Event ID: 1167874
Event Started: 12/2/2008 7:34:03 AM ET
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Now that we neared the completion of that study and agenda, we need to follow up with the rest of our issues. We did some brainstorming back then and did some diagrams on the other projects.
Today our goal is to finalize our future topics and how we need to address them and what we need to do to get the final work done. This is not going to be final -- we hope this is not time, we want to work on the scope of that work and speak with the secretary and his staff to talk about how that duck tails with their priorities so we can get some good alignment and work together.
Paul Wise has been leading this and I appreciate his work with this as a Chair of the priority task force. He will lead us through the steps that we have taken and then the members of the task force will identify the issues that we have brought out in July July. We have a long list of stuff on our plates and then we want to discuss the priorities in which we want to tackle those.
Paul?
Thank you. First slide, please. Thank you. Just to remind people that the priority setting and task force includes the members of the committee, and you can see on this slide the membership. We also starred the people who were members of the cluster leagues. And they will be discussing the issues of what are potentially our highest concerns. I also want to thank the staff who worked extremely hard in this quality of work which includes: Kathy, Sarah, Kathy, and Linda.
The next slide. This reviews the priority setting and processes that we use. 73 potential priority issues were generated through brainstorming sessions that we had at our February meeting earlier this year. We subsequently had discussions with ex-efficio members and discussions with their agencies and departments. We received comments and a broad range of their suggestions. We also had specific interviews with the context experts but also what we call vision leaders where we can expect the broadest advice in where we should head in the next few years. This is where we should use the scale and then we will and have examined the priorities that were ranked as the first most important and relevant to our work. We are also looking at the affinities between the different work issues and organize the coherent structures for the issues that were ranked high and then develop and confirm that there were, in fact, a relatively small group of work clusters based on their workmanship and the patterns that the committies were discussing. The next step was to take the clusters and the steps to initiate those. We did a nice job of capturing the essential elements of the clusters that were identified as most important and relevant. These clusters were seven in numbers, and it showed the reimbursement of the services, the genetics and training, informed consent, privacy, genomic services, public health applications of genomics search with disparities and genetics involved in the health care system. Just to identify our goals for today's conversation, we will first have presentations of each of the cluster areas by the cluster leads. There was a format that was suggested for the presentation of these issues. The order of cluster presentations in no way reflect anything about how we valued these issues. They are not ranked on the basis of any criteria, but it is strictly the way we feel the order would be most helpful for the presentation.
Then, we want to discuss the policy steps and the action steps in each cluster and then we want to develop an overarching and action plan. There is no formal vote today, but we are really looking for several things. One, we want to ensure we have the issues right and that the elements are reflected in the issue briefs and in the presentations. Also, we would like to see through the discussion that we can develop or at least get a sense of the consensus of which of the seven deserve the greatest attention particularly in the conversations coming in in the upcoming administration.
Okay. So we will work through the seven clusters. They are relatively short presentations. If you have questions or need clarifications, something you really need to voice at this time, that would be fine to ask the cluster leagues; otherwise, we have a lot of time set up for after the presentations for comments, criticism, questions, and suggestions, so we hope that most of the questions and the like could be addressed after we are completed with the clusters.
Okay. We will now go on to cluster number one. If you look under the first sub bullet, it continues and so essentially, we have heard that there is unresolved issues from the February 2006 SACGS report, and we are basically continuing to work on those unresolved issues. There are strategies to remove the obstacles and some of the recommendations that have been brought forth. This deals with the medical coding, billing, and policies.
The next slide, please. This contains documentations where we have -- that we have heard at different meetings, so I am not going to walk through each of these. But we also heard from Steve yesterday that we have been told and are expecting a letter from the Secretaries and the representatives to follow up with the remaining issues that we had discussed in the last conference calls and the letters that are going back and forth this year. The policy questions that we are interested in focusing on is the payment rates for each genetic tests, and we know that the Medicare B schedule are under relative values concerning the costs. We are trying to address the Medicare B Fee schedules. This is an issue related to offering the tests. Some of the information that we discussed yesterday also impacts the testing. The billing is related to the certified genetic councilors and how we are able to get access to the CPTM codes which we think is increasingly important based on the increasingly importance of the genetics and the activeness. As we saw from the tests yesterday, I think all of us are at least -- all of us who are at least mildly related to the payment side are good candidates for payment on the genetic testing side of the field. We have a good application here that relates to the report. We have a good application for the reimbursement audit for the procedures and the audits. We have the procedure codes and certain CPT codes which are done in multiples, sometimes many -- multiples. This is not reflective of the work that is happening in the laboratory. That is on hold at the present time, but we haven't had a resolution to that issue.
Next. We have talked to this community about the family history and we heard yesterday from Steve about the roll-out of Version 2 of the Surgeon's General tool and throughout other areas within the government to use this as a standard user friendly history tool. We are left with the issue of how we actually use the family history and then how do we fairly reimburse for that? In particular, the idea of using the family history in the use of emergency needs. Is there a way we can use the evidence groups such as E-Gap and others, where we can provide the personal history gaps and provide some preventions. Also, looking ahead to August 2009 conference about family history which will give us the best estimate of evidence that there really is in relation to the science of history. How can we look at the current system and say, are we looking beyond the family history or something such as that as you are doing a family analysis which is working outside the family history and the medical codes and is there a way to reimburse people for going beyond that effort there?
Next. In conjunction with the farm Pharmagenomic codes there, this is part of the national testing and their codes located there and that is brought to you by CMS and how that should be brought to you in that way. There could be some considerations related to the CMS which is the genomic tests. This is an issue that really needs to be resolved. Ultimately how do the reimbursement issues impact the issues related to the genomic services. How can we populate that with the issues that are being reserved.
Next. We are going to continue to monitor the considerations from the 2006 and 2007 reports. We have a list of questions to submit to the officials and we hope to have some answering boy the -- by the end of year. We are hoping to add this to the clinical laboratory in order to open the inherent reasonableness. We hope we are able to trade-off everything. There may be some decreases. As a laboratory community as a whole, would they look at this as a benefit, or would there be more harm than a benefit as the issues accrued? We have to look at the authorizations and the documentations provided by the providers submitted through the Providers Act in 2008. We have to look at the actions we are taking in the family history and we are looking at and trying to encourage demographic data so we can provide better services and populations. That is a brief overview and most of this is what the committee has signed off on and I hope we are able to pursue those things and at this time I am happy to answer any questions.
[ Speaker/Audio Faint & Unclear ]
This is in in regards to engaging the professionals in monitoring those types of history. We can actually work together in a single group.
[ Speaker/Audio Faint & Unclear ]
Why don't we move on then to Cluster 2.
Thank you, Paul. I have to disagree a little bit about my colleague, Mark Williams. We are going from money to value.
This is a topic that we have already began to discuss. Paul Billings you are on the phone, correct?
I am here, yeah.
Great.
I'm sure you will chime in?
I doubt it. Go ahead.
Wow.
[ Laughter ]
Clinical utilities is an issue that we have also been tackling in many different ways. We are also working with clinical challenges at CMS. I want you to look at the clinical utility. We don't have a set of expedientary challenges as far as genomics and things of that nature.
At the moment there is nothing dedicated to the genomic assessments in the varying degrees. There is a set of concerns as far as how we are going to deal with the avalanche effects of the sequencing and how to ensure that the information there is going to be applied in the way that is beneficial to the patients. Somebody, some organization, will be needed to ensure that we use that utility on that as well.
There is a number of organizations that have begun this group, and that is E-Gap, that is out of CDC and they have been performing standards and assessments, but it is small and they have only began to tackle a small modest set of numbers at the moment. There is a variety of commercial and non-commercial technology that is listed up here. You have Hays here, Blue Cross Blue Shield is also another one. You have the round table and the genomic research for health. And they are very concerned with these issues and in how we are going to get the technologies translated in the health care system.
The reports on the Pharmagenomics. And we have recommended that the secretary provide a department to define the standards and explain each standards in the way they should be judged and make a decision based on those clinical guidelines needed for those assessments. There are Bills in Congress that do that generally in health care, not specifically with genomics, but there are also organizations that would like to do that personally in the private sector.
So some of the issues we think we can address is: Which groups would be most effective in finding the standards and doing the reviews. The second one is: Having governing forms and involvement with those actions so that the appropriate studies will be done and we will have the information that will allow us to assess the specific technologies and how they can be applied for specific conditions. Although we have recommended in the past that this is a public/private organization that would be responsible for assessing the utilities for the tests, but that is only one option of how it could get done. This is part of the review, but it is also part of how it is organized and structured along with the scope. This also includes the important technology issues, et cetera, to better inform the users, regulations, health care providers, and how they can use that throughout their decision making. The next one is about the government organizations or groups and that can provide the standards for the utility methods and assessments and can do those utilities on a better systematic basis than what we have right now.
[ Speaker/Audio Faint & Unclear ]
This is part of encouraging or obtaining money or funding, it's a pie. Sometimes it's more appealing to pay for certain funds.
No, I think it would be part of helping you to provide that. I think it is not specifically in the genomics area, but it actually carves out a broad list of things. They talk about performing or conducting the work.
Right.
They do the clinical trials and go on through the economic evaluations. I think we want to talk about the scope and what that should be.
Right.
There is a whole range of things that can be done under this general Rubric.
Okay. That's fine. Thank you.
Other comments?
Thank you very much, Steve.
We will move on to cluster 3.
Thank you.
We have money suggestions about the money, the value, and then also suggestions about the knowledge.
[ Laughter ]
This is about the training and the initial FAC which was part of the topic which rose high on the list that we did throughout data gathering and has continued to improve throughout this conference. There are reasons for that. We have started a task force based on other priority settings in November 2007. You have heard a fair amount of our activities, so I will make this fairly brief since you have heard about this a lot. But in terms of our review, I want to touch on that a little bit. In our committee we have identified three groups to focus on to complete our goals. Another group is working on the health care providers and the others are looking at the needs for patients and consumers. This is collecting the data on those and the different ways in terms of background. This keeps coming in base the clinicians and consumers are provided with a greater source of knowledge and we are trying to keep them up with that.
Next slide. We are trying to go through the different types of programs out there. We are trying to go through those and implement the plan. We are trying to use those as models so we don't have to reinvent the wheel. What is the government's perspective on that situation? What can HHS do to help with the education and the training? We are looking to see a role played by the federal government on this.
An important where is: What can the federal government take in a role with the health care professionals and the like. We would like to help people with the 2010 recommendations with health and the health care work force through the angle of genemics and training. This is another area that we will be looking at. And the other one is the whole certifications of licenses and the government deals directly with that.
We would like to look more closely as to the health care providers, and the clinicians and their educators. I think at our last meeting we heard a lot of promotional material that is reaching us in regards to the genetic services. It is being used for marketing and education for the consumers and the other health care professionals. We might as well look at that and see if there is something to gain from that or learn from that. As our role in the FDA, we are involved in monitoring that and that was brought up at the oversight committee.
It was suggested that we can sit down quickly and briefly with the FDA and see what their purview is on this. And then we would like to see establishments on the health care industries and voluntary groups. We are working hard on the data and the surveys and other materials.
[ Phone Ringing ]
Hello.
We will also have comments in 2009 and we hope we will have reports out 2010. This is part of the next level in seeing how people can become involved in the genetics and genomics.
I believe that is it. Yes.
I was wondering what interaction you envision with the educational responsibilities and the recommendations that you made and the work task force too, because it seems to me that they should be closely related. There are tests that are not validated and those should not be used when there are tests that are validated and used for prevention.
Absolutely. It needs to be shared across the board with the clinicians, physicians, health care groups and providers. Thank you.
I would like to add E-Gap, and the stakeholders within E-Gap, they try to provide the information whether it is a positive or negative utility of that information, so it does seem to be a positive point of reinforcement.
Part of the discussion that I hope follows in this presentation of clusters is that that -- is the support of the Clusters. We need realities and linkages. Reclustering the clusters is, in fact, one of the most helpful things we can do.
Any other comments?
[No Response]
I want to thank Barbara for all of your hard work that has been identified throughout many different parts in the committee.
Cluster 4. Kevin.
Okay. Money, value, knowledge, and this is power. Information is power. What we are going to do with that information and how that information is going to be given to people and how they use that information in order for them to make choices, that, of course, works into a concept of informed consent. That is where people are supposed to get all of the relevant information they need to make the informed decision. All of the information is relevant. All of it has to be put together somehow and then we will come up with a comprehensive view of the confidential health status. As we go through the goals, it will raise some issues in the privacy, confidentiality and the privacy concerns. The most challenging is the information databases, and the idea of how to pull it together and associate things and then the provide the various aspects of health and diseases. What is the procedure of that disease; what is the realistic values of that disease, and how will that be evolved within the disease? This may force us into a new conceptionallization of support or a way of moving forward in a world of information where it cannot be held in some kind of anonymous state. This is going to be true for a research and best practices. It will be entwined and then we will be able to provide the vims with the attention that we were not able to do up until this point.
If you go to the next slide, you can see the activities that have been ongoing. This leads us to some of our policy questions. If there are new issues raised by the data, how do we begin to address that? Are they truly new or are they extensions of what we wrestled with in the 70s and the 80s? Are we the human subjects? In one sense, we are all going to become the human subjects. How do we take these challenges to the public? How do we engage them -- not just tell them, but how do we engage them in understanding this? How do we delineate this in counseling perspectives and how to understand this. Will there be different concerns and different levels of concerns when we talk about information being made public? If so, what do we do about consent needs for these large-scaled population studies. How do we scale population? There are some interesting questions? How are the processes and what can we do to improve it? There are studies there, and how do we begin to engage people? One of the strategies is teach-back, you teach them something and they teach it back to you. That is when you truly understand something is when you can teach it back to someone else. What is the role of CMS and HHS? These are big questions. What is going to happen when you see it on the journal article, and you can say, well there is only one person on the face of this earth that has this information. Then we can propose the information and place it in the pipeline so where we can take a look at it. One thing we can do is monitor the process.
I would imagine there is a diverse respect on that and a diversity on the harms and what the a diverse respect on the benefits would be. How are we going to use the information? And the person following me in Cluster 5 is going to solve all of these problems, so I will just stop here then.
Thank you.
No pressure.
Any questions or comments or clarifications?
Sure.
Just a suggestion on your first possible action step, I would add VA to the list of organizations.
Yeah, absolutely.
Thank you.
Other points of clarification?
Cluster 5, this is about empowerment. Unless you have been -- oh, now there is a pressure on the next person up.
[ Laughter ]
We are all trying to sell our cluster thes. You have been innovative by the directive consumer and articles in the media. This cluster came about because of the number of genomic services provided to the public has increased in the past few years, which is definitely a understatement. This is our involvement here. We don't have a personal health care provider. And we are wondering if the involvements of the personal strategies in this will be helpful when doing this. Going back to Cluster 2, utility and the level of understanding which is the education cluster and then the information to provide and to help better understand the patients of what this is and third parties which is going back to Kevin's cluster. This cluster encompasses every other clusters we have on the list. Genomic studies have a vast array of involvement. As of yesterday, you are able to test your children for their sporting ability which is $149, if you read that in the sports article over the weekend. The past newses letters that -- newsletters that the committee wrote in 2004 and 2006 offered the genomic services. And also in 2007 and 2008 we offered information that involved the genomic services and studies. We have education, resources, workshops, and there are a lot of activities going on right now in this area.
Not surprisingly, because this area is brought with so many questions, we have the most policy questions in any cluster. For oversight, of course, we wonder if the genomic tests will be closely related to the other tests. We wonder if the recommendations will be suspicioned to relate to these genomic studies. What are the formulas? What are the best formulas? What are the criterias between the genetic testers and markers and how are we able to point those out? Should there be standards for formatting the raw data for the genome standards? How will that be assessed and communicated to the users? When will the data be updated to change the previously recommended risk calculations?
Issues for the health care providers and professionals and what they are needing to do the testing. What is provided when you are doing the health care and research for the genomic study and testing? Are the consumers adequately prepared with information of these services. And what are the personal drawbacks of the genomic services? How will the health care systems be effected by the personal genomic health care services and what are the understandings of this the. What is the criterias involved in the values of the genomic services. Who should be informed and contacted with the individual risks. Of course for advertising what are the other criterias needed for the companies to be involved in these markets and services. What are the privacy concerns? Probably not much with the next generation on Facebook. What is the cost and benefits for persons when they share the information such as family members, social workers, fellow workers, and others. Does this apply? Does this excaptioned texter bait -- exerbate the genomic studies. There is a checklist here that the patients can look at when they want to determine whether they want to participate in these services. The personalized genomic submission has come up -- commission has come up with a basic checklist already. We can do a basic report on the selected Keynote issues or we can do the levelly indepth that we love to do on every single issue that we can think of under the sun and work on this for the next 10 years years.
I was struck about the concerns that this issue came about when there was information provided to the consumers and then sent out. Of course, some of the focus of this relates to the consumers and I think we need to fold that in somehow.
What are the privacy concerns?
We have a more general question about the privacy, but we can make sure we capture that.
Okay.
Thank you.
Okay. Other comments or questions?
You can move on to the next cluster, Joseph.
Okay. Thank you.
We are solution oriented. For us, it is about the work. Getting the work done. I will cut to the chase. First of all, I would like to say, it's an honor to present this information. I want to thank you for helping us to formulate this. When we look at the world ecologically and the way the world can be benefited in many different ways in terms of the ecological system. We want to clarify the terms. Genomics is a field that is concerned about the effectiveness and the general based technology with the population and benefits of health. We work on the policies and the interactions and actions that help us with the physical and social behaviors that play a part of that theme. We do this through our main priorities and a knowledge and evidence base core of work. We expect there will be some cross-clustering of the work. It is a very broad development and it allow us to look at a number of things. This provides the investigations, monitoring and the human health factors. This takes what we have learn and promoting that through the transformation of advancement, genetics, intervention, prevention, promotion, education and that is for clinical and population settings. We want to ensure that this is going to happen. We move from a remote process and then turned into an action. We do this through a vote of confidence where this is used appropriately and that is services that we do are met upon for the effectiveness, accessibility, and quality and also throughout the research. We look at how to assess that and ensure that these things are happening. We do that through the quality assurance and quality control. And then we look at the way we can enforce the laws, policies, and standards and then we must ensure that this is being done through the developmental assurance throughout the confidential work force.
We want to nail down what we need to do. We have comments on the characteristics of the health care, management, and strategies and then how the preventative initiatives work. What are the responsibilities and the leading qualities that the health care providers and systems do with health. We first look at the opportunities, challenges and benefits and that is part of the genomic advance knowledge. And this is to incorporate the knowledge of the technological of the public health and the public health infrastructure. Part of this is working with the system, within the system, and in and out of the systems. This is part of the business communities and more specifically consumers.
What is addressed in the ethnical and social and legal approach for the public health best practices. What is that and where does it differ? It is a clear issue. Our question is: Under what circumstances is a new consent for the archived subsidies need for the health care benefits. We need to know what the risk assessments and population is needed in these industries and what is needed on the research systems and testing for each study and tests. We also want to look at the environmental relation within these studies and systems. Also we want to look at the biological studies of these systems. Will it advance in the technologies in the shift of policies or will it be within the genes in [ indiscernible ] We want to understand the genes in both physical and social biologic paths in regards to the disease.
[ Speaker/Audio Not Clear ]
What steps are to be taken to ensure we have a confident work force. This is to promote the health and prevent the disease as well as to promote the public of the health care systems. This is for advancements in the genomic health care systems. We believe that we can perform a systems review of relevant agencies to assess the mechanisms that are already in place or can be in place to disseminate the information about the different types of population and to ensure the accessibility and the quality of services. We want to look at it and how we can use that within each form and throughout the agencies and benefiting the individuals and the families and the populations at risk for the assessment processes and how to provide the guidance in order to promote the health and the disease. We are also doing the testing on the genetics and the disparities and the clinical tests and services. You have the appropriate use of genetic information to promote the health and the disease and whether it is cost-effective to tailor that information. Like everyone else we believe that you should look at it indepth particularly in the areas of genomics, disparities, and environmentally.
Moving on to Cluster 7.
Thank you.
[ Audio Cutting In and Out ]
[ Speaker/Audio Faint & Unclear ]
Thank you.
This is not about money, value, education, power, empowerment, responsibility, it is also all of those -- it's about all of those. It's not about today, but it is really more so about the future. This is not about one issue, but it is more broadly in the health care system. We are looking at it today, and today it is useful, but how do we look at it more closely for the future. We have high points and high outcomes. It's not saying it is not working well, but we have transfers and we need to move beyond that. We have health care and nursing shortages, and we need to be prepared for how the future will change.
Let's look at the two key focus areas; value, costs, and achievability. We have the first one here and that is the genomic abilities and how they will move along. Some of these will increase the costs and some of those will be decreased. It depends on how well you feel about the costs. This is an assignment or acknowledgment on the infancy and it is not as robust as it would be in the future. It will continue to be needed. Lastly, the core part of the health care is the genetics and the genetics of the population and we need to better understand how to target those interventions whether they are diagnostics, drugs, interventions, or other diagnostics.
Now, what is the infrastructure that we need? First, we need health care delivery. We need to ensure that we have the cost effective delivery and that we believe what is likely needed for the clustering. We think about the health care counselor more broadly.
Health information technology. There was a big deal made about the critical piece of integrating of Health IT of delivering personal care and medicine. And system monitoring systems, we need to have knowledge of the systems and how to roll that information out or not.
Lastly, the broadest definition of the industry, not for profit, but also for profit. We have a number of policy questions that come out of this piece. Again, the objective here is to look forward and say, How should the government through the individual agencies through HHS resource and vast the medicine in genomics. Should the government promote them? Should they be involved? What is the infrastructure that needs to be set up to ensure that we can handle the onset is likely to occur? Number three, financial assessments in the work force? Are we facing a crisis that many are facing today that we don't have enough people in the health care work force where we are not able to offer these types of sciences and tasks and moving them forward. What else can HHS do to promote this? Specifically, we talked about the development of health and the electronic health records and the digital storage of data. We are gathering much more information than we ever have, and so how are we going to store and develop that information. How can we ensure that the quality is there and that we are able to monitor this for public health benefits? Are there surveillance systems where we need to put the ground work in today. Finally, the issue of incentives and diagnostics, and they were and they were pew ticks -- therapeutics. How can we assess this the today but also in the future.
In short-term, action steps. We talked about going to the chief medical offices to provide the plans. The group has been somewhat underrepresented in our discussion and they are a critical piece to ensure the infrastructure is going to be covered. We want to put those together, both public and private to get their feelings about this now and of course in the future as a team.
Many of the agencies have began to look at what they believe happens in the health care system and we want to be sure that we are not doing what the other health care agencies or industries are doing.
And the last one, how do we look at this? The reason we talk about the brief reports, quite frankly, for a big piece of this is that it is possible for this to go on into the future since we won't be looking into the future and we think it is critical to ensure and put a stake in the ground on the key issues particularly around the tools and the incentives and the health information technology. And lastly, the two areas that we believe need indepth work is in the area of health care delivery, and one example of that is the customized care systems and counseling to ensure that we understand what the infrastructure will need to do that going forward. And lastly, the genomics and the epigenomics period which is critical in the personalized health care. If there is data that is needed within the populations today that are not represented, then we need to get that data today and acknowledge what the gaps are. When we have the ability to go forward, there are not groups that are being left out.
Thank you.
Jim?
I have one question.
Microphone please.
Sorry.
I have question question on two of the slides, 64 and 67. There is a few cuss on the clinical lab -- focus on the clinical lab theory which puts an instance on the laboratory lab -- laboratory Januaries and the -- laboratory January and the clinicians.
We will make sure we do that and change it that way. With the terms of data storage and the recommendations, we need to management it intelligently. The clinical physician's support of that is transformed in a way that is actionable. I think that makes sense. The report that we got yesterday in the personalized health care, I think the wording may be helpful to incorporate that as well. Thank you.
To add to that in the overarching team, almost all of them will need a robust of technology in a variety of forms to actually make it happen. I think that is explicit in all of the presentations, but we need to be more -- implicit in all of the presentations, but we need to be more explicit in that as well. We are looking towards the new private partnership as it gets up and running we need to ensure that we are engaging that up to this point.
Comments or questions, specifically, on Cluster 7?
Thank you.
We have heard: Money, value, knowledge, power, empowerment, responsibility, and the future. It's always important to remember that it is about Ego.
[ Laughter ]
So on that note, it is time to go over these cluster issues in greater detail. Number one, we want to make sure we are reflecting in each cluster description, the action steps that were outlined and that were reflected on the insight offense the committee, but also to look at the linkages. I clearly picked up on the linkages that cut across. We can turn all of these clusters into one cluster, but that wouldn't be a particular utility for our work as we moved into the future. There may be ways to group these clusters in our thinking particularly in the way we represent them to our public, particularly to the administration. I would like to -- as Steve suggested, we can walk through each cluster and we will have an opportunity to talk in a greater detail.
Please pull of cluster 1 now -- pull out cluster 1. There is a handout given to you which is an outline of the action steps and you can use that to help ground your thinking and the conversation regarding each of the clusters.
We have a few thing that is we can work through and monitor in a short term. We need to look at what each portfolio looks like. I think it is helpful for us to look at each cluster and what is important. I think this is clearly laid out as exceeding our capacity. We need to sort through them and see how they are arranged and so on and so forth. I think then, we can get a sense of what is the greatest importance. We can then sort through those clusters and consolidate those clusters and begin to set some clearer priorities in moving forward. I think it is important that we still remain flexible about the next steps given that the administration coming in may want or need the priorities that requires a response and what the response is.
That's true.
As you suggested, it is very helpful to get the clarity that the committee feels we should be going. We would likely have to be flexible in responding to the new concerns and the priorities of the administration.
Okay.
Regarding cluster 1.
The good news is: If there is any questions with cluster 1, we are not indicating that we need to do reports since we just did one, but there is a lot of work that is ongoing with that. Sense I reflected in this yesterday and today, but the thing that is not part of that specifically and that is a potential impact is the coding systems. We have the CPT and IDC. How is that going to translate in the IDC 10. It is an impact of collecting the data.
We know the system is broken, not working for us. So the systems are looking at the issues where we need to engage them actively, you know, to maybe have them come together in different groups so they can talk to each other. They have an indepth expeer tease because they do this -- expertise because they do this everyday, and that is maybe one way to go about this.
I have a question. This is brought up by the committee and throughout the discussion, but yet not a lot has happened. It is still an issue and it is still a problem. What is the priorities or the obstacles going forward with this? How would that elevate the essential barriers in order to make headway on this?
I will take a crack at this. Some of the barriers relate to the lackover clarity -- lack of clarity in relation to the statutes and the regs. We have asked specifically for clarification. We talked so much about that yesterday. So understanding what can and can't be done, it will provide the strategies on how to go forward with these issues. Lacking that clarification does provide hope for us. CPTs are under the control of MEA. There are a lot of different players in there. As it has been pointed out, it is hard to get everyone involved, engaged and brought to the table. Maybe it is perhaps the correct thing to do to sit around the table and convene with SACGHS, and possibly that would be the solution to this problem.
You are going through a transition of genetic services. This is not a procedure oriented field. It is a broader view where there is other constituent says that can be conveyed. The problem, of course, is not only on the clinical side, but it is part of the issues here. It is not relative to the counselors, but to the fact that they don't have issues in relation to the standards, which also cause a barrier, but also on the laboratory side, it is clear that those procedures not adequate for the actual costs of the things that are being done. That is -- that is -- you know, that is an issue. There was another point, but it has lost me, so we will let the next person ask a question.
You have been wrestling with these issues and we have had several colleagues working with HHS, can you explain what would help us in moving this forward?
Hi, I am Jeff Roach. CMS is an interesting institution to validate.
[ Laughter ]
How does CMS address the payment and reimbursement issues in regards to the technology. This is not a one-pager, but --
[ Laughter ]
That's too bad.
[ Laughter ]
I continue to work with Sarah and others at -- within the staff. I think we are trying to work correctly on it, but there are old systems that are designed for a purpose, and they have a design where the promises are not fully demonstrated. I call to mind an editorial where the headline was: Payment now, possible benefits later. It was stringent about CMSs, perhaps, errors and the major effect that that cost has lead to. We need to be responsible for the changes in the community in relation to the health care era. These have enormous consequences. We look forward to working with you and your staff, and others to resolve these conflicts.
This brings up Jims suggestions as to the health reforms.
The other point that I was going to make was, you know, the money in the system is not a target-rich environment.
[ Laughter ]
So when we are talking about getting a bigger piece of the pie that means someone else is going get a smaller piece of the pie and that is problematic to those points of discussions. We have to do a better job and this ties into Steve's cluster. We can do a better job for ourselves if we move away from the --
[ Laughter ]
[ Speaker/Audio Not Clear ]
The bottom line is we need to develop evidence around the value of what we do. I think that make -- you know, we are not just then whining about the fact that we are not being paid.
I think the issue that Jim brings up is a good one. I think there is a lot of momentum right now. This goes to all of the different clusters. If we look at this one, and we strongly believe it, then we need to look at all of the clusters in that area so maybe all of the clusters can be connected. Yeah, I believe that is true. That is part of the cluster connect that is in the health care reports in regards to these issues. It was not shown strongly enough in the reports that none of this is going to be a development of the health care strong points and key systems.
People may be familiar with this, but about six weeks ago there was a summit in Utah about the personalized health care. And the report we have from that is the key issues of that overlap Clusters of 7, but how do we ensure we have enough resources, systems, beds, data in order to summarize that area. One of the key areas had two major recommendations. I would say the number one recommendation coming out of the business area -- again, business doesn't mean for-profit businesses but more properly reaffirmed in the business systems. I think this needs to be a priority. There are groups working in this as Andrea mentioned and they are working in the professional community. I was supposed head up a piece of that in Utah in potentially replacing the Keynote system. And I think the good news of that is: There is a groundout of support -- ground support looking a study this and saying we need to do something about it it.
[ Speaker/Audio Faint & Unclear ]
How do we ensure that the technologies will be moving forward into the best practices or not. We gather the information and make decisions and make sure whatever we communicate or continue to work with we are moving towards the initial 7 clusters and ensure they are going to work for us and the consumers. The critical utility piece may go a long way in ensuring that confidence. If we don't have confidence in the system, we can't change the reimbursement and we can't assume the adoption.
Well, that will sometimes take time.
Yeah.
We need to see how that is processed. It is not black and white, and that is something we need to keep in the back of our minds.
One of the things that is very important here that we are somewhat missing is that the big bang and shift now is the consumers. By the time the doctor is aware of the genetic finding that is irrelevant to health, the consumers have already paid $5000 to the medical providers. There is a service that they have called genome browsers, and they can go online and see if they have that symptom or not. I think that -- I don't think it is done deliberately, but I think we are being very synergistic. I think we need to find the guidelines and provide those toe the profession -- those to the professionals and the physicians, and the clinicians in the field. I have done this before. I have wondered who speaks to whom? Which group do you engage? How and what representatives are they and to who. We may be teaching and making one thing public, but then you come with --
[ Overlapping/Multiple Speakers ]
Does that cluster fit better in Silvia's cluster?
Maybe it is Silvias.
Yeah, I think your points are well-taken, but I don't think that are part and par cell reimbursement by the third-party payers. They will more than likely pay out of pocket with these things.
We as a relatively small group are not going to reform the system.
[ Laughter ]
Mara is going to reform the system, and when she does --
Ego.
My wife would say, don't remind him about Ego.
I don't know if this is a health form system, or a derivative of how the system will play a role in this, but I think it is a role of cluster one to assess where things are going and be engaged as best as possible with the movers and the shakers who are making a difference in the reforms. And then they need to provide the strategies that work best with the systems that we end up with so we are ready to provide what is needed by the time the new things are rolling out. It seems to me less a task of pulling things together and creating something that is more of an estatic document in some way and then being able to respond to a rapidly changing environment. And then we need to develop it as best as we can in order to have a good sense of what is happening.
To build on what you just said. It seems that this particular cluster is dealing with a whole set of tactical issues. It is dealing with the system the way it is currently is and how to optimize those issues. There is a whole set and link of those strategic issues. It will show you what it looks like. It will be involved in the health reform issues. It may be a way to keep our eyes on, Yes, we have a whole bunch of these acute issues, short-term, that we need to address.
Uh-huh.
And that we understand that over a longer term we need to deal with the broader issues. If we are going to move to a personalized health care system that has real value, what should -- what do we need for that system?
Any further comments on that or suggestions before we move on?
Why don't we talk formerly about Cluster 2.
We have a question.
Oh, I'm sorry.
I wanted to bring up the relationship between the clusters again and the reimbursement. How are you going to address the importance of reimbursement to any given area to the information provided in cluster 2 regarding the strengths within the association. I am wondering if there is some kind of plan as to what is the minimum or necessary amount of evidence before you can address that. Sometime ago, the internal organizations used to put out the data of high-correlation versus medium and low versus the treatment or the association of the treatment. I don't know if that is useful when you try to address this particular issue as to when use cross the threshold so that is justifiable as far as the reimbursement goes.
I think that is the reform of the health care issue going on in this country. I think it is the evidence of quality. It is based on the work units and how much you do and the evaluation systems as Jim pointed out which favors over the non-procedural activities. I don't want to use degrading characteristics about that and what you should do, but I think we need to take the actions and best steps for the reimbursement and the quality outcomes and the evidence-based medicines an how that will look. How it will look, it is not clear, but I think it is encumbent on the field. Under Cluster 2, we are able to deliver on the evidentiary standards.
In addition to reimbursement, should there be consideration in your cluster regarding payment to bring that level of action higher. I know it will begin to be announced that they will continue to do the research as long as it met rigid standards. That is importantly and it might -- important and it might be applicable and important what you need to do. As with anything, there are good things and bad things that come out of it.
(Please pardon the interruption).
Okay. Thank you, God, are you done?
[ Laughter ]
The problem, of course, is what we know about the physician practice is that we sometime decry the idea of how long it takes to adopt something, but in addition, it takes a longing time to unadopt something. We develop the evidence and then we say, it is not going to work, so we are not going to do it, but now everybody is in the practice of doing it and we have to work that all out. Now they are in the process of imaging and the importance around the arena. We haven't talked about the real issue in the room. We haven't talked about the real impact. If you look at the bone marrow issue in a breast implant, where one person, one policy, changed the whole reimbursement schedules throughout the country. We realized that that was not worthwhile. There were estimates that cost the country in the range of $500 billion and I think that is right number of zeros. It is a heck of allotted of money and -- a lot of money and that is not providing the numbers of mortality coming out of that issue. It is a double-edged sward, but it -- sword, but it is something we want to cover in our tool kit.
Well, the Cluster 1, there are clearly identified clusters that link across on to cluster number 2 and it will be an important contributor to cluster 7 of the health care reform. As much as cluster 1 needs a demand from cluster 2, it must also respond to the immediacy of cluster 1 reimbursement coverage and the intensely practical and relevant reasons in terms of how it will go about its business in the range of cluster 1 to cluster 2 and then on to cluster 7. Are there specific comments regarding the cluster 2 genetic utility information?
I think the biggest thing that this group can do is to highlight the funding disparity across the transformational arena. We heard previously looking at the T-1 through T-4 translation, there are about $100 million in the T-1, which is not allowing much for the other strategies within the utilities. We need to promote the members of some redisty because, if you will, to allow the spending on that.
I agree.
Boy, I am on a roll.
I think there will be some difficulties surrounding that.
[ Laughter ]
Tell us what that might be.
Well, whatever persons or researchers we are taking the money away from.
I will put this in a public context, but I think we have a hammer and nail problem. The human genome project is one of the greatest scientific achievements in the past my lean yum my listen item -- millennium, if you will. There seems to be a tunnel vision in terms of whether or not we can solve what we are working with and dealing with to provide this technology. There is still value and knowledge to be learned from that. We can't continue to focus the vast majority and the procedures to work into that. How can we do something with this information that is going to provide the direct benefit to the health care in this country. That provides a different model than what we have. It may be a simplistic view of it, but I think that is part of the problem.
I would say genetic conceptionallism. I think you are arguing that the federal research dollars in general should be used for applied research, health research, et cetera. If that is what you are arguing you may want to put it in that context rather than saying "genomics" per se.
Uh-huh.
I would think it is a zero to one game so to speak. I think one needs to be aware that a good applied research needs to be on good-based research, and I know you wouldn't argue with that, but I think we need to do more in the health care. I don't think we should just leave it at that and not expand.
I certainly agree with the expansion of it. I don't think this is related to -- I don't think this is a problem that is unique to genetics and genomics, it's part of the balance for the basic science and research, and that is transformational, and then we would develop that and turn it around. There is a strong argument there that there has been and is an inbalance of that. It is likely that there are additional moneys that will be injected into the system, but looking at our task here as it is related to the charts that were provided to the secretary, is the need to address the people, the consumers, who are being addressed with the disparities and we need the additional evidence of the utility to move that forward and that does require commitment and research.
I agree that it needs to be done in that area, but until we understand the basic science of genetic factors in health and diseases, there is a less point of establishing that within the health care. There is a fine line of defining that translation. We need to understand the factors before we run out there and study and optimize the studies within the health areas. I think we need to do more research in those different areas as well.
I would repress on the conversation as far as the applied and reapplied research which is going to be demanded by cross-tabling and by the constructive services in the health care industry. We need to be cautious that we don't allow this to be uneventful. What extent should the utility arguments be refrained from the reformed arguments. This is a frame. It puts a different set of demands on the clinical community to provide products that directly and quickly can address issues of imperative effectiveness and cost reduction.
Why don't I suggest since we have come to 10:00 that we go ahead and take a break. At 10:15 we will come back around we will get public comments and then we will return more on clinical utility. I have already seen hands emerge for that, so why don't we go ahead and take a break and we will meet back, again, at 10:15.
(The time is now 10:00 Eastern Time Zone. The Secretary's Advisory Committee on Genetics, Health, and Society is presently on a brief recess. The Committee will reconvene at 10:15 Eastern Time Zone).
Please stand by for real-time relay captioning.
[CAPTIONER TRANSITION.]
Thank you, one of the important thing this committee does is serve as public forum for deliberations surrounding the societal issues around genetic issues. We appreciate comments from the public always, and welcome all the perspectives they have to share with us.
I have a list of two individuals who are scheduled. If there are others, please let me know, but we would like to first hear from Ms. Freedman, the director of -- FORCE, facing our risk of cancer and power, we look forward to your comment.
Thank you for having me. I want to thank the Secretary's advisory committee for inviting me to present today. I am founder and director of the foundation FORCE, and we deal specifically with hereditary, breast and ovarian cancer and families affected by the disease. I came here from Florida, this is freezing cold for me. Part of our mission is about advocating for the health and well-being of people affected by hereditary cancers, my goal is to alert the committee about a growing issue we are seeing and trying to document.
The consumer, once the test is out, been offered, the consumer has to assume it has clinical utility, been validated, I saw that you are looking at those issues. One of the problems, the tests already out there at laboratories, there is very little oversight, and we know there's a lack of knowledge and information in the healthcare community and on the part of consumer and that gap is being filled in by the companies developing the tests. Certainly they have a place at the table, but I don't think they should be the exclusive source to consumers and the healthcare community. We are seeing not just direct to consumer marketing, but direct to doctor, wouldn't have been around if they were pharmaceutical companies and had to go through the oversight process.
I see daily, often staff the help line, we get calls every day, the wrong tests are ordered, wrong individuals tested, people being given wrong information about what the results mean, a lot based on the fact that the company that develops these test system providing doctors and consumers with all the information they are getting. No one else is filling in the gap. This doesn't happen when people are referred to genetics experts, there are standards for breast and ovarian cancer. I sit on the panel that develops guideline and it says there needs to be a 3-generation pedigree, access to experts and clear guidelines, and these are not being followed.
We are hearing a lot of cases and I provided examples, sent a letter that outlined one woman who ended up, allowed to fill out her own genetic tests, ordered the wrong test, and those results, proceeded with a lumpectomy, believing her cancer was not hereditary only to find out after that the wrong test had been ordered. That would not have happened had she sought expertise from a genetics expert. Her letter is very telling because we hear this a lot. People love their OB-gynecologists, they feel bad that he didn't know how to guide them through this. In many cases we can look back and find out that OB-GYN had a recent visit from the company making the test they are selling and the information they are getting and not complete, what it means and how to properly do a risk assessment to determine the appropriate person for genetic testing and the appropriate test.
We are seeing cases where people are being told their tests were normal when they have a mutation. We have seen cases where people have been told, while they were driving that they carry a BRCA mutation. One 25 year old was told her risk for breast cancer was 85%. Well, she was 23 and her risk was not 85% at that moment. Inappropriate information given at inappropriate times. We have reports of being people ordered for sequences testing when a single site $300 test would have been more appropriate. Insurance companies are footing the bills or the consumer, taxpayers. This is happening a lot.
With respect to where the information is coming from and where consumers are getting the information, I followed sales representatives at conferences and listened as they promoted testing to doctors, nurses, said they do not need to refer people to genetics experts, I have heard that on more than one occasion at a professional society meeting. I saw a nurse raise a continuing education guideline booklet produced by a genetic test lab, and say this is all you need to start doing genetic testing in your office. That booklet only spoke about the test that lab produced. Unfortunately, we know the healthcare community is getting information from one area.
For our community to improve things, as you are determining where to go from here, I think it's really important there be at least one government agency that has oversight and jurisdiction over genetic testing, even from approved labs and has oversight as to how they are marketed to consumer and physicians. There really isn't oversight and these companies can say pretty much whatever they want, and they can be the single source of information for physicians and consumers. Consumers need access to trained experts in genetics. I understand there are not enough experts, it's hard to argue a 23-year-old woman have such testing in her doctor's office as opposed to being referred to one of the many good genetic clinics in the city of Chicago. We see this in big cities where there is no wait, no immediacy. I think consumers don't know they are being denied standard of care or even that there are experts in genetics. That's part of it, and people have a right to know, getting below a standard of care in genetics services. They need to be held accountable for their marketing material and -- [indiscernible] not enough to scrutinize what laboratories are saying to consumers, also what they are saying to physicians and telling physicians they can and cannot do. I certainly am not qualified who can and cannot do genetic counseling, but I don't think the laboratory should be doing it either. I think they are setting the bar very low. We need an agency to track adverse events. There are no guidelines for standard of care, labeling, coming from cli A approved labs, and there's no way to say what is and is not adverse effect and to be able to track it. I believe it should not be up to the test developers to govern themselves or determine the appropriate amount of information or designate the minimal competency for conveying information. Thank you for your time and attention.
Thank you for putting a face to those issues. We did write a report on oversight, but I don't think we addressed this issue very completely. This is important. Let's take a couple of comments.
I wanted to add my thanks to you for coming. I have not met you before, but I am very familiar, taking care of patients with genetic predisposition and I am familiar with your website, of huge use to patients. It's useful to get your impressions that these types of things are occurring, anecdotal, and I would ask, if you can try to keep track in a systemic way of these things, and echo your plea that there be sources of information for patients. Something we should keep in mind. Sources of information for patients that are apart from the commercially-driven sources by some of these testing laboratories. We all have conflicts of interest, that patients need access to differently-affected sites of information.
If I can make one comment. It's my understanding that the New York State Department of Health, when [indiscernible] did the direct consumer marketing, Myriad, in the primary care, OB-gynecologist's office, there are was a standard of care -- and speaking highly of our organization, funding is a big issue on an ongoing basis. Very hard for us to meet the gap and meet the needs, we need assistance with that, so, thank you.
Thank you very much. Very helpful.
The second speaker is Amy Miller. Dr. Miller is the public policy director for the personalized medicine coalition. Welcome.
Dr. Miller: I am Amy Miller, the public policy director of the personalized medicine coalition, an organization that represents stakeholder groups within the framework of personalized medicine. I have spoken to this group before on a number of occasions about your work. Today I am speaking about consumer genomic and work in that arena.
It's unavoidable to recognize consumer genomics received more -- than any other aspect of personalized medicine, part of the PMC's charge is to educate on personalized medicine. To that end, and based on some federal conversations that have taken place over 2008, PMC has taken three different tacts to address genomics. We organized the leadings genomics companies to come together around standards of operation in their field. The companies that have joined PMC, in particular are 23-Me, decode and Navigenics. The standards they agreed on are scientific and they will be presenting that work at a CDC conference on consumer genomics later in this month. They have agreed on a number of scientific standards and where they haven't agreed they have agreed to be transparent. They put together a brief document on that work, will be sending out in advance of the CDC conference. During that conference there are scientific teams will be available to answer questions from the field.
The second is a consumer guide, part of the PMC's work is educational, we worked on a consumer guide and think that to inform the consumer guide we need to hear from consumers. We are going to have a round table where consumers and healthcare providers that work with these particular consumer groups have a round table and talk about what the standards are in this fields and what consumers want from these products. As has been mentioned, they are available, and they are being used, and purchased, so we need to know what consumers find useful and risky about these tests and we are looking to develop a very balanced document that addresses some of the scientific issues, some of the concerns about these product and then what they can be used for.
Those are the three efforts that PMC is doing and consumer genomics and I would be happy to keep this group informed of that work and in any way assist the [ SACGHS in this area.
Thank you, we appreciate the work you are doing, good set of standards. Any comments or questions Amy?
Thank you very much.
Any others who desire to make public comments?
If not, we will return to our primary task today, which is to review the priorities.
So we were in the midst of a discussion on priorities, and I will turn it back over to Paul, I know there were a couple questions from Jim and --
I think we were discussing [indiscernible] as we continue to move forward -- to find out there are gaps in the knowledge, and -- have to be done, have to be funded. Laboratories will now be able to perform some of the studies or have the power to do collective, multi-site studies. The focus of the -- trying to identify or recommend funding for that research.
One of the things I would like to -- in this section, wide clinical utility of particular interest to the future of healthcare issues, touched on it. So many issues we are face nothing personalized healthcare don't fit into the old paradigm, clinical epidemiology, talking about smaller groups, more tailoring, large clinical trials, very difficult to -- we have been dealing with, all along with rare clinical disorders for which clearly that kind of work is never going to happen. All wait the way up to dealing with common diseases with complicated genomic profiles. Getting to an understanding of the value is a whole lot more complicated than many of the things the [indiscernible] communities are doing in the area of clinical utility in terms of nature of studies, standards, so forth. This is my feeling, that if we are going to get there, not only be relevant to reimbursement issues, but very critical to how this will ever fit into health reform in a way that we can be sure is actually going to deliver real value.
I would -- I agree with you. I think it's also are important to keep in mind that some of the rules haven't changed. It's a new landscape, and there's tremendous understandable impatience with the desire to translate, get things to the bed side, that's perfectly understandable. But I think that one of the reasons the focus is on genetics in in context, because we have had an unprecedented best of unburgeoning of genetics if the field for quite some time, so the gap is more apparent. We have to have ways of figuring out when evidence is sufficiently met. In the end it is a slow process that impatience can cause problems.
I think one of the things that could come out of this is that there is in some ways, whether we can improve efficiency, if the people in the earlier stages of research are given a view of ultimately what evidence is going to be needed to move things in the clinical arena that could potentially influence how research questions are asked, so when the movement comes from not dealing with what we frequent thely encounter, the report, which is a lot of gaps in evidence that key A speck thes aspects that are not available. Continuation across the continuum -- answer the questions at the appropriate time. That really wouldn't add cost to the infrastructure, at least to a significant degree, would be less costly than going back, redoing the study to answer the questions not addressed.
That's one of our recommendations in the pharmacogenomics report.
Comments, suggestions specifically related to the utility [indiscernible]
Great. Can we move on to Joseph's -- scheduling issues, move to cluster six. Joseph?h?
Yes. Thank you very much. I know it's a skip-over for a lot of the other work. To cut to the chase, because we in public health are looking at a balanced view, trying to look at how -- we believe strongly the committee in its deliberations should consider what is the balance view. Much of the discussion this morning has been on the issue of translation. What was just said by Dr. Williams a second ago, we need to look at the beginning, how do you pull this information in? The paradigm is really the idea of assessment, that you in many assessment issues, the program is up and running before the assessment is considered or taking place. You have go brack, look at things. I bring your attention to two parts of the [indiscernible] action. The second is a big paragraph, the idea of a systems review. Because the question really becomes where does the different elements fit together, and what are commonality and differences. The system view means looking at different areas in which program, function, the issue we are looking at fall together. Then, where the commonality, what can be done. The bottom line is the last part of the sentence, which is the differences, but the assurance of effectiveness, acceptability and equality of services. How do you move from the basic science to this area, one of the areas you look at, what is being done, what are the common areas looked at. The other part, do it in a systematic way, what agencies are doing in order to meet this goal, then you move into how you can work together to make that, effect that to a better system, what this committee is, dealing with the other issues related to application, risk assessment, et cetera. I will leave it at that. That cuts pretty much to the chase on that.
The other thing I would add would be the social, environmental, ecological effect of genes, environment, and health application.
I would strongly endorse what Joseph seeds said about the systems review. At different meetings, the most recent example yesterday afternoon, different groups come to us, talk about what they are doing, then we realize, wait a minute, three different groups are looking at biospecimens that could be used for a variety of purposes in terms of testing -- that's an inefficient way to do it. We are essentially doing some degree of duplication of effort. Inasmuch we can assess what everybody is doing, look for areas of commonality, use that to build a consistent -- get more bang for the buck, don't have to be spending money on duplication. That's a great idea.
Comments, questions?
Thank you, Joseph.
Like I said, when it's clear, it's clear.
Thank you.
Then move to cluster three. Genetics, education and training.
Actually, before we discuss it, I want to say I think listening this morning, obviously yesterday as well, our first action item was to -- a small one to talk to FDA about devices and educational standards. After listening to cluster seven, I think it is the one on Sylvia's -- really fits -- I don't want to punt -- just a suggestion. A thought, perhaps we could work together on that one, put it that way, one thought I had after listening to your presentation. Anyway, one thought.
The other thought I had, other actions are what we are doing on the committee, heavy data gathering, synthesizing data from a lot of different places about existing programs, looking to the future. I think that's a logical way to go, I welcome suggestions for other ways. What I am thinking about is the whole notion of looking to the future more and part of it is [indiscernible]'s comment, trying to do that to avoid a classic [indiscernible] education to avoid the old way of looking at it, think of what are the needs in the future, new generations of people on Facebook, and the way we are all doing things differently.
The other is, what's frustrating to me, there's lots of specialty agencies involved in medical education, in traditional silos of medicine, OB-GYN, the way we deal with medical care, healthcare system for -- since it was organized, yet on the other hand we have the dialogue with the terms like systems medicine. That's on the horizon, not a landscape, but it's on the horizon. If we head in that direction that changes the way those silos are set up about education and training. It might be worth thinking a little about looking to the future of that as well, not [indiscernible] the landscape, but that is something I was listening to the last couple days. Those are my only new thoughts on that.
I was very struck yesterday by various comments that patents are important for education, and I was shocked, because just as we said yesterday, that utilities are still an issue, quality is an issue, shouldn't be mixing patents with that. Seemed to me we shouldn't mix patents with education either. The speaker just pointed out the kind of education that's provided by people with a strong interest in the sale of whatever they are selling is not going to be good education. I would endorse doing more on this particular topic so that the pressure isn't on either patentees or to have this cluster, industry groups alone, but also include advocates, healthcare providers. Numerous occasions we found relying on patentees for educating patients about their product system not a good recipe to utilize public resources.
A few comments. First, on the cluster, I think this is one of the most important ones, essential. I agree, though, that the first short-term action to me is not consistent with the rest of the [indiscernible] or policy questions. Partly because it doesn't fit here, not sure [indiscernible] number six, gets into what is a very [indiscernible] issue around the FDA requirements, laboratory tests, a number of association groups working on that, questions right now about how those tests will be or will not be [indiscernible] by the FDA. I also endorse Barbara's comment that the short-term action in number one, working with FDA officials does not make sense. I think, however, to broaden, as Michele said, number 2, to understand the regulation today, I would broaden to say it's not just to encourage the development of voluntary standards, but understand what they are today, how they work, and therefore recommendations we might have in the future. Take issue with what Rochelle said, not only the patentor has an interest in it, may produce a great piece of material, but in and of itself there may be a perceived or real bias that says it would be better coming from a neutral organization. There are highly quality materials coming out of individual companies, universities, and poor materials coming out from companies holding patents or not, or involved in commerce in what we are talking about here is the broader scope, which is ensuring a regular process so we don't have to depend on the individuals in commerce to ensure we have the right materials for the purveyors of healthcare, physicians, genetic educators, nurses or otherwise. so in summary, eliminate number 1, expand number 2 under short-term action. The report is very consistent with the policy issues you raise.
Joseph?
I would agree with the last statement on the in-depth reporting, but add it is person to the consider education is not only multidisciplinary, but also multi-directional process that has to be comprehensive, particularly in this arena. Looking at the general public, specific consumers, and professionals of all types. The second thing I would say is that because it's that kind of process it's going to be important to assure there's clear understanding, there's a means of both monitoring and evaluating the specific outcomes of the education process itself, given that it is multidirectional. Critical piece of -- add that to the action step. If possible. Thank you.
I would request we make something [indiscernible] implicit, that relates to discussions from Mara and Heath about the way medicine and delivery medicine is going to change. We're going to be moving toward very complex information sets that will be combined, require informatics -- support, some of that is going to be off-loaded into personal health records and algorithms that run on those that the individual can control. There has to be education vetted around the type of tools so if an individual says wait, I am getting this message, what is the [indiscernible] that they can rapidly find that information within the context of the clinical decision so the idea of just-in-time point of care education, electronic health records, personnel records, will be critical. The traditional way we as providers, given the time of medical knowledge has changed when I graduated at 30, only changed once, now seven years, somebody graduating from medical school now will have to relearn everything four times in their practice, depending how their 401K looks maybe six times. But clearly, traditional educational approaches, while important, not going to be sufficient to do this. We really have to make sure we are responding to that future.
In response, more of a question to the group, even if you [indiscernible] yourself to the just-in-time primary care from providers, it's a number of silos or specialty groups. In other reports we suggest oversight, that when there was disjointed or dysfunctional, communication, whatever the [indiscernible] recommendation, coordination of cost groups, I don't know if that might be something that this group -- this task force should put as one of the things to consider, recommendation there should be better coordination of -- using electronic health records, but the question --
Just a couple of responses. First, efforts to create those type of groups, national coalition for health education, genetics, is a good example, where they tried to do cross-disciplinary educational efforts. I think that there's clearly a movement to, within the informatics, medical informatics community, say if we are going to have guidelines, and they are vetted within electronic health records there have to be standards, how the information is obtained, talk about establishing a national electronic clinical repository -- if that moves forward would be an important partnership to link, going forward, what do you need to have to associate with these sort of vetted clinical decision support issues. Those are the types of partnerships that I think would be important, and I think also to recognize that, assuming the administration, incoming administration continues what has been a strong push, to have a fully interOperrable -- in this country, by 20 14, we have a very good window of opportunity to make that --
I heard about the information that comes from industry, we didn't address completely in the oversight report, but with the FTC before and FDA on labels and promotional and -- I wonder if that's something we should have as a short-term thing to have in light of the comments we heard. Clearly there's a lot of promotion that doesn't meet the FDA labeling system.
I have one comment. We heard the speaker, committee members talk about promotion that may need additional oversight and reigning in, the problem is, the FTC challenges advertising for one of two reasons. Either the claim is blatantly false -- losing 30-pounds in 30 days. Or substantiation, what the scientific community saysed evidentiary standard is, RTCs, for example. When we look at a way to link a genotype to a healthy living recommendation, will help a healthy jeej owe type person, what's the evident rei standard to show that's true, case studies to show what's happening, is it RTC that may take a long time, few million bucks. Is the FTC the right agency to say didn't meet the evidence rei standard -- gee, I don't know. The community doesn't know. This is going to be a to be a continuing issue.
I was wondering on short-term or longer-term actions, you didn't include the establishment of some type of web-based information area that would list what evidence is accumulated for linking associations. This, of course, could be indexed in two ways. One, by genetic findings and specific genetic markers, and the opposite direction would be by specific disorders. I think this could be maintained by a group of professional editors that would assess the reliability of published data, because you only want to update it with things that are very secure in terms of contents. I would think something like that would be extremely valuable, to physicians, who like myself don't have enough expertise in the area, but also the publicity, because there would be some indication as to how reliable some information has become or what is missing still.
We talked in the group about that, there's a number out there, part of the data gathering, to pull together to look at them. They are like genomic Wikipedias.
A major task to pull that together, but I think it would be of great utility to everybody in healthcare and also the public.
Rob even in, Robin, the office of -- I know the committee, workforce diversity, competence are critical issues, and I think that in the summary of the clusters, workforce diversity was in parenthesis, it wasn't highlighted in the background materials and I wondered whether in the report in progress, cultural competence and workforce diversity are going to be key issues that are addressed.
Thank you. Yes.
It's a bullet, not a parenthesis, it's written up to [indiscernible]
Great point. Other comments? Suggestions? Kevin, you are up.
I am just going to punt to Sylvia.
Actually, I think this issue, it's not one that anybody certainly would disagree with. Everybody is certainly interested in protecting privacy, confidentiality and continued application and informed consent. I think the issue is different from some of the others in that it sort of sprung out of the pursuit of -- the advances in technology we want to do sort of bring about this scenario that maybe we didn't have to have happen, but is happening. The idea that the application of these technologies and the pulling together of all this information in some kind much accessible form, large databases with interOperrable healthcare records brings up this issue. So one of the things we really need to wrestle with, what is the role of SACGHS to deal with this. I am not sure to say this is the place where it should happen. There are arguments for and against. That's what we could explore a little. To put in some context. This is an issue that hasn't been looked at, even experienced by other places. The experience in Iceland over the past several years would be instrughtive. In the United States we have representatives here at the table, two groups in the midst of addressing some of these issues. Ellen mentioned the VA and DOD, the idea we have two large groups managing numerous people's healthcare records, how is that going to be integrated and what are the issues coming out of that.
A third issue, newborn screening issues. What will we do with that, information? If you want to be efficient that should go immediately to a database, start now, use for longitudinal study. Again, the issues are with us, how we wrestle with it, our role is a question we have to take into consideration. Department of Justice issues, commerce issues, things outside of HHS, civil rights. Again, it's something that could lead to rich discussion for the group as part of a larger sphere. That is the question that's really, what role do we play? Are we objective, more less invested third-party to provide distance? I don't know. I think that's what we have to wrestle with.
I encourage everybody to read the short article in our briefing books as you think about these, Patrick Taylor, touches on privacy issues, it's good to heed some of these things as we go forward.
One other issue on that, to give another sense of how things are moving. If you look in materials on page 24, under tab 5, go back to the -- we wrote the major distinction between research and consent to treatment. There should be no presumed benefit, no reason to proceed without a presumption of benefit. With personalized healthcare, the idea is that all should provide a benefit, research, clinical, all the same thing now. How does that change the landscape for us?
As you were setting up the issue, listing stakeholders, it seemed to me one of the things that could happen in the short term would be to have one of our educational sessions focus on different stakeholder's approach to privacy. Certainly the people you listed would be very good. I am thinking now, two private groups have gone into this in a large way, one is the March field personalized healthcare coalition, and the Vanderbilt program for residual blood specimens and research. And echoing what Jim had said, having someone like that author, or Zach cullhain, differences in -- that would be a fascinating session, might really help to provide some -- the other group, by the way would be representation, the direct to consumer folks O consenting and privacy. It would be very interesting, rich session that might well provide important information that would set the tone for the report.
That's an excellent idea, one of the things I think we bounced around. Obviously we are not going to recommend it without the committee's support, but that's a great idea, if people want to do that, if that's a first step.
I would [indiscernible] when is that? February? Do you know the date?
[indiscernible]
They will be covering, a lot of people looking at this issue. Right. One of the things we have to do, check to make sure we are not reinventing the wheel on this.
Mike -- there's a higher orders issue, implied in the cluster, but not explicit. That is, when does research involving genetic data and associated clinical data rise to involve human subjects, [indiscernible] some of this would be moot. A lot of this turns on the definition of human subjects, has to do with obtaining identifiable individual information. What does that mean? A great deal of research involving stored specimens, stored DNA, stored clinical information, done in a way in which coded, unidentified, from our office we don't involve human subjects. So the discussion is short. One question implied by this policy number six is whether with the evolving technologies in genetics, information technology, whether we have identifiable and need to change the paradigm somewhat. Might be important to identify in the policy discussion here.
Sure. One of the ways we can look at this, either the move to personalized healthcare will put you out of work or you will become as big as DOD, one way or the other. [Laughter]
Comments?
Is there a sense among the group that the educational session -- do we need one for ourselves? Would that be a good short-term first step?
Do we have representation, anybody from the committee going?
Actually, [indiscernible] the next meeting, they will be coming back, saying good-bye -- a number of -- we are -- Barbara, we think, is going to be the new liaison staff -- [indiscernible] one or the other.
Are we talking about for newborn study?
Yes.
I will be at the meeting, but because I [indiscernible] collaborative, not the committee.
[indiscernible] our committee to -- make a decision, continue or -- gather more information.
We can put that under monitor the meeting, say, based on what we find from that, decide -- okay, that's great.
Comments?
Moving to cluster five.
I think the challenge with this cluster is that there is such a broad range of policy questions, some may be easier to answer, like whether the oversight report covers direct to consumer genomic testing. It also overlaps with every other cluster, so I can punt to everybody else and we can collapse this cluster into nothing.
[Laughing]
I think that looking at our action sets, it basically comes down to whether this committee wants to weigh in on the curve. Where. If you monitor, comment, weigh in lower on the curve. If we are proactively going to do, let's say, other spectrum detailed report like we do often, then we would probably be closer to the beginning of the curve. So, I just want to know if there's a lot of interest on the committee in the subject. I just I don't think know where the committee thinks it can do the most benefit in this area.
I think there's a lot of interest and a lot of expertise on this committee in this thing. My own personal feeling would be monitoring would be too passive.
I think you should head it up.
Joseph?
I guess I agree that [indiscernible] evaluation of outcomes is not. I would make the argument, there's a difference between monitoring and [indiscernible] process. I don't agree to make the short-term actions -- may be a long-term action step. This is something that should be ongoing. Should be informed, and the groups working together. I would move that -- public -- starting with the review of what is actually going on, developing the assessment based on that with some clear, agreed-upon out comes. That's important, do-able, with recommendations from that would be do-able.
Doing the assessment maybe and seeing if there's key policy issues we should address, then which things we need to punt to others. Include in their clusters.
I would agree with that.
Comments on -- that issue, we didn't spend a lot of time at the last meeting, the assessment of the landscape. Should we go back and do that, build on that?
I mean -- the [indiscernible] takes into account what has been done, uses information that is missing as well. You would actually begin to look at what is the evidence across the -- if that is adequate based on whatever group is using that, then you would go from there. But the key here is to develop accessible outcomes, particularly with this challenge, which is moving in that direction, have to be able to make sure the decisions made, evidence -- is very focused, targeted, will allow you to look at the out comes you are trying to agree upon, combination of those things.
I think we have to, because [indiscernible] such a moving target, whatever we -- in July -- really huge uptake in the last six months.
I guess I would make a plea to make sure and do this in a timely fashion. We can be reassessing forever, and this is a rapidly moving field, so I urge us to move on it. If we are not going to do that, we should just monitor, which I have already made my --
I see a strong interaction between what you are trying to address here and the educational component, which is so terribly important, and effective action counter misinformation that might come from -- a strong educational approach described by Barbara, I think you would want to see some kind of strong interaction.
Wondering if this could be pursued as a consequent of the oversight report in the sense of saying we touched on it in the oversight report, certainly mentioned how aren't an area, building on that, now we take this little piece of the oversight report, expand it within that context, framework, so we don't get into all the morass.
When the original missions were written it wasn't such an issue, has grown over the years, when ever we talk about it there's a lot of new information, emotion, so maybe that's one of those that should get its own separate category. I don't know what other agency in the government will be looking at this. Maybe this is something we should take on, in the spirit of original mission, though it wasn't spelled out like that, but seems to fit with The overall --
One of the important things, important to move quickly, whether the options, white papers, detailed reports take a long time, other than the oversight report. We don't want to repeat that.
[indiscernible] again.
So, I think that's [indiscernible] we have to make.
Why we think this is so important, can I ask, for somebody outside the field, this seems like a gimmick, doesn't seem crucial. And if we want to move it forward as a high priority, I think we would need to frame it in a way that engages in a broader challenge to the healthcare system, to public awareness about the importance, development, implications of genetic insights in a way that doesn't make it look petty for a committee to take on in a meaningful way. I just take a step back and ask why, why do we think this is such a crucial thing.
I guess my response to that would be to look at analogous movements of consumer-driven care, and the two that I would highlight would be complementary medicine and Newt neutraceuticals. A huge interest in this, and led to the formation of, in NIH, looking into the science, essentially saying, we have empiric observations there may be something here, should we not look from the perspective of science, addressing the issues Matthew brought up, the evidentiary standard to say this is good or not good. That honed for me -- in some ways we are saying you need to have evidence, if we really honestly look at the evidence we are all developing around the things we do on a day-to-day basis, it's pretty thin. We may not be naked, but are in skimpy negligee at best. [Laughter]
We don't have time to -- [indiscernible]
But we know where we are headed, I will leave it at that. At any rate, there really is value there, and also the neutraceutical argument, you look at consumer spending related to things that are not necessarily well-understood, and where there clearly have been examples of very significant harm that resulted to the public, these are the types of examples that really to me speak that this is something we need to get a handle on. We need to come at it from a fair perspective; to say there's something there, we know this is important, means something to people. We know maybe this is what, the lever we need to get people to change behaviors which ultimately will make them healthier. How can we pull this together? It's important from this perspective and I strongly endorse engaging this.
I am intrigued by you bringing that up, Paul. Many of us in genetics think this must be important, given the media attention these types of things have gotten we think wow, the next big thing. I was told recently by somebody that there's been very little uptake, despite the articles, press, et cetera. I was heartened, tells us the public is more savvy than we sometimes give them credit for. My feel suggest that, however, we might be right, after all, might be something that catches on, and there are real concerns, and that's why I like the idea of a short-term action, a relatively expeditious manner, coming up with a check list, something useful to people, something relegated in an efficient manner, easy to use, brings light to this field.
In the best of possible worlds, perhaps that wouldn't be needed because people don't really buy into the hype.
I also think this is an area that provides more extensive perspective, beyond its own current scope. That is in the ongoing debate, whether or not healthcare is just another consumer good to be driven by market forces and consumer desire, or is it a societal obligation to be delivered by a certified professional community? Those are radically different --
[indiscernible] obligation, you know -- automobiles now have become a societal obligation.
[laughter]
This is one of the things, whether the way it exists currently is of such a magnitude, it raise z that conceptual issue. On that level I think it's worth delving into.
One of the reasons I think it's important, I think it might be standing in for other things. The uptake is low, not many people find genetics all that interesting, and [indiscernible] but I do think it may be a way that consumers, all of us start learning about healthcare and behavior change. It's a window to look at other things. The [indiscernible] example is right, moving the science forward, but back further to the HIV and AIDS activism of the 80s, moving that science forward, one thing that did, highlighted who the science wasn't working for. Population and sub-groups whose needs were not being met. If we were to highlight some of this it might shine a light again on the groups that genetic services and technologies are not particularly helping. Another way to look into issues of disparities.
On the same issue, I think emerging technologies, to deal with, help shape early, once out there in widespread use it's hard to influence. They have a life of their own. In some sense, on a timely basis, certainly topical, opportunity for us to have influence over development. [indiscernible]
I had a question for Sylvia, we see the disparity things throughout the clusters. More information about this thought of doing a report on how direct to consumer marketing may be impacting health disparities, how you get at that issue, the tie you see there.
I think that was one of the policy questions we came up with. We need [indiscernible] come up with the amazingly collective data, it's really difficult. Uptake is low. All right people have to pay out of pocket for these tests, so it would be difficult to measure any significant health disparity at this time, but it definitely is a point that we can extrapolate from other instances where society has access to pay out of pocket medical care. This would be a similar, down-the-road kind of thing.
I think as we have talked about this in the past, particularly in relationship to minority health, reducing disparities, one is differential access -- services to the extent they are beneficial would enter the conversation about disparity creation. The other is how widespread consumer engagement with genetic services will alter public discourse about questions of equity, society, public programs, and larger questions of inequalities, social inequalities. Beyond access, I think there's the potential for altering public discourse around a variety of social issues, because of direct to consumer community engagement with genetic services.
Other comments or questions about this?
I had a comment, but it is timing -- We will have to come back to prioritize everything. I am assuming we will not have the resources to pursue at the same time all seven of the clusters. Maybe that's a presumption. [indiscernible] so in the context of this I wonder if, given the conversation around short-term -- I very much agree if -- with what Jim said, if we were attach a value to this, doing sooner rather than later, in the public comment, other people focusing on this, timing is critical. I suggest we look at this as really, the brief report and maybe lower prioritize the in-depth report, hire prioritize the brief report to be able to take a statement on this issue. What I am worried about, we heard a lot of great things, at least on the first few, maybe more, but ultimately the toughest decision today will be which do we want to do ahead of the others. Putting this in a slightly different category to be a briefer report on a short-term nature may help with the ultimate decision.
That's very helpful. Other comments? Is it
Thank you Sylvia.
[indiscernible] I should have one comment that I would like to make, since -- made an overarching comment, I -- might be useful, either today or as we think about prioritizing, look at whether there are gaps or areas very prominently not covered by our clusters when we think are part of the purview of the committee. One area that, as I looked at the overall schema, one area might be the treatment of people with genetic disorders, that is, progress either in [indiscernible] or -- treatments, conditions under which people with genetic disorders receive help in the United States. That's not specifically addressed, may come under a couple of clusters. That might be an area of obvious interest to this particular committee. The other area in my view is the relationship between the work of this committee and its topic and the research portfolio at the NIH and what the interface between the national center for [indiscernible] as it goes forward, and this committee, what the interplay between public areas are. Those are the two areas I would -- might be gaps, may decide we are covering them, don't need to. Those are a couple of areas that strike me from the outside that might be things you would be interested in.
Thamplg Thank you, Paul. Comments?
Kevin: For clarification, when you say people with genetic disorders, presuming you mean [indiscernible]
It's a changing paradigm, you know. We just engaged in a discussion about consumers, their searching out for what are maybe not even validated risk factors. I think we have an obligation as we invest more in genetic technology to ensure that the treatment of people with the older style genetic disorders continues to improve. We have an ethical obligation as well as a practical one, to make sure we collect evidence of trends in that area, let's put it that way.
Thank you.
Comments? Questions?
I think those two will be important, certainly in summation of our next cluster. We can see how it might or might not relate to future of healthcare systems. Mara, do you want to take us through -- cluster seven, then we will come back, have time for general discussion, and begin a conversation about how we would prioritize these, in a flexible, general way.
Mara: If we go back to the work talked about before, preparedness for the future. The first piece of the question, getting together the folks from the health plans to be able to look at -- one of the things we had done previous as part of the initiative, talk to future -- more broadly. This is where the original initiative came about, that, coupled with the idea that healthcare reform very well may be a hallmark of the next administration, giving the opportunity not looking six to 12 months out, but five years, as to the infrastructure needs. A piece is the chief medical officers public and private institutions, also having the ability to scan the various agencies in HHS to understand what planning they have done so we are not recreating the wheel with the others within the HHS environment and thirty two their look at the -- and the need to put together a respect the report to outline, in the short term what will help achieve the future we see.
Couple things. From what you said I see something different from what's written. I assumed that's an [indiscernible] would be important to be inclusive, chief medical office, not only from payers, but integrated health system, hospitals, [indiscernible] centers, et cetera, because they are all having input. As much as we like to think that we docs are in charge of the future of health and policy, the reality is it's a partnership with administrative leaders. We really need to have innovative administrative leaders that are not CMOs, but CEOs from the same organization. They will have the business perspective in terms of where they think things are going.
It's a great idea, just want to be more broadly inclusive.
That makes a lot of sense. What we meant by -- a broad, not just the [indiscernible] strategic thinkers and the emphasis which may not be clear, public and private as well. To look to the chief strategy officers, whether they are called that or not, to make sure we are not recreating the wheel.
I think we can build off some of the work the state of Washington did, [indiscernible] together, leaders of healthcare plans, third-payers to discuss what they were doing to medical -- reimbursement, the work about two or three years ago, the report should be out there.
I am not familiar with it, that would be helpful. Glad you brought that up the University of Washington, talking to the key healthcare providers, in terms of medical association, groups of hospital systems in and of itself. This implies the reimbursement piece, but we need to be broader on that. Does the hospital of the future, in anticipation of genomic medicine look different in terms of in-patient/out-patient, information systems. We would include that.
Other comments? Suggestions?
Are we going through other parts of this or is this the discussion piece?
We can keep going through any parts you like. What Haven't changed, the initial comments about clinical lab careers, and -- discussed earlier.
I would like to [indiscernible] one thing really exciting about the American society of human genetics meeting last month. It was how close it looks that we will actually have some treatments for [indiscernible] diseases based on a small molecule, take being advantage of [indiscernible] skipping, and other things about [indiscernible] medicine, some of the interesting work going on with RNA.
I think we may, in fact, in the future window of five to 10 years have extremely effective therapies for some of the traditionally untreatsable genetic disorders and I agree with [indiscernible] if we let that drop off the radar. It fits within your cluster, whether we need to do anything at a high-priority level right now, or monitor where things are at, I don't know. I think it should be represented. There's at least a couple in these two, maybe one in [indiscernible] phase 3.
But basically you are talking about with the advent of genomic medicine, diseases today not fully addressed, but may become long-term chronic diseases. The example I use here, actually fits in, as the community changes from -- very finite life span to a long-term disease, we need to change infrastructure, whether it meant hospital reimbursement, life insurance plans, and quite frankly, the shift happened quickly enough that many institutions were not ready to do that. If you look at probably two or three scenarios about these kind of inventions occurring and being successful, how do we put together the infrastructure to be ready for that without undue cost.
You could get clarification on that -- when you look at planning are you including part of the anticipated -- discussion, one that we are looking at both workforce development and [indiscernible] allocation of the workforce. Once you make decisions about where it's going who will be there to do the work, what I am getting to. Do you anticipate that -- that is --
Yes. We talk about that, talk about it as one of the policy questions. I am weary of recreating the work of the other clusters, but we will take this at a much higher level as opposed to specifics in this type of education. But more broadly talk about the type of healthcare providers and for instance, one of the [indiscernible] really talked about, dramatic change if you believe in personal healthcare, more precision, fewer physicians providing care and more non-physician care. That would be an example of the high level we would look towards if that's the case. How do we set out an educational program for non-physicians? We would not state in this cluster get into the level of detail, how would you educate them. That would be in other clusters. We would look at the big .
I get that, the question of integration -- seems to me, I recognize, respect the fact you would stay away from that, but also recognize that setting priorities, how there's intergraduation in the clusters.
Yes.
What you are talking from, actually would be efficient, looking at integration, even if -- to mean working with some of the other clusters. We will have to do that anyway.
Yes, good point.
It does seem like for this committee to engage this issue, which of course, such as every committee that exists, HHS and beyond [indiscernible] we are making a special claim of relevance. Engaging in a very purposeful way questions, exposing genetic insight, capability. The second is that this is an intensely anticipatory project for us to take on. In other words, this is really tilted forward, looking at very big-picture issues, to ensure the healthcare reform conversation is not only about changing CPC codes, may be very important, but particularly, given the trajectory in genetics and genetic capabilities, that healthcare reform must engage these issues in a very meaningful, but also in a highly pa ties pa participatory way.
Well said.
Healthcare, genetics, in the delivery system, could embrace clinical activity, certainly as I mentioned relates to policy -- and workforce, so it's clearly having strong linkages to other clusters. It may be that in our priority setting we could suggest that if healthcare reform becomes a framing activity for us that it include other issues that would threne then not be seen as highest priority issues, but be included in the participatory session, the committee -- [indiscernible]
I think that's right. The challenge in front of us in doing that is keeping up with the potential progress in the real world, outside of this room; and ensuring we remain relevant in a way that if healthcare reform moves quickly, and we don't know the answer to that now, that we have a seat at that the table. Short-term. To ensure our interest in doing that is clear to the next administration.
Comments specifically on cluster seven?
[indiscernible] as we move into trying to triage all this in an orderly fashion, I want to remind everybody that at the end of tab 5, on the grid you have, that at the end of that is a list of the things we have already done, reports we already issued and the fact that not all we recommended, strangely enough, has come to be. That we actually are continuing to monitor the recommendations we already made for the reports on genetic discrimination, substantive progress. The oversight of genetic testing, in the midst of seeing what comes out of that; the pharmacokinetics one, and related to the large population studies made several years ago. We will continue to monitor all of that work. We should have that in our minds as we think about the new projects we want to take forward, which clusters, the nature of that work.
Thank you, Steve. To remind everybody, we are not going to be voting on priorities here, this is not a formal listing, but rather to get a sense of the group, how we would prioritize these cluster issues, how we may want to relate one to the other and provide some guidance, next steps, recognizing we need to be flexible in how we approach this, and it will be some kind of -- we need to be responsive to new administration priorities, their needs from us.
I open the conversation for general comments.
This is a daunting task, to say the least; but thinking from a process perspective, reflecting on the conversations we have had already, the investment all of us have taken leadership in one of these areas have; it seems to me maybe the way to think about this going forward would be not to necessarily take the second cluster and try and arrange them in some type of a rank order, but to reflect that each of the clusters has something to bring to topic, the committee as a whole may feel heavily invested in. The concept I would put forward as a straw man would be to perhaps leave the seven clusters as they are, with leadership to keep appraising what's happening in the area, then to focus in on what are the areas where we really have opportunities to leverage. For example, we are in middle of the education report. We heard how several clusters will be relating. If that's is something we prioritize, can we then have the cluster leaders from the other area say this reflects directly to that, so this moves up the priority to support that particular effort of the committee as a whole. Seems to me, using that modular approach, particularly in terms of trying to be nimble in an environment that is going to change rapidly in ways likely to be unexpected, might allow us to maintain expertise around these very important areas, and readjust as a communal effort.
Joe and I would like to suggest an alternative approach, that you do everything, and do it all with really large reports. And start in March.
Thank you for that. [Laughter]
Other general comments? Particularly about process, how to think about moving forward?
One good thing that can help, to identify specific niches. Here's something quick we can do within one of these, the rest of that particular agenda item can be put a little on the back burner issues.
Actually, to be somewhat concrete and hopefully helpful, I think there are a couple things that came up we can put in an order. For instance, the informed consent thing, will be happening in March. We can decide what sort ever educational segment you would want in July. One thing to put downright away. Similarly, with Mara's suggestion of pulling people together. Once you look at the reports from the University of Washington you could at least fraism questions for the next meeting to look, see who are the people you need to bring in to answer those questions. Another thing we could do concretely, line these up for the March meeting, jump off from there, you might have an idea then where the next administration is pushing.
I like that idea, but I wonder if we have time for that. Whether we need to move faster, to start things before the March meeting, or prioritize. One option, obviously things are still in flux, but we have some data, to be able to meet with the new administration, relatively quickly, and have maybe -- number to propose, these are the seven priorities, this is the committee reporting to the Secretary, the Secretary's presence is important in the context, but this is the process we went through, the seven we have, and the January time frame, realistic, present all seven of them, unless there's some the group today would like to take off the list, assume that's not the case. Present those in the January time frame to say these are our seven, like your input, what is most important to you as the new incoming Secretary, have the ability to hit the grounds running, so by the March meeting we can have their input, begin to move forward.
[indiscernible]
I think that's -- particularly relating to the next thing on agenda, putting together a brief report of our activities, plans, with a cover letter that would precisely introduce not only the committee to the new administration, but what we feel are strategic contributions to the issues of the day. Going through the different clusters, listening to the public comments, I was struck there were not quite principles, but strategic contributions to help us frame the seven clusters. One clearly crucial is genetics, the service of informing the healthcare system. Cluster one, two, three and certainly seven, is the over-arching, but the utility, coverage reimbursement, making sure there's a workforce is going to be crucial. Second is the idea that genetics will be crucial to public health and population-based prevention. Clearly cluster six. But also, a larger framing construction that would allow us to engage in those issues, and which came up very high in the ranking we had prior. Third, individual engagement with genetics and protections. The public's growing awareness, engagement, direct to consumer marketing is one component of that. This issue is going to be crucial and protection [indiscernible] engagement. The last is to ensure the new genetic technologies will enhance equity in health outcomes, that we ensure we reduce disparities in the health of all is improved. There's no single cluster for that strategic contribution, but rather, we decided that would be a component of all. In think being how we would frame our seven clusters, we could just list these as priorities, but there are different levels, different histories, and I am looking for ways to frame our seven in way that's would definitely be clear, why we have picked these seven. So I am coming up with, say, in our cover letter to the new Secretary, to say look, we need to make sure genetics is a central part of healthcare reform. Then we have specific ways we think are the highest priorities to do that. Second, public Public hetle Health and prevention, protection, and last, that health equity is a crucial component to everything we do. We need to ensure the genetic insights, capabilities are issues addressed in a meaningful will way.
I will just throw that out to [indiscernible] the conversation. In the document that followed the cover letter we have all seven, would include all seven clusters in greater detail. They all have components of the issue brief, but the framing, overall framing is important, what we are about, what we feel the new administration should [indiscernible]
What we both said, it's great, organizing, describing three major fundamental areas for which the seven would fall, a great step forward, organizing it in a more -- I would obviously like the ability to edit given the comments we had today going forward. But getting it out, and emphasizing to the new Secretary, having his and his staff's view before the March meeting will allow us to hit the grounds running, going forward quickly.
I would echo, the policy, as it stands now there's a prominent -- how to bring genetics to the fore. It's important to emphasize, see the Secretary, to the public, that the advent of genetics in medicine its own -- it's going to drive medical care, effect medical care in an other direction, very important to articulate.
Other comment about prioritization?
Okay. Did you want to make a comment, we fulfilling --
We are, we have the heavy lifting, [indiscernible] where the healthcare system needs to go, how individuals engage -- that's [indiscernible] relate, understand. Then we can get to the pieces below it. I think for our own purposes we need to then think about, given all the things on the table, and the areas where we might actually make a substantive impact over the short term and the longer term, how would we think about which of these issues we want to tackle in a way that we can manage within the research available to us.
I think we should have that discussion. I think this is actually helpful, your reduction from seven to four, is actually pretty helpful in communicating effectively the components. Maybe conthing we could do -- maybe we could get that -- up so people can see it. Have a little bit of discussion about what had we think would be the most important, short, immediate kind of things we can do, as well as larger reports that we really could undertake for the next few years.
How many do we manage at one time?
Thinking one.
Usually a couple to three at a time.
The workforce is moving forward --
That's ongoing.
Then hopefully we will get to the end of patents over the next year and should be prepared to take on what we think would be a -- that means Jim can take on the next one because he will be in fine shape.
We should think about the next important topics to take on, and come of these we want to get on with, with more [indiscernible], I would be very interested in -- given all the important issues put on the table, which are the ones likely to be most -- the ones we can make the most difference.
There's [indiscernible] that touch all laboratory -- last five years, even more we haven't realized, which is the critical shortage of laboratory personnel. We have a brief report in cluster 7, we are at a very critical standpoint, where we are not -- our current workforce, working not only in genetic laboratories, the entire laboratory community is reaching the mean age of 40 to 45 years old. We don't have a lot of people going into this type of work. Some of the issues we have, we don't have enough schools, schools are closing due to lack of funding, also there seems to be [indiscernible] for young individuals to go into the field. Also, we cannot retain them. They usually go to work in IT, information technology. This is a critical issue that I think we are currently face facing in many areas, maybe we can develop a report, start investigating why -- where we are, what can be done. We could have a huge impact on the [indiscernible]
Is that part of the workforce purview?
We have talked any it, trying to decide to put that t that -- [indiscernible]
Even if it's part of the education world -- different from what [indiscernible] is talking about, the ability of the personnel. We take it up in 7, but again, more of a long-term basis, less of a short-term basis in terms of row reacting to what many see as a crisis in the field.
In your long-term view, one could differentiate different between the things that are in crisis now or will soon be, which could derail the long-term, right? Would we be able to break out of your report those issues? First identify them, the workforce issues, other issues that have to be addressed in the short-term if we are ever getting to the long-term, then something the committee could do, which would be unique.
We highlighted one of the policy questions, for that reason, comments to broaden that. I think the perceived crisis is in the laboratory, of all types.
Why I am bring it up. In the long term, could take two, three years to come out. We have to start -- proactively, something to recommend.
Your memory is sharper than mine, but we made the decision -- I thought we made the decision to exclude laboratory [indiscernible], we can always revisit that. Given that decision, whether -- maybe I should address to Andrea, if it's clearly established there's already a problem, is there something we could do that, something less than a full report that could begin to help with a solution, rather than to evaluate it.
[indiscernible] the report, very specific goal, which is, identify, start looking at specific areas, why there are not schools, not attracting, retaining, what changes can be made. I am not sure how far along on that [indiscernible] going -- why the scope of that report, get -- [indiscernible]
I think we can do a brief report or maybe white pape tore get something up and going [indiscernible]
So I still believe -- laboratorians may be included, different issue than -- talking about. The kinds of things people have talked about in this fields, and we could take a [indiscernible] seed funding, familiar with this in the educational arena, for community colleges to take on programs in laboratory medicine. That's an incredibly effective in the education field, resolved in about 10 years, the number of programs available, the two-year and four-year colleges was tremendously enhanced.
The private industry counsel, workforce development money increasing in context of recession, retraining happens, and federal dollars, not necessarily from HHS, but more broadly can be directed to careers. This happened in the nurse community where there was a tremendous amount of dollars funneled to train nurses specifically, about 15 years ago, for the next generation of nursing, and even after that we are still dealing with a nurse shortage. There are short-term pieces that don't require legislative support or new laws, fundamentally, but to prioritize laboratory medicine in a way that brings what very well may be a larger number of unemployed individuals into the field in a short period of time. It's not quite that easy, because there's a fair amount of education. You don't have it work tomorrow, but it is comparable to what happened in the nursing shortage. Universities, companies got together, priorities were made in private industry counsels, and [indiscernible] money. The kind of initiative we might be able to put together in a relatively short time in a white paper.
A question and comment. The comment relates to reimbursement aspect, particularly for PhD laboratorians, there's reimbursement -- you are shaking your head no, there aren't?
[indiscernible] reimbursed, different procedures, that I personally cannot --
When you talk about retention, some of the issues, and I know from speaking with institutions, why should we pay for these folks to be there if they can't bill for services, have to do work-arounds, whatever. There are reimbursement aspects that may impact retention.
I think you are right on the money with that, not talking about the PhD level individuals like myself, but the medical technologists, if we don't have a free market to increase salaries for these individuals. Normally we lose them to information technology, to be honest. In that case. Reimbursement could be tied into the decision, the ideas in the white paper to see how we can fully educate some of these individuals out on the workforce --
The question I have relate s specifically to a white paper, I don't recall specifically, what if anything was addressed in the Bandberg conference, the several conferences on education and genetics. Was there much time spent around that? In other words, we shouldn't create a white paper if Bandberry has and --
I think it's beyond the genetics field, to the [indiscernible] other areas, not just genetic technologies and the molecular biology. Goes to all the laboratory. Genetics is [indiscernible] every year of the laboratory. You want to -- need to have [indiscernible] another area. Not that narrow, have to be more broad.
Can I ask about the role of the committee? I know other groups have tried to address this issue, put out reports, professions, relatively recently a large report specifically on this issue. Some of the professional groups have been working, advocating on this issue. What would you see would be the role of this committee, given the workforce, clinical lab work issue is much beyond genetics? What would you see the role of this committee as being, given the other reports, other work being done more broadly around clinical workforce?
I think we can look, check what has been reported and see the area that's we can actually continue to discuss, and contribute, because there are gaps or nothing has been put forward. The survey has been done, and move forward from .
Barbara?
I am going to quickly say, ask the same question, there's a difference between genetics, education, basic education, continuing education, and fork force issues, getting people into the pipeline. That's a little where the line is. Typically, I think, agencies interested, often picked up the workforce part of the [indiscernible] not sure --
Kevin?
Andrea, looking not far down the road, this is falling under Mara's purview, the future thing, near future. If we have the $1000 genome, what does that do to demand for clinical laboratorians? If this is going to ramp things up, that's something we need to look at.
Exactly, if you have a $1000 genome, everybody gets screened for genetic disorders, we still have to have people to run the tests. Creates an issue, but beyond a molecular biology, in the genetic laboratory. You have to have individuals in other areas. I give the example of [indiscernible] and breast cancer, as it continues to implementation, move the personalized medicine, genomic medicine, will require more testing in the laboratory. We need to have a workforce, retain the workforce.
Just, the ripple effects will be huge. We will need a lot more genetic counselors.
Maybe some clinical geneticists.
Not too many of those.
Four or five.
Other comments?
I want to push folks a little here. We have heard -- need -- I don't have the magic number. But short-term things? Monitoring things, and then a couple or three longer-term projects. I am really interested in what people think those things should be. I can push back on each of the leaders, cluster leaders to talk about what those might be. I would be very interested in which people think are likely to be the most impactful to take up.
On the monitoring, we have for those. The informed consent, there's the HERSA meeting coming up. Presuming at some point in time, interested, that may be adequately addressed by other people. We don't need to Wade into that. Monitoring. The DTC issue, something we need to monitor, how to frame toward this committee. Although I know there's some entire to move desire to move ly, I don't know how we want to weigh in. That's already there, the short term needs, we can pick two or three of those as discussed. You are right, genetic counselors, part of the ripple effect. Long-term, I will leave those --
In response to Steve's plea for specifics, I would throw out there, the things we discussed this morning, two short-term items that could be addressed, one very short-term, something along the lines of what Mara suggested, a letter to Daschle to emphasize the importance of genetics and the changes it will bring about and has to be factored into the plans for healthcare reform. A short-term item could be a check-list in the DTC arena. Then I would personally advocate, given the incredible importance of row reimbursement for functioning of the field, a high-priority in-depth report that should be pursued, and initiated quickly.
So you think we need a new in-depth report.
Yes. I saw the [indiscernible] and -- yes. We need act on those, [indiscernible] vigorously what has already been --
Great. That would be good.
You should --
Exactly.
Implied sense that's something we will be doing. I don't think that's an item that's on the table for debate even.
Let me try this out on you. Having -- this discussion, I will run through each of these and you can tell me where I am -- coverage and reimbursement, I heard the most important things are monitor, and list implementation of things already out there.
Yes. Push.
We are clearly having an interaction with CMS on those issues that we will continue to, yes, more than monitor. The sense of they are there, work with the organization to help move them forward. I think you heard the clinical U utility is important, but under the Rupert we talked about, can be emerged under the future of the healthcare system. I am not convinced we need anything -- we already made those -- some of the salient recommendations, pharmacogenomicsics, we heard about genetic [indiscernible] need to add the lab report in a stronger way, that's already under already under way.
[indiscernible]
You talked about a white paper, shorter term things. Sorry, didn't mean in the context of the larger -- talked about the informed consent, probably be, as we get -- really important in the privacy issues as we get to the $1000 genome, the clinical utility, be able to use those resources. I heard to at least look into what comes from the HERSA conference. Pardon?
Ties into what Michael talked about, the human subjects. The [indiscernible] doing short-term assessments of the DTC, consumer testing, short-term thing to take up in a way we stay on top of that, more than just watch it. Details to be worked out.
Public health applications, although there's a lot in there I haven't quite got my head around exactly what that is going to be. I would be interested in -- talked about -- [indiscernible] that gets you -- within that there's -- interested in other stuff to be done there. Then I will push a little on Mara, seems to be the big one is about health reform and the key things that can be done. Clearly we can do an in-depth report, several years, and I know you don't want to do that. I don't want to do that either. I want to set a few things that we can get on with. I suspect that's going to be an ongoing, major effort.
I don't know if you are asking for comment now?
Sure -- putting up a straw man, what I am taking away from the conversation. That's my interpretation. So yes, I am looking for thoughts so we can --
Paul?
Yes.
Sorry, hard for me to raise my hand. I didn't hear whether the regs and recommendations associated with JENNA, an immediate issue, rather than long-term issue, whether that's part of discrimination cluster or whether we spent our wad on that one already.
It is currently listed as one of the things we are going to be monitoring as -- the items we issued reports on, discrimination, one of the items --
What monitoring, given we are at a crucial period, the incoming administration will have impact on the regulations, enforcement of legislation, do we want to be a little more aggressive on that?
I am Carri -- from the EEOC. In terms of title 2 we are moving along as quickly as we can. Actually the person most involved in drafting this, [indiscernible] rule making for the regs, recently left, accepted a job at Department of Justice. I am the replacement, Peter Gray, working on this issue a long time. I am doing my best to fill in for him. We have high hopes that [indiscernible] will be coming out soon, at least in terms of title 2, employment discrimination.
Sent out for public comment?
Yes, under the federal rules of civil procedure, published for 60-day comment period, take comments, come out with a final rule after the commission -- still drafting the public rule making proposal for the regs, then get comments on that.
That's
That's one part of --
Will all of the titles come out for public rule making at the same time or issued independently?
Issued independently. EEOC only has the authority on title 2.
And there's the insurance one.
November?
[indiscernible]
December.
Agencies within HHS, working together on this health insurance provision. Not sure whether that will come out as interim final rule or a rule making -- not really sure. You know more about -- perhaps we might want to have a [indiscernible] report -- things will be clearer by then.
Still be timely, wouldn't it?
My hope would be the N PRN would be published prior to that, then we would be working on comments we received, our hope it to publish final by May, title 2. Depends on -- the commission, we don't know, the administration -- [indiscernible]
What would you have in mind beyond trying to coordinate with these agencies?
I was -- if there are key components from the committee's point of view of the law, and either stricter interpretations of potential or less stricter interpretations of rules, as we just heard, the new administration is going to have a say on construct of these -- we should educate those, the leaders on that.
I have a narrow comment and a broad comment. On the narrow, in answer to your question about cluster seven, I think I could, and given the comments we heard today in committee, probably three priorities within cluster 7 that I would focus on, workforce, health information technology and monitoring -- effectiveness. So if you wanted me to at least put a [indiscernible] on that, prioritize, I could do that. The bigger issue, maybe to think about over lunch is to me they look like very different ways to go. One says we leave all seven priorities, organize them the way Paul described, send them to the new Secretary, and [indiscernible] continue to focus on the two we have going in the interim. Wait until we get feed. feedback. The other approach is that we prioritize amongst the seven, start working on them or send them to the new Secretary with a prioritized list. My concern is that's hard to do, and I would like to know what the new administration would like to do, and I don't think seven is so large a number that it's overwhelming or looking scattered, that we present.
That wasn't the thinking on the 7, just to begin to clarify our own thinking about how we would take on all the pieces within that.
There are other things, lay out the idea over the short term, convene a group of chief medical officers, other kind of people to bring together, in the near-term to inform us. Hard to believe this isn't going to become an important topic. We could get on with -- when we meet in March, we are not back here again.
That's exactly what I am trying to do, not have to go through this again in March, have clear marching orders amongst ourselves.
What I was looking for also. Yes, broad issues, but we have a little clarity to begin to take it on. Have a richer session with them e. different level of granularity. Then we can move forward.
Why don't you think about that over lunch as we -- not sure whether hypoglycemia is worse before lunch or after, depends on insulin probably.
Before we break, I thank everybody for being humane with the leader of this task force, and your are informed, helpful contributions over the last nine months, particularly to Sarah, staff, and the members of the task force. Thank you.
Great; and thank you, Paul. We will revisit this, if there are other comments after lunch. The rested rest of the day we will review the draft report, which you had in tab 6, handed identity in your folders, which is the note, we will have to send to the incoming Secretary. We would like feedback on that. Those of you making travel plans, we will wrap up a bit early. We made good progress. Let's take our break for lunch and be back at 1:15. As usual, [indiscernible] outside, I hope, and cafeteria down the hall.
[Recess until 1:15:00 p.m. eastern time]
I would add upon the genomic data and the context around those scenes and things like that.
We have the clinical part of the public health in the first bullets, but the second part is really the population-level stuff.
There are people who build their careers on the equities equalities and all of that stuff.
[ Laughter ]
I would like to bring this to closure. Is there any other issues with the framing and the other information that was brought out this morning?
[No Response]
I will move on then. In July, we would like to engage the new administration in a timely fashion. So what you have in Tab 6, also in your folder, is a draft letter who I assume that you all study intensely is the presumed secretary Tom Dashhold, and we have a little bit to incorporate, which is largely this, which is what we will be incorporating into this letter. And aside from the general framing of where we have been and the priorities that you think we should take up that are based upon our prior reports, which is something you may think is a quick action and a build-upon on the quick actions and the framing and the cover letter. Paul has played a critical role in drafting this. Paul, would you like to add anything in regards to that?
I think the approach to that is that the cover letter was going to make the broad and general case for both the existence of this committee and where we think the central issues are going. And then to have a laundry list of what we are doing and what we are framing, but also an indepth document for the basis of the ongoing decision within the community and the leadership and to begin the co-navigation process that we have discussed.
I think the letter is very well drafted and will be very helpful to the new secretary and we will be instrumental to ensure that this committy's view is -- Committee's view is subjected to that.
(Speaker/audio unclear and unavailable due to audio distortion and interruptions).
I wanted to discuss the reclusterring and such. We would then, basically, as our principal in moving forward and what we view are the strategic contribution and efforts in this arena. So I think the idea is to take that and incorporate that in the letter. Can you also be benefited from your wisdom on the transitions, what do you feel we should do to best engage the new administration on these issues? I'm putting you on the spot, of course.
No, I am happy to contribute my views. Right now the department is going through a transition planning profession. So there is -- so there is an opportunity for the staff permissions where we are actively going through an interview process right now and providing material. I think all of the ex-efficio members in going through the interviews in the presidential elect transition team can certainly bring forward their involvement with the committee and the visions that we are setting forth now. I think once the new secretary is in place and is working through the office of the secretary and getting the letter directly to him and identifying who the point person is going to be in the secretary's office in order to handle these issues and then establishing a contact will be the best way to get the information across.
Thank you.
Thoughts on the letter?
We could have done this before lunch?
Yeah?
Can we highlight the opportunities of action? Like, bullet them and highlight them 1, 2, 3, and 4?
Sure.
Those are the things we want to highlight. We debated to do that in the cover letter as well, but, you know, it is kind of hard to highlight things within a cover letter.
Maybe the opportunities of the action should go in the cover letter and in the document as well.
It's in there, right?
No.
No.
So I am responsible for yanking them out of the cover letter.
I am the one to blame.
Right.
We are talking about the health care reforms, and we are talking about broad issues of the public policies, and then in the next two sentences we have specific and immediate assets and that is not going to be on anyone's screen until the systems and the secretary is in place. It was a scale. It was jarring and so I had a cut and paste type of feeling. My response to that suggestion is to elevate the immediate action steps within the attached document and make it bold and move it up in the document, but not to put it in the cover letter because of the mismatched scale of the immediate actions and the main purpose that we would like to receive from that letter.
I agree. There is so much information here, it is hard for anyone to get there easily. It is well written. I understand about not putting it on the cover letter as you have now described it. Maybe we should have two attachments there so it is see -- accept parable -- accept parable -- separable, and then you can send it to the person that is there during that time line. I am sure it won't take that long for the secretary to review it, but that person may become identified before the secretary is confirmed. It may not be a political consent or affirmed appointee. You may want to time it and get that document to the person along with the secretary as the target, the addressee.
[ Laughter ]
I'm sorry Craig Downing.
We have submitted that to Craig and Rick and we would look forwarding to fostering that within the new administration.
Other thoughts, folks?
Anything you would like to talk about for two hours?
[ Laughter ]
Are we done?
Is there anything else?
Sarah?
No.
So anything else?
Wow. Well, let me summarize this then. It has been a great couple of days --
[ Overlapping/Multiple Speakers ]
Well, we have asked people to give comments.
No one did.
I think it was in Tab 7. As you recall the cancel on the linkages between the Academic Health Conferences and Joseph and Silvia worked on a draft in the areas of genetics where we would like to include the work force come come -- competencies. So it is due by the 15th and you need to get them in by the end of the week. So if you have suggestions on how that is worded, please get them to Kathy.
They only do this every 10 years, so it is important for us to get those comments and suggestions in there.
Please do, yes.
Just in pulling these together, you know, I am constantly amazed on the productivity and what we get done. Just to quickly go over where we have been, yesterday Jim led us through a discussion of the pass reports. And there were some not-so-easy options for us to consider. After having reviewed that and receiving the suggestions, we will tidy up the report and submit that and then we will have time to look back through the comments that we receive and that will be approximately 30 or 60 days. And then we can take a look at that. That will be finalized by the end of October. That has been a complex and an important bit of work. As we have heard with the $1000 genome and what is patented and what should be patented, there will be a lot of discussions for this Committee. We had the update on the metrics that are being developed and the standards from NIST,FDA, and CDC, and it is always fascinating to see what is going on in these agencies. They lay the ground work with all of the data that we have used. Today, many thanks to Paul and all of those who have tried to accomplish all of the issues that we needed to address. I think this has been amazing and ran smoothly in order to give everyone the understanding of this frame work, take the questions, comments, and suggestions, and then where we are able to complete this frame work and submit it and get it all done. Thank you to everyone, the staff, and everyone else involved for making this Committee productive and relevant. Thank you. Please have safe travels and safe and happy holidays. We will be back here for our next conference, here at the Humphrey Building.
Thank you.
Thank you, everyone.
Safe travels.
Thank you, Steve.
[ Event Concluded ]