On June 25, 2008, a panel convened by Florida’s Agency for Health Care Administration met to discuss antipsychotics. Below you will find the transcript of the meeting accompanied by video (7 parts). Inexplicably, the panel focused only upon children 5 and under.
Please read thoroughly, watch the video and at the end of this transcript please provide your analysis, comments, recommendations and observations. Perhaps meetings of this sort, open to public view can assist other states as they grapple with the Medicaid financial burden forced upon them by the very expensive atypical antipsychotic drugs.
Ken Kramer: You also have Ken Kramer on the line.
Woman’s voice: O.K. Thank you.
Woman’s voice: And Kim Eggert.
Diana Schmidt: Hello?
Ann Wells: Hello. Who’s dialing in?
Diana Schmidt: Hi, is this Ann? This is Diana Schmidt.
Ann Wells: Hi Diana.
Diana Schmidt: Hi.
Man’s voice: Who was with Amerigroup, please?
Ann Wells: We’ll wait a few more minutes for more committee members to dial into the meeting.
Isaac, Dr. Thacker, Dr. Cosgrove and John Lelekis, is there any other committee members on the line? OK. We’ll wait a few more minutes for more to dial in. (O)K. Any other committee members?
Voice in room: It won’t mute.
Guy in the room: What happens if you press the mute button?
Ann Wells: OK, the committee members that I have on the line right now are Dr. Isaac, Dr. Thacker, Dr. Cosgrove, John Lelekis and Dr. Castellanos. Is there any other committee members dialed in?
Whoops, somebody else just came in.
Woman on phone: Yes, it’s a non-committee member it’s Margo Adams with the Florida Psychiatric Society.
Ann Wells: OK, I think we have most of the members on the line, so let’s go ahead and get started. And there are no committee members in the room, I don’t believe.
Guy on phone: And you are Beth Jones?
Ann Wells: I’m Ann Wells and I’m gonna’ read the introduction right now.
Good afternoon ladies and gentleman. My name is Ann Wells. I am the Bureau Chief for Pharmacy Services in the division of Medicaid and this is a meeting of the agency for Healthcare Administration ad hoc Group to the Medical Advisory Committee. I would like to welcome the participants, interested parties, and the media, both in Tallahassee and on the phone line to this meeting. The purpose of today’s meeting is for our panel of experts to discuss the recommendations made by the University of South Florida Pediatric Psychiatry panel for the use of antipsychotics in children under the age of 6 years.
Let me go over the logistics of the meeting and our plan for the hour. If you are participating by phone, please put your phone on mute if you are not speaking. Please do not put your phone on hold so we don’t listen to the “on hold music” or any repeating messages.
Non-committee participants must hold all comments until the end of the meeting. Today’s agenda includes a section for public testimony. Participants in the audience will be given priority for public testimony. Is there anyone in the audience who wishes to participate in public testimony. Please give me your name now.
Ken Kramer: Yes, I do. Ken Kramer.
Ann Wells: OK, you’re on the phone. You’re not in the room right now.
Ken Kramer: Oh, I’m sorry.
Ann Wells: OK. So, no one in the room?
OK. Is there anyone on the phone who wishes to participate in public testimony? So the first name we have on the list is Ken Kramer. Is there anyone else on the telephone who would like to participate in public testimony?
Dr. Jerome Isaac: This is Dr. Isaac.
Ann Wells: OK. Well, you’re part of the panel so you’ll be participating with the committee.
Dr. Jerome Isaac: OK.
Ann Wells: OK. Are there any other non-committee participants who would like a slot in the public testimony? O.K. We will proceed. This is a one hour meeting and we are going to try to stay on time. The portion of the public testimony is kind of limited to whatever is left over after the committee has completed its discussion, and so the discussion of the committee does have priority. At this time the first item on our agenda is the introduction of the panel and I will be turning the meeting over to Beth Jones, Senior Pharmacist, for the introduction. Beth.
Beth Jones: Good afternoon. We want to begin our introductions with those panel members that are present. I’ll begin. My name is Mary Elizabeth Jones. I’m Senior Pharmacist with Medicaid Pharmacy Services. Please state your name, title and affiliation.
Elicia Coley: My name is Elicia Coley and I’m Senior Pharmacist with Medicaid Pharmacy Services.
Talisa Hardy: Talisa Hardy, Clinical Program Manager, Medicaid Pharmacy Services.
Ann Wells: And I’m Ann Wells, the Bureau Chief. If we could have the telephone committee members identify themselves please. Should I just call the roster?
Someone on phone: I’ll go first.
Ann Wells: I’ll call the roster instead and you can say…
Woman on phone: That’s better.
Ann Wells: …you can say “here”.
Ann Wells: O.K. Dr. Jerome Isaac.
Dr. Jerome Isaac: Yes.
Ann Wells: Dr. Richard Thacker.
Dr. Richard Thacker: Here, representing Florida Osteopathic Medical Association.
Ann Wells: O.K. Kathleen Wilson. She’s not here. Linda Cosgrove.
Dr. Lisa Cosgrove: Yes, here and representing the Medicaid P&T Committee for the Florida Chapter of the American Academy of Pediatrics and Private Pediatricians.
Ann Wells: John Lelekis.
John Lelekis: Present.
Ann Wells: Joshua Lenchus
Dr. Joshua Lenchus: Present.
Ann Wells: Daniel Castellanos. He was here before.
Guy on phone: He is here.
Ann Wells: And then Rajiv Tandon.
Dr. Rajiv Tandon: Here.
Ann Wells: Good, great. We have everyone in attendance.
OK. The next section of the agenda is dedicated to the mission statement and I pulled a couple of statements off our agency website. Number one, the mission statement for the Agency for Healthcare Administration: “The agency champions accessible, affordable, quality healthcare for all Floridians.” In addition, the mission statement for Medicaid Pharmacy Services is to ensure that Florida Medicaid recipients are provided access to medication that is clinically and economically effective and produces the desired outcome. The mission statement for this project in particular is to create a review process to evaluate off-label prescribing in specialized populations. The project goals, and many of these do overlap, includes, we want to facilitate patient safety, we want to assist in reviewing benefit versus risk, we want to prevent or limit poly-pharmacy, we want to promote evidence based medicine, we want to promote cost effective prescribing, and we also want to prepare for the future. Specifically in terms of deciding where the prior authorization process for the use of atypical antipsychotics goes from here. We’d like the committee to make a commitment um, to help develop a more independent review process whereby the majority of the prior authorizations can be done here at AHCA by the Clinical Pharmacy staff and where we reserve our child psychiatrist consultants for the more complex cases that need more intensive review. So that’s just kind of a brief overview of the mission statement. The next portion of the agenda gives us some history in terms of interim prior authorization discussion and Beth will take over from there.
Beth Jones: In reviewing the prior authorization process um…we’ll address three questions. The first question is, “Why was the interim prior authorization process initiated by the agency?” There are no FDA indications or official compendia recommendations for the use of atypical antipsychotics in children under the age of 5 years. Atypical antipsychotics are sometimes prescribed off-label to treat children under the age of 5 years. The appropriateness of this treatment is determined by the physician caring for the child, with informed consent from parent or guardian for treatment. Although benefits often outweigh the risk, ensuring the safe and effective use of antipsychotics in children is a primary concern. Developing Medicaid reimbursement guidelines and policy around this issue requires time and thoughtful consideration. The prior authorization requirement provides the agency with an interim step while the program’s coverage of atypical antipsychotics for children under the age of 6 years is reviewed.
The second question is actually two questions. The first being, “How does the review process work?”, and the second, “Who is performing the reviews?” Current prescriptions for atypical medications are approved for continuation therapy. The prescribing physician or dispensing pharmacist may call Medicaid Pharmacy Services for approval. The turnaround time for this process is 24 hours. Prescriptions for new therapies are subject to review prior to reimbursement. The child’s physician submits a prior authorization request form to Medicaid Pharmacy Services. The request is then forwarded to the Department of Psychiatry at the University of South Florida. A Child and Adolescent Psychiatrist reviews the request and returns it to Medicaid Pharmacy Services for processing. The Pharmacy Services staff communicates the review results to the child’s physician. The new prescription may be approved for reimbursement, or the prescribing physician may be asked to consider other options. The turnaround for this process is also 24 hours.
Finally, the third question is, “What are the criteria used in the prior authorization review process?” The review process is complex and is not determined by single factors. The child psychiatrist reviewing the request may consider multiple factors, such as diagnosis, target symptoms, the severity of target symptoms, the level of functional impairment, dosage considerations, assessment and monitoring plans, previous and concurrent pharmacologic therapies, previous and concurrent non-pharma…
Woman on phone: You keep going in and out and I can’t hear you very well.
Guy on phone: Same here.
Ann Wells: OK. We’ll move the phone a little closer. And I tried to turn up the volume. Beth does have a very soft voice, so we’ll try again.
Beth Jones: OK. I’ll start again with the third question – what are the criteria used in the prior authorization review process. The review process is complex and not determined by single factors. The child psychiatrist reviewing the request may consider multiple factors, such as diagnosis, target symptoms, the severity of target symptoms, the level of functional impairment, dosage considerations, assessment and monitoring plans, previous and concurrent pharmacologic therapies, previous and concurrent non-pharmacologic therapies, psycho-social support, and any other factor or factors that may be unique to the individual child. Individualized therapy within the scope of limited accumulated clinical data combined with close monitoring provides the basis for patient care.
And I’m going to turn the meeting back over to Ann now.
Ann Wells: At this point we’re going to open the meeting for panel discussion, and we were gonna’ let you guys drive that process. If you have questions for us, we did distribute, um, we’ve been keeping a weekly report um…of the prior authorizations and the patients involved. We distributed that quite some time ago. We’d like to open the discussion to the committee at this point.
Chris: Uh, pardon me, can you hear me?
Ann Wells: Yes.
Chris: At what point can I ask questions?
Ann Wells: Ah when we get…uh, is this Mr. Kramer? When we get to the public testimony Mr. Kramer.
Chris: No, this is…my name is Chris.
Ann Wells: I’m sorry. Your name is?
Chris: My name is Chris.
Ann Wells: Are you, you are not a panel member so you have to wait until the public testimony period.
Chris: Oh, OK, and that’s toward the end.
Ann Wells: Yes.
Chris: Oh, Thank you.
John Lelekis: So, as I understand it, the process begins by a submission of the prior authorization to Medicaid and if in fact it is a child under the age of 5, then it is reviewed by a child psychologist, is that correct?
Elicia Coley: Who is the speaker please?
Ann Wells: This is Mr. Lelekis, I know his voice. So, as you guys…
John Lelekis: I apologize.
Ann Wells: That’s fine. As you guys speak, if you could identify yourselves that would be great.
Beth Jones: OK, yes. The prior authorization request, once submitted to the agency, if it is for continuation of therapy, it is approved. If it is a new therapy, then it is forwarded to the USF psychiatrist for review.
John Lelekis: So it’s a child psychologist, not a child psychiatrist, is that correct?
Beth Jones: No, a psychiatrist.
John Lelekis: Thank you very much. I wanted to make sure about that.
Beth Jones: Yes.
Dr. Lisa Cosgrove: This is Lisa Cosgrove. Do we have someone from the University of Florida to review what their recommenda… I mean I looked at all their recommendations, but I don’t think, there may be other people on the call that do not understand specifically what the recommendations are.
Beth Jones: We have recommendations from the Medicaid Drug Therapy management program expert panel that met to review psychotropics in children under 6 as well as for other children. These guidelines were developed in 2006 and they will be updated this year in 2008. Um…and these guidelines state very generally that given the current science and clinical experience, the use of antipsychotics in children under the age of 6 is generally not recommended and should only be considered under the most extraordinary circumstances. Disruptive aggression and autism is one such circumstance. Um, I believe we have Dr. Castellanos and Dr. Tandon on the phone?
Guy on phone: Yes.
Beth Jones: Do you have any comments um, concerning the guidelines or criteria?
Guy on phone: No, that was, that was the basic recommendation, as everyone knows, that you want to be very cautious in young kids. Now, can I just ask, as part of the process, and I had to cut out because I didn’t know how to un-mute it from the *6, so I had to kind of re-log on. Is there problems with the current process as it exists?
Guy on phone: Is that the question that someone asked earlier?
Ann Wells: I think, I think the current process should be matured, to be more consistent, and this is Ann Wells, the Bureau Chief, to be more consistent with how the Bureau handles prior authorizations for other classes of medications. We do have a number of children on continuing therapy who will need to be reviewed in the fall, and so the volume of work…
Guy on phone: Sure.
Ann Wells: …that could potentially be routed to our clinical consultant is pretty significant.
Guy on phone: Sure.
Ann Wells: And, that’s really the reason why we wanted a commitment from the committee to help us build a more independent process, to handle the review, except for more extenuating circumstances. And as I said before, the pharmacy clinical team here manages prior authorizations for multiple classes of medications based upon written medical criteria that exists in the medical literature and because the medical literature is a little thin in this category is one of the reasons… is the major reason, we plugged in the psychiat… the psychiatrist consultant.
Guy on phone: OK
Ann Wells: Does that make sense?
Guy on phone: Yes
Ann Wells: OK
Dr. Lisa Cosgrove: This is Lisa Cosgrove again. I think, you know uh, because the Academy of Pedia… the (Porter Chapter) garbled of AAP is also having meetings regarding children’s mental health, and we had discussed these issues before, that it’s not an exact science, and every child is unique and individual. Obviously, we know that there is an indication for medication in the autism child from age 3 on up. Other than that, most pediatricians, and I’m speaking now as a pediatrician, would prefer our great esteemed colleagues, the children psychiatrists, to make those decisions on whether they think a medication would be valuable for the benefit of that patient or not, and I think that most, in my experience, our child psychiatrists around here are very good about using appropriate medicines first and then graduating to medications that seem to be more of the atypical type. Other child psychiatrists on the lines can correct me if I’m wrong.
John Lelekis: This is John Lelekis. I’d like to ask a question. In looking at the comprehensive report of atypical antipsychotic prior authorizations, the two dates: April 25 through June 19 and April the 25 through June 12, what I saw was that ah…the provider types was something that I would…I looked at and I sort of questioned. Only because I certainly concur with Dr. Cosgrove in that particular procedure that they have, I felt that that was the prudent way to go. When I look at and I see others that may not be as familiar for children under the age of 6 to prescribe these atypical antipsychotics, I’m sure there are situations there that do exist, however, I was questioning the provider types. Whether all the provider types there are, should in fact be prescribing that medication without a referral from either a pediatrician or another person. I looked at the other category, which was also to me a pretty high statistic there, you had anywhere between 14.4 and 15.3 percent categorized as “other”, yet we put family practitioner with “1” each time. So, you know, I’d like to know what “other” is, as well, because, here again, we’re dealing with children under the age of 6. Not that the medication isn’t something that should be considered, however, my question is, are all the provider types trained enough and qualified enough to in fact prescribe ah, atypical antipsychotics.
Dr. Lisa Cosgrove: This is Lisa Cosgrove again. When I’m looking at those data, the pediatricians prescribing, I’m not sure if that would be, I think you need to divide that out into initial prescribing, and to continuation prescribing because many times, ah, myself as a pediatrician practicing, you know, may write medicines for patients that are already on medicines, just because they can’t get into their psychiatrist on time, but it doesn’t mean that I have made the diagnosis and that I am actually treating that child for that. I’m just helping them out until they can get back to their psychiatrist because as we know, the state does not have enough child psychiatrists to go around.
Ann Wells: I just want to jump in on the agency perspective. I don’t think that we have the ability to judge which providers are more qualified than others. We did the tabulation. What we found is that most of the prescriptions um, were written…are written by child psychiatrists, by neurologists and by pediatricians. And um, and that’s con…that’s consistent with what I think Dr. Cosgrove is saying. But to take it further… past the tabulation, I don’t really think we can do that.
John Lelekis: Hey, um, this is John Lelekis again. Um, you know, if there’s no FDA parameters on this, I think it sort of gives us the opportunity to create parameters, and that was my question about the provider type. If in fact the FDA doesn’t specify ‘em, should we not take a proactive approach in actually determining which provider types? And here again, I would like to see the “other” further delineated to who “other” is. I mean, if we can, if we can say “family practitioner” is one, and we have “other” as 56, that’s 14.4%. I mean, shouldn’t we have an idea who the “other” is?
Ann Wells: We can have our analyst go back and itemize that.
John Lelekis: I would appreciate that, thank you.
Ann Wells: Sure.
Dr. Richard Thacker: This is Rich Thacker. I’m an internist, but represent the FOMA (Florida Osteopathic Medical Association) and we have a large percentage of primary care physicians. But I would say that um, I think it is within our parameters to limit some of the prescribing. And case in point would be such as an HMO or any other insurer can decline to authorize a certain medication or certain treatments or even certain diagnostic treatments, let’s say ah if I want to send somebody to the sleep lab because of obstructive apnea, um, many interns may say, well this person has to be evaluated by a pulmonologist first, or whatever. And so, that’s part of it, it’s cost control, but um, it’s also some quality control, and certainly I may resent that at times, but I think it’s within our parameter to do that. So, um, I would certainly be in favor of limiting new prescriptions, but taking into account Dr. Cosgrove’s comments, I certainly agree as well as a primary care physician, um, that many times we have to renew medications that have already been started by a specialist, and though we may not want to do that routinely, I think that that occasion comes up fairly often and is a benefit to our patient and their families, and in fact a benefit to the specialist because of just accessibility. And then one last comment along the same line about the “other” could be that we’re seeing more and more joint residency, uh, um, joint residences that have internal medicine and pediatrics together, so we may find that we have an internist that’s a pediatrician.
Dr. Lisa Cosgrove: This is Lisa Cosgrove again. I don’t know, in this committee, are we going to be making motions or anything like that, on what we should be following. But I do remember a conversation that I had at a national pediatric meeting where we actually talked about psychiatric issues in children of all ages where there was not a single pediatrician in the room that felt comfortable being the primary prescriber of atypical antipsychotics on just about any age child, and they felt very comfortable with getting our esteemed colleagues, the child psychiatrists, to do the diagnosing first, and helping out with the treatment plan, and then pediatricians were comfortable after that as long as we knew what the treatment plan was. So, if we could make a motion here, I would certainly see that it would be appropriate to have medications prescribed to this age group only if they had been evaluated first by a child psychiatrist, um, or neurologist I think would also be appropriate, um, especially if it is in relationship to certainly autism, um, it would seem appropriate there. Um, so, I don’t know if we can make a motion or not, but you can tell me.
Dr. Richard Thacker: Well I would second that. This is Dr. Thacker. I would certainly second that.
Ann Wells: OK, let…
Dr. Jerome Isaac: This is Dr. Isaac. I think we have a problem because there are pediatricians who are Developmental Pediatricians and there may be pediatricians who specialized in developmentally disabled children who feel that they have a lot of experience with autism. Autism is a um, FDA approved um, reason for prescribing these drugs and it is the only drug that is approved for these behavior problems in autistic children and I think that would be much too limiting to make that a standard recommendation. I think with time as the prescribing group of pediatricians becomes more familiar with these drugs, I think that’s going to be more and more something that pediatricians may very well feel comfortable with now that they have FDA approved indication for it. That’s a fairly new, new, fairly new occurrence. I think that I have other comments about this whole process but I’ll let someone else have the floor and come back and give some further comments later on.
Dr. Daniel Castellanos: This is Dan Costellanos. (1:30) I (garbled) only be available until 1 o’clock, but my understanding of the process was that this was the initial meeting for us to kind of chart the course and look at all these issues, these very complex issues, and, um, that it may be a little bit hasty coming up with solutions today rather than actually charting the course and getting to that “Question 3”, if you will, on how to refine that process.
Ann Wells: You’re correct, sir. And I think rather than making specific motions we want to get a general commitment of where the PA (Prior Authorization) process goes from here. Does the process remain over the short, intermediate or long term, specifically where everything is referred to the child psych…to the few child psychiatrists we have, with new and continuing therapies because, frankly, that’s potentially a lot of kids. Or do we want to get a commitment to move forward, as I said earlier, to create some criteria and some prior authorization processes where some of this can be handled by the clinical pharmacy staff here at AHCA (Agency for Health Care Administration) reserving the more difficult cases for referral to the child psychiatrist?
Dr. Lisa Cosgrove: This is Lisa Cosgrove again. I agree with Dr. Isaac and his evaluation of Pediatric Developmental Pediatricians, um that yes, they are very capable of handling that also. But I’m speaking from a generalist perspective that I think it’s better that we have these other neurologists, child psychiatrists or your Developmental Pedestrians diagnose these and confirm the diagnosis’ of these patients first, before any prescription is given.
Ann Wells: So do we want to allow at least the initial prescribing only from a limited scope of practice I mean among child psychiatrists or neurologists and automatically deny the other claims for referral?
John Lelekis: This is John Lelekis. That would seem to make sense to me. I would think that, that especially, um, of the new cases, should be referred, since here again, we are talking about children under the age of 6. And in reference, in regards to those on a continuing basis be reviewed, I don’t know what the medical team feels about 6 months or a year or whatever the standard course of therapy would be.
Dr. Lisa Cosgrove: Well if it’s an autistic child they would be lifetime.
John Lelekis: Right. Right. Right.
Dr. Lisa Cosgrove: So you’re not going to get any difference there, but as far as continuing medicine it’s, ya know, I don’t think that that’s a problem. New prescriptions I think, ya know, I think almost all pediatricians will go through the process of, ya know, getting the child evaluated to find out a basis for, ya know, an abnormality if it comes up.
Dr. Jerome Isaac: This is Dr. Isaac again. I think if you’re looking for a way to make the process simpler and not cumbersome on anyone, as long as you’re routinely approving all of the continuation therapies I don’t see that there’s any point in burdening anybody with a approval process that’s going to be routinely approved. So I think if you eliminate that category that would be a big drop in your burden.
Ann Wells: So your recommendation is to leave the process where we only review new therapies and all continuing therapies are automatically approved?
Dr. Jerome Isaac: Yes.
Ann Wells: Okay.
Dr. Lisa Cosgrove: I would agree with that. I think that’s the intent.
Dr. Lisa Cosgrove: The other issue is I think one that Mr. Lelekis had thought of before, the kind of physician, you’re not only looking at physicians that are requesting these medicines ya know. And this is a thought, I don’t know who else would think of this, but if for example, a pediatrician or you’re gonna’ have areas where you have (garbled) and you have Nurse Practitioners taking care of patients or internal medicine, not internal medicine, but maybe family practitioners and they’re in outlying areas that have no access to let’s say a specialist there, but they have been able to get their child to go to see a specialist, maybe in one of the tertiary hospitals and they have a diagnosis from a specialist. If they’ve already had the work-up done and they have the paperwork in hand that shows that they have been properly diagnosed it seems to me if you have a copy of that work-up that that would be an easy approval, rather than trying to shift it over to one of your staff psychiatrists or staff Developmental Pediatricians or something like that. So, that’s just a suggestion. I don’t know if it helps you or not.
Ann Wells: Thank you.
Dr. Daniel Castellanos: This is Dan Castellanos. Before I sign off, but, in general, I think, in certain ways we’re talking about just replicating the process… the procedures that are already there based on the assumption that certain kids need certain care. We don’t want to interfere with the appropriate care and we want to look at inappropriate care. And that the process, the utilization, the review process is based on certain criteria, perimeters done and first level review by staff and that’s where the trick comes in, developing those perimeters, those criteria which are worth mentioning. And then, meets certain criteria and then go on to a level two review and take a better look at it so therefore you put your bigger resources on the second or third level review instead of the front end review. All with the goal of making sure that the kids that need their care, get their care and that we hope to help the kids that are maybe inappropriately managed or treated.
Ann Wells: Thank you.
Dr. Daniel Castellanos: Thanks, Bye.
Ann Wells: OK
Ann Wells: Anyone else from the committee have any comments?
Dr. Jerome Isaac: This is Dr. Isaac again. I have some general comments about the whole process. Number one, I see this as cost containment, uh, measure by putting obstacles in the way of physician’s prescribing. If these drugs were not expensive we wouldn’t be having this whole meeting. There are loads of drugs that are not approved by the FDA for children which do not have to go through this type of process. I think that this is a financially driven process, not a medical care driven process. And No. 2, I think we can all agree that the data on the proper use of these medications in young children is not there. So any recommendations that we make would not be based on any medical science or any facts. We’d all be flying by the seat of our pants.
Dr. Rajiv Tandon: I…you know, this is Rajiv Tandon here…I…having been associated with the process I, I think the primary driver for the process is really a concern question about safety of children, about their appropriate utilization, and certainly one of the drivers from a Medicaid perspective is efficient utilization of medications and so cost is a consideration, but I don’t think that’s what’s driving this particular process. I think the issue really is, as you point out, there are data about the use of medication – these medications, but inadequate data. There aren’t a whole lot of data about the long-term effects, about — there aren’t the extensive clinical trials of these medications in this particular population. But there are data. It’s not…it isn’t fair to say that there are no data whatsoever. So I think we should be guided by some critical considerations.
Firstly, looking at all the data that are available – um — given the constraints of those data.
Secondly, recognize that there are different safety efficacy considerations in this particular population that we need to be cognizant of and, thirdly, while not interfering with the locals of decision making which is the physician with the parent and child — I mean that’s where clinical decisions are made and physicians are well qualified to make those decisions and parents should be provided with all the information that they need to have to make reasonable decisions in the interest of their child. That’s what the decision-making is. However I think it behooves us, ‘A’, to make sure that all that information is available out there and, secondly, that any utilization which is unusual is accompanied by very careful close monitoring and tracking of benefits and adverse affects on an ongoing basis.
So I think – and potentially are there more ah, costs, ah, more effective methods that might be less risky if you will, that can be utilized so what other considerations have gone through and I think all that is factored into the current trial authorization process.
Ann Wells: Thank you, Dr. Tandon
John Lelekis: This is John Lelekis, I ha…I happen to agree with Dr. Tandon. I don’t believe that this is a cost driven process. When I’ve seen some of the things that I’ve seen from a pharmacy perspective, I certainly agree that this medication is in fact needed. My whole issue is that, I just want to make sure that the proper providers are in fact prescribing and there is a review process for all new patients that are gonna’ be subject to these atypical antipsychotics. So I totally agree with what Dr. Tandon has just stated.
Ann Wells: From the agency perspective, we care a lot about the citizens and the pediatric citizens in the State of Florida. We care about medication safety. We are, besides agency employees, we are parents, we are pharmacists. It’s a little… it’s definitely a bigger issue than cost containment. So I just thought I’d slip that in there. Any other remarks from the committee?
John Lelekis: One other point I’d like to ask – this is John Lelekis again, regarding what the University of South Florida review form, is it best to say atypical anti-psychotics review six years and under or up to six years…
Beth Jones: Up to…
John Lelekis: …of age.
Beth Jones: …up to six years.
John Lelekis: It says zero to five years here so I would suggest that that be looked at.
Beth Jones: It’s zero through five years.
John Lelekis: Zero through five years. OK, so it’s…okay, so five years and under.
Beth Jones: Yeah, five years and 11 months.
John Lelekis: Okay
Beth Jones: To be …
Ann Wells: … and 29 days.
John Lelekis: Exactly, all right, thank you. Zero to five.
Woman’s voice: (inaudible)
John Lelekis: Let’s see, what else did I have to say…
Woman’s voice: (inaudible)
John Lelekis: Okay.
John Lelekis: This is John Lelekis, are we going to send out additional information to the committee regarding some of the questions that we ask, for example my questions on other provider types, recommendations… are we going to make the recommendations about provider types as well? Where do we go from here? Suggestions.
Beth Jones: This is Beth. Let me make a comment about the “other” category…
John Lelekis: Ahum…
Beth Jones: …That is self-reported on the form and sometimes it is just checked off and the Provider doesn’t offer that information so that isn’t information that we always have. And that’s why it’s “other” and not specific.
John Lelekis: This is John Lelekis. I can understand that but my suggestion would be from…from going forward, or…or recommendation that this committee may want to consider, is that “other” be in fact identified.
Beth Jones: Right, good.
John Lelekis: I mean when you’re dealing with under five, five and under, or six and under. We need to know that.
Ann Wells: Well I think what Beth’s saying too is sometimes the category is unknown, so are you okay with an unknown? If the provider leaves the box not checked is that a reason to deny a prior authorization for a child who’s waiting for care because they didn’t tell us what specialist they were? You know what I mean?
John Lelekis: My recommendation would be that ah, here again, we’re allowed to give up to a three-day supply in the retail environment. However, I think that, you know, a provider’s pretty smart, once they find out they didn’t identify who they are, they will in fact identify who they are in subsequent, ah, ah, you know, subsequent submittals.
Ann Wells: Okay, thank you.
John Lelekis: Ahum.
Ann Wells: We will distribute…(softly asking Beth Jones)…we have minutes…
Beth Jones: Ahum
Ann Wells: Ok, we will distribute minutes to the committee with the summary of recommendations and a plan for…we’re planning one more committee meeting?
John Lelekis: Okay.
Ann Wells: I’ll let Beth take it over.
Beth Jones: Well, how does the committee feel? Do we feel that one more meeting is adequate or do we want to just plan a meeting at this point and then see where we go from there?
John Lelekis: This is John Lelekis, I would suggest that at least another meeting and so I don’t have any issues with participating in that.
Beth Jones: Okay. Anybody else?
Dr. Jerome Isaac: This is Dr. Isaac. I don’t have a problem with another meeting. If we are going to have a meeting and there is data that’s available to drive our decisions, even if it’s inadequate data, I think it would be good for us to review that so we could make more informed decisions. I think one idea that has not been brought up is whether we should actually have any review process at all along these lines. Is this saving anybody any time, money, effort or any illness or side effects? And I’d like to know if there’s any data that this utilization review process what we’re doing is actually helpful. There’s other ways, rather than interfering with the prescribing process, that can help to make use of these medications as scientific and rigorous as possible. And one is by distributing information and our concerns to the pool of prescribing physicians. And the other is to inform patients about the, ah, concerns about these medications, and there are drug handouts that are given to patients all the time. FDA can do that and maybe Florida Medicaid would like to make up a handout they can give to patients who receive these prescriptions indicating appropriate use of that medication so that they can discuss it with their physician if they think that something’s being done inappropriately.
Woman’s voice: (inaudible)
John Lelekis: This is John Lelekis, building on what Dr. Isaac just said I think it would be ah…something that would be beneficial to the entire medical community if in fact the University of South Florida or whomever is reviewing the new therapies to prepare data and information on that. Since they’re the ones that’s going though the process to continue to give us some ah, some objective data regarding what the primary courses of therapy have been, where denials have been, where acceptances have been and what the success rate has been probably.
Ann Wells: How are we doing on the time?
Talisa Hardy: 1:19.
Ann Wells: OK.
Ann Wells: Umm…I think at this point …umm…we’re going – if the panel is agreeable, end the panel discussion and we can revisit the public testimony. I do want to…um… remind people who are interested in public testimony that it’s not a question and answer session for the committee, it’s public testimony and so…um… there’s – you can submit your opinion but it’s really not a Q and A session.
Ann Wells: Um… Is there…
Beth Jones: (talking low) You gonna’ recognize?…
Ann Wells: (talking low) Go ahead, are you going to recognize what?
Beth Jones: Is there anybody else on the…
Ann Wells: Well, I was going to ask…um…in the group again, in the room if there’s anybody who would like to participate in public testimony you can raise you’re hand…we can… O.K. Sir, what’s your name?
Richard Davis: Richard Davis.
Ann Wells: Richard Davis. Well first of all, is the committee agreeable to, you know, ending the panel discussion?
Various voices: Absolutely. Yep. Yes. Would I have time to make a statement…Or ah?
Ann Wells: We are going to take the person in the room who drove here to submit his public testimony, so we’re going to take him first and than we’ll get to the people on the phone. So this is Mr. Richard Davis?
Richard Davis: Yes it is.
Ann Wells: O.K.
Richard Davis: I am here representing the parents that aren’t able to… wasn’t aware of this meeting. But these drugs that we’re talking about are very dangerous. I hear you saying that there is no data out here to…that it’s hard to gather…but that’s not true. I’m going to bring you information, right here, that is not my opinion, it’s a written fact that Risperdal, Seroquel and Zyprexa is very dangerous. And to use this on a minor child, a 5-yr-old or a 6 yr-old, is against the law. This 5 yr-old child, which was mine, was given these drugs illegally, there was nothing wrong with her whatsoever, she was just abused, physically abused and returned back to that home. When you see these side effects – there are all here – that I forced him to put in writing, her tongue out of her mouth like a dog, tremors, slobbering out of her mouth, he said: “Oh, she’s having a temper tantrum.” You ought to be ashamed of yourselves, this data is here, all you have to do is go to your records. Daytona Beach News Journal, St. Petersburg Times they all have data, but you say you can’t find it and yet you destroy our children. I wish I could see…you say you have children…see your child, tremor, shake, slobber, throw up blood out of her mouth from taking drugs like this. You know the side effects, you see them, but you continue to give the child the drugs. How can you call this medicine? How can you call …
Woman’s voice on the phone: Doctor?
Richard Davis: How can you call this medicine?
Person on the phone: Can’t hear him.
Person on the phone: Hello?
Person on the phone: Umm…
Man’s voice on the phone: Hello? Hello?
Ann Wells: It’s O.K. Hang on, hang on Committee. Mr. Davis, do you have any written testimony you’d like to give us to review?
Richard Davis: Yes, I have Guardian ad Litem reports.
Ann Wells: O.K.
Richard Davis: Let me read some of it to you.
Ann Wells: Well, we have very li… we have other people who want to um… participate. So what we can do is leave the public testimony portion open and people can submit written testimony and I’ll give you my address. You can give it to me now or anyone on the phone can mail it to my attention, it’s Ann Wells; Agency for Health Care Administration; Bureau of Pharmacy; 2727 Mahan Dr; Mailstop 38; Tallahassee, FL 32308.
Umm, we will leave the public record open for 7 business days and we’ll be happy to accept any public…any written testimony and Mr. Davis we’ll be happy to take whatever you have and read it and add it to our…
Richard Davis: OK
Ann Wells: …information.
Richard Davis: You say there is no data, but it’s here, it’s all around you. But I don’t believe you want to accept it because you want to continue using these drugs on these children. Most of the drugs that I’ve seen used on children, I’ve interviewed a lot of parents, it was uncalled for, you remove a child, the child gets very agitated, you drug the child, then…where do you get that from? Show me in your medical books where you find that that’s the reason to drug a child? You…you…there isn’t,
Ann Wells: OK
Richard Davis: but you continuously do this. Child, tongue swollen ‘til it hangs out of her mouth, then you say, “Oh she’s got sleep apnea” so you give her some more drugs.
Ann Wells: We recognize this is a controversial situation with small children, which is why we’re all here. And we certainly have had a lot of medical input and clinical data other then what is printed in the newspapers. And it’s… it is concerning to us all, the physicians in the group, the agency members and… we hear your concerns but I certainly will take any of the written material that you have.
Umm, is there anyone else in the room who’d like to participate in public testimony? OK, no one else. Alright, we have at least one person on the telephone. Mr. Kramer, I’ll put you at first on the list, is there anybody else on the telephone who would like to participate?
Dr. Martin: I’m here.
Ann Wells: OK, What is your name please?
Dr. Frances Fay Evans-Martin: I’m just expressing my concern as a mother and as a citizen about anybody giving these psychoactive drugs to young children with developing minds, and especially when they are not indicated for them. I think Dr. Peter Breggin has gone into more detail than anyone else on the adverse effects of these drugs [that] should be strongly considered, especially for small children. There are so many other methods – behavioral methods, medical examination to see if other causes are there, and then just giving them the support and the care that they need to meet all of their emotional needs, which is a large part of some of these problems. It just seems that there are so many alternative methods for helping young children who are in emotional distress that giving them drugs to put a strait jacket on their emotions is just reprehensible.
Ann Wells: OK. Thank you for your testimony.
Ann Wells: Um, Mr. Kramer, we can go ahead and get you…squeeze you in here at this point.
Mr. Kramer: Oh good, I’m a researcher with the Citizens Commission on Human Rights in Florida, and since I’m not really supposed to ask questions, I guess I’ll reframe these as statements.
Very briefly, aside from the horrific side effects on children such as lactating breasts on young boys, tardive dyskinesia, diabetes and dramatic weight gain, and aside from the thousands of law suits against the antipsychotic drug-makers and the many lawsuits by State’s Attorney General, and despite the fact that no one knows the long-term effects of these high-powered, mind-altering drugs on children, there’s one point here — and that has to do with money — Florida Medicaid money. Per Florida Medicaid rules, in order for a drug’s use to be reimbursed, it must be approved by the FDA or listed with a supporting citation in one of three drug compendiums.
For example, Geodon, one of the atypical anti-psychotics you’re talking about, has no FDA approval for children, for any indication, and there are zero supporting indications listed in the said drug compendiums. So, this was a question I was going to ask, but I’m now going to make a statement. And the statement is, Florida Medicaid should not be reimbursing millions upon millions of dollars over the last few years, for Geodon for children, when in fact there is no FDA approval, there are no supporting citations and it is against Florida Medicaid rules!
You know, in these times of financial stress, when the states are begging for money here and there, here is a place right here where the state is just throwing it out the window, and it’s going against its own rules. Another thing I’d like to make a statement on is, why are you just looking at five and under? Why don’t you look at all kids? Why don’t you also look at the elderly, where these black box warning antipsychotic drugs applies to dementia? So there you go, that’s all I had to say.
Ann Wells: Thank you, Mr. Kramer. I think at this point our Chief Legal Counsel, Craig Smith, would like to make a statement.
Craig Smith: I was just going to clarify for the record, since we’re here in a public meeting, in response, really, it’s kind of to a point that Mr. Davis had raised, which is something Ann Wells said right at the beginning, the purpose of this meeting and the committee is to…for…for AHCA’s Medicaid program to take recommendations on the appropriate Medicaid reimbursement coverage for these types of drugs, for this population. And we are getting the expert input from the panel members and that’s the purpose. But it is not the Medicaid program that decides or prescribes drugs for children. It’s doctors and with what Ann Wells said at the beginning that has to be in conjunction with the parents or the guardians consent for this population. So, just to clarify that that is the purpose here today is to really work toward the appropriate Medicaid reimbursement policy upon the expert advice of the panel. And we really appreciate all of the panel’s participation.
Ann Wells: At that point, I think we’re at 1:30, and we know that our physican participants are busy and probably need to get back to patients, as are our audience attendees in the room. I want to thank everybody today for coming in and participating and giving us very excellent opinions and advice. Thank you very much.
Various voices on the phone: Thank you. Thank you. Thank you.
(Space in recording)
Ann Wells, after the meeting adjourned: (…take the tabulations that we have and decide where we go from here.
Man: Do you know how many of those were approved, and how many were denied?
Beth Jones: Um hmm. I can tell you that. Let’s see… 344 approved; 87 denied.
Man: How would I find out what they were denied for?
Beth Jones: What, what?
Man: How would I find out what the denials were based on?
Ann Wells: Well, recommendations from the child psychiatrist who reviewed the documentation that was submitted by the prescribing physican.
Man: Any evidence?
Ann Wells: Well, that was the recommendation of the child psychiatrist who reviewed…
Man: Right, but in 87 cases they were denied by the psychiatrist at USF. So how could we find out what the denials were based on?
Ann Wells: It’s individual patient clinical review, and you run into some HIPAA issues and confidentiality issues looking at individual patients. So I’m not clear that you can, other than the reviewing psychiatrist for….ah….multiple reasons – it’s a complex review.
Man: Were there patterns of, is that, polypharmacy are there reasons that are coming up over and over again in these 87 so far?
Ann Wells: It’s a range.
Man: Is it just for a use that it isn’t approved, I mean or
Ann Wells: Well, there’s not a lot of approved, that’s why…
Man: Even for adults, I mean, even for…
Ann Wells: No. I think it’s a range of issues – dosing, um…what the treatment…total treatment plan in terms of follow up. I mean it’s a variety there’s…I wouldn’t say that there’s a pattern that comes over and over again.
Man: OK, OK. And when was the committee going to meet again?
Ann Wells: We didn’t define…we haven’t figured out a date (inaudible) …..
(Space in the recording)
Ann Wells: …and to patients and physicians, and we’re trying to balance everyone’s needs without being too burdensome. I mean we hear all of…all of the stakeholders, and we just want to make sure we stay focused on the right thing.
Man: Have you heard complaints from doctors on this Prior Authorization?
Ann Wells: Well, complaints from doctors is not unique to this drug category or this patient population. So, yeah, but we hear complaints related to other prior authorizations and other patient populations.
Man: Ahh, just a process question…
Ann Wells: OK
Man: ….Umm, you have this group that you set up, and you’re doing this review, umm… [cut off here]