on these issues we have not heard from the following, we haven’t heard from health plans, we haven’t heard from blah, blah, blah, blah, we would be anxious to hear from you about whether this is an area of continued interest on your part in terms of further rulemaking, whether we can be of service in this area, other information that would be valuable to us such as complaints that have been filed or investigations in this area, and we’d like to help you with this issue —
MS. GREENBERG: And sort of say why you think it’s important. But I mean if you feel this is an important point of view of consumers, why you think it’s worth keeping it on the burner.
DR. FITZMAURICE: You might say that we’re helping, we need help in setting our own priority and we’re asking for your assistance, should we have more hearings on this.
MS. GREENBERG: But also I think there’s a reason why we’re still discussing this and why you feel it’s important, we have made impacts on —
MR. HOUSTON: You have to admit though the committee itself made its own agenda as to what topics were of importance. As Michael indicated though OCR may come back and say you know, we haven’t heard much on this, not that they haven’t, and that would in fact allow us to say it is or it isn’t a big issue, we heard two witnesses based upon testimony that we asked for —
MS. GREENBERG: No, that would certainly be good to know.
MR. HOUSTON: A good barometer, I think it is valuable to ask that specific question, I suspect there is a bigger issue out there but that’s just gut feel based on limited information.
MR. ROTHSTEIN: Harry?
MR. REYNOLDS: I’d like to go back to Marjorie’s earlier comment and I agree with it to a point. I guess the situation is there’s no question in my mind that a lot of the complaints are being dealt with as to whether somebody’s privacy was in fact invaded. There’s a difference between that and the administration of a law so that the entire set of people that are involved in that law can understand and that is the transmission of information that is not occurring. It’s not knowing about the individual, it’s not knowing about whether their rights were violated, it’s about here are the issues that are coming up related to marketing, here are the kind of things that are happening, here’s what’s going on and here’s what we think the law means. They can send the other to the Department of Justice and everything else because somebody just blatantly went out and took somebody’s information and wrongfully used it. There’s two different, now on transactions and code sets you don’t have that protecting of an individual, that’s a fact, that’s the difference, but you still, both situations require an administration of the law and an explanation of the law and a guidance so that people can do business. That’s doctors, that’s pharmacies, that’s individuals, that’s health plans, and that’s the part that I think is dramatically different. So I agree absolutely on the personal but there’s no guidance coming out on the administration of the law and what does it really, really mean as a structure and that’s why the confusion continued to be there and everybody’s pushing on the edges because you just don’t get it.
DR. COHN: I know this is mirroring Harry’s comment, I mean obviously the, I guess we need as a subcommittee to try to figure out, I mean what I was reading, or at least have been sort of reading between the lines on all this stuff is that the things that we were hearing are probably all okay under the nature of the regulation. I didn’t hear anything that sounded to me like it was in open defiance of regulation or FAQ, the more fundamental question is whether we think it’s right or not or that the regulation needs to be modified or whether OCR in their authority can further clarify or there’s something out of the side. But this isn’t something where people are doing necessarily the wrong thing because they don’t have FAQs, I mean this is a more fundamental issue I think. But maybe I’m misreading this one —
MR. REYNOLDS: I think some of what we heard yesterday is pushing —
MR. HOUSTON: No, no, I think Simon’s point though is that as per the law there’s enough ambiguity that would allow the practice to continue therefore people are, the practice at most would be in some way restricted so rather then broadening a right that was maybe in the case of fundraising, we’re actually going in the opposite direction potentially putting more restrictions in place so it’s not like we can delay and it doesn’t hurt, it doesn’t fundamentally disadvantage the pharmacy by the current status, or it doesn’t disadvantage providers by the current —
MR. ROTHSTEIN: Well it would arguably disadvantage consumers in the interim who were subject to these.
DR. COHN: Mark, I guess going back to the issue of Marjorie’s letter as you interpreted it, I’m of a couple different minds but —
MR. ROTHSTEIN: I was of two minds until Marjorie spoke, now I’m of three.
DR. COHN: Three minds, yes, exactly. I think Marjorie’s concept of potentially sending a letter may be a very good vehicle, the question though is it, I mean once again, and I’m really not sure if I want to discuss it right at this moment because we really may need to put this on hold and discuss it towards the end of the session. But obviously there’s a tendency to want to go back to an issues related focus letter with OCR, the question is is if we’re going to send a letter to OCR directly is it really that we need to have an issues related focus with OCR, or do we need to have a process related focus to that letter.
MR. ROTHSTEIN: What do you mean by process?
MS. GREENBERG: I’m not following your question.
DR. COHN: I’m talking about, I mean we can send a letter to them talking to them about marketing or we can talk to them about participation, interaction, ongoing agenda setting, etc., etc. I mean we have a choice of what sort of letters we want to send to them and I think underlying to it is, I mean this is a particular issue but it seems to me that there’s a process issue going on and we just sort of as I said, I not sure if I want to discuss the ways we might go at this point but I just do raise the issue that there’s different issues that we could bring up.
MS. GREENBERG: You could send the latter letter just as a subcommittee I guess, it could be completely below the radar screen —
DR. COHN: Or it might go through the executive committee.
MS. GREENBERG: Except that you could report that you had sent that, which would not have any kind of recommendations at all, just some of your concerns about, maybe that you’re not interacting enough, getting enough, and you need feedback from them on your agenda and all of those things. And then if you didn’t feel that was adequately responded to or responded to you could go the next level and do a letter that actually went before the full committee.
MR. ROTHSTEIN: I’d like to table the process elements, I think at the executive committee retreat these issues will be discussed. I’d like to focus on the options that we have now if that’s okay. And are we ready to vote on the Greenberg substitute, so in other words let’s, if this is defeated then we’ll vote on the other two options that we started with. So Marjorie would you like to rephrase your suggestion? Or I’ll stumble through it and you can correct me.
The proposal is to send a letter from the full committee to OCR in which we point out that we’ve had recently hearings, we heard from only two witnesses at this particular heard although we’ve heard from many others in prior on the issue of marketing and it appeared to one of the witnesses that raised several issues that resonated with the members of the subcommittee and committee and the three areas that we are interested in are disclosure of arrangements in marketing, the methods of marketing and whether they should be somehow restricted to try to avoid unnecessary disclosure of PHI, actually it’s not marketing, it’s really communication with patients, and whether it would be feasible to have some sort of opt out provision in these notification areas. And we think these are important issues, they involve many consumers, we recognize that we haven’t heard from all the stakeholders, we could have additional hearings from them to pursue this but at this point we would like to get your views on OCR’s interest in this area, your possible actions in this area, and some guidance as to how we can be most helpful to you on this topic.
MS. GREENBERG: And in particular you’d like to know what kind of, whether they’ve received many complaints in this area.
MR. ROTHSTEIN: I think that more or less is, and of course everybody is going to have ample opportunity to work with the language. Simon was there something that —
DR. COHN: We actually never really did talk about the opt out issue so I was trying to think of how, I mean did we want to include that in the letter?
MR. HOUSTON: I know I did raise it.
DR. COHN: I apologize, I wasn’t fully part of that conversation.
MR. FANNING: That does seem sort of specific and fine grained and doesn’t quite fit the pattern of the rest of the letter.
MR. ROTHSTEIN: Well, disclosures and how individuals can avoid being contacted, opt in, opt out.
MS. FRIEDMAN: Can I ask a clarifying question? Is the expectation that the Office of Civil Rights would actually write a response or would there be an invitation for them to do a presentation to the committee on these particular questions?
MR. ROTHSTEIN: Well we could put in the letter that we’re happy to have any response in writing or if you’re going to testify or —
MS. WATTENBERG: I guess I would just sort of put the caution out there that these issues are so complex that maybe part of the reason why people keep going round and round on it is that you’re not having sort of a direct dialogue so that you can do a lot of follow-up, really flesh out some of the subtleties of the issues, that perhaps the letter really should be to invite them to come and clarify for the committee where they stand and what the intention was on all of these issues.
MR. HOUSTON: But I don’t think it’s the committee, I’d like to have a dialogue and I think it’s the subcommittee where we should be having, I mean it becomes more formal in the committee, I would prefer to have a breakout session frankly and I don’t know what the protocol is but I think it would be real helpful for us to just simply have a good old sit down meeting with them and talk about this type of thing. Frankly I’d love to have a good old sit down meeting with them in general about privacy and our need for statistics and stuff like that —
MS. GREENBERG: And you’ve asked for that several times so I would say invite them to your breakout session in November.
DR. COHN: How about September?
MS. GREENBERG: Well, if you’re only sending the letter in September —
DR. COHN: I mean I guess the question is is this the type of letter, if we’re inviting them to come to talk to us about the issues more fully, I mean if that is really what we’re saying, if we’re saying geez, we started this, we’re really not putting any conclusions on the table, we’re not even referencing them, we realize that we really need to have a fuller discussion with you about this one, we’d like to invite you to come and discuss this with us more fully, your perspective, your understanding around marketing, I would say we could take it to the executive subcommittee, if everybody sort of thinks it’s a reasonable idea we could probably mail it out after that.
MR. ROTHSTEIN: We’re assuming that we can quickly get a letter that’s going to be sort of breaking new ground in terms of our subcommittee and have everyone sign off on the language, and that may take some time.
MS. GREENBERG: The problem too is the executive subcommittee meeting, although it’s certainly open to the public, etc., is not, it’s basically a working meeting, it’s a retreat in Princeton, that would not, it won’t be broadcast, it’s nothing like that. If you want this to be from the committee you can’t just take it to the executive subcommittee, if you want it to be from the subcommittee —
DR. COHN: I guess I have an amendment then which I think maybe goes along with what John Paul was saying, there’s a letter that we could send that has content about things that we were hearing, concerns that were being expressed, things that we thought related to that hearing. Or there’s a letter that gets sent saying geez, we held hearings, we’re just at the very beginning, we really thought it was like very important to get your understanding of this area recognizing that we consider it to be somewhat murky, we need to understand better a variety of X, Y and Z from you, we’d like to invite you to come to our breakout. There are no conclusions there, there’s really no content as opposed to a request for them to participate. I don’t know that a letter like that needs to go to anyone other then us and then off to OCR, because really what it is is an invitation to come and participate in the next —
MR. ROTHSTEIN: That’s a different kind of letter. I think the letter as originally described I think has value beyond that because it’s now posted on the website, it’s public record, it’s a statement that we’re interested in these issues, that they need to be resolved. The one that you raised is really a much broader process kind of.
MR. HOUSTON: I’m going to ask, part of what I’ve seen since I’ve been on the committee is this tension maybe between OCR and NCVHS over certain privacy issues and is the formality that you just described positive or negative, we ask people to come in and address the committee and the subcommittee all the time, the formality is some type of less formal community to OCR saying we want to come in, we want to do some planning, we’ve got some issues, potential issues related to fundraising, we don’t want to get it wrong. And not put it on the website, not make OCR feel compelled to come up with an official position, that might get us further overall in a dialogue with OCR. I just hate this thing where we see a letter and a response letter and reality is I think it was indicated that what we’re really trying to do is get communication going back and forth in a meaningful fashion and I don’t, sometimes maybe letters don’t do that or formal letters are counterproductive if you’re trying to achieve that goal.
MR. ROTHSTEIN: It would be productive if we had closer ties to OCR, there’s no question about that. On the other hand I think each of us, that is NCVHS and OCR, we have similar goals but we have slightly different missions and our mission is to be an advocate for certain positions that we think are in the public’s interest, and they may not necessarily align with the way OCR currently sees the world or sees the world ten years from now or saw it ten years ago, so it’s not, it doesn’t have to do with any particular administration or leadership in the department. And so yes, it would be nice to work with them but I think we need to independently at times put on the record certain views that we have and try to push them in one way or another on various issues. Like to work with them more but I don’t see it quite the way that John described it. Harry?
MR. REYNOLDS: As far as the letter you’re talking about preparing and taking it through the executive committee and the full committee for example, since there are no recommendations in here it’s more of a request, is there any way that we can rather then the whole committee have to eat the letter up and make sure every word is exact, can we give proxy? Since there are no recommendations, the letter comes from the committee and there are no recommendations there’s nothing more, it’s an elevated, Sarah calling the same people that testified, the people that testified yesterday and inviting them, we’re putting a little more formality to it but us having to go through the letter word by word when we do when we make a recommendation, I don’t know if there’s —
MR. ROTHSTEIN: What I would propose is that I will do a draft version of the letter if this is approved and we haven’t approved it yet, circulate it, let people send comments to me with mark-ups and whatever, then I will try to synthesize those and send a revision out to everyone by email. And then assuming that its, and I’ll ask you to exercise some restraint because I might get mutually conflicting recommendations, and then at that point ask for the approval of the subcommittee and at that point, and I’ll talk about this in Princeton, see if I can get the executive subcommittee sign off on it and not have to go to the full NCVHS, I think that would be helpful. And that might be a more streamlined process. Would that be okay with everybody?
MS. GREENBERG: And then it would not be posted on the website or —
MR. ROTHSTEIN: It would have to be approved by the full committee to be posted. Suppose it were a letter just from the subcommittee, could that be possible?
DR. COHN: Mark, I guess I continue to scratch my head a little bit because I don’t hear that we came up with any conclusions, I hear we were expressing a couple of concerns and really more then anything else what we want is to get their input and some additional information and their perspective and all of that, and then maybe after that we actually might have something to put up. So I feel like we’ve gotten so focused on are we going to have a letter out of this that we’re sort of missing the fact that we don’t have any substance quite yet, or at least that we need more substance to really be able to move forward a little bit. I’m happy, a letter, a communication, a phone call, whatever it takes to move this issue forward or the process forward and I think we’re all getting pretty convinced that the next step is to have a conversation with OCR to get their understanding of the issue, understand from them what the number of complaints are about all of this and all of that, I will support you on whatever you think is the best way to do that but that appears to be the next step item.
MR. ROTHSTEIN: I appreciate the comments, the only thing I would disagree with is the statement that there is no substance to the letter, we have no recommendations, I think we have identified areas of concern. We can say we’d like to meet with you, or let’s talk about marketing for the 100th time, we’ve said here are three areas of concern to us, we think that something needs to be done about these one way or the other, clarification, amendment, whatever, and we’d like your input about how to proceed with this, whether that means more hearings or whether that means whatever. So I just think —
MR. HOUSTON: To compound matters slightly I think if we are going to interact with OCR though I guess I do have, would like to open up a slightly broader dialogue at least A, in terms of are there other major issues that bear evaluation, some type of involvement of NCVHS —
MR. ROTHSTEIN: You mean non-marketing.
MR. HOUSTON: Non-marketing, as well as as Marjorie had indicated I know at least on three occasions I’ve officially asked for statistics and I would love to in a positive way open up that dialogue about, I’d really like to have statistics, I hate to sound like a broken record but if we get in a room with them I really want to say these things and I don’t want to blindside them by them walk in the room under the pretense we’re only going to talk about marketing when the reality is is that there are a number of other reasons why we would like to maybe to meet with them and I know that’s a broader dialogue but I think it’s fair to put in that record.
MS. GREENBERG: Also there was a letter from the committee that mentioned the importance of having some metrics or some way of evaluating the impact —
MR. ROTHSTEIN: Right, that was sent over a year ago.
MS. GREENBERG: I don’t know if there was a response to that.
MR. ROTHSTEIN: No, I don’t believe we’ve ever gotten a response to that. Well, here’s another option to make these more complicated, the issue of the relationship between OCR and the committee and subcommittee will be discussed at the executive committee retreat. We could defer on this issue, do nothing until our September meeting and then decide based on what comes out of the executive committee discussions about a broader relationship whether it’s better to have additional hearings, write a letter to the Secretary, write a letter to OCR, etc. I mean that’s another possibility although again it adds an element of delay but that’s sort of built into almost all the proposals.
MS. GREENBERG: Well a variation on that maybe is that if you could draft this letter before the executive subcommittee meeting and get input from the subcommittee, that you’d kind of have it in your pocket it would be one option. The advantage of that would be that there’d even be the possibility of asking OCR to meet with you in your breakout in September, certainly in November. If you do nothing, I mean if you don’t have anything ready for discussion then you’re putting off, putting this off either further. So it doesn’t mean that the letter would necessarily, it would just be one of the options to discuss with the executive subcommittee.
MR. ROTHSTEIN: I mean I think that’s an attractive option but the committee, the subcommittee would have to in effect delegate to, well, Simon will be there and I’ll be there and you’ll be there, the authority to recommend that assuming the initial discussion on general issues goes in a certain direction that we bring this up. I mean it’s hard to just have a sort of —
MS. GREENBERG: Oh yeah, the subcommittee would have to support that. Again, the letter wouldn’t have to be finalized, well, yeah, we think this might be useful then —
MR. ROTHSTEIN: Well and it might be a good exhibit at least, here’s one way, one direction we’re thinking of going in.
DR. HARDING: I think the subcommittee would support the chair and other members of the subcommittee there to do what’s right and expedient and move the process along as quickly as possible so that we could go with the appropriate flow.
MR. ROTHSTEIN: Okay, are we ready for a vote on this issue?
DR. COHN: What are we voting on?
MR. ROTHSTEIN: Well, here’s the vote. The proposal is to draft a letter as previously described to OCR and have that as an approved by the subcommittee draft form in time for the executive subcommittee retreat in Princeton, which is the first week in August, and at that time the chair of the subcommittee along with Simon who will be there can present this letter to the executive subcommittee as an indication of something that we’re thinking of doing to get input from the executive subcommittee in the context of a broader discussion of the relationship between the committee and subcommittee and OCR.
DR. COHN: Actually I think that sounds good and I would imagine that the executive subcommittee has a couple of options depending on what the letter looks like, it could either say yes we approve it and it ought to be sent out or B, this is something the subcommittee can just send out on their own, or C, there’s enough content here that you really need to hold it to the full committee.
MR. ROTHSTEIN: Or you need to wait on this or it’s setting a bad precedent by having subcommittees write, whatever. So hearing no additional amendments —
MR. HOUSTON: I second.
MR. ROTHSTEIN: So all in favor of the proposal as amended, clarified, and revised, say aye.
MR. ROTHSTEIN: Okay, opposed? The proposal carries. If it’s okay with you Maria we will take a ten minute break and we’ll take up the e-prescribing issue at 10:30.
MR. ROTHSTEIN: Good morning, we’re back again with our hearing on the Subcommittee on Privacy and Confidentiality. At this time we’d like to detour from our discussion of yesterday’s hearings and talk about the issue of e-prescribing and I want to recognize Simon Cohn and Maria Friedman.
DR. COHN: And this is really meant sort of as a joint quick presentation/discussion I guess, ask for I think forbearance, interest, participation, leadership, all of those other things. And I think we’ll try to spend about ten minutes overall discussing it.
I think as you know obviously under the Medicare Modernization Act NCVHS was asked to advise the Secretary on e-prescribing standards and I think as you all know in fact some of us are sort of living in Washington at this point, trying to get sort of the first set of recommendations for our September full committee meeting. So we all know that that’s going on.
Now as we’ve been holding hearings and talking to the industry about these issues we’ve also been hearing and beginning, actually it isn’t that we’re hearing, we’re beginning to get inquiries, from the industry about investigating and I think a more in depth discussion on possible privacy and security, especially privacy, issues related to the whole issue of e-prescribing.
Now as I say this one I don’t exactly know the content that may be coming forward and I think we’ve all been sort of trying to figure out if there’s anything that’s a real hot button item. We think it’s not likely really to the underlying standards per se but obviously there are a number of layers here of complexity, one of which was one we just talked about, the issue of marketing which can either be a privacy issue or it can be more of a general what’s right to do in the world of e-prescribing. It’s also an issue that’s further discussed in MMA, but there are probably other issues that we just don’t know about.
It occurred to us as we were hearing these that it was really the responsibility, not the responsibility but we hoped the leadership of the Privacy and Confidentiality Subcommittee to sort of hear from the industry to understand better where there concerns maybe coming forward so that we can advise on any, the department on any issues and potentially mitigating strategies that might involve all of this.
Now as we’ve talked I don’t think that this has to happen before September, which is good, because I don’t think anybody has any time before September. But given that there is obviously a lot of department interest in e-prescribing, given that the timeline for pilots and all of this is relatively aggressive already —
MS. FRIEDMAN: And being accelerated.
DR. COHN: And probably being accelerated, and given that this is actually a piece of the overall issues related to actually the EHR if you think about it because obviously e-prescribing is a major module of whatever’s person view of EHR and LHII and all of that, it seemed that this would be something that the subcommittee should be interested in, should consider as a high priority item because the department considers it to be a high priority item, and that we should try to probably plan some time for at least an initial investigation, I guess I’m presuming probably some time in the fall, early to mid, we can arrange time, we can discuss between subcommittees the appropriate timing of all this and with the department, but I guess I’m hoping that the subcommittee would be interested in at least investigation in this area. Maria, do you have any comments?
MS. FRIEDMAN: I just think our hope was as Simon indicated in our travels and getting these hearings together people are starting to raise these concerns and we hope that we could tee this up for the subcommittee and talk about, put it on your issues list of nothing else and then talk about investigating it and fleshing it out further.
MR. ROTHSTEIN: Where are you with your hearings?
MS. FRIEDMAN: Which ones?
MS. GREENBERG: Mostly here, that’s where they are.
MS. FRIEDMAN: We have three days the end of this month, we have three days in August, we hope that that will result in recommendations to the full committee for consideration in September. We cancelled our September meeting but we’re on for October and November —
DR. COHN: October and December.
MS. FRIEDMAN: October and December.
MR. ROTHSTEIN: Now is privacy brought up sort of indirectly or I mean do you have any hearings planned that are committed to just privacy or focused mainly on privacy?
MS. FRIEDMAN: No, the immediate focus right now is marching through the stakeholders as specified in MMA to make sure that we hear from everybody we’re supposed to hear from and coming up with these recommendations, and then coming up with the recommendation. The hearings farther out into mid-March will be aimed at solidifying the recommendations and adding others that we didn’t address early on.
MR. ROTHSTEIN: What would be the timetable, let’s assume that we had hearings, what would be the timetable by which you would need those hearings to have taken place to be helpful to you in your work?
MS. FRIEDMAN: I think there’s segregable issues, I mean one thing there’s standards, and that there are implementation issues with getting e-prescribing up and running not only in Medicare Part D but elsewhere because everybody seems to be doing it all over the place. It’s mushrooming and so there are issues that are arising everywhere. I’m not sure how privacy effects the standards so much, at least some of the transmission standards, maybe some of the content standards that we’re going to be looking at, but I’m looking at it more as an implementation issue, at least from where I sit anyway.
DR. COHN: I think that’s something, I mean this is that issue that we need to hear from the industry to find out what their concerns and issues are. Of course the good news is is that there’s two members of the subcommittee who are actually members of the Subcommittee on Standards and Security and actually John Paul who just left the room clearly sort of borders on the edge of interest in this area also.
If there is interest from the subcommittee, and once again we think it’s an important issue, one that really does need to be investigated by Privacy and Confidentiality Subcommittee, we can sit down and work with the chair to sort of figure out what the optimal time for a first hearing and then, sort of working back from when we think we need information in all of this.
MR. ROTHSTEIN: Okay, because the last thing we’re going today, and I hope we get to it shortly, is to sort of prioritize our issues for future hearings and I was just trying to get a sense of whether this was something that you thought we needed to start in 2004 or could start in early, sometime in 2005 —
DR. COHN: I mean I think that this is a 2004 issue, whether it’s a September or a later in the year, I think we’re going to have to have a little bit of discussion about it.
MR. ROTHSTEIN: So it’s something that we need to take up in the short run rather then in the medium run.
DR. COHN: Right. I mean that’s my feeling currently, obviously I tend to try to, as a general rule I think for these sorts of things you try to integrate them into department processes so we can be maximally useful.
MR. ROTHSTEIN: And you see this as something that would require multiple hearings? In other words more then let’s say two days of hearings? You think it might have sort of a series?
DR. COHN: Well, I’ll tell you what my thought is is that one would probably want to start out with two days or a day, if we had a day we’d take a day potentially to just begin to understand the issues. I tend to think that they, and once again I’m projecting because I don’t know, we need to hearing from the industry what the issues are, but I suspect the themes don’t necessarily look all that different from the themes that we’ve been talking about history, I mean privacy is privacy after all, I mean marketing may look a little different but it’s a flavor that tends to run through a lot of this stuff —
MR. ROTHSTEIN: If we knew what it was we could envision it in other contexts.
MS. FRIEDMAN: I would say that it’s probably something later in the fall because for one thing we will get a sense from the industry in July and August from the attendees just talking to people as we normally do where they’re headed that on this and what they see as the emerging issues. And for one thing e-prescribing is one of those issues that’s just all of a sudden burst on the scene, it’s kind of a big bang issue for a lot of people. And to some extent not everybody has gotten their head around it yet but once people start to focus on e-prescribing and once Medicare Part D starts to move along and people focus on it more then I think there will be even wider interest but I see that as a longer downstream kind of issue. But I think it might be helpful in the fall just to find out some preliminary discussions, find out where people see the initial issues lying or shaking out.
MR. ROTHSTEIN: Questions from subcommittee members? Okay, well thank you and we will revisit the issue when we come up on our plans. Thank you, Maria. If there’s nothing else at this time I’d like to move then to the second of our topics, which is fundraising, and you’ll recall yesterday’s discussion. After lunch we had two speakers on fundraising, John Zeller from John Hopkins and Bill McGinly from the organization representing Association for Healthcare Philanthropy, something like that, and so the floor is open now for discussion of the issues raised at fundraising. In other words is this something that we should become involved in now in terms of drafting a letter to somebody saying something and if so what are some of the issues that you’re interested in. John?
MR. HOUSTON: I think we heard very clear testimony yesterday that there has been an impact because of the privacy rule on fundraising, both in terms of additional effort and cost but also a substantial decrease in actually getting fundraising dollars in the door, and that that’s had a pronounced effect on non-profits engaged in this within health care. I also think we heard strong testimony yesterday that the purpose of these fundraising dollars was to do such things as to support research as well as treatment and that my own personal opinion is that I think we feel compelled to do something here, I think the recommendations that I heard very clearly was that they needed to at least have one general piece of additional information related to, let me make sure I get this term correctly, at least from AHP they thought that they needed to have point of service, I think they use a different term here, needed to have information related to —
MR. ROTHSTEIN: The division I think is what they called it.
MR. HOUSTON: I had it underlined and now I can’t find the darn thing. Patient service department information is how they characterized it within their testimony. I think the only delay that I can think in putting a recommendation together was that during the morning testimony on marketing I did as Joy Pritts what their opinion was from the Health Policy Institute on the inclusion of this additional information, piece of information, for fundraising purposes. And she said that, off the record she’d indicated, she felt like they could support that but that she wanted to go back and research the issue and talk to others in the organization and I think she’s committed to providing some type of written response to us regarding their opinion. But I feel strongly like we need to make some type of recommendation here to allow this additional piece of information to be made available for fundraising purposes because of the actual documented impact of this on fundraising.
MR. ROTHSTEIN: And is that the only particular recommendation you have?
MR. HOUSTON: Yes.
MR. ROTHSTEIN: Other comments? You know we did have a recommendation on this in a prior letter to the Secretary, we should probably pull that up, I think it was, they said at the testimony yesterday was March of 2000 and that’s the date that they used but I’m not sure that’s right, I think it came later then that. But the question is we had a broader recommendation and included more things, it didn’t include that particular point and I suppose in the letter we should, if the subcommittee and committee agrees, we should reference our prior letter and say that we renew our recommendation along the lines of blah, blah, blah, and in particular we are concerned with such and such issue.
MR. HOUSTON: Right, I think the letter needs to emphasize the fact that they have documented actual impact, detrimental impact, and I think it’s another issue with the, I apologize, I do have one other comment, back to the OCR, it would be helpful to know if there have been complaints regarding fundraising, because that was the other point that they made —
MR. ROTHSTEIN: They claimed that there were no complaints.
MR. HOUSTON: Or so few that they are demonstrating that they are good stewards of the data.
MR. ROTHSTEIN: I do have some concern with saying that they have documented that there has been an effect, I think we can testify that they believe there has been an effect, I don’t know that the evidence, there’s enough evidence to document that, I mean who knows why people aren’t given and in what amounts —
MS. GREENBERG: The economy.
MR. ROTHSTEIN: Yeah, it’s just too complicated. I think we are better off if we want to take that position in making the argument that we talked about yesterday, someone who goes to Fox Chase Cancer Center or MD Anderson or the Hutch, they can get a letter asking to contribute for cancer research. But if you go to Hopkins and you’re treated in their oncology department the fundraisers can’t be told that you’re in the oncology department and you have to get a general fundraising letter unless you sign a specific authorization. I think that is a very sort of strong argument, I would personally be more comfortable arguing that then saying there’s been a demonstrated thing. In his original testimony McGinly said that fundraising would decline 50 percent if they couldn’t get that information and I don’t think there’s any evidence anywhere near that.
MR. HOUSTON: I think it’s fair to state the testimony described a drop in fundraising, and he did provide statistics about a drop, percentage of individual contributions —
MR. ROTHSTEIN: From 70 to 50 percent.
MR. HOUSTON: 56 percent, I think there was something else that said 50, and that they also said that, Bill McGinly indicated that they believe there had been a drop in giving from $8 billion down to $5.5 billion —
MR. ROTHSTEIN: Which is before the implementation date which he claimed was due to confusion in the donor’s minds, which is just, I mean that’s his assessment. Now that’s why I just want to stay away from that.
DR. COHN: Do we want to use words like impacted and just leave it at that?
MR. ROTHSTEIN: I think we could write it around where there is evidence that there has been a decline, that the professionals in the field think this is attributable at least in no small part to the privacy rule. Harry?
MR. REYNOLDS: I think that the law has definitely, from the testimony yesterday the law has cost them more money —
MR. ROTHSTEIN: That we can clearly say.
MR. REYNOLDS: And that it has given them less access to donors.
MR. HOUSTON: Well I think we’re allowed to say and we’ve said it in other testimony that the individuals testifying indicated that statistically speaking they believe there’s a drop in individual donations. I know we made, it’s one thing for us to say that that we believe that there has been a drop, and another thing to say that the testifiers indicated that there had been an individual drop and I think it is fair to cite their statistics or at least cite the fact that they have statistics in that regard, maybe not the actual numeric statistics.
MR. REYNOLDS: And further I would like to see us make a recommendation that HHS take a look at this differentiation, I mean specialties and non-specialties because that whole situation of I have this condition in one place and I have it at another, you’re able to talk to me in one and not talk to me in another —
MR. ROTHSTEIN: But if we, our recommendation, should we adopt and should it go through wouldn’t that eliminate that problem? In other words if we recommend that this patient service department information be provided wouldn’t that level the playing field between the specialty hospitals and the general hospitals?
MR. REYNOLDS: Well, if we’re also, I guess what I didn’t read into it, we’re recommending that the information be made available but then aren’t we recommending that just like a specialty they can approach that person? If that’s inherent fine but I’m not —
MR. ROTHSTEIN: Well, what it would say is that PHI can or that information can be disclosed to the individuals doing fundraising at the hospital as well as their business associates because that’s the way the rule is currently written, and then there are provisos but it says that the only you can give is name and date of service. And what we would be proposing is to add another thing, that it can also include the service department information.
MR. HOUSTON: I think Harry’s point also is that you could then use that data for more focused fundraising activities.
MR. ROTHSTEIN: Oh, you mean why they want it.
MR. HOUSTON: Right, so that —
MR. REYNOLDS: Well, without an authorization can I still approach?
MR. ROTHSTEIN: No, because it’s limited —
MR. HOUSTON: But even if you give it to them you still want to be able to say if it’s cancer patients you might want to do a focused cancer fundraising effort and therefore it doesn’t make any sense to have cancer patients but then only be able to do generalized fundraising that don’t relate to the disease state or the department of service. So I think it’s important to be able to both have the information and be able to use it for fundraising related to that particular department.
MR. ROTHSTEIN: The other thing that I think is important should we adopt this approach, or renew our recommendation, is that the loss of privacy by the individual patient if we did this would be de minimus, I mean the privacy rule costs, everybody knows that, and everyone or many covered entities are expected to sort of contribute to that, but we expect a payoff in terms of protecting privacy and here is a cost that we’re documenting even though we can quibble about the exact amount, but I’m not sure what the payoff is because I mean as we discussed in the hearings people can, anyone can view the directory, go to the room, they see it’s on the oncology wing or the surgery wing or the obstetrics wing and they know more or less from the director what sort of condition they have and we’re not authorizing the release of much more then that anyhow.
MR. HOUSTON: By the way, in my original comments this morning was talking about that sort of level playing field, this is information that frankly in large measures by pharmacies as we heard to do what amounts to what some people would argue as marketing. So it’s not like patients are going to receive, patients are allowed to receive lesser information, or fundraisers are allowed to provide lesser information to patients for the purposes of fundraising then a pharmacy can provide to the patient —
DR. COHN: Let’s not go exactly there, but I agree with you.
MR. HOUSTON: Maybe we don’t want to state that in a letter but frankly it does seem —
DR. COHN: Mark, I guess I would ask for your guidance on this one, I think we’re all in favor, I’m not hearing anybody objecting to going forward with a letter on this and it seems like we’re spending time just wordsmithing the arguments, but I think it’s a relatively, I mean unlike our previous conversation this is clear, specific, focused, has a very good rationale and I think we should just let you and the staff put together a paragraph or two that basically supports this recommendation.
MR. ROTHSTEIN: Okay, are we ready to vote on the substance and then we’ll talk about procedures?
DR. HARDING: The rationale for the original delineation from not getting into the point of service in a general hospital was for the specialty sensitive issues, which were infectious disease, genetics, psychiatry, some types of reproductive issues and so forth. I mean isn’t that why that was in there like that?
MR. ROTHSTEIN: Right.
DR. HARDING: And is that not a valid thing anymore? Does this trump it to have the ability, I mean far be it from me to want to stop research and gathering of money for hospitals to help with, I mean I don’t want to be the person that throws cold water on that in any way, but there was an original reason why, the rationale was there that we did this or made that recommendation, and it’s a change now or as they said, and have always said, there are very few complaints about approaching people, about fundraising, and maybe it’s just not an issue.
MR. ROTHSTEIN: Well maybe they don’t realize how they became targeted. You go to a hospital you expect to have fundraising and maybe you don’t realize that they received, this is sort of pre-HIPAA, maybe you don’t realize that they received information about, I want to get this right, the patient service department, in doing that, you just assume that you got the letter that everybody got.
MS. GREENBERG: These letters, what if the letters are coming directly from the institutions, obviously knows where you’re having your service, that’s okay or is that the problem too? Or is it only if they’re coming from a third party who’s a business associate of the institution?
MR. ROTHSTEIN: No, it can’t be shared with even internal fundraising people at the institution.
MS. GREENBERG: Within the institution. They would say they don’t have a need to know.
MR. ROTHSTEIN: Correct. While John Fanning speaks I’ll try to dig up the actual provision.
MR. FANNING: With respect to Dr. Harding’s question, I don’t think anything has changed, there are still those sensitivities, but I harken to Mark’s observation de minimus, the other factor here is that the institutions involved have every incentive to get it right from the privacy and intrusion standpoint. If they don’t do it right they won’t get money so the tradeoff for the institution is different from the tradeoff for certain other uses and disclosures.
MR. HOUSTON: And if we were concerned, if we are concerned which I think is reasonable that we should be concerned about these stigmatizing conditions and services, that we could make a recommendation that these materials need to be appropriately packaged to maximize the privacy protections of the individual. I know from talking to our fundraisers, they just don’t send fundraising materials to psychiatric patients, it’s just something they don’t do. But even if you were to say we’re going to send it to family members or somebody who has, a parent of a child that’s getting some type of treatment, if you were to say it has to be appropriately packaged so that it comes from, please donate to our psychiatric clinic since you were a patient here, you don’t say, then it would be no different then a lot of other types of communication that are otherwise permitted under the rule.
MR. ROTHSTEIN: Well obviously we I think would go down the wrong path if we wanted to list carve out areas, but we might have some sort of recommendation that says that care, special care and professional standards and fundraising need to be closely followed in fundraising for sensitive or stigmatizing conditions, something like that. Richard, would that satisfy you?
DR. HARDING: Sure.
MR. ROTHSTEIN: I mean we want to recognize the issue but without tying everybody’s hands. Excuse me for a minute, I’m just trying to, I can’t find the fundraising, you can’t find it when you want it, I know what the provision is, it just allows them to have those two data points and we are suggesting a third data point.
So are there additional comments or amendments or points of order? Okay, so we’re ready to vote. John, you want to repeat what we’re voting on?
MR. HOUSTON: Sure, I recommend that we make a recommendation of the committee that the fundraising provision, I don’t know if it’s clarified or amended, to allow for the provision of data related to patient service department for the purpose of fundraising.
MR. ROTHSTEIN: You know we might in our letter put our own definition of that because the Secretary doesn’t know what they mean by that and our interpretation of that is broad areas of service and that’s all they want anyhow, we don’t want all the sub, sub —
MR. HOUSTON: You want cancer in general not —
MR. ROTHSTEIN: Oncology, neurology, orthopedics and so forth, not anything that’s going to be much more —
MR. HOUSTON: I would say the one area that would be a departure from that specifically would be where general surgery is a specific area within a hospital, transplantation is an area that typically much fundraising goes on —
DR. COHN: Mark, aren’t we micromanaging at this point a little bit? I mean —
MR. ROTHSTEIN: No, that’s explaining because what we are not recommending is that they be able to get within oncology whether it’s lung cancer or liver cancer or whatever, it’s just oncology, and that’s all they want, they don’t want any, the testimony yesterday was they don’t need it finer then that and they don’t want to finer then that, more then that would be really diagnostic —
DR. COHN: Okay, so we’re describing it at the broad sort of just descriptive category, i.e., e.g., probably e.g., oncology, and whatever other examples you want. Okay, that sounds fine.
MR. ROTHSTEIN: Okay, with that description all in favor say aye?
MR. ROTHSTEIN: Opposed? No abstentions? Alright, let’s talk about specific now in terms of getting this through the pipeline. I assume we’re thinking of September and we have a kind of a staff hiatus now to describe to you, Kathleen is on temporary reassignment and she’s relieved of her duties to the subcommittee, she’s working on NHII stuff and when that’s done I don’t know. John has temporarily moved to fill in for Kathleen but that will be only through the end of this month and we don’t know what our staffing situation is going to be like.
MR. FANNING: Well I would point out that we do have additional staff people who actually put the particular sections of the hearing together —
MR. ROTHSTEIN: Correct.
MR. FANNING: Evelyn for fundraising, Katherine for marketing, and Sarah for the press, so those people are very much here.
MR. ROTHSTEIN: Yes. What we don’t have is a lead staff person and with all due respect what we don’t have is someone who has worked with us in the past in putting together a letter. So what I’m suggesting is that, I’ll see what you think of this, I’m going to be working initially on putting together the marketing proposal in the next ten days which we will be circulating. Can I ask for a volunteer of a member of the subcommittee who would be willing to do a draft?
MR. HOUSTON: I’ll do a draft.
MR. ROTHSTEIN: Thank you. And that would be to take the lead on the fundraising letter for us, so let the record reflect Mr. Houston has generously agreed to do that. And then it will just follow normal procedures from there.
DR. COHN: Just in terms of timing I think it would actually be very nice if these letters were completed and maybe the subcommittee had a conference call prior to the executive subcommittee meeting just because both letters need to be, the first one really needs to be —
MR. ROTHSTEIN: I don’t know that the second one needs to be considered by the executive committee, the reason that the first one does is it’s sort of unusual, it’s a letter to OCR and we’re trying to get advice —
DR. COHN: My memory of the process is is that we try to have members of the executive subcommittee review letters to go into the packet for the full committee and it would just be very convenient —
MR. HOUSTON: I will do it next week.
DR. COHN: I’m just sort of thinking we won’t have to have multiple conference calls, I mean let’s try —
MR. ROTHSTEIN: That’s fine, I was just trying to save some of the —
MS. GREENBERG: Well, it’s possible the subcommittee could agree on this letter by email, I don’t know if a conference call is necessary. But generally what happens if you can’t by email then the conference call.
MR. ROTHSTEIN: I’m looking for my notes, if there’s nothing further I’d like to move on to the issue that we discussed in the afternoon and that was the media. I’m sorry, Michael.
DR. FITZMAURICE: I’ve got a thought and that is that you mentioned that we don’t have a lead staff and I know in the past it’s been effective for someone like John Lumpkin to make the call to the particular agency that would have a responsibility for a given area, for example calling AHRQ for quality, you might consider asking him to call Rick Campanelli, the head of OCR, for staff support in an area that is particularly important to OCR.
MS. GREENBERG: I think we can discuss that in August.
MR. ROTHSTEIN: That is a key issue for discussion at the executive committee retreat. Thank you. Other? Okay, let’s move to a discussion of our media presentation in the afternoon, we had six witnesses raising all sorts of wonderful issues, and we had a series of recommendations in some of the proposals, especially the one from Barbara Cochran listed a variety of things that we may or may not want to do.
MR. HOUSTON: Since I’m drafting this letter I was writing down notes, one point of clarification on this letter, are we asking for a recommendation that we modify the privacy rule to add department of service or are we asking for a clarification that would allow, a clarification from OCR that would allow the use of department of service?
MR. ROTHSTEIN: I believe it would have to be an amendment because it was a prior recommendation that was rejected by the department and in the comments to the amended rule they described why they were rejecting it so I don’t think they can —
DR. FITZMAURICE: If you want to add another piece of information it probably has to be amended right there where they specify those two pieces of information.
MR. ROTHSTEIN: Right, they need to add a number three as well.
DR. COHN: This is just wordsmithing but you might just sort of say either modify, modify the rule or release guidance at their discretion just so that you can really —
DR. FITZMAURICE: I agree with Simon because if they can do it by guidance or something then it’s a lot easier then have a regulation change. If they make the decision that they have to change the regulation, better that they try to find all the opportunities, that’s a very good suggestion.
MR. ROTHSTEIN: So we just tell them what we want them, want it to be and let them worry about whether they need to do it but parenthetically I don’t think they can.
MR. HOUSTON: Thank you, sorry for that interruption.
MR. ROTHSTEIN: Okay, on the media, are there areas that were raised, and there were certainly many of them, many interesting ones, are there areas that were raised that you think are appropriate for us to have recommendations on or further hearings or pursue in other ways, so the floor is open for comments or suggestions, recommendations. Michael?
DR. FITZMAURICE: I read through the testimony, I wasn’t here for the testimony but I’m a little puzzled because the privacy rule was put into place because some protected health information ought to be under the control of the individual and not available to the public. You can hardly make it any more available to the public then to have it printed in the front page of a newspaper, maybe the last page of a newspaper. It seemed to me that this is square against what the privacy rule was trying to guard. Now it’s one thing if you’re going to ask an individual, a report asks an individual and the individual says yes, but if you’re lying there comatose and somebody wants to know protected health information about you, it seems to me that there’s got to be a public health reason to release it and that could be made by a public health authority as opposed to let’s put it in the newspaper and see if anybody reacts.
MR. ROTHSTEIN: I think that’s an excellent point. One of the things that I think came through yesterday was the belief by various media folks that they were frustrated by the unwillingness of health care providers, particularly hospitals, to disclose information about patients, but other people as well, that is public officials, police, fire, etc., by claiming that HIPAA prevented them from doing that. So I think they’re frustrated that HIPAA has become the all purpose excuse whether HIPAA applies or not, even by non-covered entities who don’t want to release information. And I pointed out to the panel members that HIPAA only prohibits certain disclosures, it doesn’t make them give you stuff that you want. And that’s what, they want stuff and the best that we could do I think, or can do, is ask for greater clarification of what the rule does and does not do, who it applies to, who it does not apply to and so forth, so that maybe this sort of mistaken use of HIPAA as a defense will be obviously pointed out. But beyond that —
DR. FITZMAURICE: I know we face the same thing in research, that there are ways for information to be released to researchers but it’s permissive, they don’t have to release information to researchers. In a side conversation with John I was discussing well researchers have institutional well researchers have institutional review board, would the media like to have a media review board, a media ethics board to say here are the methods by which we collect information, we want your judgment, give us a waiver, give us an approval to go get the information. But John reminded me that that probably could fly against the face of the first amendment and might not be constitutional. So I just want to bring that suggestion up to draw the parallel of the parallel kind of stuff because researchers don’t have such an amendment.
MS. GREENBERG: But news on Tuesday is old news by Wednesday it seems so sometimes.
MR. FANNING: I think what was discussed yesterday was not what might be called research by the media. There was an article in the New York Times five, six years ago about deaths in hospitals in Harlem that might just as well have been something funded by your agency, Michael. And if they come as researchers and make the necessary promises I don’t know that they’re any different from any other researcher, we’re simply fast researchers. And my understanding is that the model law for vital records treats things that way, if you come and make the necessary showings you can get it for research, showings and promises, but that’s not what was at issue yesterday.
MS. WATTENBERG: I do think one of the issues was that they believed sort of investigative journalism should be considered research and that in fact since it’s not generalizable knowledge it doesn’t meet the definition of research but that that was their concern.
MR. HOUSTON: I agree with you, what I am concerned with though was, I forget who it was, I think it was Rebecca Daugherty who almost, I’m paraphrasing her and I hope I’m saying it correctly, but her basic attitude was that public figures are fair game. And that is disconcerting to me because it goes well beyond the bounds of we want to do investigate journalism because we see some egregious issue here like the Muskee(?) Project. I really think that its in my mind sometimes, I don’t want to say more sinister but more politically motivated, it’s almost like what’s happening up in Chicago or in Illinois in their candidate for I think the one house seat and them going into the sealed court records to get information about his divorce. That in my mind, it’s sort of politically charged and my fear is is that the reason why researchers are able to get at patient information, and by the way there’s extremely rigorous controls in place, is to do something that is absolutely clearly, to pursue the public good and further medicine and the like and we look at the controls that are in place for research, they’re substantial.
DR. WATTENBERG: If I understand the way they ended up I think what they were saying was, or what they were reluctantly agreeing to, is perhaps we wouldn’t think the public figures are fair game, there is that whole issue of Arthur Ashe, but the issue of whistle blowers, that when there really is a concern about that somebody has and they want to provide information to the press because nobody else is responding, the kinds of penalties that whistle blowers would suffer really impedes the ability to be an independent observer of fraud and abuse and so forth.
MR. ROTHSTEIN: We did have that discussion yesterday about whistle blowers and the provision on whistle blowers as we discussed yesterday provides in 164.502 that a covered entity is not considered to have violated the requirements of the subpart if a member of its workforce or business associate discloses PHI provided that the workforce member or business associate believes in good faith that the covered entity has engaged in conduct that is unlawful or otherwise violates professional or clinical standards, or that the care blah, blah, blah, blah, blah. And the disclosure is to a health oversight agency or public health authority authorized by law to investigate or otherwise oversee the relevant conditions of the covered entity, or to an appropriate health care accreditation organization, or an attorney retained by or on behalf of the workforce member.
There is no provision in that section that covers reports to the press and so we explored you’ll recall yesterday ways in which that language might be amended to protect from the civil and criminal penalties provision reports to the press about misconduct in various ways at covered entities, and we didn’t want to use the media or the press because of the definitional problems and we haven’t resolved that but that’s the concern. And so that’s one, clearly one discreet area. I mean I had and continue to have major problems with many of the things that are on their list for the reasons that we talked about yesterday but that’s one that I think merits some discussion because it’s not just making the media’s job easier for them, there’s really a public interest that’s reflected already in the privacy rule but that arguably does not include some kinds of reporting. Any comments? John?
MR. HOUSTON: My gut reaction, I mean I think I spoke about it yesterday to whistle blowers is it’s an imperfect environment for whistle blowers but I think the government has taken, has obviously agencies and statutes in place to facilitate whistle blowers and this rule very clearly identifies the fact that disclosures to them are permitted. There are no controls whatsoever for the media and what could become a pretense for disclosing information as a whistle blower activity and yet that I think there’s a lot of opportunity though to use this to potentially do things such as litigate matters in the media, as well as to just simply use it as a catch all. And I don’t know, again, I’m going to go back to the whole, the comment that public figures are fair game which I’m almost positive, I’m positive I heard that yesterday and maybe I’m paraphrasing it somewhat —
MR. ROTHSTEIN: That’s hardly the most contentious thing that was said yesterday —
MR. HOUSTON: But that was in the testimony before it even got contentious, she made that statement as sort of a part of her —
MR. ROTHSTEIN: Well one of the most contentious things, one of the most troublesome things to me was that they should have not only access to medical records of public officials but shouldn’t we have access to the medical records of the people who fly our airplanes and drive our buses and if you go down that route, and who sit on federal advisory committees, and so on, I just think that’s —
MR. FANNING: Well, even more immediately one of the reasons there’s a special statute for drug and alcohol abuse treatment is so the pilots will go and get treatment, so the risk of the pilot getting it wrong in the airplane goes up if he’s discouraged from getting treatment.
MR. ROTHSTEIN: There are just all sorts of reasons why that’s in my opinion not a good idea.
There is one other area, oh, I’m sorry, Simon?
DR. COHN: Well, I was just actually going to, well first of all I apologize because obviously my knowledge of this discussion which sounds like it must have been very fascinating is based just on the written word as opposed to what was actually said. I guess what I would observe as I look through all of this that the themes seems to be sort of the same as the public health theme, when we were, at least to me 50 to 60 percent of this issue, the same thing we heard from public health which is sort of like geez, people are just not getting it right, they’re not aware of really what the rules are, there needs to be an educational effort —
MR. HOUSTON: I think they know what the rules are, they don’t like the rules, I think that’s a big part of it, and then the other part of it is —
DR. COHN: No, I was referring to, I’m not speaking about the reporters who don’t like it, I’m speaking of their comments about law enforcement, fire rescue personnel, and all of that, and a request that there be some focused education of those group about what they can and cannot do —
MS. WATTENBERG: And about open records, law and public records, right? That was a concern about the confusion —
DR. COHN: I just thought that basically there’s a recommendation here that I thought at least at the very basis, regardless of whether we talk about substantive changes to the regs, that there was a piece there which I thought was reasonable that we needed to sort of alert OCR, and this is based, I think what I’m seeing in Sara’s written testimony as well as the flavor in the rest of this testimony, that people seem to me, I mean part of it is that people would be using HIPAA as an excuse, but I tend to think that a lot of it may be just like the rest of the world that we’re seeing, that they’ve heard of HIPAA, they may not quite understand it and so they’re being overly sensitive at points where they really could disclose information.
MR. HOUSTON: But some of this by the way, I think some of those people that they’re describing as either disclosing or refuse to disclose information aren’t even covered by the rule, that’s part of it —
DR. COHN: That’s part of what I’m saying.
MR. FANNING: That’s his point, I must say though OCR is pretty clear about all this, it’s not clear what they could do beyond emphasizing that the rule covers certain classes of organizations and not others. Actually my impression is a fair number of the complaints are washed out right away because who’s being complained about is not a covered entity. And I suppose they could go to the conventions of fire chiefs but I’m not even sure that it would be desirable to keep emphasizing that other institutions are not subject to a privacy rule, that is true as a legal matter but it sort of misses the point of what rules they perhaps should have.
MS. GREENBERG: Was there an issue of preemption? It seemed they were saying there were some public reporting laws in some states that people were not now, they weren’t responding to because they said HIPAA didn’t let them —
MR. ROTHSTEIN: They were concerned that people were not obeying state open records laws because of HIPAA.
MS. WATTENBERG: That they thought HIPAA preempted state open record laws. I do think a lot of what they were asking for was just clarification of some of this stuff, that open record laws are open record laws, HIPAA is HIPAA, who’s a covered entity, and I think you’re right, John, about do we necessarily sort of put out there for high visibility that law enforcement doesn’t have privacy protections and stuff, it’s a question.
MR. FANNING: Possibly some clarification about the intersection between local law and this, the privacy rule says that any disclosure that is required by law is an allowable disclosure, so if in a particular case some record held by I guess a covered entity that’s subject to a state law that forces disclosure, that disclosure is an allowable disclosure.
MS. GREENBERG: What about if it’s held by a non-covered entity?
MR. FANNING: Oh no, that simply isn’t involved, whatever law applies to that applies.
MR. HOUSTON: Well let me say this, if there is one recommendation that I heard out of yesterday that I guess is actionable in my mind is that one area they were concerned about was if there is a disaster and they wanted to simply get information about patients who are being treated, I think that I guess one recommendation we could make would be that OCR provide guidance that to the extent that information can be already made available to public authorities that I guess maybe it would be encouraged that there be processes set up so that something be documented so that in the event of a disaster it would be clear that the media could go to public authorities rather then hospitals and that information could be disclosed to those public authorities for further dissemination to the news media.
MR. ROTHSTEIN: It’s clear that that can take place now under HIPAA, what they wanted to do is they wanted to change that because as they described it with certain cases like the Conagra(?) shooting in Kansas, they believed that the public officials were too slow in reporting information about the identity of the victims and that the family members and the press couldn’t get enough information from the public officials, they wanted to get it directly themselves from the hospitals and they couldn’t get that. And I’m not sure, there’s certain kinds of emergencies, the John or Jane Doe patient, the amnesiac patient and so forth, that I have, I’m still not sure how to work it out but I have some sympathy for that position. I’m not sure that I agree that you should be able to go around the public officials because you could have the situation where the family member finds out that their loved one was a victim on the TV and nobody’s contacted you first to tell you about that. And I don’t know that that’s a good thing.
MR. HOUSTON: I agree. One of the things that was cited, I can’t find it in the testimony but there was a citation in one of the written testimonies related to something that happened actually in my neck of the woods which is the hepatitis outbreak in Western Pennsylvania at Chi Chi’s, and the fact they couldn’t get information from hospitals. Well, frankly, same thing, what’s wrong with that, I don’t think we should have been providing information unless there was an authorization. And one lady accused me of being an attorney but this is basically just privacy matters, this is basic privacy 101 and if the public health wants to release information about the outbreak, if we get authorizations from the patient to do it or the family that’s great but there’s a point where privacy I think does dictate, I mean it’s very basic in my mind. Come on Harry, accuse me of being an attorney.
MR. REYNOLDS: No, I’m not accusing you of anything, John, we’ll talk later.
The sense of what I heard yesterday was regardless that the rule allows some of the things that we talked about, let me get the information while it’s still new and that was an overriding what I heard. So your statement earlier Mark that they can get this information by going through these sources, I mean they said it almost to a person, it’s not news tomorrow —
MS. GREENBERG: Like I said, Tuesday’s news is Wednesday’s old news.
MR. REYNOLDS: But it is still private information tomorrow and it’s private information next week and it’s private information next month. So I look at it so the law, and I think there need to be some, I’ll agree with Sarah, there needs maybe some clarification of a few things. But the law is in place to set due process in place, that if somebody can’t get the information they want, not because it’s important to have it on the 6:00 news, because they need to have it for some reasons, there is due process to get it. And I would hope that we would protect that due process, not turn it into a 6:00 news thing and then tomorrow they don’t care that they ruined somebody, or they don’t care that somebody got exposed, the process is there. I mean everything you mentioned, subpoenas and everything else can go on to get some of this stuff to happen a little faster, if you needed it for really the public good you could get a judge to agree —
MR. HOUSTON: Let me say this, I mean I’m looking, I did find the testimony in question and I’m looking down through the examples cited. Here’s one example, according to this TV station in Virginia because of HIPAA hospital and rescue services in Virginia Beach refuse to identify a man shot by police. Police later determined that the person was not a suspect and because he was never charged they also refused to identify him. Well, if the person had a concern about being shot by the police inappropriately they would have gone to the media and said I’ve been shot by the police, but that person also may say you know something, I don’t want to make this into anything that it isn’t, or I don’t want to litigate this in the news, or I don’t have —
MR. ROTHSTEIN: Maybe I was in a place I shouldn’t have been.
MR. HOUSTON: Exactly, so the point is is that that person has privacy rights and they choose to exercise them and the media doesn’t like it. I think this is, I’m not compelled by the examples we’ve been given.
MS. GREENBERG: Well, I don’t know if this adds anything, I should, in all fairness of disclosure I should say that I worked three summers for the Fargo Forum, the Fargo North Dakota Forum, so I understand the newspaper world. But what you were saying, I mean it is about process is very true, I mean we have a process, this is sort of an analogy I think that once a letter is approved or a report is approved by the national committee, if somebody is here of course, these are open meetings, if somebody is here and they have a copy of it fine, we make everything available during the meeting. But then once we actually finalize the letter we send it to the Secretary and we don’t make it available to other people until, we send it FedEx but until it’s gotten to the Secretary, we don’t feel it should be appearing in newsletters for example before the Secretary receives it. So if somebody who was here from a newsletter took it with them and put that, obviously we can’t stop that, and then we post it on the website. I always get calls about well, we want a copy of the final letter and I explain that’s a process, yeah but we’re going to press today. Well, I’m sorry, but that’s the process, I recognize you’re going to press today but we’re not releasing the letter until tomorrow. And it conflicts with their press deadline but it also would, if I were to give it to them it would conflict with our process. And I think it’s a tension that always exists, I mean this is, we do everything in sunshine but we don’t have to just change our process to accommodate somebody’s deadline.
DR. COHN: Well, once again obviously I lack unfortunately the excitement of the conversation yesterday but as I’m listening to everybody it seems like everybody is sort of saying the same thing which is that, I guess I’m sort of still trying to hear somebody saying yes, there’s something in here we ought to be recommending in a letter going forward. Now I suggested that maybe there needed to be some background, some educational materials, and that wasn’t even accepted particularly as an item of excitement, so I guess I’m left sort of saying geez, we had a hearing, we investigated an issue, not every issue needs a letter —
MS. HORLICK: Mark, this is Gail, I thought that the woman from Columbia, that talked about the archivist and historians raised some questions, I think she was asking for clarification that were sort of different from the media issues, she asked if the provision was retroactively applied and I just don’t have really clear notes on it. I know she said that the historical research doesn’t meet the definition of research but I wasn’t sure if the issues she was raising, if they were things that were clear in the rule or if they were something that then we might want some clarification on, but I think that that was sort of a separate think then the media.
MR. ROTHSTEIN: I agree, what I’d like to propose on that if it’s okay with everyone is that we just hold that and that will be one of the topics to consider on new issues because I was fascinated by that and I think that may be something that we want to separately take up along with e-health and e-prescriptions and so forth. But thank you for reminding us of that.
MS. GREENBERG: We only heard the one person on that.
MR. ROTHSTEIN: Exactly. What I’d like to suggest on the media is the following. After the meeting I spoke with a couple of folks on the whistle blower issue and they are going to send a letter, I think to Sarah, for all of us, in which they make the argument that the four categories of permissible whistle blower contacts should be expanded to a fifth one, which would cover other people but certainly the media as well. And if it’s okay we’ll just wait on that one and then maybe as a subcommittee revisit the issue when that comes in. But I don’t hear too much support for any of the other specific provisions so without objection we will just sort of move to our next topic. Is that okay?
DR. COHN: Sure, I guess it’s just, the outcome of this is we’ll just monitor things in the future.
MR. ROTHSTEIN: Right. So let me, the last thing, and this is very important, that we need to discuss today is to plan our agenda going forward and there are some issues that have been raised that we have to discuss. One of course is the e-prescribing which we heard from before, another one is the archival information and anyone want to talk about that. Gail, did you have something further to say?
MS. HORLICK: No, I was looking at my notes, I thought they were clearer, but I would like to go back and read it over. I have a question where she said something about whether something was retroactively applied and if so how far back does it go and I’d like to look at that again and see if it’s in fact something that needs clarification.
MR. ROTHSTEIN: Right. Just to summarize for those of you who weren’t here, she said that the medical archives issue is not addressing the privacy rule and the privacy rule is preventing important historical research that’s conducted at covered entities because the archives often are kept at a medical school or a hospital, which would be a covered entity, if it’s kept by a university as such is not a covered entity and therefore they can disclose that. The archives association sent a letter to the Secretary in 2003 asking for clarification but they have not gotten a response and in other areas there has been an over zealous use of the privacy rule to deny access. So it raises interesting issues and I definitely think it should be, I would propose that we place it on our agenda, we haven’t prioritized it yet but just on the list of stuff that we want to talk about.
So the floor is now open for other things for us to add to our list and then we will if it’s okay prioritize and see what order we want to take them in. Simon?
DR. COHN: We haven’t discussed security which obviously was briefed yesterday, obviously we aren’t writing a letter on it but it was intended to be a preview to some sort of an additional investigation or hearing from the industry, so we just need not forget that.
MR. ROTH: Thank you, security is on the list even though it’s not at the top of our list.
MR. HOUSTON: Actually it probably does need to get some immediate discussion, I think there was desire to use some time in September and again I think we sort of identified this as being sort of a joint Security Committee/Privacy Committee issue in one sense though it’s more in the Security Committee side, and I would like, I think it does bear discussion now.
MS. GREENBERG: What was that?
MR. HOUSTON: If we need to take some security testimony, there is an immediate need to get that fleshed out, and I think that what we heard yesterday was that there really weren’t that many substantial issues as we sort of had thought that were readily apparent. I think that when asked there was concerns over security incident response reporting, some concerns over unique IDs et al, and then a little bit of concern over medical equipment which Simon I think was something that you and I had discussed and I know that, I thought that was probably the one area I had seen as being worthy of some discussion. The other two frankly, I’m not sure whether there’s much to say about —
DR. COHN: You mean emergency departments?
MR. HOUSTON: Excuse me?
DR. COHN: Emergency departments?
MR. HOUSTON: Using unique IDs —
DR. COHN: When you said unique IDs I was thinking about patient IDs, you’re talking about provider IDs —
MR. HOUSTON: Log on IDs, and I think even in fact the guidance that was really stated yesterday was is that in the case of unique IDs that there was going to be some flexibility in that regard through some FAQs. Again, I sort of get the same sense, I sort of concluded which is that there really isn’t the controversy or the concerns raised that we’re hearing on the privacy side. The only thing I can think of out of all that is maybe a discussion on medical equipment.
DR. COHN: And maybe the issue there is is that if the department comes up with an FAQ on that we need to make sure from the industry that that’s sufficient, and if they haven’t come up with an FAQ on it we need to find out from the industry what the real issue is. Of course one has to recognize that there’s a strong representation on the full committee of emergency physicians so this is an area that just happens to be, just because the way it is, it isn’t just me, there are others.
MR. HOUSTON: By the way we did have one round of security testimony out of which we really didn’t have, I mean I did write a recommendation but we sort of tabled it, these things didn’t come up in the context of that committee, or those hearings, so are there really any issues here?
DR. COHN: Are there any issues beyond what we’ve described?
MR. HOUSTON: Right. By the way even on unique IDs for security incident response reporting we didn’t hear any of that, we asked for generalized testimony regarding issues with the security rule, we didn’t hear any issues regarding those topics.
DR. COHN: I’m sorry, your point is?
MR. HOUSTON: Is it worthy of discussion, more discussion if we didn’t hear anything before.
DR. COHN: Oh, okay, so there are new issues coming up is what you’re saying.
MR. ROTHSTEIN: Gail, did you have any questions or things to add?
MS. HORLICK: I’m sorry, it’s harder to hear on the phone so the internet is the second delay, did you ask me something?
MR. ROTHSTEIN: Yes, did you have any topics to add?
MS. HORLICK: No, I don’t have any additional topics. I think the one that was raised earlier about the Medicare Modernization Act is something that is really timely and we had some discussion here about that.
MS. GREENBERG: E-prescribing you mean?
MS. HORLICK: Yes.
MR. ROTHSTEIN: I have a couple of issues I’d like to raise for the subcommittee, one is the use of protected health information as a commercial asset, and let me describe to you two scenarios. One is in bankruptcy so this happens a lot with start-up biotech companies and also start-up biobank companies. Biobank companies are companies that get human specimens from various donors and often they either do the research themselves or they serve as brokers and sell the specimens to researchers. And as small companies they’re often under capitalized and sometimes go under. When they go under they have no assets other then the samples, now they may have promised the sample donors privacy and confidentiality but according to bankruptcy law those promises are abrogated by the bankruptcy filing. And therefore the creditors can require that these assets be sold off to the highest bidder and therefore the confidentiality issues that are the basis on which the people donated their specimens disappears when these companies go under. And so that’s one issue of PHI as collateral, as a commercial asset —
MR. HOUSTON: Can I ask you a question about that? I’ve heard of cases using marketing data that’s been sold has been considered to be an asset that could be distributed by the bankruptcy court. Has this issue ever specifically come up with regards to PHI or is it, I know I’ve heard of other cases unrelated to PHI where this has been ruled.
MR. ROTHSTEIN: Yes, it actually has come up in a couple cases. Lora, did you want to comment?
MS. KUTKAT: I just had a question about the biobanks example, are we assuming that these biobanks are covered entities or not?
MS. ROTHSTEIN: Well, I mean if we wanted to view it narrowly as a HIPAA issue we could assume that they’re covered entities. If we wanted to view it, I mean we’re not strictly limited to HIPAA and some year we’ll do non-HIPAA stuff, then we could view it more widely. My guess is that the ones who were most likely to go bankrupt would not be covered entities, I mean the biobanks by hospitals and established institutions which would be covered entities are probably not as likely to go bankrupt, but Sam’s Deli and Biobank is more —
MR. HOUSTON: I don’t agree with you about going bankruptcy, we’ve had a number of hospitals in Pittsburgh go bankrupt, one which closed, and they actually had, I forget, a medical records guardian appointed for the information but I don’t think it’s beyond the realm of possibility based upon this scenario to say that somebody wouldn’t come in and say I’m willing to buy those medical records and make an argument that they do have some commercial value, that is a covered entity, so you may be closer to reality then you think.
MR. ROTHSTEIN: I suppose that’s right, I mean it’s not unheard of for hospitals to go bankrupt, that’s true. So that’s one use of PHI as a commercial asset in bankruptcy. Another I was told by a lawyer who represents large health care clients that PHI has been used as collateral for health care financing, collateral in putting deals together in mergers and acquisitions and all sorts of commercial transactions —
DR. FITZMAURICE: You mean beyond owed claims, that here’s a stack of claims that are owed and I’ll factor them to a bank.
MR. ROTHSTEIN: No, this is an asset, it’s good will and so forth.
DR. COHN: Is this collateral or is this an asset?
MR. ROTHSTEIN: No, she said, and I wrote it down, as collateral for loans —
MS. GREENBERG: Whose PHI?
MR. ROTHSTEIN: Well, yours and mine and patient PHI.
MS. GREENBERG: I mean how’d they get it?
MR. ROTHSTEIN: Well this is a health care institution that wants to, a covered entity has PHI, they’re sort of, they need a loan, that’s their collateral.
MS. GREENBERG: Is that legal?
MR. ROTHSTEIN: Well that’s what I want to find out.
DR. FITZMAURICE: It’s legal to get them a loan but they can’t pledge to sell it because they would then be disclosing PHI so I’m surprised anybody would give them money for it.
DR. HARDING: Who determines the value?
DR. FITZMAURICE: They can’t disclose it or use it. Who’s going to loan them money on it?
MR. ROTHSTEIN: There must be some circumstances under which that happens and I said I would raise that —
DR. FITZMAURICE: — can’t do anything that the privacy rule would not allow them to do, so they can’t sell that on the open market because the privacy rule would not allow them to do that —
MR. ROTHSTEIN: Unless it were pledged to another covered entity who could then acquire that through some sort of business merger, acquisition —
MR. FANNING: And use it only for purposes for which —
MR. HOUSTON: Even if a covered entity is not allowed to do it I mean obviously you’re correct, a covered entity isn’t permitted to do something like that, that doesn’t mean that people aren’t doing it and it isn’t an issue. The rule varies from practice and we need to investigate it.
DR. FITZMAURICE: Should we send out the HIPAA police?
DR. COHN: Mark, are there other issues —
MR. ROTHSTEIN: Yeah, I’ve got one more. The other issue is that elected officials at all levels of government in doing constituent work call up agencies that may be covered entities and inquire about the health status of their constituents —
MS. GREENBERG: Like a church, that’s what we heard yesterday.
MR. ROTHSTEIN: No, it’s a little different. Congressman Smith calls up CMS and says Mary Doe has concerns about her Medicare payments and her providers are not being covered, she’s being denied benefits, what’s going on with Mary Smith. And CMS says well, Mary had a heart attack last year and filed the following claims and disclose PHI without an authorization to someone who is presumably trying to act on Mary’s behalf.
DR. HARDING: Without authorization.
MR. ROTHSTEIN: Without authorization at various levels. I don’t know to what extent that goes on, I don’t know at what levels of government that goes on, I hadn’t thought about it until someone asked me about it but it certainly wouldn’t surprise me that some people in one agency or another would feel that they were required to give the information to Senator Jones’ administrative assistant.
DR. COHN: You never know. And the person is generally very pleased that the Congressman gets this thing handled.
MR. ROTHSTEIN: Right. Well, that’s as weird as I can get so now —
DR. COHN: Can I add some? Well, I guess I’m, I don’t think I can top your last three. Now let’s see, what was I going to add, I was actually going to add two. And one of them actually is probably that we need to first of all have a conversation or talk to the department but one would observe that the new coordinator for health information technology has as part of his charge to develop some sort of a document, some sort of an evaluation, relating to EHRs and privacy and confidentially in the current HIPAA privacy rule, at least I think. I think I’ve got the bullet just about right but it would seem to me that maybe we ought to have a conversation with that department or with Dr. Brailer to see if we can be of some help in terms of either identifying, illuminating, better understanding the issues.
MS. GREENBERG: He’s coming to the executive subcommittee meeting.
DR. COHN: Oh is he? Okay, well the question is that this is an area where it’s on the executive order, it’s something that Brailer has to do, once again the department is going in this direction, can we be of assistance. So this is just a very concrete statement of something —
MR. HOUSTON: Is this outside the context of NHII?
DR. COHN: What?
MR. HOUSTON: Is this outside the context of what’s going on in privacy and NHII?
DR. COHN: I think it was related to EHRs but it could be in the context of the NHII, I mean the difference between the EHRs and NHII is getting increasingly blurred.
MR. HOUSTON: Right, because obviously there’s the conference coming up, there is a track specifically on this, I know I personally have been involved on that —
DR. FITZMAURICE: I believe it’s part of the President’s Executive Order specifying what he should —
DR. COHN: What is there a four hour session at the NHII on all of this stuff, I’m not sure that that somehow solves the problem. I think the question is whether there’s a need for public hearings on this issue. The other piece, and once again I don’t know, I think it’s maybe this committee that’s the right area for this other area, which is that there’s been a long standing sort of issue, conundrum, discussion or something relating to CMS and their use of the internet for personal health information. And I guess I’m thinking that maybe we might want to have CMS come and discuss their policy and the reason for it as well as hear from others in the industry about their views on all of this, just because it is something where a lot of the industry is sort of, I don’t know that the rest of the industry necessarily follows suit but it might be something for us to look into just because it really does have a lot of impact on everyone with this particular policy and the question is is whether or not in this day and age it’s still the right policy or night.
MS. GREENBERG: Is that a security issue?
DR. COHN: Well, I don’t know that it’s security, maybe privacy, I mean I sense it’s hard to know what’s what.
MR. FANNING: I guess my instinct is that it is a security issue, this is a technical question of type of encryption is needed if you’re using the internet as your communications medium for health information.
DR. COHN: I don’t know, and maybe it’s a conversation we need to have to figure out where it sits because that may really be a standards issues, Standards and Security Subcommittee issue because it’s a technical one —
MS. GREENBERG: Nobody is suggesting that you would want to release information on the internet so it seems to be really more of a Standards and Security issue.
DR. FITZMAURICE: In part it’s covered by the privacy act, the Federal Privacy Act, when it gets into the hands of CMS and so if the contractor sent it up to the main office, that’s covered, and I’ve heard recently that CMS has relaxed some of its views saying that even though a provider may pull information from the current Medicare beneficiary file and use it to make a claim, they can send that claim through the internet to the clearinghouses, but then the clearinghouses cannot send it through the internet to the intermediaries or the carriers, they have to use the secure networks.
DR. COHN: I guess we will talk to the executive subcommittee to figure out where this one goes, I just think it’s been an ongoing strange issue that seems to be not clearly, I mean in terms of the difference between privacy and security, I mean in the world of security you still need to understand the privacy issues around all of this and so it does sort of overlap a bit. I’d be happy to retract that from the list.
MS. GREENBERG: Well, since we’re just putting issues out here, and I think we should see what comes out of the meeting next week, but it’s clear that a continuing issue with EHR and the NHII is the need to uniquely identify individuals in some ways —
MR. ROTHSTEIN: You’re not retiring or planning to are you?
MS. GREENBERG: Would you like me to?
DR. COHN: I vote we put Marjorie in charge of a special task force of HHS and NCVHS.
MS. GREENBERG: I have a cal that I need to return from someone about smart cards and some of these issues, which I just picked up on my voice mail last night so it sort of made me think about it. But it’s possible, and I’m not talking about the old trend, the unique identifier for individuals, I’m talking about the need to identify a person uniquely in some way so that you know that you’re exchanging information about the same person. And all the different ways that that might be done, and I’m just saying that there may be a need for some types of hearings or further work in that area if it —
DR. COHN: I don’t mean to jump in but this is an area that obviously you identified when you talk about e-prescribing, and we actually are sort of, I mean I think this is something that the full committee needs to discuss about what it wants to do with it.
MR. ROTHSTEIN: It might be part of e-prescribing right, isn’t it —
MS. GREENBERG: Well, it’s as you said, e-prescribing is sort of like the vanguard of the electronic health record in some ways.
DR. COHN: I think the real question is I think for any motion in this area it really needs to be an executive subcommittee or really a full committee discussion of how we might, if and how —
MS. GREENBERG: But just if you’re taking issues that you even want to take to the executive subcommittee I would say we can’t hide from this one.
DR. HARDING: [Inaudible.]
MS. GREENBERG: The prohibition is still there, but that’s the unique identifier for individuals, I’m talking about methodologies for making sure that you are exchanging information about the same individual.
Our policy has been geared toward preventing the intentional or negligent disclosure of information by careless employees, hackers, and so forth. Most of the privacy violations, even though it doesn’t violate anything, or the privacy intrusions on individuals, is perfectly legal and it’s through the compelled authorized disclosure of information by individuals. So in other words if I, take one example, if I apply for a new job after a conditional offer of employment my prospective employer can make me as a condition of employment sign an authorization releasing to my possible employer all of my medical records, that’s legal in 48 out of 50 states, and legal under the federal Americans with Disabilities Act. It’s also legal for an individual health insurer to do that, for a life insurer, and a mortgage company and a whole range of people, anyone who has any sort of leverage, economic or otherwise, over the individual.
And our medical records system including our electronic health record system is not designed to facilitate any sort of protection of privacy including all the new fangled stuff that we’re spending billions of dollars on because if we enacted a law that said that employers only had access to information that’s related to the individual’s ability to perform the job disclosing that information would be an impracticality, it would be an impossibility for health care institutions who have records this high that contain all sorts of junk, to do it you would need a committee to spend two weeks deciding what is relevant and what’s irrelevant, so they just send the whole thing. So enacting a law like that wouldn’t help.
But if we enacted a law like that and also invested in developing an electronic health record system that could identify that, that’s the beauty of electronic systems because you could identify, I’ll spare you all the informatics, you could identify certain attributes of certain conditions in certain fields and you press in three things and all they get is this, and we’re not doing that and we’re not even thinking about doing that, and I think that is really the most important privacy issue of the future, it’s how anybody, school, employers, they could get this information by just making you sign a release, it happens every day and nobody is talking about it.
DR. COHN: Mark, I think you actually bring up a very fascinating topic, I’m not sure that I would want to listen to you alone for three hours —
MR. ROTHSTEIN: I didn’t say time limit —
DR. COHN: But I guess I would suggest, and the question is the time urgency and how we put it together, there’s one of two ways for us to sort of deal with this one, one is dealing with previously mentioned EHR and privacy and have that come out in those sorts of conversations, or maybe what we need is a roundtable that includes you and others sort of talking about the future of privacy protections and their enablement by new technology and sort of the future or whatever. And I think either could be fascinating and I think it would be well worth a morning or an afternoon of our time to sit around and kick around where all this is happening. I don’t know if that’s where you were going with this —
MR. ROTHSTEIN: Well, I just wanted to raise the issue and see if there was interest —
DR. COHN: I think suitably framed and with the right balance is probably a wonderful conversation.
MR. HOUSTON: We want to have the counterpoint from the media people here.
MR. ROTHSTEIN: John, suggestions?
MR. FANNING: All along we heard murmurings about well how come just the information in covered entities is covered, there was much health information elsewhere. And Mark’s question is a sort of a subset of that, who else is getting it, under what conditions are they getting it, what can they do with it. And my own view is that it might be helpful for this committee to push a little ahead of the specific statutory command to cover these three classes of entities.
DR. COHN: Yeah, I mean this is really sort of how to protect health care information in the electronic age.
MR. ROTHSTEIN: And of course once these people get it they can redisclose it, they can sell it, they can do anything they want with it.
Okay, we’ve got on our list so in our last few minutes we’ll prioritize the following and please let me know if I’ve skipped anything, e-prescribing, archival records, the privacy issues under the security rule, public health information in bankruptcy and commercial transactions, disclosures to elected officials, unique identification issues in electronic health records and NHII, privacy, and electronic health records including or related to or as a subset of information held by non-covered entities. Have I skipped anything? Okay, so now the issue —
MS. GREENBERG: Well, then there was the internet issue which we’re not sure about.
DR. COHN: We’ll talk to the executive subcommittee about that.
MR. ROTHSTEIN: So now the issue is of these issues, the question is what should be our prioritization of these things.
DR. COHN: Well, how far out do you want to look?
MR. ROTHSTEIN: Well, first we need to see whether there’s interest in them and then we’ll put them in order. So let’s do that, we’ll have a run through, a vote of whether they should be on our agenda and then we’ll figure out the order.
DR. HARDING: A, B, or C.
MR. ROTHSTEIN: A, B, or C?
DR. COHN: Well, I guess the other piece, it probably it is an A, B, or C, but also one needs to realize that whatever it is, I mean given that we’re talking about getting OCR in to have a conversation with them, there’s other executive subcommittee discussions that may impact the agenda, I mean we think EHR and privacy is critical but it would really be nice to get Brailer involved in the conversation too. So some of these things may move around a bit.
MR. ROTHSTEIN: Okay, how about if we do one, two, and three, because I can add those, and three is the highest, one is the lowest, and no cumulative voting. So the first is e-prescribing, how many vote it a three?
MS. GREENBERG: This is only members are voting?
DR. COHN: Is three important or is three not important?
MR. ROTHSTEIN: Well, members only vote or, members only. Three is the most important. So how many threes? You’re holding up a two, okay, how many twos? Okay, so we got three threes and one two, John voted a two, and I’ll vote a two.
Alright, archival records, how many threes? Hold up fingers here, this is ridiculous, we’ve got three twos, four twos and one one.
Alright, privacy and the security rule. Simon?
DR. COHN: This is having hearings about the security rule is going and the issues that we had talked about.
MR. HOUSTON: [Comment off microphone.]
DR. COHN: Well, I had thought it was being led by the Privacy Committee so I guess there needs to be agreement, I mean if the Privacy Committee decides it doesn’t want to do it then we need to figure out someplace else to do it.
MR. ROTHSTEIN: Other then the narrow privacy issues you’ve got jurisdiction, security is under security.
DR. COHN: Well, I think we initially identified that if John Paul was going to be taking the lead on that one and I think we thought that this was going to be, at least the hearings were going to be scheduled and conducted out of the Privacy Subcommittee. But we can rediscuss that if it becomes an important issue to discuss. I hadn’t realized that that was up for discussion at this point.
MS. GREENBERG: Are you still on the Standards and Security Committee?
DR. COHN: No, because we focused it here.
MR. HOUSTON: [Comment off microphone.]
DR. HARDING: I think it’s pretty important for us to work with —
MS. GREENBERG: It has to be joint.
DR. COHN: I guess I’m having a hard, security I think is sort of a funny issue and it just has to do because it’s time limited, or it’s not time limited but as the implementation proceeds —
MR. ROTHSTEIN: John, you’ve got to get to a mic.
DR. COHN: As the implementation proceeds the committee has a responsibility to monitor the implementation. And so I think we heard that sometime this fall we need to have at least some sort of a session, and I’m not suggesting a two day session but a session to sort of review where we’re at and identify, sort of identify issues, give the industry a chance to comment. And so is it here or standards and security or yet a whole other identified activity that is jointly sponsored but I don’t think we have an option. John, do you have any comment on that?
MR. HOUSTON: I think we do need to take testimony, I think we’re going to find, again, I think medical equipment is ripe for testimony, I think we need to have another open panel but it’s a day. And if we want to take, I thought that the time in September was originally Security Committee time that we were going to try to take and use for this testimony.
DR. COHN: Well, that was what I was going forward on but I’m not sure that I’ve ever heard a yes from Mark about that.
MR. ROTHSTEIN: Well, it’s a question of how the committee wants to view the issues. So having heard that discussion are we ready for a show of fingers? Okay, the security rule, three, three, so we’ve got four threes —
MS. GREENBERG: You can vote multiple times? Is this the way it works?
MR. ROTHSTEIN: You vote for everything.
MS. GREENBERG: You could give everything a three?
DR. COHN: But you vote one, two, or three —
MR. ROTHSTEIN: You could but you’d have to be committed to move here.
Alright, public health, I’m sorry, protected health information and how it’s used as a commercial asset, which is the bankruptcy and related issues. How many fingers appear on that? A one, one, two, two, I’ll remember that.
DR. HARDING: What did you vote?
MR. ROTHSTEIN: I’m voting a seven. And disclosures to elected officials? Is that four? Okay, you’ve got to vote one, a bunch of chickens here, and that gets a 33 from me.
MR. HOUSTON: Mark, we’re behind you 100 percent.
MR. ROTHSTEIN: And now the, Marjorie do you want a separate vote on the unique identification or is that subsumed in the e-prescribing?
MS. GREENBERG: No, I’d have a separate vote on that.
MR. ROTHSTEIN: Separate vote on unique identification, smart cards, NHII sort of stuff.
DR. FITZMAURICE: Unique identification of individuals?
MR. ROTHSTEIN: Correct.
MS. GREENBERG: Mechanisms to assure that you are identifying the person —
MR. ROTHSTEIN: The correct person, even though they may not have —
MS. GREENBERG: It may not be a single ID unique identifier —
MR. ROTHSTEIN: So unique identification, two, two, one, three, and I’ll vote two.
MS. GREENBERG: What did you vote?
MR. ROTHSTEIN: Two, oh I missed one, two, two, one, three, two, two.
Okay, privacy and electronic records, records held by non-covered entities, how the future of health records with or without my participation. You can’t vote twice, with or without —
DR. COHN: I’d say three but this gets to be a question of timing, and I don’t think, by my voting it doesn’t mean we do this in September, it means it’s probably an early 2005 investigation —
MR. ROTHSTEIN: Okay so that’s, alright so the low scores, which are put on the non-burner are the two that I raised, the public officials and the bankruptcy, and the highest one would be e-prescribing and the security rule, then the archival records and the unique identification were about the same, and the big picture privacy issues received a high score and a low timeliness index. So that I will report to the executive subcommittee that we will plan hearings in the fall dealing with the issue of e-prescribing and privacy issues under the security rule, probably let’s say after the first of the year on archival records, and the unique identification, and then after that we may need follow-up hearings so it will be at the earliest in the spring on longer term bigger picture privacy issues. So let me repeat that for everyone, so for the fall e-prescribing and security, for the winter let’s say archival and unique identification —
DR. COHN: And I think the EHR is probably determined after discussions with Brailer and that group probably.
MR. ROTHSTEIN: And we could move that into the winter as part of the unique ID sort of thing, or in the spring as part of the long term privacy issues.
MS. GREENBERG: Do we have any dates right now for hearings in the fall?
MR. ROTHSTEIN: We have not scheduled any dates, I was going to wait until we had a lead staff but I suppose we could do that —
MS. GREENBERG: I think we should start polling for dates.
MR. ROTHSTEIN: We can poll for a two-day hearing on the first issue on e-prescribing and security, two day hearings on each, is that correct Simon?
DR. COHN: I don’t think security is going to require two days —
MR. ROTHSTEIN: Okay, one day hearing on security?
DR. COHN: One day and I think to be determined on how much we need on the e-prescribing and let me work with MOIA(?) in terms of figuring out what the optimal time for that should be.
MR. ROTHSTEIN: If it would work a two day hearing, one on each topic, would be easiest to schedule.
DR. COHN: Exactly. As I said it’s really, the e-prescribing issue is a question of making sure that the timing is the right timing and then we will fit the amount of time we have to sort of deal with it.
MR. ROTHSTEIN: So let’s with the consent of everyone we will poll the committee for a two day block in the fall and with the goal of having one day on e-prescribing, one day on security, with the understanding of course that there is likely to be follow-up hearings, certainly on the e-prescribing issue. Is that acceptable?
MS. GREENBERG: So with Marietta not here —
MR. ROTHSTEIN: Sarah, would you mention that to her?
MS. GREENBERG: And I guess she’ll just get some dates from you and then poll everybody.
DR. COHN: Mark, just some clarification for me, are you talking about a single two day hearing sometime this fall or are you talking about two two-day hearings?
MR. ROTHSTEIN: Well, that’s what I asked and you said only one on security, so that we could have one on e-prescribing let’s say in October and if we need the follow-up we could have one in November, unless you want to schedule both now.
DR. COHN: I just think it gets problematic when you sort of keep rescheduling single hearings, I was just trying to get a sense of what you’re view of hearing dates were going forward —
MR. ROTHSTEIN: See, I don’t know how much time you need, if you’d tell me that would help me. You don’t know either —
DR. COHN: No, I actually know that we’re going to need more then one but we’re going to need, I think we could probably start with a one day hearing and then go to future hearings —
MR. ROTHSTEIN: Let’s hold the poll and schedule two two-day hearings in the fall —
MS. GREENBERG: Two two-day hearings in the fall.
MR. ROTHSTEIN: The first hearing will be e-prescribing and security, and the second hearing will be if not all e-prescribing then we can move to the next issue on our list.
DR. COHN: Great, that sounds super.
MR. ROTHSTEIN: Is that okay? Any other comments? So Marietta did you get that? We’re going to poll the committee and try to come up with two two-day blocks in the fall.
Other business? Well, I want to thank members of the subcommittee, certainly the staff and our meeting facilitators who helped us put this together and get it on the air and thank John as well and wish him all the best. So that concludes the end of our hearing for today.
[Whereupon at 12:25 p.m. the meeting was adjourned.]