Event ID: 1319122
Event Started: 3/13/2009 8:19:45 AM ET
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Please stand by for realtime captions.

Welcome back. I any we had a terrific day yesterday. I want to thank the committy for the exlend discussions. I think we touched on a lot of important issues. We need to follow up on a lot of them. Before I begin today I have a ceremonial function to perform on behalf of the secretary to be named later. [ LAUGHTER ] I'm honored to do it, but also reluctant but it really means we'll be saying fair well to members of this committee who have contributed an enormous amount. I want to present a certificate to Kevin. Where are you Kevin? [ LAUGHTER ] You got her just in time to leave. Thanks.

Don't let the door hit you or anything. For out standing vision and [ Indiscernible ] Improving health care in our country and -- we should have a photographer but you just got back from India.

Working for foreign government.

Tomorrow you can start doing that. Not today. Kevin sincerely, you have done an enormous amount on this committee, keeping us on the straight and narrow. The large population studdies and we are going to keep interacting. Thank you so much. It's been terrific. We know you right here in Washington and we brought you the [ Indiscernible: Speaker/Audio faint and unclear]. We're all set.

[ APPLAUSE ]

Hi team camera here. Capturing the moment.

Thank you so much. Another one we'll bidding adieu to is Joseph tell fair.

Wanting to thank you as well and we're going to miss you. From a public health perspective and very much appreciate all the work you have done in the [ Indiscernible: Speaker/Audio faint and unclear. ] I can read this. It says the same thing -- I'll just smile thank you so much.

For those ho are new members, once you are in, you are never out.

[ LAUGHTER ]

Keep trying to leave but they keep pulling me back in. It's extremely gratifying that we have such a deep level of expertise on the committee. We can't quite let go. We're going to pick up where we left yesterday hearing from our exofficial owes. As many of you know we met last week weanticipated we would have a new secretary named. Behave prepared a new progress report. It's in your notebook, which captured where we were, some of our thoughts on the priority settling process that we completed. A set of the recommendations we made as well as a few we thought were ready for action. We're still waiting for a lot of the appointments to be finalized. We will proceed with that working with the administration as they get named. But obviously time doesn't wait and we have been asking our ex officios how they're rounding to the new environment, particularly the recovery act. We want to turn back to them about where they are.

Alberto who is just joining us from the FDA. We actually have a new member, we introduced you yesterday. So everybody knows who you are. But we are absolutely delighted that you are here as part of the committee and as those who have looked ahead on the agenda, we're already putting him to work before he arrived. So thank you Sam. Alberto?

Good morning.

I'm going to talk from here. I'm replaces -- let me -- we were asked to give you a quick mission statement --

Sorry.

I wanted to just give you an idea of what the mission of the agency is. I must admit that [ Indiscernible: Speaker/Audio faint and unclear] excluded two major part of the agency which are foods and veterinarian drugs. The focus for this committee is drugs on [ Indiscernible: Speaker/Audio faint and unclear]

I want to point out that our mission, we have a twofold mission. We're really supposed to protect public health but also promote public health that. Is a mission we take seriously. You'll see a lot what we talk about today goes toward the area of what we do to promote public health. We obviously have a part on post market and making sure they continue to be safe and effective. The agency has actually moved in a couple of ways to strengthen it's -- the role of genomics and writ's going. Our acting commissioner at the moment as chief scientist created a new position with the senior genomics advisor. That position is being fielded by [ Indiscernible: Speaker/Audio faint and unclear] she is from our office and is on detail to that position. Beside when the commissioner appointed Liz, he mentioned three areas where the agency is working or has programs that are important in genomics. The national cancer toxicology research program has [ Indiscernible: Speaker/Audio faint and unclear] form psychology really looks at the issues with genomics all the way through with discovery. Data submissions that is a non-regulatory program that they actually allow manufacturers to come in with data and they help them decide how that is going to influence their drug development. They also have a bio marker qualification program and they have programs in terms of how to speed up the development of drugs such as the early or the end of phase two guidance that they publish on what interface 2A. What are the purpose of those meetings. They help us with consults an they look at in terms of [ Indiscernible ] [ Indiscernible: Speaker/Audio faint and unclear] role to play in research. In terms of OIVD, obviously I'm not Steve [ Indiscernible: Speaker/Audio faint and unclear. ] you know him well. That's good news. Probably won't be hearing a poem after each talk. [ LAUGHTER ]

But we will miss Steve actually. He -- his shoes are going be hard to fill. The acting office director and knowing Don, he will be moving on as soon as he can. He opened a search for an office director and we expect and actually interviewed people and we expect we'll have an office director some time this spring, I hope. We have also received quite a bit of financing for this year, next year. We have created enough staff of [ Indiscernible: Speaker/Audio faint and unclear] medicine that is in some ways outside of our current structure an they will be coordinating outreach and internal issues that have to do with personalized medicine and genomics in our office.

We continue to put out guidances when we can or sometimes we continue to work on them in trying to get them through the system. The IVD guidance is still in the works. There was a lot of work done by the agency and the department, but unfortunately, we were unable to get it out before the last administrationnded. We are -- administration ended. We'll waiting for the new administration to continue putting out the guidance. We have other guidances that effect genetic testing that we continue to put out. We continue to do our every day work that is clear or prove deviced. Among them obviously devices that are genetic tests such as the influence of Tests or actually as of yesterday, we approved a new HPV tests that have just come out. When there are issues that are notable and need to be discussed. Some panels have been drug panels. So we had a panel in -- two panels in December. One dealt with a specific devise called the ROMA. The other was a general issues by the oncology drug advisory meeting and all the issues that are arising with the KRAS and whether there are a couple of drugs that are innewsed with -- whether it is time to begin to think about label changes and also there was a couple of effects on ongoing trials and whether the exclusion criteria for those should be changed. We continued to take actions when we see devices that do not meet the definition, for example, the definition of laboratory tests and we send a [ Indiscernible: Speaker/Audio faint and unclear. ] the test was removed from the market. We continue towork on critical path programs that have to do with genomics with our colleagues in NCI an CDC. Importantly among those we have put a lot of work and effort into is cancer bio marker consortium where we have been dealing with bio rogatories and data sharing. We also have an interagency task force, which deals with oncology and NCI and this has three areas that we actually are particularly active on that is molecular diagnostics an specimens and a genomics that is being formed. Finally and this one goes to one of the recommendations from this committee, we are beginning to work on a petition on genetic file. That petition asks to regulate all laboratory tests an we're beginning the ground work for background and options for the new administration to figure out how they want to proceed. That's all I have. Any questions?

Right. Well thanks so much Alberto, we have a lot of work to do, along with you. Great to see there's new organization devoted to all this. Denise? Can you give us a little update as resources and services administration.

Can you use your mic?

I'm from the health resources services administration which is one of the agencies within the Department of Health and Human Services. It's known as the access agency. It improves access, the quality health care for people who are underserved, uninsured, isolated or medically vulnerable. Provides 1100 grantees that support 7000 clinics that provide primary preventive services to almost every state in every single community. Serving more than 16 million low income people. We have the HIV AIDS bureau primary care for about 530,000 low income people. Within our agency, we have the maternal and health child bureau and arrange of programs for women and infants in need and children with special requirements. Specific focus onager nettics which I think is of interest to this committee. The inheritable programs screening service collaborative. There's a national coordinating center which was established to work with resource centers and address issues of importance regarding access and utilization of genetic services at the national state and community level. The regional centers have as their primary goal ensuring that children with inheritable disorders have access to quality care an appropriate genetic expertise. Funded under this bureau that support cooperative agreement. The focus on education and community outreach. There are two new projects, one screening for inheritable [ Indiscernible: Speaker/Audio faint and unclear] in children and ensuring access to quality information and education in genetics. They've also funded a family history project, which will provide a downloadable customizable brew sure that disease groups can use. The agency strives to ensure health care work force that is diverse, well trained and accurately distributed around the nation. Scholarships and student loans are given out. We've supported more than 28,000 clinicians who serve in some of the most economically deprived and isolated communities in America over the past 35 years. We support work health professions work force development. [ Indiscernible: Speaker/Audio faint and unclear] of the U.S. health care system by targeted grants to support post graduate retention. Increase staff and critical specialties such as nursing and funding programs. Clinicians benefit from these programs annually an I'm sure that many of us have benefited from these programs. There are two reports that have been produced that I think are of interest to this group, the genetic counselor work force training program professional practice issues and the clinical laboratory work force the changing picture of supply and demand education and practice. We also have a health care systems bureau that oversues the organ and tissue transplantation system. We have a rural health office which makes health care accessible for more than 60 million residence of rural America. I'm pleased to announce we have a new administrator. She joined us this week. Dr. Mary wake field. Has recently come from the university of North Dakota where she was the director for the center of rural health as well as associate Dean for rural health. She is an expert in rural health, Medicare payment policy and public policy. She is well known in Washington and I'm proud to say she's a nurse.

Thanks Denise. Katie, representing CDC. Somewhere between Vancouver and Atlanta?

Good morning. I'm Katie, policy officer. [ Indiscernible: Speaker/Audio faint and unclear] work over the years and for this opportunity for us to provide an update on our activities. CDC's mission is to collaborate, create the expertise, information and tools that people in communities need to protect their health. Through health promotion, prevenes of business and injuries preparedness for new health threats. Focused on the effective and responsible education of genomics knowledge and tools to promote knowledge and health. [ Indiscernible ] Environmental health occupational health infectious disease and other areas. A particular relevance to G [ Indiscernible ] Public health genomics an the division of laboratory systems which include the following highlights. First CDCs public health of genomics to access rate and streamline the effective knowledge and tools into the practice of medicine and health. Include the following. In regard to the evaluation of genetic tests applications and practice and prevention are E gap initiative, reached important milestones in January of this year with the publication of three new evidence-based working statements. Steve is on that group. These recommendations statements assess the validity of three cancer testing applications. The E gap methods for the genetic tests. In regard to genomic translation and research programs awarded over $1.5 million for three years -- per year for three years. To help move evidence-based applications into practice. Also, CDC and NIH are working together to launch research and programs genemic programs. A paper describing gap net had been accepted for pub ligation. In regard to family history clinical utilities early publications are now coming out to a clinical trial that examined whether family health risk assessment influenced health behavior. Assess the risk belief across -- published in February in thereunder of medicine. Population genomics prevalence data, includes major -- the estimates provide the human genetic variation in the U.S. that serve as important reference for future investigations. Play in population for disease and how genetic variance may affect the health disparities. I wanted to highlight the personal yes know micks activities. CDC has conducted consumer and health care provider surveys and those analyses are underway. A few items from CDCs laboratory systems which is working to improve laboratory service. First CDC will publish a report this spring on good laboratory practices for inheritable diseases and conditions in a morbidity and mortality report MMWR. This document was based on the recommendations by the clinical laboratory with input from CMS and FDA: It is intended to serve as a guide for considering and implementing divided by laboratory practices to improve the quality outcomes of genetic testing for inheritable diseases and conditions and -- Moe lek tar testing under theically that regulatory frame work. Practices for bio chemical testing. This would be based on aically lack recommendation. Formed to evaluate that need guidance for gad laboratory practices for consideration. They'll meet in June and a work rock is expected in the 2009 meeting. CDC is working collaborative with the rand corporation and professional groups to refine a piloted framework from laboratories to clinical settings that promote both understanding of genetics and laboratory care. CDC sponsors the genetic testing materials or get RM. This activity fosters coordination among the laboratory community to facility the character drapment [ Indiscernible ] By the research and clinical laboratory community for test development. Valuation and fish incy. What I can tell you there is the efforts at HHS are coordinated throughout the develop. In particular the areas of prevention of wellness health technology and comparative effectiveness.

Thanks Katie. We heard a little bit about what was happening in OHRP and I expect there's more. So Mike from OHRP.

I'm the associate director. I'm representing two offices today. The parent office of our organization is the Office of Public Health and Science and that is an office comprised of 12 public health program offices which include OHRP. It's located within the office of the secretary. It is headed by theassistant secretary of health and the current acting assistant of health is Steven [ Indiscernible: Speaker/Audio faint and unclear. ] of the public health service. The public health service is also located and command structure is within the office of public health in rural PHS. Has the nation's top public health physician [ Indiscernible: Speaker/Audio faint and unclear] acts ash is responsible for communicating the best science evidence and data to the American people in order to promote healthy choices and to promote safety and security of the American people. Dr. [ Indiscernible: Speaker/Audio faint and unclear] identified four current priorities. Disease prevention, eliminating health disparities increasing health preparedness and on the website for the Surgeon General are each of those key objectives. In addition to the office of program offices within OPH in addition to our office there are two regulatory offices in addition to our office is the office of research and integrity and there's a series of offices that deal with areas of public health. The national vaccine office the office of HIV and aids policy. The minority health. And some office advisory committees to the secretary. In terms of current recent activities of OPH,is that may be interested to the committee, we want a note to the committee, there was a recent release in January of a new health care tool or updated health care tool that was initially issued by the Surgeon General, that's the internet based family health history tool. This newer Veterans Administration, which is again -- this newer version can be used in electronic health records and personal health records because of those mechanisms. Completing the family health history online is simple and takes about 15 minutes. The uploaded information is not retained by the government. Another initiative coming out of OPH is the development of healthy people 2020. The first one came out in 1979 for the period 1981 to 1990. They are now developing the new healthy people for years 2011 to 2020. For those who want to know more details about how that is being developed you can go to the website of OPHS and click on the office of disease and prevention and there's a detailed description. I'll now turn to the office of -- promoting the protection and safety and welfare of human subjects who participate in research conducted by the Department of Health and Human Services. The office is headed by the [ Indiscernible ] Programs include approving assurances, compliance that you must have an institution if you want to get money funded by our department. We have an IRB registration process that review and approve research covered by the ainsurances have to register with our office. We have a variety of education and training programs to promote the protection of high man subjects. We have a compliance site that oversees compliance with the regulations. We have a staff who developed policy and provide guidance documents to the community. In terms of a couple of important things that may be relevant to this committee, we have developed a guidance document on the genetic information describes important implications when doing genetic research. That is going through it's final clearance through the department and hope will be released within the next few weeks. When it is released there will be public notice of that and through a list serve notice. We also published and sought p comment on a draft document for participation of human subjects and [ Indiscernible ] Data retention when subjects withdraw corrected up to that point. Our document talks about parallel issues and issues related to tissue samples that have been already obtained.

That's all I had. Thank you.

We'll turn to the colleagues in other agencies. Dan, you want to give us an update from the Department of Defense?

I work in the office of air force Surgeon General, I'm here on behalf of the office of the assistance of defense. DoD's mission which is a little bit unique is a dual health care mission. There is the readiness mission, which is the one that people may be familiar with, which is the care and support of the war fighter or the military operation but there is the health care benefit which is over 9 million beneficiaries worldwide. It's a complex system. A lot of the activities of these committees are very germane to the Department of Defense. DoD's reimbursement structure although being in [ Noise on the line. ]

Funding based on reimbursable amounts based on our care that we provide under CMS structure. So one of the important issues that we have for us particularly for the readiness mission is the ability to perform preventive care F. our funding streams are dependent on the treatment of disease and IP codes and coding recapture and our need for our readiness mission is a highly prevention mission it's difficult for us to align our funding streams with the care we provide out of our own budget. Giving that DoD has always been very supportive and closely associated with any programs for our health care system. The Department of Defense is very actively engaged with the personalized health care and the electronic health record. Follow offices in national coordinator particularly in areas where they're looking at research aggregating research systems given a number of patients that we have, millions and millions of patient encounters all coaless in one site where we have those clinical data association studies obviously have a high possibility in the Department of Defense but have not occurred to date. In terms of research inform the genetic setting, most of our research in this arena come from the supplemental DoDs medical research. Has not changed much over the past decade but the supplemental budget has gone dramatically up. We have many programs that are relate today genetics. The largest amount of breast care research money is handled by MMRC. It is a peer reviewed NIH style of research and many people are on the research panels including like prostate cancer, autism, tubular sclerorow sis, genetic allergies. Two others that are rather large and new and have a Ltd. of genetics in them is the armed forces institution of regenerative medicine and clinical rehabilitative medicine. Which have just started in the last two yearsment stem cell research in them and regenerative medicine using genetic medicine reprogramming itself. Additionally in our beneficiary mission we heard it was 4.1 deliveries in the United States each year. DoD has 50,000 alone over our coverly benefits. DOD is actively involved with the secretary's advisory committee in addition is looking into aggregating their newborn screening data with the national registry for DoD as well as the national contracts with all of our members wherever they are getting the newborn screen. If a child is borne overseas and doesn't have -- born overseas. Expectations that child that had the newborn screen there can be clinical challenges at the point-of-care.

Thanks. We really do appreciate it.

Mike give us an update on what's happening.

Good morning. I'm Mike. I'm going to talk about the stimulus act and the recent omnibus -- at the department of commerce. I'm at the national institute of standards and technology and our mission is to by advancing measurement science, standards and technology in ways that enhance economic security and improve quality of life. At the department of commerce, we received $7.9 billions in the recovery act funding. A lot of that goes to these types of thingses and the thing you're probably most interested in is the next to the last line down, the national institute of standards and technology because that's where most of the health care stuff is. So what we received was 67 million including 360 million to work on some construction things and also to provide $180 million in competitive construction grants for facilities around the U.S. 10 million in funds for interoperable smart grid. Now the fun part is that we got $20 million in funds transferred from DHHS for working on developing test beds for help IT infrastructure. $220 million for grants, fellow ups and equipment supplies for really basically pass through money from the initiative down to congress -- from congress to nest to dull out and spend. The spending plan is still pending since we don't have a secretary either. I guess that slows things down. But just historically what I can tell you is we've had about $15 million in diagnostic spending for total health care of $21 billion in 2008. Of that only about $5 billion were ever appropriated by congress specifically for health care-related activities. The rest of it has been really reprogrammed from other things that we do based on decisions by the directors of the different laboratories. I'm happy to say under the 2009 omnibus will receive an additional $3 million this year to work on current generation diagnostic measurements. Basically that will focus on laboratory medicine, medical imaging and with the justification of trying to improve the information that actually goes into the electronic record, it's good to have good information that goes into it.

So we'll -- 3 million they not sound like a lot, but this doesn't traditionally get big budget increases. This year we received $27 million in new money for a total of about $800 million for nest. 3 many million is a big chunk of that -- 3 million. The fund thing is we're planning on our 2010 budget. 2011 expanding our work in laboratory medicine and medical imaging and delving into more than next generation things that I talked about in the last meeting, focusing on multimedical examiner technologies and new ways to get -- multimedical examiner multiplex. Things in plaque are the things we're working on. Things in red we're not going to work on because of other national measures around the world are doing that and have more expertise. We're going to focus on nucleic acids in proteins. In medical imaging we're going to focus on MRI, CT and opt rale imaging [ Indiscernible: Speaker/Audio faint and unclear] for that, thank you.

Thank you very much Mike. That's great. Clearly, what's going on across the government germane to our work, we have a couple of minutes so if you have any questions for the speakers on the agency's plans, the recovery about money, where it's going and how it can be used?

Do you need any advise to the committee, to give it out quickly.

You have some?

Hearing none. Thank you to all our speakers. We do appreciate all that you do not only to keep us informed with what's going on and your participation in all of our work.

As we did yesterday, we will be hearing from the public again sort of a public forum and welcome all the comment from the public. We set aside time at each of our meetings to do this. This morning, we have Daryl bump herb. Who is the director of research program advocacy at bio technology industry organization. Well we look forward to your comments. Welcome.

Good morning. I'm Daryl richer from the [ Indiscernible: Speaker/Audio faint and unclear] we appreciate this opportunity to testify before the committee this morning. Bio is the largest organization to serve and represent bio industry in the United States and around the globe. Bio tech companies academic institutions and state bio tech centers and related organizations in the United States. Today the committee has set to discuss the future of the health care system. We would like to suggest and reiterate a few things that the committee might do that may be able to ensure the [ Indiscernible: Speaker/Audio faint and unclear] diagnostics are used to improve outcomes and efficiencies. Some of my comments may echo the comments made by my colleague yesterday. This exemplifies across industry we share the same concerns in the reimbursement system for molecular diagnostics. Diagnostics must receive timely and adequate reimbursement that reflects it's value. The reimbursement Lange scape also -- chronic disease and management. New policies that expand payer coverage and reimbursement focused on disease prevention. Must be modified to that encourages appropriate use of beneficial diagnostics. For the use and the development of innovative tests an I wanted to just to kind of point to some examples of those obstacles in today's public comment here. Committee considers the health care system, encourages that you move forward an action plan as soon as possible. Coverage and reimbursement, consider areas in that report that may need to be updated or reemphasized to take into considerations the problems methodology that we're progress going to discuss today. Encourage that -- recommend to the secretary immediately to direct long overdue action lab fee schedule. We also encourage you to look at to create a transparent and [ Indiscernible ] We appreciate the opportunity to briefly discuss these points. It is imperative that the DHHS include reimbursement system reform and consider the recommendations in these area. Health care reform must consider the tremendous value of diagnostics to patients in terms of clinical outcome, quality of care and reimbursement policy must reflect this value. The CMS rate methodology and fee schedule is an example that does not accurately reflect these systems. The courtroomed by CMS by either cross walking, the test to an existing code or rate, or creating a new code for if test allowing the carriers to get fill or establish their own prices for a period of time until a national rate is calculated. Market based and inslow vision is slowed accordingly. Secretary to implement and -- value of these tests. Developing and brings to market the new generation of market tests is typically far more costly and complex than traditional lab tests. Aimed at new tests where there is no comparable existence tests. Among the Medicare contractors may be so great and so unpredictable that it will impede patient access to these tests and innovation. National payment amount when the market for the test is not yet well established -- [ Noise on the line. ]

Later everyone if it is acknowledged that rate haves not been set appropriately. In addition, because many of the new tests are proprietary and performed by only one lab in the country becomes a [ Indiscernible: Speaker/Audio faint and unclear] if it is in sufficient it may not -- insufficient. Does not clearly state it's decision making process when determining the amount [ Indiscernible: Speaker/Audio faint and unclear] lack of transparent -- gapment process for important move diagnostics particularly those requiring expensive perspective clinical trials. By assuring [ Indiscernible: Speaker/Audio faint and unclear] [ Noise on the line. ]

This will go a long way toward improving outcome in our health care system. I'd be happy to take any questions.

We do have a few minutes, if you do have questions or comments.

These are clearly important issues as you recognize. The reimbursement report from a couple of years ago we addressed them. There's been an ongoing diagnose log with C -- dialogue with CMS. About some of the reimbursement issues in lab testing. That's a continued and interesting dialogue. I don't know Jeff did you -- no. Okay. Thank you very much.

Why don't we take a 15 minute break and then when we return, we'll spend the bulk of -- remainder of the day the key issue of how genetics and genomics can inform the changing and evolving health care system. So grab your coffee and come on back. We have a terrific line up of presenters.



[ Conference taking 15 minute break. ]

Okay. Well welcome back everyone. We took a longer break than normal. [ Indiscernible: Speaker/Audio faint and unclear. ] we can go ahead and get started now with the main agenda items for today, which is our round table discussion on the health care system. This discuss will be part of our work on the priority topics genetics in the health care system. We'll be focusing today and the next meeting at least on beginning to understand what the role of genetics can play in the new approach to health care. Clearly, this has been with the new administration's interest in reforming health care and what they hope to do in President Obama's first year in office. That is a bit faster than we nationally anticipated. That should spark us to move more rapidly. The administration's hope that a reformed health care system will be less costly and more effective and more equitable. New jet nettic technologies and approaches to health care provide good value for our health care dollars. Today's round table test can particularly speak to the issues of cost and values since they are all members of the community. Before I turn this over to the committee lead in this area and helps us pull this session together, I wanted to note that at our June meeting we'll have a round table discussion again from other stakeholders in the health care reform. Our hope is that from hering from various groups, the patient will be able to provide a comprehensive assessment that genetics can use in the health care system. We'll continue to monitor their progress in the area and should our health care views be needed on short notice, ahead of our timeframe we'll be available to provide relevance guidance to the secretary. It should be a fascinating year an I'm looking for ward to this session because we have a group of speakers that have a lot to tell us. Let me turn it over to Mara and she'll give us a great introduction.

Thank you Steve. Today's session is going to focus on looking at the future. There are a lot of discussions about the future and the committee send time with six futurists which is a profession that is interesting to put your kids in it but there are not a lot of jobs out there. Everyone is a futurist but these are people ho actually have it on their card: When you think about the future, a lot of the discussion is very abstract, what might happen, what might occur? A lot of brainstorming about the systems of the future. We're going to take that aspect of the future and combine it with a practical aspect of the future. As I see it today and as the committee talked about everybody's talking about genetics. I heard a statistic yesterday that 14% of U.S. A. today front pages have had stories about genetics whether that be on the first page or the life section or occasionally in sports, that means genetics has arrived. I didn't know about your household but when my mother talks about genetics -- if you're on the web, hi mom -- she's listening to the web and we're moving forward. Genetics has very much arrived but the real question I have is avoiding the should have knowns. We know that many of the innovations that have happened, where many people would say we would have a crisis in the number of nurses in our health care systems. Ten years later we had a crisis and not enough nurses in our system. We need to use the time and step back an say how can we be prepared for what is possible, maybe likely, and everybody is talking about the onslaught of genetics testing. What the group is about to kick offed to an in our continuing work to share with us your thoughts about how we as a committee, but really HHS and more broadly the health care system and the administration what do we need to be doing today to prefair for a future where genetics play a larger role? That's the basic objective that we have. We want to really have some fun with this. We have an interactive [ Indiscernible: Speaker/Audio faint and unclear] somebody on the phone to give an appearance. I feel like we should have her picture up there. So it will be an opportunity for a lot of discussion with some very interesting people. So with that I'm going to start with just a couple of slides to say why I think this is important and what I see today when we consider genetics. I have an old version of Power Point. Right there? I lose some of the drama here. When I think about genetics and the future of health care, the first thing that everybody talks about is the million dollar genome. That's something to prepare for but what we really need to prepare for is the thousand dollar genome. We talk about education or physicians. We need to education our physician what is genetic and the future of health care. It doesn't stop there because it's counseling for patients at the same time. It's not just directly from our physicians to our patients. Are there going to be labs on a chip? Is the chip going to be on your arm or in your arm? Is the chip going to be in your wallet or is more relevant and a lot of companies are talking about, it's not just in your wallet, it's in your kids wall lets. Maybe it's your knapsackers or diaper. Genetics and genomics and how does that work? Is it from an industry point of view about companion diagnostics that has been used frequently. Companion diagnostics -- both of these happen when you have genetics playing that link between diagnostics and therapeutics. Lastly and fundamentally and this committee has really attacked these issues. Are we in a world of genetic exceptionalism?

These are the kind of questions we're going to be asking and each of our panelists will be talking about to be prepared for a future where genetics plays a different role than it does today.

I'd like to introduce our first speaker who's going give an overview of the field and have four -- three separate sessions. Our first speaker is Rob Epstein. He has a broad responsibility from formulary to clinical guidelines, research, acad dig and personal Iowa -- accreditation. Epidemiologist and is a true leader in the field and has spoken frequently. Is involved in a number of Policy Statements include policy organizations including most recently he was appointed a member of E gap. I ask Rob to give us our overview. Thank you.

Good morning everyone. It's a real pleasure to be here this morning and to be invited to speak. I was asked by Ameria to do something that's so fun. -- Mara. I know I only have about ten minutes so I'm going to try to stick to it. Get us back on schedule. I do want to however open this up with a core toon. I have a copyright approval to show you this. Here is my sequence and looking at all these jars and looking at the pharmacist for help. This was the vision nine years ago. That's becoming a reality today. Even though we cover 60 million lives. We expecting -- and provide advice on should I take the drug? Should I take a lower dose? It's actually happening. So it might have taken nine years but it is happening. I'm going to cover these six areas. For me these are probably six very key issues in drying to drive genetics into our health care system over the next several years, none of which are easy to solves all have issues. Let me start with the proposition that you all know too well, it does take and has been shown and published. It takes 17 years from what we know to actually turn out at the bedside. Is that something we are satisfied with when we think about this emerging genetic information? Probably not. There are lots of reasons for it. A lot of them are on the slide. The one that resonates for me is there are 2 million articles published every year. I read everything. I get maybe 20,000 articles every year if that much. Where is the practicing doc who is out there. How do they screen through 2 million articles to learn what they learn? It's not possible. We don't have an information structure today that prompts providers with new information. It doesn't exist really. We have to think about that if we want to drive adoption of this great new science to the bedside. It's a whole big conversation. But what is our e debt eye bay dis-- we've been really hooked on randomized control of trials. But let's back up a minute and think about everything we've ever proven or looked at in health care. Cigarette smoking and lung cancer. We have a whole series of observational study what are called the Bradford hill criteria proving causation minus or absent a randomized trial. I wonder if the standard for assuming genetic information useful always requires our CTs an if so it's going to slow this field down. The payer needs a primework for providing access to this technology. This may not be the right framework but all this genetic information needs to fall into a bucket. I can see the value in this one and not that one. If you think of diagnostics, do I or don't I have a genetic disease, that makes sense, people need to know if they have that disease. Predisposition testing, am I going have Alzheimers That may not be something that they need to -- feel compelled. That's probably important if there's a value equation there. But whatever the framework is, I'm hearing from the payer community, they need some help on how to evaluate these things and put them into areas where they can concentrate and go I get it, I don't get it. Maybe yes, maybe no. That leads to a whole controversy of how it is calculated? Are the benefits that are -- lived from all this technology outweighing the cost? I think there would be some help provided here. Is it a strange forward health economic evaluation? Something that economists talk about where you put everything into dollars and cents the costs and the benefits and you do the equation. Is that the right thing to do? Or is it cost per quality adjusted life years or cost of life years saved. Something we don't do so much in the U.S. but elsewhere for decision making. Somehow making a value judgment is a good enough that people should be providing access for reimbursement. Those are thorny questions, luckily I don't have to answer those today but it's issues to help to get this to move faster. I would challenge some of the speakers to think about this. We live in a disarticulated health care system where data sits in various silos in claims files, pharmacy data over here, ablator over here, laboratory, computerized over there, personal health records over here. It's here, there and everywhere. If we want to pull it all together anilining it and do something with -- together and link it we need to figure out how to make that happen. A framework for standardization of the data itself that goes into this idea, but maybe the placement of all these data into some repository somewhere that's password protected or something. We're not going to get the mileage of this information if it's sitting in various sigh lolls. In a file in the doctor's office. So we really aren't leveraging all that we are collected when it's all over the place the way it is today. On top of that I would say we need to think about a protocol driven system to layer on top of the information. It's great if all that data is sitting in electronic somewhere. Shouldn't take drug Y. If there is somebody that says that and puts it in the system as a protocol, who writes that protocol? It goes beyond a guideline. Literally a protocol that messages a doctor or a member that says danger, danger, this is not good. These are bad combinations. In the world of pharmacy today, has been linked electronically since 1990, all pharmacies are link realtime. If you are over 65 of age, don't take this drug. Outline which drugs are unsafe in the else already de. When you push those messages -- some of the physicians change the drug. I'm being to close and gain you back some time. Given all the talk of health care, the time is right now to address some of these major issues to help facility the aAnd dissemination of all the science that's out there. I believe that the science is exploding right now. You can't open -- there are new journals every day being formed to look at genetic information. But we have to kind of harness this in a delivery system where it is linked in hoard for us to get the best regard for all this information. With that I'm going to stop. I don't know if there's time for Q&A now or discussion after?

In terms of structure we'll take questions after Rob and each of the panels and right after lunch we'll have quite a bit of time to have a panel discussion mung all the speakers -- amongst all the speakers.

[ Feedback on the line, can't understand speaker. ]

The issue in the United States is extremely problematic because of the different stakeholders. The answers an your cost implements is different if you are under a capitated system versus a fee for service system. I work in an integrated system so we can actually track costs to different things and it's funny, we always think the payers that we wanted to introdoes a [ Indiscernible: Speaker/Audio faint and unclear] [ Noise on the line. ]

Costs come out of the DRG the insurance company doesn't get anything until the [ Indiscernible ] Genetic testing. So it's really -- it's important to have cost effectiveness and cost benefit and all those things out there to give us a rough idea but I don't see it as actually helping implementation because of the different amount that each stakeholder has in the game. I don't know if you --

It's more a -- I agree with you we have a patch work of decision makers in this country that use different approaches to this question. We ought to have greater transparency so whoever the stakeholder is transpart about what they put in their equation. I say that opens up dialogue then. To your question why would this help adoption? Some stakeholder is not transparent, tomorrow is transpart surfaces up good discussion an they revise the way they approach the question. That will force as corporation. Today you don't know what goes into the mix of how you calculate that return? How are you coming to that decision? What are you using in your institution veries is people two seats over. At the very least that's what we need.

[ Indiscernible: Speaker/Audio faint and unclear] [ Inaudible ]

I'm really glad that you brought up the issue of how we determine when something is ready to pay for or more importantly introduce into clinical practice. I think I just wanted to amplify that because I think as we perceive that's really going to be one of the critical questions. You're right, your implication that we can't afford RCT for everything is absolutely correct. On the other hand we have to be very cogcy sent of the lessons mostly HRT in which we can easily be mislead an I think that [ Indiscernible: Speaker/Audio faint and unclear] technology as anybody but I think we have to be very careful not to get carried away with our enthusiasm and begin to implement things that don't have good outcome data.

I agree with you. I think Hengestly, it would -- honestly it wouldn't be a bad idea to look at the Bradford hill criteria. Consistency dose response. Causation. It's not a single retro swept of coverage.

As we collect more data.

I'm with you.

Rob, first of all I want to thank you. Your company touches a lot of lives and so the fact that you're thinking broadly and thinking about genetics is a tribute to you and the vision of your company. I wanted to say that. I want to return to the return on investment topic. It seems to me that given the economic environment that there's going be a lot of pressure foreigner term on invest -- for near term on investment. Usually increases costs first. Then benefits in terms of lower costs are return on investment are 5, 10 years delayed. I'm not sure there's much appetite for that right now. So I'm curious about what you think the low hanging fruit, where we might -- where there is near term cost reduction that we could demonstrate in this system?

That's a great series of questions actually. I've had the fortune of speaking to probably close to 1200 payers on this topic individually over the last four or five years an I would say to the earlier point, we do have a patch work of decision makers that have a time line. They have their employees for 20 or 30 years. They're not looking at the 2 year time horizon. I think first of all let me just say different audience haves a different time horizon of what they're most concerned with. I'm seeing for things that are not major outcomes, like cancer recurrence, those kinds of things, people are looking for the shorter time horizon, so called serious like that, they give you a little bit of the boy on the topic. Testing that we do some of the models, can get you to a 1, 2 or 3 time horizon or for the testing out there. Payers are really interested in those kinds of things. I'm going to get disease X in 2020. That's a different timeline.

I'd like to come back to the issue of how you make this kind of change happen? That would be great for the whole panel. Just a question on the survey you showed at the end with the pharmacists and the data that went out that seniors shouldn't be taking certain prescriptions, how do you evaluate 25% of the time? The sense that this is increasingly an inflammation business. It seems that pharmacy may be the most integrated part of our health care system that you can get that information out. Why isn't it 100% of the time we should be expected that this is 100% of the time? What should we look at as a good standard?

That's a great question. In the pharmacy system that exists today, it's never as God as all the information that a physician has so while you can send the message out it may that the person has been on the therapy for three years and doing just pheno. Maybe they're allergic to the other drug. There's lot of reasons why. The background rate of the absence of the system is 2%. You weren't from 2 to 25. I think that's not bad.

[ Indiscernible: Speaker/Audio faint and unclear]

What do you think are the biggest barriers to bring these things to correct? The [ Indiscernible ] [Speaker unclear due to accent.] that people have known about it for over 20 years and the testing, not only when it is commercially available, but should have been able to test it for a long time. The vast majority of people would take important drugs that are metabolized are not tested. Why? What can we do to shorten the gap?

So I'll just reveal a little bit of information but I'm holding the rest back for a publication submission. [ LAUGHTER ] Right. This I can because both partners have supplied this little bit of information. We've collaborated with the national medical association to find out their attitudes an awareness. The two snip its, the one piece of good news is that 90% of physicians think Jeans provide information about drug response. The docs get it. Genetic information can -- 90% of physicians say they don't remember having genetic training in medical school and don't feel comfortable ordering the tests or how to interpret it. The good news or bad nos story, they don't feel comfortable yet. This is a general statement. It at least points one big uphill battle that we don't have people feeling comfortable yet outside of genetic counselors on what to do with the information even though you and I may seen very clear.

That's what I know the most about. I think there's often a confusion about causation and increasing risk. There is.

So I think that there is -- there's certain -- the other thing that I looked at is when you were talking about elderly seniors -- about being -- there are so many different ways of being over 65. There's young 70 and old 70.

[ Captioner hanging up audio for transition to new captioner. ] to this by saying -- by thinking, how we can refine things like deadlines and the more personalized. So instead of [indiscernible] to your point that it chronological 65 year-old should or should do something, he then next set of rules should be, if you are over 65 and your union and creatinine are something, then we could still use that approach but we would have to come forward with more personalized guidelines. Not just, XY, XY. Or like Ex and then it'll subset. [indiscernible] mistake or throughout the country except because she can get more granular. Otherwise we will be stuck in the system we're in today.

Thank you, that was terrific. Keep the questions coming and we have more great speakers.

Our next panel is on the public health. Perspective. And I don't think it is an overstatement to say that many of the industry would say that all roads lead to DMF. We will start with Barry stroke and give him -- a terrific presentation yesterday on how the agency thinks about genetics and how they will move forward. Our second speaker will be Bruce Quinn. And when breeze brings us the perspective of a physician, researchers and policy expert. He is a senior health policy expert for [indiscernible] and the former health director for the California Medicare part B program. We'll take the two speakers and some quick questions if it is clarification, or will take questions at the end of the talk. Thank you.

Good morning to you again. I am going to be chairing some anecdotes about CMS again like yesterday that we encounter. My flash came up and it was put into the computer but it is so well in scripted that we can't even open it up. But there are hints handouts that we will be going through.

Everyone should have them.

They're is a two pager, front and back, and then a diagrammatic handout that I will refer two because you probably can't read the writing on the presentation.

Chris and I were given to framing questions to use this session for. One was, how could the value of the emerging genetic and genomics technologies best be evaluated in a timely matter. The coverage of terminations. And the second was, what was the change in coverage determination will be necessary to address the increasing trend in prevention based medicine. An example given was Medicare covering all [audio interference] screening test which we talked about yesterday.

I thought I would continue, and I wanted to thank again Steve and the Committee for giving me the time that I had yesterday to give you kind of coverage of decision making 101 in CMF. But there are two issues that I didn't bring up in that session that I think are germane to this session. A first is, if you look at the diagrammatic scheme of the coverage [indiscernible] because this is at the timeliness of the issue. And that is also one on the larger slide and easier to read.

Go to the left-hand corner and you can see that we begin with coverage decision making at any point in time where we have preliminary meetings with Technology directors, people in industry, advocacy groups, [indiscernible] or other entities. And we actually discuss what needs to go into a proposal for a national coverage decision at CMS. This can include a discussion about what type of data points are needed by as an add CMS for coverage determinations into the research protocols that are being developed. And I think this is a very key point in the discussion which I think has been underemphasized or under realized in the past but it is important to make a more timely decision that perhaps getting more technologies to be covered that have been done in the past.

Is a benefit category request that needs to be made to the agency, and that is, folks have to be able to devise a decision as to whether in this case for Medicare, actually covers the potential device or not. Whether there is an actual benefit category for that or not. That was discussed yesterday for some things that are specifically excluded from the statute. We then get, and should go to the right on this middle tier of boxes, where a formal request is made to us, and I said yesterday they had to have some degree of information that would warrant us to move forward. It can't just be a black box and say, we would like to cover this. It must present some kind of information that has been tested, and there is some relevance in the medical literature breast to be able to make a reasonable and necessary determination. And as you can see there, because her six months on a routine national coverage decision where the staff drafts a decision memorandum and riposte that. The variation down below with the dotted line which should go downward is, in some cases, we don't believe that we have the necessary information for the subject expertise in the agency or within our direct consultants to make a decision or pose a decision. So we seek outside Technology Assessment, and you can see that is done through ARK are MEDCAC or other entities.

After it is posted there are 30 days of comment which is very important and is not replicated in many other decision making processes. And then we have 60 days after public comment is closed to issue a final decision memorandum with instructions on how to [indiscernible]. So that is how the process works.

The next slide, number four on the tenth Light handout is another process we did not discuss yesterday. Many of you are probably familiar with this, but for those that aren't, CED with coverage [indiscernible]. And in the past, if you look at the top, it on the left-hand side, there is an oval box that says [indiscernible] reasonable discussion yesterday. In the more remote past, it was a guess or no decision process. Either it gets things recovered or no things were not covered. In the more recent past, that was extended so that sometimes, there was a yes, but it was with conditions. You might have a technology that could only be implanted, or provided to the patient in a specialized center that had to have certain criteria with CMS.

About four or five years ago, we introduced the concept of coverage with evidence development. This diagram is a long complicated story to talk about reasonable and necessary, but, suffice it to say that now, we have in some instances, if you go down the left-hand schema here, where we determined that there is sufficient evidence to say yes to coverage. Are there is almost sufficient evidence, just barely away from our standard criteria, just getting a little bit more information with the tip things over the edge in a positive manner. So we now have guidance documents out that will allow us in that instance, that is where we need more evidence to be developed and/or, we are almost there and just need a little bit more evidence to make a Yes decision. But it is dependent on the gathering of more data, which is referred two as appropriateness data.

There are other situations where we can make a reasonable and necessary determination, and the answer is actually, no, we do not have enough evidence there to really say yes. However, the statute does allow us, if we prescribe specific data collection, usually through a randomized clinical trial but some cancer registry collection of data etc., do in fact make a determination of test coverage, but only for people who would be going to the randomized clinical trial or some other specific, very defined it data collection process.

So keep those two concepts in mind.

You can now go to slide five. The first question had to do with timely evaluation of Teaneck technology options. For your consideration, we put down here at some of the ways that we might be able to determine or timely evaluations. Firstly I think it needs to be up front, and if you go to that first acrobatic scheme or there is a preliminary meeting. Unique research coronation to determine output means. Right now, FDA has certain needs for its determination of Safety efficacy. We have certain needs for a reasonable and necessary. And their media their needs through the process, including determining payment analysis, especially as we get into cost-effective analysis going forward. I said here in the bullet that we have to meet such juratory requirements reasonably necessary, but we do, I always have and we should continue to result with appropriate entities prior to any coverage decision making. So I think if we can coordinate and define what the research means in the various blood on private-sector [indiscernible] it would make for a more efficient process of people did not have to redo research and come back and try to plot together other research that was not perhaps included in their own primary research process.

The second opportunity for more timely presentation is, if you go back to the schematic would be to try to streamline the NCD process. But this is not likely to cut the time frame significantly. The staff review time is the longest period of time that I have there as well as the technology assessment at times. And I think again that try to shorten the list -- in some cases it is possible but we are only talking about shortening things by month or two or three at best. So that is perhaps not our greatest opportunity foreshortening the timeline. I do think the public comment is extremely important, and that needs to be preserved in whatever process we do tend to have.

If you go to north six slide, Technical Analysis and Technology Assessment, which could shorten the process by having a technology assessment done not just within the coverage decision process, but up front sooner. But I think that in addition, to defining research needs in the first bullet on the Paris light, we have to think about, can we do technology assessments Center in the process and have those available at the beginning of in fact the national coverage decision process starting. And I think as we get into the discussion about comparative effectiveness institutes and such, we might be able to include technology assessment center.

We talked about the difference between national coverage decisions and local coverage decisions yesterday. One of the possibilities here is to use the local covers decision vehicle more locally. We talked about pros and cons of LCD 's, but if people were to approach the local contractors earlier in the process and work with them in a more coordinated fashion, it could be that we could speed things up also. But the flip side of that is, if you fall into the other camp that feels that local coverage decisions are not the most effective way to deal with things, we could an intact centralize things that a national coverage decision [indiscernible]. So that is something to be considered and has spent for the past few decades.

I think we're going to increasingly get into the need for comparative effectiveness of genetic screening and genetic testing and genetic interventions are therapies, if you will, so comparative effectiveness and cost effectiveness will be very important in the process. And again, the sooner that is done, potentially before the coverage process is even begun, it might help us.

We could lower the standards of evidence. At that was alluded to that in the first presentation, because now, we have very strict standards as to the levels of evidence that need to be met. We could consider lowering those.

And finally, I think there is some confusion when people have to deal with the private public sector entities at the same time, so I think discussions about how we might align both of those processes would be warranted.

Slide number seven gets into the second question, and that is potential coverage changes that we may have to consider at CMS. And I alluded to some of these Yes today. But the issue that we're going to have to discuss that might get into changes has to do with, what is the definition of screening test versus a diagnostic test? And should in fact there be a change which would require a statutory change in the exclusion of screening test for the Medicare program? I think this whole issue of preventative services and screening test etc. It is rather murky. In some instances, what is a diagnostic test that could be a screening test. So I think getting at that issue is something we will have to do going forward, and whether we go so far as having a Congress change, or prohibition on the use of screening test remains to be seen. However, as I could hear, section 101 of NIPA, Congress allows CMS to make preventative service coverage decisions, including using cost-effective analysis in this determinations going forward. So we don't have to rely on Congress to tell us that they have passed a law and a certain preventative service is covered. We can now begin that process by ourselves without congressional approval.

Another area was to broaden the use of CED, covered with evidence development. As you could see from the diagram, if we were to use CED or liberally, would be opening up the possibility of covering some of the genetic testing or genetic intervention sooner rather than later, but with the requisite that additional information is going to be covered.

And to finish up, which can review, update and revise as necessary the national coverage decision manual, the definitions, the guidance documents we have. Remember, we talked yesterday on the NCG we have on genetic testing and the antiquated language we have in there, and I think we should bring those up today and that gives us opportunities to move forward. We should do [indiscernible] local coverage decisions, and determine whether there is some inconsistencies. We ought to do in national coverage decision on those that are inconsistent, and, should we in fact consider genomics as the perfect pilot situation going forward that we have better coordination between the local carriers and CMS going forward. And finally, a process we have been working on the last three or four years, having any discussions with FDA on so-called parallel review, that was my earlier point, about the need to work together earlier in the process in instruct people with the need to do in their clinical trials that satisfy that as soon as possible.

I will and at this point, Mara.

[speaker/audio faint and unclear] and then we will have questions for both.

Thank you.

Thank you very much. It is great to see you all and he was my local medical officer when I was the regional director in California. Also, I have been reading site it's transcripts for years, and the next time I read one it will be like a fairy tale where you appear inside the story.

(laughter).

Have a few comments and will use the same free market. From my perspective, it is a question of whether we covered diagnostic test with signs and symptoms of disease, but we don't cover screening test can actually be very parking practice or very logical. For example, there is a benefit that if you are African or American or you have a grandparent that is, automatic glaucoma screening benefit. But if you have six relatives with go, and it. With early onset glaucoma, it can have a test for Club, unless you're starting to lose your Vision. So it get a 70 percent chance, it can have a screening test. If heavy 2 percent chance, you can. So there are times when it is inconsistent.

Another example is the bracket gene. Where an actual clinical management a woman has six Alton's with early onset breast cancer and she has a small sized clump, it would be in the context of her family history but the bracket [indiscernible] can't be matched in the family history. So there are some things that don't make sense.

There is an interesting story, when the talk about how much evidence we need, we hear in conference after conference, no one ever says, how do you define evidence? Is it in meters or cubic yards?Pounds, jules, for mpg, there is no quantity number for evidence. If we say, how much evidence do you need and we need to find the evidence.

There is an interesting parallel between safe and effective at the FDA and it reasonable and necessary at CMS. Which I have noticed in the last couple months.

Congress gave Medicare reasonable and necessary and several years ago. Three years later, they gave FDA to freeze sit sit and effective. They immediately applied it into real making documents and revised [indiscernible] particularly in '69 and '70 and moved into other things like fast-track and accelerator [indiscernible] in the next decade. And I think one of the differences it is, Congress gave them more than a phrase. They said, safe and effective means there is reasonable assurance to raise substantial body of evidence or a panel of experts that the claims being made for the product are correct. It is actually -- That paragraph makes it much easier to move forward. Also, the FDA had to make adjustments every time, every month there is a new package. When Medicare started in 1965, the room millions and billions of claims going through. Most of them flows through Endicott have to make a cumbersome decision. So it has crept up. Like putting the frog in a pot of cold water and it becomes boiling water, where the FDA was confronted with the problem in its fees right away.

There is also a third standard which is used in some context of the FTC and FDA which is called scientifically reasonable. I think scientifically reasonable changes depending on the context. Three things like the tape raft studies in colon cancer. Where there are several trials with retrospective analysis that virtually everyone agrees and gives the right answer. In fact, it wouldn't be ethical to do a new forward looking randomized control, the trial. So Data [indiscernible] has something to do with the way people interpret the data. A wonderful anecdotes there is from a woman from Miami and a trustee. She points out if you go back to see it original Watson [indiscernible] point paper, they had five kinds of evidence that DNA was a double helix. But [indiscernible] only writing the five together and putting the brain of [indiscernible] and the reader, it became obvious that DNA was a double helix. So evaluating medical history is often like that.

The other topic was, making the process faster or more reasonable. Everyone has talked about the reimbursement issue, that there fix prices for molecular lab test, 10 or $20 per step and it is not rational. And for awhile, I thought maybe that was the market of power of medicare. Maybe it has a lot of market power and is a natural process. But it is not actually market hours. So prices were fixed in 1984, generally. It was price-fixing, which is a different thing than having a lot of market power. John Kenneth dye worth from a book about price-fixing during World War two. The biggest problem they had was not black market the deal with innovation. Their innovations were not things like cell phones are plasma screen TVs, but innovation in clothing. Because clothing was not the same year to year. Is thousand Branson fabrics, it drop the price fixtures bananas. So with lab tests, the six depresses and there is no relation to value at all. NASA plans at work. People could make a genomics kit for testing, and it cost $50 easily to a hospital and it actually works. The overhead, the management, the legal costs and so forth. But there are other things where it doesn't recall, so you are constantly running into companies were testing can develop and media costs $200 to amortize the cost but the new Medicare would fix the price of 15 or $20 so there would grossly lose money on it even if that I my save $2,000 every time it was used. So the system is so irrational we don't see things people are developing. We all remember the shock comes story about the dog that didn't bark. They knew someone had to B murder because someone went out the door of the dog didn't bark. The dog that doesn't bark doesn't get much attention. So if you have [indiscernible] proponent testing has huge value and quality adjusted [indiscernible] pays $15. So we are caught with things that work on the 50 or $20 fee schedule and things that are being developed that actually save money. So if you [indiscernible] the health-care deficit, we also think about [indiscernible] on disruptive innovation. But things that get so expensive it creates room for people to come and underneath with cheaper costs antiseptic technology. But in genomics, enormously important field with the team Don [indiscernible] we're not letting people to that, come in and save money, even though it is below current costs of about $15. But I think that is about the paradox [indiscernible] Special Committee and working group and so many people have talked about that, it is time to afford.

The other point I can make is, I rise that as and medicare carrier which contains the fee schedule and it paid doctors want a try to run the operation to make it as easy as possible for doctors. Lost checks, Veronese claims, the dollar is the doctor's costs and even though it can raise the fee schedule, we could raise the top for the doctors. And finally Medicare cannot [indiscernible] very counterproductive in society. One of the things we have today is much more complicated but high value genetic testing. Just like the enabling technology for genomics is actually a robotics. The enabling technology for these tests is actually FedEx, because it can get a sample from any place in the country to in that that does it overnight. You have institutions like Ex de Ex and genomics health [indiscernible]. And a roll of Medicare came up with there recently that it nexus for 15 years was a 14 day will. So if a hospital draws a specimen, four weeks into the year, the hospital's responsible for any tests on the system. You could have a breast biopsy and Sioux City Iowa, and the patient goes to health clinic for a cancer chemotherapy and need to run some special tests, St. Mary's into city has to pay for that, and then they might need a gene panel test or a [indiscernible] region test so that is done in California and again, city I what is expected to pay for it even though they have never heard of the doctor at meal clinic or anything about the patient. One problem hospital runs into is there then responsible for future audits and recruitments on the pavement. So then have to produce medical records from male clinic or anyplace else appeasement two, by reports and future from the lab in California which might not even still be in business. So I would say it makes more sense to we did it up until 2008 when the levers responsible for billing and lab was responsible for recruitment. I had a lot of interest program integrity in Medicare which means recruitment. It is easier when the money stays at the lab because she can't go and audit the claims and take a million dollars back. So they have financial advantages from medicare.

Those are some of the things I have seen and I think it is definitely true, more national coverage decisions would be a good idea. We had several test in California that are referred for national coverage decision, none of which had been taken up yet but Medicare may still cycle back to those and come to those.

Thank you. Yes.

Thank you. Barry, if I could ask you to come up and if you could stay. Let's have a few questions before we go to our public-private peers Panel.

Once again, Barry, I have shed some light on the black box of CMS. Thank you. (laughter).

One of the things I was wondering about that struck me, listening to you describe how difficult it is to come to these decisions, is that, our country is not in this alone. We may be uniquely fragmented, or unique challenges that make it difficult, but it does seem like many of these things must be being stated in other countries. Is there a way to take advantage and not duplicate all that work and for those decisions?

I think there are two responses, Jim, to your question. One, if you are asking whether we entertain results of decision making process these that have occurred in other countries, or ies, or the other analogy would be from commercial health plans, the answer would be yes. It is not a primary piece of decision making but it educates us and may influence the final decision, especially if we were to seek that many carriers or pay yours, or not to bring a certain technology and had a had a good reasoning behind that to support what we had come up with. So that is one setting. We do look nationally and internationally that decisions made for better technology we are looking at. If the other part of the question is, should we be looking, particularly internationally to enter models for coverage decision making, the answer to that is, yes. And I think that will be a major part of the debate for health care reform, and Ford, particularly, you should have information in your packets, several articles that I get about this, but you look at Nice and the UK. We have had a relationship with them for many years sharing information and concepts about how to wear. Coverage decision processes. I think they are. Trade with the coverage develop a process and comparative effectiveness decision making that they have been doing for years. I think that needs to be debated in the public sector as we go forward.

Seven?

I am intrigued as we wrestle with how this is going to go forward, words that come up constantly, like benefits and harms and balance and calculation, all of those things, keeps being raised. But one thing I want to come back to -- and I space being thrown off because I only ask these questions -- is the whole concept of, what is the benefit. So, personalize Madison, as we're starting to get into, let's go to lung cancer. Someone says, I have had by genome sequence for $1,000 I have found that I'm resistant to cancer, even if I smoke. So that should not be something that is held against me as far as my health is concerned except for the public secondhand smoke. But then we find that someone might be actually it susceptible to type two diabetes from weight gain. Is that a personal responsibility to go back to personalize Medicine, [indiscernible] or the employer or whoever takes responsibility. Are we going to shut down McDonalds.

And I have no stock in any of these companies. No food, restaurant or trans fatty acid or things like that. So I guess as we go forward and this flood of information comes out, however going to take that into the process of taking into consideration the very practical issue up mistakes in hospitals, and the idea of cutting back reimbursement if the hospitals aren't taking care of the fact that they may be transmitting flight resistant pathogens around -- drug-resistant pathogens? Well obviously, it's getting adequate sleep for the health care professionals has an effect on that. Do we take that into consideration, how to restructure these kinds of things? So my concern is that personalize Madison will just open this floodgate of information. And I like what you put down here, about a way to more rapidly integrate that, but I'm just wondering if we indeed are really preparing for that, trying to look ahead as Mori is doing, or are we still sort of to focus on the short term and what we're putting together now will not be adequate in even five or 10 years.

[overlapping speakers] that is another easy question, I apologize.

I will let you take that. (laughter).

A think Kevin could answer that in a couple of steps. One, first, I haven't mentioned overall, the overall financial status right now for the Medicare program as you probably know, we spend about $700 billion a year right now. The Medicare trust fund, the ravenous are now -- revenues are now less than the outflow. The CMS actuary has estimated that it will be 2016 when the Medicare trust fund will be completed if we don't change something quickly. That would be within President Obama's administration if he gets a second term. So this is unequivocally something that will be paid attention to during this term or at least leading up to the election. The actuaries have estimated that in order to correct that problem, and make the trust fund whole over the next 30 years, we would have to raise premiums immediately by 100 plenty% or reduce benefits immediately by 50 percent or some combination thereof. Those two things are not likely to happen. So I am saying this, because whatever we do will be in the context of, we're running out of money to pay for basic services, alone in some cases to gather information, which may be arguably discretionary. Although in a personalized medicine context, it makes it very important to the individual to have that kind of information. So that complicates the field.

The second point, as I said yesterday, right now it is Prix track and white. For our reasonable and necessary, it has to be two improvement in outcomes, whatever we do in the process of covering something, it has to lead to an improvement of outcome in the affected individual. So for now, are marching orders are pre clear. But what you're suggesting for number three is, there might be the situations from a where it is clear from the outcome standpoint, from the individual standpoint, they want to know how much information they can't even if it is like flipping a coin in terms of the outcomes of that. And that is with a proper bill hits the road in terms of how we incorporate -- to worked extent are we going to divert from population Health, principles where we are doing the greatest good for the greatest number of people two in fact allowing exceptions for individuals, and in this case, probably more for information. And I don't have an answer for the last one.

Steve? Then [indiscernible] and we will conclude this session.

Raised the issue of course from paying for this going forward, and most of the technologies that it introduced or even -- are high the cost effective or cost additive. And giving the challenges that you just talked about, and the constraints on using cost effectiveness within the Medicare program, which you pointed out was limited to fairly specific uses. How do you think this could move forward so that you can balance those public needs from the public good and keep solving it?

Steve, I think that first, the recovery Act that just passed and she now has three major conflicts in the health-care arena. But its adoption and use of health health information technology and the second is a whole series of health and prevention wellness issues. And some attention will be paid to personalize Madison and the expenditure of those monies, and the third area has to do with comparative effectiveness, which NIH will be leading but HIH will be involved. And certainly at the federal level, the use of comparative [indiscernible] research. And I don't see how we can do comparative effectiveness research without incorporating and dealing with the question of cost effectiveness in this economic environment, especially. So I think that is going to happen, and we will end up asking are answering some of these questions.

You know, there might be it a good example in Section 101 of NIPA. Which just completed a national coverage decision and completed it on the use of CT colonography for use in the prevention of colon cancer. And are determined termination on that was -- and this is out for public comment right now, so people can make comments on this and we have not made a final determination, but the literature did not show any advantage over existing technology in terms of using CT colonography. We also felt the literature did not discuss [indiscernible] so in 70 and 75 year olds, are you doing more harm by picking up polyps that will never turn into cancer. And the second question was, the cost of effective technology and the reimbursement that we pay currently for diagnostic CT colonography. We did not deny the use of colonography for a specific diagnosis, we would have to have the reimbursement for what we're paying currently and I don't think that the providers would find that to be acceptable on their end. So that is an example of what we are already at as far as the statute limits us, dealing with these issues, I think it will explode into everything.

Two questions. When Fort Barry and one for Bruce. I am not an expert on Gina, but I sense is that there is a prohibition of using genetic information for [indiscernible] decisions. And if that is right, is there a potential of limitations and how covering the evidence development is done for genetic tests and by definition a need for having [indiscernible] of effectiveness before a final decision is made?

Our understanding of Gina is such that, we can still gathered genetic information through clinical trials and so forth. We obviously have to respect privacy components of Gina, but we think we can do that.

And for Bruce's presentation, I wasn't clear about -- he mentioned cost of the test being a critical fact and many of those tests R [indiscernible] dollars. But I wasn't sure it that the [indiscernible] cost and value was brought into the presentation. There can be test offered for free, but sometimes they cannot be effective or [indiscernible] by you. [speaker/audio faint and unclear] and on the other side, there certainly many genetic test, especially in the breast cancer that are in the $30,000 range. So I just wanted to make sure that I got a sense that you were distinguishing cost from value in your presentation. [speaker/audio faint and unclear]

I was thinking mostly of cost. So if you have a five per dollar procedure that could be replaced by $100 test, yes, the fee schedule for the test is $100. But no one will develop a $100 test is a bit of 500 odd thing. Ninth note [indiscernible] assumptions you use, but there are some things that are cost-effective under nearly any assumption. That is rattling, that that would be a place to start.

Super. Thank you.

We appreciate that. That was terrific. Now we will hear from the other pillar of the peer community which are their private health insurance companies. And today we have two speakers. And I just want to check, Joanne, are you on the line?

I am here.

We have two speakers. Sam Nusbaum and [indiscernible]. And both of these are leaders not only in their own community but in the industry more broadly. At the introduced them. Sam will be here to get the first presentation and then JoAnn -- Joanne will get the first presentation and I will control the slides here, and then Sam will do that and then we will continue to have this multimedia and have JoAnn on the phone. So let me start off by introducing it Joanne who is the senior medical director for ETNA. She has an M.D. and mph at has a strong background in public health and epidemiology. She heads up the women's health and two medics unit for ETNA and has been a frequent speaker both nationally and internationally in the area.

So as we do that, Joanne, I am bringing up your slides. And we will webcast grade, for Steve to put in the password on his computer.

Courtesy of the federal government.

Just let me know when you are ready.

Okay, here it is.

And Joanne, thank you for your willingness to do this this way.

Okay. Joanne, we are all set on the cover.

I will click.

Okay, let me know when you want to go to the next slide. Joanne, we're on the cover right now. Good morning everyone, and sorry I have added extra complexity by not being there and going through it this way that I do appreciate the opportunity to share our perspectives about treading value in personalize Madison. Now I am on the second slide. And I think to highlight this, Rob spoke about this this morning but it can't say it often enough. Prisms medicine is a merchant at a bullet critical time in the health care of United States. This is a challenge to the committee and the people attending their and [indiscernible] outpaced our ability to pay for it. They're wonderful opportunities but they are just in aggregate expensive and we simply don't have the money for all of it.

Delivery of health care is that [indiscernible] care is not delivered often, their 40 million plus individuals without health insurance in the U.S. Delivered care is often not needed and [indiscernible] in quality and that has been well-documented by IOM and others. If and needed and a precarious is often ineffective. And we have seen examples of that like patients with anti-depressant their behalf often received a reduction in sentence. It is this other area where needed and a precarious ineffective where I think personalize medicine has most promise. The concept that you can deliver the right care at the right time to the right person has the potential to improve the efficiency of care, the city of characters certainly at the cost effectiveness, and I think that is certainly where health plans are beginning to focus their attention.

The next slide is just to illustrate that the size of this opportunity and personalize Madison as fast, because of this increasing personalization and all areas of medical care and things that we consider social problems have some genetic link.

Slide four. This is just a snapshot of what personalize medicine looks like when you just look at it the activity in this space. Everyone is familiar with these grass that come out of gene passed, and I think every year we sort of marvel at the height of the Kurds that come out in terms of the new test that are available. We see about a 10% increase in the new testing that is available year over year, and in our own data, we looked at the utilization of genetic based testing and that increases by about 20% per year. So there is significant interest on the part of clinicians patients to use these technologies. And this slide also illustrates what the intelligence are in staying on top of what the evidence basis to support coverage and it reimbursement and clinical use of these tests.

On slide five is a look at what the cost -- emerging cost information is in the area of genetic tests. And in aggregate, the total spending in genetic diagnostics is very small, Austin half a percent of total medical spending. But the trends are significant. We see in ETNA data, the costs are about 70% per year and we have been tracking this for the last four or five years or so and that trend degrade continues.

We're also seeing the emergence of some breathtaking prices and diagnostic testing. Three and $5,000 each, and we certainly recognize the many of these are also currently on the market at 20 and on hundred dollars protest. So that is not a statement about value but simply a comet that many of these are coming on the market at least significant price tags. But this pricing is said to be based on volume and value based reimbursement. Dicom tear that there is scant literature that actually links price to value. Item that we have defined what value looks like but we have seen from a marketing perspective the language that these presents are based on value and I will just comment that that there is not really evidence that that is the case.

The next slide, the diagnostics are increasingly being linked to therapeutic and companion diagnostics. Most of these are the biological therapies. And we are seeing at similarly high in a cost in this area, and trans. The biologic trends are about 70 percent and they have been running for years at that. And the comparison of the cost of the drug is about half the price. Not a statement of the value but what the trends look like. And at a per prescription costs, again, there because that are coming at $50,000 a drug and $200,000 per drug, so it is really incumbent upon us to us understand what is [indiscernible] for consumers.

And this is just sort of the test for use the genetics are going. And this is -- delivered care or will it just beat additive medical costs will marginal Healthcare gained? And from a ETNA point of view, we have been watching this and tried to plan it carefully really over the last three or four years. I think many health plans are doing the same because we do recognize the inherent value of the approach of the right person-right drug-right time, but given the amount of technologies that are just pouring on the market, interest the possibility of a collision. And it does need to be planned for carefully.

On the next slide, I have highlighted probably four of the many challenges that we are facing and trying to effectively sort of integrate personalized medicine and genetics based medicine into medical care. There are many more than this, but I think these are some of the four sort of high-level problems or issues.

The first one is, to ensure that the evidence these technologies is strong, both to support the coverage and reimbursement for the technologies, but also, to prioritize which of these technologies are introduced into clinical practice, and that there used well. The second challenge is the need for clinical and economic outcome data that demonstrates the value of personalize medicine strategies compared to the status quo. That is critical I think compared effectiveness research will help there, but there are again many more examples that what the capabilities will be in comparative effectiveness research. The third major challenge is the need for decision support tools for clinicians and consumers and health plans and everyone else but uses these technologies that picture that they are used in an effective manner.

The fourth challenge is to look at the CP system for laboratory testing. Many people have looking at this. --

Please pardon the interruption by our conference contains less than three participants. Please press star one now or the conference will be terminated. (laughter).

Are we okay?

Yes.

Okay, so the current system does hinder the ability to use our genetic test and look at the data and an understanding activity that does take place there, both to help us understand strategies from a medical perspective to work in the area of reimbursement strategies including diet based reimbursement if we intend to do that. Even things like coverage with evidence collection, how do you actually look at that, plan for that, allow that in your data, if you don't have the subtlety and the reimbursement system to enable and allow that. And finally, I think Robb has spoken to -- many people have spoken to the potential yesterday of the data we have in our system stooges that for various steps of research activities, but we are hindered by lack of specificity of the coding to ratify the testing that is being done in the clinical condition that it is being used for.

So I will just take us into a little more detail around these four challenges. The first one from a cartridge and reimbursement point of view from a plan perspective, it is really critically important that the technologies that are covered and promoted use have a strong evidence base. And the coverage policy that dites reimbursement for genetic technologies and personalized medical technologies are the same as for all other technologies, specifically that the services need to relate to the prevention, diagnosis and the treatment of an illness. There is significant interest in information utility and genetic test. A lot of the boutique genetic testing going to that. Some of them that are not to take tests but have a longer-term potential implication like testing for Alzheimer's I think are examples of tests, that while they may have personal information, information of utility and plant financial planning meets, the are currently not related to prevent to diagnoses and treatments that are not covered in a reimbursement environment.

Secondly, the information needs to affect the course of treatment of the member and the care and/or treatment is likely to improve health outcome and the improvement should be attainable outside of investigational settings. And importantly, the [indiscernible] is consistent with plan design. I don't think there has been a lot of plan design and genetics, and I am not sure that that will happen, but I think it is a risk if these technologies come in at a very high price level. Sources put that out there to watch.

In terms of the department's [indiscernible] I think the summer it is it is similar to all other technologies. So for the early years of personalized Madison discussion, we talked about whether there should be a exceptional as status. I think there is a greater consensus that the answer to that is now.

The evidence standards are intimation from the published peer review scientific evidence that permits exclusions concerning past performance and the effect on health outcome. Analytic ability and clinical ability. I think it is a legitimate question about what is the evidence standards and what is sufficient versus optimal, and more conversations need to take place in that area. With luck for the final approval from the appropriate regulatory bodies when it is required. I think this is a challenge in the area of the diagnostics where it is not required part most of the market, and what that means is, what we do, but health plans poor much more technology assessment than the [indiscernible] bodies or government agencies that are potentially tasked with that. And I think in a short term will be doing this, and necessarily by choice, but by necessity. And finally, the cover its services need to [speaker/audio faint and unclear] comparative effectiveness has a role to play.

On slide 11, the slide is a little bit outdated, but it's sort of speaks to the disconnect between the conversation behalf in the field about value based activity, and what we actually know about the value of the technologies that are on the market. And this light is a summary of Catherine Phillips work in barnacle economics and is the exact cost effectiveness of targeted their piece, and there are very few that have been systematically studied and the outcome did on that is next. It is a fair question, what is valued? We don't have the answer to that and I don't think we have had a decent conversation about what it should be, but cost effectiveness and net balance of risk versus gain, etc. And from a health plan perspective, other may be a perception that we do these analyses on every technology, the reality is, it is done by tiny minority of the services that are covered, simply because there is. Little data. We ourselves are towns with the resources to do this type of work and where we do it, and in many ways, we do it to figure out where we're going to prioritize our own activities and other some of these technologies without warrant being incorporated into disease management and other types of programs.

Slide 12 to last two minutes.

I will go into much detail here, because understand it was discussed yesterday but suffice it to say, there are significant challenges in delivering a decision support tools for both consumers and physicians to use effectively, coding issues on slide 13, we have talked about before.

We are sensitive on 13 to the privacy issues, health plans have been very active, both in supporting Gina and it now in support of the regulations around Gina, and we are aware that consumers' confidence to share this information is based on the confidence they have that it will be used appropriately.

And the slide, the graphic on how you actually use all of this data aggregated together to help consumers and physicians make decisions, Rob talked about this in a pharmacy setting. I will say that ETNA and [indiscernible] point and others are doing this already in a broader pharmacy and general medical setting in total.

This is an example of ETNA 's Personal Health record which takes all the data available -- he will see that on the left-hand side of the schematic. It is a laboratory data, and Burt and Sauve reporting data, all the administrative data we have, and we aggregate got into a big data aggregate and on top of not apply rules about what best practices are. And it's based literature from the guidelines of the proposal medical societies from the FDA or other bodies. And provide these rules looking for standards of care and drug-drug interactions and send this message is out. But this type of personalize Madison is taking place today already. The question is, how we personalize it in a genetics area and the Orange are the areas we need to do more work in. Particularly on the [indiscernible] site in order to message patients, we have to be confident that the messages we're positioned to them are prepared. The final slide are the parties from a health care perspective on where we should be going in this area. Just to restate that we need to strengthen the evidence basis for these technologies, is more than 1400 typecast that are available. We need to review the premarket to support coverage policy, sufficiently data and are we asking the right questions? We need to generate outcome data that helps us to identify values so that we can both prioritize it and help support the services that we're covering, and we need to promote the session and Consumer engagement, decision support tools to push this information to providers and patients. It is impossible as a broad said to read 20,000 journal articles and synthesize and integrated into your own clinical decision making. Still other entities are needed to help would not work.

I will stop here and thank you for your interest.

Thank you. And with that, our next speaker, Sam Nusbaum.

Thank you Mara.

I am going to try to get this to be full screen. Let me try this. That wasn't it.

So we are going to add to our knowledge share, that is the goal of creating these lights. I am delighted to be with all of you this morning and to be a new member of the committee. I wanted to build on what a shared and short yesterday and earlier this morning, because like a tale of Two Cities, we do live in the best of times and the worst of times. The best of times because all of this extraordinary new genetic and biological information should lead us to personalized medicine that is timely, that improves health and health outcomes. We have breathtaking advances in medical technologies. Yet, the worst of times because we have care that is unaffordable. Half the time, don't get the appropriate care. We have too many medical errors, and we need desperately to transform our health-care system.

So when I sort of think this through, when we look at what the drivers of health care costs are, the key driver in many ways is advancing medical technologies applied to an aging population with chronic illnesses.

So, if we could manage that, better care coordination, better use of evidence based medicine, that is our greatest opportunity to immediately control costs. And I believe it is so necessary to immediately control costs because that will lead us to have room for innovation. The biology and the opportunity that we are talking about.

So, if we look at what the Institute of Medicine has done, but the new legislation on comparative effectiveness research, we have an opportunity to determine what really works and health care, because we need to understand this, to balance this against these extraordinary cost. And on this slide, I share with you at some of the new biological therapies we are using to treat cancer, to treat rheumatoid arthritis and multiple sclerosis. And these are drugs that are no longer several thousand dollars a year, but 40 or 50,000 or in some cases several hundred thousand dollars. And there are several specialty drugs still in development in addition, to the large number we have today.

Two part of an understanding of new biology and personalized medics and genetics is to look at the approach.

Let's look back a few decades ago when a bone marrow transplantation was thought to be the best treatment for women with breast cancer. And it took a decade before we realized that billions of dollars were spent and that treatment did not work. There was no difference in survival. And to think of the pain for these women and their families as the women are undergoing their peak, and think of the delay in developing a more opportune therapies and better therapies. And then today, had we approached this biologically and genetically, women whose tumors Express [indiscernible] receptor, their candidates that should be treated with acceptance. So we are candidates and we want to make sure that if this treatment can work in the biological setting of women's breast cancer, they receive it. So think about where health plans were two decades ago opposing these mandates, which in retrospect was right, but today, making sure that women get a pretend therapy.

So what I would like to do now is to take you through how well point, which covers one in nine Americans. There by members of the largest health benefits company in America, 1.5 million. How is that policy today and how we are bleeding into the future.

Basically it with the medical health policy assessment group, it takes lots of input. Input from a medical specialty societies, input from all of the literature, input from [indiscernible] Technology compendium, from Nice, where the information is, and essentially consolidates that information and works with many academic medical centers, which is what the medical specialty societies. Surveys changing practice patterns, FDA decisions, and makes decisions on whether we're going to cover, whether we find these treatments medically necessary.

Now even within this complex structure, we have subcommittees, apologist and health experts, but what is most important is that once we make this decision -- and Barry Scheck with us in about a nine month time frame, this is a time frame that could be literally days or weeks depending on the therapy. In fact, for new preventive therapies is based, and for new therapies, like after eight and a Fazio beating, it could be days or not weeks. But to emphasize the concept of transparency, all of this information is put forward in a compendium. It is all heavily referenced and on our Web site available to all to look at interview. And if there is additional information, to be critical of that and get back to us. Because, what Joanna said is so important, and I will repeat what she said, but we're not only looking for the analytic and diagnostic debility of test. That is the first step. But is it clinically valid, and in genetically damaged genetic testing, does the test reliably link [indiscernible] aspect and what is the clinical [indiscernible]

Is there a health benefit compared to the current care, and what happens if the test was not performed? When we use these criteria, we make certain decisions. And I will share with you briefly some of those decisions that we have made in the area of genetic testing.

We certainly covered bracket one and Two, and you can see, all genetic testing for cancer susceptibility, that is covered. We cover pre implementation and diagnostic pierco. We cover [indiscernible] for archetype DX, but not yet a mamo print, which is a different profile. Because for take our ASL testing to look at in a tight ETS therapy. We do not covered by chemical markers for diagnostic testing because we do not believe it is used to reliably confirm a diagnosis. Or screen is in is symptomatic patients without or with family history.

And use the others that we do not cover.

The reason we don't do this, it is not just financial risk and reward. Certainly, we have to contain costs. But we actually go into this without cost as our primary factor. It is what represents the best quality medicine, the best evidence based care. And it is only then -- because we're looking at how to better diagnosis and manage risk and populations, to better diagnostic prenatal disease. But the potential risks are the faults negatives that may result in failure to seek unnecessary care. That was a very real concern for loss on a lot of the testing for breast cancer.

False positives lead to a Damocles perhaps in how people can deal with that. And then we have the issue ultimately of cost.

So as we look to the future, for companies like WellPoint, ETNA and others are pure companies doing? We are doing many things to try to learn the answers to better define, in some cases observational studies on what works and health care. The have a company called Health Corps, which is the health outcomes company, and we partner with all health plans but more importantly, strong collaborative research relationships with academic centers and have about 110 research projects under way, in breast cancer care and asthma and room toward arthritis and to see what drug devices work. We are even building a research network as part of the Indiana CT as I, but beyond that we were good academic centers and large organized physician groups to actually use that position to explore what can or can't health care. So it is not only to do the observational studies, in some cases, RCTs, but having this organizations [indiscernible] so we don't have the 17 years that ruptured from new knowledge to the introduction, so the rapid dissemination of information. We talked about the electronic ^ records and talk about in integrating at a health-care record. Here is an example, not just taking imaging information or to record information or claims information but not genetic information along with drugs and medical records and creating an antiquated record as we have in Ohio and that is available to doctors, hospitals, members, patients and employers in emergency rooms and have shown better outcomes in care and improvement in care. And this is an idea of what this would look like any precise way. He would see more about genetic information, rather gaps in care where informing that member, patient and his or her physician what can be done better. Whether it is to save costs or whether it's to have an issue of committed therapy and not being effective date effectively monitored.

The last point I want to make a closing is, we want to build partnerships. And Barry articulated that we all have to work together to advance knowledge. And example of this is working with the FDA and others on the safety sentinel system. So once a drug or device is available, but it's it's real clinical use. And by looking at this, we would have identified [indiscernible] and had 30,000 individuals with myocardial infarction and took of India and didn't have an increased risk. So an example of the studies done well can make a huge difference.

So to truly recognize the value of technologies from a health care prospective -- health plan perspective from I believe ultimately all of our best interest, they have to be proven and improving health outcomes. And to get there is to continuously evolving technology and look at outcomes research and comparative effectiveness of research and make sure we disseminate technical knowledge into clinical action.

And finally, to make sure that, not only do we disseminate it, but we close the gaps in care at the point of care.

Thank you.

Thank you. So with that, Joanne, you are still on the phone? Let's take a couple of questions now and then take a break and bring everyone up together.

So, questions? Mike?

Vickie for both of your presentations.

[captioners transitioning]

I some a paper where there was a study on a clinic in, I think it was in May where I think they were getting 30% false positive infalls negative test results. It was crazy so without the kind of standards and things like that to ensure that you have some confidence in the measurement, your clinical assessment and clinical utility assessment could be wrong. [ LAUGHTER ]

Mike, what you say is absolutely true. All of this starts with scientific precision and accuracy of the measurement and the more that we're going to rely on tests to guide therapies for very, very critical illnesses like breast cancer an therapies that are very costly and that make a difference in a life or death, we absolutely need that rigor behind the clinical performance of the tests.

Paul?

Joe Ann it's Paul billings. Sorry you are not here. I have two questions. One is for benefits -- thinking of molecular diagnostics, how do you require prior authorization for payment? How do you assure that the people doing the prior authorization understand the technologies given that some of these are fairy complicated and difficult for the experts to understand much less other folks the.

When you look at all the challenges preparedness to effectively juice genetics -- use genetics. Clearly the same lack of knowledge gets replicated inside health plans as well. For etna, behave a small number of these technologies that are on precertification lists or other lists that prior preauthorization and for etna they are handled by a very small limited staff of people who have been extensively trained and for the technologies we work with the manufacturer so we have a clear understanding of what information is required in this preauthorization system.

Okay. Then to change gears slightly, etna was an early adopter of bra coo one testing, which could be argued -- BRACA testing, which could be argued as medical tests and valued price. Why did etna adopt that test earlier arguably than other payers?

I think from an evidence point of view it met the standards of coverage. At the time, we were actually the we were engaged in a series of genetics. One thing I will except about is that we've been watching that. It's been on a precertification list for ten years. About 5% of the requests did not make medical appropriateness of criteria. They were the AMCG criteria. Now we use [ Indiscernible ] Non-appropriatete use increased between 20 and 25%. That directly correlates with mass education. As directed consumer campaigns take place in various yesology arefies we see the rate of non-approachly yet tests. Afternoonlyfy that the physicians understand what they're ordering.

Other questions now? So with that thank you Sam. Let's move to the next panel. We'll take a break and then move everyone up. We're going to give you a challenge about what do we actually need to do. Is this this -- with this committee or directly with HHS change for the future.

As we're getting ready, our last panel, the prospective from employer-based insurance Klans. This is something -- plans. This is something that has been a quiet but critical trend whereemployers are not working for payers public or private to change health care. They are taking it into our own hands. We are lucky to have two key leaders in this field. Michael yes tellly, just recently retired chairman of pitny bows. Including very aggressively lowering the health care related increases at pit any bows. He is playing an active role. Our second speaker in this area is Richard [ Indiscernible: Speaker/Audio faint and unclear. ] I'll give you his bio in between. Let me start with Michael and talk about pit knee bows.

I'm going to skip over and going right to the problem that we had to deal with when we took over responsibility of health care in 1990. We had poor employee satisfaction and very poor health. My boss the CEO said you have to fix all three problems. What became clear to me, was that we needed to approach it very differently from traditional health insurance plans design. We had a four prong strategy. Before I get to that, I want to make two preliminary comments. First of all, I'm a strong believer in the employer health care system because when we think about value, the employer or the union are the only players other than the patient who have an aligned interest in reducing costs and improving health. The only players. Our interests as an employer goes beyond reduced health care cost, they include among other things absenteeism, improve productivity. We get a lot of benefits that you as clinicians or CMS do not get from improving the health of our employees. The second point I'd mic is there are four -- make there is four payment systems. Public system, the private insurance system, there is the mandated system in states. So if you think of an insurance company they really have to deal with two things. One is their own ideas, which [ Indiscernible ] Speak aide eloquently talked about and both partners are partners at pit any bows but there's is 50 state insurance plan dates that are based on very bad medicine and are not revisited about the other systems. We can draw upon the expertise of all the other systems to try to design value-based health care. So what do we do? We have four strategies. Strategy number one is primary prevention, nutrition and exercise, lifestyle changes and infection disease prevention and containment. We provide food in my of our facilities. We stack the deck in favor of healthier foods both in terms of surprising, presentation, information and Ms.Ing. We have -- merchandising. We have health care facilities, redesigned work spaces. We've been smoke free since 1990. We also provide services right at the clinics in the buildings and we have a pharmacy right in the building. What are our learnings from clinical care close to the work site? Vent access improves people use of the health care system. A lot of benefit of continuity of care and increased adherence to treatment plans. We have done some studies through med stat. Our employees who use our clinics are more likely to stay on a chronic disease medication program. We do value based health care. We've done it for a number of years an try to work on patient and provider behaviors to drive the right beHIV yours. We can actually on a continuous realtime basis draw upon best evidence to change plans. We not only look at effectiveness, but we also look at behavioral responses. One of the things we did some years ago, is actually take our preventative decide medication -- disease medications down to zero costs. When we increased copays we lost money over time because people wound up in emergency rooms and hospitals. What were the results of this? For the clinicallyic -- clinics we saved -- we saw an average cost of care decrease for diabetes, asthma. We also saw reduced hospitalizations. Our total over all savings was $40 million when you looked across all programs, medical, disability and workers comp. This does not include a paren teism and absenteeism savings, which is probably significantly more, but aren't easy to measure. We are now recognizing as our fourth strategy the need to implement health information technology and the chairman of an initiative called DOS yeah which is a personal patient electronic health record. We at pit niobous patient self-management. What I really like and what I turn your attention to is the lower left hand corner, the personal data sources. As we move forward, we do not expect to compete with nor would we want to compete with some of the great EHR systems out there. What we are really focused on is supplementing EHRs with patient self-management. So in addition to having nine companies in our consumption, we also remember the continuum align January to figure out better ways to get interoperability between the diesises. -- devices. Just to give you some thoughts on the potential role of genetics and genomics. We will want to use tools to determine what we cover or offer for what populations at what reimbursement rates. Let me talk briefly about another dimension of our health plans. Do we cover or not cover something? Do we have any processes other than diagnostic tests? For behavioral health, we use our EAP providers as -- in a sense incentives or screens. We have up to 8 free visits at our option for someone wanting to enter the behavioral health system. They can go out of network and go straight into behavioral health system but we would reimburse for 70% of that. If they go through the 8 free visit model we reimburse at 90%. Those are growing at the low single digit rates and we're also capturing more people who have conditions like clinical depression and being able to identify comorbidities with other conditions like diabetes and cardiovascular disease which proves to manage those conditions. I do believe that over time we will warrant to use the -- we will want to use the tools to improve our ability to deliver value based health care design. I believe very, very strongly that health care reform needs to inisn't people close to the work case will to be better -- not only buyers of health care but more importantly better drivers of creating a culture of health where people spend their waking hours. I believe that we've had an 18 year controlled experiment in some ways. We've had phenomenal results but I would like to see some of what we do be scalable on a bigger program. Thanks very much.

Thank you. Our last speaker. Richard [ Indiscernible: Speaker/Audio faint and unclear] comes to us another leader in the field of employers who are taking dramatic actions to take things into their own hands. Most recently was in the medical practice as internal medicine specialist and comes to coo tah pillar and practicing and working in the medical school and educating the next generation of physicians. With that, Richard?

The question that was addressed to me was how do we at cat pillar -- coo tah pillar. Take -- 50% of our employees outside of the U.S. we cover 150,000 lives or so. We have a legacy. We have the same you non-that the auto workers have and our annual spent is [ Indiscernible ] Turn over rate of about 5 to 10%. So typically with someone joins Caterpillarrer joins for the life. That's the first that frames our health care strategy is taking the continuum of health model and saying if we're going to have these people and be responsible for the costs their whole life, what can we too to maintain health? To promote health? Prevent disease? See that evidence-based medicine is practiced at theky suit and chronic -- acute and chronic levels. Strategy started in the '30's that same exam that's given to the executive office is afterring to every employee on a regular basis. It's cost would drive it out of the country to manufacture if they didn't do something to control costs. They went from a payer. They had up to that point in paying all their claims. They went to a true push chaser. Set up a network of hospitals. Preferred physicians. In 1995 as part of the demand strategy of the executive office approved a health promotion program. That program was started saying we had to have the ability to get 90% of our employees spouses and retirees to participate twice a year on HR arkoses risk assessments. That's what we've been getting. That's because we built incentives of premium reduction that was aimed at 90% level. The [ Indiscernible: Speaker/Audio faint and unclear. ] was started between our hospital, the university of Illinois in Peoria and the Caterpillarrer benefits designed corporate medical. Screening to our wellness exam back in '99 because our population is basically from the northern European decent. Dr. [ Indiscernible: Speaker/Audio faint and unclear] mentioned the area of breast cancer. In roughly 2000, 2001, our insurance did not cover investigational procedures. Just about every academic center in the world was doing high dose chemo therapy and bone marrow transplants. We created a program outside the typical benefit program. Group A insurance plan A. The requirement for this is we could cover high dose chemo therapy in stem cell rescue if the employee or dependent would enter national institute cancer studies. There was no question in transplant centers that this was a Benable. Had lots of trouble recruiting people. As an employee we field we needed to know the answer and why not participate in that program? The results of that program actually proved that fads do not just exist in Hollywood. No one's doing that high dose chemo with transplants at this time. In 2002 through our health risk assessment, the twice a year thing we get 90% participate, we combined with addiction counseling free and clear. We added preventive services for nicotine replacement [ Indiscernible: Speaker/Audio faint and unclear] if you entered into this program the telephonic program across the United States. We only took people who we staged through our HSA health risk assessment in the preparation stage. We limited to our smokers, our production workers smoking rate was 25%. Our salaried rate was 15% and our management rate was about 10%. So one survey they did is are you currently a smoker, if they answered we staged them for [ Indiscernible: Speaker/Audio faint and unclear]. If they were in the preparation stage, we would then pay for the free and clear program with whatever medicines was necessary. The quit rate five years down the road is 38%. People who are in preparation stage who did not enter the program, their quit rate of five years is 5%. We added 0-dollar coverage to medicines that we thought was essential for our chronic care diabetes and antidiabetic medication. Antihyper tensive, [ Indiscernible: Speaker/Audio faint and unclear] last year we started health work side programs so we could interact with our employees on lifestyle changes using motivational interviews, to not just make them aware of what they need to do but how do you motivate the person to change. This is an example of our continue yum care model for -- continuum care model for colon cancer. On the left is the stratification. This is where we think genetics could help us. In the second HRA if the answer is yet I have a first degree relative, we've dig into a detailed family history. We've added total of 100% coverage for color cancer screening at age 50. We have a sick sigma program looking at people under the and of 50 who have one first degree relative. We're having trouble figuring out -- with the united health care, since there is no screening colon os dopey that's hart to pay for that at 100%. We need help on that. You can see our second part of this is we're not ignoring equality of the colon os comy. We haven't had the ability to take the cost at that pint. The network of hospitals and colon os cos through practice center if you are going to measure a quality of -- what are the elements you would be measuring. Are they documenting fee call and documents withdrawal, things like that.

The third example I want to give you is are drug example. This is 2006 data. The antilip Deeics was the chief highest drug cost. C IC stappeds for calculated ingredient dispensing fees. What the employee pays and the society pays. 70% of that was in [ Indiscernible: Speaker/Audio faint and unclear] prior to that before we had strep therapy and preauthorizations the ulcer drugs were number one. You can see what we did with the ugh sore drugs -- ulcer drugs. If you look at the far left corner there, if you were going to choose a statin to lower the goal was to lower the baseline LDL35%, any of the basic stat ins on the market would have that LDL lowering. The area in the green are the generics, the blue are the brands with therapeutically equivalent but not generic. There is not therapeutic equivalents available. The goal is to reach the NCEP of 100. You need 35% reduction, why would we want to pay for a brand when you can get the exact result with a generic. So in 2007, we created the statin generic dollar copay. The blue line there is those on brands with generic therapeutic equivalents. And not effect the red line. The red lines are those brands without generic equivalents. We said yes, we're gaining ground. But it's not op id enough. Therefore, we then put step therapy in place. We sent letters to the employees and the physicians noting that in August, we were going to make the change. By August 80% of the people were on generic drugs. Generic statins.

This is the key part that really showed me the value of 0-dollar copay. The red lines compare generics 2006 versus the adherence versus 2007. The blue lines are the brands. These are new starts nine months out. Basically in 2006, they were all roughly 69-70%. The generic brands when we added the 0 coway addherns went to 83% at 9 months. Part of everyone we do in cig sigma is make sure we're not causing harm. We track any consequences of any drug change. You can see the trends down. This is not saying the changes made, but this is really a notice to us that we just did something and something has changed to adverse, to look deeper into it. Went down this is elevated liver function test. When we trend 2006 before the change that trend was upward. Hospitalized for MIs but again the trend is at least not giving us any warning that we should re-examine our decision.

So if we get better adherence, this is a cost savings both to Caterpillarrer in yellow, the member savings the 0-dollar copay and the CIC cost is the total cost. It's by month so at the time we went to step therapy for generics in August 2008, that month of savings to Caterpillarrer enterprise was close to a million dollars. This is a quote from a [ Indiscernible: Speaker/Audio faint and unclear. ] article represents an important public health tool for improving patient treatment and adherence. I think planned design, not just pharmacy planned design represents a public health tool. I want to end with this. This is Caterpillarrers cost in 2002. Was the blue line the 7% increase per year, which you know sometimes it's higher than that. Actually, the bottom black line is what Caterpillar's costs are with increased employees, increase adherence, adding 100% coverage for U.S. preventive task for and 0-dollar copay. I'd like to end there. Thank you.

Thank you. Richard if you can say up with Michael, we can get questions on this and then we'll break and come back with everyone as an interactive panel. Mark?

I asked this question to the EEOC and of the civil rights representatives an I know this is somewhat speculative since we're still in the rules process and neither of you have any systems that are currently using genetics or genomics to make some of the decisions that you talked about but given all that, with Gina title 1 affecting insures title 2 affecting employers but with self-insured employers seeming to be caught with both of those pots could you talk a little bit about your perceptions of how Gina is going to impact some of your desires to move some of this personalized medicine into the disease management and other health programs?

I'll start with that. The color cancer, I'll stay on that theme. Right now we're using family history and we're using average risk at age 50 or so. Only at 6% risk. Lots of our people are going invasive procedure. Decreased our cost for the colon os coo my. I do think an employer like us would refer our patients who are under the age of 50 if genetic testing does change the adherence to following the guidelines and does it really lead to better out comes than just family history. I see lots of areas on our HRA using self-recorded family would tell us who to concentrate on. Receptor positives and the colon cancer we use it now for bio logics.

I would only add one comment, which is that I think the personal health record properly used with the up front consents on the part of the people that have the record is going to be an extremely critical tool, particularly if we can get more self-management and self-entered and self-tracked data into the system. I think over time we can develop richer data sets but we need to aggregate it and have the freedom to aggregate it into population data. It could have crippled aggregation of population level data. Unfortunate -- fortunately the Senate language prevailed. We're going have to use judiciously.

So again, I want to get more of the issue, do you think there are provisions in gin that that are going to essentially fire wall that information you would like to use ethis through traditional health electronic records or through personal health records so you would be prohibited to use that information to make important decisions?

With our hey Moe toe binchrosis screen that question came up. On people who had high transference [ Indiscernible ] Iron overload. Our lawyers would not let us do the genetic testing. So we developed a letter to the employees saying you got to talk to your doctor about this. What you're talking about in that letter we did educate the physicians of the mooning of testing in this -- meaning of testing in this person. Many had levels above a thousand an they were all asimple toematic. Unless we get legal they won't let us do testing as an employer. They will get out into the public of the HR departments even though we keep everything in corporate medical, that's not a big enough fire wall for our lawyers.

We have an alternative, which we are looking at, which is to what degree we can outsource providers have our freedom of action. I think if I look at our clinics, we split down the middle, 4 or operated by company employees and 4 or operated by outsourcers. I think this is going to drive more to an outsourcing model. I think it's a workable model because there are other benefits to the outsourcing model at least to the states we have clinics. They have more freedom to treat dependents and retirees than we do.

I'd like to follow up -- thank you for the presentations. It's fascinating what you are doing. Following up on the informed consent issue that you mentioned. Using an specific example special insurance group for those who had breast cancer. Minessing is you incentivized them to go into an NCI clinical trial? What was the alternative if they didn't want to go that way?

No coverage. It was investigational. The evidence at that time if you read it closely, it was unproven and we did not cover it. So in order to cover it, we Croated a special program out side of us in order to get to the answer you had to participate in the study. If you didn't want to participate, it was not covered.

Breast cancer coverage but they don't get coverage to that service?

They get the chemo therapy with the tavern plant.

It sonded like they get nod -- sounded like they got no coverage.

[ LAUGHTER ]

Thank you. Didn't want to leave any questions there.

I'm not as -- obviously I've retired from pitny bows and I'm not sure at what direction they are going. I operated on the principle of never fully taking away choice but nudging people through different rates of reimbursement depending on whether they went through an informed con isn't system versus whether they didn't. We stack the deck but -- on the specific example of the breast cancer, we did have an ethics committee that looked at that because we knew it was life or death whether we paid for it. So that was a unique situation. But on most of these situations, we work -- we did this for example of per yak trick surgery but you have to go through another process first. If you go through the other process you have a much higher rate of reimbursement. Anything that's on the margin, we try to have a predecision process and stack it by higher rates of reimbursement. So let me pass it over to Steve with the announcement of hundred.

Many thanks to all of you. Hopefully you can stay with us. We want to continue the discussion with you. Since I always know we [ Indiscernible: Speaker/Audio faint and unclear] could I ask that we come back at 1:00 and as yesterday those who ordered box lunches will find them outside and then those who didn't, the calf material yeah is down -- cafeteria.

We'll end a few minutes early.

At 1:00.

Yeah.

[ Lunch break taken until 1:00 p.m. eastern time. ]

They're is a lot of music playing in the background. Great.

[speaker/audio faint and unclear] what are the areas of this group should take on to really help achieve the clarity that your asking for in the future.

So what is next? By different categories. We talked about this book today in our community meetings. For drugs and pharmaceutical companies, what I have heard, and we can debate this, of more targeted drugs with smaller targeted markets. More effective drugs with fewer side effects. Of that increase the cost per drug? Several people in the industry are saying that but it at the same time, what it increased complaints. I am asking you if this is the future you think Jesse?

When you look at oncology as an example, it is pretty compelling. 10percent of drugs were targeted in 2001, and maybe 60 percent targeted in 2010. Is it all about genetics.

No, but probably 80 percent of those targeted on 19 basis doesn't mean inherited basis.

Physicians, overwhelmed. We heard that today and heard that yesterday by the volume of data. They need more tools and more education on genetics and genomics. Right now, fully 17 percent of medical schools have no formal education on genetics and two genomics in there for your education. They need more treatment guidelines and will this bring them increased liability as we look to the future?

Next, employers. We hear they are taking a long-term view of employers' health. Growing use of health insurance plans and aggressive use of a bonus plans. But we see this trend of self insurance continue?

Laboratories. Intense data acquisition and storage requirements. Personalized medicine into genomics is all about the data and not about to let let any more. [indiscernible] new technologies and I think it's fair to say that we have heard this time and time again, increased focus and scrutiny in all parts of the health community. What does that mean for the future and what actions we need to take.

HIPPA yours, we have heard this a few times. They're demanding evidence based medicine. Tide to get it to them? Maybe contingent on evidence based medicine. We spoke about nice. It is a money back guarantee. If the drug works, they get paid.

Lacross has talked for many years about funding their own database and patient outcomes. Not having Barbara diagnostic companies doing it and getting their own data. And lastly, demanding test of proving the relevance to the patient's physician.

And lastly, a group that is not represented on our panel except all of us as individual is patience. I'll ask about, what does consumer directed health plans will impact us in that area? Patients more educated but more stressed. Increased decision making, whether it is copay or no copay, the need to get more involved than they were in the past. Recruit complaints as personalized treatment grows potentially, and maybe most importantly when we talk about predisposition of testing and other whites, and living with the potential of the disease, not the disease itself.

So as you look at health care spending going forward, the current practice, and I think this is borne out in much of the work that we have heard, relatively little is spent early and much more as we get older and sicker. Is this the potential of genetics, two genomics and personalize Madison a very different trend? Is this the investment and diagnostics and Prevention, genomics, and do we get a benefit in quality of life and financial savings?

So if this is the future, A, is this the future we want to get two, and B, how do we get there, how do we actually do what some of you, all of you had asked. Is this where we need to go, so five years from now, we're not sitting here again and again saying, this is what we should do? Tied to retake the proactive action in a moment and see this tremendous opening two health care reform.

So with that, but believe that open and take some questions from the group and have a facilitated but actives and interactive discussion.

I have a question, which is, all of these models that we make in evidence based medicine is very nice and neat, but the way that the data are collected -- and I do some of these studies, are in very artificial conditions. You recruit people that have that disease and you put them in the protocol that the very stringent and crucial criteria. And did my protocol, I have a 10% recurrent. So if ice-cream 4,000 people, and get 400. But the people that are set out there are the 3,600.

For example, when I was at UCLA and the geriatric clinic out there, the patients are on average taking 14 medications. So there is no evidence is Madison in of these combinations that we give to people. Many of these combinations have never been tested, but even in animals. Then we talk about evidence based and try to be bearing scientific, but the reality of clinical care is very different than the world of light no clinical studies and evidence based. So how do we bring this Sorrell -- to real life where people have three or four or five different diagnoses as? And other had breast cancer and a Nordiques in buses and had medications for all of those and these things are combined and [indiscernible] so how do we take care of that?

(laughter).

Go-ahead.

Let's start -- what is B-2 is the most important issue, and outside of the randomized controlled trial, how do we know what really works in health care and what works in a real-world setting. And that is why I was emphasizing the fact that those of us who have aggregated data, who have huge databases, I think are really open to work with the federal agencies and others in a collaborative way and academic partners to look at those databases. And I used some of the examples on drug safety, and this is after a drug is approved after -- following its in the D.A. and RTC. And how does it work in the real-world. And while there is not the purity of the RTC, the purity of the data that we have with the numbers of patients, but in Vision patients. In our population, we have just under 1 million individuals with diabetes. The way we could look at the population and how they use insulin for example, or what A one C correlations are or any of the therapies for diabetes can be applied to that setting, and, you know, it is not the nuance of the medical record, but claims data is quite accurate when you are trying to correlate with major events, be it myocardial infarction or stroke, because most hospitals to submit a claim for getting not care. And when people look at claims based information, while initially at a striven for financial results, we are able to work with it and develop performance measures. But in summary, I think these massive databases can be used without creating new ones. They can be used for safety, and used for effectiveness and outcomes.

I would just like to add to Sam's point of view which I completely agree with.

I like to view the two as being complementary. So, for me, I oftentimes in a randomized trials, you're looking at efficacy, not effectiveness. So that means in preconditions with perfect compliance and everything. And people who are only the disease of interest, can it even worked? But that doesn't ask the question you're asking, which is, in a sloppier world where people have lots of problems, that is what he effectiveness is about for me. And I think in the polls really to understand how things work. And I will give you what illustration that I always find in this interesting. The two go back to the pivotal studies in lipid luring their piece, up until the 90's we developed even did any good. Then along came a four and a half year randomized trial but said, for people with a placebo courses cholesterol, is it mortality. But if you look at those papers, at 92% persistent rate at the end of four and a half years. In our effectiveness in the world world of lipid lowering of users, 50 percent dropoff in the first year. So the outcome you see in the clinical trials at the end of four and a half years, are not going to be the outcome in the real world because people behave as they do in the clinical trial. Which you so rightly pointed out. But in need to do efficacy studies to prove in a perfect world it would even work at all, and and effectiveness studies for the world to examine to see if in the Messier world, it -- does it still help.

Out like to add also, in the messy world, but don't consider a complex patient like your mother and what she really needs. The whole delivery of care system has transformed into processes of Team care. And one of those you listed, it could general practitioner or family practice could handle it. When you start combining three or four things together, they get lost because it she comes in because her knee hurts. And we don't have the processes in place. Hopefully the medical home would allow this but that won't survive unless we are willing to pay for a whole different way of going from a volume of payment systems to value payment systems.

There's also another twist to that. We usually think of advocacy being higher at real-world effectiveness been lower. It can go opposite when we're finished studies are one of those. Everyone is consented, they have built logs and a half I and R3 times a week, and then Warafin -- follow-up question. As a talk about the evidence of this and Warafin testing and other testing, how do we raise the standard for diagnostics in today's world that is higher in terms of evidence necessary in trials that we have four drugs, whether it -- I mean, you could go back over all drugs that were approved a long time ago or processed cheese and a new surgical interventions, like a bone marrow transplant which did not a to be approved, per say, people could start doing it as as opposed to specifically approving genetic tests.

I don't think evidence is higher for drugs per say, but it is approaching that level. Which isn't true for a lot of other medical interventions we talk about outside of drugs. Drugs have their own, very specific, very intense and rightfully so, because what happened in the past with safety and what not -- standards of evidence for approval in this country, and a lot of the rest of the health care interventions do not.

And is genomics based labs seem to be moving up into that area, or you don't have the business model to support it the way you do for the pharmaceutical industry.

So this is an extension of a Julia's question.

First of all, to endorse the and responses from the group, I would extend perhaps the database argument that Doctor Nusbaum brought forward, and that, we have talked several times during this meeting and in other contexts about integration of data. And I think that is a critical issue, because certainly, for those of us practicing in integrated health-care systems where we have access to claims data, medical data, and a lot of different data, I think we can then not depend on this old data sourced to try to answer questions. And I think certainly if we look at some of the and CQ a data and that they are completely dependent on claims data, we could do it better job answer questions about the previews of to antibiotics. If we had something to go on better than claims data, but that is what we're stuck with.

As many people have called for, I think it is clear to me that one of the things that we need to endorse as the secretary's advisory committee is to say, the integration of the database with rules to protect individuals is one to be absolutely critical to learning things.

The second point is that, one of the challenges and think from evaluating the evidence is that, it is very difficult for some of this real world information that is extremely important around effectiveness to actually get into the literature. Because it is using a paradigm that is different from what people are used to which is a hypothesis based clinical trials. I know at our institution, we have some extremely interesting work around Warafin management for people that are long term where we have used industrial process management to reduce tampering, where we have increased our time and range by about 75%. And for three years, we cannot get this published because it is not a randomized controlled trial. We think that is kind of important and a very simple thing. Basically, you just don't change the does if they are between 1.8 and two or 3.3 and three. This looks to be a problem that could impact all of us as we try to pick what are the most effective therapies. So I am interested in your perspective about how we could get those types of, if you will, for a world clinical trials or real-world data around effectiveness into a venue where we could all see it.

Market, I would be happy to start. Absolutely, I agree with you that much of the data that exists that is observational studies often doesn't meet the rigorous criteria for publication and academic journals, and even for many of their academic colleagues to be intrigued by the data. That is why I am very impressed that perhaps the translation -- the science initiatives, any of these CTS Is would give us a different breed of researchers that will work with different data bases, and perhaps could partner with those organizations, ETNA, United and Medco, because I think the pendulum is swinging now that even the RCT as cat that weren't so beautifully done in trials didn't give us the strong answer on safety of drugs. So I would argue that the transitional science initiatives of CTS A and CT as I asked I can get us closer. But I think we heard from Mike and Richard what companies have extraordinary databases. And if they have a longitudinal employment, there is a transition that is in as hybrid, not claim information but if you have on-site care models, yet that robust set of databases. But I was excited so much of the stimulus package, because that in that comparative effectiveness research and the 1 billion in there and the 1 billion to CDC, perhaps some of that money can be earmarked for new methods of analyzing these large databases and given us confidence that the knowledge derived from them can be just as good as the knowledge derived from more traditional means.

The HRQ has got sort of Bible, a 200 page book called easing registries for outcome analysis that came up a few years ago. Some people have not heard of that.

We have to be mindful of two things. When is, that the patients are going out and seeking out there on the data sources through sites like Web MD, and their connecting the dots not necessarily accurately or in a scientific way, or they get anecdotal information from friends or family. And I no there is a concern about scientific rigor, but when there is a vacuum that is caused by the absence of clinical trials, I mean, what happened with that bone marrow transplant, because I remember it. What really got back into the legislation was not science, it was efficacy. And had science come up with something less than randomized clinical trials, but reasonably valid, they probably could have short circuit to that. But it was because we wanted to wait for the perfect answer. The advocacy groups got there first and got legislation passed.

By the way, one of my frustrations with the current health care reform debate is, there is absolutely no appetite to take on legislative mandates at the state level, which are very often based on bad or nonexistent science. And, I think if we are going to look at this problem of evidence based medicine, I think we have to look at the mechanism of what is being used to revisit. It was fortunate that in the bone marrow example, the scientific evidence is so compelling and the results were so bad that states had to reverse themselves. Those cases, it is not that simple. It is more murky and bad medicine kits practiced and institutionalized, because insurance is first to cover it. So I think that we have to recognize that there will be a vacuum here if we wait for perfect evidence, and it will probably get killed the wrong way.

It seems almost too good to be true as you describe the programs they have put in place at the employees sites, and really owning that. You see the improvement. But reaction have you gotten from your employees in terms of putting this and, at how long did it take, if you could share that, to begin to get a return on investment? Because when you hear this multiple years later, it looks like everyone to take this up, and I am sure it is not as easy as it appears when you look at great results 10 or 20 years down the road.

With the colon cancer, the return on our investment will be about three or four years, because we have about 250 New cancers perjure diagnosed and 60 percent of those have metastasized at least to limp notes. So they're getting chemotherapy at that point in time and it is about 50 or $60,000 per year.

The cancers that we diagnose by behavioral changes, the cancers we are diagnosing so far were last year, four of them were diagnosed and they were all basically curative at biopsy with surgery, not needing chemotherapy. So when you attack disease that we are late in diagnosing, to return in investment for an employer is quite good if you can cure it. And basically 85 percent of colon cancer should be curable or preventable.

They're is a range of return on investment for a few months of immunizations and avoidance of outside doctor cost from a clinic to plan design changes that avoid hospitalizations that probably take too hot on to for years payback. We try to figure out disease by disease, what is the ROI planned design change. And I know that sometimes when we raise the copay, would get immediate feedback, so we cut back -- we raced the copay on MRIs, and got the next year of reduced use of them on something like chronic disease medication or the goal is to avoid a future emergency room visit or hospitalization. I think it is longer term payback. So we get MX of paybacks. But unlike the government that has a balanced budget requirement at the end of the calendar year, we are able to look at beyond the calendar year and it gives us the opportunity to make public plans.

I want to ask you a question on the whole different level. With the talking about the health care system and a lot of the thoughts about genomics had been about prevention but that is really about delivering care and and and the Jule level. We haven't really talked about the fact that 16 or 17 percent of people don't have insurance and their major equity issues. And the way we have been delivering to manage population is more on an across-the-board basis in changes in policy and more traditional public health measures. That this should ever be an either / or type of thing, but we initially only deliver our primary health dollars and a change like that -- population health approaches. As we move in this direction, I wonder if you could all reflect -- because I no you managed populations -- about how this committee could really think about how we optimize the social benefit of all of this, and since it is not exactly the same game are coming out of the same pocket, but there is still likely to see increased money devoted to health care as opposed to some of the population Health Services and the underlying determinant.

One of the things that is being debated in health care today is, particularly to cover the 46 million uninsured, is a basic benefit package. And many of us who develop products believe that preventive services should be the first dollar coverage. Some of you, I think one of you in your question said and what about directed health plans? Those are our fastest-growing health plans. Those are plans were you can have your own savings account. But beyond having a savings account, then you have shared accountability corresponding and after a certain amount it becomes more of an insurance model. But what is critical about those accounts is the benefit designed encourages preventive services.

So the first dollar preventive services don't come out of your seat savings account, they are paid for by the health plan. And it is a good policy. In fact, we have seen, when we look at our products, we saw an increase in preventative services that went beyond that 3 percent. So that is more health preventative services. So I think that is what we have to do. We have two, when you look at their ranch work from several years ago and the more recent work in children, we should make sure that preventative services are delivered at 100% of the time. It is not acceptable when you have at 40 or 50%. Such a big part of the paper for value in any part of the reimbursement.

To take it to the next level, is, what then are the next level in preventative services? And Mara, if you drew a nice curve. And it's still suggested didn't happen that way. He would seek an early rise in expenditures and that have an interval, but that but say, you are at increased risk for these illnesses. So for you, exercise or counseling or a different lifestyle could hopefully prevent that increase peaked later. Or maybe even for you if it is eighth lipid lowering therapy or stat networks, it would have research showing it is a generic staton and those therapies would be it later in life. So I think the sum would be less and be an increased some at the beginning but the payback would be an increased lifestyle. But the one thing we didn't determine is, but talk about the genetic determinants of Health, but of course there are all the other determinants. And those are the ones that we can sell most profoundly effect early on in life.

What is helpful to me at Caterpillar is the U.S. preventative task force when we talk about preventative services being an external body and hopefully not biased, which comes out with a great outcome of our great B recommendation. And that is not [indiscernible] [indiscernible] looked at our external data and making tough choices. But it is still controversy. And CT colonography still controversial with all of these findings. And again, I trust into the judgments of the U.S. preventative Service Task Force and that is what sold it at Caterpillar to the executive office is hearing about the U.S. preventative Service Task Force over and over again, and then they bought into, cover at 100% of the grade -- if we had something like that in genomics, that would be helpful.

I would agree with the comments about 100% coverage. I would just say that we go a step further and actually deliver the care and the services on site, or at a place that is very convenient. So I think in addition, two coverage and plan design, the on site or at your site delivery, and we actually go a step further with prenatal, because we cannot only deliver to prenatal counseling on-site and cover it, we actually give people a gift afterwards. Because the savings and the payback for reducing the population of low birthweight babies is so good that we are willing to pay people -- now we don't give them a lot of money, we give them a portable baby carrier, but it works. We get a very high percentage of people in the program, and over the years, we have significantly cut down the population of premature low birthweight babies. So I would go even a step further and if you want to say, first of our system, on-site plus subsidy for certain types of services that have exceptional medical benefit.

[captioners transitioning]

That high bar has allowed for general acceptance. How do we get that kind of information that would justify that sort of thing as well.

I'm glad you said that. It circles back to the conversation about publications an quality methodology because if you dig deep into the staff criteria for an A. We're largely looking for RCTs. Things that are Bs or Cs they are observational. Deemed as being not so good and therefore people who are reimbursing is not so good. You are setting up a system that's what's a better than what's another study. I think this exit tee can work on that question. I don't know if it's in your per view, it certainly is controversial. The criteria could be different depending upon the disease you are working with. If there's a genetic disease that's a life killer, something terrible maybe you'd expect different evidence if it was something else. A loot of the criteria I have seen in these standards apply to everything whether we're talking about a save saving therapy and take the risk versus cosmetic surgery or something different. There may be a way to flex the criteria according to the condition you are talking about.

This is Joanne, I would add that A hip and [ Indiscernible ] Matrix. If you can imagine on the X axis of the matrix is the medical benefit that accrues. Substantial medical Ben it. Imagine along the Y axis is blotting the level of certainty you have about the effectiveness of the published literature. You can then map to that the types of studies, the traditional SUPTF the A level far upper right hand range. Moted rat certainty of effectiveness but substantial net medical benefit. Those types of studies might be the ones that would go to coverage with evidence collection. No potential significant benefit, but so so, certainty of the science. It's that type of grid or matrix that would allow you to map the evidence that exists now. The evidence that is being accumulated to an ultimate level of certainty. So I think that that is a way to be. The challenge is to get all the various entities that use these evidence-based grids an may trycease you'll get this variable -- different requirements of evidence. But I do think that is the way to go.

It seems to me with can look at Legacy issues. Back surgery, there's a lot of science that's unproofen except those treatments are in sort of the frame work of certain medical professions. The question we can ask ourselves we've emerging with a new set of diagnostic an clinical tests, don't way want to build a different frame work here? That frame work we can say as a posed to everything we've done in the past where we have to reverse Legacy issues where we tried to say, there's no better science than genetic. I think that would be one way of going forward. When we have new dollars being devoted to comparative effectiveness or effecttiness or outcomes that can be a recommendation. Now where the funding for it comes, early phase companies as opposed to large farm -- it's a much more problematic area. Let's not find ourselves in the same set of issues that much of medicine is today, that 40% of what we do is not shown to have proven benefit.

I appreciate Joanne's matrix but we're making an of rare assumption is that the best evidence is RTC evidence. I'm saying that there is evidence that's emerging in the real world that really tells us what works an has the substantial medical benefit. If we continue to say we understand what is the best type of evidence and we're going to through it against that matrix, we'll lose a tremendous value object what works.

When it is based on a several of certainty not RTC evidence. You can get there in a lot of ways. It tries to move beyond a clear hierarchy sign of approach?

Don't we need some guidelines to do that because when -- it is still the current standard now for therapeutics and interventions for diagnostics even if it doesn't felt. We need a process in which it's acceptable to do. At the early stage of academe yeah, you can't count on your point and --

Sorry. I'm taking this a little bit out of sequence so I wanted to go back to it bone marrow transplant treatment for women with breast cancer. I think there were many, many things that happened because I published a number of stories on it. I think it was absolutely true of advocacy run a muck. That's one part of it. There was always one group against it because there wasn't enough information. There were also oncologists that were true believers and many, many people that were doing it. I practically witnessed apheses fight. People were looking for reasons to do it. That was the last study that showed that it had a benefit. But it's willing also really important example of doing -- also the media. We've all gone through this with trials. The media demonized the insurance companies for not paying for it. Caterpillar would cover it through clinical trials?

Yes.

It was a very courageous thing to do. That was the problem everybody outside of the clinical trial, it is patients -- they absolutely do seek information and they seek information some of which is better and some of which is not. I just wanted to say that it was not just the payishments were dying to get it and were going out and going around the system that it was the whole system that fell down on this and one of my aunts actually died of a bone marrow transplant at the very beginning of that time which she did not need to have. It was a system-wide failure, not just people pushing, not just individuals pushing or the individuals pushing Caterpillar an other people were courageous in coring it in the context of a clinical trial.

It's nice to see a nuance discussion of what types of evidence are going to be used an the thresholds for evidence, because I think we're all very cog any sent of RTCs are not going to be able to answer everything. We have to be careful of course in our enthusiasm for things genetic to not rush to the othernd of the spectrum which sounds so good this must be true. The second thing I wanted to underscore is something that's on at least two of Joanne's slides which are very important, I think, where at the bottom of two of the slides, she says same coverage policy principles as for all other technologies. In our enthusiasm for genetics that we should forget the levels of evidence are levels of evidence. The game is not different because we're dealing with genetics. Simply because of the public enthusiasm for things genetic an our own enthusiasm, I don't see any difference between standards of evidence that need to be applied in genetics as for other things. It's important for our committee to remember that.

I've been thinking about that a lot. I think the things that's different about diagnostic tests, is if you do a therapy like radiation for prostate, ten year survival is you have to wait for ten years. People may -- you have that wait ten years. If row have a diagnostic test sometimes that's very tightly linked to the therapy, then repeating at ten year trials, it's kind of point less. When you know about the therapy, the logical link to the diagnostic test is tight enough, I think that's where people have to make the adjustment in the link. The other thing that happens with diagnostic tests in genetics they can be so fast. The 1970s they were invetting great think things in chemistries but nope said we have to debt this into patients right away. You knew you haled to do animal experiments for three years. I discovered this Jean and I can do it -- Gene and I can do it in six hours in a lab. We have to use judgment to make that barrier and --

That will be a novel thing in medicine.

[ Overlapping Speakers ] [ Indiscernible: Speaker/Audio faint and unclear]

Move on from there. Kevin?

Well I want to take off from there actually. I think that's a great example. I think again kicks back to something that maybe this committee can continue to attempt to addressand digest. It is, your example points out, what counts as evidence is going to depend on what the goals are. Who decides what your goals are and which goals you are pursuing. That then gets back to who gets to decide what goals are going to be -- something that we have wrestled with is public engagements, stakeholders engagements. People have different goals and obviously should. How does this committee go forward wresting l with this idea -- wrestling with this idea? The the sense that everybody pretty much is on board with evidence-based medicine. Perhaps evidence based medicine to work as a foundation that will come into health care reform. I guarantee you they will be there. Those interests will be the primary goal of other people. So how evidence-based medicine is to be balanced against that is going to be a huge political question will have to be addressed in health care reform. Those interests will not go away. Getting those standards really straight and clear because they will be tested in fire. No doubt about that.

Is there a question at the end?

How much work do you want to do? Joe and I have a list.

Let me take off on that comment to say and we've talked about study design integration of databases. What should this committee do to make a smoother future, in order to -- not fix the problems per se, but these are problems we're having in anticipation of new technologies coming forward, but we do have limited resources, limited time and need to prioritize how we go forward to help the secretary an HHS at HHS deal with the future of genetics health and society. We've gone through a major process to get a few priorities, but I'm going to open it up to the group. I'm going to say pick one area where we could come in with guidelines with regulations with -- I guess we can't do regularrations -- recommendations to the secretary that would impact helping genetics be -- I don't want to use it -- move smoothly into the future regardless of how you value them.

I'm just thinking out loud with you, but perhaps the committee could weigh in principles that you could gain concurrence around that could facility access to -- for the population of access to their own genetic information. I think you folks could outline what those principles are. I think some of them are in the discussion today.

I just meant from the greater good of figuring out how to get access to this technology as it's emerging. What would be the principles under which within -- think about that. Some of the issue I I heard today, one of them I think it was from James over there, one thing might be don't treat this any differently than we do a lot of other new technology in terms of -- another might be what is the evidence? What's the evident eye standard that's needed?

[ Indiscernible: Speaker/Audio faint and unclear]

You have to come back. I didn't realize you were going in order. I was thinking.

We have a pass at the first round and coming back. Sam, Joanne we haven't forgotten about you.

I think it would be good to start with principles. We articulated some. The evidentiary basis should be comparable. I would go beyond that. I have not looked at all of the publicly available information, but a big discussion today was coverage of these tests. Have we as an organization, new to the committee, looked at all the public an private payers where there are similarities and variances in tests. That might be useful to do but the other would be do we want to be as bold as to suggest -- I know this has been something that ark has taken on, but does AHRQ or other agencies take on really producing the evidence basis of the OIM of what kind of works in genetic testing? Therefore you have a roadmap of groups of people that have come together with a strong scientific knowledge. Others who represent public policy and advocacy and payers. Literally see if you can get commonality of principle. If not -- one thing that Steve Pearson and Joe hand as referenced to work and others, if we have something that and unproven but very promising, a genetic marker for breast cancer. It's dealing with a very big issue, do we take an area where there's controversy, it's so called unproven but has great potential, and then organize a national registry or observational study or data base going forward. I think to define that path forward as a strong recommendation, these critical areas could be emerged from the pins millions that are shaped -- principal areas that are shaped.

Would you suggest across the model of position that you all represent that everyone would basically have access to those tests that have been passed through the evidentiary process?

I'll speak to health plans for coverage. It strikes me that if the evidence is overwhelming and there's net clinical benefit, I can't envision even under the resource constraints that we are living under that no one would cover that therapy. When people are somewhat the public perception of health plan limiting care, give me an example of any health plan? The evidence is clear where the health plan has said no or the evidence is clear where CMS has just not covered. I know we've heard some examples, but I'll stick with the health plans for a minute. I think Paul, there would be commonality when the evidence is clear. It's when the evidence is ambiguous.

In my experience in going to health plans, what constitutes adequate evidence, there's a debate. I also have had the experience that tempt plans may -- different plans may not be united but other plans because of regional variation in culture and other things have been slower to adopt certain standards of the same prenatal testing than others. Let's just been my experience.

There's also the benefit issues that the purchaser from the health plan may say we want a plan that does not cover genetic tests. We don't want to pay for genetic tests. It's not an issue of whether it's good or bad, we just don't want to pay for it.

You're speaking for the several insured employers, but I would think in general health plan's responsibility is something that's compelling and it has net health value and that is listeninged over time. -- linked over time. I haven't seen many of those examples. That's because people feel there were other alternatives that were not tried. Nutritional counseling and other approaches. But you are right.

Michael?

Sorry.

I think we can learn this committee can learn just fromlooking at the pharmaceutical companies that has happened with drug costs. The high return on investment. For Caterpillar's return investment is on drug costs. It's the direct to consumer advertising. The free samples. I read about the direct to consumer advertising by genetic companies. That scares the hell out of me when your survey shows the doctors are uncomfortable with interpretation of this. We go the next step forward where the consumer is a wise choice. To me, the committee ought to take a stand against direct to consumer advertising by genetic companies until they have outcome data. Then everybody will support. That's my one.

Okay. Thank you. We're smiling because that one is on the agenda, not to say -- we haven't taken an opinion on it but the director consumer testing and advertising piece of that is definitely on the agenda.

I would second some of what Sam said. I think to review the evidence framework to support coverage policy is important to get some uniformity across the public sector as a private plans and to really explore two questions. One, are the right questions being asked to support coverage decisions. Bruce raised this question on whether we should be thinking about diagnostics differently and everything else. I don't think so but that needs an exploration. Are we ask the right questions if technology helps you dose a drug on the market. If it's possible, around what is ideal evidence versus sufficient evidence. I think that would be very productive both for the plans, for the manufacturers but it is important here that we get some agreement about this framework once it's developed. That is agreement between the private payers, government payers etc. I think those are productive areas to do some work in.

When you talk about evidence, you mean scientific and economic?

Scientific first.

Absolutely. Scientific first and then one can look at the economic value.

Exactly.

I would say scientific first and then out come so you are not just measuring efficacy. Just because you tell me something doesn't change my outcome. The whole package works with me with knowledge. So to me it's the committee's job to find out improved outcomes and no one is going to argue.

Bruce?

Sure. I think that we should -- the system should be more geared to actively promoting things and cost saving technologies. But there are some technologies that loo cost effective no matter how you define them. That's what I'm talking about. I think the system does not do that. We have our system. We don't need things that add more cost to add more quality. I was just at a conference who in addition to being a public policy speaker. Our health care system is upside down, look at what's in front of your face. His early works in the '70's was very illuminating. We know that there are groups in society, people who do studies Mormons 7th day adventtist. Half the costs. So it's in front of our face, we need to encourage it to be done.

Mark and then any last comments or questions.

That was -- I had another question but what Bruce just said really triggered something for me -- this was something that Jim and I were wispiering about -- wispiering about earlier. Do we need to step up to the plate given what you just said. You know what secretary? Don't invest anything in genetics and genomics. We have to fix what we already have. We're going to add DOSes. We don't have anything to demonstrate that we're going to save you time an money especially if health care is going to go belly up. Get back to basics. What you just said, because I recognize that if I were to pick up my steaks and go to Ethiopia, there would be no need for my services as a yes notice. There would be a lot of need for my services as a general pediatrician. We're operating on the luxury. Do where we need to be that basic to examine what we're really about?

I'm being misquoted. Maybe we should encourage things even if it's genetics, I think they are amples that are. A thousand dollar test that gives you more -- that's what I mean. If we pay $18 for that, it will never exist.

That's what I.

I degree with what Mark said.

Going to Ethiopia or --

[ Overlapping Speakers ]

I agree that we have to be very careful to not oversell genetics. Looking at the utter lack of value of genetics when you add it to standards say risk factors for breast cancer, diabetes. I think the answer to all of that is exactly what Bruce just said, which is you have to use the same criteria for genetics as for other things and if there are aspects of genetics that can improve care and reduce costs, then that's fantastic, but we should not -- be very careful not to oversell genetics, not only because it is the wrong thing to do but it's a backlash.

Daniel?

Standard from the Department of Defense which is another health care organization and said this morning with 9 million beneficiaries has it and similarities to yours. One of the key areas we look at in terms of picking the right prevention strategies because USPTF can look at a few diseases over a certain period of time. It takes a long time. Many, many studies, many, many people. In our EHR when which have prostate screening for for example, with PSAs the witness on it is that there may not be a lot of evidence behind the PSA. If you go back into the language and have an African American with a strong family history, there may be indications of those who are at higher or lower risk. That's not bubbling to the top of that recommendation of the USPTF which brings me back to what all three of you were illuding to to get that evidence. I don't think we're going to get it with RTCs. If you stratify the people out, we need the clinical data with these modest genetic variances. So is there a way forward we can take our clinical database and DoD with our EHRs with well months, for example, and we can match our cohort that have had certain clinical characteristics with certain snips or gee know types and is there a way that the federal government is allow us to match those data points? It's very difficult with HIPAA and what we've heard about for us to match the clinical gee know types and with other research other organizations is almost impossible to do.

Michael?

I think the committee needs to supply the secretary with the information what exactly can genetics be used for? What is the value? When you talk about genetics, just talking about -- most of the discussion we talked about today and most of the time when we talk about genetics we talk about nucleic acid testing. It depends on how you define genetics. It's like the thing in -- the article in the last --

Yeah. [ Overlapping Speakers ]

I think there's going be things that nucleic acid test reason going to provide great value in medicine. Okay? But is it going to save money in the long run that's really unclear. On a case-by-case basis really. If you define genetics as we put it in the task force report as any kind of test that you can run on the genetics. I would expand that too, genetic testing is understanding the environment's influence on the genome. That could be a great value to medicine. In fact, that's what I talk about when I gave my talk last time. Really trying to understand what is it that the environment does to the genome that creates chronic disease? Sam said, he started out his talk, hit the nail on the head, a society of aging people with chronic diseases. That's the biggest cost to our health care system right now is in chronic diseases. So the question really is back to what I first said, what is it -- what in nucleic acid testing if we limit our discussion to DNA and RNA, what's the value proposition? If there is no value proposition, I think expanding the discussion to other ways of looking at genetics is an appropriate way to do it. That's what I would be looking for if I was secretary of health and human services.

I have two points in terms of what the department has been looking at an some of the information that has been getting up to the top. It's a good thing for this committee. Under secretary lev its initiative. Identified four prongs that we were going to try to address. We had a thousand days to make some progress on that. One of those prongs was to figure out exactly what Stan had mentioned earlier, how do we take these exists databases with all this information, [ Indiscernible: Speaker/Audio faint and unclear] genomic information and do what we essentially described to the secretary as a Google search but one for investigators. Privity based protection. We did in the FY'08 budget look at how we would accomplish something like that. I think that was a really important point and when the folks who are working on these things at the department are already starting to think about how can we make this information that we already have something that's more useful to move us forward beyond some of the traditional old standard of randomized control trials. Also to your point doing work on environments and genomics for the environment. I can't remember the acronym for that work that's going on. Maybe we can get information on that for the next meeting and that can further our recommendations and how we can narrow our recommendations down for something that the secretary could use.

Mara two points. I'm hinding behind you. Family history. Frankly we know frightenly little as a screening tool for preventive services as you look at the literature base. This will be borne out of the state of this science conference. Low cost potentially high impact of services tool. Doesn't have anything you can sell to anybody at this particular point in time. We have sort of a lab to study evidentiary requirements looking at E gap. They have had folks directly involved in that obviously with USPSTS. Recommendation from this committee could go back to that body to begin to play around with sort of looking at setting different thresholds and what the effects would be -- as a parallel tract. It would be very hard to get them to pay solid attention to the literature base. We know for a fact they wouldn't take up family history as an entity basically for that run. That has more literature around it than many of these other newer tests.

Okay. You can decide if this is going be inbounds or out of bounds topic. There are two principles for these general questions. One is that you charge us to think about the future and the second is I'm trying to one up Kevin in terms of the difficulty of the questions here. Michael said something. If I had one wish list for health care reform, that we address state mandates. Well the idea is that we're going to inevitably be embedded in health care reform in the next couple of years an it seems that we have to have some mechanism as a body to be able to respond to that changing environment. So the question I would pose more to you as moderator are clearly thinking about how this is going to impact their various sectors, would it be reasonable to hear hair thoughts about where they think it is going to go and how that might impact the work that we do?

I think very much in balance and having interest and in preparing for this we talked a little bit about that. I think that's useful to the extent that folks are comfortable in talking about where you expect it to go and where you would like to it go. The near term future will probably be the biggest single determinant of where we are ten years from now if health care comes out the way people continue to talk about it. Can I pose that to the group? The question being where do you either expect or like health care reform to go? In the context of this the secretary will come to us where do you think it should or will go? Visa I have genetics so we don't open the entire gamut of health care right now.

I think there are a few themes that I will summarize that I mentioned earlier. Number one is, I think we have to be for science and for scientific achievement. One of the areas we can continue to lead the world. I think there is both good health that can emerge and good scientific research and still be a beacon for the world in science. That's number one. I think number two though, we have a health care system that is far too expensive and it's far too expensive for a number of reasons. One of those key reasons is we use technology before it's proen. If you look at us -- proven. If you look at our health care, it is not in the top ten. It's in the bottom grouping whatever grouping that we look at anywhere. So we need to use services that have an impact and that speaks for genetics and genomics and everything else that we're going to do that's really buy logically based. Taking it to the next level, I think there needs to be science -- there needs to be science where drives consensus points Orrin coverage. I think the best place to start because it will be about dollars, when you look at some of the companion diagnostics for these 100,000-dollar or so biological therapies for cancer. That's a wonderful place to start whether they'll be proof points. I think when we start looking at knowing our genome to predict public health over time, we can all theorize, we can have hypos these that can be tested but those are not going to be proven for decades. It strikes me, let's go where the best opportunity is to prove science. Number two where the best opportunity is to provide economic review and I believe that as we do that we will learn a lot. We will learn for how to use databases differently. How to use registries and that will begin to take us to the more rational decisions to how we can improve health and obtain affordability.

I want to second the -- I think the biggest bang for the buck for the secretary is companion diagnostics for the most expensive drugs. If someone could have the incentive to invest in a test [ Indiscernible ] You show that which one of these five $30,000 biologicals could treat that test it's worth a huge impact on the outcome and a lot of money. But people have to be innocented to recognize the scenario and be rewarded for investing $20 million to do that.

I would like to add to what Bruce just said. Not only to help to the person who's going to respond it avoids the complications to the person that would not respond.

It also buys people time for sick patients, particularly cancer, I voiding something that doesn't work, it gets them something that would work quicker.

[ Indiscernible: Speaker/Audio faint and unclear] [ Overlapping Speakers ] Even with the poster children of [ Indiscernible: Speaker/Audio faint and unclear] have yet to prove their worth. So it's a tough problem.

Let me try to -- other comments or questions? Let me try to summarize what I heard in terms of priorities and some of the proses executives. What I heard was clearly three key issues both throughout the discussion now and earlier. One is the role of director consumer information, whether that be advertising or testing or otherwise. That's something that we as a committee we have taken on. But the two pieces to be clear about, and I think the first starred one, would be evidence based. There was broad agreement in the need for evidence-based medicine. Very easy to say focus on the science. What I heard to articulate it but the need to put together a clear roadmap on how to achieve that for different aspects and different products and services in there. This committee is not going to say what that evidence is, but call for the need for a clear roadmap whether it be diagnostics or procedures or drugs, and that that is there with transparency. I think that's what I've heard everyone saying. If that roadmap is there people developing products and services can use it in various entities can refer to it, have you checked off the check marks on the roadmap. Do I see nods mostly?

Number three is the low hanging fruit issue. This one is a little less clear for me on how this exit tee can work -- committee can work on it. How can we encourage the use of systems products or systems that currently exist to improve the health of Americans or very importantly, which will improve the health is lower the cost of health care. I am less sure how we can in a committee can encourage the use of that but I see there's a need for you all saying to do.

Mark?

There's a fourth that I heard. That relates to the database data sharing issue. I think the specific things that we can do in addition to what we talked about yesterday which was to work with the other secretary's advisory committees including the new one on health information technology to just again, get behind the effort as a sort of generic strategy, but the specific strategy is that if you really look at issues relating to collection of genetic and genomic data, we have severe deficiencies in terms of our ability to collect that data in a codable and computable fashion at the present time. That is an area where I think this committee could definitely weigh in and say if we are really going to realize some of these benefits, then we have to put this data into databases such that it's computable. We can run decision support and rules and things against itment we don't have the ability to do that today.

The committees roll to be -- role to be specific about it to outline a process and keep people part of that to make it a priority for HHS this point going forward. For the generic basically add onto the group that's saying we need to have the ability to share data of any type across all --

That was another theme that I think actually came out at the last two meetings, which has really moved the genetic exception allelism. The really new normal. Needs to be included but not necessarily separate from other information.

It is now exceptional because it can't be coded and computed.

Get it to the new normal. We've got four -- do I have general nods at least those are the right four? Any disagreements? Shout. Throw things. Did I forget things? And then the principles in the evidence-based. Why don't we separate that as Rob said as a separate piece to it's one of the principles that under pin the evidence piece.

The access to which evidence is a key component.

Okay.

Time to go.

[ LAUGHTER ]

Could someone explain the difference that E gap does with that group versus the evidence-base, how would this be different than what this group is doing? [ Inaudible ]

I'm sorry to even take the time of the committee, but we're looking at at CMS is they're converging E gap methods and the ones that Steve will tell us are actually forming the basis where we see the evidence that we're going to use for coverage determinations in the future for screening and diagnostic uses. Your question is are they converging? Yes. We think they will. We don't think they are perfect yet but we look forward to them doing that.

How to get there but I wouldn't imagine we would get specific enough for the number of patients in a trial. They have the literal standards.

I sit on these groups frequently and they are all trying to do slightly different things, which is the challenge. Part of it is to get to some reasonable hear monoization. E gap is specifically looked at how do you review evidence for the use of genomic tests, everything from prevention on through prediction and prognosis and farm cogenomics with the idea of making clinical evidence of net benefits. That's one -- it was also designed to provide information for innovators to source tell them, what's the road map? What are the benchmarks you have to hit along the way to be successful. It's done -- critical to those processes. But different groups are using slightly different things. I think we need to talk about how these things converge to different uses and so forth. E gap is sort of your slightly purest preventive task force idealistic verge we'd like to see but may be too high for others. I say that having been party to that.

We're in the real world because this genetics health in society. Just academic in doing that. So with that, I think we've isolated five key areas that will help inform the future tests more broadly as we move forward and with the new secretary coming in we'll get some additional clarity from Steve as to our priorities going forward. Thank you. It was really a terrific day. Wonderful panel and very much enjoyed your presentation.

Thank you.

[ APPLAUSE ] [ APPLAUSE ] Thank you Joanne.

.

Great. First. Thank you. This was a fascinating rich discussion. I really appreciate everybody's careful consideration of these nutty issues. I think you have to change it on there. While they get that up -- thanks to everybody for a terrific discussion. I want to recap of a little bit of what we've den. That slide hope -- done. Hopefully that slide will do that soon because they've taken my notes. Now you're going to check my memory. Tell you what, I'm going to go up here and talk. [ Unable to hear speaker, too far away from the phone. ] Related to the recovery act. We certainly heard an indepth presentation from CMS which was particularly helpful. I think that some of the topics that we heard about, I sense people will want to revisit at subwent meetings and particularly the issues of the implementation of Gina. We then heard about the consumer initiated genomic services. Develop a task force to look at all the recommendations. Put together a summary of those so we can take that forward. To look at some of the issues that were raised in the course of our discussion so we can see which of those we want to move forward on. Some of those are here. We talked about how does personal utility fit in with public utility. As it relates to these tests. Some of the translational issues to get them into care. How we're going to take care of the funding of the information that ties into what we say about consistently. Getting information about what really works. We talked act equity issues for the use of these technologies and how to monitor and evaluate some of them. Sort through some of those issues on how we move forward so at the next meeting we'll have the recommendation from the past and some thoughts about what we need to do further. I think we had an exciting discussion about informed con isn't privacy and discrimination and how that relates to new paradigms research. What we talked about is reviewing with the agencies what their currently doing and their plans, coordinator as we discussed with the other advisory committees if there's a need for collaboration among us or who's carrying what part of this forward and maybe indeed one of the add virile committees just been formed. One of the key issues we have to grapple with and we touched on it is the relationship between the clinical da a and how we get that data into research interventional studies so that [ Indiscernible: Speaker/Audio faint and unclear] talking about how does this -- are there some things that we should be doing too to inform that discussion? We heard from Barbara on education and training. They will be completing these surveys. It was delightful we had data already. Get another update at the next meeting. Then aim to get a draft report out later in the summer so we can get it out for public comment after our October meeting. With the goal of a final report in mid 2010. Now I get to see what we said about this one.

Realtime.

We're in realtime. We did have a pretty broad range of discussion concerning the future of the health care system, talked again a lot about the DTC information, but I think what we came into is what are the principles that need to be in place which includes getting a clear sense of how we're going to go from where we are now to a real evidence-based road map, what are the effect eye standards and what going to be done. Whether we can identify some specific area which are prime for doing that. We heard that there may be some specific things that this committee should try and foster where we can begin to look at where these technologies can lower the cost of health care and what incentives or disincentives to the developing and implementing them. Then again -- finally last thing on here is outlining the process of make -- how do we use this information to petter understand the real world effectiveness so we know what the real value of all these things are. We've had a pretty rich discussion. Then we come to the meeting in June where there--I think these are the topics that I've seen that we will touch on and be interested in your thoughts on these since we haven't discussed them systematically. The implementation of Gina. It has plenty of implications. We're interested in the implementation of it. We want to continue the discussion on the health care system. Provider perspective as well as from the industry as well. The patents report is all out for comment. I think there's copies that were placed on our desk this afternoon for those who haven't had a chance to see the version that went out. We will be having the public comments back in May. We won't have them fully digested but probably get a preview, Jim, so --

[ Inaudible ]

[ LAUGHTER ]

We have confident that there's a high -- confidence that's a high survival rate.

It's available online now. It's available for people to see so they can see the public comments right now.

It's out on the list serve so it's out there and comments are due by May 15th. So we'll have a brief period of time so kind of get a continue on who's responding, the kinds of comments, probably won't have the kind of detailed analysis that Jim -- 400 pages that Jim is going to go over to sort through.

Now I know Jim wanted that other picture circulated of himself.

That's the prepicture.

Then consideration of what we talked about earlier the report from the consumer initiated genomic tests as well as how we should proceed.

Be able to add somebody from industry. Maybe there's someone from -- I'm not quite sure who, can give us an update as to health care reform at the time from HHS.

Hopefully we'll have a secretary in place and we'll begin to have the kind of discussion at the next meeting that we'd really hope for here. There was a little -- premature so we'll want to revisit that and see how it goes as we go along. We have the progress report, which is here, which hopefully we'll find a receptive ad why yens and -- audience and be interested this hering their work. Let me ask a specific question. Any comments on the agenda for things that people feel should be on the agenda? We'll see about squeezing everything in? Anything other final thoughts before -- let me take this opportunity to thank the staff who always do an incredible job of makes it --

[ APPLAUSE ] -- making it a reality. All her folks that make this all possible as those of us who work with them know. Thanks to all of you who are active participants in this process. I think it's been a productive meeting. Thanks even and safe travel.

[ APPLAUSE ]

[ Event Concluded ]