Confirmation Number:334092
Event Started: 2/28/2005 8:27:16 AM
SACGHS CONFERENCE
I was not worried about the snow but then I got a check. We'll press through today because we really do have quite an awful lot -- to accomplish over the next two days so we'll do our best. If it looks like tomorrow is going to be -- we'll worry about that as we go along and to be sensitive to people, but right now, I think we'll put that out of our mind and focus on the agenda before us.
Let me just say, the public has been made aware of the meeting through notice in the Federal registry well as announcements on the SACGHS website. I really want to thank everybody here in person, but, also, I want to make sure the committee members are aware and are appreciative of the webcast. I've gotten -- as these meetings go on, you didn't warn me. But emales come in during the process of the meeting so there are a lot of people out there who are actually paying very close attention to what you say. And they are okay with me. But apparently, it's you. So just be aware there's ally interaction from people back and forth and we appreciate that. Also, for those who have sent e-mails asking about the meeting minutes from October, those will be up shortly and we do know that those haven't gotten up from the last meeting but they will be, I'm assured so I want to make sure that those who have asked about that are aware.
I want to welcome two new people to the committee. We are very pleased at Dr. Joseph tell fair has joined us from the department of many tern natural child and health from the school of public health at birmingham where he's an associate professor. He's a doctor of public health and MSP from the University of California at Berkeley. His work is focused on healthcare access issues for the the poor, rural, multi-cultural and multi-ethnic populations well as been a very strong advocate for patients with chronic diseases, particularly those with sickle cell disease. Dr. Tell fair is serves as the Lee a son to the advisory committee on inheritable disorders and genetic diseases in newborns and children and we thank you for taking on that role. We'll hear more about that today and so, we are very appreciative of that. But Joe or Joseph, how would you like to be called?
Joe.
Joe, welcome aboard. We you.
We're also pleased to welcome father canin Fitzgerald from the department of on cooling at gorgetown University medical center. He's the chair in catholic healthcare ethics as well as a research associate professor. He received duel Ph.D.'s in philosophy and molecular Biology give from Georgetown University. His research has most recently focused on tumor Genesis of the MLL and MLL2 genes. The father will participate in the meeting as an ad hoc member while 2 processing of his appointment papers completed. But, Kevin, you are fully on board here and we'll expect you to work just as hard as Mr.
No grace period.
I try.
We are pleased to Dr. James Rollins will represent the centers for medicare and Medicaid services. Thanks a lot, Dr. Rollins, as well as Dr. Willy May, well as at the department of commerce.
Dr. Melissa freeze will represent sent the department of defense . And I think she must be on her way.
Kim Z Zell ma will join us and Chris Hook can't be in person but will participate later in the morning and Joan Reede is unfortunately, able to attend this meeting.
As you know, Mike have was aproved at as the new secretary of health and human services sworn in on February 11th 2005. Let me say that I want to express my own appreciation for former secretary, now Tommy Thompson who was a very gracious and very helpful and received our committee's reports. I think, with great interest and responsibility and question hope he is doing well. We're pleased now to welcome the new secretary of health, Michael leave it have. He's former governor of Utah. And served most recently as testify administrator of the environmental protection agency can. And we're going through the process of getting on his schedule. It hadn't happened but I'm it will soon and we'll have an opportunity to update the secretary on the work of this committee.
Well, behind you on the chart is the strategy plan and our study priorities. I put that up there again to remind you that this committee is very focused on its agenda. Once again, I have to give acknowledgement to the leadership of Ed Mccab and as I take over now and continue this stream of activity, I want to make sure that we keep from front of us what we have agreed to do and we always understand what it is that we are responsible for trying to complete. Last March, we did identify these 12 issue that is we thought warranted various levels of attention by the committee. In August of 2004, we did submit a resolution to secretary Thompson on genetic education and training. Which is the second item there. By the way, genetic discrimination, the number one item, we'll spend a great deal of time with and talk more about that. But we did submit the resolution on genetic education and training which made nine recommendations aimed at ensuring the add question saw of genetics and genetics healthcare and healthcare professionals. The next one is patents and access. As you know, we received an extensive report on that at the last meeting and we're awaiting the latest developments from the national academy of science and their work which I think we left that last discussion assured that this is moving forward with thoroughness and deliberateness and I think we need to see what they deliver back to the process.
The overall oversite by the Federal agencies stays on our minds and that is one that we track regularly and consistently. And then, there is the vision statement report which, of course, we have, also, submitted to the secretary and will be one of the main items on the agenda when we have the opportunity to meet with seek tear Levithth. We.
The harm from consumers to direct to consumer marketing requested HHS to collect data on the public health impact of the marketing and to collaborate with the Federal trade commission on the monitoring of such advertising. We have sent this forward to the secretary as well. That is in your package, I believe N. your briefing books, I believe that letter is there. And so -- for those who are monitoring us through the web, you can find that report on the website.
Given the -- let me see what else is on the list. The coverage of reimbursement is obviously the subject of today. Large population studies tomorrow. Farm co-genomics. We have a task force and we'll come to farm co-gentlemen nock. That's today and tomorrow and that will come back to visit very soon and I mentioned the direct consumer. Access is an issue that cross cuts all the other issues and I think we view the coverage and reimbursement issue to be a key issue for access and so, we'll be hitting that mark as we do the coverage and reimbursement discussion.
The public awareness and understanding issue is one that I would like to just taken seconds to put in front of the committee. I still, at least as one observer, am concerned. I'm concerned about how well the public is prepared to understand the issues that are before them with this new revolution. Integrating it into the personal healthcare decision-making. The counseling activities and so forth and don't want to I'm not going to ask for any action on that issue today, but maybe by tomorrow we might think about or not we need to convene, at least, some kind of a discussion with the best folks in the country and in the government, who are thinking about this what are we doing to educate the public? I just know every single day in terms of the world in which I'm working and living is that the individual American is expected to integrate extraordinary amounts of information as they take on more responsibility for their healthcare decisions. The last item on that agenda said genetic exceptionalism and the issue of genetics are so intertwined with so much of the healthcare system and or not the public is adequately being prepared or other steps can be done, whether to elementary school, junior high school, high school education, whether it is through -- the kind of pamphlets and education the government puts out as the normal course of what it does I'm not sure. We need to start thinking about that as an issue. At the end of the day we've got to stay focused on what's in front of us. And don't want to take us too far afield. I'll it there and see at the end of the meeting if people have any thoughts.
Well, let's see. Let's go straight, then, to the agenda. That's what we have now. And you will see that at the very beginning of your booklets. We'll start the meeting with an update on our efforts on genetic discrimination and what's occurred since you are, I'm sure, all aware, there have been a great deal of activities since October. So that there will be a full committee discussion in light of those activities on our next steps. Keeping in mind, the goal of our discussion is to determine what is the appropriate steps that we should take as a committee to push forward and to add our own unique opportunities to add value to proexpecting against genetic discrimination or in this case as we also understand, equally important, the fear of genetic discrimination in employment and health ininsurance through Federal Legislature. We'll spend in afternoon considering coverage and reimbursement, the in-depth high priority issue we training highest, which has been the focus of much of the work over the past year. We'll review the revised draft report, developing a consensus on 12 recommendations that have been made. And discussing strategies for gathering public comments on the draft report. During our deliberations we'll be briefed by the genetic counseling services work group which was formed after our October meeting to respond to our requests for evidence supporting the value and effectiveness of genetic counseling services.
We also classified large population study as an issue warranting in-depth study. We need to learn more about large population studies and what scientific public health, ethical and policy issues they raise. We're devoting 5 hours tomorrow to these issues associated with such studies. By the end of the ten presentations we have organized on this topic we'll need to determine what next steps, if any, we wish to take. And so, I, again, we'll need to determine what next steps, if any, we need to take.
In addition, as we agreed at the last meeting we'll begin hearing updates and briefings on three other important issues we need to be aware of. First, following the genetic discrimination update this morning. We'll be briefed about the national health information initiative. This topic was introduced during our discussion of the surgeon general family history initiative at the October meeting and we want to consider out genetics, gentlemen know mix and family history will be incorporated into the broad initiative. While we did focus this and got into this through the family history initiative, I think the events are moving so rapidly now in the area of health information integracious, that it will have very broad implications for every part of healthcare. I think it's important for many reasons that we hear and listen carefully to that report.
After the NHI briefing we'll hear a report on the newborn screening have been made by the advisory committee on genetic diseases in newborns and children which is a report that's been of great interest to many.
Tomorrow afternoon, we'll be briefed about a collaborative public private effort to promote quality laboratory testing for rare diseases. This briefing resulted from a specific request by CDC for feedback from our committee on their evidents.
Due to the full agenda. We won't have the session of the pharmacogenomics at this time but we'll look forward to that coming forward.
The public comment sessions are always appreciated. This committee is committed to a great respect for listening to the public. And as such, we have public comment on -- for both days of our meeting. Seven individuals so far have signed up to provide testimony. And so that is just terrific and we're pleased about it.
And finally, I'd like now, and by closing out this part of the meeting, to start with -- to give us the reminders of all of the very serious rules that you're under. And you can barely breathe without being in trouble, so, watch out!
Thank you, and good morning, everyone. I'm actually only going to talk about two of the rules today. One is the conflicts of interest the screens process. And the need to be attentive to conflicts of interest during the meeting. As you know, fer ?oaf oh the information -- compromise your ability to be objective to give advice during committee meetings. While we waive the conflict of interest in general matters -- affected by your interest in such matters we also rely to a great degree on you to be aten tiff e during our meetings to the possibility that an issue will arise that could affect or appear to effect your interest in a specific way.
In addition, we've provided each of you with a list of your financial interests and covered relationships that would pose a conflict for you if they became a focal . of committee deliberations. If this happens we ask you to recuse yours fro discussion and leave the room. Lobbying... since we're talking about congressional affairs and Legislature in a minute, I did want to remind the committee that as government employees and your special government employees, we're prohibited from lobbying and thus, we cannot lobby, not as individuals or as a committee. If you lobby in your professional capacity, or as a private citizen it's important that you keep that activity separate from the activities associated with this committee. Just remember that we, this committee, is advisory to the secretary of health and human services we don't advice Congress. We appreciate your attentiveness to these two rules and all the others that apply to you and we appreciate how Cobb sheen shoes you are about them.
Well, we've got an admonition to be attentive and with the reassurance we're all special. We're going to -- by the way, let me ask. Does anybody on the committee have any opening issues or anything you want to put on the table early or any thing before we launch into the agenda? Everybody is okay?
All right. With that, let's turn, then, to Agnes and to Cindy, who will take us through this very important first part of our meeting with an update on genetic discrimination.
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As reed indicated a lot of activity from the task force well as legislative action happening so we wanted to update you on all of these activities so Cindy and I will be splitting the presentation. Just as a recap, the genetic discrimination has been noted as of the highest priority categories for our committee's work. In the past, already two letters were sent to secretary Thompson supporting Federal genetic nondiscrimination legislation and senate 1053 in particular. The committee in our October session, held a specific session on genetic discrimination to gather the public's perspective on the magnitude, the scope and the impact of genetic discrimination and most specifically, we tried to address the issue of the fear of genetic discrimination in society. We received testimony from members of the public, healthcare providers and other steak holders. So, what we're going to present today is some of the legislative activity that's taken place to you an update on the report that we're to put together that's to go to the secretary and as Dr. Mccab indicated at our last meeting we wanted to make it about telephone-book size and then, to update you on the fact-finding efforts that have been going on with the stake holders and this is the specific part Cindy will present and then, as a committee, we'll discuss what steps we would like to take next.
So, these are the members that have been on the genetic discrimination task force. And also, I just wanted to . out the work of Amanda and Sarah car that have been working extensively behind the scenes with the task force members. So, for the legislative update, as you have seen in your packet that is you got, your briefing books, that the genetic information nondiscrimination act of 2005 senate 306, has been introduced earlier this month. It was sponsored by senator snow, co-sponsored by senators frisk, Greg, Kennedy, Jeffers, dod, and you can see the rest on the slides. This bill is nearly identical to the one that's been passed by the senate in 2003. So, the bill prohibits group health plans and health insurers from denying coverage to a healthy individual or charging a person higher premiums based solely on genetic predisposition to developing a future disease. It also bars employers from using genetic information when making, hiring, firing, job placement or promotion decisions. this bill actually has passed the health education labor and penk committee earlier this month. And then was debated on the senate floor on February 16th. And all to with all the work that's been done we can't take credit for everything, but just to mention that there were several references from the work of the committee and its for genetic nondiscrimination legislation well as secretary Tommy Thompson's response to the committee's letters that he has received. And a specifically, senator -- mentioned testimony of our last meeting and the testimony of Heidi Williams and Tanya phillips and senator Kennedy mentioned the testimony of Heidi Williams and Phil Hart. Almost simultaneously to that particular action, the executive office of the president from the office of management and budget, gave out a statement of administration the policy on February 16th. And that administrator statement is in your -- was passed out in your books for today. To highlight one of the aspects of it. And that is the administration favors an estimate of Legislature to prohibit the improper use of genetic information in health ininsurance and employment. The administration's supports the senate passage of 306 as reported. the concern about unwarranted use of genetic information threatens access to utilization of existing genetic tests, well as the ability to conduct further research. The administration wants to work with the Congress to make genetic discrimination illegal and provide individuals with fair and reasonable protections against improper use of their genetic information. So, this is all been very, very positive and we've been very excited about this movement itself. And then, the next day, after the administration policy was issued, the bill was unanimously passed by the Senate.
As far as the house goes, no bills have been introduced to date on genetic discrimination. And in the last Congress, even though the Senate passed the 1053, several bills were introduced in the house but none of them moved forward. The committee is hopeful that the senate bill will be introduced very soon in the house. so as far as the update on our report goes, to the secretary, at the conclusion of our public testimony and the roundtable discussions that were held in October of 2004, the committee recommended that we take several actions. And one of the first, was to compile the testimony that we heard and the public comments that were received by the committee and relevant scryity fibbing articles to submit them to the secretary. This was I was referring to as our telephone-book size to the secretary . And then, to gather information from stake holders and to facilitate a meeting of the stake holders and some of these stakeholders wither were the genetic information, nondiscrimination and employment coalition, the AHIP is the American health insurance plan. The chamber and coalition for genetic fairness. We did receive testimony from one the groups but we wanted to have further input from all of the stakeholders to get perspectives from all of the issues that they had. And then lastly, our third job was to facilitate and analysis with the department of justice and the equal employment opportunity's commission of the current laws that we had in terms of protecting the public against genetic discrimination.
So here's what has been happening. the task force held a call in late November to further develop a work plan and carry through on the outcomes that we had decided upon at the October meeting. The task force found that the broad testimony received from the providers and other stakeholders pointed out the range of perspectives on this issue and really did need a deeper analysis. So the task force workd out a 3-part structure for the report to the secretary.
The first of them was, of course, the public comments. So, prior to the October meeting, the committee had solicited the public comments and received a significant number of responses, in addition the 14 testimonies and public comments received during the October sessions and all of these comments have been compiled in a document. The task force also concluded that the testimony of the seven patient that is presented to us was so compelling that we should take excerpts and highlight them in a DVD. so what you have in your briefing book as you'll see, you actually have the script for that DVD and that's something we would like to discuss further in our discussion .s.
Secondly, the second component in the report to the secretary, will be the stakeholder analysis and this is looking at all the stakeholders positions and .s of agreement and disagreement and where consensus possibly can be reached. And Cindy beer Ray will go into more detail from the fact findings to have stakeholders meeting.
The third component we were given to on was the legal analysis and that is actually being prepared by a -- our committee staff with technical assistance from the office of civil rights, the centers for medicare and Medicaid services, the department of justice, of Labor, and the equal employment opportunities commission. and all of this work is actually to help us inform the debate about the accuracy and completeness of the current legislation that we have.
And now, I want to turn it over to Cindy so that she'll give us an update on the fact-finding from all of the stakeholders opinions.
Thank you, Agnes, our fearless leader. How do I I do hit "im"?
Okay.
Fact finding. This component of the report really centers around the different perspectives and opinions of the variety of stakeholders. And we wanted to consult with as many groups as possible to really get a good feel for what their view is on genetic nondiscrimination. We know in Washington, while this issue is a high priority for this committee there are a variety of viewpoints. People come at this issue from different perspective. Employer, health insurer, consumer perspective and we really wanted a deep understanding of these different views and gather much more detailed information that could be compiled into the report. So we confer with the U.S. chamber, America's health insurance plans and the coalition for genetic fairness and will report to you on each of those conversations. Starting first, with AHIP, America's health insurance plan, they shared a copy with us of a letter they sent on February 22nd to chairman Bayneer to have house education and work-force committee and chairman barton of the energy and commerce committee, this letter is in your table folders and it outlines in greater detail AHIP's position on genetic none discrimination legislation. You have the letter before you but I'll highlight a few of the key points. AHIP expresses opposition to genetic discrimination. Stating that consumers should be protected from discrimination based on genetic information. In the letter, AHIP also expresses support for protections established by HIPPA, the health insurance portability and accountability act. Indicates that F306, the bill that just passed the Senate, would nod undermine important quality improvement and disease management programs. That was a positive statement with regard to that bill. The letter goes on to state that AHIP is committed to continuing to play a constructive role in the on going debate on this issue and urges Congress to address the issue at a deliberate and thoughtful pace.
Next, we turn to the U.S. chamber and as you all know, the chamber is large business federation that represents millions of businesses, state and local chambers and business associations across the country. Their mission is to advance human progress through an economic, political and social system based on individual freedom, incentive, initiative, opportunity and responsibility. And we talked to the chamber about their position on genetic discrimination. They outlined for us some general .s and then, more specific issues with regard to the Legislature at hand. The chamber believes that employers should be able to make decisions based on genetic discrimination in cases where the employee is an emnent threat to the work place or the employee and they gave us an example. And that example would be an employer needing to reassign an employee, working with a particular hazardous material, if the employee has a genetic predisposition that makes it likely the hazardous material poses a greater threat to the employee. So, that is one example where the chamber said they probably need to have, from the employer's perspective, a certain amount of flexibility to protect even members of their own work-force.
The general concerns of the chamber outlined for us are listed on the screen there. Basically, there is no record of employer's discriminating or no widespread discrimination in the work place that's been documented, so they feel that the goal of any legislation should be focused on reducing employee fear of potential discrimination. They are also concerned about the possibility of increased liability and frivolous lawsuits. And thirdly, the chamber contends that current law does provide appropriate protection of confidentiality of medical information including genetic information. the chamber outlines for us specific concerns as well in addition to the more general concerns that we just went over.
First, they feel that damage provisions in the law, in the statute should be limited to equitable relief. They believe that one Federal standard should apply and should preempt different state and local laws. the definition of family should be limited. And lastly, they feel that the study commission should be truly independent and not housed within the E. OC.
Next, we spoke to the gene coalition, this is a group of employers, trade associations or professional organizations that have, on their steering committee, the chamber, the to site for human resource management, HR policy association, college and University professionals, and the association for human resources. and we asked them about their position on genetic nondiscrimination legislation. They contend -- contend there is no preeshable evident of genetic discrimination in the work place, their focus is on employment discrimination, not health insurance discrimination and they, too, have concerns about unintended consequences, unnecessary regulation, and excessive litigation.
The coalition for genetic fairness strongly supports Federal genetic nondiscrimination Legislature and their mission is to edge callet congressional policy-makers and staff about the importance of -- educate the -- and passing nondiscrimination legislation at the Federal level.
I won't go through all the members of their executive committee. They are up there on the slide. But they are looking to broaden their existing membership to include patient groups that address not only rare diseases, but also, common complex diseases like cancer and heart disease. They are looking to expand the membership in the provider community to include umbrella provider or organizations. They are currently working, of course, with the American academy of pediatrics but want to go beyond that specialty, society and focus on the broader groups as well. And looking to expand into industry so that the business community is represented in this coalition as well. their position on the genetic nondiscrimination Legislature is that it is important because of the need to have predictability for consumers and providers. They feel that the lack of Federal legislation in this area creates an unfriendly climate for companies trying to develop new invasions in this area. And they feel that patients and rough viders must be willing to participate in research supporting the development of new products and the lack of Federal legislation this warts that goal.
They feel that employers would benefit from predictability this this area and are not convinced current law provides sufficient clarity or protection. they also contend that the remedies available under existing laws are Americay and not necessarily limited as they are under the S306, so they feel that the Federal legislation as portrayed in S306, the bill that just passed the senate will provide a greater deal of clarity for employers well as consumers.
They have been embarking on a variety of legislative effort. They've been very supportive of S306. The senate majority leader and the health committee chairman are advocating for this bill and the coalition's efforts have been an effort to support passage of this bill. Not only in the Senate, but now as the action shifts over to the house . they are in discussion with a number of key senior house Republicans regarding introduction of the Senate bill. I think their hope is that a Republican will step to the plate and serve as the lead sponsor, along with represent slaughter who was the congresswoman who was the lead in previous Congress on genetic nondiscrimination legislation. And I think their goal, also, it was articulated to us is to have the Senate bill introduced in the house as opposed to having a different house version. The idea would be that this would streamline passage of the you wouldn't have competing versions and then have to have a prolonged conference. They are going to be working with the house energy and commerce committee, emg occasion and work-force committee and I believe the ways and means committee unless someone has figured out a way to draft the bill to avoid that committee's jurisdiction. That was the difficultly in the last section of Congress, when a bill is in three different committee's it's hard to get it going through the entire process. I will stop here and, Agnes, I believe will lead us in a discussion of next steps.
First, I guess, before we go on with any of our discussion on the next steps is that to hear we have any questions from the committee members about the work that has been going on? Or if you'd like to further explain what was presented. Ed?
I just would like to commend the task force on your excellent work. Clearly, you've been doing a lot of work on this very important effort and I hope that that work leads to greater success in the house this year then we've had in the past. Thank you.
Just a question. And you may or may not be able to respond. The letter from America's health insurance plans and I'm torn in trying to interpret and read between the lines of whether this is actually a generally supportive letter on their part or whether, when we read phrases like "it's critically important for Congress to take time to consider the implications" whether, in fact, this they are more in favor of stalling or slowing down the process in the interest of obtaining further information. But, clearly not in the interest of driving this to passage in the session. any insights from the task force perspective?
I've been on sort of some of these calls and let me make, first of all, a general observation athat I want to echo Ed's sentiment to the committee and also, to the staff who have been working this. There have been some very intense, I think, very specific and detailed conversations with each of the stakeholders you've heard. I think one the things that's hard to guage, I think N. a power . slide is the sense of the subtlety's and the knew wanses of where different constituencies are really coming from. No question that, at least from my listening to those conversations, that the sense that people really do, on all sides of the issue, understand the need for moving legislation forward. Where, I think people are really concernd as the power . indicated are around the unintended consequences, in particularly, the legal exposures. That's just another issue. And if there was some way of divorcing, you know, of having the conversation about the legal stuff separate from some of the genetic stuff this thing would be just a lot easier. It's not like you can can sense from anybody involved in this process that they don't want to see the fear of discrimination gone away. I mean, I think people get that. The issue is, what you do about the unintended? What's that's is subtlety. The way I read the letter from AHIP, and I'm not in a position to speak for them, but from listening to the conversation with them, seemed to be what they're looking at are the same thing the committee is looking at doing. Which is the legal analysis around the adequacy of current protections and that same kind of trying to get clearer of what things sort of can exist now. I think the other area that AHIP seemed to be emphasizing was just a -- making sure, again, that the use of information in service to the coordination of care for people, was not violated. Other then that, I can't tell. But I did not, as one person, get a sense that they put that in as a stalling takeic, that's not what came through at all. Others may see it differently.
A quick question. One -- in listening to the presentation I'm appreciative of the fact I'm learning more about this. But in your conversations with them, did you get a sense of -- a lot of times when you have this kind of discussion with them, they are sort of this is what we recommend. This is where we think it should go. This is what we believe will be the case. I was wondering on the part of -- "do you believe this to be the case" is this realistic. Will it happen? What did you get from discussion where people were with this in terms of their hopefulness that the next steps will occur and be effective and in the direction they would like to see? I ask that question because that's really important when you try to make decisions about recommendations because you need to get a sense of where people believe it's going to go.
For the committee in general as to where it is?
Yeah.
Okay.
Things you don't see.
I think that's one of the reasons why some of the next steps that we have up there is that one of the things we wanted to do is actually move ahead with the report to the secretary. But actually, divide it into three separate components so that since we already have compiled testimony from the public, that that would be something that we already have that we could move forward with if we get the approval from the committee for the script the DVD. To do further investigation with the stakeholders so we clearly present the perspectives of all the stakeholders involved. And then the third component, is legislation, so once we get the analysis, that might even help with the perspective from the stakeholders as well. We don't have that completely finished. The legal analysis as of yet. Nor a complete in-depth look into all the perspectives or that have exield because things are changing all the time with the Legislature.
I think the other thing, Joe, I guess I would say is that, this slide -- although these issues are new answer and subtle they are fairly specific, also, in terms of -- knewians and subtle. They are fairly specific. I must, again, I'm being very careful here. What we did see in toes conversations was a willingness, I think, on the part of all the constituencies that were consulted, tone cage in pretty serious discussion and to try very hard -- very serious discussion and to get to some place of agreement on these sirs to people are working these issues. As a result, I think the only thing we can predict reasonably, is that we will not know any more until Legislature gets introduced in the house. And that people will then react very specifically to very specific parts of that legislation and they've been very clear as to where their concerns will be. a result of that, Joe, I think what your question is getting at, therefore, what do we understand to be reasonable next steps? I would say that in terms of trying to predict our ability to get any more consensus then you see on this piece of paper, I doubt there's anything else we can do until the specific legislation is introduced in the house. I think that's what you're trying to get at.
Frances?
I also want to commend the task force for the work you've done to track this issue and for all of the consultation you're doing which are critical, with really important groups that will have a big impact on what happens. I confess when I read words like "well we need to approach this at a deliberate and thoughtful pace" that it does seem like we've kind of been doing that. if you look back at the record of what's gone on it's Ben ten years now since article was published in science magazine advocating the need for Federal legislation to protect against genetic discrimination. In health insurance, two years later a similar article advocating about the work place. Both of those articles not only pointing out the need, giving examples where a discrimination was occurring, allbeit not a lot of them, and also making specific recommendations about definitions and the kinds of language that would be needed in effective legislation. Many of which are reflected in this current bill, F306. It does seem like a fairly deliberate and thoughtful pace has been adhered to. Just the same, we still, I think, are facing an uncertain time here. I looked back or my staff did, at the history of S10533, which you are remember passed the state senate, the 5--- 95-0, unanimous N. October of 2003. And 12 months went by without any action being taken. Not even being referred to committee. That was the only bill in the 108th Congress in a two-year session that passed the senate unanimously and was never assigned to a committee in the house. So, that indicates to you that there's something going on here in terms of resistance and it's not going to be trivial to overcome that. Just the same, I think we have a real opportunity this year to revisit the question -- and I agree with what reed said about the willingness of the various parties to get engaged on the specifics of the details once there is a bill introduced in the house to be discussed -- and I do think timing is everything. And this momentum to try to get this considered in the house is really important and not allow that to linger on and I do, also, think it's an ideal moment for the new secretary of health and human services to be quickly engaged on this issue. You reported on the statement of administration policy. It's very clear where the Bush Administration stands on this. But the personal role that the secretary steaks in this could turn out to be pretty important. Whatever you decide to do about next steps, I would urge you to try to do it quickly.
Emily?
I guess, you know, sort of on that same vein, one of the things I want to clearly understand and don't know if you have the information, Agnes, or staff does, what is the timing that we have to do before this, once again, just falls off as unacted on? And we should work with that kind of schedule in mind? I would urge us to try to get, at least, part I finished today to whatever . we feel it's ready and -- part one finished and send it on so we don't have a lot of stuff stuck within our own committee and then to move forward with other two parts as quickly as we can.
Your would be: What would the timing in the house be to have the bill presented before we're going to lose the opportunity?
Before it falls off like 1053 did. So it wasn't acted on in a certain time and then it just disappeared. I just personally don't know that is. Is it this fall. A two-year period?
It's a two-year preerd period. We just started this 109th Congress, so we don't have a full two years, obviously, if a bill is introduced one month before the session is supposed to end, chances are bleak far as passage goes. But we have a little bit of time. That doesn't mean we should necessarily take a thoughtful deliberate pace. But we do have some time before a house bill really needs to be introduced. Keep in mind, if it does get referred to three different committees as the last bill in the house did, that will take an enormous amount of time for hearings and markups for it to go through the regular process. The only other way to pry it loose -- and this was tried the last time unsuccessfully -- but it can be attempted again, if the Senate bill is introduced in the house in an identical version, and they bieps the committee process and take it directly to the house floor. That's an -- bypass the committee process. It's been done. Not the kind of thing the committee chairmen like to go along with because they like to exercise their jurisdiction over these things and it's an important enough issue I don't imagine the three committee chairmen would willingly give up their jurisdiction to allow a bill like this to go directly to the floor. That's sort of a tactic of last resort. So I would guess within this first year it would be to be a bill introduced in the house to give i us another year for the regular house process to go through possibly, result in floor action.
Ed?
With that, I would urge us to move with dispatch here in terms of the report that's been proposed. And especially, the DVD. When I read the script of the DVD it really brings up the passion of the individuals who were involved talking about how they had to hide their genetic information. How they delayed testing for ten years because of concern about this. I think that saw -- twice I saw in your slides, statement that this isn't the problem there. 's no reason to worry about it because it's not really a problem. And yet, we it is a problem. I think I admonished the genetic's community to stop publishing statements that genetic discrimination is not a problem. Those papers have been skud. They were poorly performed. And they've done it to a disservice to the entire American people. We've got to get that telephone book out there so that that can no longer be used as an excuse. No problem, therefore, no need of a remedy.
Let me make one other quick comment to Ed's . I really do understand how hard it is to follow this. I want you to look, though, at the -- just because I'm always looking for as a chairman I'm always trying to find ways to trying to get the consensus and trying to find the common ground and making sure we don't lose, at least, site of where there are opportunities to bring constituencies together. I'm always going to try to find the silver clouds. If you look on your handouts on the slides on page 3 under the chamber's position on genetic discrimination, the second bullet, we had to off set it. Does not believe employers are currently engaging in genetic discrimination. Then they added a phrase: Though it does recognize that fear of potential discrimination may warrant a legislative solution. This is, again, where I want to make tho the knew wanses of the words are noticed by the committee. This is an addendum that they made to after the end of our discussions with them. So, that phrase is important and, again, I want you to not fly by that phrase. What it ultimately means when the bill goes to the house yaud yaud yaud, I can't predict. But, I think Ed's . is important, that, notice that that is a closing -- a recognition of something there and it's a subtle . but it's a very important . Is it determinate? I don't know. I want to highlight, there are looking at these issues.
Ed, you have a follow-up comment?
Just a follow-up, I think that does leaf e the door opened a crack or, at least, we may agree to disagree but allow things to move forward. I think we need to take advantage of that. I also think we need to . out to secretary leave it have and time sure you'll do this, when you brief the secretary, this is a civil right. We're seeing a violation of individual's civil rights. And I think that we also need to recognize what they're concerned about is the litigation, the remedies as they put it, but I think we need to also -- and I've said this before -- if, in fact, gentlemen meties discrimination is not occurring then what is the fear of remedy? Genetic discrimination is not occurring what is the remedy? If they don't feel anybody is really doing this and it's simply the fear of the American people, it would seem to me that they should be willing to support this legislation because, in fact, there is no fear of litigation. If they'll really, firmly, believe that no one is discriminating.
Barbara? Emily? And then Kevin. I mean, Debra.
So, 1053 got stalled by not being introduced into the house. We have the three committee chairs. Are the flee committee chairs the same as they were in the last Congress? -- the three committee chairs the same as in the last Congress or have they changed?
They changed a little bit last year. Chairman barton was new last year. It was Mr. Tosan before he left Congress and Mr. barton took the chairmanship. Ways and means is the same and education and work-force is the same.
So there are several steps. One is simply getting a bill or the bill that passed the senate. This time, introduced? So, how do we do that? That wasn't even able to be accomplished last time. How does that get influenced to happen? And then once it is introduced, can we encourage the secretary to distribute the report to him to the committee chairs as well so that they have this, you know, phonebook-sized information emphasizes that genetic discrimination is happening? But I'm very concerned about that first step. How do you get a bill introduced and what are the barriers to that happening? Do we know that yet?
Because basically, we're talking about when it's introduced. Par Whatwe do. But if we don't get past that introduction step it's not going to happen.
I think that Sharon's group is probably one of the most effective ways of getting it introduced. That is getting a large coalition together and, you know, maybe taking their information straight to the Congress. I mean, if this is not a problem then there should be nobody standing on the steps of the Congress when they deliver their message. But my guess is, they could get a very large group of people.
Let me ask the staff if they can help us. We are well aware, I believe, and let me make sure, that the advocacy coalition is moving with some deliberate speed to use their considerable opportunities to get something in place. So I think that, Debra, you're asking a couple of if I understand you, one S. there a role we can play in that regard? Of course, as Sarah said up front, we're advisory to the secretary. But there is something in play right now to make that happen. And can we just ask for what we know about that
My understanding from the conversation that is we had with the coalition for gentlemenairness they are working hard in the house and talking to members of Congress on both sides of the aisles to try to find a sponsor of the senate bill and they are interested in seeing one bill introduced in that chamber and that bill is the Senate bill. So, it seems that the advocates for the legislation are very hard at work on finding a sponsor of the Senate bill. And they found quite optimist -- they sound quite optimistic. Maybe it will happen. I'm not sure if anybody from the coalition is here. Joe bossman is here. Our good friend, would you like to come and tell us more?
I'm a member of the steering committee of the coalition of genetic fairness. Sharon Terry wasn't able to be here today because she has her own board meeting. Sarah and others have, in fact, represented the activities of the coalition, I think, very fairly. There have been many meetings on the Hill with staff members and Congressmen on both sides of the aisle as you pointed out, Sarah. And we're working very hard and as quickly as possible to utilize this momentum. I think it's fair to say we do have some president Miami, we hope it's naive optimism. But we certainly have a lot of energy optism.
I got an e-mail from Sharon who is probably at the board meeting monitoring this on-line. I expect to be probably getting a note from her in a couple seconds saying everything we just heard is absolutely right. Debra, if you might want to continue your line of questioning but, be assured that there are extremely aggressive activities to try to get something into the house.
So it seems that in the past, 1053, that the stakeholders that we've spoken with were some of the individuals or groups that were potentially blocking the introduction. Sit possible since we had conversations with them and I don't see any of the groups come out and say "this should not be introduced." Even the chamber said it recognizes that fear of potential discrimination may warrant a legislative solution. Is it possible for us to get statements from these groups? So that those could be introduced with this document? So there's something in writing about their positions or would they not at all be willing to do that?
Well, one of the next steps that we wanted the committee to think about was to have a meeting of the stakeholders and bring them all together in one room I think we would like to continue too work with them and we can certainly make that request of them to actually address the specific question of whether they would sportth the introduction of the Senate bill the house. But it is a -- I mean, these are sensitive negotiations that are going on in the Congress. And I'm sure there's a lot going on we're not aware of. I think our role, you know, we do have to be careful of our role. We can't serve as a platform for negotiation of a bill by any means. But I think our effort has been -- we've been trying to focus on finding out as much as we can and understanding as much as we can, the concerns of the other stakeholders so we can inform the secretary about those and in his discussions with the Congress, that he might be be more fully briefed about those hish issues and, perhaps, in discussions with Congress, might be able to find ways of overcoming the differences and bringing everyone together. So I think what we would probably want the committee to address is whether we -- whether you would agree we should have this request as a sort of stakeholder meeting. I think the other thing on the table, and perhaps the most important thing right now, is whether the committee wants to write a letter immediately to the secretary. We can do -- the stakeholder analysis and the legal analysis will take a little more time. And what -- as Agnes indicated, we were hoping to have all three things together because it would be the more complete way to brief the secretary. But given the momentum as Frances said on the house side and things going on, it might make nor sense for the committee to write another -- and this is a new secretary. It's a new Congress. We said these things before. It's a new bill. It wouldn't hurt, I wouldn't think, for us to let this secretary know right away, what the concerns of this committee are and also, sending up the telephone book as Ed said, that, along with it, the DVD which will be a very powerful way of demonstrating the concerns of the public and the patient community has about this.
Agree that should go forward. That's just my opinion. But I do think that that should be encouraged to be distributed -- I mean, have the secretary distribute it to whoever the important people are in the house and the committee chairs, for sure. But if there are other key people.
By the way, in terms of specific answers here to your other question of getting something in writing. I think what you have in the slides is about as far and close as we're going to get. They did write that in the sense. So, there was approval for those slides and the comments made there. That was very, again, careful. I think you have something in writing as it were. It's probably as much as you'll be able to get, quite frankly. Imemphasizeing that again because there's an awful lot of conversation going on. One of the things -- the committee is justifiably frustrated as Frances and Ed and several of you have said. Just know that there's been, you know, on your behalf, a lot of work is going on trying to move this thing. People have not been sort of sitting back since the last meeting. And the last comment was, there was a meeting. don't know whether we know anything about it. But there was a conversation between the some folks, I think the chamber and some of those folks, and the advocacy can committee, together within the last three weeks. I'm not sure if we know anything about that conversation and how it went but I do know they are meeting offline as well. So, there's a lot happening here, and I'll just leave it there.
Did you have a comment, Ed?
No. I would just like to second Debra's support of a letter going to the secretary. It's been the tradition of this committee and it's predecessor committee, the SACGHS said it's the first core spoon sentence with each of the secretary that is we have advised and I think -- correspondence that we advice them on genetic nondiscrimination and I think it would be appropriate for us to keep with that tradition. I would also, whatever we have together, I would send in of that. I would think we have all of the testimony of the folks. We have thebility to do the DVD with an can excellent narrator. And the person of our chair. So, I would support that we -- what we have in the hand we send along with that letter.
What would you like, specifically, in terms of -- and we'll find out what the expectations are for the DVD to be produced and I think Sarah and them need to let us know the time line -- but whatever that information, would be your sense of -- give us guidance around how soon you want this? And secondly, Ed, how specific you want the letter to be regarding acting and sort of saying something about the house?
Well, I would like back at the letters we used before. But I would emphasize the need to, you know, and the appropriate jargon of inside the beltway, pry it loose, in the house. I'm sure there's a more appropriate art form to that language. But basically, to try to move it forward I think -- I'm sure secretary understands the legislative process much better then I do. But Cindy's comment about the most expe way of moving it forward being to introduce -- expe dishes way. We need to put the alternatives in there. I would trust the staff and to you, reed, in terms of what the best language is. I think we should be as detailed in terms of what we feel the steps are that the secretary should take.
Yes? Melissa?
What were the lessons learned from 1053 in terms of its travels through the house? Because it seems to me -- did it even make it? Did it show up anywhere? It never showed up. So, obviously, that's the critical . What would be the strategies that we have? Any other new information? Anybody else that can provide value on how to approach differently for different strategies?
clearly, you have a frontal approach. But you've got to get passed that, too.
Well, I think that gets to one of the one of the issues. Clearly, the coalition is busy. The staff is busy and this committee is busy and I don't think any of the questions have been questioning that. But when we first started this committee, we had a presentation from a legislative aid, if I remember, one of our first meetings who was very helpful, although frustrating but helpful, nonetheless, pointing out there wasn't going anywhere. It would never get introduced to committee much less make it to the floor so, my question is -- do we have any sense now that there's any support -- do we have any friends anywhere in the the house leadership where they tip their hands and say "yes, this will make it. This will work its way through the process" or are we being stone walled as we were in the previous session in which case, we may have to think of a totally different strategy because business as usual isn't going to get us anywhere. Do we have any sense of anybody that's willing to take it on?
We have comments from the audience, please, give us your name.
Yes. I'm Frank swane and I'm among the people that's working with the coalition for genetic fairness. And I very much appreciate this discussion. Try to make just a couple of remarks. It's distracting but in our view, not critical, that the bill has not been introduced in the house yet. the bill have been introduced last year's bill could have been introduced four weeks ago in the house. And our attempt to hold back those sponsors wrus purely to get a bill that is more acceptable to a broader -- sponsors that were purely -- the Republican leadership so, in fact, the bill doesn't have the faith that it did last Congress of just going nowhere. I would dearly like to have told the staff that we have Congressmen X and congresswoman Y as the key sponsors and they'll put the bill in tomorrow. Congress was on vacation last week. It might have happened had not been on vacation. We're hopeful a bill will be introduced quickly. We're hopeful it will have bipartisanship support and including support from some people that are significant in the house Republican leadership. We're working in a moving target trying to get people to move th bill along constructively. The fact, certainly frustrating to you, there's not a bill that you can talk about on your table this morning. If you're meeting, I can guarantee.paryou the bill will be introduced by the time of your next meeting. More importantly, we're optimistic not only will the bill be introduced there will be constructive hearings scheduled and constructive on the issues that the chamber has raised of concern.
Joan, did you have any further comment? Kevin?
Thank you, I was just wondering trying to follow the conversation -- eight pierce to me as far as your action items are concerned, your first one says "should the committee conduct a stakeholder meeting with the key stakeholder to further inform the report's analysis? Did you have specific information in mind that you thought would be useful to have? At least from the sounds of things we're at a catch-22. Nobody now knows exactly what the legal ramifications will be until a bill is introduced specifically. So, that is, you know, sort of guess-work and speculation and that can't do anything but sort of grind the whole process to a halt. Is there anything other then that sort of thing the committee sees as necessary or beneficial? Otherwise, we just with the action steps.
Very good . Ed?
Well, this is where we might use some help from people who know the process a lot better then we do. And that is, if it's helpful for us to have a meeting of this group. Or if those meetings are already going on in ways that are a little more sensitive to some of the issues, is that a better way to proceed? You know, I'm all for a frontal assault. But ultimately, I want the to go through. So whatever the best way for that to happen, I think is the way we should go. So I would ask Cindy, or maybe Mr. swane, to -- whether us having such a meeting is a help or a hindrance?
I think it depds on timing. And certainly -- I think it depds on timing. Certainly, the secretary could have such a meeting. If this is, in fact, a tree administration priority and they'll really wanted to see something passed in this area, all the stakeholders would certainly listen to the secretary. And the secretary could reiterate the administration's position and attempt to get some sort of consensus. I'm not sure that a meeting before our committee would necessarily move the ball forward. don't know that the parties would change their position any. We don't have the ability to influence legislation and can't really influence legislation directly. My view would be a meeting before us wouldn't be too fruitful, but, perhaps, if the secretary were interested and willing he could bring all the stakeholders together and they could negotiate and work out the issues that are currently slowing up the process. One other things I wanted to mention, I think what we can do to help move things forward in a constructive way would be to provide the secretary with all of the information outlined in the slides, and then he can make use of it in the most appropriate way. And my view also, is that we could go ahead with a letter right away. But I would advocate keeping the other elements of the report together until they're all -- all the elementtion are ready and moving it forward in one big piece. Because yings the legal analysis is a key I think the legal analysis is a key component. The current law is adequate and protects the consumer. If, in fact, that's not the case, I want that to be part of the secretary's report. I wouldn't rush the DVD and send that up and then send some other people piece and then the legal analysis. To me, that's not as effective as one big report that addresses all of the issues of contention and give that to the secretary and he can make use of it whether it's consay have aking the information to the committee chairman, the coalition for genetic fairness could make use of that information and provide it to the key sponsors of the house bill wherever its introduced and they can make use of it on the Hill. I think one big compelling pa cang would have greater impact then sending things up piecemeal. But that's no reason to with -- then piece meal. I think the letter could be the first piece.
Let me get this straight. We're trying to get to closure and I know our chairwoman is getting us there. Details. The DVD -- first of all, keep in mind we can approve the script today and you can do the DVD. That can get done in a couple weeks, quick. The telephone book can be out in a couple weeks. The legal analysis, Cindy, is a great . I'm being informed a great . That won't be ready and you got to be through clear ranlses and it may not be until May or June for that. So clear answer so as you make your recommendation I want to you that data. It may not be until May or June.
We would have one further comment from the audience and then we'll try to bring our recommendations to a vote.
Thank you. I'm Jennifer Lieb. I think it's wonderful in the last meeting and this meeting you spent so much time focusing on this very important issue and it was exciting to see it so quickly through the Senate earlier this month. I think it would be helpful, we have an administration that in the last Congress and this Congress, has been very supportive of this Legislature. Other then giving that statement of the administration policy there really hadn't been any other effort to help move this legislation along in the house. I think it would be great if you could recommend to the seek tear Levi-t-t to help through through the house. And we always turn to the agencies to he have brief us and educate us about the policies and they are the experts and it would be great if the secretary could look into having a briefing on the house side on the the issues on the discrimination showing the administration support bringing constituents from the chairman's district who has the experience on the gentlemen me ticks discrimination and I'm sure there ea they're out there. I think that would be really helpful move and a breefg slowing the DVD. I think those things need to happen quickly as well. I would encourage you to do that as soon as possible.
Thank you very much.
So, I think we have a few things on the table right now that we can take a look at. First, I think the easiest one is to get approval for the script for the DVD.
So moved.
Second.
All in favor?
I.
Any one aposed?
(No response).
So we have the approval for the DVD to toer Ward. The second is how we want to proceed with the report to the secretary. Do we want to send up very quickly -- move forward. Do we want to send the DVD along with public comments and testimony, and possibly, also the administrator statement policy that was received? Things we have in place we can can send to the secretary, along with a letter? Actually, the would be a separate recommendation.
In addition, we could include stakeholder information so we can include the summary. Really, the only thing missing from this is the legal analysis which needs all sorts of approvals and may hold up. While I understand the complete package may be better. I think the timeliness of the rest of this is extremely important. So it's out there and available to be used by whoever needs it. So I think a letter, plus all of the public comments, the DVD, and the stakeholder analysis that's been done should be sent.
I don't want to the stop the flow but I just want to make sure the staff tells us exactly on the stakeholder analysis, apparently, that can't go up. That takes a little bit of processing as well S that what you're say something.
Well, I think what we can certainly summarize the perspectives as we have through the power . presentation. And we want to be very careful that we portray the stakeholder interest and concerns accurately. We need to go back and forth but we can make it a very high priority and do our best to make sure we include some of that in the material that goes to the secretary.
I think the spirit of the recommendation, Sarah, and I want to make sure again, we're all tracking here^-- take the best that we can get. We have quite a lot of it done. And just give everybody one more chance, quickly. And then get that up. I think the clear mandate is forming that we want to get that done expeditiously. And if we don't, whatever level that is, that's what it is.
Emily? And then Ed?
So I think what we can do to try to address Cindy's comments because those are real legitimate comments, we can inform the secretary, send a letter, you know, our summary letter, you know -- dear secretary -- we still feel this way... and then say, you know, enuns yate to him that we have part completed and it's coming right now. You got which the this letter. The next part we have summaries of the sort of where things are with the various stakeholders. And the third part, the legal analysis, is uns way. It's coming. And you can expect it in around, let's say, the June time frame. And then let him make the decision about does he want to wait until he has all his pieces of ammunition before he goes to talk to the house leadership? Or does he want to act now? That would arm him with all the ammunition we have today and allow him to be responsive to whatever is happening between now and our June meeting, which will be the next opportunity to really aprove something to forward. And you know, I think it addresses Cindy's comments. He may feel that it is better to wait until he has all the pieces before he does something. That's his decision to make. We're here to advice him.
If I could make a friendly amendment to that that. Two things, one, we would encourage the -- the legal analysis is being done by ad hoc members to this committee. Those are the folks involved in this. We would, first, make it explicit that we will ask the colleagues who are involved in that analysis to please move it forward. Secondly, maybe what we can do is in the body the letter, Emily, put in to the secretary urging the secretary to ask those agencies to expedite the analysis since they are in his government so that -- he has a relationship with those people. We can ask him to do that as well.
From past experience with these letters I know that if we did the letter alone, that can probably be prepared within the next week or two. following this meeting. I would urge us to move that and, you know, I was the one who proposed we put what ever we had together. But also, knowing reed's schedule. I would guess the DVD is going to be a month or six weeks have to identify a production company and then, do it. How fast could these things torward?
We actually already identified the producer of the DVD and I think he's actually done a mock-up of a draft script. So I don't think, technically, it will take that long. The chairman is going to be the narrator and we can.
The chairman is terrified of the wrath of the committee. You can be sure I'm not going to hold it up.
As somebody who lives close to Hollywood, I would argue that there is power in the people speaking and just looking and remembers those quotes. Also thinking that if it's going to take a while for the analysis I would urge us to try to have this out within the next three to four weeks, perhaps, with the DVD, we could then send along as part of the final report. I think that, if anything, that's going to catch the attention of the secretary within the next month or two. It's going to be that DVD. I understand the importance of legislative analysis. I would also ask, I heard that there might need to be clearances from -- regarding the legislative analysis. I don't know if there's a possibility that that could come as a report of the committee rather then as a report from the various agencies because if it comes as a report from the committee, we don't need the clearances because if we screw up, then it's our problem. So I would urge us to look and see if there's a way to do it as a report of the committee and avoid the clearances by the various agencies.
All right. Well I think I'm a little concerned about the time now and I think we'll have to -- I think -- I think we have a very clear sense of the committee. And so, let us try to work this. The clear thing is, if I can can sum rice what I think you're telling us is: Get this letter and -- summarize what you're telling us: Get the letter, the compilation of the testimony and the DVD and the urging of expedition on the part of the legal analysis and we'll ask about whether or not it can be done through us versus -- I think it will be tough but we can look at that offline. Try to get all that in play right away. If there is some reason that it holds up any element -- any of those -- the DVD or any of that stuff -- if it's a technical thing we can't perceive that will hold it up we need to use good judgment and get the letter in place so we're moving and active. We'll inform the committee if there's any glitch. We'll work that through and get a sense of what the committee wants us do we'll update you by e-mail.
Ed?
If that's okay?
I just wanted to add to what you said. I think Cindy's . that we should also include in that letter a request or an urging that the secretary's -- secretary hold a meeting of the stakeholders. I think that will demonstrate to me, as a member of this committee, whether the administration is, in fact, supportive of this effort or whether we're just -- I think it will demonstrate whether they're supportive of this effort. Thank you.
I think that's --
As well as including the recommendation or suggestion that the secretary could have briefings for the house on the issue. I mean, I think we should make a specific recommendations for actions that the secretary could take with this information, within the letter as well.
Let me thank our two chairs, Agnes and Cindy, you've done a terrific job. I thank the committee. Thank you very much to those that provided input to our work.
Let us -- that was important. We got good work do done today.
Let's move now, directly to our colleague from the national health -- the office of the national health information technology coordinator department of health and human services. And there's a -- a space right there. Did you have slides or anything you needed set up?
Good.
On behalf the committee, thank cow very much. You weren't here earlier but we talked about how important this knish you're doing is and we're very eager to learn more about what you're doing so that as we go forward we can think about it generally, in terms of the work of this committee. Also, specifically, around activity that's moving on in terms of testify surgeon general and the NIH regarding the family history initiative. So, thank you so much for coming.
My pleasure, Mr. chairman and members of committee. I guess I should first ask how you would like to handle time manage ?ooment we're glad you're here and keep to the time we you. That's fine.
Okay.
Go right ahead.
What I'd like to do is y'all a sense of why ultimately, the president decided the time is now to forward with this initiative. Part of it, of course, is the wait of ten years of recommendations from various groups and committees and public occasions. But part of it is not just a matter of publications. Not just just a matter of changing or reducing medical errors, for example, but it's really a matter of transforming our healthcare system and how we organize, finance and think about healthcare. This is potentially, a truly -- if implement theed well and properly -- a transformative technology. We know the business of medicine is in key ways the business of information. And this process of bringing information to the points of decision and the way that produces high-value care, I think, is our biggest challenge. We know we do a great job of acute care. We know we do great at invasion. We also know that we have problems in the areas of huge costs. Efficiency and value in our system. We know that there are quality issues that need to be addresseded, both things that are done that should probably not be. And things that are undone that should be. we have a problem of care fragment frag men expectation and the particularly, in the care of chronic illness. Information technology is one way to integrate a system without integrating it from above. Costs, we know we're dealing with 1/6 of the economy of the United States. and we know, also, the technology -- and this is of particular relevance to this advisory committee -- is a key driver. that's of the cost increases. And what we've seen in in a sense, is tremendous advances, but also, tremendous increases in costs. This is a major challenge to genetic and genomic medicine or more accurately, gentlemen me knick and genomic medicine poses a major challenge to cost issues. Genomic. You have clearly grappled with key issues of ethics, privacy which we share with the information and health technology area, and ownership of information and intellectual property rights which is another issue that is we will see is a problem with the implementation of health it, and economic issues that are often, simply not directly addressed. I was very pleased to see the material for the report about reimbursement that goes head-on into the question of, not just cost, but also cost-effectiveness, or value. Because this is a conversation that we, as a society, need to have more of. we know healthcare market is not really a market. It is full of so-called "market imperfections" partially third-party payment that is divorce that incentive structure from the time of decision. And it's partially the absence or asimilar triof information that we have when we, as providers make decisions when we, as patients, try to decide on a course of action. We lack information about quality of care from different providers. Often we lack information about outcomes, particularly outcomes that are individually meaningful. And, most notably, we lack information about price. Of the service that is we get. I don't know how many of you have had occasion to go recently, for example, for laboratory tests and have looked at your health plan statement that comes back that has the -- here's what was charged. Here's what we reimburse^-- which is often the most recent one I saw was my own, was something like $230 which warranted a reimbursement of $23. I felt like I was back in the bizarre, IN 19 69 bargaining! It is a system that is so unlike much of the rest of our economy and, in part, it is an issue of information.
We have an am biff lense about technology assessment and how we put it to use. Who does it? What are the criteria that we use? And then, how does it consider individualality in the process of making recommendations? Most importantly, what's the end result of technology assessment? I think we learned in the 90s from managed care that for that to result in, no, as a flat-out answer, is difficult, probably, unacceptable. The question is: How can we implement this kind of increasing information about outcomes. About value. Into a reimbursement system that uses incentives rather then a simple "no." That encourages choices based on value. And I think, ultimately, from a series of six months of talking with a variety of groups about this, we, and the president, became convinced that health information technology is, indeed, a key, if not "the" key to patient-centered and provider friendly and information-rich system of healthcare that really empowered patients in a way they have not yet been to date. That frees us, as providers, to do what we do best, which is exercise judgment and come passion. Not search for information. compassion, not search for information. To gather information that flows both ways. Bring information to the points of decision but also, gathers information in a way that informs us about the kinds of sort of resource allocation that informs guidelines based on information coming from the real world of clinical practice. That give i us the kind of surveillance capacities that don't exist today as recent headlines have shown us. So the challenge is high to bring about this kind of interconnected system in a way that promotes value, promotes good care and protects privacy. so this is, in a sense, our challenge. Part of it is how to use it to bring about virtual integracious of the healthcare system, rather then top-down decision making. .
It is not a task without major challenges. And I think I'll ultimately close with some of the p potential pitfalls. Let me first try to outline the kind of daff i individual brailer, who was appointed last April, to be the national coordinate or has outlined in the framework for health information technology.
There are different structures that we need to think through. The first is how we build a kind of nationwide network for -- for health information sharing. that is, how we layer on top of an existing physical network, the capacity to exchange information in a secure way to authorize the individuals. so one of the questions -- and I was at a meeting last week where a lot of energy was put into sort of beating down the idea of a national database that would have health information, individual self information -- no one is talking about a centralized database. That just is not in the cards. Talking about a fed rated system where provider systems remain the repostories of information, but there are ways to access that information with the appropriate security and safeguards. It involves a kind of not peer to beer exchange of information, which is the way health information passes now -- peer to peer exchange of information, but a structure of trusted HIERARCHYs where there are, basically, organizations that handing the information interchange probably within geographic areas and then can exchange information with one another. But it's those entities that will build the structure that is assure that the person making the request is who they say they are. And they have the appropriate authorization to gather that information and that the information moves in an appropriate way. that is the second structure. The so-called regional health information organizations.
To date, they have, to some extent, been somewhat larger then local regions or state. I think there are many reasons why states are a natural geographic grouping for doing this. We know that state laws vary with regard to privacy and medical information. We also know that -- as we know, states are the laboratory of democracy. And I think we can see that in the implementation of health information technology. No one has the answers about implementation. States will have very different approaches as we're seeing in other areas of health policy. And I think that to some extent, we need to encourage that. What we don't need to encourage is the prolive ration of different standards for the exchange of information and that's one way that a major focus is emerging, both the 24 realms of standards for information that have already been developed, but more accurately, assuring that when these are actually implemented that the systems have ways of communicating with one another that is effective. And.
And the last challenge, of course, is actually adopting electronic health records in the local provider systems. We know larger hospitals and larger practice groups are much more likely to adopt. They are more likely to find, at least, the rudements of an economic case for adopting electronic health records to get efficiency us. We also know for many practices at the current time, implementing electronic health records is a losing economic proposition. This is part of the issue. How do we incentivize the adoption, particularly by physicians, because that may pose the greatest challenge, of the systems that ultimately, will change the way, I think we all practice medicine? Do you give people money to buy the systems? Well, none of us, I think in the administration side believe that's an effective way of encouraging. But incentivizing use and/or ultimately performance and outcomes is the way to this adoption process forward. And there are some things that you can reimburse for gathering information that is for use. And there are other kinds of performance measures that really can only be achieved mishtly if you have a system of reminders. Of electronic health information and of decision support. So, I think those are the challenges. How to build a set of incentives clab ratly with the vat sector with health plans and the government, at pay for healthcare working together.
We need to reduce risks through processes of certification of record systems. We know that one of the real pitfalls -- and I'll touch briefly on that -- is that many implementations have failed to date. Kaizer, for example S. on their third implementation of electronic healthcare record system. This is a problem. One of the key efforts has to be to develop a way certifying the systems do what they are supposed to do. And what they say they do. So, part of that will be a certification process that's formal. Part of it, I hope, will also be the emerge ens of private sector consumer reports type of information that not just assesses the formal characteristics of the system but looks at the actual use of the system that gathers information and then Weiss choices of electronic health records by physicians, by hospitals and, particularly, by smaller groups that can't hire a major consultant. It's just not feasible. So, there have been a number of strategies to provide this kind of digs support in the purchase of an electronic health record system, oh both through the QIO's in medicare, which now will have a statement of work that's aimed at provides sportth to physician practices in of electronic health records. And similarly, the regional health information organizations will have a role in facilitating adoption in a way that works.
What are the challenges and pitfalls? Number one, the one that has to be at the top of the list, is privacy and security. I think there is no question that these issues of identity, that is, how do you know this information belongs to this person and not this person? How do you establish that fundmental issue of identity? How do you establish authentification? How do you know the person making the request is who 24E say they are? And then, how do you establish authorization? This person is authorized by the patient to access these data? How do you establish an override system when a person is unconscious arrives in the emergency room? So these are all key issues.
What are the characteristics of trust relationships that you have to develop? This is, you know, in the peer to peer level, it's "do I trust you to have assured me that the person making the request is actually on your staff and authorized to make that request"? Particularly, how you manage it in the context of differing state laws that have very different requirements for the kind of assure rainses that to be provided?
And finally, the information in privacy that opting in or opting out. And this is an issue for the individual. individuals who just simply do not trust information systems, what do we do about that? Do we allow total opt out? Yes. What do we do about the partial opting out though? What do we do about protection of classes of information that are widely regarded as pre-- particularly sensitive? More so, for example, I have to problem talking about my triple bypass in a public setting. Would I feel so free about talking about my psychiatric history? Or a of direct relevance to this committee, what about genetic or genomic information? How is that dealt with? And do we allow partial opt out? So that most of the information can flow, if I end up in an emergency room, but not all of it? If you do that, how do you alert the person caring for you that I've excluded certain information? So that the doctor doesn't rely on this being a complete story of my medical situation and leaves out the fact that I'm on a MAO inhibit and therefore, causes my death through a drug interaction? I think these are curable questions. Do we flag that? Do we have a way of this by saying "this is the person's record and certain information in terms of medication has been left off? " I think it's crucial to the question of this being a system that we can trust, both we trust what's in it and we have some awareness of what's not in it. .
How about the ownership of information? Who owns our medical information? you know? I think many of us believe ultimately the answer to that has to be "I own my medical information. " but we also know entities are both protective, appropriately, of our information, but also, have a certain intellectual property interest. In holding our information. There's a reason that many of the health information systems to date allow you to view your laboratory results on-line on the web. But don't allow you to import it into your own system. It is away of building, if you will, a kind of competitive advantage, to provide information and support, but it's our information and sportth and it's a way of building loilt and commitment to this healthcare system and what it does economically is it makes it harder to move. It makes switching costs higher. It makes portability more difficult. These are all very real challenges. They result in a kind of very muddied economic picture about why this doesn't -- why has this just not moved forward on its own? It makes so much sense in terms of improving quality and reducing costs. What is the economic analysis here?
There's a very real risk that the natural end . points are silence. That is, system that is don't communicate very well with one another because there's an economic case for that, particularly larger silence. There's less economic case for sharing information. it's hard to see what business case for that is. So we have to, as a responsible -- find a way of counteracting that. Building a kind of economic case.
There's a risk of brain-dead decision support. That is either e that there's poor input into decision algorithms, namely, they come from highly controlled clinical trials but not from the real world. This will problems of how you put guidelines into a form that can actually operate in an electronic health system. How they are actually implements. Stwl's a problem if we don't have a system of bringing guidelines to providers in a way that's both individualized in relation to that patient, but also, allows for exceptions because I can't imagine something that would be more likely to evoak a rebellion then a system of guidelines that has a kind of mandatory, rather then advisory, nature to it. .
We have a danger of wasteful parallel systems. -- for health information. We have a parallel system developing in HOMELAND SECURITY, for example. For surveillance. We have parallel systems in the CDC for surveillance for avariety of things, both infectious and drug related. We have FDA surveillance systems that all of these are sort of partial, expenses in relation to the kind of information they gather. But they're what's out there. How do we assure that ultimately, we end up with a system that accomplishes all of these aims, and in addition, facilitates research, both health services research and clinical research without producing multiple different systems that drive providers and prepares and everyone else slightly crazy?
We have a risk of a system that can't generate the kind of deidentified large-scale data that will us real information about comparative effectiveness and cost effectiveness. That they can't track outcomes. That can't identify the events and can't routinely provide surveillance. So, I think all of these are pitfalls but they are pitfalls that with ecan anticipate and avoid. So I think our greatest challenges are going to be privacy and the kind of discussion that needs to go on about that. The cultural challenge of introducing value and cost effectiveness into our healthcare system through, in part, through health information technology. And ultimately, the question of fairness access and cost. I think, you know --
Let's stop there
That's terrific. Let me ask you quickly on this. How do you see, then, given the kinds of issues that you've raised? How we might be able to help inform the process and, certainly, again around this idea of the gentlemen me 2EUBGs. I think you're sort of laying out two things I see that are critical. On the one hand, you're saying in the health delivery system of the future, which is soon, not way out in the future. It's going to be a system that's categorized by a lot more patient centered information with lots of access to decisionable actionable information to give you a total comprehensive care opportunity. So that's happening. Meanwhile, you're saying that the real issues are around privacy, confidentiality of sensitive information which is what this committee has to worry about. So, we have one hand, folks with chonic disease, that are genetic based that need coordinated comprehensive care. On the other hand, you got folks with diseases for which there may be some sensitivity. I guess the question ultimately for us is, how do we help get into the process to inform that conversation?
Umm -- I think part of it is through exactly the sort of broader issue. You've already discussed sort of genetic privacy issues much more broadly for which the health information technology is sort of a specialized case. But I think it's useful to have a sort of range of discussions in multiple different settings about the questions of boat of value and, also, these conflicting rights about information. First of all, there's the question of what goes in the medical record and how it it flow about the individual? Secondly, there's the question of support for processes of deidentification. That really provide a way of gathering information, including family hitsry and genetic information and outcomes in a way that's divorce identity from that process. So it's helpful, technically, to discuss that.
Does your -- you report -- your office reports to the secretary?
Yes, sir.
Okay. So there's a possibility there that -- okay, that's what I wanted to
Absolutely.
Who's hand over here? Quick?
Thank you for your presentation. I guess family history is probably one of those low-hanging fruits that this committee can work with you and the various agencies that presented here given the interest of the surgeon general and the various public health initiatives and integrating family history into risk assessment. And I think this is the time is right for that. It's complexes because, you know, of the issues that you raise. But you know, when you have estimates that 50% of the population have a family history of one or more common chronic diseases for which you can take action to prevent either disease or to manage people more, so we're not talking about genetic diseases only. But the fact that the people have a first degree relative with diabetes, heart disease or various forms of cancers, I think the various initiatives that the department and of us, including CDC, NIH, and the various players will have to work together to find a way to integrate the family history information into the records and how that can be actionable. Right now, family history is of the medical record. But it's collected poorly. Nobody looks at it. It's not actionable and it takes time to collect and the providers don't have time to collect it. The patients don't realize the -- I mean, from the survey we did at CDC last year, only 1/3 people collect information that can be used in that regard. I would encourage this committee to take that on and work with you and your office and all of us in the Federal agencies to, at least, begin to integrate family history in into the health information infrastructure.
It's a real challenge, isn't it? Trying to figure out what a standardizeded electronic health record should look like. There were major fights about this, quite frankly. Different agencies had very different perspectives about. And the providers on the the front line will have a very different perspective then researchers or agencies with a surveillance responsebility. Family history is an scpel lent idea. The operation, the actionable component of it, how do you record it in a way that allows you to operate on that? Well, doctors will take four times as long to deal with a system where each thing has be coded in in relation so to a particular person, and when they're paid for a 10-minute visit or a 20-minute evaluation, that's probably not feasible. We probably can't provide in a way that's provider didendly, the kind of information that CDC might want, for example, or that FDA might want in its report. This is going to be the kind of balancing. But ultimately, I think the first -- the north star initially has to be the provider. Because the providers don't adopt the system, it's not going to happen.
Let me just -- thank you, let me get one last question from Joe. And then I'll try an action step to see if we can take good advantage of 24 presentation. Joe?
My if is basic in terms of a starting . I was wondering, maybe at the macrolevel in your investigation, that, you have -- have you seen a potential area where precedents exists? In other words, at the macrolevel, where some small group has taken on this issue and has worked it effectually. Or is it even at that level that you can't generalize it to this group? My question is, where can we start? If we have a committee that needs to look at this and work with you, are there case examples that where it's been successful?
There are examples of --
Where information exchange where a lot of the challenges you presented, for example, have been dealt with. Have been approached and done effectively. At the macrolevel that can be generalized to the large level?
Most of the states have sort of developed as sort of regional organizations, for example, in Indiana. That is based on many of the institutions and is bringing in community providers. There are five states that were recently approved which I don't have at the top of my head and should, and funded to provide the initial regional health informational organizations and I think it would actually be tremendously helpful to have this kind of input into those discussions at the state levels as well. So some extent, our initial prototypes are going to arise out of the regional health information organizations on the one hand. They'll also arise out of what the vendors build into their software. I can see there are several different fronts on which discussions would be extremely helpful. And we can certainly provide information about implementations and various areas. Santa Barbara has had one. Boston is launching one. Agnes, broadly, is launching one. Utah, the secretary comes from, he's Utah, he's was very active and extremelyive of information technology and information interchange in a stay model. There are a number of, sort of, examples that are either moderately well I'm letted or just underway. In a sense it's being if all those that know that the ones getting underway that might be the most use ?oofl thank cow very much. Let me do go things by way of follow-up. Part of the committee's great have been attended do by asking you to -- being having a relationship with you and by meeting you. I hope that you will take back to your office the interest of this committee, particularly, on the specific . that.
That we describe. Which is, how can we get the -- what are the best way to start thinking about integrating the genetic-based information for family history into the electronic medical record and trying to get that as a part of the national standard. So, if you would, we would appreciate if you would bring that back to your agency and say there are a bunch of very thoughtful people who are charged with advicing the secretary of health on genetic's health and society, who are making this a pretty big priority and really want to reach out. That will accomplish something today. Number two, for the ongoing, I think we'll probably be sending you a letter or something, I think, some kind of way, to try to get at this a little bit greater specificity. Particularly, you can expect us to ask about how we can work with or who we should know about in terms of the various committees you describe. Whether it's a certification economien the on health information technology trying to get the standards for physicians. Interopenbility standards and the various things you outlined. Which one of those places are the place we need to drill a little deeper to try to get at this. And fine lish, what things should we worry about in terms of the confidentiality things. Maureen, if I could ask you since you were sharp enough to raise it. To try to help draft what we might send, in combination with either Frances or Allen there? Given you guys have the lied on that family history project? And so, we'll sort of, sair are, try to figure out how we do that with Maureen and Frances and/or Allen and get something to you? So you'll know who they are. Maureen is CDC and you know Frances and Allen are NIH. These are your -- you can move th along. So, can you expect, okay?
Absolutely.
Thank you very much for your time, very excellent report. We're glad to meet you.
Thank you. Good to see you again.
Can I get rod, can you come on -- by the way, for you guys, you need to look at on tab 3, and something we have to come back to at the end of the day. The second letter in tab 3,-- the second letter in tab 3, is a draft of this activity and so, we'll be flushing that out a little better based on what we heard today B aware of that.
Rodney howl is a known to all of that. He is the chair of the advisory committee on inheritable disorders and genetic diseases in newborn and children. They face many of the same challenges we are regarding access, education, and appropriate standards for validation of genetic tests. In recognition -- great, I won't kill any more time N recognition of the liaison reelingship and our common interests as a liaison we have between the two committees and as I mentioned, Dr. Joe Telfair, is advisory committee is the reviewing recommendations for the -- an the overlap of the committee, Chris Hook suggested this occur. Chris is on the line S that right? Do I have do anything?
Hey, Chris, are you there?
Yes, sir. I've been listening in the last few minutes.
Okay.
And I don't want to interfere with anything. Thank you for letting me call in. I appreciate it very much.
You are beaming out of the ceiling. You have a Celeste alpresence at this meeting. Extraordinarily impressive. Thanks a lot.
With that, I'm pleased to welcome Dr. Rodney howl, to speak about his work. You know dork Dr. Howl as professor of pediatrics from the University of Miami school of medicine and long history surrouding genetics and child health. Thank you.
Thank cow very much.
I'm dlietd to be with the distinguished group this morning to discuss the work of the -- dwished to be with genetic diseases in newborns and children. And one of the things I would welcome is anyone that can think of a worthwhile acronym for this committee. We have not, so far, been successful.
I'm going to spend a mercifully brief time with you. But I'd like to discuss three areas, I'd like to discuss a little bit about the environment in which this committee was formed and ten environment surrounding it. Et cetera. Ill talk a fair amount about newborn screening and so forth and also, talk about the charge to this committee and some of the work the committee has undertaken.
The central focus to this committee -- and I'll talk about the charge in some detail -- has to do with newborn screening. And the environment in which this committee begins its work in this area of newborn genetic testing is that there's an enormously rapidly changing technology, literally, by the week, with multi-test testing flat forms that have move the whole pair game from the classic gutry newborn screening test with one blood spot with one test. To a new paradigm where you have one blood spot and you do many, many tests simultaneously on that same spot. the problem that's been around for a long time is that there are large numbers of extremely rare conditions and few providers with greet expertise in this area. And there's new technology on the horizon that will clearly be better then this.
In addition to that, there were specific lienal slags for a rare disorders program that established the advisory committee on this, and also, established the grant program for reasonable collaboratives. At the same time, HERSA had a contract that has been underway for some time at this ., about three years with the American college of medical genetics to develop with a large expert and diverse group, a -- under a contract -- a panel of information that would provide for a uniform panel in newborn screening. There were other parts to that contract, but that was the core part of the contract was to think of the mechanisms by which you would decide what to screen for and to recommend those longterm. .
Legislation that establishes this committee was actually a congressionally mandated committee in the healthcare act of 2000. The it established the committee as well as a couple other areas which I'll comment because they's relevant to this. Section 1109, directed HH sa. to provide screens, cangs link and healthcare services that would be of benefits to newborn and children at risk for these disorders. It also authorized the secretary to award grants for demonstration programs that we hope will be very valuable to evaluate the effectiveness of screens, counseling and healthcare services morbidity and mortality, caused by disorders of if newborn and children.
Section 111 of that act established the secretary's advisory committee I'm reporting to you about this morning. And the purpose of this committee are varied exsentence -- very extensive ily spelled out in the legislation and the prime purpose is to provide the secretary with advice and recommendations concerning grants and projects authorized under these previous sections that I mentioned. And also, to provide technical information to develop policies and priorities that will help the states and local health agencies provide for newborn and child screening health services for newborn and children at risk for these disorders.
Specifically, and it goes down into even greater detail, to provide guidance to the secretary regarding the most appropriate application of universal newborn screening tests. You'll see why the A this. MG report was highly relevant to that particular requirement -- technologies, policies, guidelines and programs that will effect tiff i will reduce morbidity and mortality in newborns and children at risk for these disorders.
The add rice advisory committee Constitution was further spelled out and said the members should have medical, technical and scientific expertise in these disorders in providing scrines, counseling, testing or specialty services for newborns and children at risk for these disorders. Members of the public with special expertise about or with concern about these conditions and representatives from such Federal agencies, public health constituencies and medical professional societies as deemed necessary necessary to fulfill the duties by the secretary.
I'll go through briefly the members of this committee to simply . out points out what they do so you'll be aware of that. And this is an alphabet Cal list. Bill Becker is the .
(Captioner switch. Please stand by)
BUT THE POINT IS THAT EXPANDED NEWBORN SCREENING IS MOVING ACROSS THE COUNTRY EXTREMELY RAPIDLY. AND AS WE STAND HERE TODAY, 36 STATES CURRENTLY HAVE PROGRAMS IN LINE. AND I SIMPLY SHOW THIS VERY COMPLICATED MAP. DON'T PAY MUCH ATTENTION TO IT BUT I WANTED SIMPLY TO POINT OUT THAT ALL THOSE LITTLE STARS INDICATE THE LOCATION OF MAPSPAK LABS AND CERTAIN STATES SEND THEIRS TO OTHER STATES. MISSISSIPPI HAS A CONTRACT FOR A PRIVATE LAB, MISSISSIPPI I MIGHT POINT OUT HAS THE LARGEST NUMBER OF MANDATED SCREENING TESTS IN THE JURISDICTION TODAY IF YOU LOOK AT IT IN 2004 AND YOU LOOK AT IT JANUARY, IT'S CHANGED A LOT AND I MIGHT POINT OUT IT'S CHANGED EVEN SINCE THEN BECAUSE MY HOME STATE OF FLORIDA THAT IS STILL THERE IN GREEN MEANS THAT WE ARE NOT SCREENING FOR MANY THINGS HAS NOW CHANGED TO PURPLE AND IT AS OF FEBRUARY 1 IS AGAIN SCREENING FOR ACTUALLY THE ACMG RECOMMENDED LIST. THIS GIVES YOU A LITTLE MORE FEEDBACK INTO THE DIVERSITY FROM STATE TO STATE, AND I MIGHT POINT OUT THAT THERE'S ONE STATE, ONE OF THOSE SQUARE STATES UP IN THE MIDDLE OF THE COUNTRY THAT CURRENTLY AS WE ARE HERE TODAY SCREEN NEWBORN I KNOW FANS FOR THREE DISORDERS. AND THEN YOU CAN SEE THE OTHER DISORDERS THAT SCREEN FOR MORE THAN EIGHT AND USUALLY THAT'S THE SO-CALLED 30 THAT -- BUT -- AND AGAIN, THERE IS ONE CONDITION THAT THE EXPERT PANEL WORKING WITH ACMG AND MOST EXPERTS IN METABOLIC DISEASE FEEL SHOULD BE SCREENED FOR IN THE NEWBORN PERIOD IS PROBABLY THE LEAST CONTROVERSIAL AND THAT'S M CAD, A DISORDER OF FATTY ACID METABOLISM THAT CAN BE EASILY TREATED AND IF UNTREATED AN AMERICAN CERTAIN PERCENTAGE OF THE BABIES DIE. SO THERE'S A FEELING THAT THAT SHOULD BE CLEANED FOR. IT CAN ONLY BE -- IT SHOULD BE SCREENED FOR, AND THAT'S THE REASON I SIMPLY SHOW YOU THE STATES THAT OF EITHER MANDATED KREENGS FOR M CAD, SOME STATES HAVE IT MANDATED. FLORIDA IS NOW DOING IT, THAT HALLS NOT YET BEEN IMPLEMENTED BECAUSE THEY'RE WORKING ON IT AND CALIFORNIA HAS FOUND THE MONEY. THEY STARTED AND STOPPED AND NOW THEY'VE RETURN TO MASPECKTROSCOPY. THIS IS A DEMONSTRATION OF WHAT PEOPLE ARE SCREENING FOR. THEY SCREEN FOR PKU HYPE HE WERE THYROIDSCOPY. TWO AREAS ARE EHIME NO GLOBULIN OPT THINKS. AND THEN IT DRIFTS OFF THAT SUCH A FEW PLACES SCREEN FOR THIS. AND YOU CAN SEE THAT M CAD DEFICIENCY ON THE RIGHT. I WILL NOT GO INTO THIS. THIS IS VERY RECENT CHANGES IN SCREENING PROGRAM AND I WANT TO, I WANT TO EMPHASIZE THE FACT THAT THESE PROGRAMS ARE MOVING RAPIDLY. THE COMMITTEE HAS HELD THREE MEETINGS WHICH HAVE FOCUSED ON NEWBORN SCREENING AND RELATED TECHNOLOGY. THE NEXT MEETING IS SCHEDULED IN APRIL AT THE DATES YOU SEE HERE, AT THE RONALD REAGAN BUILDING, AND WE CERTAINLY WELCOME IN APPEARING FROM THAT TO DISCUSS ANYTHING OF INTEREST IN THAT MEETING. WHAT HAS THE COMMITTEE DONE? THEY'VE FOCUSED ON NEWBORN SCREENING AND HAS SEEN MAJOR PRESENTATIONS OF DRAFTS OF THE REPORT, THE AMERICAN COLLEGE OF MEDICAL GENETICS. AND THE COMMITTEE HAS BEEN VERY POSITIVE ABOUT THE PREM MISSES THAT ARE SET OUT THERE AND FELT THAT BECAUSE OF THE IMPORTANCE OF THIS THAT THE COMMITTEE WOULD LIKE TO SEND A NOTE TO THE SECRETARY AS SOON AS THE FULL REPORT IS AVAILABLE SAYING THAT PREMISES IN THERE HAVE BEEN SUPPORTED BY THE COMMITTEE, HOWEVER, THE COMMITTEE AND ITS LETTER CONVEYING THAT TO THE SECRETARY, -- AND I MIGHT POINT OUT IT HAS NOT YET GONE -- ALSO POINTED OUT THE COMMITTEE HE HAS NOT HAD A CHANCE TO REVIEW THE FINAL DOCUMENT AND WILL COMMENT ON THE FINAL DOCUMENT AS IT'S RECEIVED AND GONE FORTH. LET ME COMMENT ABOUT THIS REPORT BECAUSE THIS REPORT HAS CREATED MORE INTERESTS SHALL I SAY, I'LL USE THAT TERMINALLY LIGHTLY THAN MOST ANYTHING YOU MIGHT IMAGINE. THE REPORT IS A REPORT THAT WAS DONE UNDER CONTRACT WITH HERSA AND THAT QUITE PROPERLY YOU DON'T RELEASE DRAFT REPORTS. IN OTHER WORDS, THE DRAFT IS STILL IN WORKING AND ONCE THE REPORT IS DONE, AND IS TO HERSA THEN HERSA WILL POST THAT, THE REPORT HAS BEEN ACCEPTED, I'VE BEEN TOLD AND IT IS ANTICIPATED THAT THE ENTIRE REPORT WILL BE ON THE HERSA WEBSITE BY THE MIDDLE OF THIS WEEK. LET'S GIVE IT A FEW DAYS BUT THE BOTTOM LINE, THE REPORT HAS BEEN ACCEPTED, AND IT WILL BE UP THERE. I MIGHT POINT OUT FOLKS HAVE ALSO COMMENTED, FOLKS HAVE GOTTEN SMALL PARTS OF THE REPORT HAVE COMMENTED ABOUT THINGS THAT WERE NOT IN THE REPORT, THE DRAFT REPORT THAT WAS SEEN EARLIER BY THE COMMITTEE WAS 60 PAGES LONG. THE REPORT THAT GOES UP ON THE WEBSITE THIS WEEK IS 380 PAGES TO GIVE YOU SOME IDEA OF THE SCOPE OF IT. IT'S AN EXTENSIVE REPORT THAT IS INVOLVED THAT HAS INVOLVED GREAT NUMBER OF PEOPLE OVER THE YEARS. BUT THAT'S BEEN A MAJOR FOCUS, AND THAT WILL CLEARLY TO BE A FOCUS AS WE REVIEW THE FINAL REPORT OF THIS COMMITTEE. AS THE COMMITTEE HAS LOOKED AT THINGS THAT ARE DERIVED FROM THIS REPORT AND THAT IS WHAT YOU DO WITH THESE THINGS AND HOW DO YOU IMPLEMENT THEM AND SO FORTH, ET CETERA, THE GROUP DECIDED THAT THEY WOULD LIKE TO FORM THREE SUBCOMMITTEES. AND I'VED THOSE SUBCOMMITTEES HERE. THERE'S ONE THAT'S BEEN FORMED ON EDUCATION AND TRAINING, ONE ON FOLLOW UP AND TREATMENT, AND ONE ON LABORATORY STANDARDS AND PROCEDURES. NOW THESE COMMITTEES WERE FORMED AT THE LAST MEETING OF THE GROUP AND THEY ARE CURRENTLY HAVING E-MAIL EXCHANGES AND MEETINGS BY TELEPHONE TO LAY OUT WHAT THEIR AGENDA WILL BE AND WHAT EXACTLY THEY'RE GOING TO APPROACH, AND THEY WILL BE REPORTING ON THEIR SUBCOMMITTEES AT THE NEXT TIME. IT IS ANTICIPATED THAT THESE SUBCOMMITTEES AS YOU WILL SEE HERE WILL IDENTIFY EXPERTS ALL AROUND, PEOPLE WHO ARE CERTAINLY NOT MEMBERS OF THE COMMITTEE BUT ANYBODY IN THE COUNTRY WHO HAS EXPERTISE IN THESE AREAS ARE LIKELY TO BE ASKED TO EITHER BE A CONSULTANT AND RAPS IN TIME THEY CAN BECOME A FORMAL MEMBER OF THE SUBCOMMITTEES TO WORK ON THESE. BUT THESE ARE FOR EVERYBODY IN IN THIS ROOM AND TURKLY AROUND THE TABLE UNDERSTAND THE EXTRAORDINARY THINGS THAT NEED TO BE DONE IN THOSE AREAS. BUT ANYWAY, WE EXPECT THAT WE WILL HEAR ABOUT THAT SUBCOMMITTEE. THE REPORT ALLUDED WILL BE PUT UP ON AN INDIVIDUAL WEBSITE, AND IT'LL BE AT MC HB HERSA GOFF SLASH SCREENING AND FOR THOSE OF YOU WHO LIKE TO SPEND QUITE A LOT OF TIME, I WOULD SUGGEST IF YOU DECIDE TO PUSH PRINT THAT YOU FILL UP YOUR PRINTER BEFORE YOU DO THAT BECAUSE OF THE LENGTH OF THE DOCUMENT. I'VE HAD TO -- YOU'VE ALL THAT THING YOU DECIDE YOU'LL PRINT SOMETHING QUICKLY AND YOU COME BACK AND THE PRINTER IS OUT OF TIME. THIS IS THE THING TO DO. BUT THIS IS THE-ADVISORY COMMITTEE, THAT IS THE WEBSITE FOR THE COMMITTEE AND AT THAT CURRENT WEBSITE, ALL OF THE MINUTES OF THE PREVIOUS MEETINGS ARE THERE ALONG WITH THE PRESENTERS AND I MIGHT POINT OUT THERE'S BEEN A VERY GRATIFYING IN PUT FROM THE PUBLIC. THERE'S ALWAYS AN AREA OF PUBLIC COMMENTS AND THAT RECOMMENDS PARENTS AND INDUSTRY AND VARIETY OF ORGANIZATIONS THAT HAVE HAD A LOT OF COMMENTS AND WE WOULD LOOK FORWARD TO THAT AND DR. MICHELLE PIER AIR AT HERSA IS SECRETARY OF THE COMMITTEE AND SO WITH THOSE BRIEF REMARKS I WILL END.
THANK YOU VERY MUCH. WHY DON'T YOU STAY THERE FOR A COUPLE OF QUESTIONS. I'M SURE WE'LL HAVE A FEW. EMILY.
OBVIOUSLY NEWBORN SCREENING IDENTIFIES INDIVIDUALS WHO HAVE GENETIC DISEASE. SO HAVE YOU DEALT WITH THE ISSUE OF HOW THOSE INDIVIDUALS GO ON IN THEIR LIFETIMES TO EXPERIENCE OR NOT EXPERIENCE DISCRIMINATION?
THE -- INTERESTING ENOUGH, I DON'T THINK THAT THERE'S BEEN ANY WILL FORMAL LOOK AT THAT. INTERESTINGLY ENOUGH, SOME OF US HAVE BEEN INVOLVED IN NEWBORN SCREENING BEFORE MOST OF THE DISTINGUISHED GROUP AT THIS TABLE WAS BORN AND SOME OF THE, FOR EXAMPLE, WHEN WE HAD, WHEN THE MIH HAD A CONSENSUS CONFERENCE ON THE DIAGNOSIS AND TREATMENT OF UREA, ONE OF THE PANEL MEMBERS WAS A COLLEGE MEMBERS HAD IT. WE SEE NOW ADULTS WHO HAVE THESE CONDITIONS AND WE HAVE A LOT OF CONVERSATIONS, BUT I'M NOT AWARE OF ANY FORMAL EFFORT TO LOOK AT THE BIGGEST CADRE WOULD BE PATIENTS WITH THING CAN I UREA AND HYPER THID ROADWAY ITCH BACK IN THE GENERAL COMMUNITY.
ANY OTHER QUESTIONS WITH CHRIS ON THE PHONE. I'VE GOT FRANCIS AND WILLY AND CHRIS, IF YOU WANT TO GET IN, JUST LET US KNOW.
SO, I APPRECIATE YOUR REPORT. IT SOUNDS LIKE THIS IS COMING ON QUITE NICELY. WITH REGARD TO THE TANDEM ASPECT, WHAT'S THE CURRENT INFORMATION THAT'S BEEN DERIVED FROM THE STATES THAT HAVE BEEN DOING THIS ABOUT THE CONCERN ABOUT CREATING GREAT ANXIETY AMONG PARENTS WHEN YOU FIND SOMETHING AND YOU'RE NOT QUITE SURE WHAT IT MEANS BECAUSE THAT'S BEEN ONE OF THE MAJOR ISSUES ABOUT INTRODUCING THIS INTO NEWBORN SCREENING WITH THE CAVEAT OF DO NO HARM ARE WE CREATING IN SOME CIRCUMSTANCES UNNECESSARY ANXIETY AMONG PARENTS BY A FINDING OF UNCERTAIN SIGNIFICANCE, AND IS THAT A REAL CONCERN OR ARE PEOPLE HANDLING THAT PRETTY WELL? WHAT'S THE PRELIMINARY DATA ON THE CONSEQUENCES OF GREATLY ENLARGING THE NUMBER OF CONDITIONS THAT CAN BE SCREENED FOR INCLUDING MANY FOR WHICH NOTHING REALLY IS KNOWN AND NO INTERADVANTAGES -- NO INTERVENTION IS AVAILABLE?
I THINK THAT HAS BEEN DISCUSSED EXTENSIVELY OVER THE PAST COUPLE OF YEARS, FRANCIS, WHILE THIS WHOLEST WAS UNDERWAY. ONE OF THE RECOMMENDATIONS THAT WILL APPEAR IN THIS REPORT IS THE SYSTEMATICALLY LOOK AT THAT BECAUSE THERE HAS NOT BEEN ANY SYSTEMATIC LOOK, I'M TALKING ABOUT OTHER THAN PEOPLE TALKING AT A COCKTAIL PARTY OR ET CETERA. BUT I THINK THAT THERE ARE A FEW THINGS THAT ARE CLEARLY IMPORTANT. THERE ARE CONDITIONS THAT YOU PICK OUT ON -- WITH THE TANDEM ASPECTSCOPY THAT WE KNOW LITTLE ABOUT AND ONE IS K CAD DEFICIENCY, A SHORT CHAIN FATTY ACID DEFEBRUARY,, YOU PICK THAT UP, HOWEVER, IT IS CLEARLY KNOWN THAT FAMILIES WHO HAVE THIS CONDITION AND ONE OF THE PEOPLE AT THIS MEETING HAPPENS TO ORGANIZE A FAMILIES OF K CAD DEFICIENCY, THOSE PEOPLE DO HAVE PROBLEMS WHEN THEY DO HAVE PROBLEMS WHEN THEY FAST WITH HYPERDOUGH CYST AND SO FORTH. IT HAS BEEN FELT BY MOST THAT CERTAINLY WHEN YOU PICK UP SOMETHING YOU DON'T KNOW A LOT ABOUT, YOU CERTAINLY SHOULD TELL THE HEALTH PROFESSIONALS AT LEAST THAT YOU HAVE AN ABNORMALITY. BUT ON THE OTHER HAND, I THINK A MAJOR RESEARCH AGENDA IS GOING TO BE TO FOLLOW ALL THESE PEOPLE AND SEE WHAT THE CONDITION IS REALLY LIKE, AND THAT'S A KEY PART TO FIND OUT WHAT THEY REALLY ARE LIKE. NOW, YOU KNOW, ONE OF THE -- LET ME COMMENTS ON B ONE THING BECAUSE THIS IS FOLKS HAVE THIS REPORT HAS BEEN WONDERFULLY INTERESTING TO A LOT OF PEOPLE. BUT ONE OF THE THINGS THAT HAS TO DO WITH WHAT HAS BEEN CALLED SECONDARY CONDITIONS AND THAT WHEN YOU'RE LOOKING WITH TANDEM MASS OR ANYTHING ELSE FOR A PRIMARY CONDITION THAT NO ONE ARGUES ABOUT, YOU PICK UP A VARIETY OF CONDITIONS RELATED TO ELEVATED FILLALMEAN THAT ARE NOT PKUU, THOSE ARE SECONDARY CONDITIONS, YOU ARE NOT RUNNING A TEST FOR SECONDARY BUT IF YOU SEND ME BACK A FILLALMEAN THAT'S 18 PERCENT AS THE PERSON DOING THE DIAGNOSTIC FOLLOW UP, I MUST STUDY THE SECONDARY CONDITIONS, BECAUSE THE SECONDARY CONDITIONS INCLUDE HYPER FALAL MEANIA, AND BYOPTRA, BYOPTRIN RECYCLING, ET CETERA AND IF YOU HAVE A CHILD THAT'S GOT A BYOPREASON TO DEFICIENCY, YOU ADD BYOPTRIN SO THE SECONDARY CONDITIONS TIE INTO THE PRIMARY CONDITIONS TIGHTLY AND SO FORTH. AND THEN THERE ARE OTHER CONDITIONS THAT YOU KNOW VERY LITTLE ABOUT AND THOSE FOLLOW INTO THE CATEGORY OF RESEARCH THINGS THAT NEED TO BE LOOKED AT BUT THEY'RE GOING TO BE THERE.
LET'S QUICKLY GET WILLY AND THEN ED.
I'M FROM THE DEPARTMENT OF COMMERCE BUT THE NIC T SPECIFICALLY SO I HAVE TO ASK YOU YOU THIS QUESTION. CERTAINLY TANDEM, POWERFUL TECHNIQUE, LOTS OF DATA, BUT THERE ARE DIFFERENT PLATFORMS, THERE ARE DIFFERENT PRACTICES OF THE ART. SO HAVE THERE BEEN ANY STUDIES ON THE ACCURACY OR LET'S SAY KPAIRNLT OF RESULTS THAT YOU COMPARABILITY OF RESULTS THAT YOU GET ACROSS ALL THESE TESTS THAT ARE BEING PERFORMED EITHER QUALITATIVELY OR QUANTITATIVELY.
BUT NOT THE EXTENT, THERE'S A QUALITY ASSURANCE PROGRAM THAT IS CURRENTLY DONE BY NUMBER ONE, THE CDC DOES QUALITY ASSURANCE PROGRAMS AS YOU KNOW ON NEWBORN SCREENING IN GENERAL BUT THERE'S ADDITIONAL ONES DONE BY THE COLLEGE OF AMERICAN PATHOLOGISTS AND ACMG THAT LOOK AT SOME OF THE RARE METABOLIC DISORDERS. IN THE REASONABLE COOPERATIVE GROUPS THAT WE TALK ABOUT THAT HERSA HAS FUNDED ONE OF THE FATES IS PILOTTING A TRAINING AND EDUCATION PEOPLE FOR PEOPLE DOING MASS TROSCOPY AND I THINK THAT'S GOING TO DO A MODEL FOR TRAINING OTHER PEOPLE BECAUSE YOU NEED PEOPLE HIGHLY QUALIFIED. YOU NEED TO GET THE FALSE POSITIVE RATE AS LOW AS POSSIBLE BUT YOU CAN'T MISS AN EFFECTIVE PERSON SEAU I THINK THAT QUALITY ASSURANCE PROGRAMS AND THE LABORATORY STANDARDS COMMITTEE OF THE SECRETARIES OF THE ADVISORY COMMITTEE I ALLUDED TO THAT WOULD CLEARLY BE ONE OF THE THINGS THEY'LL BE FOCUSING ON.
ED.
I JUST WANTED TO ROW IT RATE SINCE WE DON'T KNOW -- REITERATE SINCE WE DON'T THOUGH KNOW THE HISTORY OR THE TREATMENT OF MANY OF THESE DISORDERS I THINK IT BRINGS HOME THE NEED FOR LARGE STUDIES ON THE CHILDREN'S ONCOLOGY DONE FOR CHILDREN WITH CANCER SO WE SHOULD LOOK TO FOLLOW UP STUDIES. THE OTHER THING IS IN OUR TABLE FOLDER IS THE ARTICLE FROM JENA CALADA THAT YOU SORT OF ALLUDED TO I WANT TO SAY ONE POINT, MANY OF US TAKE EXCEPTION TO IT, TO QUOTE FROM THE SECOND PAGE, THE MAJORITY OF NEWBORN SCREENING TESTS HAVE FAILED SAID DR. NORMAN FOSS, A PROFESSOR OF PEDIATRICS AND DIRECTOR OF THE PROGRAM IN MEDICAL AT THE UNIVERSITY OF WISCONSIN, OVER THE YEARS, DR. FOSS SAID THOUSANDS AND I QUOTE, THOUSANDS, OF NORMAL KIDS HAVE BEEN KILLED OR GOTTEN BRAIN DAMAGE BY SCREENING TESTS AND TREATMENTS THAT TURNED OUT TO BE INEFFECTIVE AND VERY DANGEROUS END OF QUOTE. SOME OF US HAVE TALKED ABOUT WHERE THOSE THOUSANDS OF KIDS ARE. THERE WERE SOME STUDIES EARLY ON WITH PKU WHERE THEY WERE TRYING TO FIGURE OUT THE TREATMENT AND THE BEST OF THE HANDFUL OF CHILDREN, BUT -- AND I'VE BEEN ON PANELS WITH DR. FOSS AT THE AMERICAN ACADEMY OF PEED DIRECTION A COUPLE OF YEARS AGO WITH ONLY HUNDREDS, WHICH I STILL THINK WAS OVER, WAY OVERSTATING THE CASE AND CERTAINLY THAT'S GROWN TO THOUSANDS. THESE ARE EXTREMELY EFFECTIVE TESTS. WE ALWAYS NEED TO FIND TUNE TESTING AND MANAGEMENT WHENEVER WE INTRODUCE A DISORDER BUT I THINK A QUOTE LIKE THAT THAT IS COMPLETELY UNFOUNDED IN THE MEDICAL LITERATURE OR IN THE EXPERIENCE OF THE CLINICIANS DOES A HUGE DISSERVICE TO A VERY EFFECTIVE PUBLIC HEALTH STRATEGY.
LISTEN, I WANT TO THANKS, FIRST OF ALL, RODNEY, THANK YOU FOR -- BY THE WAY, CHRIS, I'M SORRY, DID YOU HAVE ANY COMMENT YOU WANTED TO MAKE?
VERY APPRECIATIVE OF THE PRESENTATION AND THE OPPORTUNITY TO HEAR IT, BUT I DON'T HAVE ANY ADDITIONAL QUESTIONS.
THANK YOU. WELL, ROD, THANK YOU AGAIN. YOUR COMMITTEE, YOU KNOW, IS DIFFERENT FROM OURS, AND SEPARATE. YOU'RE DOING THE WORK THAT YOU NEED TO DO. I WOULD URGE OUR COMMITTEE MEMBERS WHO WOULD LIKE TO ENSURE THAT YOUR COMMENTS ARE INTRODUCED INTO THE DISCOURSE TO REALLY CONTACT JOE. JOE IS OUR LIAISON AND IS WELL ABLE TO REPRESENT ANY CONCERNS, QUESTIONS, DISCUSSIONS, GUIDANCE OR THAT AND, OF COURSE, RODNEY, WE WILL TO THANK YOU FOR TAKING THE TIME.
THANK YOU VERY MUCH. I WOULD CERTAINLY LIKE TO UNDER LINE, IT WOULD BE WONDERFULLY APPRECIATED TO HAVE INFORMATION AND ED AND I HAVE DISCUSSED THE FACT THAT WE LOVE CONTROVERSY, BUT WE DO LIKE TO HAVE THE FACTS HAVE SOME JUSTIFICATION.
ALSO, WE'RE DONE. I'M RUNNING A TRAIN A FEW MINUTES LATE. I APOLOGIZE, I'M GOING TO AT LEAST GIVE EVERYBODY THEIR 15 MEN'S THAT THEY'RE DUE, WE'LL HAVE PUBLIC TESTIMONY. THE FIRST PERSON AT THE MICROPHONE AT 25 AFTER, 25 AFTER 11:00, THE FIRST PUBLIC. THAT MEANS COMMITTEE, YOU'VE GOT TO BE BACK HERE AT 25 AFTER. Sack Ghs mandate, --
We are ready for Maureen to come back. We can't start without Marie: thank you all very much for your promptness and as everyone knows, public testimony is a key part of what we are about. And we're very happy that our first presenter is someone well-known to us. Judy Lewis. Judy, would you please introduce the hat you're wearing today and please make your comments.
Thank you. My name is Judith Lewis and while my day job is professor, I'm not here today not wearing that hat but the immediate past president of the international society of nurses and genetics. We're an international society and we have members of all six continents, they're involved in the research in genetics nursing. Today I wish to speak with you about the nursing force. Our country is facing a nursing shortage. While 2.7 million nurses in the United States it's immenently clear that this number is nowhere sufficient to meet work force needs. The average age of the nurse is increasing and as our baby-boomers near retirement the crisis will become more pronounced. The shortage of nurses available to educate the next generation of clinicians makes it difficult for increasing programs to expand to accommodate increased enrollment and many schools are forced to turn away qualified applicants because of the faculty shortage. Again this situation promises to worsen years to come. Of the nurses currently in practice, there are approximately 150,000 clinical nurse specialists, nurse midwives and nurse practitioners priming primary and specialty care in areas including women's health, family health, adult health, pediatrics and gerontology. They're here to collect date and it courses to the American nurses association 2004 scope and standards of practice the advance practice nurse is qualified to initiate and interpret diagnostic tests and procedures relevant to the patient's current status. All advanced practice nurses hold a minimum of a master's degree and the involve the majority of states require that advanced practice nurses be certified in their specialty as a prerequisite to advanced practice licensure. In addition to the credentials offered by the certified nurses corporation they're certified by the American nursing credentialing center, the national certification corporation which does the health book, the Cong kolg corporation which does cancer nurses or other specialty-based credentialing group. Each certified group must maintain continuing education and/or practice requirements to continue their status as a credentialed specialist and we almost present evidence of currents certification in order to renew our license. Right now there are five universities that provide specialty in genetics as part of the masters program. In addition there are several programs for nurse clinicians, nurse educators and nurse researchers who he wish to engage in the studies of the increasing the capacity of existing programs will serve to further enhance the knowledge of those nurses who I know Corp genetics into their practice. Program grants for schools who wish to enhance our expand programs, especially those which focus on medically underserved or rural populations and those which enhance the public helicopter capacity. The expansion of such programs is such as the advanced education in nursing grants would help build the infrastructure of those prepared to meet the healthcare needs of our population. I have no idea how many grants just went into hersa but I know they reviewed more as an individual than there's money to fund so there's a huge need for qualified programs to receive funding. Increasing and ensuring reimbursement for services for all provide gentlemen met tick services to patients including nurses and advanced practice nurses will help to meet work force needs. I look forward to working with your committees and needs and other important nurses issues to ensure that work force is available to meet the genomic champ. I'd like to say how gratifying to see the work that we started in our previous lives in 1999 move forward and start to come to fruition, I like to thank all of you to the work hair's doing and I look forward to continuing to follow your progress.
Terrific, you did it in four minutes and 15 seconds which we really like. One quick question.
Judy, thank you very much for your presentation. I also wanted to ask you, you missioned about the American nurses association scope and standards of practice that that is a document that is put out by the American nurses association. Is that something that could be made available to the committee?
It certainly can. There are basically three documents that I think are important. One is nursing social policy statement wills the document that basically outlines our social contract with patients and with society. The second is a scope and standards of practice for all nurses that the ana puts out both are available from the American nurses association and unfortunately my personal budget was sufficient to provide copies for all of you, but I'm sure you can get then and third is the scope and standards of practice of clinical nursing practice which is jointly published and that is currently in revision, and we're hopeful that the new document which will actually be a companion to the major document will be out sometime this year.
Yes, Ed.
I was wondering if you might be able to provide a copy of each of those to staff so we had them for the archives of the committee.
We can certainly work with ana to see if they can do that, sure.
Thank you very much. Rick Carlson, University of Washington, thank you very much for joining us .
Could you turn your Mike on, Rick?
Start off Rick Carlson clinical professor universities of Washington. I wanted to do three things very briefly. One tell you my will perspective on reimbursement and genetic discrimination. Second some experience that may be relevant to the point which I'll make which there be third point that will be problematic to some of you. My perspective is this. You have been looking today at other times at genetic discrimination by purchasers and payers. And you've been looking at reimbursement issues also, reimbursement by who I wanted to shift and look at the other side, not the constituencies that you're looking at but rather payers. But in strategic in terms of the evolution of their role in the healthcare business. My experience which is relevant to this is that I coined term the HMO please forgive along with Paul wood some 30 years ago and have work half of my professional careers in the strategic and business capacity with both purchasers and payers. I undertook some projects for Robert wood Johnson starting in 2001, and 2002 to action sells the level of knowledge monkey stake holder groups across the healthcare system including primarily purchasers and payers, interviewed 600 people to assess what they chew and wanted to know as far as genetics in terms of their business and I've served as a consultant on market development issues over the last three years. I mention that because the major point I want to make to you today which has a couple of supporting arguments may well seem quite radical to you and that is as follows. You have been looking again at the constituencies and the impact that genetics has on stakeholders in the healthcare system. Within five years, certainly within 10 N. my view, bolt the purchaser role and the payer role in healthcare will be radically transformed. Purchasers have been trying for a very long time to exit the system. This is not a big surprise to anybody. The alignment that exists right now politically and in terms of purchasesers and payers objectives to incremently from benefits seems rather clear. This is an observation of what seems to be occurring. This is not an accident. The alignment is very strong for this movement against for payers, if you will, to shift their business model. Most of my 35 years of consulting in this field has been with payers on the fundamentals of their business model. My point in making this point to you today is that as you examine these questions, as you have been, and apparently according to Dr. Collins you've been looking, for example, at genetic discrimination issues for some 10 years, if it takes that long, the landscape will have dramatically changed around you insofar as payers and purchaser are concerned. Again to repeat my perhaps most fundamental point, payers will no longer be providing health insurance. Purchasers will no longer be paying for it within 10 years, possibly as much as five. That's a very bombastic and large point to make without any supporting data but a few minutes they will doesn't provide me time to do that but the alignment point which I've already made, second.think about it for a moment what genetics contributes to the understanding of risks be a profiling of risks is additive but powerful. When you know more about the risks associated with your member population that you're he ensuring I know insuring then you don't, you don't have a insurance product any more, you have an annuity product so what we're finding increasingly as we understand that both cancer and heart disease are now treated fundamentally as chronic problems when you know the prognosis of the bulb of your members you're not insuring toward accidents or untoward events. You're looking at how to manage costs for needed care for those people over time. That's where this model is going, genetic information certainly adds to that argument but it doesn't make it dispositive. The third point related to this is we have some very powerful enabling events. The hsa legislation may have seemed to be relatively innocent but I will remind you in 1970 a one sentence amendment to Medicare which I drafted specifications for allowed Medicare to pay HMOs ahead of time rather than afterwards. That launched a massive social experiment called managed care from which we are still recovering or experiencing. The hsa legislation has a trim tab character. Once it's there it can dramatically change the landscape of the industry, couple that with the movement of information to the end user such that within 10 years certainly they can A consumer will have all of their health information at their disposal and their entire genome on a chip for potentially as little as $10 per person.
If you want to make my last summary.
The landscape that you're looking at you address the quells of purchasers and payers will I know evidently change over the next 10 years.
Anybody have a quick question as all?
More a comments, not a question. Maybe it's a question. We said I said earlier today that this was a new civil right. How does that fit in with your predictions?
Well, in one sense I'm not sure it's elevated to a right until it's right legislatively. I would agree with that that it should be recognized as a right.
I would argue just in counter point that civil rights were recognized as a right before they were legislated.
I don't question philosophically or otherwise that it is a right. However, it should be pointed out I think by in a sense imputing the access of insurance companies to risk information, you're you know cutting the action actual model on which it's based. That's not apology. I'm very much in favor of antidiscrimination legislation. But it's another reason why the insurance modelless no longer supportable and will eventually disappear.
Thank you very much. Appreciate it. And next is Judith cookssy from the university of Maryland medical school.
Thank you. For the past 4 1/2 years I have led a multidisciplinary and multi-institutionalest to study the ways the genetic are organized and delivered in the U.S., the roles of health plofls and emerging models of care. There is a handout that committee members have and I'm sorry there were a few for the audience. Today I come before you to present a new and e voluming consistent evolving, that provides some of our findings to an established conceptual framework to assess the quality of medical care and health care. We believe this framework for assessing quality of genetics care is successfully developed could be useful to this committee and others. In other words, what we're trying to present at a very draft phase as over arching way to pull together and think about a number of the issues that this committee has discussed. I will skip over sort of the history of three generation history of ways to assess quality of medical care, but would highlight one feature and then quickly move to the applications of this conceptual framework to genetic surprises. The one feature that I would indicate is on page 2 and at the top of the page there's a very small screama that has structure with schemea with an arrow and this reflects a very traditional way of looking at the quality of healthcare services through three domains. One is to look at the structural elements, the basic components that are needed to support the delivery of healthcare or in our case genetic services and care. The second level of looking would be to look at the processes of care. I'll give some examples of that shortly. And the third way, and some people feel the ultimate and best way -- is to look at outcomes. Outcomes from our patient's perspective and from the family and in some extent the communities outcomes, not by just medical outcomes but well-being of the patient functional, physical, psychological, and social outcomes. This concept was developed in the's 60s and has been advanced a very well designed research study in the '80s and in the institute of medicine studies that have look at safety and quality of care. What I present to you on the last two pages of the hand out are a beginning model or framework for thinking about the structural elements for genetic services or the genetic services infrastructure. And this has seven tiers that are listed there. The first being genetics science which is the foundation translated to clinical and population-based applications. Next level would be organizational resources, these are the institutions that support genetic services in Allman if he is taigz, the thirdless the manifestations, the third health work force and data information transfer, football financing and reimbursement systems, health services research which looks at and studies organization, delivery, access quality of care as well as elsy, ethical, legal social implications research and the seventh infrastructure, element policy development. I would say that the genetic infrastructure for the country now is under developed in many, many areas and you're well aware of this from the studies that you're doing. But I think that this sort of sorting out maybe a useful conceptual framework. As far as infrastructure. This sort of describes what is now. For processes -- the proflz of care, looking at the way gentlemen met ticks care is delivered. The Institute of Medicine identified four process levels that really look at different arenas. The first arena and the most important is the patient, family outcomes. Our study did not look at this, but it's extremely important and it can be studied. The second level looks at microsystems. We sort of go from individual up to societal. Microprocesses of care, and our study we look at this a lot. Was the patient provider interaction, patients team interaction? There's much variation in these microprocesses and these microprocesses vary by their sponsoring institution. As we looked at academic medical centers children's hospitals moving to level Cwe saw that the institution supported and organized the ways that the care delivery was provided in many different successful but different ways. We saw that some institutional processes such as state-sponsored newborn screening, early hearing loss detection and intervention involved a series of microprocesses of care, baby seeing Jeanette sifts, nutritionist if it's a genetic disorder and the external environment which you spent be a lot of time looking at policies and whatever. And I'm getting the high sign so I will cut this in short only to let you know that it's in progress, and we'll delight to do a further exploration at a later time.
This is a second time to update us on work that you're doing in this area. And I guess the real question is how do we see in terms of all that's available, is it all go collected at least in terms of what you have he done to this point in an easy accessible way?
We have amassed, a vast amount of information, we are in the process of preliminary report writing and are hoped to have that finished. Our funding has ended. And I think this sort of research, health services research is another way to look at what do we have now and what might be coming down the pike. So we're eager to see if this sort of mile is a useful framework for people to look at things and we only have only analyzed a piece of the data that's been collected.
First of all, I want to thank you for keeping us up to date. What I've got to try to figure out and you know us well. You know our party list that we showed up on the board.
Yes.
I think if you would just keep thinking about opportunities in the subcommittees that we're working on to reminds us of applicable issues as we go forward. I think that's probably the best way, because I don't want, five minutes is not enough to get all the point you want to make so if you'll track with us and insert you know the knowledge that you have and the places you think it goes we'd sure appreciate it.
That would be great.
I was very intrigued by the outcomes information. That's a fairly old study 1989.
Yes.
Are there relevant. Are there updates baby, e gap is looking at very practical ways to define up comes as a way to define clinical utility that are broader of the strict there a treatment for the patient to get better types of definitions of outcomes so one of the things you may consider doing is interacting with Linda braidly heading up the egap program.
Yes, and there are others looking at outcomes working with quality institute and I think this is a beginning of much opportunity to think and to look at the information. Thank you.
Yeah. James.
In looking at your model, is this on page 8, I'm sorry, on page 5 does this go all one way because I can see how health services research would vascillate back and forecast between financing and reimbursement as well as policy development?
Yes, and this is a very new conceptual sort of putting some pieces down, discussing, thinking, there's overlap. The narrative gives a little bit of a example of sort of how process and structural issues relate but, yes, clearly, research looks at those issues, and, you know, research helps inform policy around those important issues as you'll hear about more today.
Good, I was actually I'm glad you said it. I drew an Arrow making it more sick Klahr as opposed to hierarchyAl in my report.
Thanks for the work you do on the counseling work group. We appreciate your involvement.
Judy, thanks for isong's help as well.
Pam when Williams, universities of Oklahoma, welcome and thank you.
Thank you. Ladies and gentlemen, my name is Pamela Williams, I'm a graduate student in the nursing program at University of Oklahoma, health science center. I'm a student in the program that Dr. Lewis described earlier. I'm pursuing, I will pursue and I am pursuing the advanced practice nursing and genetic credential. I also am member of the Oklahoma bar association, I've practice law in Oklahoma for over 20 years. I'm here today, I did not prepare in advance a statement because having looked at the agenda I didn't see any point to stick my neck out at that point. And when I made my decision to come up here on in my own nickel it was a decision made in pursuit of research resources. I came to your meeting today to formulate or to finetune my research question as it now presently stands to study the psycho social impact of genetic testing on brc one and brca two, a potential potential patients getting tested for those particular genes but then I heard the presentation of Dr. Hall and his presentation was fascinating regarding the diverse opportunities to have testing done on newborns and then Dr. Collins asked the question about the anxiety impact on be parents and was surprised to learn that as far as he knew there wasn't any descriptive studies in that area. And so my purpose of coming forth today to make this statement is to let you all know that there are nurses and nursing students in research right now wanting to know these questions, dying to know these questions and research these questions, and by qualitative and quantitative methods, and as I continue to pursue completion of my currents program and my Ph.D., I'm hoping that there will be funding, not just for the gentlemen nets tick nurses at the bench but for the genetic nurses that want to study the psycho he social and the psycho neuro, immunological impacts of this information. So those of you that do sit at the right table of having dinner and attend the right cocktail parties and sit on the other committees that make the decisions for funding in nursing research, please, if you would, make sure there's funding for us that want to pursue the answer to Dr. Collins's question. Thank you. Thank you very much for coming forward. We very much appreciate it. Interest in time we have to keep moving forward but thank you so much. We'll move now until 12:30 to start and then we'll reconvene after will you have and continue our discussion on the draft report on coverage and reimbursement. As I mentioned in the earlier comments and to make sure that also our new members are well award of the history of this, we determined last year that coverage and reimbursement of genetic test and services was a high-priority requiring in-depth study and we started working on an as a result in our March of 04 meetings. We got the perspectives on the issues from experts and the public and private areas. We appointed a task force to investigate these issues more deeply and that task force held a meeting last September and developed policy options. In our October meeting we reviewed the draft report and made significant headway in our declarations about the proposed recommendations. We have also engaged and I will tell you that staff has been terrific, we have gone to experts, far and wide and reviewed every line of this report, but from every possible way, and the report has grown I think considerably in sophistication, precision, and so the staff has been really terrific. We've really work them very hard. You have the latest document or version of this in tab 6 of your briefing book. And again, that document is considerably different than where we started and is really moving forward I think to really becoming the document that we had hoped for. In addition, some outstanding issues. With regard to genetic counseling services became identified through this process. a Small work group was formed to gather additional information on those issues. And we'll be hearing a report from that group later this afternoon. I'd like to thank Cindy Berry for our leadership on this issue as well as Debra Leonard, Francis chezny from CDC and Steve from CN s I also wants to acknowledge Susan good win and their extraordinary work. Cindy will review the changes that have been made to the report over the past few months and lead the discussion as we further refine the draft report and then get it ready for gathering the public comments. So again even after we've gotten this as tight as we possibly can get it tight, then, of course, it goes out for public comments and we'd get more input this has got to be really letter perfect as it goes out there because it will gain a lot of attention so with that, let me turn it over to Cindy.
Thank you, Reed and I want to echo Reed's comments with regard to staff. This report as enormous undertaking and Suzanne, Sarah, Fay, Amanda, really performed heroic efforts and I'm not exaggerating, I mean, really when you think about all of the impact, all of the comments having to deal with all of our edits and commence and put it together in a thoughtful way it was nothing short of heroic so I wanted to thank them and recognize them. To start we can go over what this session is going to try and accomplish today and that is to review the report thoroughly. In the course of putting together this report as Reed mentioned the issue popped up with regard to genetic counseling, we all instinctively knew that that's the type of service that we think is beneficial and should be rereimbursed appropriately and we leapt to that conclusion so we thought it would be useful to have background work done that would support our conclusions and so that work was done by this working group and we will be briefed by them. The other purposes of our session today is to go through each barrier to access for genetic tests and services and then proposed recommendations, most of which you've seen before in earlier iterations of the report and ultimately we want to reach a consensus on the recommendations so that we can finalize to the extent that it's 5-he not a final final report but final before being issued for public comments. Finalized the recommendations and then formulate a plan for gathering public report on the recommendations that we agreed upon. The report itself --
The report itself is really designed to identify the problems of coverage and reimbursement that genetic tests and services are facing and that limit accessibility and integration to the healthcare system. The report is designed to describe the currents state of play, what are the problems, what are the barriers and then to offer recommendations for how we can address these specific barriers. And then the ultimate goal, of course, is to improve access to and utilization of genetic tests and services by ensuring appropriate coverage and reimbursement.
This is how this slide identifies how the report is structured and as Reed mentioned it's in tab 6 of the briefing book. These are the different sections. Previous iterations of the report had the overview of the such the healthcare system as more of a U.S. of the healthcare system as more of the introduce we moved it from the appendix and restructured report in a way that makes a little more sense. It addresses the specific issues and barriers and recommendations together. Now issued lay out the ground rules here for our discussion. I was going to come with -- bring with me a whole arsenal of air guns and water guns and pistols and all kinds of probably hardly political incorrect weapons in an attempt to keep us focused so what we decided we were going to do. This is kind of a congressional thing, we'll light up, 20 minutes for each recommendation. And what we'll do, hopefully is spends a little less time on the recommendations that we already analyzed at our last meeting because we went through a lot of that, adjust Ted the report, came up with some revisions so hopefully we won't have to spends as much time on the recommendations we discussed previously. The idea would be we'd have 20 minutes per recommendation, if we don't finish then we'll move on to the next one and any time that we have left over at the ends we'll go back to address that recommendation that we didn't reach consensus on. And hopefully this will keep us focused. We want to make sure that all of our comments are very precise, directsed to the specific barrier and recommendation that we're considering. And we'll just ask everyone to keep that in mind as we move forward because we really want to get through all of the recommendations so that we can finalize this draft of the report.
With that said, the first barrier evidence-based coverage decisions we did discuss this at length at our last meeting. Hopefully all of you have had an opportunity to review the recommendation as it has been revised, and I would ask the committee to provide us with some input citizenly as to who whether you think this recommendation captures adequately the committee's position on this matter and then specifically to ask -- can everyone see that. You have also in your books and issued call attention, is that in the folders or the briefing book. The actual recommendation so that you can have them in frons of you. If you can't see them up on the slide.
But we discussed having some sort of group or body to develop a set of guiding principles with regard to which type of genetic tests and services should be could have had and when and one of the questions and one of the issues that we talk about the last time was the eGAAP as a possible entity. Do we want to recognize them in this specific recommendation be a suggest that they be the body or do we want to keep it vague so that the secretary could come up with some other entity? And I'll turn it over tot rest of the group. Debra.
Having gone to the evidence-based review meeting of the egap I think, I think we at least need to bring to the attention of the secretary that the egap working group exists, and it may be appropriate for filling this role. It's pretty much doing exactly what is stated in that first paragraph looking at analytical, clinical validity and clinical utility.
Your request for that be taken care of by paragraph 2 which specifically calls out the egap work here.
Yes, and you might want to say that the egap work group is in the CDC because it's not stated it's in there where it's from, but or where it's originated out of.
Do you think maybe, is a mention of the egap's mission and work as sort of an example but not necessarily designating them specifically in their recommendation, would that do the trick, do you think?
Right now the egap process is into a two to three year pilot project status. So I think at least -- after we've been discussing this for a while. Marie.
Timing is everything.
We're talking about the very first recommendation that's in the coverage reimbursement report and that has to do with tasking some sort of body to develop guidelines and principles with regard to what types of genetic tests and services should be covered and when. And one of the discussion point that you were involved with the last time had to do with egap and whether we should specifically designate them as that body or whether we should mention them as sort of an illustration, or whether we should not have any reference to egap and just keep the recommendation more vague and leave it up to the secretary to decide what the appropriate body would be.
My advice is to mention them as an example, but not charge them with things go but just mention as a -- I mean, examples of these efforts are being done within the department and the secretary will decide what he wants to do and convene the agencies to work together.
Ed.
That could be -- you can take what you have and just say the egap work group is an example of such a body which involves, you know, so it would be very easy to amend that second sentence of paragraph 2.
And take out the part about it may be an appropriate body to be tasked. We don't reach that conclusion.
You could say this is the kind of body that could be tasked so again it's an example, it's a possibility but not tied directly.
All right. Anyone have any other comments? Debra.
This is rather specific but in the third line you say genetic tests always should be covered. I just don't like the wore "always." It makes me nervous just to parallel the next statement, categories of genetic tests should be covered, should not covered and should fall into uncertain Gray zones, could we remove "always" and second paragraph, that's going to be changed anyway but I didn't understand what the last word "raised" was. I think that can be dropped from the sentence. And it'll still be okay.
Any other comments on the first recommendation?
All right. Do you think you have enough guidance to revise it. We'll move on to the second one.
Barrier two had to do with the influence of Medicare on private plans and the fact that Medicare often is the model for private health plans in determining coverage of benefits. And we discussed in the report the fact that genetic technologies are such that they may not be widely used or appropriate for more senior populations and, therefore, Medicare is probably not the best model for private health plans that cover other populations. So the next recommendation, it's -- this recommendation simply encourages private health plans to make sure own coverage determinations about gentlemen met tick tests and services rather than using Medicare as a model. And to a great stents I suspect that is already going on, and this is sort of a statement of that trend I would say. But it's a recommendation, nonetheless, that addresses a perceived barrier, and would like to open it up for comments on any potential changes to that recommendation. Emily and then Reed.
Well, as it's written it's talking strictly about Medicare so if you intended this recommendation to be that Medicare is not the appropriate example, then I think we need to substandard -- substantially with respect write this paragraph because right now it's national coverage decision-making which is a Medicare process.
No, it's -- you're up one.
I'm sorry, I'm sorry.
Reed.
Well, I think that your explanation of this section was different than I think than what I got from what it says so if you're trying to get at -- first of all, I think I think we benefit more in healthcare when things are more consistent rather than not. I mean, when you have mass confusion with everybody doing different things that, you know, if the evidence is there the science is there, you want to try to get folks on the same page. Otherwise it makes it very difficult to navigate through complexity. If you mean that, for example, that pediatrics is not covered by Medicare, therefore, there is a need for that not to be lost in it, then I think we should talk about pediatrics, but I'm not sure that we want to imply that it's best for everybody to sort of do their thing. I think we're trying to line these things up so some evidence-based consistency. So I'm not sure I guess, I guess where I'm for a loss what is the actual intents here.
The idea, for example, that Medicare has a screening exclusion, and in the private sector however, plans often as you know, do provide those types of services to their enroll he's and want to do and enrollees and win want to to and see a little benefit so we shouldn't let Medicare hamper in the private sector what might be worth covering so Medicare is subject to statute that is hard to amends and subject to congressional action which takes an enormously long amount of time so that's the idea is that it would be wonderful if everything were consistent but Medicare has its own quirks and problems that we just want to make sure don't handcuff the private sector and prevent it from moving forward with coverage and reimbursement in this area, I hope I've captured it properly. Ed, did you have a comment and then Emily.
I was thinking that you could say what you said and add it to this arguing that standardization would be ideal and referring back to proposed recommendation one to look to for guidance in this standardization.
Emily.
Yeah, so I thought night also be informed by putting some very concrete examples such as the fact that children are often screen for genetic disorders and don't really fall under Medicare's per view. I'd also like to see us specifically mention the issues of I'll call it preventive medicine of identifying risk factors early in life so that you can do something about it which will benefit Medicare in the end maybe is not going to be something that they're going to pay for up front that a lot of this, the issues in genetics are going to fall in the private payer arena and somehow we need to get the private payers working together and standardizing how these things are going to be done in sort of the same way that Medicare works through local coverage and national coverage decisions.
Ed.
, and if you wanted to reference for that, there was a compendium with the risk of being self-serving there was a compendium of the no one journal genome articles that was put together as a book and there was an article by Kory McCabe and careening -- screening so that there is that information, but I'm sure probably Francis could find a copy of that book laying around for you to look at.
For which I receive no royalties, let me point out.
Any other comments on this particular recommendation? So I think we need to adjust the language a little bit to recognize the point that Reed and Emily and Ed made talking about standardization would be ideal but recognizing some of the limitations of Medicare and cite a few specific examples and then lead into the recommendation as it's written. Does that adequately capture the consensus of the committee? Any other comments? Yes, gene.
I think it's equally important not only to stress the tact that because the statutory regulations, Medicare can only provide certain services but also I think if you take a look at the Medicare population, 85 percent of the Medicare population, 65 and over, and I think if you take into consideration population characteristics, I think that that might be to explain one reason why Medicare population genetic testing might not be as appropriate as opposed to another patient population group such as private payers where they have a whole spectrum from newborns all the way up to the geriatric population so I think the regulatory as well as the patient population need to be taken into consideration when looking at that proposal.
Okay. Any other comments before we move along? All right. Hearing none, barrier number three -- do you have --. If you have a specific --.
Do you have a specific -- okay. Thanks, Suzanne could use some of our additional guidance to rewarding that relevant agency, I summarized but didn't provide any specifics on wore wording.
My suggestion would be genetic tests and services in pediatrics and those with the prevention component so to specifically mention peed direction should be pediatrics should be mentioned to the benefit of the populations they serve. And the second sentence I think we need to say something about Reed's comment about adding, you know, encouraging standardization of coverage decisions among private carriers.
Reed, did you have any specific language to lead in there?
I don't have, you know, good enough, you know, camera ready language but I think what I'm sort of trying to get at here, again, you've got to -- that we are what we're encouraging that these principles that we talked about as long as with best scientific evidence that all these things are made available so that we can get to a a database base and a set of guidance that will hopefully give us better standardization across public and private insurers to the greatest extent possible without stifling progress and innovation because of the federal concerns, federal process. I'm sort of trying to get at a process of using best plains and available standardized database that allows you to to be able to assess this new technologies so you can then begin to get people working together to make the best and right decisions without being caught up with the inherent limitations of the federal process .
Do you want to have a lead-in -- well, let's see the encourage standard -- I have to fix that. Do you want to say something that while standardization across public and private payers would be ideal using whatever whatever,.
Right.
-- then lead into the rest of it?
That's it. As opposed to sort of saying which is what it says now, sort of which is getting at, you know, anyway, what you said I like, so you the goal is to try to get -- the goal is that we want healthcare to be more simple rather than more complex, more based on best science and best principles. So it should be easier not harder, it should be more consistent not more divergent, you don't want to drive anybody nuts. With that goal there should be the tools able to achieve that to the greatest extent possible.
Make their own coverage determinations relevant or relative to their populations serve and taking up James's statement, because really the major difference is that, you know, genetics is going to be more useful for not people over 65 .
Does that do it, James, do you think that does it. It doesn't specifically come right out and talk about, although the body of the report talks about the coverage, the screening exclusion and the population and all of that, do you feel we need to have it in the recommendation itself or do you in this recommendation is sufficient?
As long as we include something in reference to populations served or as we have with -- yeah, as we have here the populations served because our population is a little different than populations that may be served in private insurers.
There is the disabled component for some folks who may be younger, under 65 and I think that's referenced in the report though so that really the lion's share of the people served by Medicare are 65 and older so that is addressed there. Debra.
Rather than saying Medicare's lead could we say rather than following Medicare's coverage policies?
Yeah.
Yeah, I think that we're getting close here on this -- although standard station coverage best scientific evidence is ideal, private payers should be -- I left lane think should be supported with necessary information to make their own coverage determination about these tests and services relative to their populations served and not be limited to only following Medicare's policies but I think that's -- it's the idea of having this stuff available for people to do what they need to do. The bottom line, I don't want to solve a Rob that isn't there. Private payers make their own coverage decisions. They do what they need to do so the question is how do you have available to people the information that they need that helps them to make better and more intelligent decisions, it's the information base.
What happens if you just finish the sentence at to the populations served, period , and --
And can we put a reference to recommendation 1 after all those San decision of coverage decisions using best recommendation one?
Are we there? Standard standardization.
By Jobe, I think we've done it. Move on to number 3.
At the risk of, I know you can March through the recommendations, I have a global question.
Yes.
We call this coverage and reimbursement of genetic tests and services but we change the definition of genetic test midstream. Are we only talking about genetic inherit believe tests now are we also talking about genomic tests because when we started this gentleman net tick tests was defined as genetic, genomic, inherit believe and somatic now we've changed that to have a genetic tests an inherent believe change but this committee is also tasked with looking at genomic testing and applications and so do we need to -- right now with these recommendations are staining, we're only talking standard standard ding, we're only the talking about testing for inherit believe traits.
It's page 17 of the draft.
Specifically addresses somatic mutations.
Right and it calls those genomic tests, not genetic tests.
What are that would box, they're subsumed under genetic tests, second paragraph on the bottom.
We don't appear to be distinguishing in the recommendation in the report on page 17 is where all of the definitions and sort of the scope of what we're talking about are laid out. And it's really just a definition Al section. Do you feel, Debra, that we should be more precise in the language used in the recommendation?
I am just concerned that when you define-what are genetic tests? That first paragraph now says a genetic test now is performed on and chromosomes to detect inherit believe -- so we've taken out the somatic part. So I just want the committee to be aware that now we are when we refer to a genetic test as defined in this whole report, we're only talking about inheritable tests and that later on we define genomics as the broader test of Harrietable and somatic.
I would just delete the adjective Harrietable in the second line but the box is inconsistent and conflicts with it over and over and over again but if you get rid of the worst word HR aritable so associated with disease without bias as to whether it's inherited or not inherited because the examples that are given throughout that box argue on both sides.
Ed, did you have a comment?
Well, going to respond more back to the recommendation, not to the definition so I can hold that. I mean, in the recommendation we can make a genetic genomics the way we did in the bottom box related to technology so if we said genetic/genomic in recommendation one I think that takes care of Debra's issue. I think we should say pursue hunt's comment. Would that take care of your concern, Debra?
It's just genetic/genomic, yes.
Then I have the concern about the word Harriet believe we have putting our names on a box that are internally conflicting we only mean inherited mutations only or we don't and we need to decide that and make sure the techs text reflects that decision.
You're talking about the reference to mutations in the stool? For colorectal nfrlts terms of the writing there yes, but I think in general as I read through this draft report, I would personally be uncomfortable saying that this report only applies to inherited conditions and someone else later will have to come up with a whole other report of somatic disorders, I don't see that we shall do that.
I agree but there's been a longstanding controversy about gentlemen met tick tests that goes back to sgt and many people who did that have problems when you almost those to go and can't separate them out by any means of definition because many of the ethical, legal, social issues that are associated with Harrietable tests of genetic test as defined as inherit believe are not necessarily associated with somatic testing. And so having a definite petition of a genetic test that leaves it as inherit believe or for an inheritable change is useful because then you can distinguish it from a genomic test and did this get changed because we did define genomic as the broader Harriet believe and somatic and did this get taken out.
That's the second box on page 17 regarding genetic and genomic technologies.
So maybe hunt is right that this third paragraph in the upper box is more relevant to put down in the genetic/genomic box rather than leaving it up in the genetic test box since mutation analysis for colorectal cancer wouldn't necessarily be considered a genetic inheritable test but rather somatic test.
Would it be all right if it's left there and we delete in the very first paragraph the word Harrietable so a genetic test to detect general no types mutation, Fino types, take out the word Harrietable and further on down there is a discussion of bog inherited and acquired? Does that improve the consistency. Does that address the problem or. That certainly addresses my problem but the issue of whether there is a prior narrow definition of genetic testing that some people like we'll have to decide whether to retain that or broaden it.
I would favor the broader definition just because I think that the boon in genetic test is actually going to be with the somatic mutations and the Harrietable disease right side much more rare but the use of genetic tests for things already available on the market are genetic tumor expression profiles to help actually give a risk category for women who may be more likely to recur in breast cancer is going to be available. And I think that if we don't address this now, then we'll be behind the 8 ball when those types of tests come out.
My own sense is the public at large, that's an a great example of the public at large would view that I think as a genetic test. They're not going to look for a footnote well that's not really a genetic test because --
But that is a genetic test because it's looking at the genetic makeup of the woman that influences the risk for breast --
Expressing of genes in the tumor.
Only in the tumor being.
, some of which may be modified no doubt by constitutional Geno type but we don't know the answer yet and we certainly don't know the answer in any given case.
I'm wholly unqualify to make any kind of determination here other than to maybe ask if, I know Debra you're concerned about it. Is that the rest of the group is there a preference in terms of broader versus narrower definition? I think we've got the recommendation down okay, but this relates back to a definition and a problem with the language that folks have identified and I'm wondering if we can reach some sore of -- if it's an absolute unanimous consent at least majority rule here in terms of whether we go broader or narrower?
I mean, truly a little bit, Debra, by what you were talking about, I'll grand you that there are certain differences in the ethical issues that can be raised whether it's an inheritable or so matic mutation but it appears to me to be the intend of this language to set a baseline and I'm not sure it's inappropriate to say inheritable and somatic. We want to group everything here then if in the process of dealing with the policies that are coming on about genetic testing or genomic testing, one wants to say yes but then one has to take additional things into consideration for Harrietable conditions. That may be necessary. I'm just wondering, is it still that Zarrella a distinction in the policy realm. But in the policy relevant will is is that distinction still have that much traction?
Yes, because how this committee divers a genetic tests may influence how others define a genetic tests fan they have pre and post testing requirements that are relevant to a truly inheritable genetic tests those could be imposed on somatic tests as well. Like leukemia testing or other types of genomic tests that are not truly inheritable genetic tests like documentation of informed consent and other types of -- it does have implications for policy .
Okay. Kleeaz what you're worried about in.
Inheritable and genomic as the broader one as Ed had suggested in the last meeting.
I just don't think outside of this committee room that that would have broad acceptance. It would be confusing and people would subject to misinterpretation where as you can take the broad definition and you can refine that by referring to a genetic test or and I Harrieted condition or a genetic test for an acquired condition so you can always modify the broad one later but just to declare at the level of definition something which is not broadly accepted I think would cause us some difficulty.
Willy and Ed.
I guess scientifically I think I agree with hunts but if you think of the commonly spoken English language when people hear the term genetics they usually associate with that something that's inherited or hairtable so I wonder if you won confuse the general population with a more broad definition.
And Debra mentioned this but I'll just let it out a little bit more. And I think what we're really dealing with is turf issues so that just everybody's clear why these definitions are important to certain individuals. And that there has been somewhat of a conflict between the genetic testing community and then the pathology testing community over where the border is between what is done by whom and that border has for the last 15 years been drawn that the genetic community does inherited testing. The pathology community can do I know haired or so matic but definitely the inherited should not be genetic the same as the somatic, it allows both communities access to the entire range including molecular biology but that's the sensitivity of what may seem a bit arcane to many people significant around this table.
We can take this up later, but it does be even the title and as we use the word genetic test throughout this thing, you know, with all the recommendations it has implications how we define the genetic test in this box on 17.
Why don't we break for lunch but if I can impose upon the folks who know about the most about this and if you're most sensitive to this, if you could scribble something on a piece of paper and see if we can work on some language behind the scenes and then when we come back to this recommendation, we'll put that up and see if that does the trick rather than spend more time on it because I think there's a bit of a debate such that it will prevent us from reaching a consensus on it and Debra, hunt, Ed, if you can --
That's good because Debra and I spent a bit of time back and forth and so I think it's important to have hunt and somebody else who might be interested who was not a part of crafting this since it still is you in the air and maybe not involved in the arcaneness that we have been.
Okay. Did you have something?
Okay. All right. Reed should we break?
We start back at 1:30. We actually lost five minutes, so --
Where's lunch?
Restaurant? Follow up, Abbe, we're like little ducks. The audio needs to be reset. It's busy.
Can't get through to the audio line. It's busy. . The phoning line is busy. The phone line is busy. The phone line is busy. Brap
Can't connect to the audio phone line. It's busy. S TESTING TESTING. [CANNOT CAPTION DUE TO AUDIO LINE BEING BUSY]. SGLE POINT IS TO MAKE A DISTINCT BETWEEN THOSE WHO IN SITUATIONS WHEN THEY GO INTO A POSITION AND THOSE WHO ARE IN SITUATIONS WHERE PHYSICIANS ARE NOT INVOLVED AND IT DOESN'T DO IT. BECAUSE WE NEED AN OR IN THERE TO SEPARATE OUT. WHERE YOU HAVE AND IT SHOULD BE OR. NOT AND. BECAUSE AND MEANS THEY ARE QUALIFIED AND THEY ARE CURRENTLY [INDISCERNIBLE] SO I AM SAYING IT DOESN'T MAKE A DISTINCT IF THERE ARE TWO SEPARATE --
NO IT'S NOT. IN THIS RECOMMENDATION IT'S FOCUSED ON ONE GROUP AND THESE PEOPLE ARE QUALIFIED BUT THEY'RE ALSO FORCED TO BILL INCIDENT 2.
THIS ONE IS ONLY DEALING WITH THAT SINGLE GROUP NOT BHOTH OF THEM.
YEAH IT'S ONE GROUP.
SORRY NEVER MIND.
ALL RIGHT.
SO LET'S JUST JUST TRY SOMETHING A LITTLE DARING HERE. I MEAN I AM WATCHING THE CLOCK HE WE -- HERE WE GOT HALF-HOUR. CAN WE -- LET'S JUST GO TO NUMBER 10 AND LET'S JUST STATE WHAT WE WANT THE IDEAL TO BE RIGHT NOW. LET'S GET THAT LOCKED. THEN COME BACK IN AND SAY OKAY IN THE INTERIM THIS NOW DEFINES THE REALITY. BECAUSE WE KEEP GOING BACK AND FORTH BETWEEN THE IDEAL AND THE RISK. LET'S JUST GET -- WE GOT A GOOD -- WE GOT IT 90 PERCENT OF THE WAY. LET'S PAUSE THERE AND GO DO THE OKAY HERE'S WHERE WE THINK THIS THING OUGHT TO GO AND COME BACK AND SAY IN THE INTERIM THEN LOCK THIS ONE IN. HOW ABOUT THAT.
SO THIS WILL BE MOVED UP. THIS WILL BE THE FIRST RECOMMENDATION UNDER THE GENETIC COUNCIL SECTION OF THE REPORT? NUMBER 10.
RIGHT.
IT'S GOING TO BE NUMBER 8.
OKAY. HERE WE GO.
JUST REAL QUICK IS THIS GOING TO CHANGE THE ORDER IN THE REPORT?
IN THE TEXT OF THE REPORT?
YEAH. I MEAN AS FAR AS I MEAN THIS TENTH RECOMMENDATION WAS ON PAGE 52. WE ACTUALLY CHANGED 49.
WE CAN COMBINE ALL THREE RECOMMENDATIONS SO THAT IT FALLS AT THE END OF THE SESSION OR -- SECTION. OR SO THE ORDER OF THE TEXT WILL REMAIN THE SAME.
OKAY.
ALL RIGHT. I THINK ONE QUESTION TO THROW OUT THERE ON HELP GUIDE US. THE FIRST PART OF THE RECOMMENDATION FOCUSS ON AN ANALYSIS. WHO IS QUALIFIED TO PROVIDE GENETIC COUNSELING UNDER WHAT CONDITIONS, WHO WHAT SUPERVISION? DO WE FEEL THAT IS A WORTHWHILE EFFORT? HAS IT BEEN RENDERED MOOT BECAUSE OF THE WORK GROUPS EFRLTS? OR ARE THERE STILL GAPS THAT JUSTIFY IT? THIS TYPE OF RECOMMENDATION.
I THINK WE SPENT AN HOUR SAYING WE DIDN'T HAVE THE DATA WE NEEDED. AND DESPITE THE FINE WORK OF THE WORK GROUP. SO I THINK THIS IS VERY MUCH STILL NEEDED.
OKAY. JOSEPH?
I WOULD CONCUR. BECAUSE ONE OF THE THINGS THAT THE WORK GROUP IN ITS WORK DID IS THAT PRESENTED ONE PART OF THE STORY. THE OTHER PART OF THE STORY HAS TO DO WITH WHAT I KEEP BRINGING UP WHICH IS THERE ARE A NUMBER OF PEOPLE WHO PROVIDE GENETIC COUNSELING SERVICES WHO DO NOT, WHO DO NOT GO TO THESE FORMALIZED PROGRAMS. AND THEY ARE NOT EVEN REIMBURSED DIRECTLY. SOME OF THEM ARE REIMBURSED THROUGH HERSELFA GRANTS -- HERSA GRANTS. SOME THROUGH THE STATE SIDE OF MEDICAID. SOME REIMBURSED THROUGH PRIVATE INSURANCE AND CARE. AND THEY'RE USUALLY ATTACHED TO A SINGLE CONDITION OF ONE TYPE OR ANOTHER. AND I CITE AS EXAMPLES CYSTIC FI BROTSES -- CYSTIC FIBROSIS, HEEMO FILL YEAH AND METABOLIC DISORDERS AS THOSE WHO ARE TRAINED TO DO THAT. AND THERE ARE MASSES TRAINED PERSONS INVOLVED. BUT NINE TIMES OUT OF TEN PARTICULARLY IN RURAL AREAS THERE ARE USUALLY THOSE WHO ARE TRAINED SPECIFICALLY TO PROVIDE [INDISCERNIBLE] FOR THOSE PARTICULAR CONDITIONS AND ARE REIMBURSED MAYBE NOT DIRECTLY BUT INDIRECTLY THROUGH OTHER MINES. I THINK WE AS A COMMITTEE NEED TO TAKE INTO ACCOUNT THAT IS A BIG REALITY WHEN WE'RE TRYING TO MAKE RECOMMENDATIONS RELATED TO REIMBURSEMENT.
UM, WHAT ABOUT THE POINT THAT CAME UP DURING THE REVIEW OF THE WORK GROUP REPORT AND EFFORTS THAT THE DATA REALLY JUST SGONT -- DOESN'T EXIST AND THEY'VE BEEN THROUGH LITERAL -- LITERATURE REVIEW AND CONDUCTED A PRETTY THOROUGH. BUT WHAT IS THE ANALYSIS GOING TO LOOK AT.
THE ANALYSIS IS RESEARCH. THE RESEARCH AND SUBSEQUENT ANALYSIS IS WHAT'S NEEDED. IT'S NOT AN ANALYSIS OF PRIOR RESEARCH.
SO THEN WE SHOULD CLARIFY THE LANGUAGE THEN.
TO ME ANAL SITS IS SORT OF ALL ENCOMPASSING. BUT IF IT ISN'T OBVIOUS TO YOU AND THEREFORE MIGHT NOT BE TO THE SECRETARY.
SO YOU WOULD SAY FURTHER RESEARCH AND ANALYSIS.
WOULD IT BE APPROPRIATE TO WITH THE WORKING GROUPS TO USE SOME OF THEIR LANGUAGE. THEIR THIRD RECOMMENDATION WAS TO SUPPORT THE FUNDING OF FURTHER STUDIES TO ASSESS THE VALUE AND EFFECTIVENESS OF GENETIC COUNSELING SERVICES PROVIDED SPECIFICALLY BY NON-PHYSICIANS WHICH WOULD INCLUDE YOUR SINGLE DISEASE COUNSELORS. THAT'S ONE OF THE RECOMMENDATIONS. SO WE COULD USE THAT RECOMMENDATION IF THAT'S OKAY. THEN IF YOU WANT PIGGYBACK ON TO THAT WITH YOU KNOW THE INTENT TO RECOGNIZE NON-PHYSICIAN PROVIDERS WITH EXPERTISE IN GENETICS. THE IDEA IS WE'RE GOING DO THIS ANALYSIS AND SEE ARE THERE INDEED NON-PHYSICIAN PROVIDEES WITH EXPERTISE IN GENETICS THAT SHOULD BE REIMBURSED?
AND I WOULD AGREE WITH KEVIN THAT YOU HAVE A SET OF RECOMMENDATIONS.
DO WE WANT TO RECOMMEND SPECIFIC BODY TO CONDUCT THIS RESEARCH AND ANALYSIS?
I WOULD ARGUE WE SHOULDN'T RECOMMEND TO THE SECRETARY WHO WITHIN HHS DID THIS. BECAUSE IT MAY INVOLVE DIFFERENT AGENCIES. BUT I REALLY THINK THAT'S THE SECRETARY'S DECISION.
REED?
I WOULD LIKE -- I THINK AGAIN THIS SECTION AS I UNDERSTAND IT WHAT WE'RE SAYING IS THAT IT IS -- THAT WE ARE RECOGNIZING THE IDEA THAT THERE ARE -- THERE IS A GENETIC COUNSELING ACTIVITY THAT CAN BE, NEEDS TO BE DEFINED, BUT THAT CAN BE INDEPENDENTLY ENGAGED AND BUILD -- BILLED FOR OUTSIDE OF ANYBODY ELSE'S SUPERVISION. SO IT'S DIFFERENT THAN THE PEOPLE THAT JOE IS TALKING ABOUT IN THE SENSE THAT THE SINGLE CONDITION STUFF THAT'S DONE WITH THE DOCK I. MEAN TALK ABOUT -- DOC I MEAN TALK ABOUT AN INDEPENDENT FUNCTION. AT LEAST I A POINT I WOULD LIKE TO ARGUE IS THAT WE SAY THAT WE RECOGNIZE THAT THERE IS SUCH A NEED AND THAT THERE ARE CERTAIN PEOPLE WHO THEORETICALLY FROM LACK OF BETTER WORD CAN DO THAT FUNCTION. THEREFORE THERE SHOULD BE I THINK THE FIRST RECOMMENDATION FROM THE WORK GROUP IS ACTUALLY PRETTY GOOD IN THE SENSE THEY'RE SAYING THAT WE DO NEED TO RECOGNIZE THAT THERE ARE NON-PHYSICIAN PROVIDERS WITH EXPERTISE AND WHO SHOULD BE CREDENTIALED BY A NATIONAL GENETICS ORGANIZATION. I THINK THE WAY TO HANDLE WHO SHOULD DO THAT THEN AS AN EXAMPLE IS WE HAD THE REPORT EARLIER TODAY FROM THE OFFICE OF INFORMATION TECHNOLOGY. ONE OF THE PLACES THAT THEY ARE, ONE OF THE WAYS IN WHICH THEY'RE WORKING TO CREATE THIS INNER OPERABILITY STANDARDS FOR THE ELECTRONIC MEDICAL RECORD IS TO CREATE THE CERTIFICATION COMMISSION FOR HEALTH INFORMATION TECHNOLOGY. GOVERNMENT CAUSED IT TO OCCUR. BUT IT'S PRIVATE, PUBLIC SECTOR JOINT VENTURE THAT IS CREATING THE CERTIFICATION STANDARDS. ON THIS GROUP SITS THE OFFICE OF HEALTH TECHNOLOGY, CMS BUT ALSO THE PRIVATE SOFTWARE VENDORS. WHAT IMGETTING AT THERE ARE MODELS BY WHICH GOVERNMENT CAN CAUSE THE STIMULATION OF A MULTI-DISCIPLINARY GROUP CHARGED TO CREATE THE STANDARDS THAT ARE ONGOING SO. I WOULD JUST GIVE YOU ALL SOMETHING TO SHOOT AT AND DISAGREE WITH BUT THAT WE WOULD CALL FOR THE GOVERNMENT TO STIMULATE THE DEVELOPMENT OF A CREDENTIALING GROUP THAT ALLOWS THIS FUNCTION, THIS REDENIALING TO OCCUR TO INCLUDE AT THIS POINT AND TIME OF THE A. C. -- THOSE TLI. AND TO BE AUGMENTED AS NECESSARY. IMTRYING TO GET AT YOU GET THIS IDEA SAYING THERE'S THIS GROUP. THE CHARGE TO THIS GROUP OUGHT TOING PRETTY SPECIFIC. IT OUGHT TO BE TO CREATE THE CRITERIA AND TO CONTINUOUSLY UPDATE THOSE CRITERIA BASED UPON RECOMMEND DALGTS -- RECOMMENDATION NUMBER 3 WHICH IS WHERE HUNT STARTED OUT AS WELL AND THAT BE THERE NEEDS TO BE JOB GOING STUDIES. WHAT IMDIFFERING A BIT IS IF YOU DECIDE THAT YOU CAN'T START UNLESS YOU HAVE EVERYTHING IN ORDER YOU WILL NEVER GET ANYWHERE. SO YOU GOT TO HAVE SOMETHING THAT GETS YOU STARTED. BASED ON THAT THEN WE CAN START TO SAY TO MOVE TO THE THOSE THAT HAVE TO PRACTICE WITH SOMEBODY THEN WE CAN GET TO THE INTERIM FOR THE OTHER THING. THAT'S JUST SOMETHING TO SHOOT AT .
HOW ABOUT AS A SUGGESTION HERE BECAUSE YOU TOUCHED ON THE LICENSURE ISSUE WHICH WE HAVEN'T YET GOTTEN TO. YOU'LL SEE IN THE RECOMMENDATIONS IN THE BULLETS WE'VE GOT FURTHER ON DOWN UNDER THIS MEDICARE DEMONSTRATION IDEA. I DON'T KNOW IF WE WANT TO PROPOSE A DEMONSTRATION PROJECT OR NOT. TAKE THAT OFF THE TABLE FOR A SECOND. LOOKING AT THE ALTERNATIVE THAT'S PRESENTED HERE IN THE BULLET IT TALKS ABOUT STUDIES THAT ASSESS BARRIERS TO BILLING AND REIMBURSEMENT AND WHAT NOT. WHAT IF WE COMBINE ALL OF THAT IN WITH THE FIRST ANALYSIS SO WE HAVE BACK UP HERE WHERE WE'RE TALKING ABOUT RESEARCH AND ANALYSIS TO DETERMINE WHICH HEALTH PROVIDERS BLAH BLAH BLAH. ADD TO THAT THIS BUSINESS ABOUT BARRIERS TO BILLING AND REIMBURSEMENT SO IT'S ALL PART OF ONE STUDY OR ONE ANALYSIS. THEN THE SECOND RECOMMENDATION WOULD DEAL WITH THE LICENSURE COMPONENT WHICH YOU IDENTIFIED. ARE THOSE TWO REASONABLE WAYS TO ATTACK THIS? DOES THAT GET AT EVERYTHING?
I THINK WHAT IT DOESN'T DEAL WITH IS THE CMS DEMONSTRATION PROJECT. WHICH I THINK IF WE'RE GOING TO USE THAT WORK THROUGH CMS AND MEDICARE WE'RE ULTIMATELY GOING TO NEED THAT. SO AS LONG AS WE LEAVE IN THERE SOMEWHERE THE CMS DEMONSTRATION PROJECT PIECE.
SO MERGE THE TWO SECTIONS THAT DEAL WITH FURTHER RESEARCH AND ANALYSIS. THEN ADD THE DEMONSTRATION SUGGESTION. THEN THE THIRD PIECE WOULD BE LICENSURE? WHICH ACTUALLY I THINK WE NEED TO TALK ABOUT A BIT MORE BECAUSE I DID NOTE IN THE REPORT THAT THERE REALLY WASN'T -- THERE WAS SOME DISCUSSION ABOUT WHAT LICENSURE CAN AND CAN'T DO. I DON'T KNOW THAT THERE WAS THE CASE MADE THAT THE THAT IS ABSOLUTELY CRITICAL. AND THAT THERE'S BEEN ANY DOCUMENTED HARM TO CONSUMERS WHEN THERE'S A LACK OF LICENSURE. SO I AM NOT SURE IF WE NECESSARILY WANT TO RECOMMEND THAT OR WHETHER WE WANT TO WAIT UNTIL THE ANALYSIS IS DONE.
A BIGGER PROBLEM HAS TO DO WITH JUST THE STRUCTURE OF HOW WE OPERATE. THERE WON'T BE NATIONAL LICENSURE THAT'S A STATE'S RIGHTS ISSUE. SO IT'S NOT GOING TO HAPPEN. SO I DON'T THINK THAT'S ONE THAT WE SHOULD EVEN GO AFTER. I THINK WHAT WE'RE TALKING ABOUT IS REALLY -- AND THEY'RE ARE ALREADY CERTIFYING BODIES. SO I AM NOT SURE WE NEED ANOTHER CERTIFYING BODY. I THINK WE WE NEED A GROUP THAT JUST BRINGS TOGETHER THE VARIOUS SEGMENTS OF THE NON-PHYSICIAN HEALTH PROFESSIONAL COMMUNITY PROVIDING GENETIC COUNSELING TO BE EVEN MORE INCLUSIVE THAN THE PANEL WE HAD TO ADDRESS SOME OF JOSEPH'S ISSUES, TO REALLY LOCK AT HOW ONE -- LOOK AT HOW ONE COULD GO ABOUT MAINTAINING QUALITY IN TERMS OF CERTIFICATION. BUT MAKING SURE THAT WE'RE CERTIFYING ALL OF THOSE INDIVIDUALS WHO OUGHT TO BE CERTIFIED.
I THINK THAT'S A MORE PRECISE WAY OF WHAT I WAS TRYING TO GET AT. I MEAN AT THE END OF THE DAY I THINK PEOPLE HAVE CONVINCED ME MAYBE NOT HUNT YET BUT THEY'VE CONVINCED ME -- THAT'S GOOD THAT'S WHY I'M TRYING TO LISTEN AND LEARN FROM HIM. IS THAT IT MAKES SENSE THAT IT EVEN THOUGH WE DON'T HAVE ALL THE EVIDENCE AND EVERY PIECE OF DATA IN YET THAT THE IDEA THAT A CERTIFIED COUNSELOR MAY WELL IN FACT ADD VALUE. ENOUGH SO THAT IMPREPARED IF THERE WERE A A REAL BODY OF -- A REAL BODY THAT COULD CERTIFY. THAT THERE ARE ARE REAL DISCIPLINES HERE, REAL RIGGER AND THAT NOT THE FOLKS ACTUALLY HAVE TRAINING AND COMPETENCY AND CAN DEMONSTRATE AT LEAST A STARTER SET OF KPE TENSE -- COMPETENCYS THEN I AM PREPARED TO THINK MAYBE THEY OUGHT TO BE GIVEN AN OPPORTUNITY TO DO THEIR THING AND BE COMPENSATED. IMPREPARED TO BE ACCEPTED THAT THAT NEEDS TO BE STUDIED. IMPREPARED THEN TO DO THAT UNDER THE CONDITIONS THAT THERE IS A ORGANIZATION THAT HAS SOME LEGITIMACY THAT IS ACTUALLY CONTROLLING THIS. SO IF YOU GOT THE CCH AND THE AMGA THEY CAN BE PULL D TOGETHER AND THE SUM -- SOME UM BRILLA THAT HAS RIGOR AND DISCIPLINE SO THAT FLY BY NIGHT CERTIFYING AGENCY A DOESN'T JUST JUMP UP THERE AND SAY ALL MY PEOPLE ARE NOW CERTIFIED THAT. THERE'S SOME RIGOR TO IT. SOME CONTROLS.
ALL RIGHT. AGNESS?
I WOULD JUST KIND OF REITERATE WHAT JUDY LEWIS HAD MENTIONED EARLIER IF WE LIMIT IT JUST TO A SPECIFIC GENETIC ORGANIZATION THAT WOULD SET THE CRITERIA OR PROVIDE THE CREDENTIALING THEN YOU ARE GOING TO OVER LOOK THE VARIOUS GROUPS THAT ALREADY PROVIDE CREDENTIALING FOR SPECIALTY ORGANIZATIONS. FROM MY OWN PERSPECTIVE IN ONCOLOGY, YOU KNOW THE ONCOLOGY CERTIFICATION, THE TRAINING PROVIDES BACKGROUND IN! NET EKS AND THE -- IN GENETICS AND NURSES ARE CREDENTIALED AS ADVANCE PRACTICE NURSES. MANY OF THOSE ADVANCED PRACTICE NURSES THAT WEREN'T REFLECTED HERE ARE ACTUALLY PROVIDING AT CANCER GENETIC RISK COUNSELING. SO WHEN YOU LOOK BACK THE NUMBER OF NURSES WHO WERE KRE DETERMINED THERE WERE ONLY 30. BUT IN ORGANIZATION THROUGH ONS THERE'S OVER 150 NURSES WHO ARE PROVIDING GENETIC RISK COUNSELING SO. THE APPROPRIATE CREDENTIALING BODY WOULD BE THE ONCOLOGY NURSING SOCIETY FOR A PROVIDER OF OTHER HEALTH CARE PROVIDERS THE SITUATION MAY BE SIMILAR.
MAYBE THEY CAN APPEAL TO THE GROUP AND LET THE GROUP WORK. I DON'T THINK WE COULD EVER WORK THAT LEVEL OF DETAIL OUT.
I JUST DON'T SEE WHY WE ARE EVEN GETTING INTO THIS. TO ME IT'S PRESCRIPTIVE POTENTIALLY. LET'S DO THE ANALYSIS AND WE CAN'T PREDICT WHERE IT'S GOING TO GO AFTER THAT OR SAY WHAT IF WE'RE GOING TO NEED CERTIFICATION. WE'RE GOING TO NEED LICENSURE WEECHT WON'T. -- WE WON'T. WE WILL. TO ME IT'S GETTING WAY BEYOND WHERE WE CAN GO WITH A RECOMMENDATION TO THE SECRETARY.
PART OF THIS DISCUSSION I THINK WE ALSO NEED TO LOOK AT JUST SAYING WHICH HEALTH PROVIDERS ARE APPROPRIATE. AGAIN I THINK YOU ARE BACK TO IDENTIFYING SCRIPTIVE STUDIES WHICH IDENTIFY THE QUALITIES AND CHARACTERISTICS OF THE PROVIDERS BUT I THINK YOU ARE OPENING ON THIS WHOLE THEME OF DISCUSSION A HUGE CAN OF WORMS ABOUT SCOPE OF PRACTICE, LICENSURE AND EVERYTHING ELSE. I THINK YOU ARE MAKING A BETTER CONTRIBUTION IF YOU SAY TO IDENTIFY THE QUALITIES AND CHARACTER STIKS OF THE PROVIDERS. NOT SAYING YOU'LL [INDISCERNIBLE] BY WHICH ARE THOSE PROVIDERS. I THINK THAT IS PART OF THIS DISCUSSION I THINK IT'S TRACK YOU MAY NOT WANT TO GO DOWN.
YES EMILY?
I AGREE. I DON'T THINK WE SHOULD GET INTO THE WHOLE ISSUE OF LICENSURE IN PARTICULAR. BUT I WOULD LIKE TO THROW OUT TO THE COLLEAGUES WHO PRESENTED ON GENETIC COUNSELING TO US THAT THEY MAY BE -- MAYBE THINK ABOUT A MECHANISM TO, QUOTE, CERTIFY INDIVIDUALS PARTICULARLY INDIVIDUALS WHO ARE PROVIDING SPECIFIC DISEASE CHARACTERISTICS KIND OF COUNSELING AND WHO ARE NOT GOING TO GO THROUGH A FULL BLOWN MASTERS IN GENETIC COUNSELING PROGRAM BUT WHO COULD BE CERTIFIED AS A QUOTE OFFICIALLY DEEMED COUNSELOR FOR CF OR SICKLE CELL OR SOMETHING LIKE THAT SO THEY, THOSE PEOPLE DID HAVE SOME TRAINING AND UNIFORMTY IN THE WAY THEY'RE PROVIDING SERVICES TO THE COMMUNITY.
WE ARE RUNNING OUT OF TIME. DO WE HAVE A CONSENSUS THAT WE SHOULD ELIMINATE THE LICENSURE RECOMMENDATION AND STICK TO THE FIRST TWO WHICH ARE THE ANALYSIS AND THE DEMONSTRATION PROJECT FOR THIS RECOMMENDATION?
I MAY BE THE ONLY ONE BY THE WAY IT'S NOT LICENSE BUT CERTIFICATION WAS MY THING NOT THE LICENSURE. IF I AM THE LONE PERSON FOR HAVING THE CERTIFICATION GROUP SET UP AND THEN STUDY SIMULTANEOUS AND IF -- SO IF I AM THE ONLY ONE THEN WE SHOULD RUN ME OVER.
YOU ARE NOT THE ONLY ONE.
THEN STICK TO THE KRERT STUDY FIRST THEN LET THE STUDY DIRECT WHAT HAPPENS AFTER THAT. WHICH IS I THINK THE HUNTINGTON AND OTHER POINT OF VIEW.
DEBRA?
I BEEN SITTING HERE LISTENING I AM KIND OF UPSET BUT I'M NOT SURE HOW TO VOICE WHAT'S REALLY BOTHERING ME. I THINK PART IS THAT I HAVE MANY COLLEAGUES WHO ARE GENETIC COUNSELORS WHO ARE PROFESSIONALS AND I'VE HIGHLY VALUE THEIR EDUCATION, THEIR CERTIFICATION. AND THEY HAVE A CERTIFICATION PROCESS. AND THAT'S BEEN DESCRIBED TO US BY THE WORKING GROUP GNCC AND ABGC. HAVE A CERTIFICATION PROCESS. THEY DESCRIBE THE CRITERIA FOR THAT WHICH SEEMS RELATIVELY THOROUGH AND THE TRAINING THESE PEOPLE HAVE TO HAVE. NOW YOU CAN ARGUE THAT ANALYSIS IS NEEDED FOR THE VALUE ADDED, THE OUTCOMES RESULTS OF GENETIC COUNSELORS GET, BUT THESE PEOPLE ARE PROFESSIONALS. AND I FEEL THAT WE ARE SITTING HERE AND DISCUSSING THEIR PROFESSIONAL STATURE AND IT'S INSUL TION -- INSULTING TO THEM. AND TO ME WHO WORK WITH THESE COLLEAGUES. SO I AGREE WITH REED THAT WE SHOULD SET UP SOME PROCESS TO ACKNOWLEDGE THESE PEOPLE AS PROFESSIONALS. THEY'RE CERTIFIED. THERE'S SOME WAY OF SAYING THIS IS THE GROUP OF THESE PEOPLE WHO ARE QUALIFIED TO PROVIDE GENETIC COUNSELING SERVICES. AND THEN THAT BODY CAB CAN DEAL WITH THE PEOPLE WHO ONLY COUNSEL FOR CFN IN OBGYN OFFICES AND OTHER ANCILLARY GROUPS THAT AREN'T DOING A FULL GLON MASTERS. BUT YOU HAVE PEOPLE WHO ARE HIGHLY PROFESSIONAL AND WE'RE TALK ABOUT HAVING TO DO ANAL SS THAT'S PROBABLY GOING TO TAKE TWO OR THREE MORE YEARS BEFORE THERE'S ANY RESULT COME OUT AND THEY'RE ALREADY CERTIFIED. SO I WOULD AGREE WITH REED THAT THERE SHOULD BE A CERTIFICATION PROCESS. LICENSURE I ALSO AGREE WITH ED. BUT LICENSURE IS NOT SOMETHING, THAT'S A STATE BY STATE BASIS THAT I DON'T THINK WE CAN INFLUENCE MUCH. IT'S WHOLE LEGISLATIVE PROCESS. BUT THE CERTIFICATION SO THAT THEN IF THESE PEOPLE ARE RECOGNIZED AS CERTIFIED BY THIS BODY THEN THEY WOULD HAVE THE RIGHT TO BILL EITHER -- I MEAN THEN YOU COULD WORK ON THIS OTHER THINGS THAT MAYBE NEED TO BE ANALYZED UNDER THIS ANALYSIS SECTION. BUT I AM JUST FINDING THE WHOLE CONVERSATION INSULTING.
I DON'T THINK WHOEVER ALL THE FOLKS WHO ARE INVOLVED IN PUTTING THIS TOGETHER THE INTENT WAS NOT TO INSULT ANYONE BUT IT WAS ACTUALLY TO FACE THE VERY REAL SITUATION WHICH IS TO GET REIMBURSEMENT FROM GOVERNMENT PROGRAMS OR FROM PRIVATE FRAMS -- PROGRAMS. IT'S NOT THAT WE'RE QUESTIONING THEIR QUALIFICATIONS AND THEIR VALUE. IT'S THE FACT THAT THESE PLANS AND MEDICARE AND OTHERS DO REQUIRE A CERTAIN AMOUNT OF PROOF. THEY DON'T JUST LET ANYBODY COME IN AND THE BILL FOR ANYTHING. AND SO --
BUT ABGC AND GNCC ARE NOT PROVIDING THAT KIND OF PROOF? I THINK THEY ARE IN THEIR CERTIFICATION PROCESS. IT'S VERY STRIGENT.
THEY SHOULD BE BUT I THINK THERE ARE SOME PROGRAMS AND PLANS OUT THERE THAT APPARENTLY AREN'T RECOGNIZING THAT. OTHERWISE WE WOULDN'T BE FACED WITH THIS PROBLEM THAT THERE ARE SOME DIFFICULTIES IN BILLING AND REIMBURSEMENT. I MEAN THAT'S THE SENSE THAT I HAVE IS THAT THERE ARE SOME REAL BARRIERS OUT THERE THAT SHOULDN'T EXIST FOR THESE PROFESSIONALS WHO ARE PROVIDING THESE SERVICES. SO WHATEVER IT TAKES TO CONVINCE THE PAYERS THAT'S WHAT THESE RECOMMENDATIONS ARE FOCUSED ARE. NOT TO INSULT ANYBODY BUT TO HELP THEM MAKE THE CASE SO THAT WE CLEAR CLEAR AWAY THESE BARRIERS.
AT LEAST IN SOME DISCUSSIONS PARTICULARLY WITH ANDREW NOT SURE THAT THE ASSESSMENT AND VALUATION PERIOD IS GOING TO BE THAT LONG NOR THAT DIFFICULT FOR THE VERY REASONS THAT YOU POINT OUT. I THINK THERE'S A GOOD BIT OF EVIDENCE THAT'S OUT THERE. I DON'T THINK IT HAS BEEN PULLED TOGETHER AND STRUCTURED WELL SO THAT IT CAN BE ANALYZED IN A WAY THAT GIVES PEOPLE THE SENSE OF THE KIND OF OUTCOME MEASUREMENTS THEY WANT TO HAVE. SO IN THAT SENSE I MEAN I AGREE WHATEVER WORKS IS I THINK WHAT WE'RE TRYING TO GET AT. IF IT'S STUK THAT SAYS PULL THE CERTIFYING GROUPS TOGETHER UNDER SOME COORDINATING ENTINTYTY THAT'S FINE. LET'S GET MOVING ON THE ANALYSIS AND EVALUATION SO THAT THE PROFESSIONALISM OF THESE PEOPLE AND THESE GROUPS CAN BE DEMONSTRATED TO THE CRITERIA THAT'S BEEN USED BY THE REIMBURSEMENT AGENCIES. OBVIOUSLY THERE'S A GAP. AND I THINK THE EFFORT IS TO CLOSE THAT GAP AS SOON AS. JUST BECAUSE WE KNOW OF THE PROFESSIONALISM OF THESE PEOPLE. AND WE'VE GOT TO DO WHATEVER WE CAN DO HELP CLOSE THAT GAP.
I THINK IN SOME WAYS I'M HEARING WE'RE STARTING TO GET CLOSER HERE. AND MAYBE IT IS THAT YOU KNOW WE SIGNAL WHAT WE ARE ATTEMPTING TO DO. WE'RE SAYING THIS OUGHT TO OCCUR. WE'RE SAYING THAT THERE IS A PLACE TO START. SO THAT YOU GOT THIS FOUNDATION. THEN WE'RE SAYING THAT WE HAVE SOME CRITICAL QUESTIONS THAT NEED TO BE ANSWERED QUICKLY. MAYBE THSES THE GROUND. SORT OF BEING WHERE I HEARD HUNT AND A COUPLE OTHERS SAYING WE REALLY WANT TO KNOW THE ANSWERS TO A COUPLE THINGS HERE. BUILDING ON THE FOUNDATION THAT EXIST NOW. MAYBE THERE'S A HYBRID SOMEWHERE THAT LETS THIS THING MOVE.
COULD I JUST ADD A COUPLE POINTS OF CLARIFICATION FROM ABOUT TEN YEARS OF DOING WORK FORCE RELATED RESEARCH BECAUSE THERE'S SOME CONFUSION OF ISSUES THAT'S MAKING THIS MORE DIFFICULT THAN IT NEEDS TO BE I THINK. LICENSURE IS SOMETHING THAT EVERY IDENTIFIED HEALTH PROFESSIONAL GROUP WOULD LIKE TO ACHIEVE LICENSURE IS A VERY POLITICAL PROCESS AT THE STATE LEVEL. I HAVE A SENSE THAT THERE IS PROBABLY UNIFORM SENSE FROM THE COMMITTEE BUT YOU COULD GET CLARIFICATION ON THE ISSUE THAT GENETIC KOUN IS SELLORS ARE -- COUNSELORS ARE CLEARLY A NEW HEALTH PROFESSIONAL. A HEALTH PROFESSIONAL THAT HAS COME ABOUT BECAUSE OF THE GROWTH AND EXPANSION OF GENETIC SERVICES. AND AS ADVISORS ON THAT, I THINK YOU COULD SEND VERY STRONG SIGNALS. I DON'T QUITE KNOW HOW YOU WOULD HAVE TO FEESBLY DO IT BUT THAT IF YOU RECOGNIZE THAT GENETIC COUNSELORS ARE A NEW INFORMATION, THEY'RE NOT RECOGNIZED WITH LICENSURE, BUT THAT WOULD STRENGTHEN THE GENETICS WORK FORCE. AND HOW YOU DO THAT IN YOUR VERY TIGHT CONSTRAINT ABOUT WHAT YOU CAN RECOMMENDATION TO THE SECRETARY OR NOT I THINK THERE'S A WAY TO DO THAT. LICENSURE IS POLITICAL. IT'S SOMEWHAT COSTLY TO STATE. YOU HAVE HEARD THE PERSON. A PROFESSIONAL WANTING TO GET LICENSURE DOES NOT HAVE TO SHOW TO ANYBODY GENERALLY THAT THEY'RE COST EFFECTIVE OR ANYTHING. THEY JUST HAVE -- IT'S CONTAINED IN GENERAL WITHIN THE PROFESSIONAL TO DEFINE WHO IS ELIGIBLE TO BE NAMED AS A LICENSED GENETIC COUNSELOR AND WHATEVER. I WOULD STRONGLY GO YOU KNOW SAY THAT IT WOULD BE AGAINST CONVENTIONAL CERTIFICATION OR WHATEVER TO TRY TO ESTABLISH A SUPER STRUCTURE CERTIFYING BOARDS TEND TO BE VERY PROVE SPECIFIC -- PROFESSION SPECIFIC. AND YOU HAVE A WELL ESTABLISHED CERTIFYING BOARD WITH THE AMERICAN BOARD OF GENETIC COUNSELORS. AND WELL DEFINED CREDENTIALS, TRAINING PROGRAMS, WHATEVER. THAT'S NOT BROKEN IN ANY WAY. SO THEY WOULD EASILY WHEN THEY HAVE POLITICAL SUPPORT OR WHATEVER WITHIN THE STATE COULD BECOME LICENSED. THEY'RE TINY. THAT'S PART OF THE PROBLEM RIGHT NOW. THEY'RE A NEW PROFESSION THAT PEOPLE DON'T VERY WELL UNDERSTAND AND IT HAS TO BE DONE CAREFULLY SO THAT AS WAS MENTIONED YOU DON'T EXCLUDE OTHERS FROM THE LEGISLATION BUT I THINK THE GENETIC COUNSELORS CAN DEAL WITH THAT. I THINK WHAT THEY'RE ASKING FROM THIS GROUP --
LET ME JUST SAY.
IT'S DIFFERENT THAN --
'WHAT DO YOU SAY THE GNCC AND SO FORTH ARE NOT IN THE AMERICAN BOARD OF GENETIC COUNSELORS.
I AM NOT.
DOES THE AMERICAN BOARD SOLVE THE PROBLEM OF LETTING THE GNCC IN? AS AN EXAMPLE.
NO. LIEUTENANT THAT'S A DIFFERENTISH -- BUT THAT'S A DIFFERENT ISSUE THAT THE NURSING PROFESSION HAS TO WORK ON. BUT THE 6 PROFESSION OF GENETIC COUNSELING GETTING LICENSURE IS READY TO GO IF THIS GROUP FEELS THAT LICENSURE IS APPROPRIATE FROM ALL THE EVIDENCE THAT YOU HAVE HEARD IN YEARS OF PRESENTATION BY GENETIC COUNSELORS AND YEARS OF CUMULATIVE EXPERIENCE OF WORKING WITH GENETIC COUNSELORS. I HAVE A FEELING THERE'S CONSENSUS THAT GENETIC COUNSELORS YOU KNOW THE TIME HAS COME TO RECOGNIZE THEM AS A PROFESSION. HOW YOU DO THAT CAN BE WORKED OUT. BUT GETTING A SENSE OF THE BOARD WOULD BE USEFUL. IT'S VERY DIFFERENT THAN REAMBURG ISSUES AND -- REIMBURSING ISSUES AND PROVING YOU ARE COST EFFECTIVE TO PAYERS AN WHATEVER. VERY, VERY DIFFERENT ISSUES. RELATED BUT YOU CAN TAKE A STEP AT A TIME.
WHAT ABOUT THIS LAST IT RACING HERE OF WE WOULDN'T BE RECOMMENDING LICENSURE IT'S NOT WITHIN OUR PURVIEW BUT RECOGNIZING THAT THERE MAY BE STATES THAT DO FOUGHT HAVE LICENSURE -- DO NOT HAVE LICENSURE THAT PUBLIC PROGRAMS AND PRIVATE HEALTH PLANS SHOULD RECOGNIZE CERTIFICATION BY SOMEONE. AND I DON'T KNOW IF THESE TWO ARE THE ONES WE WANT TO NAME OR DO WE NAME ANYONE AS EE QIF LENT TO LICENSURE.
YOU ARE TRYING TO MERGE REIMBURSEMENT ISSUES WITH LICENSURE ISSUES. I THINK IF YOU -- I THINK WHAT WE WERE ASKED TO SORT OF PRESENT IS GENETIC COUNSELORS ARE RELATIVELY NEW PROFESSION. THEY'RE VERY SMALL, THEY'RE GROWING. THEY'RE EXTREMELY IMPORTANT TO THE DELIVERY OF GENETIC SERVICES IN THE COUNTRY FOR THE CURRENT AND NEAR TERM. AND I THINK A STATEMENT THAT WOULD BE FASHIONED IN SUCH A WAY THAT WOULD SAY THE COMMITTEE YOU KNOW RECOMMENDS, RECOGNITION OF THE PROFESSION OF GENETIC COUNSELORS. ONE OF THE FEW HIGHLY TRAINED PROFESSIONALS THAT IS NOT LICENSED.
THE REASON WE'RE LINKING IT IS BECAUSE IT'S COVERAGE AND REIMBURSEMENT REPORT. THE LACK OF LICENSURE OR SOME REFUSAL BY SOME PLANS OR PROGRAMS TO RECOGNIZE CERTIFICATION HAS BEEN IDENTIFIED AS A BARRIER TO COVERAGE AND REIMBURSEMENT.
THAT'S CORRECT.
THAT IS WHY IT'S IN HERE. IF WE NEED TO DELETE IT ENTIRELY WE COULD DO THAT.
IT COULD BE A TWO STEP THING. BUT WHAT I HAVEN'T HEARD YOU SAY AND IT WAS BROUGHT UP BY DEBRA A LITTLE BIT IS WHAT IS THE SENSE OF THE GROUP AROUND RECOMMENDING YOU KNOW THE SENSE OF THE COMMITTEE ON LICENSURE FOR THIS HIGHLY TRAINED, HIGHLY PROFESSIONAL NEEDED NEW PROFESSION.
LET ME JUST AS THE MODERATOR OR WHATEVER I AM STOP FOR A MINUTE AND DO A PROCESS CHECK HERE. WE HAVE A CHALLENGE. FIRST OF ALL THANK YOU. APPRECIATE THAT. CINDY'S GOT TO GO. WE'RE PAST THE 5:30 MARK. PEOPLE ARE TIRED. YOU GUYS HAVE WORKED REALLY HARD TODAY. OUR CHAEJ IS THAT WE'VE GOT A HECK OF A SCHEDULE TOMORROW. WE GOT TO BRING SOME RECOMMENDATIONS TO CLOSURE. SO AND WE'VE GOT -- WHAT'S THE SNOW LOOK LIKE OUT THERE? I WAS MORE WORRIED ABOUT TOMORROW MORNING. HUNT'S WHERE I AM GOING HERE. IS THAT DO WE THINK WE'LL BE HERE TOMORROW?
[INDISCERNIBLE]
WE'LL BE HERE. THE QUESTION IS WHETHER WE LEAVE.
I THINK WHAT I'D LIKE TO DO IS THIS. I THINK WE'D LIKE TO START AT 8:00 TOMORROW. THE QUESTION IS CAN CINDY BE HERE TOMORROW? GOOD. SECOND THING IS I THINK WHAT WE NEED IS TO HAVE A FEW PEOPLE TRY TO SIT TODAY WITH CINDY AND SUZANNE -- YES.
WE CAN'T START AT 8:00?
THE FEDERAL REGISTER SAYS THAT YOU CAN'T START UNTIL 8:30 BECAUSE WE DID THE 8:30 SO THERE ARE THEREFORE. LET ME ASK THIS IN THE RULES. CAN WE HAVE A WORK GROUP MEETING TO WORK ON THINGS AND THEN AT 8:30 TALK ABOUT WHAT WE'VE CREATED? CAN WE MEET AS A COMMITTEE AS A WHOLE AS A WORK GROUP THEN SAY THEN REHEARSE EVERYTHING WE THA WE DID AT 8:30. CAN'T DO THAT EITHER.
AS LONG AS RECOMMENDATION -- AS LONG AS THERE'S NO DECISIONS MADE DURING THE WORK GROUP DISCUSSIONS AND THAT.
DON'T WORRY. LAFSES LAUGHS.
[LAUGHTER]
IF THERE ARE ANY RECOMMENDATIONS THAT THEY ARE DISCUSSED IN PRUB.
BUT I DON'T THINK YOU CAN START AT 8:30. I DON'T THINK YOU CAN BRING IT TO THE GROUP -- I THINK WE'LL HAVE TO DO IT LATER IN THE DAY BECAUSE WE HAVE TO GET GOING ON THE. DON'T WE. OR DO WE HAVE TIME FOR THIS?
NO WE HAVE TO START WITH LARGE SGLAUK SO WE HAVE TO RELOOK AT THE SCHEDULE THEN WE'LL DO THAT THEN. AND WE HAVE TO FIGURE OUT SOMETHING.
WE'RE ALLOWED TO CONTINUE --
TONIGHT.
YOU CAN HAVE IT TONIGHT IF YOU WANT.
NO CONTINUE THE DISCUSSION RIGHT NOW.
OH YEAH YOU CAN CONTINUE.
YOU ARE JUST NOT ALLOWED TO START EARLIER BUT YOU CAN CONTINUE LATER.
I DON'T THINK THAT THIS COMMITTEE SHOULD BE SUBJECTIVE TO THE TYRANNY OF HAVING TO KEEP WORKING ON THIS RIGHT NOW. I THINK PEOPLE ARE TIRED AND THEIR NERVES ARE FRAYED. I THINK WHAT I WOULD LIKE TO DO IS TO HAVE A SMALL GROUP OF PEOPLE TRY TO FRAME THE ISSUES VERY CAREFULLY FOR TOMORROW. AND IF HUNT IF YOU WON'T KILL ME ON THIS I'D LIKE YOU TO SIT WITH CINDY AND WITH SUZANNE AND I WOULD LIKE ED TO SIT FOR A FEW MINUTES AND TRY TO LAYOUT THE ISSUES IN TERMS OF WHAT ARE THE DEBATE POINTS HERE. AND AT LEAST LAYOUT IN STARK CONTRAST WHAT WE SEE AS BEING THE SEQUENCE. STARTING WITH THE WAY WE WANT THE WORLD TO BE AND WHETHER OR NOT YOU ACTUALLY HAVE YOU KNOW A CERTIFICATION CRITERIA FOR INDEPENDENT BILLING. WHAT WOULD IT TAKE TO BE ABLE TO MAKE THAT HAPPEN. I CAN'T DO THIS TWICE. YOU GOT TO WRITE THIS DOWN. THIS IS IT MAN. THE ASSIGNMENT IS TO JUST LAYOUT IN CLEAR TERMS WHAT THE DEBATES ARE AROUND STARTING WITH A IF YOU COULD CREATE CERTIFICATION WHAT WOULD IT TAKE, WHAT ARE THE CRITICAL QUESTIONS THAT HAVE TO BE ANSWERED TO SATISFY PEOPLE. SECONDLY IS WHAT CAN THE SECRETARY RECOMMEND ABOUT THAT THAT'S REL HAVEN'T. THIRD, IS WHAT DO YOU DO ABOUT THE FOLKS WHO ARE NOT INDEPENDENT BUT INCIDENT TO. AND THEN FINALLY WHAT DO YOU DO IN THE INTERIM WHILE YOU ARE TRYING TO, WHATEVER YOU ARE TRYING TO CREATE. I MEAN TRY TO LAY IT OUT IN TERMS OF WHAT ARE THE DEBATE POINTS AND CLARIFY THEM AS PLEA SISLY AS PROST POSSIBLE. -- PRECISELY AS POSSIBLE. GIVE US THE LANGUAGE TO CHOOSE FROM AND LET'S TRY TO -- SO CAN YOU ALL DO THAT AT 8:00? FROM 8-8:00 THIRTY.
YOU WON'T BE HERE.
I WILL. AMANDA WE CAN DO NA YOU WILL BE HERE TONIGHT? SO LET'S TRY TO GET THAT DONE THIS EVENING. SOMETIME EITHER BEFORE DINNER OR RIGHT AFTER DINNER. OKAY. THANK YOU. WHAT DO YOU WANT TO DO TONIGHT OR 8:00.
8:00.
ED? HUNT? AND CINDY. CINDY WON'T BE HERE.
YES SHE WILL.
CINDY WILL BE HERE IN THE MORNING. AND KIBD CINDY AND WHO ELSE WANTS TO -- I SEE A VOLUNTEER.
BARBARA.
CAN WE DO IT AT 7:30?
IN THE MORNING. [LAUGHTER]
IS THAT OKAY. THEY KEEP TELLING ME WHO IS GOING TO BE HERE AND WHO IS NOT SO I AM GETTING CRAZY. 7:30 IN THE MORNING. MEET RIGHT HERE? AND JUST WE'LL JUST HAVE IT LAID OUT. JOE WANTS TO JOIN THAT. WE GOT THE WHOLE COMMITTEE COMING.
YOU CAN'T HAVE THE WHOLE COMMITTEE.
IMJUST KIDDING. OKAY 7:30 THEY'LL DO THAT. NOW THEN WE WILL FIND SOME TIME IN THE DAY SOME KIND OF WAY TO WORK ON THIS. WE'LL FIGURE THAT OUT. WHAT TIME IS DINNER?
SIX.
SIX WHERE?
YOU ALL HAVE WORKED VERY HARD AND CAN I JUST --
CAN I JUST ASK BECAUSE THERE WAS ANOTHER SUB COMMITTEE PUT TOGETHER THAT I WAS GOING TO HAVE BRIEFLY TOMORROW MORNING BUT YOU HAVE JUST CO OPTED HALF OF US. SO DEBRA, HUNT, KEVIN AND ME COULD WE MEET FOR TEN MINUTES RIGHT NOW PLEASE AND TALK ABOUT DEFINITIONS.
DEFINITIONS. OKAY.
OKAY.
DINNER IS RIGHT WHERE WE HAD LUNCH. ALL RIGHT THANK YOU VERY MUCH. GOOD DAY'S WORK.