Event ID: 692848
Event Started: 3/26/2007 7:46:26 AM ET
Please stand by for real-time relay captioning.and

Please stand by for real-time relay captioning.

Good morning.

My God, good morning!

Y'all better fire on up here. We have two very intense days. Let me thank everybody for being here, all the members who are in the audience, we appreciate your involvement. Everyone looking in, following on the web, it's always good to get these emergency e-mails on the Blackberry, somebody who says wait a minute, what about this? We know people are extremely attentive. This is the 12th meeting of SACGHS. I want to welcome all of you again, and for everyone's interest in the work. Members of the public who would like to testify, we urge you to sign up at the registration desk. Our committee is a little larger today, thanks to secretary's appointment of a new member, Dr. Mark Williams. You know yourself, but the rest of us may not, you are a certified board clinical jee geneticist.


All those included, editor ship, chief of medical genetic services, makes you extremely important to this committee. Thank you.

I always want to welcome back two key staff, Sheila Walcoff, J.D., and our friend Dr. Greg Downing, program director of the secretary's healthcare initiative. Sheila met with us in November to talk about the commitment to improving the safety, quality and effectiveness of healthcare by leveraging advances in genomics. She told us accelerating healthcare is a top goal and there's an urgency. As of Friday of I saw the urgency in action. I represented in two extraordinary events, you will hear more from Sheila in a moment, but clearly this is a secretary who is inspired, gets it, understands it's a historical moment in being able to merge the benefits of science and health information technology to ensure better health for each individual. He gets it as far as this committee. In any history I have participated in this committee, I have never seen the extraordinary added attraction, in terms of how this secretary treats this committee. He's listening to us. The good news is you are respected. The bad news is you will have to work a lot harder. We appreciate that. You will hear a lot more. I will say a quick word about Sheila, where is she, and Greg Downing, where is he? Imnd Behind the scenes doing so much work. We have long warranted the person to -- publicly I want to say we are extremely pleased by what we are seeing and really makes the work we are putting in seem so much more real and relevant.

Following the conference, if I ever get done, we will hear from Robert Kolodner, I am really interested in hearing the national office of coordinator for health technology, and -- policy special research, about the role of technology, how this will move this agenda forward. I will tell you Robert is also just terrific and I have had a lot of time to work with him in the days past. Welcome to all of you thank you very much for coming with us.

We have a very broad charter and mandate. Within that our agenda is guided by a strategic plan. I want to put that up, everyone in the committee, and Mark, you am you will catch o I will go through laborious effort to review this strategy. It's important at the end of the day we are able to say that we have kept our commitments, that we are moving our committees and our work forward in a logical way designed to produce results. It's too much work to bring you in and have lovely conversations that go up in the eghter somewhere. Where we are, we have identified 12 issues we thought identified the attention or in-depth analysis.

Cross-cutting issues that effect all of them, always addressed in our work. Priorities on the left-hand side are checked because we have produced reports, recommendations on the issues. Priorities on the right are ones we are currently focusing our an litical efforts. As I rip through quickly, I want you to keep in mind for preparing you for tomorrow afternoon. We are going to relook at the priorities, status. I want the committee to feel comfortable that you, there's not a scent of omission on the agenda. If you feel something else is emerging we should be a tending to, something here is less important than something else, we should revisit to make sure we are Marx mally relevant to the events of our time. Keep this close in mind.

genetic discrimination, we have written a number of letters championing, and we provided a legal analysis of the add qasy of current law, compendium the size of a phone book, and a DVD documenting the concerns, public testimony from the committee. Kept close watch on congressional development and in a small way we have, within the limits of our appropriateness tried to bring folks together for a common way to resolve differences of opinion. We are thrilled to see the development in the current Congress, looking forward to an update from staff on what's going on with the new gi NA as it's called, bill. GINA. In 2004 we made recommendations to the second about the importance of genetic training and professionals, how it should be enhanced. Government has a role to play, we ask the questions, where does genetics, training, education ask training stand today, we in better shape than three years ago. We will discuss the strategic planning being developed and revisit recommendation necessary lited light of this issue.

There are developments, early disease detection, intery intervention, has an acronym, JEDI. Can head to detections to improve outcomes. CDC, NIH, collaboration, test translation project working to enhance genetic testing between providers patients and the testing laboratories. The American nursing association, to its credit, the international society of nurse s in genetics. The well-respected -- national coalition for -- in genetics continued to advance it's hard work, reaching special language pathologist, audiologists, dieticians, developing a database, providing genetics information to non-genetics -- and creating a program on pharmacogenomics, that is important.

We will see whether you are comfortable with these thing and want to move further forward on revisiting this important topic.

In 2006 we transmitted a report on coverage and reimbursement for genetic test and services, highlighted the problems in the system that we thought effected patient access and nine steps to overcome the barriers, a range of -- eferdz based covered decision making, codes for genetic tests and services

Sipedy and I had the tune the to brief Mark Mcclel an on the issue. It's was a positive meeting, expressed a strong interest in the recommendations. We will turn to Jim Rollins now, my script says he is -- Jim Rollins isn't here yet. You are going to hear later from Jim Rollins on an update on where things stand in cms concerning activity on these recommendations. Let me again say mark Mcclel an was great and his leafing out does not mean this dropped. There are activities moving forward,CMS, we will come back and hear from Jim. Whenever that happens, the thing to key esm sighs in my comments, we have been attentive that sipdzy and I did not just have a nice meeting, the key thing, we are moving forward.

We wrote letters to the consumer marketing -- genetic tests, collaboration between FDA, CDC, federal trade commission, issued a consumer alert about using at-home genetic tests not evaluated and be wary of claims made by companies marketing. It's an interagency collaboration, tremendous accomplishment in that respect. We commend HHS for its leadership in moving forward. What's the benefit? How many people did it reach? Our o fishio, for providing us data on how widely it's been disseminated 6461 so far on the website -- copies of the brochure, total distribution is around 18,000 for web and brochure. Wide covered in the media, New York Times, FDA news, medical device week. Out there, moving forward, if anyone can think of other ways to disseminate let me know.

We completed report on power issues without undertaking another large study, transmilted to the second earlier this month, copies of the printed verges are now publicly available, you have a copy in your folder and available at registration desk for the public or you can download the pdf version from the website. I happenedded a copy to the secretary in a one-on-one meeting on Friday. I know high he has it and we will quiz him on it later. Our thanks it Hunt Willard and the task force for guiding through a long difficult process. We are thankful to the experts who broaden our vision and greatly enhanced by the public comments last summer.

Bringing the report to fruition, particularly -- and in the early stages Amanda Cere at on. Pharmacogenetics -- announcement of personized healthcare initiative at the national press club. I want to thank, and appreciate our task force led by cefn fits Gerald, as well as the office of the assistant secretary for planning and evaluation, the lieu in group, and the group for getting the draft ready to release in time. It was a race to the finish, you couldn't miss the secretary announcing, having it at the press freeness conference on Friday was terrific.

We are making progress on the study of gene patents and licensing, you will recall at November meeting we developed a -- licensing practices. Our friend Jim Evans will provide foundational knowledge and how we are moving forward, the basis of the patent system, and how licensing works, and in-depth developments. We will be updated by Jim and Dr. Robert Cook-Deegan from Duke. This slide illustrates the structure of our study, components being carried out by the Duke group will revisit this later in the meeting. Jim will hold announcement, task force meeting tonight -- no basketball games. With Bob and collaborators. Committee members who wish to attend, really looking for a fun thing to do, should let Jim and Sarah know. We will be making provisions for overflow seating.

Extensive discussion about the oversight of genetic tests at our last meeting. CMS will not be moving forward with the rulemaking under cly a, after much discussion it's fair to say the committee was left with many questions about the adequaciy of the federal oversight framework for genetic tests. We decided to engage in further fact-finding at this meeting. HHS created a work group to determine where problems, and gaps lie within the federal government oversight, keeping SACGHS informed. Specific charge from the secretary's office to us. I will say this, once again, I don't want to embarrass Sheila or Greg, but I have to say it was very encouraging to me there's no question that each of you and I personally, at the end of the last meeting were confused, concerned. The responsiveness by HHS and the secretary's office to that anxiety was palpable. They are on top of their game and I am personally convinced that this issue is a high priority. I have had several meetings with them, and I will tell you that I understand that they are taking this seriously. So I just want to say to you that while there were a lot of anxieties in the commit committee at the last meeting, they are responsive and will hear more about that.

We are taking on two new topics, the economic consequences of genomics, and our good friend -- were you here? These guys have to come earlier! The -- on the evaluation of real world outcomes. We look forward to your terrific ideas. There won't be any time for it, but we are happy to have you. Before we adjourn we want to discuss developing a new long-range plan. We may have to outline new stuff, but as we do this it's useful to keep in mind that as long as as it took me to rush through, be out of breath to read all of that, it's important that we have done enough to have to read all of that and rush through. It would take that much time. You have been a busy committee and I hope when you check off your form around effectiveness and annual survey in the package you will be able to grade yourselves pretty highly by saying you guys don't fool around.

Before we go on with the meeting, and I will slow down for this, and acknowledge Joseph Hack et, who died last monthDr.Hack et participated in a income of our meetings on behalf of Steve good man and the FDA, dedicated 30 years of his life of carrying out the important mission of the FDA, an expert in methods standards, many achievements during his long ca require, one of the first to understand how important genomic testing would become, thought the first interactions with industry. The gathers were affection atly called the Hack et staff college, his appreciation to new ideas, dedication to mentoring. He was a valued colleague and friend, I know, and his passing has been a profound loss for you and your colleagues. On behalf of the committee, please accept our condolences. Terrific, thank you.

Since our last meeting there have been staff changes, terra Hurd joined in January, terra? Administrative tasks. A med a mor at a took another job, we thank her, search is under way for subject matter experts. Whoever is responsible for the Readsteer bunny joke -- we'll be speaking to you at performance appraisal review time. Finally, housekeeping matters related to lunch, to save time, order from the hotel menu, fill out the order in front of you before 9:30 or else, because of the special task force committee meeting tonight, the full commitly will not meet. We will have a dinner buffet during the meeting. Sar a time for the official ethic scare you to death comment.

Conflicts of interest: Before every meeting you provide us with information about your personal, professional, financial interests. Information we use to determine whether you have real, potential or a parnlt conflicts of interest, affecting your ability to be -- we believe your ability to be objective will not be aiveghtded we require you to be attentive to the issue arising that affects or appears to affect your interest in a specific way. We have provided you with a list of financial relationships that would become a conflict if they became a focal point. If this happens we ask you to recuse yourself and leave the room. Lobbying, you are government employees and are prohibited from lobbying -- special government employees -- we may not lobby as individuals or committee. If you lobby in professional capacity or as private citizen it's important you keep that activity separate from our activities. Keep in mind as well, as Reed has, SACGHS is advisory to the secretary, do not advise the Congress, and I thank you as I have always for being so attentive, as I know you are, to these rules.

Tuck son: Go home, tell your family you are special. If you note by your clock, it's actually 829. I have gotten through that a minute early. This is the standard we want to keep for the rest of the meeting. With that, I turn to -- I told Sheila she could have as as much time as she wants. Counselor for secretary of public health, extremely important person.

Sheila Walcoff, J.D.: I am wondering if today is National Compliment Day. I appreciate the opportunity to return to the SACGHS to update the committee on the department's work on accelerating personalized healthcare. I noticed the bunny, I admire Reid's energy so much, it makes me feel like wlofer is not here is probably going to suffer the consequences of the bunny sometime later on today. I have a few slides I think I would like to outline, to reiterate what reed said. On Friday the secretary outlined the personalized medicine coalition, the healthcare initiative. I would like to provide a brief overview of his remarks, discuss steps under way to develop the important information, as well as steps to build foundation for personalized healthcare and make sure gene based technology are used appropriately.

About a year ago secretary Leavitt defined 10 priorities on which he in10eded to spent personal leadership. Personalized healthcare is, we always put it at the top, but delve definitely on the top 10.

The secretary understands the advances present opportunities for enabling healthcare practices to take into account differences -- the desired outcome, safety, and -- noted a number of times, increased value and transparency for patients.

Up here you will see the secretary's visions, the secretary's words, personalized healthcare describes the approaches across the healthcare enterprise, high value on consumer focused health by using modern technologies to improve safety and health. We have a healthcare sector in the United States, not a healthcare system. You will hear Dr. Kolodner later, focused on as well. Incorporated new methods of analysis to better manage disease or predisposition toward disease, facilitate the testing of new products, getting the right treatmentment or approach to the right patient at the right time every time.

Some of our long-term goals, and the secretary looks at this as a long-term vision, project of our generation we refer to it sometimes, and very specific short-term goals. He understands, and I believe we have 666 days left with the secretary at the wheel of HHS, we have countdown clocks and are very aware with the limited time we have to make a significant difference, accelerating personalized health and moving forward.

Some of our long-term objectives of the next five or 10 years are to promote connectivity, the hetle care information network. Access oversight approaches, develop incentives across the healthcare system, genetic information. Develop -- pharmaceutical -- industries. Encourage participation in healthcare management, prevention, consulting support and incentives, and establish real-time -- for disease management strategies using health --

Short-term goals, to prevent AHEC with what we are calling -- genomic medical testing and family medical history for electronic health records.

In parallel with infrastructure and capacity development, encouraging development of validated -- as Reed mentioned, and to establish networks of interactive data sources.

You will see on the slide a diagram we use pretty consistently to describe the overall vision we have. This pyramid really captures where we are. At the base is health information technology and knowledge development, underring pinning this development, two global forces shaping consumer care. Information technology and knowledge management. The foundation. The full potential cannot be realized unless the electronic systems and repositories under development are based on a common set of definitions and standards. Moving up the pyramid, intervention development and review, need to integrated data sets, higher quality information about efficacy and safety outcomes. Using integrated databases the ability to assimilate, relate experiences is incredible power for disease management. As capabilities develop better information based on individual differences will aid in future medical product evaluation and post-marketing assessments of safety and efficacy. Health measurement tools will foster measures to -- preventive approaches. Finally, translation into clinical practice. The key players in this transformation are healthcare providers, doctors will play new roles, rnldzing the unique aspects of each of us had healthcare pljment, continued advancement and biomedical research, particularly evident as need for better bridges for healthcare delivery. We wlak lack the infrastructure at this time for data management across biomedical research and health delivery. Formats can enable among willing partners in healthcare, hoping to create a healthcare system. We envision a continuum of transfor mages to support integration of discovery delivery in the healthcare enterprise, pave the way for a more modern Dr. Patient relationship where value in the ultimate objective.

Basically, we describe the secretary's role in this initiative as being two parallel tracks moving along quickly together, technology development and appropriate policies to support that technology. You will see outline of the first set of goals, technology goals including establishing the foundation for networking partnership to enable researchers to research clinical data in an almost google-like system. You will look in the small document, the president's FY 08 budget, includes $15 million for the personalized healthcare initiative to begin the distributed network, genomic and clinical data to add efficiencies, clinical best practices and better method of tracing adverse events, right at the starting line for that, excited about having that money. That will be coordinated through Dr. Clancy's office at -- ARC. I know Dr. Kolodner will give you a greater understanding, but tracking standards are genomic health information, personal history, and health records. Established a special working group to advise the AHEC on these issues.

Our secretary track is support appropriate use of genetic information. Because genomic information is immutable, the public is concerned about issues of privacy. It's definitely in the news now as well, with the genetic information on discrimination act. People fear discrimination in health experience, employment, public attitude. The secretary as a number of times said he supports passage of legislation to prohibit discrimination. Before the secretary stepped to the podium on Friday we received word the GINA bill had, and is soon headed to the House floor. The president inned KATEed a willingness to sign such a bill, and -- I think we cannot ever get past the discussion on this legislation without turning to Dr. Francis Collins, instead of call it fing it GINA we should call it FRANCIS. Couldn't get the acronym to work. Analytical, clinical validity of -- reed touch odd earlier, the validity of genetic testing, the usefulness, making important clinical medical decisions, there's a lack of clarity in the regulatory oversight system.

Finally, the initiative seeks to standardized -- policies, the sequence database by public funding, create many new opportunities that will benefit public health. Currently policies for accessing are inconsistent about who has access to specific information and the time frame in which this information will be made public, and the level to come it will be made public. The initiative is working to harmonize, bring consistency to the policies move forward effectively, efficiently in that kind of research.

As I noted earlier, the AHEC established healthcare working group, broad section of stakeholders, listed here to get a sense of where we are going on that. We recently had a meeting, two weeks ago. Really encouraged by the comments I heard while there, ex10 the to which folks are taking this extremely seriously, taking time and effort to work through the issues.

Currently there's a lack of consensus on policies surrounding genetic testing, family history information in the electronic health record. That could impede further systematic and useful adoption of the technology. Genetic tests are being used in -- no standards edge bedded, certified for genetic family history, to ensure information in the health records. You will see other work the group will take a look at over the next two years. The standards are not widely cap accepted, a patch work of ideas -- exchange of useful information.

The healthcare acceptance and understanding of new medical technology is not keeping up with the rapid pace of research, the charge of the work group, something very much a part of the healthcare initiative, and Dr. Downing should have a bunny because he never sleeps, working on all these issues so hard, really the string of continuity through the various issues happening at the department that will promote the secretary's initiative.

I would like to wrap up my remarks with focus on an area we believe the SACGHS could assist us in developing knowledge to support some of the work I just referenced. Fortunately, since my system was not working very well last night we still have glitches in technology, Reed doesn't have this in advance, but I will outline the charge referenced earlier and leave a copy so the committee has a chance to look over that, consider whether it would like to take that up. As part of the personalized healthcare initiative, oversight of genetic test suggest a tarn concern for many stakeholders. It's a concern, the SACGHS heard over the last few meetings a range of testimony on the subject, many, not all of the agencies involved in oversight of this important technology have participated in the discussions you have heard. Through this proationz the committee identified a number of unresolved issues. We understand and recognize the prnsz of this discussion and also see the complexity as the use of genetic technology expands, plays a larger role in the personalization of the healthcare. The secretary is committed to supporting advances and appropriate regulation without stifling innovation. As we look back we have been carefully reviewing your work, still relevant in today's conversation of the many important topics, recommendations were covered in the report, enhancing oversight of genetic tests. We agree with the principle stated, the public is best seferd by -- continued developed of such tests. Subsequent to the report, you are a very very busy committee reed, in September of 2001, clarification of -- genetic tests, the committee found the feasibility of categorizing based on limited set of elements, simple linear fashion was not possible. Closely following the information gathered by a broad cross-section of stakeholders to bet are understand the issues and discuss internally how the department should -- to that end, we are interested in the work of this committee and ask you to continue to provide valuable information to inform the secretary's initiative. We specifically appreciate your input on several questions critical to -- the secretary announced the personalized healthcare initiate is -- regulatory policies concerning genetic tests to identify the scientific information and oversight needed to be sure tests are being developed and properly used to encourage patient access to better genetic test and improve transparency of the system of oversight over all. We suggest this committee undertake the development of comprehensive map of steps needed for eferdz development and oversight for genomic tests with improvement of health quality as the primary goal. The following questions: The pathways examining the analytical validity, clinical validity, what organization are responsible for, and what are they doing to address the issues, and the potential pathways to get clear information and treatment selection by providers. We would like infuts on the -- and clinical validity such as what evidence of human harm exists regarding genetic tests. The validity, clinical valid ID -- if evidence does not exeft exist -- what resources, such as standard -- or materials are needed to develop po proefficiency testing requirements, what information is provided by proficiency testing. What new approaches or models for public, private or public/private engagement in -- for developing effectiveness measures for use of genetic tests and what should be considered and why?

Finally, if where and how additional revised government oversight would add value for patients. On behalf of secretary Leavitt I appreciate your time and attention and look forward to receiving input on these and the broad rage range of issues you went over earlier.

Reed V. Tuckson: We appreciate -- in the spirit of almost always true dictum, be half careful of what you asked for. We asked for an assignment, I think we got one. We got a pretty big one. Pretty powerful one. What we will do, and I am well-aware of the anxiety that goes with someone trying to present a report on Sunday night, and your compute commer doesn't work, you are running around with the senior people at 6:00 Sunday night, that's no fun. We will take a copy of what you have, I will have it copied for the committee, curn return to the issue tomorrow, start to think about it. The charge is important, while we have Sheila here, she has to get back downtown. I will say I am comfortable, excited by the charge. Especially because I think it is important the committee understand the context of the charge. I want Sheila to comment specifically, you have to hear it from her. I, through a series of meetings, am convinced that hh system understands the importance of protecting the public, and they are doing their work to coordinate the federal agencies and are looking carefully themselves at what Clia and CMS and FDA and all are supposed to do. I want the Committee to be confident that as we look to take on the assignments we have, it is within a context of an overarching activity at HHS.

Sheila Walcoff, J.D.: That is exactly right. It's the secretary's initiative, one of the policy areas we identified pretty early on, a number of folks here are very engaged in this from the department's perspective. But it's something we think in the next two years we would really like to move forward on and try to establish some clarity and consistency so that the area of personalized healthcare isn't stalled. Promote innovation with an eye out on the issue of public trust.

Reed V. Tuckson: You ended exactly where I wanted you to end, that is the sense that one of the things that impressed me about the secretary's comment, his realization of the public's anxiety about privacy, confidentiality, the sister of this issue of trust, of oversight. It's pretty clear to me this movement is not going to go very far, very fast if the public is not assures there's confidentiality, trust, and on the regulation side has to be addressed, it's keenly important.

Sheila Walcoff, J.D.: And Dr. Kolodner will talk more about what AHEC is doing in that area, something moving along as part of that track I spoke about earlier, right along with technology and the other policy areas we are trying to develop.

Reed V. Tuckson: I am buying time for your computer brains to figure the question you want to ask Sheila, but let me say the other thing that -- this is the second meeting Sheila has come before us and mentioned "the clock."the one, again, one thing I like about the way the secretary does his business, he's keenly aware he's only there for a certain period of time, he's not interested in a lot of yammer yammer yammer. He wants to see something happen. We have to think carefully about the things we can deliver to him in time for his watch in these areas, as that committee process goes forward. Maybe through Greg Downing we can have a way of continuing to keep track of, maybe help us Greg, think about, as we organize and respond to the challenges the timeline for us on this. Something we have to consider. Sheila Walcoff, J.D.: I have an assignment also, have to provide the secretary for not one, but two quizzes, may have to start traveling with him on overseas travel to have time for that. I am happy to take questions before I head back to Washington if anybody has any.



Good morning, thank you for that presentation. I have, if you could speak briefly on the initiative, if you can say a little about financing and access issues, one. Secondly, consumer and public education and engagement as it relates to the rolling out of this. I know on the committee you have listed some of that, in the presentation you didn't discuss it that much. Maybe say a little more.

You are asking about reimimursment policy and education?

Well, reimbursement policy is one thig, but the literal access to whatever comes out of the work itself by those it directly effects, more than reimbursement. Education as engagement. One thing to be aware, oork the to be educated, another to be involved. Speaking of the part, an outcome of the work, but have there been discussions, thoughts around that? So far, we are just getting started.

Sheila Walcoff, J.D.: Exactly. Across the department, looking to try to figure out what we can do, he can do, as a focus of this initiative. In that we looked at a pretty big vision, long vision, generational, tried to narrow down, direct leadership over the next couple of years. In those discussions we talked about transparency, education of not just providers, but consumers, researchers, spectrum of stakeholders, reimbursement policies. That list we have on the AHEC slide is really a brief snapshot of, I think, a broader number of issues that will certainly touch on there and are worthy of discussion as we continue to go through.

We haven't identified some of those as priority issues mainly because we have limited time and to some extent limited resources, although I don't think Greg Downing ever sleeps. We are, I can let you know, we are engaged in those kinds of discussions and continue to seek input and discussion on those, they inform our other policy processes, as you noted.


Any last questions? Is


Thank you very much for that presentation, the secretary's comment, charge to issues of oversight. I haven't seen the chart in detail or had time to look over, there are a couple of things I would like you to go further if today, maybe at later time, as we go more into the charge to provide us more detail, specifically what you are looking for. In the area of oversight, the role of the states and the federal government, could you tell us more about that? Do you want us to actually look at the role of the federal government, the states, the private sector, of genetic testing?

Sheila Walcoff, J.D.: We have left the charge in some respects purposely ly broad, we noted to get the best look, broad spectrum look from the variety of stakeholders on this committee. Our focus certainly would be more on the federal side, our ability to impact, but we would like an understanding of what private sector sees, public/private partnerships, and where the federal government is on this with the extreme importance of it. In terms of state reelingulation, issues, there's work done by the committee in the past, but I think we would be looking more broad, federal look to try to identify specific areas we can take action.

Question: The clinical -- with regard to the analytical and clinical validity, if you can provide more specifics of what the secretary is looking for.

Sheila Walcoff, J.D.: Sure. This is the first lout line of the charm and charge and we will continue to work with you, and discussion will come out as we move forward. An initial look at how committee feels about the charge, we can further develop from there, have more specific discussions.

Reed V. Tuckson: What we will probably do then, Sheila, Greg will you be around for much of the meeting? The whole time, unbelievable. When we get to the discussion and agenda on this topic we will have a chance to engage at that level of granularity. Sort of negotiate out a little in terms of how much we can get done on the timeline available. I think this idea of the relationship between the public and private sector is one that particularly engaged me intellectually. We are uniquely able to do something with this. That will be important. Sheila, your question was really important in terms of helping them to understand a better, if I understand the charge at this level, really clearly trying to understand when it comes to clinical, analytical validity, if there's evidence of harm, what the large speaks to, or threats.

With that, I want to again, amazingly, it's like one minute of! Gosh. That's why I am calling the question here, saying thank you again for this, and we look forwards to responding back to you, and the secretary, with the results of this meetings deliberations, and we will shape that between ure committee and the secretary 's office within the next couple of weeks.

Sheila Walcoff, J.D.: Sha sounds great. I didn't mention timeline, I left that for more discussion, but our clock is ticking and we are anxious to put you on a fairly accelerated timeline for this. Fortunately you have already done a good amount of work on this to date, focusing in on the specific questions that help the policy process will be extremely helpful. Thank you very much. Don't eat too many bunnies.

We are all about the deliverables. Thank you very much. Right on time, look who's here, it's Dr. Kolodner and Jodi G. Daniel. The key to many meetings is how important the health information technology infrastructure is going to be to the transformation of healthcare, and in particular personalized care, particularly in the noigz notion of genetics. Dr. Kolodner stepped in to try to be the leader of 18 different task forces, I am on half of themwhy I really know that Dr. Kolodner is on his game, believe me. Thank you very much for joining us, giving us this background. I hope the committee will get from this, not only the overview of what's going on in HIT, seeing, thinking about how this infrastructure is available to advance the interests we have. Thank you Jodie for joining as well.

Dr. Kolodner: Thank you very much, it's a pleasure to be with you today. Look forward to, not the presentation as much as the Question and Answer afterwards. I will do part of the presentation, Jodie Daniel will be doing the second part. As you know, there are multiple challenges to the advancement of the genomics, and we heard about a number of the issues of discrimination on the basis of static information we need to protect against, genetic information is unique to the individual, predictive of future health and immutable once disclosed. Unique among information really does not only effect information about individual, but other rlghted family members. While we had that with family history it what you want as powerful as it is seen with genetic information itself. Finally, the challenge that genetic information by then being supplemented with other types of data by noncovered entities could be relinked and that we need to do the protection to make sure that sort of violation of privacy does not occur. Health IT itself, as mentioned earlier on, can really add to genomics, helping advance the adoption, huge amount of information to bring to the forefront, frontline clinicians to make a difference to the individual themselves, we need IT to enable that. This issue of trust in the privacy and security is fundamental in order for individuals, you and I and our friends and colleagues, as well as family, to allow that information to be used and captured now and into the future.

There are a number of drivers for health IT adoption and one of those that is pushing us is that rising cost of healthcare in the U.S., the fact that in the U.S. healthcare is double the -- and we are frankly not getting value of the dollars we are investing. If it continues to rise it will fundamentally undermine our economy in the neuter even now as it's challenging the global competitiveness of the corporations. There are positive drivers, the fact consumers, economy begin to see the substantial benefits that can come from it, and some organization showing where health IT can help improve care. We will sigh see that.

Administration leadership, both in the executive branch, president, secretary Leavitt, as well as on the Hill, there's real bipartisan support for the health IT agenda. Finally, the strong endorsement from industry and commercial leaders who will be able to benefit in terms of their global competitiveness, in the fact so much of our current costs going to market, services, products overseas are tied into the cost of supporting health care.

Now, when I talked about the health IT there are several components I would like to address. At the top of the screen you see the end points, electronic health record, information, systems that are where that information gets used, either by providers, individuals or by the community and nation. Underpinning that are standards we need for data, technical standards and security. Without that we have a tower of babel. In order to get the benefit we need to link them together securely, robustly, in order to flow the information among the different islands, users in a way that honors the privacy, security of the individual r but advances knowledge, the health of the communities. That network is what we talked about as the nation-wide health information network we are seeking to foster, not a single network, but a network of networks at the community and national level.

For those who aren't familiar, the President did issue executive order in April of 2004 establishing the office of the national coordinator, to advance division for developing this nation-wide interoperable health structure,le as well as achievingwide spread adoption. The key for ONC is to provide then leadership to achieve this goal. To improve the quality and efficiency of healthcare, as well as ability of consumers to manage health. By that we mean the national health IT agenda. Let me emphasize the purpose of that national health IT agenda is what you see highlighted at the bottom. It's not to achieve technology. It's about the outcome, it's about improving the quality, efficiency, safety of healthcare, enabling consumers to manage their health.

So health IT is a critical component for a transformation to occur. The transformation is not the adoption of health IT. The transform ation is in the individual and population health, not just incrementally improving based on what we are doing today, but bringing about a change in how we support the health of individuals and the nation.

The framework we have builds from that would 2004 charge to 2014 when there's a widespread use of a variety of things, the network, public infrastructure, other things, home telehealth, even beyond the home, continuous monitoring of one's health so, people talk about the fact you pick up the cell phone, make a call, it's monitoring your vital signs, using ailing algorithms to determine if something is going on, recording who to notify, you, your significant other, primary care doctor, if something is abnormal. It's really very different way of thinking as opposed to now where we have the episode where you have to go to a provider, have that small snapshot where you are getting care. This allows you to actually have a monitoring of your health in real-time throughout the day and night.

We have set up four goals to support this charge that we have. Things about informing the healthcare professional, interconnecting healthcare, personalizing that health management, and improving population health. You can see there's a real overlap between the areas that you are focused on as a committee, and the activities that we have; because the things you are doing cut across multiple goals there we are charged with.

We also have a federal advisory committee, the American health information committee, community. This community, this AHEC, is one chaired by secretary Leavitt himself, public/private collaboration, and serves to provide input with regard to our advance towards the digital health records and interoperability. A lot of this is also how we a sure that privacy and security of the records and how we enable the market forces, because frankly in the area of health IT the market forces, the market processes did not work. Our role is not to replace those, but to set certain boundaries, certain targets to remove barrier and provide incentives in order for the market forces to work, for creativity of the community, the providers, the nation, to move forward and to advance us so that we achieve that interoperability, and the transformation of the health arena.

Our work is done in work groups, and so we have a variety of work groups that have been set up. We have been fairly busy, last year we had over 50 meetings involved 120 stakeholders. The focus is to make recommendations to AHEC regarding policies, technical, policy and social issues so the AHEC then, as you do, can make recommend gzs appropriately to the secretary and the department. We start ed in November of 2005 -- for example, the electronic health records established we wanted to make laboratory results available to front-line providers, even if that provider didn't order it. Sometimes that's an issue. We wanted to make sure consumers had a medication profile to pull up, make available to whoever they want to make it available to. We established two other groups in May of 2006, because each of those groups identified the confidentiality, security issues, rather than dealing separately in each group we brought them together into a group that would discuss and advance those and Jody will talk about that in the future, in a little bit. We had a work group on quality. Finally, the most recent work group established in October 2006, the personalized work group Sheila talked about previously. Of these groups you can see there are two particularly relevant to the work you are doing here.

We use the collaboration to advance our agenda; and that term national coordinator is important, because my role is to help coordinate the activities. We have public/private initiatives to do so. There were three contracts established, the first two are meant to foster the establishment of organization that will go on and have a regular role to serve the nation. The first is a standards harmonization, hitsbe. We like a lot of alphabet soup as well. This group is looking to take standards in areas, harmonize, which will we use going forward? The problem is having so many to choose from. If we are going beyond the tower of babel, we have to decide as a nation which we will use to speak the same language. We have a verification commission certification commission, moving forward on personal health records in order to provide certification for those. Two-fold, first to help, push forward adoption of standards that have been identified, and secondly, to help reduce the risk for the frontline providers, coming to electronic health record, so they aren't having to decide does a product meet my needs, the standards? They will have certification there to depend on, in the first year we have 55 inventoried e HRs, get to over 70, and that represents over 25% of the products on the market, and over 75% of the installed base already. That's the good news. The bad news is the installed base of really significant electronic health records being used is only at 10% of the provider community, whether in-patient or out-patient. We have a long ways to go to move that forward, but that is what our charge is.

Now the final contract is not to establish an organization, but to foster the development of that network, and we started last year by issuing contracts to electronic consortia to develop prototypes to develop the test ideas. We drew from that, demonstrated on AHEC in January, and our next round is to go not to the technology companies, but to the health information exchange communities that are out there in the regions, local, state, in order for them to contract for the services. We will be defining certain capabilities that need to be there, particularly with regard to enabling individuals to control the information that flows over the networks. The reasons for doing the latter is not to say that's the policy, but to say as this technology moves out, the technology doesn't limit or define the policy, but that in fact support what ever policies we adopt moving forward as a nation.

The other collaborative activities are at the state level, because the state and communities are where the real action is occurring, not the federal level. We can foster development of standards and certification, but the true implementations occur locally. Two activities there, the first is activity within the privacy and security which was a collaboration at the state level to identify where the variations in state laws occurred that might act as barriers to the movement of information. The one at bottom is state alliance for e-health, contract with the national governors association committee, one of many Dr. Tuckson is engaged in. That's really looking at establishing, has established executive level advisory body, into the governor, legislative levels at the state in order to develop consensus solutions for state policy.

Another state activity we had went out through AHIMA to work and identify some of the top leading edge health information exchanges to identify best practices and to advance those, cull them out so others that are proceeding to establish the health information exchanges can learn from them, see what issues, strategies were addressed by those early-adopters.

One way of looking at this is that health IT supports the transforming healthcare, and that like a tree, it, privacy, security and confidentiality are at the basis of all we do in transforming healthcare. The health IT activities feed the roots of the tree, you see a number of them there, a few of which I talked about. The governance process, the AHEC, the real purpose of it is not the tree trunk or roots, it's the foiliage, you see the providers, improving public health. Three of them, individuals managing health in a safer, healthier nation, not just transforming healthcare, but health and care, goes beyond the healthcare arena or sector itself.

The issue of privacy is critical in terms of policies, principles, and transitioning the a tech unlike what you would be doing, transitioning to a public/private entity, the real governance will move to an entity that is a public/private entity in the private sector. We are in the process of starting that movement.

You heard from Sheila about the personalized healthcare group, a broad charge there, I am highlighting here about the issue of common standards, the incorporation of clinical useful genetic laboratory test data, electronic health records, the specific charge having to do, highlighting establishing the standards for recording a corporation, medical genomic test data, and providing incentives for adoption.

The standards will -- we will be fostering. We need to be managing the systems, to generate the knowledge by having better -- give us better information on the individual differences, we will be able to draw the information, standardized information so we can do closed market surveillance, get better evidence development, what we need to do is figure out how to do that, honor the privacy of the individuals and do this in a manner that all of us as a society can benefit from.

We need to move -- automating the revenue side to automating the core activities that are the delivery of care. You look across any industry it's when you automate the core processes you get the benefits from the auto mages. For the last 30 year necessary healthcare we have been automating the edges, the revenue, not the healthcare delivery.

Health IT, again, is not the end point, it's the means to improve health by supporting the physician, and the care provider, keeping up-to-date with medical information, making sure they have access to the nsmtionz, all the information about an individual to give that better care, improving the diagnoses, decision support at their fingertips, point of care, being able to know, various parameters, genetic tests, results, what the anticipated curious of the illness might be for that individual. It supports the researcher by making available a variety of tools and providing access to a wealth of information that goes beyond what we can achieve with our normal randomized control studies where we have to refine the population in a very tight manner and where most of the individuals that we care for actually have multiple diseases and will be we'll be able to draw that information from the databases. Supporting the consumer, the real beneficiary of all this, by helping them to receive the bested care possible, personalized health; so they get the right diagnosis and treatment the first time, every time. As I say, it's really beyond healthcare itself, it's transforming health and care. So not only do we deal with improving the diagnosis and treatment, the healthcare delivery portion; but it's really about moving to anticipate and prevent illness, and by that really transforming to healthcare health.

With that let me turn it over to Jodie, she will talk in more detail about the privacy, security aspects and we will take questions at the end.

Terrific, Jodie is director, office of policy and research in the office of national coordinator for health information and fecknology, known as a U.K.

Jodi G. Daniel: Used to be -- so we shortened it, not a perfect acronym, but better than the alternative. Good morning everyone. I will drill down on some of the issues related to privacy, security, that Rob touched on. To highlight a up tole of things Reed and Sheila talked about, privacy is one of if not the most important issue we face with respect to health IT. Trust is the key. If we don't have patients trusting the -- if providers don't trust the information is reliable, protected, then we will have a real problem in achieving health IT goals. This really is the key policy issue that I face and that we face in trying to roll out health IT goal and initiatives.

Two things to highlight. I think the technology clearly does provide some added risks for health information to be disclosed. There's greater ability to aggregate, greater ability for a large amount of information to be shared, and also provides really great opportunities to protect data in a way much more secure than in the paper world. You can build in protections that might be administratively purden some in a paper world. You can identify when there's been a breach where in a paper world you can't necessarily, real opportunities to, and trying to look at how to minimize the risks and increase the protections that are available with technology.

Rob mentioned the executive order establishing our office, one goal is about privacy, security, nation-wide health information technology infrastructure must ensure patients identify information is secure and protected, key tenet of everything we are doing, part of our mission of the office. One thing I like to highlight, there's always debate, policies in place before the technology? Technology ahead of policy? Issues addressed in medical technology and health information technology, and we really see these as having to work hand in hand. These cannot develop in the abstract. The policies have to be built as the technology is being developed. The technology will provide insights on how best the policy goals can be achieved. For instance, particularly as technology is being developed you can come up with great policies, but if they are difficult to use, people will find work-arounds and will have less protection than different policy incorporated, for example, I know everything has different passwords, you have to change every few months, more and more difficult for people to be able to figure out. Because of that people always have a little sticky note with their password on the computer, which make its less protective than if they had a simpler password to remember. Developing policies, technology that fits well together.

Rob also mentioned the NHI N, nation ride -wide health information network, the technology architecture standards are being developed, tried out, incorporating the ability for different privacy policies to be developed and be incorporated into the technology. The trial implementations have control capability, as developed there's the ability to work those into the technology, rather than technology being developed without considering those at the onset.

So where does this all start? When we are looking at privacy and security issues hip a always comes up as the issue and the foundation for everything we are talking about. And I think some of the challenges we face with respect to health IT and genetics, some similarities here based on the HIPAA baseline. The roles are strong foundation for protection, first nation-wide protection of health information, and they allow, federal floor, allow for state protections greater than federal protechs, and some of those provide greater protections for specific kinds of information, including genetic information. As looking for privacy, security policies, not only federal policies, but state policies and how the two can work together. That's why we are doing so much work with the states, as Rob mentioned, both federal and state level, to address those issues.

There's some things though where health IT may pose additional privacy or security issues that may not have been considered by HIPAA. There are opportunities for greater data sharing, aggregation, and so these raise questions as to do we have the right policies based on these greater abilities to share and aggregate information. New entities entered the market, in the relght realm of health IT and technologies, exchange technologies, regional oceans oceans and the like not necessarily covered, may be through contracts, and raise questions when those entities are holding a lot of information, aggregating a lot of information, does that raise new challenges, policy questions we need toe think about in order to make sure the information is private, secure, and can be trusted and safe.

Sheila mentioned the ability to aggregate a lot of genetic information, have genetic databases, the entities holding this may or may not be covered directly by federal or state laws currently existing, new opportunities and challenges to look at those areas.

Some of these issues are being raised by the privacy and security levels, also things looking at internally and have been talking with the office for civil rights about, office of civil rights at HHS, and as we get new information from the states, both state and federal level, of what are challenges faced, we are taking those to heart and looking at how to best develop approximately sees to policies to address those concerns.

At the state level we have the health information security and privacy collaboration. This was an effort to look at a state level, state laws, 34 states and territories are working within their states, collaborating across states through regional and national meetings, to look at their state privacy laws and business practics. Groups to identify how things really work in the real world with respect to privacy, scoter security poll policies and practices, entities more protective, variations in laws, and those states are each identifying variations and policies, practices, laws, looking at state solutions, developing implementation plans in their own state to address legal or policy barriers at a state level with respect to privacy, security. Where we are going with this, we want, have 34 states looking at issues, cost discussions at meetings, and in the future we want to find opportunities where there are issues overlapping across the states to bring those states together to have regional or multi-state collaboration to look at challenging issues that come up at a state level, organizational level that really require collaboration across jurisdictions. Patients don't stay in lines, crootionz cross to states, people travel, from rural may go outside, to cities, and we want to make sure we don't end up with 50 state stove pipes but have collaboration across the states on privacy, security issues, legal issues.

Because the -- identified the need for the cross-state collaboration it was one of the drivers for the state alliance for e-health, by the national governor's association, council for state legislatures, national association of attorneys general, and -- to build consensus by state leaders, alliance made up of governors, insurance commissioners, folks from their health agencies and the like, as well as technical advisers, including Reed V. Tuckson, to look at these issues coming up in various different manners and to try to see if there's consensus that can be drawn across the states, promoted across the states so as they take on these issues they have a baseline to work from, understand what other state s are doing, and Harmonization of policy discussions and decisions.

Particularly with respect to privacy and security there are three task forces providing information up to the state alliance. One of theme is health information protection task forced, focused on issues of privacy and security at the state level, taking information from the collaboration, as well as doing their own work and research, testimony to try to identify where there are issues, opportunity for cross-state collaboration on privacy and security policies.

Then, at a federal level, one of the biggest things we have, one of the biggest sources of policy development we have is the confidentiality and privacy work group of the American health -- the broad charge of this work group is to make recommendations to the community regarding the protection it of personal health information in orders to secure trust and support appropriate interoperable health exchange. The specific charge is the break through areas Rob mentioned. This work group was formed by a recommendation of the first set of work groups, focused on the break through areas, electronic health areas, consumer empowerment, they were replicating the same discussions in all of those, not necessarily having a means of coordinating, experts at the table who really understood the privacy and security issues. They made the recommendation to have a specific work group focused in the area. We start indeed ed in August of last year, operating about 7 months at this point. Have come up with recommendations on securities -- how entities would identity-proof a patient, make sure the patient is who they claim to be, advanced by the American health information community to the secretary based on their January meeting.

They are trying to now go a little broader and look more at some of the privacy focused issues, and are looking at the implications of having some entities within health IT and electronic health information exchange being covered by federal and state laws, whereas others new and emerging are not covered by federal and state laws, trying to figure out the implications of that, to ensure appropriate protections, and just started down this road the last meeting, few weeks ago, will continue to have hearings on those topics this month.

The other thing they are very focused on, interested in, personal health record privacy policies. The consumer can put information in a health record they control, as opposed to the doctor's health record. Many of those personalized health records are not necessarily covered by state or federal laws, new entities, the consumer empowerment identified this as area to focus working with them to identify policies for personal health records.

As I mentioned, a sort of summary of how all these things work together. Everything we are looking at, security and policies, the legal framework we are focused on. The CP S work group, and the phase two, how does the work of the CP s cans work group fit in with the -- the informational, and solider direct link. We see the work of the group feeding our verification activities for electronic health records and for network. We see it providing some input into the state alliance, state level issues raised, and we see a direct link with the trial implesmations, policies developed, we want them incorporated, requiring contractors to look at policies. Clearly their work will effect our federal policy development and thinking on how to protect information from a federal perspective. Then it will help with standards efforts, as the hitsby group is -- and other AHEC work groups. We see them working closely with consumer empowerment, electronic health records, and personalized healthcare work group, we have talked to them, about our activities and Greg and I are in constant dialogue on how to make sure the groups work together.

The goal isn't to have the activities, but to make sure we end up with a nationwide health information system, to make sure they are incorporated. As we start moving we hope to see the circles get closer and closer, vearn will have an overlap so privacy policies and -- are in harmony. With that we will take your questions and comments.

Reed V. Tuckson: As colleagues begin to think about questions, I will reemphasize for those of you who don't live in the world day-to-day of AHEC, again, the reason that this stuff is being presented to you is, from where I sit, I can't think of anything that is currently more transformative in the real life of healthcare delivery than what's going on in these committees. This is absolutely fundamentally redefining the mechanisms for the infrastructure of care delivery at every level. All the stuff going into electronic record, everything that will be standardized, expectations for how the electronic record will work, not only collecting information, but providing the prompts for information, evidence-based guidance that will effect care at the point of delivery. Everything on the task force's agenda around how to you educate fission physicians, other professionals, around appropriate stuff. This is one of the incomes to dump those informations into a point of access care record delivery. It's how we're going to evaluate physician's performance around are they doing the right stuff? That's what's going on in this space, the personal health record for the patient, how they will accumulate family history, genetic based information, so a patient can take that from one care setting to another across the fragmented healthcare delivery system. That's what this stuff is essentially all about. . So I want you to keep in your mind, this is transformative. The question I would have as my colleagues think through, two things, one, how can we influence or at least ascertain that genetics is in fact a priority in the electronic record committees, in the personalized -- patient health record committee. Is it only or specifically through the personalized healthcare work group we ought to follow-up, but how do we say genetics -- the committees are making decisions every day about what they can do, what they can't do. Certain things are more important than others in a timeline. This committee may need to understand where are we in the line? Our interests in the line. Secondly, if you can remember a second one after that long first one, for us to start thinking, trying to understand better the privacy, confidentiality, how the natural linkages occur in antidiscrimination. I am trying to get to -- try to keep both of these in your head, I know I am killing you here. The concern around discrimination is one thing, legitimate, real. On the other hand, of all the people in healthcare that will require an infrastructure for coordination of care, complex illnesses requiring lots of interaction with the healthcare system, so the ability to have information about that person put forward into the healthcare delivery system in a way that allows the coordination of cross-care settings, having that protected, but used, not discriminated if it ever get out, fundamental issues. I put both of those before you.

Robert Kolodner: I will take the first easy question. We are balancing a lot of priorities as we move forward in the agenda. The AHEC has a lot of things that its identified, moving forward. Everybody's particular interest is number one, we have a few number ones. This, however, because it is part of that transformation of healthcare and health, has to be built in at the foundation as well. So personalized health group is certainly the main vehicle for connection and Greg Downing helps to foster that, as this one, and is a direct link. In addition to that, as with your meetings, all of our meetings are broadcast, widely available. Whether it's monitoring the AHEC meeting itself or reading the transcript, which they go faster than listening to the meeting, or the work groups, which are also broadcast, where there are issues, you can see what we have for agenda, if there are issues you think either touch on your area of interest, or should touch on your area of interest, first of all, through Greg you can make sure if it should but it's not clear that it has, get the message to Greg, that is something that put its on our plate at the time of the meeting.

But by monitoring those things you can see where we need to add, pay attention to something that we may not be paying attention to. I encourage you to use those means, but you have a primary channel. The AHEC will be considering those things and for the next 666 days, if that's right, secretary Leavitt has this as a top priority. You have an advocate, as chair of AHEC, and the separate hat, in his role as secretary.

Reed V. Tuckson: As Jodie gets to my other question, I would like to make a specific request. I would like to acknowledge Greg , who expends a lot of energy, and as you considering new candidates for the personnellized healthcare work group, you consider someone from this group to be formally on it, I understand how complex it is, populating the committees, if you notice the Carol way careful way I phrased it, I would like you to consider someone from this committee. I would like secondly, to have as a standard part of our -- our n briefing, meeting, perhaps several to come, a formal update from the personalized health group, either a member of that committee to come brief us or staff function, however you best decide, Robert, but somebody to brief us as to what's going on. We will monitor. My thing is, you gave the right answer, but unfortunately these folks are so darn busy on this committee, with their regular lives, I think they need that going forwards. If we can do that, I see Mark --

Too late. There are two of us already on the personalized healthcare work group. Steve -- and myself, I can't speak for Steve, but I will anyway, I think we would be most interested in formally liasing with this committee, doing that. Yeah.

Reed V. Tuckson: I wasn't too late. I was pressing it. No, great, Mark. Why don't we do this, we have a committee of the committee. You are connecting it. We will hear from you as a team report. I think what we ought to do, when we get to the discussion about next steps, tomorrow, let's see if we can't give our team a little sense of guidance about what we see as some of the issues, go forward. This needs to become one of our strategic goals. Basically one we can claim since we are already doing it, we are in perfect shape.

Glad to put the check mark next to the -- there's another one with the box, no check mark, might be worth having the same connection to the CP S work group, confidentiality, privacy, security, somebody sensitized to this, we would entertain that if there's another member who would like to sacrifice their time, ob multiple committees.

Reed V. Tuckson: The connection between this stuff and the electronic -- certification committee, and the health record crew. Jodie, in terms of my question on the confidentiality, privacy --

Jodi G. Daniel: If we would be open to including more folks, and we have, I have talked with Greg Downing on trying to find somebody with research and genetic background to join the work group, haven't identified a person, so we would be open to suggestions at least. In addition, we have been internally, Greg and I, talking about how to make sure genetic and privacy issues, as well as health IT issues are considered simultaneously. As I mentioned, the CP S work group is starting to look at the landscape of some entities covered, some not, looking at those aggregating data from a health IT perspective, but also the same thing with genetic information, similar issues that are being raised. We were talking and are open to input on how to inthe great those.

Reed V. Tuckson: The thing I want to tee up, the antidiscrimination legislation, it really is this extremely sensitive and specific point, that there are lots of effort being done to coordinate, have information that allows you to coordinate care for chronically ill complex people. The genetic discrimination stuff is clearly trying to make sure that you, again, not able to harm, misuse that. There's a dynamic tension between how do you solve that equation and so I just want to keep that in front of the committee as we go forth. Let us take other questions.


Thanks for a very interesting presentation, obviously a critical topic for the future of all medicine and personalized medicine. In terms of the charge to the personalized healthcare work group you outlined, it seems heavily focused on the use of genetic laboratory tests as a means of making sure the information is properly standardized, integrated, so it's possible for all communication priorities to be achievable in terms of physicians and other healthcare providers to have information, using it to benefit healthcare. I was surprised not to see any reference to family history, given that at the present time it's a strong driver of whether genetic testing will ever be -- and independent predictor of -- it's poorly collected, poorly represented in any kind of electronic record. There's a great opportunity here to optimize that part of personalized medicine, effortses under way by many groups over the years to provide the tools to make that possible, including the work with the surgeon general and the work of CDC. I would like to be reassured the charge here, by focusing on genetic tests is not missing the chance to take advantage of use of family history in a more effective way than we do.

Fortunately, the work group, like many advisory work groups isn't limited by the charge. One of the first activities they looked at as we identified areas to work on family history, one of those areas they are focusing on, and I expect it will have a recommendation coming forward on that, which will then form the basis in the way we flow, forms the basis of scenario, technically a use case, we then give to the standards group, to identify standards to use, and can be put into the certification process. The work group has corrected that shortcoming and we will be moving that forward.

Reed V. Tuckson: The list we have, Kevin, mark --


Question: Thank you for the presentation and esm size emphasis both of you gave, to occur, there will have to be public trust. We want to reassure the public there will not be harms coming out of this, at the same time, I am wondering, in order to get the public trust we will have to engage segments of population who unfortunately, but justifiably already don't trust the system. Instead of just reassuring people they will not be harmed by this, how can we engage them in such a way as to say this is actually going to give you greater empowerment, control, on a policy level and technology level.

Excellent question to come I can't say I have the answer, but as we move forward, ferret out what policy should be, we need to think about our experience in other realms, and specifically to me raise the issue of Internet, use of credit card information on the Internet. On any issue we have, we have early adopters, taking risks, people on the other end who may never adopt that technology, never trust it, certainly more risk averse. We need to figure out how to allow the population to develop that trust, and to -- for them to choose when to be a part of it, how fast we move it forwardI think those are the challenges with the policy development, because on the other hand, and this gets to things labeled as opt-in, opt-out, you allow it to be a part, opt out if you don't trust it, pros and cons to each of those. It will be exploring and discussing in great depth in a variety of forums, but this issue of recognizing that there are different levels of trust, different levels of risk taking, no matter how much assurance I give, or the department gives, there are people who are going to take a long time to develop that trust, and how do we address that, how do we -- what sort of policies do we do in the meantime?

If I could add also; I think the personalized health records can go a long way in gaining the consumer trust. It is a place the consumers can gather their own health information, have greater control in disseminating. That's something new where now a consumer's health information is basically held by the healthcare provider and -- not them. The consumer driver of trust and involvement that can help us. A couple of other things, we are very much including consumers in all of our different collaborative efforts, consumer advocacy groups in work groups, as well as the health information security and privacy. We are trying to get consumer engagement up front as policies are being developed, many have recommended consumer education, part vert state implementation programs, and again, opportunities for consumer control so that if folks aren't comfortable with sharing some information, there may be opportunities create policies if that area, not at this point, but there are opportunity to get more consumer engagement and trust.

Reed V. Tuckson: We will do real quick questions, quick answers. This has been terrific, but we have to get a break in here and we have to be back in here at 10:15, all these important people call nothing for the next part.


Question: Brief comments, to reinforce what Francis said, moving ahead to family history, have a draft use case to take forward since that information is available, unfortunately, unusable form in electronic health records, trying to see if we can convert to something useful. The second point, interaction between the different use groups, excellent vehicle, reviewing those out of other work groups I see where pieces of what our charge is would fit into others. Using those as a point to be able to interact, suggest perhaps we include something from our work group to enhance the use case could be quite powerful. And the thing Reed mentioned, the harm from privacy violations which for most cases still represent a theoretical rather than tajible harm, against the tangible harms from the inability to use what we have. The information is already in the medical record, available for anybody who wants to look at the medical record, but if if we can take it, put it into usable form we can prevent tangible harm.

Let's come back to that in the discussions that will come. It's important.

Question: I would like to find out -- provider, provider b, they are from different -- where a patient goes to two different providers and how they would be connected, and how they are being protected.

At the heart of our agenda, standardized information, usable within each, not just text turl information, and then developing a network that is secure, how do we authenticate the user, know they are authorized to receive the information and how we move it across the systems themselves, receiving the information, what we are challenged with doing. We have examples of that on small scales, how do we foster the widespread use.

This will be important for patients that do not have insurance, just going from provider a to provider b, and just for a specific treatment, that's it, how these are going to be connected, and how they are going to be followed through.

You got to the heart of the matter, just then, the heart of the issue.

We are working with -- to make sure we don't increase the gap, actually address safety net provider needs, rural, underserved. That's key. Joe? Is

Question: INAUDIBLE I have to keep it short, I will cut down on the number of questions I had.


You're the boss.

If you could speak to the maintenance, sustainment, of the system itself, how you anticipate, long-term issue, you have a lot of development pieces, but -- development piece, now what, how do you maintain that?

First question. Second is what do you have in place aits the current time to address issues related to monitoring the policy and work group process? There are a lot of those. I am wondering, know everyone in the group has goals, objectives, but how do you get a sense that they are moving in the direction that's consistent with the overall intent of the effort itself? Because that to me will have a lot to do with your outcome.

With regard to the system, part of what I mentioned, our focus is to enable the farkt forces to work so it isn't we are developing systems, fostering development. The electronic health records have to be self sustainable within the provider setting. The personal health record, Jodie mentioned, may impact, disruptive technology, may be the thing when the consumer gets it, understands the value of it, may take off faster than the providers who are adopting may actually push that forwards. We will see whether that happens. It's certainly possible.

Those will be ones, right now a number of efforts, employer based, insurer based, individual based, types of personal health records, each of those -- need to occur, need to look at how we have governance process, looking at having AHEC move to public, private process to oversee and foster that. You look at other examples, other networks, not sources of profit, but by-products.

How inefficient healthcare is today, a small portion of that, would more than sustain the infrastructure.

Question: My point, I wonder whether or not any of your groups are actually developing the -- concrete, adoptable recommendations about the intent. The wish side of we hope this occurs, there's the side that history may play itself out, then there is the aspect of will they actually get this done, given, given what we know about the way our healthcare dollars and decision-making around the dollars are actually spent, how that information is influenced. I am try lging to get to the point this is a very good system, for both of y'all, very good system. Butted always falls apart when the rubber hits the road. Particularly around those who are trying to access this, and if you are talking about working with states lorksicallities, that's pretty much what they're really concerned about. Given that, do you have groups focusing on concrete usable recommendations for both sustainment and assessment of the process? Is

Jodi G. Daniel: Almost all of the contracts we have with the standards folks, certification comigdz, state alliance, others, we have asked them as part of their one tract to identify sustainable business models, and with our NHI prototype contracts one of their requirements was to develop sustainable business models that could be used to sustain nation-wide health network. They presented those at a public forum we held for them to display prototypes, as well as business model for sustaining those networks, it's something we are -- understanding it's one of the biggest challenges we face, making sure as folks look at technology, policy issues, they are looking at those as well.

Reed V. Tuckson: You have to realize, Joe, a lot of this stuff is, may be a model we need to think about for the roadmap, challenge from Sheila a moment ago around public/private partnerships. It will be difficult for a software venders to put forward a product without cchit certification in it, just hard to do business. Certain things are built in. Let me do this, here's the deal, this committee is in training, we are in shape, we are an in-shape committee. I think we can probably manage to know when you need to slip out quietly to do a bathroom break, grab a cup of cough see. We don't need no darn breaks, this is a hard core committee. You have four important people about to call in at 10:15, we asked these people to stop their work to do t. we won't worry about the break. We are going to keep asking questions to 10:15.

Question: I admire your firm leadership on this. I will try to be quick.

[]Captioner transition]

[Replacement captioner attempting connection to audio line 1-301-985-4641. Line is ringing busy. Will continue to attempt connection.]

[Replacement captioner needs somebody to disconnect phone line so that I can call into audio. Cannot resume captions until audio line is freed and replacement captioner is allowed connection.]

[Captioner still getting busy signal on line 1-301-985-4641. If this information is incorrect of assistance is required, please contact Caption Colorado at 1-800-590-4197. Captioner will continue to attempt connection.] to what I know is an extremely thorny issue over the years which is the definition of what constitutes a genetic task. And reading through the language it refers to, of course, DNA and RNA, but I believe the language is analysis of proteins that metabolites that would also allow detection of a genotype. That, I know, has caused some concern, as that could be broadly interpreted and terms of what you mean by detecting a genotype. You know, so would a blood pressure measurements, could that be interpreted by some as detecting a genotype? And I did not know if that had received any attention in the markups in how that was addressed and whether that can be further clarified its rulemaking or whether we are ultimately going to come to a test case law once the bill is out.

I guess I will make a brief comment on that. I would kind of at least like to hear Chris' opinion upon the regulatory side of things as it relates to that. Number one, I think you saw in the committee an effort by a number of Republicans. Mr.Stern's amendment is the highlight Of an attempt to narrow the scope of the definition of genetic information in such a way in the definition of to the tests that would be rather problematic. And this concerns the amendments in an attempt to amend the definition of genetic tests to basically force the services to create a master list. So in a sense we are only protecting tested information that is always under this list maintained by the Secretary of Health and Human services. So I think that is a huge regulatory burden for Secretary of Health and Human Services and also not very functionally efficient as well. So obviously there have been some attempts to narrow the scope of the bill like that, but I would say those attempts have been more problematic than anything else. I would be happy to hear what the shall have to say on the subject or anything Chris had to say about how the current version functions and whether or not they think it will be able to provide the regulatory guidance to make sure these are properly addressed.

Thank you, Francis.

Just to add onto what Bryan to but this is Michelle. The attempts to change the definition were defeated. We are moving ahead with the definition that is in the bill.

As far as regulation goes, we will work with congress. We do have a regulatory process. The regulatory process usually works with public comment. It is something that we are prepared to address. So we would look forward to seeing what comes out of the house as a final bill after reconciling after recess.

Thank you, Francis.

Thanks, I certainly would like to compliment those of you who have taken time to be on the telephone with us this morning, Chris, Michelle and Bryan efforts you all have been putting into getting this bill as part at it is. After 12 years of trying to see this happen it is truly gratified to see this come together in a bipartisan way that as real momentum and I particularly would like to recognize the important efforts of representatives of slot and beer in the house and rating at so by their strong of the ship and many other it to others who have endorsed it as well. I would also like to recognize the Coalition for genetic fairness, an organization that has come together to support this legislation and has become a very important voice in that effort led by Sharon Terri is here this morning. And I think they have brought together many different constituencies that all see the need for this particular form of protection in a very detailed way. I think they assisted in the process of trying to be sure that the bill is crafted and put forward in a way that will provide what the public needs and deserves. A lot of people are putting a lot of effort into what now appears to be a very encouraging series of events. But we are not quite there yet, of course. There are still some obstacles that could get in the way. The Rules Committee will have to figure out what to do with these three different versions and then we will have to figure out in terms of the house and Senate version. In terms of the question that was just asked, that was of the I wanted to bring up. There was this proposal that, in fact, the definition of a genetic test might be something which would require it ongoing list to be carried by the secretary. I'd just want to comment from a purely scientific perspective what a really bad idea that would be because but the ability to define on any given moment what has actually worked it could be potentially useful is such a moving target that I don't know how anybody on the planet would have the ability to do that, especially as we are now seeing in the course of this year and a couple of years to come we will have all of these discoveries about genetic risk factors and common disease and diabetes and heart disease and asthma. Each one of those discoveries is relegated and many of them will potentially be a useful topic for research to figure out try to use that information in their own personal medical agenda. But we wish to do that in research before but the practice. But what of the great risks right now in the absence of a federal legislation to protect against genetic discrimination is that research is being impeded. We have very good evidence of that at NIH, that lets the people that would like to be part of projects opt out because of their fear of this kind of discrimination. But up the things we ought to be able to say to them very soon is that there is now that at a press -- protection and they need not fear participating in a NIH study because of that risk that the static information might be used against them. If we had to also fold into that this sort of on going to ration minute by minute that might fall into a research study somewhere, we would be totally impracticable. So as difficult and challenging as this test and [ indiscernible ] are and have been developed a course over many years, I think one should not try to impose upon that the responsibility of any person to try to say what is on the list and what is not. It just simply won't work.

By the way, that is very important. I have asked Sharon Terri to come up. She was going to be quiet there in the audience, but, Sharon, it is so important to hear from you, especially with our legislative colleagues on the phone. We need your response to how you see things and any issues that from your point of view, in charge of barriers to getting this done. And by the way, let me in doing this explicitly second Francis' comments about not only your personal leadership will be or as this is leadership in moving this forward.

Thanks very much, and as you know I have had many visits to this committee where I was not able to be smiling all the time to say that we are actually moving the ball forward. And I would second or third the thanks for the huge effort made, especially by Michelle Adams and Bryan Peterson. They have really worked day and night and literally day and night on this bill, especially over the last few weeks. I am really thrilled to be where we are. It is remarkable to me to think that this early in a session we have this number of co-sponsors, to 15 or 19, a starter exactly what today to be able to have gotten the bill through all three committees as quickly. And there were brought many hearings at markups over the last few weeks. It has been enormous. It has not been easy with those on the outside say, is a fabulous how this is flying through? I think Michelle and Bryan will agree with me that it did not fly and was a big rock that we pull up a very steep hill. It was not without bumps. And there were certainly a lot of special interest groups interested along the way including other interests that I learned as it as the bill started to move fast. I joked that only the beef lobby did not jump on the bill. So have -- we are really pleased to have it in this shape and this place. But my concern is that we are clear in the reconciliation of the three different sets of issues around the bill. I know that Michelle working with others will be very careful about making sure that the bill is the start of that can be and that it does what it need to do. And around that I think the issues around genetic testing or worrisome throughout the process, and I think it might even be good for Francis to make another comment about the issue of the definition, particularly since the issue that Mark brought up about whether or not metabolize and proteins that indicated to the site should be included. I think Francis made that quite clear in his testimony in the testified twice. I think that would be good for him to come on. The last thing I would say is something I did not get to say in the hearings. This has been fabulous with industry and patient groups working together. I think that we should as a patient should think about, what have we lost? Not only in the numbers of people who have been discriminated against but in the number of people who did not enroll in research, in clinical trials and where we might be as a nation today had we not had this implement the other countries don't have and that other countries look at us as an advanced nation and say, we can't even protect our peoples genetic information. So set that is very significant as we move forward in that think both Republicans and Democrats patients can stand together when we finish this bill and say what a great thing we did for people. It is late in coming, but here it is.

Before Francis engages your question, let me just -- I don't know whether you work in the room earlier but we talked about the health information technology discussion, but I don't expect that you do, but in case you do I want to give you the opportunity if you have any thoughts on the privacy Alliance and the discussion and a relationship that you see. I tried to underline that issue and don't know what you wanted to comment.

I appreciate your underlying that and I heard Secretary talk about the press on Friday and he was quite clear as we're the people here today about the importance of the health privacy issue. I cannot imagine that without this bill passing any of that can go forward. I wish we came again to this center and had more forethought several years ago from the secretary on down [ indiscernible ] had to push hard to get this done quicker. I am glad that there are practical issues on the table so that we can get real about how fast we need to make this implanted. At the best things are totally married and without it it would not be very effective.

Thank you so much. Francis?

Well, this issue up the definition of genetic tests and genetic information has certainly been a challenging one to try to put down in a limited number of words what exactly is intended. Again, the goal is to protect people against discrimination based upon that type of information. One recognizes that the ways that you detect genotypes are not always limited just to DNA and RNA. Essentially there are indications that times were one can do that using the measurement of a protein or of a metabolite, and it would be unfortunate, therefore, if you intended to protect somebody but it just happened that the test is being used at that point was not a DNA or RNA test, but was a protein test. For a sense that you wish to protest people with sickle cell trait from discrimination and that they would want to [ indiscernible ] of the state bills that have been in place the longest or for that very purpose. That is truly not detected by DNA or RNA but by hemoglobin. It is measure of proteins. You would want to have that under the umbrella of protection. Similarly a [ indiscernible ] carrier, that is usually done with an analysis to see if the is of his present at 50% of the normal level and if it is that essentially infers rather directly what the that individual must be with that actually going to the level. It is that kind of circumstance covered under the way the definition is written about what is protected. But in terms of other kinds of metabolic measurements were perhaps teams are playing a role, but a very complicated one key are just not to use [ indiscernible ] to also want your calcium, all of those are of course that vary over time. The art since the top defect it's a desolate by diets and other circumstances of what is going on in your environment. The intent of this bill is not to shoot those under the umbrella of protection given that that what you are measuring their -- while it has some relationship to a long list of genotypes is influenced by many other factors. At the it would be very helpful. I think what I have to [ indiscernible ] is the consensus view of all the people who have been commenting upon the definition. It will be good to have that the corporate and to report language and the bill when it is altogether brought to its conclusion and that will assist the process of figuring out the regulations which of course have to be implemented after passage to be sure that this bill is to interpretable by those who need to enforce it.


I appreciate that, and I certainly am completely with you in terms of where that is. I think the concern that I have is that as much as the genesis of this bill has been from the perspective of the harm that could accrue from the discrimination that can result from genetic information, there is also the realization that there are interested parties that would look to bring as much under this bill as they could possibly bring under to essentially protect all information under this rubric of genetic discrimination which would be equally harmful in terms of the ability to do things such as quality improvement and disease management and things that I think we would all agree are good things. Again, it is a tension issue and an interpretation. What reasonable people would consider to be the intent versus what unreasonable people on either side of the debate would consider to be how they could use the language to foster an agenda.

So I appreciate your clarification also what some of those concerns. There are two issues here. One really is, which part of information is protected under this legislation in terms of it not being something that can be used by health insurer or an employer to make a discriminatory decision? And the separate issue about will this get in the way of actual delivery of health care. And as has already been touched on this morning The intent of this bill is in no way to damage that relationship. The bill is written with the understanding that it is health care providers to make those patient care it [ indiscernible ] decisions, not health insurance companies. Health insurance companies are in a great position to encourage well as programs and to put out affirmation about what is now available that might be valuable for individuals to take advantage of as far as personalized medicine, but not to request or require that someone actually undergo that kind of a genetic test. That really, we felt, was a conversation that ought to be between the provider and the patient. The bill has been very careful to try to make that distinction.

Members of the committee, do you have any other questions? Well, this is just fantastic, and on behalf of all of us, let me thank Chris, Michelle, Bryan, not only for your willingness to be on the phone with us today, but for the efforts to have been through behind-the-scenes to make this a real opportunity to actually deliver something. Thank you again for coming up. Any the last comments from Members on the telephone?

Thank you for inviting me?

Yes, thank you for inviting us as well.

Well, take care and let us know if there is anything we can appropriately to from our role at this late stage to move this board. Thank you everybody.

As for the committee members, you see if you are a disciplined and tough and strong you get a reward. So the reward is you actually will get a break until 11:00. So you do get that 10 minutes. There you go. We will see you exactly in 10 minutes and if you are late, oh, my God, the sorrow that you will experience.

[10 minute break until 11:00 a.m. ET]

We actually are going to start on time. We are actually trying to start. Sarah, did we find Gregg? Did we ever find Gregg? Did we find Gregg? Yes, we will have to do it that way. Does everybody have a copy of the hand out?

I am going to go get them now.

Are the public comment people here? Good. Deborah is here? Okay. All right. We are ready to begin, if you could close the door. All right. Here is what we are going to do. We are going to ask Gregg who does not know that we are asking him -- Gregg, we are calling to ask you to come on up to the table for a second if you could and help us out a little bit. Those of you, by the way, we were right to come to you for public comment in a minute. We are way early. So we are doing good. If you look at your schedules that after we come back from lunch we are scheduled to go into our discussions on the oversight of genetic testing, we were very pleased to have gotten the guidance this morning from Sheila. So what we want to do is put up on the board, on the slide the summary of those recommendations, the charge that we got this morning. So what I want to do so we make sure that we have a focused oversight discussion when we come back from lunch, I want to just review with you those recommendations, those charges to us to see whether or not there are any questions or if we have any issues there as we start to look at things going forward. And I asked if Gregg would be here in case we had questions that we wanted to ask him about helping us to understand intent or anything that was unclear. So if you look at the -- at what was presented, we developed a comprehensive map of the steps needed for evidence development and oversight of genetic and genomic tests to improve overall health quality. Next slide. Good. So if you start out with, we are being asked to describe the existing pathways that examine the analytic validity, clinical validity and clinical utility of genetic testing. And then to define the responsible organizations who are, in fact, responsible for those three things. Let me stop there. Is there any question or issue about our taking up this descriptive assignment? So it is really describing or documenting the existing pathways that examine and analytical validity, clinical validity and clinical utility and then defining the organization is currently responsible for each of those.

I mean, that is a very good question. Actually, this job should be made much easier given all of the work that has been done over the past three years. So, I mean, it is just pulling out these old documents and looking at them.

Right. It is the defining of reality.

When you mean organizations, can you be a little more explicit?

That would be from sponsors to federal regulatory agencies, research organizations and professional organizations. And we are looking -- and that may be different depending upon where you are in the development of this from political validity to clinical utility or cost effectiveness, we could include that last parameters, but there are conduits of information aggregation and analysis that we think could be useful if you wind up in terms of the responsibility and question of what evidence is needed. This would enable certain tests to be performed. We would like to see some sort of categorization, if you will, of the types of information that are needed at various steps.

Is this limited to the critical issues or are we looking at things that relate to the public health utility of these tests? Or is this limited to the clinical side.

If you could clarify the distinction is on how you would see as being separate, maybe we can help with the answer.

I think we understand how it could be used [ indiscernible ] and at the individual level, but to the extent that what is right to have this information out there, the teddy information will be used for population Health that may be related to exposures and the environment or recommendations for nutrition Policy or you could think of a lot of things were these tests might have population health impact for specific ethnic groups.

I think the question would be -- and really it has been thought about all but I am try to understand your question. I don't think that this first question that are raising is depending upon to but this simply any test for whatever purpose as to have some utility and validity. And therefore, if you put it in that context, regardless of the ultimate application of it, does this thing work? That is the fundamental question. So if you are saying that you can think of some tests that you would want to see that which could be used at the world population base, then you should I think think about putting that in this mix.

It is exactly what it is intended to do.

So in other words, you are diving -- you are taking a higher level you here for the minute moving from the specific to an overarching thing saying -- let me to see if I can we interpret your question or if I am listening to you correctly. You are saying, is a generic purpose of the oversight of genetic testing -- should it be that it would be for clinical individual use and in addition testing used in population based environments as well? Should it be that the oversight is both from a generic point of view? And I think that, Gregg, your expectation from the department is, yes, it would be both.


So that is good. Now, what I am doing now to talk where I am now on querying the committee is I am combining, as you can tell, the first and second bullets, essentially which is one thought in my mind. Again, it is saying to us that they would like us to document and define the existing pathways for analytic validity, clinical validity and clinical utility and define the organizations that are currently responsible. What we have heard in his opinion is that this is pretty much a fact-finding activity. There is a lot of work that has been done and we have got some clarity from Gregg that that would include almost all of the domains of organizations that may be relevant to this, whether they are the Academy, whether it is, you know, Private Sector initiatives, whether the government regulatory agencies. It is really to try to lay out a road map that says, here are all the relevant organizations that are involved in this oversight in definition of acceptability. Are there any other questions on this first point?

We have heard this morning that Secretary is actually looking very closely at the oversight issues with the independent agencies, and I was just wondering as we go through these different questions that cover not only the public sector, but the private sector, how do you think we should focus our work on this issue since the HHS of this is already looking at this issue? Should we just first to focus first on the private sector? What is your take on that?

The bulk of the efforts as far as looking at -- as you know each of the agencies that play in this space with regard to genetic tests have a lot of different authorities designed and how it was aligned. How they are applied whether it be in the sections of them. That has been the focus of trying to develop more comprehensive testing. Internally that is one of the rules of the department, To ensure that the communications and interactions of various regular this to the real story aspects and the Department of their policies are cleared and are understood what the other organizations and aspects of the duties of the other agencies perform which are done in concert and understanding of that. So our efforts to this point have been trying to, in an exploratory way, look to see where those intersections are and see where the authorities of one agency aligned or perhaps intercept or not in terms of gaps or overlap of a particular policy or regulation.One element, I would like to interject here also is on the aspect of [ indiscernible ] whether it is the performance of them or the ways which the information is required and delivered to those that use it, there is many types of technologies involved now, and I would think that looking historically at the documents from 2000 and 2001 -- I realize many people have moved on from the committees to work on that. One aspect of the be of interest for this group is to look at specific requirements for different types of genetic tests, whether we are specifically talking about PCR or complex [ indiscernible ] or are rate analyses and how the information from that is developed may have some differences in terms of the clinical validity as well as analytical validity and how that information is developed. So we would ask that the interpretation and defining genetic test take into consideration methodologies and the types of information that is developed, how it is processed and presented which is to be utilized.

Let me make sure. We have a couple of issues here. On the first point, Gregg, as we to look at putting together the map that has public and private sector initiatives that are involved in political and clinical validity and clinical utility, you are saying that even while the government efforts are going forward to look at its domain we ought to be looking at this comprehensively. And pointing out from our map where those gaps are and that sort of thing. So I think that is the assignment that we are being given. Secondly, you are saying that that you want us to be sensitive to the methodological -- the methodology is that are driving these tests and how information is processed and disseminated as subtleties that we should be thinking about in case there are issues that are obtained there, and that is something we would add to this first mix. All right. Related to this, then -- this is what I see as .1. Set it is the first to hash marks there. I am combining that into one as a sign it. Can we move the slide to one mix done? Yes?

One thing of the second bullet, and this is maybe the second portion. This is an import distinction. The second bullet says [ indiscernible ] also which implies that somebody is actually taking the possibility. The terms you are using are currently involved with, and I think that is better like it because there is a lot of this taking place in a very informal or ad hoc way as opposed to a formal way in at the we need to capture all of that a formality.

Well then let's try to do both points in them and we get to the recommendation part, should be explicitly responsible for. So somebody can capture that and at the Mark is onto something here. We want to say, are currently involved with. When we get to the end of the exercises should [ indiscernible ] are making recommendations as to who should be accountable for, responsible for. Unless that informality is working as it should. Will we move please to the slides. I would like to skip down to the one that says what new models or approaches for private, solely and public-private sector. Could you move to that one? What I would like to do is I would like to -- yes, sir?

I know I am interrupting, but you covered the first two bullets on that first one. Did you literally not cover the last one?

Exactly, for the moment. I have tried to make logic of this because I am not as smart as you. I cannot do quantum mechanics with permutations. I have deliberately lumped together what I see as one coherent idea and am now moving quickly to a related idea as part of the first idea. But believe this question of what new model or approach for private sector versus Private public-sector engagement and to [ indiscernible ] this chemical validity and utility for developing effective use. So I am trying to see, at and work with Gregg here, I am interpreting this, and I may be interpreting it to nearly to get to the point that Mark is to around, responsible for. What I think it is getting to is, you have got some of these things which can be -- this responsibility is government whether it is CLEA, FDA, who should be what. Some of this may be that you can work out a responsible public private partnerships and accomplish the goal. So it is not always done by government regulation. And I think what they are asking here is for us to think about a legitimate role for public private sort of partnership as a solution to some of these problems. So let me just ask Gregg, am I over reading the intent of this one or not?

No, I think that what we have been trying to do is to understand, much like was discussed earlier this morning with the use case scenarios, at what point -- where is the information hand of? Who needs what information to do what with? That has not been clear in some of the earlier meetings in terms of where does that information come from, how is it applied in the decision making process. And from a standpoint of effecting critical care or population based approaches, what are the key political questions that have to be framed and answered in order to develop that information as necessary to use the test and use it in such a way where there is transparency about the results. What it would take in terms of organization input and medical and put, the health systems and put in terms of the deployment of these technologies and information necessary to make the process in which information continues to recruit and there is refinement about the use of those tools and their applications. So we don't have a concept in mind specifically, but we think that it will take more than just the better a government role in defining.

So what I think you have clarified is the reason I wanted to engage this discussion as part of the clinical validity and utility definition was whether the challenge was more focused on public-private partnership role for clinical validity and utility versus the appropriateness of the use of the test in chemical practice. I hear you emphasizing more the latter, more on the clinical use of the test and not as much on the former. Or is it both?

I think it is clearly both, and that is one of the intersections we are trying to cross here. Where are those responsibilities currently falling and what are better ways to recruit that information as we go forward?

Kevin, your hand.

Just also for clarification, Gregg, in the pharmaco genomic report we also identified a medical outcomes as a important part of this whole formula. Now it is not in here specifically but I am presuming you also be that.

I think that is probably certainly useful if the [ indiscernible ] can stretch to that point to look at those efforts. And I think again, there are various stages of technology development and deployment. There is more and more [ indiscernible ] about that. There is inside and expertise of this group to deal with that, great. If not, certainly the evidence that we are working for more partially is listed too analytical validity and the oversight of the test kits themselves and materials that are bought and, performance of this test. Those things are permanent concerns of this committee has been debated in the last few meetings. You would like to try to get more clarity. But those logger more difficult aspects of it, I think, if there are insights about bodies or authorities or ways to agree that information, obviously we see the help of these -- the future of help IT facilitating that which is why we were working on that downtown. We would certainly be eager to do that and I know a number of the other agencies here today are also quite interested in does.

So let me do this in just so the folks -- the logic of where my head is event is what I think we are being asked to do -- and you guys are going to be to track this here. On point one, this describing the pathways that exists now for analytical and political utility and defying the responsible organizations, the people that are involved to build, to talk ultimately is possible and accountable, as a cold part of that charge it also includes to look at -- to look at the appropriateness and need for public/private activities in terms of this base. It's basically saying, let's look and see if there are roles there was be laid out this road map for whether or not it is all government regulation, government oversight and also the role of public private partnerships in this regard. So just as a point we are putting all that together as a bundle. If we will now go back to -- and while [ indiscernible ] I just did not want to always best your name up. You are from now on GR.

Just G.

Wow, man, G. Would you -- while we do that I want to scroll back up of the slides back to be -- they will begin by of the third bullet. That is where I am headed. Go ahead.

I just wanted to reinforce the idea before we get to this because those public-private partnership discussions have already occurred on the deliberations of British committees. I think, you know, the clinical validity and the utility of tests and over such as it exists right now would never allow for the complete type proof, so to speak, of testing seeping from research to practice so that it will always have to be this public-private collaboration moving gone. I think we discussed it at length at previous Committees. I think part of the existing pathway discussion could be existing in suggested pathways. So that leads you into I guess number three.

That is where I am headed. Dr.G.?

Thank you. A point of clarification. I am reading the [ indiscernible ] and it is developing effectiveness measures. Is it developing new measures or is it just collecting measures we already know and synthesizing them appropriately? I was not quite sure what the intent of that bullet was.

I think, if Greg will answer that, but let me ask you to restate that again. We ask it one more time.

Sure. Two parts to this question. One, inherentlwhy is chemical validity for developing effective this measures. The two parts I am getting stuck on are developing effectiveness. So in terms of developments thinking of new measures, we already know many existing effected displeasures. Are we developing measures or are we to synthesizing?

Okay. So I think that, if I understand the very important question -- I do not think that the charge to this committee is to be concerned about the adequacy or how to stimulate more measures per say. It is the oversight of whether or not new measures are being developed or promulgated appropriately, that they are rational. There is some accountability for the oversight of it. I don't think we are being encouraged to get more stuff the, genetic testing done, more tests. It is more of a sense of being clear that there this a relationship in science to the measures that are being developed and that they are connected to science so that the public can feel confident that just as in the tests themselves, that there is someone who involved whether public or private sector, involved in making sure that it is not just snake oil. Now let me just double check that.

Yes. And we could [ indiscernible ] terms of evidence developments but you would like to use the terms of how do we know that the test is providing the kinds of information that questions and health care providers and consumers want and need and can trust and reliably use and other what parameters is it useful and those conditions. If you're thinking about new ways in developing that information that would be insightful and useful to whomever carries of us as possibilities. I am not suggesting on the technical or scientific level that we need guidance. The size should carry forward and the science involved. We are not looking for -- we need more specific ways to measure our RNA and the sort of thing. Is that kind of to your point?

That helps. The other part was the effectiveness? Are we considering efficacy as a product effectiveness or are we focusing only on the effectiveness?

No, I would combine those two approaches. As Sheila mentioned this morning am giving some latitude to how this committee wants to frame these issues.

By the way, I did a poor job of introducing this topic and moderating it. I think that last, is extremely important. By the that what we are, in fact, doing here is that the secretary's office is trying to give us a sense of what they think they need. And we are trying to get clear here. The secretary's office recognizes that the committee is its own ego. This is a pretty headstrong group, and they are trying hard, I think, to say to us to but they are not trying to -- and I should not have made it this way. They are not trying to dictate to us what we do, but we ask them, how could we be most helpful. So you are right, within sort of the terms of latitude I think what they are trying to do is come back to us and say respectfully to the committee, if you want to know what we need to go to look this agenda forward within the department, here are the issues that are on our mind. We are trying to get down to the levels of regularity and what it is you think you need help on. So Dr. G. raises an important question which I had not fully understood. There is a subtlety here. We are moving from the actual over set of tests which we have been fanatically working on to now introducing in addition, to the test the measures of effectiveness which is a step outside of our normal box which is something we are going to have to think about whether we want to engage. And I think that we clearly have that in front of us. So your question has actually been very helpful. All right. Now we are going back to bullet number three on slide number one. So far we have stayed, you know -- we took the first bullet, second bullet and this last thing. We took half of whatever but this was down in the bowels of the thing and brought that up into one giant mish. Technical term, mish Now we are moving to topic number two which is the potential pathway to communicate clear information to guide tests and treatments selection by the provider. So what we have just done is to take the second half of the stuff we just went through with public-private partnership stuff and we are now bringing that up and grafting that half to this. So now we are saying, we understand that we are being asked as part of this one to talk about the role of public, private partnership, and that means the academy and professional societies and to those but in terms of being able to communicate their information to guide. I am grafting that are to this number two. Do we have any further comments around this number two in clarifying this bowl?

Gregg, as this where you think we can look at assistive technology at how we can communicate clear information to guide critical treatment?

Can you repeat your question?

You mentioned earlier that you wanted us to look at how we can do testing in the different technologies, how you go about looking at the different technology and the thing that information to the decisions and how they get interpreted and ultimately tested. The do you think that we can, within this number two, I guess, something that we can address?

I think that, as mentioned earlier, we are not looking for a complete inventory of every test that can be done and categorize it as a genetic test and what is needed for it, but surely from -- some framework for understanding particularly those cases where it is not just a positive and negative result, but we are talking about something like PCR. But where there are cognitive and sort of the interpretive skills and analysis that are needed and what levels of the parties and then how is that result interpreted and what is the affirmation that is passed to whoever is going to be making decisions. Reflecting on some of the earlier reports, a lot was focus become on the test performance. We think that is still a very important question. Is the test performed by the particles which are required and the evidence supporting the analytical validity of that instrument or the reasons that are used to perform that test? But I think as we are moving onto more and more complex areas that we use in some of the earlier reports art in those cases in which there are an interpreter's site who is providing the information in what the levels of evidence that the test results are benchmarks against. And if that is utilizing other datasets and me, how is that performed and what are the datasets capabilities that are needed to make the accurate determination? So I think perhaps there are some means of an ad hoc basis beyond this group that would be important in performing those processes. I think to step up to what we are backing down on all of this is that one aspect is that, we have found it particularly difficult to start from the very beginning problem a specimen it's a laboratory or when it will be used or a method is developed. All of this steps to go through in terms of developing information for a commission or consumer or whoever is during the test and making decisions about it, lining all of that up and expanding it to someone. It is a very challenging thing to do and I am not sure I can do it yet. That does not mean that there are others in the person who cannot. What we are trying to do is say where it does the information flow go. That is at the foremost of importance. It is difficult for me in looking at the kinds of cases and are units that have been made its way to go to the abstract and describe a genetic test. It does not help us [ indiscernible ] and we are not able to put it into some context of saying, here is the kind of information accrued in here is how the tests are performed. Whether it is a number of a piece of paper that is taxed somewhere or put into some protocol that are able to develop numbers and probably statement. And long-term wise what we are trying to get to is a world in which that information is part of a critical decision making process. So we are certainly not quite keeping their yet, but the -- all of those steps required different pieces of information to line up to make the assumption at the end of the pathway that their number has passed through all the processes and has about me.

By the way, that is something we'll discuss when we come back from lunch in terms of the oversight committee, but one way to get at this is to actually take a few examples and start from beginning all the way through and trace it and say, okay, what happens? Some real use case scenarios might be the way to get added. I really like what you are trying to do. Let me move quickly to the next slide. I probably should have and am thinking now that what we might want to do is to make the first bullet, the first - there, the very first question and make that at the very top of the whole thing and make that number one. Because at the end of the day that is the fundamental question. What is the point? It is like buying out, what evidence of harm exists regarding genetics. Do we have any sense that there are real harm being done because of the gap? I think it is important to identify -- and if we don't -- if I understand the question, it is identifying other what are the harms or what to be the likely harm that will exist through various development of case scenario. Let me tell you there is a whole you Can Drive a truck through that allows maniac test number three to be inflicted on the public. Whether it is actually occurring or not to buy and we have to define actual harm examples and potential.

Just for clarification, are these all interconnected? To ask it another way, what if -- and I not suggesting we will find this, but what if we got there is no harm, no potential for harm, no gaps, current regulatory schemes are working --

[ indiscernible ]

Everything is great. You recommend that we still go to that the bullet under general questions which is, what are the potential pathways to communicate clear -- I become are they connected? To we have to find that there are gaps and all that to get to that or is that a separate -- can I pull it out?

Great issue.

If you think about where the committee is, I think as I understand it, we would still -- if you take the case scenario and travel along, you do have that issue. It still exists. At -- that the point in your training, is still exist as an issue and I would assume we would still have to do.

And I think it develops to the element of transparency of how the information is gathered and used and what you decide this safety. We still need to know the processes to do with information. I would like to address this issue. The importance of data information in a lot of ways, how is that different in other kinds of genetic tests in the context that for the was the purposes that is every broad definition where if you decide how you want to define that. But in the context of the types of information you get that have genetic origin being used for a lot of different types of decision making processes. It seems to us that levels of risk and tiers of risk, perhaps, about the nature of the types of positions made has some bearing on the level of oversight and kinds of questions and evidences necessary in those circumstances. So the aspect of our best not necessarily mean that somebody has to be harm to other to the order were subtly to not be doing be analytical work and that sort of thing. What is intended here is try to distinguish how these types of technologies and the types of testing performed here distinguishable from other types of medical tests, CDC. We are not talking about crossbills I don't think today. Can we use those for population base studies? What is it that is definable of the type of to attests that caused concern?

I think this is a good discussion about exactly what is the point of that particular bullet. And I guess maybe we ought to be a little more generous in terms of what we are looking for. We are not only looking for the evidence of harms our potential threats saw but aren't we also looking for instances where public benefit has been slowed or limited? Not that harms are occurring, but benefits are not occurring as rapidly as they might to put a more positive view on it and also indicate that genetic testing in general [ indiscernible ] going to be a public good. Of course it could be limited if in fact it is used in inappropriate ways to cause harm, but not exceeding the public good as quickly as it might optimally happen is also something we should be concerned about. So perhaps I am reacting to the language. If you will say, that is a harm its benefits are slowed, but it is bit of a different use of the word and many people would assume what they think of somebody actually been injured. Here I am talking about somebody just not benefiting because our process for over set up to the test has and somewhere retarded the introduction of highly validated and useful tests at an affordable cost that the public can take advantage of.

But there is the challenge. You were growing and then you got to the end. You had about 14 caveats. You will give great chance to see what you means by it, but it is a provocative point. We have a whole afternoon session to talk up these things. I might be possibly you are getting at. We make it seem as genetic testing is something to be so scared about. Fear for your lives all. But at the end of the day, the original way we get into this was pretty simple and did the Committee to make a chance that make sure the body does harm. You are adding something that I think is philosophically terrific, really complex to define, but still important. So I reserve the rest of my college for that at the end. But do you think?

Sheila address this earlier, the ability to apply to policies in new ways. I think that we see the lack of clarity and transparency as having at this point some stifling effect on whether it is commercial investment or academic investigators not wanting to really go in the development in some context because they don't know what the obligations of research will be. So hard is broadly defined here in the context of, what is the application of the result of not knowing or having that information?

Good. So we will -- yes, thank you.

I just wanted to make a plea, if it is appropriate, for being appropriately narrow in this. In other words -- and maybe that can be accomplished by just switching does to sub bullets. I don't think that we as a committee are intended to address all of the harms that can result from problems with clinical validity, clinical utility. Those are very much the same for problems that arise with the fact that we may be doing harm with PSA and whole body scanning. I think what it might be worth, if that is appropriate, defining in some manner that we are looking at the types of arms that can result because these are genetic tests. Is that in the spirit of what your get?

There are many open questions relative to the appropriate critical applications and knowledge. And you have mentioned a number of public health implications. I think at least from my perspective there are other federal bodies that they're dealing with that and you have described them in a broad context. We don't expect that is necessary to focus a lot of time and energy on.

Let's do this, somebody turned off -- staff, I am going -- follow me carefully here. This is what we want to do. We are going to the thing so that as we come back and talked about this at the end of the lunch break. By the way, public testimony is coming. Don't get scared. Be happy. Number one, that becomes describing the evidence of harm. Number two, that now becomes genetic exceptionalism because we are focusing on genetics and the issue is what is it about genetic exception was within the context of worrying about harm. What is different about genetics is number two. Then number three becomes the combined stuff we did on analytics -- analytical and publicity and describing the responsible, you know, involved organizations and the point about the role of public, private partnerships in that regard. That all becomes number three. Then we move to what now becomes number four which becomes the notion of the models for choosing the right test and making sure that the roles for the right choices and write test and all of that are getting out there. And that then leaves us with asking in the last few minutes that remain, what do we mean by -- and I am not sure I understand this point about the resources needed for proficiency testing. Maybe we could just hear a little bit about that and figure out where that goes in the flow.

Thank you. You have a number of people here this afternoon that can address this question fairly well, and I think there is a substantial talent here. We heard, at least in the November meeting, I believe, and others that the development of proficiency tests [ indiscernible ] different laboratories performing those tests. We have not gotten a good handle what that looks like. Are those things, available and what are the implications of the laboratory for everything from costs to availability. If you are trying to set up a proper framework that will not work in the real world. Those things are not developed and there isn't a commercial place one can go to to get the re agents to do the testing, and what has been achieved? So if there is a menu of materials and things that would be needed in a framework that addresses different types of genetic tests, how are those materials necessary to provide the kinds of analytical validity requirements if those are available commonly. Would be helpful to others.

So let me do this. If you would please in the ordering, move that proficiency up to right before describing the potential [ indiscernible ] bad tests and treatments election by providers? In other words it comes right after clinical utility. So then you to the proficiency and then from proficiency you move to you have all this stuff done and now it will be introduced into the world. Physicians and others have to select test. What about the data is there? And then you end up at the end of all of this with the last thing which becomes -- the big problem is, what else should the government be doing to do this job? What is your conclusion about your guidance to government?

One of the examples -- and this has been borne out previously and Kevin's report is just to back up a big about this a little more broadly in the context of voluntary submission data for example, not selectively utilizing those, but in the context of what can be done to foster and enhance or bring the Science Board by new models of developing the evidence, the scientific framework by which to do this. There are very good ways and [ indiscernible ] to do comparative analysis of genetic tests. So we are asking this body to be creative and think outside the box a bit in terms of the methods or approaches that we don't have, perhaps come on the ground today that could be developed without a great deal of [ indiscernible ].

Bottom line, I could resubmit this to you and it will become part of the discussion that Andrea will be us through. Of course the community - - committee had pre saved some of the questions in their work. She would be creative at been able to enter read the two together in a logical and coherent organized and efficient discussion this afternoon.

[Captioner transition in 10 mins.]

Am I taking it too literally in suggesting -- and I will mess up what Rita already stated because the way you outlined the questions makes logical sense and I support that. But if our charge is to put together a diagram to map out these pathways and communications of oversight, is that something that was intended here so that we should separate the consider that as a task? Or is just addressing each of these [ indiscernible ] in a logical fashion what we need to do?

We think a tool that would help visually and graphically explain and provide some transparency that my mother could understand in some context. There is an overview process that goes through and the technologies are developed and performed in ways that there is an affirmation flow that enables her physician and her clinical provider to know the right information held anything that would facilitate that would address Joe's issues as well as ours.

I think by the way you will probably see -- I'm not sure whether the staff had a chance to do that, but by the way, it is both. It is laying out a great as I see it. And we actually have a staff taking that. They are probably trying to buy out, where are -- what is existing today? What is not existing? Where are the gaps so that you can start to look at it. Here is the thing that has to get done and the FDA has as part of it and Clea as this part of it in ain't nobody got -- nobody has this part of it. In case my English teacher from high school is watching -- I think that that is key. I think the second map we have just heard today is the individual cases, you take a [ indiscernible ] and trace it all the way through so that the longitudinal map walks through the woods will be terrific. That is a great question. Let me stop here.

One quick question on clarification back to the point I either four or five depending upon how you arrange the sequences. The potential pathways to communicate clear information to -- tests and treatments election, treatment selection really has not been the focus of the oversight to this point. Out the you want us to conceptualize treatment? ManagementPulp -- management, genetic counseling, pharmacologic intervention?

That is a good question. The context is being applied in the process for guiding or at least anticipating to be realized in making choices, but in this context it is also more broadly in terms of other wellness decision making processes or others. So interpret the context of simply taking a test and making a decision and altering some process or help function as a consequence.

I think that is a great question in a good way to conclude. That me just make sure I did it. I think what I'm hearing and what I am animated and excited about is, if you in some way start at the end and say, Mrs. Jones receives guidance that was significant to her health and life and/or that of her family as a result of some information. Now, where did that information come from? To make the choice of using that information? Was it the right choice? Was she be appropriate candidate? Was the informaytion that was given about her biological processes accurate? Was the test work [ indiscernible ]. So you start working your way all the way through to the back chain. That is what you're trying to get back track.

And then how come measures will naturally?

Of course we take the question -- I think it was Mark [ indiscernible ] it could be level of population. The entire Asian American population of Seattle was given such and such information. Was that relevant and right based upon some genetic base testing or information? I think that is the way you work it through. We are going to have to rock. No. This is the last begin to hear from Gregg. I'm sorry.

This is very quick. I just want to be explicit about something. A lot of what we have talked about is a decision support algorithm. I agree need to be explicit and relating to oversight of development of those things because there is already some talk relating in other venues, critical decision support algorithms, that are now being scrutinized under the rubric of the device. And relating to the last bullet which is what additional or revised government oversight, I want to include elimination of one of the options that we will not necessarily keep adding things.

You guys are quick to sub populate this outlined in your afternoon discussion. By the way, I have the feeling knowing you that you are going to augment the outline because you probably have other things that you want to look at beyond that. You are not limited by what the secretary's office is asking you to look at. You are informed by it and as a conclusion, Gregg, and if you will send it back to the Secretary, we are just extremely appreciative to know where we fit in to your effort so that we are able to be responsive because we are the advisory committee to the secretary and it is nice to know what the secretary wishes to know more about. We might decide to augment. It sounds like the committee is squared away on that point.

As I said, we are agnostic about the manner in which this is prepared whether it is reports or workshops or conference calls or summary documents. There are some deliverable is that we talked about which would be helpful, but I want to underscore timeline is of some assets here and I will leave you to deal with that.

What that means, Gregg, and we are rushing to close here. This is important to slow down on. As you have been very engaged with us outside of the meeting did today, we are going to have to give the committee members some sense of the time line that you guys are rolling on. We understand your overall 600 day calendar. The question this basically to hear back from you. By the way, there is an interagency task force meeting on April 15th -- bad day I chose, but we would like -- we are going to deal with questions one, three and seven. You have anything by then it would be enormously helpful to get it in. That is the kind of thing we are going to have to look for. The subcommittee will wind up being fluid and doing a lot of work by conference call and you guys will join in as need be. Thank you. Let me invite -- you did not expect to do that. A good job. Debra? Did I say it right? We appreciate the public testimony. You know the draconian five minute rule, did I tell you that? Did I tell you what happens if you go over five minutes? You don't want to know. We appreciate the public testimony and we are really happy that you have come forward and thank you.

I'm sorry. Good morning to members of the committee. I do represent [ indiscernible ] corporation. As one of only a few manufacturers currently focused on the incoming -- emerging community we manufactured products for predicted said testing including reference controls and in vitro diagnostics. From the beginning we have been directed by the FDA to exceed current on all products. So the process is not entered into by least as their products [ indiscernible ] well compliant with current good practices. However, we agree with the FDA that this is the best way to ensure that consistently reproducible reference control obtained from properly consented patients are readily available to make clear testing requirements. We have met these challenges and received clearance for six human genetic DNA reference controls for testing of the P450 Gene. We chose reference controls for our first product submission based upon the fact that there was one platform for testing. CLEA requires that laboratories use controls when performing static testing in order to respect -- ensure accurate results. We agree with the FDA that it would be very helpful to be genetic testing industry to provide reliable, clear controls for this platform. Our concern is that this committee might be unaware that noncompliant materials from other sources is also being used for the same purpose. This discrepancy is very disturbing to many in the arena and calls for action on the part of those in a position to effect change. Currently there are three main resources for labs wishing to obtain genetic testing controls. One, left over patient specimens with or without direct informed consent. Number two commercially available products obtained most notably from the Institute for Medical research. They are drastic differences between these types of resources. These are not required to be manufactured under regulations. So they have a virtually no regulation Quality assurance requirements and are not subject to FDA audit. The performance characteristics have not been established and they are not used for diagnostic procedures. In sharp contrast a small company dedicates large resources in time, money and personnel to perform clinical trials, says for FDA clearance and maintain stability data and manufactured products. We can find no justification for lowering the bar for reference controls when there's such at the sets will component of testing. It is evident that a great deal of potential is focused on providing rigorous guidelines for genetic testing sets up until now only our product and residual patient material was available to elaborate. We were grateful to have had a source for reference great reasons material. However let's do have other alternatives for controls as companies like ours are ready and willing to take the baton and meet the highest standard of producing the controls. Unfortunately, we continue to see research grade products were about the repression samples be put into like a practice as long as maps are [ indiscernible ]. This disparity need to be resolved before companies lose their incentive for manufacturing controls. It is unreasonable to expect the manufacturer to produce a big related product when alternatives are still available at a lower cost because they are essentially research great products. So what are we asking of you, the committee? The regulatory infrastructure has not caught up with the state of the art technology. The result of this is confusing regarding what the rules actually are and a failure to apply the rules even the for all. We urge the committee to recommend to the Secretary for Health and Human Services it is to seek congressional legislation or some other means that would create parity for manufacturers and harmonize the oversight of this area. We will note that the FDA is doing its best to enforce the rules to ensure that only FDA cleared products are used in situations where there are life-threatening consequences. But we also know that they are seriously underfunded. We are asking the committee again to recommend to the Secretary that his office seek increased FDA funding for the oversight of this particular issue. This committee can play a key role in ensuring that the health care community has access to the highest possible level up genetic testing controls. Thank you for the opportunity to bring this to your attention.

Thank you. This is terrific. Are you going to be around this afternoon or are you going back?

I have a flight, but I will be about for it awhile.

I think this is great importance. And this is just my opinion, one of these that the committee is often legitimate concern about is private-sector saying that regulations stifle innovation. So it is like, you guys don't run companies, you don't know that when you come up with more regulations and more regulations what you're doing is stifling innovation. Here you are saying, we want a company and [ indiscernible ] to be better regulation. So it is not a black and white deal. What we are saying is that we would present with a need and have met that need an hour we are seeing is Laboratories unable or unwilling to use cleared products because they can get something else and it is not regulated.

We -- the time of your position could not be better. Would you be available outside of the process if you could provide specificity as you have done in your testimony? This is one of the things you were asked to do, find the areas of our work read of harm, and you have very granular knowledge year ended you could provide that to the staff so that the committee can start to examine that, you will have gone a long way in advancing the committees work.


On its own and in the interest of time I don't want to violate the committee member that want to ask a question but you are right on target. Your time here was worth it.

Your follow-up? Did I say that right? I'm good. International society of nursing in genetics. We have always appreciated their involvement with this committee and we have always learned and benefited from the committee who has come before us. Thank you.

Good morning members of the committee. I am Anne, a nurse scientist and educator and the current president for the National Society of nurses and genetics. Our membership spans six continents and includes conditions, most educators and nurse researchers. We are a specialty nursing organization dedicated to caring for people's genetic health through excellence in the provision of genetic health services while fostering the professional and personal growth of nurses and human genetics. There are over 2.7 million nurses in the United States. Of those approximately 2.2 million currently are practicing as registered nurses. Approximately 7.3 percent of nurses or slightly fewer than 200,000 are advanced practice nurses. Half of these or about 100,000 are nurse practitioners who are delivering primary health care services. Compared to other primary health care providers nurse practitioners are more likely to be practicing, serving patients who are economically or socially disadvantaged or are medically underserved. The average salary for a nurse practitioner in the United States is slightly over $60,000. This nursing work force holds great potential for caring for people's genetic health. We have in conjunction with the American nursing an association developed and promulgated the scope and standards of genetic chemical practice. This document delineates the genetic competencies' expected for nurses practicing at the basic level as well as enhanced competency for the advanced practice nurses. In addition, we are one of over 40 endorsing organizations of the nursing competency and curriculum guidelines for genetics and genomics. Thus leaders along with us from the American nurses Association and the American Association for the College of nursing, the National League for nursing and others are actively working to implement these competencies. Articles have been published in journals including the Journal for nursing scholarship and MCN The American Journal for maternal child nursing. Presentations have occurred at meetings such as the American Academy of nursing and the American Association of colleges of nursing. And we will be at the upcoming presentations for the National League for nurses educational summit. We are committed to working toward ensuring that the nursing work force is well prepared to serve their patients and the public's need for genetic information. We are committed to ensuring that all individuals have the appropriate access to genetics and genomic health-care and have a pre definition statement defining the key role of nurses and ensuring access. We are eager to work with the secretaries Advisory Committee on genetics, health and society as you work to insure access to the appropriate level of genetic care for all citizens of the United States. This includes is work to instead the impact of gene patents and licensing practice on patient access to genetic technology. We are committed to working toward the goal that our over 2 million nurse colleagues have the knowledge and skills they need to practice effectively. Thank you and if you have any questions I am available both today and tomorrow.

Well, thank you very much and I appreciate your response to the end about supporting and helping us on the patent and licensing. I don't know if you were here when we address our strategic priorities. I for one would appreciate if if you would send us a thoughtful analysis on the issue of the status of professional education. And whether or not you feel like from your observations enough is being done in the private-sector to handle all of this, whether we have a problem or not from a point of view or whether or not there are some real gaps here. I think you are in a unique position to help us to think through that. We keep this on our agenda as an important priority. Any quick question from the members? First of all, your statement is eloquent and stands on its own and clearly as I said we have enormous respect and know that we can turn to you as a resource for many things.

Thank you.

So thank you on that and if your staff could keep me on track. I appreciate it if you could send us to the extent that you feel comfortable or are willing to do it, your analysis on the status and things that begin to think about going forward on continued Professional Development professionals.

Thank you.

Thank you. Great. Next is Gale.

I am filling in for Gale.

See, the trick is when I ask the people their name it is to help to move them when going to the chair. Thank you very much for joining us and taking the time to present.

Thank you for having me. My name is Kathy and I am the director at John's Hopkins University and almost exactly a year ago my colleague appeared before you and expressed our strong concern about the inadequacies in genetic testing oversight. Sadly little has changed over the course of the last year and I would like to take a couple less to review what CMS has and has not done to respond to some of the sum to the statements that they have made over the course of the last year. So briefly to review, CMS last June told you that a proposal for genetic testing specialty creation was on its way possibly by early 2007. Fewer than three months later the agency said the specialty area would be developed. CMS has given many different explanations for the policy reversal. They have told you last November that there was no evidence that there was a problem. With respect, we differ. On the issue of evidence we feel that a survey of laboratory directors can ask them about their participation in an existing formal PT program. We found that fully a third of laboratories are not participating in an existing formal PT Program. When Congress passed Clea it was concerned about the failure of laboratories to perform PT and it's consequences for patients help. For this reason, directed the Secretary to require that laboratories participate in PT and less the Secretary determines that an appropriate PT program cannot be implemented. Bluntly stated CMS is neither either the spirit or the letter of the law. Because of the way in which they have implemented that they first need to create a specialty and as you heard they have now decided not to do that. The specialty and no PT. CMS has said that the lack of the mandate has no practical effect because there are so few formal PT programs available. While it is true that the number of tests far exceed the number of formal PT programs available to the extent that CMS could require that laboratories participate in available formal programs it would certainly cause a shift in the situation. Moreover, I think, we could predict that more formal programs would be developed, simple market economics. CMS has characterized our survey findings as identifying pre and post analytic errors in genetic testing. Unfortunately that is an inaccurate representation. 30percent of the errors were analytic errors. Moreover a strong predictor of labs most strong is the level of PT performed by the lab, the take-home message is pretty clear. PT in labs are not doing it. Finally on the issue of transparency that was addressed briefly, in enacting clear Congress directed that the Secretary make the results of PT testing available to the public. CMS has not done this taking it impossible for any external body, it yourself included to assess the quality of laboratories. There must be more transparency on the issue of letter to equality. Finally CMS has asserted that only a few organizations want the this is to issue a genetic testing when in fact over 100 organizations representing industries to leverage areas, patients and help the providers have called on CMS to move forward.

[Captioner transition].

And [Captioner trying to dial into audio line. Line ringing busy. Please hang up phone.].

In important ways. In the end from the coalition will and--of innovated diagnostics and role in reducing healthcare costs and birding the burden of disease and personalized medicine. Will want to determine the most appropriate pathway, while preserving a forward-looking innovation environment while patient safety is the highest priority. Various legislative initiatives will be introduced and enacted that establish--earlier this month, the laboratory test Improvement Act works with health committee staff and leadership and we ought to share the interest in safeguarding all laboratory tests. The coalition remains concerned about particular elements of the bill. Any new regulatory--we believe that the improvement at may hinder such improvement at by regulating--we are concerned by the provision dealing all laboratory developed as to be medical devices. We'd feel a great theory about the smaller labs, but today those with rare diseases. The coalition is committed to securing all tests but all tests that would present enormous difficulty for all labs and FDA. We are Working with high-quality LTDs and the flexible approach produced in Senator Obama's goal. In ensuring the patients and physicians have timely access to these diagnostic. I will not go into the issues around those, but we agree very much with the details that Kathy gave you. The Coalition for 21st century medicine is committed to working with CMS, FDA and Congress vote so that regulation support diagnostic test services for patients as well as reliability and quality. As a result we have formally requested a letter that Secretary Levitt convene a meeting to make sure that the wide range of views are heard and considered and that a proper it coronation is achieved among these initiatives before any final decisions related to a new regulatory provision are put in place. We look forward to working with the secretaries advisory committee and all parties involved in these vital matters of public health, safety and Madison. Thank you for the opportunity.

We are going to have to go to what. I think the real question to get from you is, when you see as laid out the outline around oversight and where the pieces of plug and, if you could give Andrea, where do you see it fitting and and being specific there, you will get involved in but much more effective way. At the end of the day we will be figuring out what to do with it all. I thank you need to--think you did it into the outline.


Deborah, can we get to New it later today or tomorrow. We have to get this committee to lunch. Before you do, I want to hear from David from the American clinical Laboratory Association. David did sign up for the is a particular session early on. David, we appreciate it. We have also appreciated the fact that ACLA has provided comments to us in the past and has been well received. Thank you.

We appreciate coming here. I am David, vice-president of policy and medical affairs at the ACLA. Many of not all of our members perform genetic testing you are going to hear some redundancies from the 21st century collision. I think it is important to hear that the vital nature of these comments. We wish to focus our comment on recent activities related to the genetic testing tests. The FDA has Newell did on in vitro. We will continue to play a and genetic testing. Over 300 representatives were present at the public meeting and over 30 comments were received from clinical laboratories, manufacturers, government officials, academia and others. Some common things emerged in the presentation. Alter toward tests should be saved, clinically valid and effective, a theme which ACLA agrees with and endorses. Two important bills were introduced this past month. Genomics Bill was at introduce an senator Kennedy's bill was introduced on March 14th. And both of them to address issues associated with molecular genetic test oversight. ACLA was not one of 25 organizations that sent a letter to Senator Kennedy respectfully requesting additional time for more careful analysis and discussion of the Bell. I thank you have a copy of that with your comments. The organization represents professional and entities comprising medical interest including genetic disorder grids, genetic and molecular practitioners, a genetic Order Policy Group, a pathologist, and clinical laboratories. It is interesting to note that the organization that signed the letter may have a varying views on the need for additional oversight of laboratory developed tests. They are fully denied in the request to provide more time in feedback and to discuss pathways that will not have consequences on patient care and a laboratory services. But they are for the United the any of legislative initiative should be carefully crafted to focus on the specific areas of concern and not be so broad as to encompass laboratory tests that are currently established or serving a valuable purpose for a rare disease groups and public health needs broke her overall message today is simple. Let's not rush to solutions without thought of deliberations on all of the issues for increased genetic testing oversight. This committee has professional expertise and the understanding to contribute significantly in advising these issues as they are deliberated. The touched this morning and the discussions that will follow this afternoon are certainly a major step in that the direction. ACLA ask that you communicate your desire for input on these issues before they are finalized. We thank you for the opportunity to comment and look forward to working on the committee with these important issues.

To read it. Thank you very much. I continued to the continued - -encourage you to find places that you might want to comment as you get an. That we have to go to want. At your lunch is outside. For those that are not on the committee, I am informed that the hotel answers at lunch at the Cafe, which is around the corner from the ballroom and the Garden Restaurant, which is also well known. Here is the deal. It is 12:33. We are supposed to start at 1:15. That is not fair to you. We will start at 1:20. That means that you will start at 1:25. The problem is that we have people calling in at exactly 1:30. We have some table setting to do before they come in. They do not know that we are late. We cannot reach them. They are on the beach. I will see you at 1:20.

[Lunch break until 1:20p ET].

We are right on time. It or we move forward, and it is less whether Joe is about done, --

I am ignoring you for the moment.

What do you mean for the moment? It has been ever since you were on the committee. [ LAUGHING ]

Before we move forward, it is worthwhile to recap where we are common-sense things were left in November on the issue of oversight of genetic testing. As you recall, Judy and Tom reported to us the notice of proposed rulemaking was not going forward as planned. They decided to explore other avenues for strengthening genetic testing oversight. It would be faster to implement, providing technical insight in collaboration with CDC to publish materials. We have heard some public testimony today about that issue. We will be revisiting it in the course of our discussion. To our great enthusiasm, Dr. at the New York state doctor of health provided us with some insights that were very useful. She gave us some concerns. We invited her back and are very appreciative that she came. We want to thank her for that. If you can find such a seat at the table, we will have you come up and be a part of this. We are very glad that you are here. In November, we had them to draft guidances' on the oversight of certain genetic tests. The first draft clarified that agents, which are the active ingredients in that genetic tests marketed in combination with other products or instructions for use with specific tests are considered-and let me just read that again. That is technical and complex. I want to make sure that you all catch that. What Steve said was, but the first draft guidance clarified that analyte agent, those the active ingredients, marketed and combination with other products or instructions for use in a specific test are considered test systems and are not exempt from premarket notification. The second draft guidance targeted a class of--or as commonly known, indiscernindiscern ible in. [ LAUGHING ]

IVDMIAs to calculate a patient a specific result. It clarifies that these types of tests must meet pre and post market requirements appropriate to their level of risk including a pre-market review requirements in the case of Class two and class three devices. There will be a quiz on that in a moment. Later this afternoon, we would like Steve to give us a brief status of these documents and the public confidence that FDA has received about them. During our oversight session we heard conflicting perspectives about gaps with genetic tests. We define the nature of the gap. A gap access, but we were frustrated at the nature of the gap and who is responsible for fulfilling at. We reached a consensus about writing a letter to the Secretary about trying to illustrate the oversight gap. We thought we needed to find out about the advisory committee on the decision not to go forward with the augmentation of the CLEA. On the second day we decided we needed to probe these issues more fully to pinpoint more precisely where the main gaps like. Very organized a fact-finding session for today's meeting. To our great pleasure, Andrea was convinced, arm and twisted to serve as the chair. Her group met twice since the November meeting. It is a small group, two people. Who is on it? It is you and Cindy. [ LAUGHING ]

There has been some negotiations going on behind the scenes. Certain people have had their arms twisted. Mark will let you know that he was convinced to join the committee. We might need another one as well. We will looking as the discussion goes on for the calling, Kevin. [ LAUGHING ]

You are on another one. We just want you to facilitate the process of the calling for someone to get the spirit to join an. Does wonderful committee has discussed the content of the letter. Since the committee-it was premature to send a letter to the Secretary. They developed a framework for this session, identify speakers and following through on our recommendations from CLEA. Based on those conversations this morning and the one we had just before lunch, it is pretty clear that things are now moving forward in a very organized and assertive way. I think that is good. Let me just thank Andrea for your effort and having such a complex of committee. [ LAUGHING ] Out by the way, I am assuming, and I did my job was to fill until the 30 minute moment where the people should be on the telephone. Is anyone on the telephone? It is a videocast. I did not know that we could do that. Dr. Wylie Burke is going to be on. I had to do all of the hard work. Before you get started, we will make sure that Wylie is there.

Let's move to our presentation. First of all, let's have an overview of the oversight roles of federal, private and state [indiscernible]. This will be followed by a more detailed presentation of New York and other state systems. Finally, we will learn about private sector to responsibilities for clinical laboratory accreditation and the development of clinical practice guidelines for genetic testing. Our first presentation will provide an overview of the approaches and various sectors to provide oversight of genetic testing. As many of you are aware, Dr. Wylie Burke is a noted expert on these subjects. In addition to her work at the University of Washington School of Medicine, she'd served on the NIH Council and was on the secretary's Advisory Committee on genetic testing, which is the predecessor to this committee. Hopefully, we will be able to connect with Dr. Wylie to hear her presentation.

I told you that you should let me fill more. We will take just a second and see if Wylie has joined yet.


Du camp when bashed out that you hear me?

We hear you clearly. Date although Iceland the slight chill, I do not have it here with me. The slide will not be protected for you. I think that everyone has a copy of them. I do not think that will be a the problem. I will go ahead and give my presentation without slides.

The presentation is in our pocket. We have a copy of your slides.

I think that will work fine for this presentation.

Thank you very much. Go ahead, Wylie.

I would like to give an overview of the oversight system. Before I began, let me say that particularly when it comes to the details of the federal agencies involved, I am well aware that there are X official members who know far more than I do about the details. My efforts will be to give you a picture of where oversight ochres and what the potential interactions of different oversight mechanisms are. I will be happy to be corrected on any details, if need be. Let me just start by saying the reasons for oversight are clear. That they have been discussed now for many years, basically for a decade. We see coming out of the human genomic Project, and many genetic tests and a lot of complexities in the thinking how best to use those tests, many technologies, often difficulties in determining or at least complexities in determining who is a candidate for a particular test, and genetic test results can be difficult to interpret. Superimposed on that is the difficulty that many clinicians at this point in time have limited knowledge of genetics, surveys tell us that many clinicians are uneasy about interpreting or using genetic tests. Of this leads to concerned about appropriate oversight. Sources of oversight are multiple. I really want to emphasize four different areas where we can have actions or take actions or oversight. What I want to reflect on in particular with you is what-how we might think about the interaction of these different methods. There is the statutory regulations. I know that that is receiving a lot of discussion and your committee and the prior committee. Out there is also public leadership. I will talk about the very important role that public leadership can play it. As a separate issue comic decisions about health care funding, which in our society can make a profound impact on how tests are used. Finally, professional leadership. So, talking about such a tight regulation of genetic testing at the federal level, I think that we can say that there have been two major areas of the this. One is on the certification of CLEA and its implication and the potential of FDA, potential and actual role of the FDA and premarket review. So, at the well established a model for regulatory oversight is that for oversight, a Fort the and CLEA system that provides certification for laboratories the provide test results for clinical use. But what this oversight system does is it to provide oversight regarding laboratory procedure, the documentation of it within Laboratories, standards for the training of laboratory personnel, and also, the credentials needed for test interpretation. As you know, I know it has already received discussion in your committee, when we talk about the CLEA system, which we all agree is a very well functioning an effective system, there is a question about whether there should be a genetic specialty, that is whether there needs to be specific enhancements of the oversight with respect to a genetic test, a genetic test that might involve a complex technology. I understand that that is still an issue that people are discussing. I want to mention another issue with laboratory and oversight. That is the issue of results obtained in research. I know this has been a discussion now for several years. I want to bring this to your attention because I do not think it is a result issue at this point. Both in 1999 and at a working group of NHLBI a couple of years ago set out criteria by which we can identify those results that should be closed to result participants. In general, there is a consensus but when research studies produce invalidated results that have implications for health depth and for which there is a healthcare intervention, that these are in essence should be disclosed to research subjects. What to do if the laboratory at generated those results is not CLEA certified? I am well aware that CLEA offers opportunities for small laboratories that are focused on research to develop CLEA certification, but I also hear from colleagues that this is not always a peaceable way for researchers to go and that researchers are troubled about what their responsibilities are. But I think this is a meticulous small piece of the laboratory oversight picture that needs further discussion. I want to talk now about the regulatory oversight of the use of tests and clinical care and does start with the historical notes that in 1997 when the task force generated its report, this was a task force, chaired by Tony and Mike Watson, one of the things they call for for the safety and effectiveness of genetic testing was evidence based entry of genetic tests into clinical practices of. What they acknowledged was that there were not necessarily concerned with all genetic tests but that some genetic tests needed more attention than they were currently getting to ensure the right kind of evidence when they entered clinical practice. They called for criteria to identify those tests where special measures should be taken, and special measures specifically to requires validation and clinical utility data before the test entered the marketplace. Out date envisioned that this process would include an independent, external review of tests before premarket and the professional organizations might potentially play a role. They also considered that the FDA might have a role because the FDA did have a role, does have a role with premarket review of test kits. At was a recommendation from the task force and the secretaries Advisory Committee on genetic testing which preceded your committee and met between 1999 and 2002, and took this recommendation very seriously and gave it a lot of consideration as Reed and others can attest. What the committee did is try to figure out a way to categorize tests building on the NIH Task Force call, looking at diagnostic versus predicted status, that in a lot of the early discussions seem to be a critical distinction. The short version of the effort that went on for many months is that there was no simple way to categorize genetic tests ordered Dean SACGHS could not find a way to categorize genetic tests that enable them in a clean and simple way to say that these are the tests that require higher scrutiny, and these are the tests that do not. There are a few reasons for this. One is that many genetic tests have multiple uses. Most do. There are different definitions. If you say that we are more worried about predictive than diagnostic tests, you get into an issue out of diagnostic tests. I remember a conversation about our good genetic test. That is diagnosing a predictor of who, at predicting a particular drug response. Obviously, there would be incentives to test manufacturers to go with what ever characterization of their test would be least onerous from a regulatory perspective. Where did that take the SACGHS discussions? Well, in the end, the committee recommended that all genetic tests, including home brew, which is where the large discussion ochres, should go through some form of premarket review. The committee was concerned that it not be onerous. The ultimate outcome of that discussion was to create a template, a template that laid out basically, words often quoted what, would lay out what we know and what we do not know. I am not sure who exactly to a debate that "to. I think was the first person do say that phrase it. The point is. SACGT reveal said that we would get information about what the test was, accurate information about what we know about being analytical ability, which we assume will be well established and we believe CLEA overshirt overseas oversight that. Validity at all about when a test comes to market and clinical utility where information is often more limited. A pre-market review would enable health care providers and patients to know exactly what they had with the test. That was the recommendation, and the Secretary of HHS accepted the recommendation. I know that you have heard a lot of testimony in your tenure in your tenure, I will highlight a few issues that I think have been important actions taken by the FDA since that time. First, there have been several draft guidance statements related to the pharmacogenetics Act and the voluntary collection and submission of data. What Steve described in testimony to the committee about the idea of creating a safe harbor in which to explore interesting data that might help to inform manufacturers and the public, ultimately, about a proper it uses drugs, but guided by pharmacogenetics, corporate development and the data and the development process as well. More recently, we have had a statement from FDA about the intent to pharmacologoy and one of the points in that change is to create the opportunity to showcase pharmacogenetics and information when it is relevant to the use of the test. I think these efforts on the part of the FDA said no, what I think is a very appropriate decision making process, obviously I cannot speak for the FDA, but what I see in their actions is the decision that pharmacogenetics is a particularly important area for the FDA to be looking at as it is looking at the items that they can provide about the appropriate use of genetic testing. That is important in part because the use of pharmacogenetic testing is obviously tightly aligned to the safe use of drugs. I think it is also important because it seems pretty clear that pharmacogenetic testing is going to be a very important early product of genomic research in terms of impact in the clinical arena. At other FDA efforts, well, obviously, in the past several years, FDA has approved a new genetic test kits. That has been a very important process. It creates a precedent. Also, what I think is important, it has equal importance to the efforts that FDA is making to pharmacogenetics its efforts with respect to in vitro that. I am speaking about the draft guidance that came out last fall, proposing the extension of oversight to these the [indiscernible]. That as you know, these are tests that utilize the the laboratory data and analytic tools to generalize results. We are talking about the gene profiles that can be used in chemotherapy. What I take from the FDA efforts is that they are identifying two areas of priority. One it is pharmacogenetics, and the other is test complexity. I think that might be a much more functional way to think about what tests need higher scrutiny than the it diagnostic, predictive kind of categorization that wouldn't SACGT was working with a few years ago. I think this is a very interesting approach. I want to go on to the next topic and just say that another area port very interesting discussion is the area of a threat to consumer tests. The question there raised is, but is there room with four additional are different kinds of statutory regulations when we are talking about us going directly to the consumer? I know that you are well aware of the General Accounting Office report on new trop genetic testing in which it raised questions about whether websites offering pads neutrogenetic tests were misleading consumers. It concluded that this was so. There are other potential sources of regulation about truth in advertising that might be important here. It also raises the question whether a test that is proposed to be offered directly to the consumer should be another category raising questions about regulatory oversight. Let me talk briefly about genetic discrimination. For some years there wasn't any hope that the 88 that would provide protection against discrimination. Some years ago, and 2001, this was related to workers that had work related claims for a couple tunnel injuries, and weren't subjected to genetic testing without their knowledge. In bringing a claim against Burlington Northern for these activities, EEOC did invoke the ADA and claim protection from that bill against genetic discrimination. I think we have to say that when we look at how the courts have interpreted ADA claims and non genetic diseases, it seems likely that the ADA will be interpreted as primarily provided protection against people with disabilities that actively interrupt their life out and that genetic susceptibility itself is not likely to be it something that would meet that standard. The other opportunity we have a form of oversight around genetic discrimination laws that prohibit genetic discrimination and at the federal level, not Gina is now before Congress, and you will be during the update of that later. At the state level, a statutory regulation can also be very important for Genetics. In particular, some states have more stringent laboratory oversight than in is called for by CLEA. Out many states, I think the count is now 41 have acted genetic nondiscrimination legislation, although it is fair to say that this legislation has not been tested in the courts yet. We are not really sure what the scope of protection provided by this legislation is. I obviously, newborn screening is a state function VAT is under oversight of the state. Let me conclude these remarks about statutory regulation by saying that I do not think that the role of statutory regulation and oversight of genetic tests is yet clear. I think that we'd see pump conversations that are very important going on at FDA. I think we have an ongoing concern about whether or not there should be more regulation of around performance of genetic tests and laboratories, and I think we have uncertainty about a certain kind of delivery of tests like the threat to consumer and exactly what measures we should take to make sure that consumers safety is protected. I do think that statutory regulation is a potential vehicle to standardized reporting and labeling of information about genetic tests. We should think seriously about how to best used statutory regulation for that purpose. I think not a dwarf route to establishing a standard of practice around genetic tests and other mechanisms will likely be more effective. Let me talk about some of those other mechanisms. First of all, public leadership. In addition to the regulatory responsibilities of many a federal agencies, we also have the opportunity at the federal level, of federal agencies have an opportunity to provide leadership in a variety of ways. We have many very positive examples happening now costs, as I have outlined in my slides, these include promoting the best practices, education and training, practice guidelines and research, all of which are important efforts. Just picking out a few examples, because there are many, I wanted to mention the division of laboratory sciences at CDC. When we are talking about genetic testing, this particular division of CDC and particularly the laboratory testing and the genomic branch and that division has a variety of roles that I think are making a very positive impact. It provides leadership for Quality Control, Quality Assessment in the development of technology and of practice. That includes the proficiency testing. I think, also, as an example of a very interesting work that has come from this agency, there has been an interesting project, looking at a genetic test reporting. When we think about the complexity of genetic tests, the fact that there will be many new ones and the fact that many providers are not necessarily well grounded in genetics, and this represents a very interesting kind of example of how appropriate use of genetic tests can be enhanced by looking carefully at how information is provided to all providers, to guide them at the point of the service, at the point where they need to know. This division has many other activities, education and training, research activities, and also it does take a role both nationally and internationally and policy development including an interaction with CLEA in terms of standard setting. Public leadership extends to other areas as well. I want to mention the role of public leadership and the support of prophecies have a very important one in the line development. That I know you will hear more about EGAP Leader. It is an important initiative on the part of CDC, and to not just provide guidance about the use of some genetic tests but do not work on establishing for evaluating genetic tests and hopefully also defining, addressing what what is a very important unresolved question which is, what kind of evidence do we need? What kind of evidence is sufficient for us to be able to say this particular to netted test is ready for political use? The U.S. preventive Services Task Force has provided some important guidelines, their guideline about the best-genetic diseases in newborns and --where opportunities for contributions can be made, we need to think in terms of the pathway. I have shown you might diagram of the transitional cap way, the idea being we have a huge amount of research going on that is helping us to understand, with increasing detail, the genetic contribution to a disease. That is not one end of the pathway. At the other end of our improved health outcomes. Clearly, the federal research support is a critical component in the early part of that pathway. NIH, makes an important contribution to the research enterprise. When we think about oversight of genetic tests, what I think it's important to emphasize is that there is not --at what really does help providers, what helps patients to assure proper it use of genetic testing, the creation of additional resources, and ongoing focus on clinical utility, which starts on clarifying what we mean by that term, and as I said, what kind of evidence we need to support clinical utility for different kinds of tests. Also, of research into the legal and social implications and the policy options did think it is fair to say that federal agencies are providing support and all of these areas. Identifying crucial areas where more work that might be needed. Now I will turn to binding decisions as an alternative to statutory regulation. I do not mean that funding decisions should replace statutory regulations. I think it is really important to recognize that binding decisions play a crucial role in the use of genetic tests or for any medical tests in in our society. That is, whether a not a test is funded will have a powerful impact on whether that test is actually used. A test might be billable for clinical use. If it is not funded it is not likely to be used. Do what we want is for people making the funds available make wise decisions about what they find and what they do not fund. How they should be taking a of genetic services. When it's counseling available and what kind should it be?

[CAPTIONERS TRANSITIONG]. regulation of genetic testing doesn't address really core problem in our society. That is an equitable access to a genetic services which comes from people from people lacking insurance are being under - funded. The under - funding being important for genetic services because these are viewed for more marginal services less likely to be funded. Now, I will move on to the role of professional organizations and collaboration's grid the same way the public leadership can play a powerful role in creating standards of practice, so can professional organizations. Professional organizations can help identify for their members the importance of genetics issues. An interesting example was the American Association of Family practice which identified genetics that its membership should know about and created partnerships with federal agencies. They can provide education both at national meetings as well as stand alone educational programs. If we see a professional organizations playing an important role in the laboratory of oversights in working with or within the context to the standard might create proficiency testing. And professional organizations play an important role in developing practice guidelines. Practice guidelines are what most stocks look for when they are faced with a new area rea of practice. They look for guidance from sources that they trust. This is why professional organizations play a key role in practice guidelineguideline s. The problem, if you look at what we have today is that our kind of all over the map, practice guidelines. Many different bodies set themselves up to provide guidelines and use different process these. Some more transparent than others. Some more evidence-based than others. We have had some reports that suggest interests may sometimes insert themselves into the process in a way that is not good and methodologies vary. They are not always disclosed. With all of these process problems, that is what kind of process these should we have to produce good practice guidelines, we also have the on-going frustration on the part of the guidelines panels that even if there process these are good there evidence maybe lacking. I think this speaks to the importance of public and professional leadership making sure we are doing the research we need to do to get the evidence we need but also providing leadership to ensure that practice guidelines follow a rigorous procedures so that they can provide a valid and legitimate guidelines. As we do so we have to read knowledge that standard of practice is an evolving concept you can't fake a guideline and then there will be new data which means you have to rethink the guidelines. This is tremendously important in Genetics where technology is evolving and the quality of evidence is hopefully increasing over time. We have seen that with BRC testing. And what recommendations were made on expert opinions. Tenures lady we have a body of data and make evidence-based recommendations for people who test positive. And case law will influence a a standard of practice. I will finish by mentioning health professional education. I've alluded to this as an important issue at the federal level where we are looking for support for educational research and resources at the professional leadership level at the public leadership level as well health professional education has potential to enhance the other efforts by enabling health care providers to make good judgments in a gray zone areas. We know that the traditional methods of calling a conference and giving a lecture don't necessarily have an impact on physician profs text -- practice. We know many genetics critics have been created and they sit on the shelf and probably because we really need to go out to the individuals that we hope to bring genetics' education to and talk to them about what is going to be most helpful to them. I think when people have those conversations they discovered that Genetics education for health care providers needs to be focused on the relevance and from the primary Care perspective, focused on health outcomes, that's what primary-care providers see as their mission. I will finish by saying all of the different ways we can provide oversight for genetic testing are complementary or hopefully complementary they have the potential to be complementary and one of the challenges is trying to think test through what reasonably should we expect from a statutory regulation and how can we make that happen but not expect statutory regulation to do everything. What can we accomplish with a combination of a public and professional leadership. What can we accomplish by were hit on the research agenda? What to do we accomplish by making practice guideline process these better, pushing on those standards and what can we accomplish by education I think that issue of thinking through the will of different oversight mechanisms and try to promote a complimentary use of them is where a lot of attention is needed. I will stop there and be happy to discuss more with the committee. If force that you, Dr. Willey.

Dr. Willey, I want to make you aware that we did have a -- I it messed up and called Dr. Willey. Of the accord to write a letter and a note and I get yelled at. [ Laughing ]

That's no problem, Doctor Reid.

I actually write a health, called ask Doctor Reid. Anyway, just to let you know as you participate in that discussion, we had a long session this morning with some guidance that we got from the secretary's office regarding oversight tests. And questions they wanted us to address. You've covered, quite frankly -- your presentation anticipated a lot of the kings of that came in a discussion earlier. Some people may refer to that. The point I'm raising is the activity that we are engaged in as an advisory committee to the Secretary is really in a way which it has not been before specifically advising the Secretary around grander issues we have not been asked before. Just giving you a sense of the importance of this activity as it goes forward. I will turn it back to Andrea.

So are you calling to call me Willey? Dr. Burke, the queue so much for that. And I want to echo Doctor Reid's comments. It really falls within some of the discussions which had this morning. He's done a good job and looking at a comprehensive way of the oversight of the federal state and professional organization in different issues but also to bring attention to our what has been occurring at the federal level three different committees to these specific issues. Like you say there is room for additional oversight for specific goal -- specific areas and improving how we record the testing we do to be a vehicle to educate I like the question he had framed in the last slide treated this goes well with some of the comments we heard this morning with the secretary and some of these other areas we will be discussing. I like to open for questions if anyone has questions for Dr. Burke? Mark?

One of the issues we touched on briefly but haven't talked about in great detail was what might be in the drug parlance termed post-market oversight because what we learned with the release of genetic testing and they connect all practice is relearn much more after the test is out there and being used is the potential impact I'd like to hear have your cake on the post-market debt collection and surveillance?

Thanks for bringing up that point. I think it is an important for it for discussion it is obviously the other half of the discussion about what evidence do before something comes to the market place. The is simple answer is the less evidence of you have when it enters the clinical and renounce the more evidence you are going to need post-market to understand how things turned out. I think that is reality. Most genetic tests come into the political realm based on partial evidence, based on a strong presumption that can provide benefits but not necessarily fool proof. There are some questions that could only be answered over time because there has to be a duration of the following people who are tested positive before you are certain you know what management date should be offered or what the clinical solidity of the test is. I do think that's a very important question and, of course, it leads to sort of the practicalities to what extent would it be possible for pre-up market review to generate conditions for certain kinds of post-market collection would be a be a one question. Another question is realistically what kind of partnerships might me to think about put in place to maximize the quality of the information we get post-market and perhaps the speed with which we answer questions. I think you can imagine a circumstance where a partnership that included participation of the lab offering the test or the labs participation of perhaps some large health-care systems that have a stake in using these tests properly and some appropriate participation through funding that if he could create these kind of a partnership's you might be able to create systems where as tests come in you can prospectively plan on getting certain kinds of data to be sure you understand the uptake, outcome and the ultimate political effects of new tests. I think how to construct and promote those kind of partnerships is an important question. And.

Any other questions?


The other question I had, looking at your slide on the trans relational pathway, having participated on review panel for SETH the, I'd been impressed with that model has walking his through the genius Disease Association to the interventions and implementation with incentives built in to translate this into the clinical of arena with the caveat that there be transparency, educational materials for patients and for providers, but that there is a requirement tied to that about collecting data after the test is in clinical practice for a five-year period of time that is used to be able to insert some of the questions. It is obviously a rare disease test model. Do you think any possibility of taking that model and translating that into something that would work for a more common-diseased based genetic test?

I think you are getting to a crucial issue guess my short answer to it would be all the questions are going to be the same. Some of the logistic issues that arise in answering the questions will be different. They include thinking about a critical evaluation of a genetic test versus alternatives. Just for the sake of an example there has been a lot of interest in the last year, your and at half about gene variants that identify individuals with a moderately increased risk of type to rediabetes the relative risk might be one print five or stew, substantial numbers in the population will have these numbers and they're certainly our claims of political utility. These might be used to motivate individuals toward healthier lifestyles. I think what you think about the model and applying that to a test like this, you have to take on not only the potential focus of data collection might be broader. You also have to think about collecting a comparative data that will be crucial to answering the question. Those of data include just how well do we do motivating people with a healthy livestock to begin with? What measures work? What measures don't work? Identification of genetic risk, the best way to go versus non-genetic risk factors like body index and how do we measure the impact of different strategies for achieving the same outcome at the level of patient experience and acceptability, taking into account the possibility the genetic results might have a list it impacts on people's motivation. A fatal mistake -- and actual clinical cal measures of outcome and hopefully long-term measure I think the questions will be the same and how to answer them will be a more complex undertaking.

I have a quick question you said in your second slide touch up on the reasons of concern from oversight. He started alluding to some of these issues we heard this morning from creditors committee which had questions and one of the questions was what distinguishes genetic tests? We were wondering if you could elaborate or give your perspective on that particular issue? How the issue of genetic sectionalism is a really tough issue. We can't say a couple of things about genetics. One is that Genetics certainly does provide us with a sub cut in a set of tests that have an extraordinarily high predicted value. You don't find medical tests that have a predictive value of what a Huntington's disease test. That would be very unusual and other medical reasons. I think the notion that genetic tests required maybe a different approach to oversight starts with that fact, that there are some tests that are by degree, if not by nature, and different in the kind of information they provide. Clearly as a corollary of that, genetic tests and genetic testing a process these race often questions about the family that other tests don't race. An example there would be testing for mutations associated with hereditary non Pauley poses cancer. A cost effectiveness study showed that the greatest DOW of of that kind of genetic testing comes not at the point where you've tested the person affected but the point after that having the positive test results you're able have to go out to the family and to test individuals with in the family at risk and who could benefit I think you reach extraordinarily greater cost effectiveness if you are able to reach two on or relatives. That kind of testing paradigm is different and raises questions about appropriate use of tests and corollary issues about confidentiality and privacy. I think that is another reason why the there are some oversight issues you need to a genetics. The third is probably a cultural one, we live in a society that at this point in time a huge amount of power to DNA, a huge amount of power to genetic information and people are concerned about that. I think that the state, non-discrimination laws reflect that concern. I think those are the reasons to think of genetics differently. Having said that I think we should also be extremely cautious about not pushing that concept too far. If you look at the example I just gave you of a genetic test for increased risk for type two diabetes that predicts a 1.5 trip to fold higher risk compared to a person that doesn't have the gene variant. I'm not sure that test should be differently than any other risk factor in determining how to use it and political career. At the same time call treat it is likely to be viewed differently and we need to take that into account.

A quick question related to that. I think there isn't an issue with modillion disease which everything is said is very accurate your non-modillion, but for, and complex diseases there are many risk factors [ indiscernible ] and having that market has no predicted value in terms of whether you are going to develop in the future may have some but are very limited. It is not like [ indiscernible ] if you have one of the variants that give [ indiscernible ] you may easily have the disease or you may not. How is that going to be dealt with in terms of this? Is it really -- that serves and even a different kind of protection or not? Having a specific variant that is associated depression, diabetes or arthritis doesn't mean you're going to of the disease are not have at.

You are identifying a tremendously important issue. I really do worry that the very into [ indiscernible ] it is going to be viewed as having the same power as the same test for Mendelian disease troop I think there is reason to be concerned about that when you look at how to mix is covered in the media where you see a headline that says the gene for crones disease but it is a variant of that increase risk a little bit. I am not sure what are going to be the most effective actions though it would seem if we could figure out how to craft the right kind of messages that is an area for public and professional leadership and if we can think about how to approach education properly, both public as well as health professional education that might be where we need to put energy. We need to figure out how to communicate this notion of multi factorial disorders better than we do.

This are very important issues that will help later on frame out the work we need to do. They keep, Dr. Burke.

Ask you do that, Dr. Willey, can I assume as meet go forward we would be able to draw upon you enter expertise from time to time as the journey down this road?

I would be happy to do that.

One of the things I mentioned was the request from the secretary's office did ask about looking at issues and be tough, and the predatory issues and they brought up the thing around professional society and so forth and so on and use our spoke to those issues in here presentation. Falling up is going to be very important.

Think you very much. I'm glad to be here.

We can go to the next speaker will turn to the role of the state. Welcome back Dr. Willey. We are having to have you here.

Is good to know I am not the one that screwed that up.

Welcome back. If we are happy to have you here with us again. For those of you who are new, Dr. Willey is the director of the laboratory policy and planning at the Wadsworth Center York State Department of health. She is also director of cyber genetics or she is responsible for genetic testing laboratory including newborn screening. Over receive the practice of genetic testing and related research activity and administration of the York State genetic service program. I will turn the floor to you and I'm sure we can learn about the Rose in New York state oversight.

And one of the things I try to do and hopefully you are feeling well introduced to the committee is needed for the people that have been here for ever it is impossible to keep up with all of this stuff. You're obviously sophisticated in everything that is going on and I also want to remind anybody that may not have been in the last meetings, what we are getting at is that what people don't often think about are the roles of the state as they have oversight appeared with think about federal government apparatus the dog from the state. We did not have a Doctor willy on the agenda last time she leaped to her feet and educated us at heart. What we also learned last time was New York because so many of the lab companies are based in New York they have this legislative clout. We also heard learn there during a whole bunch of stuff that in some ways our models to what the federal government ought to be doing. As we all listen to this presentation is to start populating that map around who does what and the gaps, we have to have a big special caller for this date and specifically New York for the part that they do and see how that lines up. Thanks again.

I am technologically always a challenge and I really speak from slides. I am frequently asked hundred state back to the position is this. We've had clinical laboratory oversight stenciled Tory regulatory authority sys 1964. We had deemed status' CLREA under 67. The relative section of our program for discussion today this [ indiscernible ] States and all tactical procedures in deployed in a laboratory shall be a proven reliability and generally accepted by leading authorities and really critical portion and/or approved by the Department of Health. That has given this program the authority to review and all lab tests and even those approved by the FDA as supplied by their state. The other piece of tissue injury is in 1964 with the statute was passed was intended to limit the practice of laboratory medicine to laboratories located physically in New York there for infringing cottager State chemistry the statute was a challenge in federal court and overturned in terms of its ability to restrict business, but the same court said that the state of New York could apply its standards whenever they were to any laboratory doing business in the state of New York. We currently regulate lavatories and Iceland, a United Kingdom, a Hong Kong and all over the United States if the specimen is stronger in the state of New York are shipped to a laboratory and work in the world that laboratory is subject to New York state licensure requirements. This question maybe beyond your area of expertise, just to get it right, the FDA which is pretty scary in terms of I mean [ indiscernible ] swaggers Wylie says this is okay. New York can say not necessarily so for the people of New York?

Correct we have rarely if ever done.

You have the ability to tell Wylie to go sit on?

We have the ability of the marketer of the service and the state of the year that for New York and have to meet additional requirements. If you consider in New York considers doing business in Europe meeting and a blood coming out of a a New Yorker in New York. If I am here near can I get blood drawn --

If your inside the boundaries of the state of New York. And when fortunate enough to be at that moment when every company is involved with that process is doing business in New York even if somebody in its at Iceland company makes the lab agent and the blood goes in a tube at that point that company based in Iceland is doing business and your?

Not that company, the laboratory performing the test. The laboratory this in Iceland or the United Kingdom that are subject to our oversight. That could be buying from anywhere in the world which do not regulate the manufacturer, we regulate the user. That was the distinction I needed continue along those lines in some things are regulated like that by the state of New York let's say a for a lab in Kentucky who are United Kingdom, because here is such a big market do those labs follow those guidelines for everything they due?

Absolutely because it leads the U.S. in tort law cases looked very dimly upon a laboratory that meets those standards from the specimens in your that applying from lesser standards from other sources.

I will ask everybody to hold their questions for the end of the session so we can continue with the flow and let her go over some of these issues.

I've been asked is expected of a laboratory in this process and the second half of this slide says lead tribal perform only this assets at the site where they will be performed this per applies primarily to multi site large commercial entities who might want to validate at one site and transfer it to other sites they can do that but they will have to reproduce the validation data at any site they intend to offer the test or ship all the specimens to one side. The must call the appropriate permits category for the test. New York State has 26 specialties and all of the sub specialties give us 70 different categories in which we issue permits to laboratories and every test falls in more than one of those categories in the must meet all of the other requirements related to personnel and proficiency testing at on site inspection. Our review of a validation using certain agents is an integrated program we know the personnel in the lab, we know every category has an assistant director or a director Colin specified credentials they are all post doctoral clinical lab experience a minimum of two. All of their other personnel must meet training and experience they're physically inspected every two years for their quality assurance program their physical location and that are required to participate in New York State's proficiency testing program and it any other relevant proficiency test. Essays that to required specific delegation review. This for approval prior to offering the test. Any S.A. commercially either label as research use only and other words they are avoiding review are any assets develop using agents and we think the Wylie for its clarification but for think it will create significant problems. Investigational use only that have a way been modified from their intended use for approval by and intended uses and the thing that changes the specimen type, and type of analysis the purpose I during screening diagnosis prognosis of target populations as specified in the package insert for an IDE for investigational use. FDA can be used by no fine the department that the lab wishes to add. I am frequently asked what is it we actually look at when we look at a validation package? We have been regulated genetics labs since 1990 but again I want to emphasize our validation Review process applies to any laboratory use it any one of the multiple categories we do have category specific standards by which we look at these materials with these packages are the same of you are doing a hematology and save setting up a new side of pathology at say or microbiologists are genetics. The material the lab submits, tell us what they are calling the test. You would be amazed.

Tells the manufacture of any of the agents they are using other than those they might the majority of laboratories are not making their own agents they are getting them from manufacturers. If using manufacture components what is the commercial designation of that compound. Go to the Kellogg. What is the basic method of scientific principle is this a DNA, it is a subtle genetic using a fluorescent hybridization process. What is it they are proposing to do appear what near a state permit category and this takes great insight to they think this belongs in and we will tell them what they think they are right. The implication of this was a lab previously only doing S.A. for chromosome rearrangements they will have to qualify for a cytogenetics permit and they will have to hire someone who leads the qualification of the site oogenesis. There are implications. What specimen type to they intend to use, blood, tissue, bone marrow? What is their target population? Is this intended for individuals with symptomatic with this disease, intended for general population screening if so what are the population parameters is it a diagnostic test a screen test a predictive test is a qualitative or quantitative in its intent and how to they intend to establish its performance. I they going to compare it to another existing S.A. and? Or are they going to use clinical status of test subjects as in a new test. This list goes on and have it in your side and I won't describe each how are they doing the task? Down to the procedural manuals that they would provide to the technician in the lab who would have to learn how to do the test. They must also provide another practitioner information including the limitations of the test. I think this goes to that issue of how to we disseminate information appropriate to hell they condition interpret the test after he has done it. Relying on the laboratories to draft this material but we do critique this material often too great extent trade principle how did they know it is a clinically valid and we talked earlier very often these new genetic tests it is based on ligature description of some association of this analytic marker was some political condition. What the description of the actual gene structure. Political liberty is generally for test ledger based on observation at least initial seed trade where they getting their controls? How are they going to calculate and interpret the results. This goes to that question. We don't care whether it is a single satellite or a chromosome rearrangement or is multiple allies taking direct credit characteristics it is the latter we want to see the equation and they statistical basis on which that equation is derived how is the laboratory going to interpret the results? What compounds are substances interfere what are the limitations of the test this goes to the issue of what patient population has the laboratory study. Some of these are her their trading access to a known positive patient is sometimes close to impossible. Laboratory will wish to offer the test having never seen an abnormal. We have never approved and I laboratory to offer an analytically valid test that can detect the target whenever it is so long as they inform the practitioner who is going to order the test prior to ordering the test and at the time of interpreting that they laboratory is reporting the results but they've never seen an abnormal and therefore their ability to interpret these results is limited. For germ line, how to they actually describe the test her for German wine a genetic test they have to indirect state document their compliance with our privacy and confidentiality statutes which a civil rights 79L law applies only to assure my genetics and predisposition tested, non-stick to that test about Ross Laboratories just apply to any genetic test. We want to see their sample reports including all necessary disclaimers. We want to see their scientific references. They can simply give a list. Finally, the critical component of this package is [ indiscernible ]. How many specimens have a tested and what do for those results and what basis are they calling these animals or abnormal? How are they and recording the data but I would caution we frequently review and approve it packages and genetics that tested ten normal patients. Quality particularly if they buy and ASR, the FDA has agreed that Manufacturing is a GMP manufacturer. If they buy a RUL eight -- they will have to establish some means by which it lives verify the DNA sequence or floor chrome or whatever. We try to make the point to manufacturers as well if you are gorgeous sell agents to laboratories developing clinical tests, you're not doing them any favor by being a RUL vendor. If you are 88 vendor at least the laboratory can rely on the product for whatever it is Terry the must then establish performance characteristics, the accuracy, precision reportable ranges sensitivity and sensitivity and how many genetic slabs don't know what those terms mean Karen work performance evaluation is based on we need to know how they've established that it isn't the result of this test it tells them that are normal or abnormal their head to head [ indiscernible ] however they are calling this than normal or abnormal patient. What they're doing their validation the analysts should not know who is normal who is abnormal when they get this discrepant results how they resolve them and calculate their predicted value is a must interpret the test. Our standards require that the report with an interpretation symbol for a non-geneticists' position. If we bore them that's too bad they can skip it want to make sure those of others see something they might be able to understand of their references for germ line genetics I get results. Does it predict a lot of assets are not indicative of risk factor but they don't predict disease. The data for actual runs in what is their Quality assurance Plan and internal design. In York State we offer our own tests. We occasionally test the ability of a lab to perform the [ indiscernible ] but it would be for one are to target probes at any given proficiency tests event. We ask all of these laboratories to have some form efficiency of placed fourth year for every and like treated no commercially available efficiency tests will provide them with materials for every gene they are doing. For some of these labs there is no commercially available material for the gene that they are doing. They will have to have developed their own probably using materials derived from previous specimens the difference is what our surveyors visit they will ask to see if the data and the design of that asset. We're frequently asked about work load. Here is the statistics and stripping keeping them since 1995 this program started primarily for Genetics although it applied in 1990 because there were no FDA approved [ indiscernible ]. In 1995 when we started keeping the numbers three actually looked at eight they're all genetic in 2006 will look to edge 586 and the majority are genetic but this includes not only genetic testing chemical, the de base, it also includes for us the categories genetic diagnosis, forensic DNA technology his stock compatibility and oncology molecular markers and they get thrown in there as a genetics. Project testing workload in 2006 with unfit 86 DNA based primarily single gene disorders five biochemical types of [ indiscernible ] this would-be enzyme metabolites I personally look at 44. Look at three paternity identity and a one forensic these to be different markers and 92 molecular oncology markers for changes and expression in Cancer periodic are often asked what is the impact of the New-York state program on testing in this country? We currently have 70 laboratories in the country in five of these are pre implantation genetic diagnosis for genetic testing should be bold print my PowerPoint technology is limited. Thirty-two of those performed by Chemical Becky anything from qualitative amino acids to tender [ indiscernible ] 71 including four that from freon plantation I include those because that is a category the state of New York the impact has all major reference laboratories solicits and none of them have their primary labs located in New York therefore subject to New York lab including approval of the house [ indiscernible ]. Has been estimated by others that as much as 75 percent of all cytogenetics and genetic testing and performed is the U.S. and that is in terms of number of specimens tested not in terms of the number of labs saw I have given you a list of about list of 170 and it is not in terms of number of analyze because there are lots of rare genius testing that goes on in the labs that do one for to diseases that may not fall so it's not the number of labs are a number of tests but it is in terms of numbers of specimens tested her subjects to near a state oversight. Torero a medical malpractice cases have not looked favorably on laboratory is trying to get away with using lesser standards. I was also asked to review what I know from other states and their applications are 26 states have statutory authority for oversight of the practice of clinical laboratory medicine and some respect or another. There's only one other state that has exempt status and that is the state of Washington. They do not have specific standards for genetic testing in the state of Washington the State of California and this newborn screening and prenatal screening program has rigorous review to New Bern screen newborns screen follow-up and female screaming that go on as part of that program. That does not extend to other genetic testing carried the state of New Jersey does apply personnel standards related to the port of genetics to their labs that perform genetic testing but I know of no state that actually requires have validation data for individual [ indiscernible ] to be reviewed perhaps in the context of inspection at least restate program does not involve. You not another geneticists laboratory I was also last to address the issue of do we know about bad Tass and harm that might happen is specimens are going from New York to one of these labs that wishes to offer unvalidated [ indiscernible ] of that we believe are problematic we are aggressive sending a cease and desist letter. We warned that we do have the ability to find them to thousand dollars a day or $2,000 a specimen. Some of the recent examples have been a laboratory in New England that was offering to predict the gender of fetuses for moms when they were about five weeks pregnant. There we believe the significant problem his analytical solidity. Therefore predict male fetus in the have some predictive female fetus. For clinical publicity if you could do that, you might be able to detect gender but frizzed never received any validation materials and the other laboratories have been offered to do snipped profiles and offered to provide the commission with a CD which have the patient's entire snip profile. They tell you your position will be able to provide interpretation to predict all of your medical needs. Since they have not been able to document the clinical and validity for the vast majority they are authorized in Europe to market testing I believe all lame four of their thousands of snips. We've had serious challenges from laboratory as they will do a detailed profile primarily of since they claim are linked to particular genes that may predict here response to a nutritional products not unlike the survey done again, the lack of clinical validity there is no association with disease and that we would say there are testing a specimen derived through the human body for the assessment of some components for purposes of health assessment. It doesn't have to be Disease Assessment it can be tough assessment and the consumer expects to be advised from their state of health the response to their nutrition and therefore will say they should not be doing this. The other hand area of big concern is [ indiscernible ] genetics. There are entities out there who are offering profiling for your ancestors. Profiling for paternity he got the kid for the we can send us a little shake swab and you've always wondered and we will tell you if. Since we regulate forensic DNA, the private eye and the personal private eye if you wanted to know if there was a little infidelity going around send us some sheets and in it York State consumers cannot legally order laboratory tests other than those approved by the FDA for over the counter self testing so that the laboratories can not accept a bed sheet a sheet swab, whenever and in genetics they cannot accept any of those tests without the written consent of the persons being tested. We also tell the laboratories they must cease and desist there are issues, New York State can order tests and does not include genetic counselors and to can receive test results. The greatest challenge to the near state program is this is expensive. The program costs for the personnel and the expertise to undertake all of these reviews with significance we currently have a hot lawsuits pending and cost to the laboratories is also expensive. The preparation to these delegations and a format that is readily reviewed by the staff and department takes time and the major criticism is there's a turnaround time to try very hard for 45 days five had passages have been my office for a year in very often they go back to the laboratory a couple of times before they get one approved. It is costly in terms of time, cost in terms of expertise and costly to the laboratory. The biggest problem is how labs frequently ignore previous critiques and poorly organized submissions so they end up going back a couple of times. In terms of we talked earlier about post market surveillance. It is Stanley been our experience a few will the health-care market dross the survival of the passe. It is not good are predicted for not meeting needs of the medical community and the laboratory will withdraw its permit our next inspection and tell us they are no longer offering the test. We do have an active program for receiving complaints and we do investigate and as I said we do have the capacity to find laboratories' if they told us that we work or default one protocol now using another when they can be told the must cease testing. They're is a lot of enthusiasm for new tests. As a side of geneticists I would say three or four years ago the big new test was fish probes that were going to detect all of these cryptic -- we have only three laboratories that were approved only three laboratories Balt bothered to make their not bear package a multiple probes. So there are three labs that approved to do it free the essay and cross [ indiscernible ]. The new test that has made enthusiasm that this sort of related to cytogenetics is compared to genome hybridization and there are a few labs that are saying we are getting some of positive hits but we don't know what they mean. After you get the array C G. H result in have to go back and verify it by conventional fish and essays on chromosomes and we don't know how that is going to play out. We have four Labs which have their validation approved we also have a system in Europe don't make physicians wait until we get around to reviewing all of these have physician wants to order a test that is not offered various only offered any they can make a specific request to the Department for what we call a non permitted Lab approval that patient back test that lab and the letter had that goes back to the ordering physician says you can send the specimen copy goes to the lab we won't find you for this patient for this purpose but the letter from the position also says will know anything about this test we don't know whether you'll ever see a result. And so we do have a quite a few of those requests we have a 24 hour turnaround time so now you can offer the test put all the right to decide wrist's into it. I would be happy to take questions if there is time these are very comprehensive. Have a couple of questions. In the material submitted for review you commented when an evaluation is based on clinical outcome and you make an allusion laboratory crossing, is that a clinical validation or do you actually look at the political utility of test? We do not examine clinical utility by clinical outcome of misses pace should-it clinical correlation I calling the station a known positive or a known-you do not cover the clinical.

My second question is you have been able to identify these consumer laboratories that are able to go after them. How do you know they are going after our biggest challenge is the Internet. The direct to consumer marketing of anything. Health care in general, pharmaceutical and laboratory test there are one like the gender mentors that are quite obvious is a laboratory entity soliciting specimens there are also several companies out there that have established themselves as test facilitators they're not hash a performing and a test of their marketing to the consumer population for a significant mark up often times ten times the money the lab would cost sometimes they're using legitimate labs for legitimate validated essays in which case their state also has some lab practice general business loss regarding directed to patient billing we do not allow third-party facilitators the laboratory must bill the patient and not billed through a facilitator. That is the other history.

One more version before we open up you mentioned that a company has submitted a test with a number of different [ indiscernible ]. And then you only approve the use of four of those games. What was the rationale for approving only four versus the rest? For those for they were able to document from the literature there was a known association of that snip in that region with a known physiologically active gene product or whatever that is associated with a particular risk for disease predisposition. Those four meet the criteria of being clinically valid and all of these steps analytically valid it's not hard to detect.

We are open for a couple of questions.

You mentioned reports for positive and negative when the big has your department begun to develop any standards about what the laboratory should be reporting back in terms of what has been Dawn to leave them and that ambiguous classification? Do require certain steps to be done before one can stop determining whether it is a true positive or a truth negative for variants of unknown significance for DNA and I'm looking at something one of my colleagues provided I think they have to be able to describe how are they going to resolve the issue are they going to sequence, sent it to another laboratory. How they report it and resolve at a not a going to put it in a data bank to follow up at a later point, those kinds of things.

We see that in hist cider genetic [ indiscernible ]

The question boils down we're here earlier? I've been here all day.

It would be great if you could help us as Andrea and her committee of shoe can hold together this map of what exists now and what I the gaps and if you could give some thought to that it might help Andrea steam out a little bit sort of SEC the activities. If you couldn't -- I'm going to write a letter to your boss because you are devoting a lot of extra effort to this stuff so we need to write a letter of thank-you. [ Laughing ]

I've been coming to these committee meetings since 1997.

PRN to write a letter of thanks. If you could think the fall he would advise and the best of all worlds what we should be advising so that we don't have this redundancy. We don't want to spend the money of the people in Europe and the United States and this seems a little bit unfair for citizens in New York to get hit twice. Because I assume New York still pays taxes even though the of told the FDA they are not.

This program is supported by fees collected from the regulated laboratories and unlike CLEA we do not have a cap fee structure. We charge a very small percentage.

They're probably not pleased with that?

They are suing us.

I think we really do want to sort of lay that out. If we can talk to offline but if you would be willing to do that?

These collaborations and corporations are very good. Relied on professional organization lab standards when laboratories want to argue about how to go about validating an asset we pointed to the documents have that professional group.

If you could be the head of CMS for a day, he if you had a blank piece of paper and you could just do this the way it ought to be done so all would be lined up right, I would be interested to see what would come back from that point of view. If you could be in charge of fixing this, what would you say?

A break? What is that?

Of course, you can have a break. I believe we are due for a break.

Ten minute break grid it has to be only ten because she asked for five and I am being a nice. Going.

Please stand by for realtime closed captioning services

Buffee Powell-Merrick: Audio Conference Number: 301.985.4641. .

We are going to continue. Do you want me to yell?

Is that what you want me to do?

Come on everybody, let's continue.

[ Speaker/audio not clear ]

I know, my teenager.

We are a little behind schedule. We will have the next presenters going back to back and at the end of the three speakers, we will have the questions for all of them.

Okay. Now, we will turn to -- now, we will take a closer look at the private sector. Beginning with the genetic testing laboratories with the College of American Pathologists. This is Gail Habegger Vance. At the university school of medicine. We are privileged to have her today.

Doctor, vans?

Thank you. Thank you for the opportunity to present the college of American pathologist accreditation program to you. I need to keeks -- explained to you that I have reviced the -- revised the order of the slides. That's the blessing of the posh -- power points. There will be a few out of order. The presentation of the overview that I am going to discuss today is the shared goals, [ indiscernible ] program, pathology, genetics, and the [ indiscernible ] that cap offers. The goals that I am sure are the goals of this committee. They are lit cly and clinically valid. Woe are a -- we are asewer of the -- assure of the agency, and the health of the patients. We are in the improvement of the laboratory gobbed test. -- developed tests. The accreditation program -- program is that the testing are provided by the high cred den usual labs. Laboratories have [ indiscernible ] in place and there is increment el approvement and testing. And that that testing is not impeded. The college as we are in the private organization of the discussions, it is a professional organization. It is proposed of 16,000 [ indiscernible ] pathologist. The [ indiscernible ] program is aprofd. It has like New York state it is a hire -- higher standards for the regs. We have specialized requirements for those inspectors inspecting genetic laboratories. And many of the standards that are in addition to the [ indiscernible ] standards arise to the scientific resource committies and in the college of the American pathologist there are three or four of the scientific resource committees for the pathologist. They are also from the scientists. You are -- you will here from -- hear from Sue Richards next.

The laboratory that is enrolled in the laboratory accreditation program is to to -- is required to update their testing. This is for them to not only know what they are testing nor, -- for or also to test for the P. T. It again in 1961 for the [ indiscernible ] and it was initially voluntary rei. There was a checklist with inspections in 1976. And then years later the checklist was. As a member -- they are required to under go biannual inspections. These inspections take claes -- place in the plan -- laboratory, but by a team of external reviewers. They will go to the hospital and the hospital lab and inspect that lap story -- laboratory. They are be a -- by a team of inspectors. They are scientists in the field of what they are inspenting. There is a checklist for the inspector and the lab story and it is used as a a tool. There are approximately 18 checklists that [ indiscernible ] offices. -- offers. It -- over half of those requirements approximately 1700 questions are in the [ indiscernible ] standard. There are standards not covered by C lex -- collie ya,. Sections within traditional disciplines that go beyond the standards are the [ indiscernible ] testing much like site genetics, computer systems, prenatal standards, and flour ride testing standards. The laboratory, this includes the genetic plan stories are required for inspection every two years. They require special knowledge of the science. Therefore inspectors are clueing -- choosen for the checklist and posing the -- posing the -- possessing the skipping -- skills. That I shall are training modules for the live inspector training seminars or online interactive training modules. And there are also [ indiscernible ] for discipline -- splin -- discipline inspector areas. There are also team leaders that must take the man story -- mandatory testing and must take that every two years. There are teak -- team members who are required to do retraining every two years. Some of the standards that apply to the genetics again exceed, [ indiscernible ], everybody is aster Ricks -- aster is ks here. Recommendations for genetic counseling and studies and the turn around time. I will give you examples for that just -- in just a minute. Other standards for the capital beyond [ indiscernible ] is the pastology -- pathology checklist are they characteristics of the documents they added. And internal study results. Does the final report inlewd the sum -- include the summary of the methods. The analytical interpretation and the [ indiscernible ] The molecular checklist considers all of the testing and it always -- also inherits the genetic testing and that is his to -- his toe compatibility. Any testing that involves DNA, RNA, or the [ indiscernible ] would constitute the molecular testing and that would be by a standard of the moll lek lar pathology checklist. Tech negs are -- techniques are also included in this checklist finish -- for the amplefully occasion and the realtime, [ indiscernible ], and the araise and the hibernation. Ann was just talking about arise -- araise. They are in now in the resource committies and offer that as a [ indiscernible ] test later on. We are also setting standards for the analytical and clingal call -- clinical studies if we can. There is a genetic testing checklist. There is a molecular checklist. This is for the Amy nottic, knee Oh playsic plod, and bone mare row. It has to do with the cultures, band [ indiscernible ] and resolution and as I stated for the hibernation or the molecular genetics. What happens if a laboratory conducts it's visits abides by the standards and is inspected at the time of the inspection the inspector sees that the laboratory is not in compliance of the checklist or standards. Then a [ indiscernible ] is sited. If that holds then there is a -- and in other words there is a discussion of whether it is deefficient or not. It -- deefficient -- de official or not. There is a 2002 tier review process. This is composed of the staff analyst of cap and also a prases -- Prague path -- practicing pathologists. They determine the add quo si of the -- add a -- ad quasi of the plan. They reside with the accreditation committy of the counsel of the accreditation. This is the lab experts who render their decision. On alternate years if a lab is not being external inspected they are required to complete a self-inspection and complete the results of that self-inspection. The results of that go to the inspector pocket. And they will have with them the results performed by the laboratory in the interim years.

Just to give you a -- a -- some of the information that the -- of how many labs that cap accredits. There is about a total of 166 laboratories acredded. -- accredits. There is approximately -- -- 700 with moll lek lar pathology discipline. As included in the modern health care in is 9806 the -- 98over the hospital. These are accredited by the American college of pathology. Some of the deficiencies that are done after the pathology. Hay are -- they are listed here. You can see the approximate number of that. The first one reeds -- reads where there is a no commercially or external PT and that is in semiannually. That's in compliance with [ indiscernible ] And the reliability of the analytical testing. About 3.9% of the laboratories received a deficiency in this. They must respond to cap with an action plan on how to take care of this deficiency. Is there a summary statement signed by the laboratory director in approval of the test for the clinical use? In this situation there is a about 3.3% that received a credit for the deficiency. There is a rapid rorting -- reporting test that is available. That is the final report not the preliminary report. At least [ indiscernible ] spes man. 7.6 were sited for -- cited for this deficiency. Think is -- this the for the [ indiscernible ] marrow blood. 6.8 of the laboratories were cited for this. This is am -- this is coat -- quoted as applicable and appropriate. There is three criterias that they must be used if one of those are missing then they are cited for a deficiency. That's an oversite of the inspection or the overview of the inspection -- inspection sprues. I would like to go to the proficiency testing. This allows the laboratory to evaluate their performance and improve the accuracy of their results. They are told the category, but they are not told what the spes man is. The -- specimen is. The results are evaluated by the scientific resource committies or resource groups. And statistical reports are provided by cap. -- crap. --

One -- this st u -- this is one of the few that offers this testing. Some of them that are available are the cloam sone yam and molecular analysis of [ indiscernible ] and leukemia. This is an al beer rich that shows you what happens when there is a PT failure in the laboratory. The al beer anymore star -- starts of -- on the lested -- left. It -- if it receives an unsatisfactory then it gets a warning for that. They are provided with educational material on how to do better. They are then monitored if they receive one unsatisfactory report of the next 2PT events. They are given a cloys -- choice to decease testing on that or [ indiscernible ] document corrective action plan. If they document the corrective action plan they are continued to -- they are allowed to continue the testing. The next -- if the next PT is satisfactory then they are monitors for -- monitored for another PT cycle. If they are good then they are good for another testing and they start all over again. If that PT is again unaccept able they are required to cease testing for that lite up. The Earl list -- Earlist -- earliest. Bio chemical an get nettics committy. It's a busy slide. I will go through it with you. On if left hand side of this slide there are different anal lits -- lits. The number of -- lites the number of labs were [ indiscernible ] Right underneath of that is the appropriate interpretation for the value of the receipt or the day that discovered it and that for 2006 for A there were 786 laboratories that participated in that PT. 782 obtained the proper documentation for that ANAL IT E. And both challenges were 88B was 99.6. I will read the annual lights. There is [ indiscernible ] [ indiscernible ] interpretation. [ indiscernible ] mall la retard dation. , he Moe chow Moe tose sis. And he Moe globallen SSCC. The laboratory of these were quite good in 2006.

So in conclusion, the cab -- cap laboratory accreditation program, we believe in your module in the lab testing to create a test that improves the patient care and protects the prublics -- publics health and does not stifle or impede the test development and improvement.

Our recommendations to the committee are that the private organizations including the cap and laboratories should continue to build on the work with [ indiscernible ] which has been successful over the last 15 years.

Thank you.

Now we will go to [ indiscernible ] and a member of the CDC [ indiscernible ] working group. She is a chair of the quality en -- assurance committy. There is a moll lek lar test for the commit -- chemical testing for the rare genetic disorder.

Dock o -- doctor Richards.

Thank you very much for visiting me here to reps this -- represent this area. So I am involved for the number of standards for the groups. Aam going to be -- -- I am going to talk with the American genetics in the various groups. I am also going to in this big and important project.

Professional guidelines are important to us for stetting -- setting standards and practice. There [ indiscernible ] there is multiple mechanisms that we set guidelines. One is through the laboratory I understand -- insurance committee. We also have the mechanism of developing special projects of commission guidelines and I will try to give you examples of all of these throughout the talk. There are three different types of tame -- statements that would be used -- used -- viewed as practice guidelines. Policy statements, clinical roles, and then accompanying that quite often is the laboratory standard and guidelines. It addresses what we are addressing here in this meeting on how laboratories should perform specific tests. The purpose of these guidelines, while they are voluntary, they provide an educational resource for the laboratory and we want to ensure quality of the genetic testing. And with that we address technology and procedures in the clinical genetic laboratories and all of the specialties. I am going to turn to the quality ashyness -- assurance quitty -- committy. They are there for developing technologies. And monitoring laboratory proficiency testing. We have [ indiscernible ] that attend these meeting for the cap resource committy. When they come in we want to know how they are using them. We use these as triggers. If they are performing poof -- poorly as we may have seen in the mid 90's then we address it with the guideline and we see the guidelines improve. Our guidelines are a notebook or a manual which improves the updates. With have -- we have in 2000, which I will show you. We are also showing monitory lab reports going on through time. This is part of it with CDC as far as looking at reporting issues. We funded a resource for that education, and that's not for the ennettics -- genetics committee. We try to be involved in the different groups and organizations and do workshops to make chose -- those aware that new guidelines exist. Getting the message out is part of the issue. That is for the test quality and the discussion of the results.

Who is involved. I try to answer your who, what, and why questions?

Who is involved?

We have three week -- working sub committies for the -- from the laboratory insurance committies that we have a bio statistician that help with st -- the stat tis call work that we need to look at. We choose experts in the field of talks -- groups that we are talking about.

The [ indiscernible ] is made f -- up of clinical begin -- again net tises in these areas. The [ indiscernible ] institute say finish say [ indiscernible ], D -- CDC, gap, representatives working with the CDC reports and how that is translated with the physicians in efforts. We have a pulse on what is going on the get nettic testing and we try to address new issues as they surface. Just to recap, how do the standards for the genetic testing. They set practiceses in the field, they use checklist for cap as a regulatory requirement for accreditation, and they are used for the testing challenges and test interpretations through the cap process and the educational resource.

So, I want to -- want to give you an example as how railroad -- our private guidelines have interacted with the government. I am going to use an example that came out of the CDC and ifs -- niefs niefs -- NIH testing.

It was the first national meeting that would address quality and availability and a -- accessibility for the testing. Many of them came to the table in 2005. As a result this is where the project came out of. There were other products from that meeting that might not be recognized. This is the charge, the diagram that I believe mark Williams was referring to. This is the get nettic testing for the rare diseases. As you can see, as the government can do, it was a complex module. There is so much room for interface for the professional, government, organizations and translating the test into ts ssh service at the end. There is a need for the guidelines and standards to ensure quality assurance for the genetic testing. This is where we feel we play a big role in the development of the standards. We want to work hand and hand with you. This is the other product that came out of that meeting. It was a laboratory guideline developed by the American college of medical genetics of the guidelines for the ultimate Tra rare -- ultra rare disorders. There was a need for that guideline. I listed here what each section addressed. For example what type of technologies are needed for this testing. How might a person might need to be more qualified in this area. How should test validation be done. Quality assurance programs and what applies to this type of testing. We address preanalytical, analytical, and [ indiscernible ]

We even involve genetic testing to this where it is emphasized. We provided samples and laboratory document -- tests in this document. This has been a helpful resource both nationally and internation lal -- internationally. We have a number of guidelines that are being developed through the various working groups and this list here is shown for a number of documents recently that have come out of the bio chemical again net kick work -- get -- again g -- genetics. Cystic fibrosis was a guideline of course that was prompted by the [ indiscernible ] to offer prenatal screening for -- to all rejected couples. That guideline for the laboratories came out shortly after that recommendation came through. The fragile X guideline was trigged because of the -- triggered because they did not perform well on the cap proficiency test. Now as far as -- as ta -- a result of our guidelines they have improved.

There are various techniques and guidelines for the cancer. We do have a recent guideline for CGH raise. Hand and hand that goes with the practice guideline. Not only are we quopping -- developing specializing processes, but we have programs that we are wanting through our committee to ensure the genetic testing. I would like to show you the quality program for the -- they are for the advance on the -- that are suspected for the [ indiscernible ] that would pre -- perceive active genetic testing. This is something we are looking forward to next month.

Let me turn to how standard development is supported. Our committy from AMG is comprised of engineers we all have day jobs. Commission documents from ACG comes from industry grant funding and the cost of that can come at a vor -- very high press. It's estimated that it is estimated at $100,000 per standard and guidelines, this covers meetings costs, reviews, and administrative costs as will. And you might be aware of the act sheets from A CM G. The standard development does not come cheap.

How is standards developed?

First is to identify a need and to make sure we want to move in that direction and once there is a go ahead we identify a leader for the project who really is the one that is responsible for getting that written, but it is a work committee assigned of approximately five or six members to company that leader and through conference calls and e-mails they develop documents. I will impress upon you that with all of the standards and guidelines we have developed through this time there are 23 hour meetings face to face and the rest of the work is done behind the seens. Screens skeens. With no funding available.

There is a process for this that we are trying to [ indiscernible ] the [ indiscernible ] con census review. We are triffing very -- striving very hard to do that from review from the work groups and the -- and the committee that we send to experts in the field. We postthe -- post the documents once we are happy with them. We take member communities, we take -- comments we take those to hard. We take it for approval, and if it is passed it goes to the website and then poased in genetic and medicine. There is a continual renewal provision, and -- and either we continue or revise ever year. The more guideline you get the more you do. In our guidelines we say that are completely voluntary, but you have hear that they are for developing standards and proficiency testing and modules. They are enforced through cap. How do they regulate to the quality requirements. We have hire -- higher standards as far as the requirements we have in our standards. We have paid attention to the [ indiscernible ] recommendation, we have coordinated them preempalely in -- pre-emptily in the requirements, we [ indiscernible ] and we also interact with the urine -- European, and commerce parts for this word wide. -- worldwide. We are for the [ indiscernible ] standards and the reporting standards.

Now do these standards interact and work with the government. We do follow the golf -- government on the propose db proposal, whether or not they want to hear from us, we do. We develop a committee and work groups for the guidelines. We produce documents through the CDC and through the [ indiscernible ] and now through the gap process with the evidence based reviews that will be useful in our decision making process. I have showed you the ultra rare disorder examples in the guideline. How do they advance with the technology. It is a new example. If they change we are quick do make the changes to the document. This there -- this is a limited document for the resources and challenges. This is to reflect that we have a big job to do. There is -- there are a lot of genes and there are a lot of clinical testing that is available and new tests coming on all the time and when you ask me to address if there are gaps and standards, I can't stand here and tell you there around -- aren't. There are always gap els. I think there is a gap that perhaps this group might want to address and that is a gap that ininvolves a -- insolves an -- ininvolves an area that you are going to be speaking about tomorrow. I think what we -- is happening now is the license sure of the tenty -- tentity or the expertise for the pro situation si test -- proficiency testing and have the resources to do that.

Are there opportunities to collaborate?

Salutely -- absolutely we would collaborate with these efforts. We do think that funding is an issue. We could use more funding for the develop. -- development. We coiled have a -- could have a full time individual doing this and still have more to do.

We think meeting to break through to discuss these areas and to give inmute through the different stake holders and groups and users would be a very good step. Providing more funding for the based reviews and the orders such as the E gap module. And providing funding for the [ indiscernible ] One of the documents that missing for the farm ma code -- Pam -- farm coyed.

Doz -- do the laboratories o follow the standards and guidelines W. we -- we think they do. The cap surveys from Gail Vance show that the laboratories that are participating in the survey are doing quite well. We believe since we were so connected with this that that means they are using those guidelines. This is a resource that I would encourage you to look at. It is freely available to everyone. You don't have to belong to A CM G to get this information. It is free on the website.

Thank you Sue for the wonderful presentation.

We will move next to our next speaker, doctor Berg. He will connecting with us through the conference.


Video conference.

We will start to introduce doctor Berg, even though he is not here. He is to discuss a development on the practice guidelines. He has been active of this -- many channels in this area. He was a process or -- professor and the chair. He's a member of the IR M -- IH -- IR M working group. [ Speaker/audio not clear ] Post traumatic stress discord.

Doctor, -- doctor Berg?

Brief brief -- brief pause.

Goods afternoon -- good afternoon doctor Berg.

[ Speaker/audio not clear ]

Thank you.


[ Speaker/audio not clear ]

We gave your presentation while we were waiting for your connection. Please go ahead.

Thank you.

It's a pleasure to be with you this afternoon. I wanted to start with this slide. When it's spayd spaed -- [ Speaker/audio not clear ] it's still early on the west coat -- coast. I appreciate you allowing me to do this rather than traveling.

In in -- in the out line there is a map of miff -- five states. I spent a good deal of my time traveling -- traveling around the issue. I can tell you that the issues of genetic testing is a very big issue in our regone. Regouge -- region. I am going to be -- spend a few minutes giving you an overview of the guidelines. My baked ground is not -- background is not in genetic and genetic testing I worked with the [ indiscernible ] task force for a number of years with the institute of med sign for the guidelines of that [ indiscernible ] And I am on a C PC panel with the genetic testing that I will give -- get to you in just a minute. My -- mine are more on the guidelines than it is on the get nettic testing. Guidelines have always been with us. And we've always had them. Professors awe then Kate and textbooks give us advice. The problem is that in the past many of the guidelines have been wrong. They have been well intentioned and well practiced, but they have been wrong. There is a wide variation in outs come and -- outcome and costs. [ indiscernible ] is complex to get the [ indiscernible ] to get their arms around it. Patients are more interested in the decisions and guideline that are pull cly -- publicly available. The [ indiscernible ] of the guidelines is that we have better methods to again rate them -- generate them as we have had in the past. The [ indiscernible ] is enormous and growing. There are guidelines with thousands of articles on the topic. We hope to improve the quality of the decision making and increasingly provide justifications to the patients, payers and the legal systems as to why the decisions are made the way they are. The guidelines are useful to transmit medical knowledge and to assist patient and physician decisions. There is a -- ways to help political norms and that is good -- and for good practices. They are -- they are finish -- for testing and [ indiscernible ] and all -- also for legal and medical evaluation. The technique where you lock the technicians in the room and tell them to figure it out. You don't know the process, but know the guidelines are explicit in the evidence base. They should be explicit and clearly laid out and transparent and so you can figure out how you reached the conclusion. And it should also be accountable.

Here are some of the characteristics that the institute of medicine believes should be specified on the clinical guidelines. You must be clear on the condition, the health practice or the intervention proposed, the health care target, the type of cling nishs -- cling in addition, the purpose of the guideline was to have clinical care and purpose. And final the ours -- source of the guideline and the sponsor ship and that is who is paying for the guideline to be instructed. The health and policy has specified a [ indiscernible ] of characteristics these are things to look for on the clinical guideline. How is the panel selected. What are -- what were the screens of the interest how were they specified. How was the literature search strategy comp rised -- This is the beaks back in the -- black box in the clinical guideline. To be clear about the clinical outcomes and final the process should be sen tiff to -- sensitive to cost and practicality.

There is a separate slide on validity but the guideline needs to be valid and it need to do pass the search. It knee -- needs to applicable and clear. It should be reviewed before publication and it needs to be well documented and final the issues of the clinical guidelines here are the characteristics that [ indiscernible ] recommend. A valid guideline should be clear on the projected outcome and costs and on any costs for the policy rationale and -- rationale and based on evidence. This is a -- an extremely review of the guidelines. I see a number of ex -- people who are experts on this so I would like to move on. Again I see a couple of people in the room who is familiar with this. That's the gap process and that's for the disease and applications. This is for geo know mic applications and [ indiscernible ]

This is a slide of the parents of gap. This is where they were formed. There is an obvious growing of genetic tests. You have to go to internet to hit genetic tests and you can see how many checks you get.

The cling niches -- cling in additions need medical advice. They would really like to know if they are ready for the clinical use. Final one of the parents that I think is a national evolution that is used for the process previously is for the use services tasks force. Here are some of the challenges that I see. First of all as opposed to the some of the conditions of the task force work for example of breast and coretty call cancer they are uncommon and clinically rare. The interventions or the test character is -- test characteristics change quickly and the clinical outcomes have not been examined in detail. They may be very effective test in a hylly selected -- highly selected population and when they are [ indiscernible ] that have -- they have a poor predicted value. Many of the test are in the [ indiscernible ] and market for the [ indiscernible ] reasoning with no clinical trials yet. There is an important over lay of advocacy and that is from agencies and special agent support groups. Gap is a none regulatory panel, that is we don't have an inside track on the regular employees. We have independent and [ indiscernible ] employees that are very disciplinary. We have a conflict of review so no one has made up their mind of the testing and we are trying to very hard to make the panel evidence base, transparent, and public accountable. Our goal is to establish and re -- evaluate mechanism of the preand post[ indiscernible ] of the United States. We have spent a good year of our first coupleover years on the moth oddology -- method -- methology. Dee viseing -- devising a mothology -- methology. There is an lit tick validity which you look for in the testing. It has presented it's own particular challenges to the panel and final the methology to the clinical outcomes. Many of the outcomes are different than the ones we look for the domain of medicine. We have gone fairly far, I think of advancing the field, we are pretty far in a manuscript of the publication of four cat gores, one of the categories is the diagnostic thinking and impact, the choice, and the impact on the family and the society.

Our work plan is to select topics and define the outcomes and conduct reviews and then to test the methods and the first topics we are examining is the [ indiscernible ] and sew vary January -- oh, -- owe var January cancer. So the scope is narrower and not as much depth. So our first review is the AG101. We are midway of the three year project that has been extended to four and rumor has it will it be five years.

I thought -- I thought I would conclude by walking you by -- through one Tom -- topic to give you a sense of how the panel works. This is a seen nare Oh of how we -- skeen near Oh on the test -- testing. There is a selective ser row tone anyone for none psych cottic depression or is the testing results useful in the decision making. This is a question that we hope to provide to cling in additions and patients and others. The moth odds that were used was to first develop a frame work. We have a frame work that goes around key questions and then we conduct a search using abstract and full text and two reviewers assessing the quality of the evidence and [ indiscernible ] the [ indiscernible ] which wasn't often.

These were the key questions. They do test and improve outcomes. The second di rifty question is the correlation of the tests are there any known of course of management clinical outcomes and decision making and are they [ indiscernible ] We are not ready to release the recommendation yet, but here are some preliminaries observations so far. We received [ indiscernible ] on [ indiscernible ] and no studies linking testing to clinical outcomes. The studies that we have are small and poor quality. We have no studies that have compared to the alternate testing strategies. It has made this very difficult to combine the studies in a recommendation. You can tell from that that this has been a challenge. The panel is meeting in three weeks to finalize this recommendation out of the data source. Here are the other topics that are currently in review, owe vary January cancer, core reckal cancer, [ indiscernible ] testing fro filing for the -- profiling for the breast cancers and [ indiscernible ] for pain management.

So I will conclude with two slides. This is kind of my summary of the apparent gap in evidence given my experience so far in this domain. There is a gap in the pref lance in the [ indiscernible ] and also a gap in the [ indiscernible ] of the abnormalities and for the [ indiscernible ] for the recognize able. There is an absence of studies that fully assess all of the are the -- relate -- relevant outcomes and very little literature costs, fees, and availabilities. And then my concluding slide which is my personal ocean -- observation for the cling in additions and the consumers and now -- how to make sense of this. We tend to be in a national add -- attitude that more is always better and technology is always good. I just hurricane -- returned from a [ indiscernible ] from germ any -- germ my -- germ mini. There a environment that is hostile towards the recommendation. And unfortunately, finding limited evidence. I have to say that I new this is going to be a problem getting into this, but our -- our efforts are going to be limited, but I didn't realize how limited. We choose some topics for reviews, but we are finding major gaps of the evidence we have under taken so far. I apologize for zipping through this, but I know the questions are more interesting for the reviews.

[ Speaker/audio not clear ]

Thank you doctor [ indiscernible ]

Come forward. You can see at the front of the table.

I will ask the meeting to come -- call for questions. We have a limited amount of time.

Doctor Berg this is a question for you on one of your slides you talk about the profiles of the breast cancers the insurance companies paying for the [ indiscernible ] and for the G profiling for the breast cancer and it seems like the carte was -- cart was put before the horse. This is a study that you are looking loo -- into as far as the gap goal.

Yes and thank you for that question. One of the reasons this area particularly interested me is that I spent calf -- several years in the gap where the horse was well in the barn before we [ indiscernible ]


I was hoping for this domain that we might have a crack to get to some of these things early enough for the [ indiscernible ] before it becomes a standard of practice without evidence -- evident.

I am hoping we can act quickly to get ahead of it to see what is a good idea and if so what are the circumstances and if it's a bad idea where are the circumstances in that area. I there -- this there is is a many things in this area. There would be many things that would -- that would be nice to have the assessment before the ours -- horse of -- out of the barn.

Doctor Berg, I am going to try to catch you up in 102nds on the conversations that occurred prior to you ging us. Earlier today the secretary of health offices gave us a specific challenge to respond to the relevant questions regarding oversite. One of those was actually very relevant to your point and that was to 3R0E6D -- provide some guidance on how tests are selected by providers as part of our oversite responsibility. I think you sort of spoken to those issues today. I am going to asking -- ask -- since I am the chair I get to the be -- to be the bad guy to ask for these request. We have an advisory committy which is shared by an dree what, which was joined by you all three of you today. We also have Cynthia burk and also mark Williams. I would like to ask all three of you and maybe you don't want to say today, but I would like for you to join the committy. And doctor wily if you are here I am going to ask you if quo would join the committy and doctor burk as well. I am going to ask you all to see if you were willing I don't want to put you on the spot, but if you would join in on us and we would ask you to help us think of these issues. The work will go like lightening for that. Not to take the time up of the committy today. You did wanderful -- wonderful presentations. What needs to be done that you are not doing. What are the gaps?

And second, I don't know whether or not your part of it as proud as you are on each of the components that you presented if you really became designated as the scheme Mattic as your deal. Can you sustain the work, do you have the scale. Can cap [ indiscernible ] I just want to -- want to make sure as part of the committee that speak to the issue of [ indiscernible ] U the two sort of things that I would challenge with is you told us what was wonderful, what are not wonderful. Can you sustain in scale and would you join the committy. That's what I would look forward to.

Any other questions?

I have a questions for doctor Vance. Earlier in the day we have -- we had a comment from the [ indiscernible ] which states that two/3 of the laboratories is involved in the PT testing and a third is not. You put in -- this many the data of the [ indiscernible ] laboratory and the most recent is the -- 3.9 of the laboratory. I am trying to figure out the discrepancy.

It's not all labs that are involved in the cap. It's a voluntary program. I think that's where the commentary is coming from. The other thing you need to remember is the dynamic number which is a moving target. There are new labs comes -- coming out of the market all the time. I think it is a wise to keep tabs on all of those all the time and make sure they are involved in a [ indiscernible ] or cap inspection process.

If I may make one comment.

Who is that?

Oh, doctor Berg go ahead.

Just to -- just a quick comment, a number of the tests that are out there and are being promoted are single source tests which present prmps -- presents a lot of the problems in the data. And secondly, a further result is that there is a very little in the literature that allows us to look at them. This means that they are not subject to the [ indiscernible ] testing. This particular domain has some special challenges in helping laboratories doing a good job because of the nature of the test and who is providing them.

Any other questions for the speakers?

Dock dor burk -- doctor burk I would make one other request of you. One of the things to think about on a go guard bay -- forward basis if you are interested in going forward. We are interested in developing case studies to allow us to see in the con tin yule -- continue yum activities as -- all the way through to how tasks are and that are chosen by the cling in addition. We are trying to think about some of those test cases. Cling nition. I was hoping you would use the CYP450 for example. If you would take that to the chain and where the patient gets the test and work your way back to the clinical [ indiscernible ] and [ indiscernible ] that might be one of the interesting examples that we might use. It might not be the best one, but I want to get your brain to think about it and kick it around to -- through all of the tests. Does -- do the test actually do what they are supposed to do for the people who are supposed do it. I appreciate your example and your presentation seemed to predict much of our discussion.

It sounds very interesting, thank you.

I have one more question for doctor Vance. In your -- [ Speaker/audio not clear ] Available to the public is the college of American pathology is to have the [ indiscernible ] with -- we -- can we as a group have some of them for ourselves.

[ Speaker/audio not clear ] [Audio Cutting In and Out]

I know the college presents some of its results to the [ indiscernible ], but I don't know if they would render them to the public.

So [ indiscernible ]


The other question I have and then [ Speaker/audio not clear ] You have a -- have showed a diagram of the proficiency testing and when they have failed and what you are supposed to do and when to do it. Who are responsible for the proficiency program is it up to the laboratory or is the [ indiscernible ] keeping a tally on this?

That's a very good question. Actually [ indiscernible ] has recently gotten involved with that. It's a -- it's a -- it's a accreditation program. One of the [ indiscernible ] of this is CTC which is con -- continuous monitoring K34EU9 -- committee. It's a two prong review. One to make sure we are reviewing the laboratory testing manual and to see see if they are doing what they are required to do. And to make sure they are performing adequately and successfully in the PTment -- PT. One other thing is that the [ indiscernible ] follows the testing center. The other part of that is then the inspector, too, when that inspection process comes along every other year, the inspection will have the PT -- PT results of those lab results as well. They will be able to target and look at the evidence and as their plan of action if they have been unsuccessful previously.

[ indiscernible ] and Steve.

I am taking this up with [ indiscernible ] to thank doctor Berg in his leadership to moving gap forward. Gap has been a process that has come out as sort of the [ indiscernible ] for the different committees that come out in the 90's. I think that just for the first time we are beginning to see a little bit of an road map, and I think that E gap and gap parking group and by the way many of them are here, like [ Speaker/audio not clear ] And they have give -- this has given us a leadership module to go by. [ Speaker/audio not clear ] A lot of the [ Speaker/audio not clear ] so to speak and the use of the evidence in the practice centers through some of our work and we have a committee for the SP AA IH and all of them -- [ Speaker/audio not clear ]

Thank you all for your hard work.


We have [ Speaker/audio not clear ] on the phone Oh -- you have talked about getting guidelines out and getting the guidelines in practice and getting all of the [ indiscernible ] on that end. I am not sure that is going to be within the scope of the oversight. I think that the real issues that goes beyond the laboratory getting the recommendation, I wonder if you have the reflections of getting this trans -- trans-- translated into practice as far as infrastructure and port.

Well when talking about the preventive services is I think often make a comment that the task force part is the easy part. They can be complicated and tedious. It's not rocket science. The real challenge comes when the recommendation is out there and it's available, how do you get it in practice. Those of us in primary care are extremely to see the road map leading towards the T SA's and the [ indiscernible ] and moving towards. And T1 is bedside and T2 is bedside to the communitity. We are moving clinical guidelines and practices into practice. We hope that appropriate other groups will be able to help with that.


I have a question for the gap committee members as well as the doctor Berg. We talk about lit -- analytic and [ indiscernible ] we are from a population perspective it seems like there is not a lot of emphasis on the clinical utility. Early they asked of a case that starts and go to the beginning. How can I be sure that this gap is a -- is going to result in a certain outcomeover the pop you -- ow -- outcome of the population level or be a better resource for the patient.

I would encourage others to respond, but I would not want to be misunderstand -- under stood that gap is not interested in clinical study. Infact we have spent a huge amount of time on o -- how to present the community guide. That is focusing on the utility and provide them on the [ indiscernible ] testing for the validity. On the [ indiscernible ] test we almost never exam issues of the abling -- littic of the [ indiscernible ] The get -- genetic is the huge issue.

That's where physicians, insurers, mere -- employers, live, patients live. We will probably fall short in a significant number of cases.

Correct me if I am wrong, the member of the gap is a member of the blew cross -- Blue Cross Blue Shield work growvment I 30 -- I think it is a a key of importance. Man -- mag gi Piper is a wonderful addition to the group.

We have no other questions. We are putting on our thinking caps and we are going to move forward. Thank you for the speakers for the thoughtful presentation and we hope with can challenge some of you to join our committee.

Noted -- not some of them we welcome all of them.


Before we move into our discussion, I would like to close some of the issues that we brought in. We would question -- request the feedback on the specialty. In our package in [ indiscernible ] number five there is a summary of the committee meetings that occur in -- occurred in February. And I am going to read a partial -- read partialover these.

On a November meeting we learned that [ indiscernible ] was to not go forward with the [ indiscernible ] [ Speaker/audio not clear ] specialty under clear. Given the complexity of the oversight issue we feel it was important to get a [ indiscernible ] from to held -- hold their discussions. I want to thank you Joe turner and [ indiscernible ] bloom for providing us a summary of their delegation. A copy of that is in tab number six. Let me highlight the minutes of the meetings and for the rest please go to the tab six for the rest.

[ indiscernible ] presented to us in November. That has improven their website, genetic testing and [ indiscernible ] of educational material. Provide technical training to occur -- surveyoring and providing CDC for the collaboration. However they have [ indiscernible ] not to go forward with the study of [ indiscernible ] clear. I am -- they have pointed concerns of the genetic community of the quality specifically to the personnel and -- American kneel. There are qualities that are now being captured in CMS because they are nene -- again net cly testing the laboratories. There are a number of them and I would recommend you go back to tab number six and go back and check.

Okay. I just want to make sure that -- I was trying to make neuro -- sure that we -- she was hearing what we -- was being said as well.

I am a little confused and I aappreciate this. We hear that this was keyed up and put up on a public testimony by Kathy Hudson who was specific on a number of issues. I am trying to understand where we are. What you just read was from -- who was that from what you just read.

That was fra [ indiscernible ]


It specifically addressed the issue of -- of why this was recommended by CMS. And they con lewded at the -- concluded at the ended of the day that it would provide website, [ Speaker/audio not clear ] So they were 245EU -- they were in the agreement of the -- those with the -- were the plans of the oversight. I think I want to -- I just am trying to make sure. Do you get the since -- sense as a result of the discussion that [ indiscernible ] is okay with the CMS not going -- doing a specialty and that they -- there are strategies of those other tools are act -- auk accept db auk September able. Or do they -- are they saying to deal with the whole strategy and not to deal with the specialty issue.

These es -- these -- that's my understanding. There was an endorsement of the members from the CMS. There was -- were some concerns of the members of the committee that were not sufficient.

I see that Steve has his hand up.


They are hardworking and -- and well-meaning by going after they are wanting to do. I don't know what to do with the testimony we heard earlier on John Hopkins. They were specific on the reports regarding the relationship of the speciality designation and the proficiency testing. I am concerned about one fourth and -- again, I don't think the presentation from o hop -- hop dins -- roup -- Hopkins was a [ indiscernible ] of study. They didn't oversell their presentation. I think they made an observation that [ indiscernible ] of the labs are not doing the prosituation si testing -- proficiency testing. I think I would ask us to tighten down and take that test -- testimony that we got there from Kathy hod di -- Hudson and look at these issues carefully, if the [ indiscernible ] have reviewed this thoroughly and have bought off on it I just want to make sure what part of Kathy Hudson's presentation they are on. If I am on the beurre rack si and redun Dan si. I think the presentations that we heard today present the pry ma fascia quais. There is a need. All of these people would not be spending the time, money and effort, that they are spending if there wasn't a need for the oversight. We wouldn't have a an argue if people wouldn't have taken the bawl and ran with it.and the if the college of the American pathology haven't created their guidelines and prosituation si -- prosituation -- proficiency testing then I think we would have a huge crisis. In some sense there is an ability to not take ownership in the sense that some of them are taking it voluntary rei. The probable could -- this could be --

No. First of all, well stated and well articulated. Just to 12 -- 12 -- dwell of -- dwell of deeper. Kathy race -- raises the issue of if I understand her testimony that about the relationship of that and the proficiency testing and I want to make sure that the cub -- -- sub category prosituation -- profission si then we need to ask for that.

We need to take a task for that on the [ indiscernible ] and make that decision and where these other individuals presented toed -- today have brought to our attention.

Quick comment -- comment to complete the thought. I apool gies -- I apologize, I want to make sure the committee nails down. The Congress have [ indiscernible ] the proficiency testing to the public. And apparently this may have not been done. I think we need to look into this and see whether or not this is an issue that needs to be addressed. It's kind of like our tests is a concern and it ice not -- it's not easy to ignore them.

Quick comment.


I am representing CMS. I think of the conversation that took place that -- that took place this morning on the defission si part. I think that some part of dialogue and meeting should take place and a clear -- aged a -- and a clear representative. And number two if we are talk k about the CM social security -- CMS on the recommendation that were made and some of the things that this committee wanted us to perform. They have been reviewed by the -- by different divisions of CMS. Most of them are feasible and recommendation able. Because of -- that -- the document hasn 't been cleared we couldn't present it today. At the time of the next meeting it will be cleared.

Let me just note and I want to be careful I am trying to walk a very deliberate, transparent, and very public fine line. I am trying the -- very hard not to be critical or put CMS in a defensive or negative posture here. It's important not to do that. As -- we are not going to be as far as this goes as far as attacking or putting CMS in a negative nature. That's an important principle that we want to acknowledge. I am sure that they will be called into the supporters.

The exfish Ohs don't get to be on the sub committies this time.

James recall -- raw Lynns has stepped on -- up and I support that. James whether or not or now -- noted you work with the Hopkins issue or not. I think more of the issue is the generic issues.

These is a focus of the part of the subcommittee and this is not an add verbatim -- adverse yam type of thing. This is on the high road, high ground, trying to accomplish things which everybody has the same interest in is to do right by the public. We are working on behalf of the American people and let's keep that in mind.

Now with the American issues, let's put back again fur the -- for the questions that were putted forward to us this morning. There were seven questions. There was another set of questions that was for -- the oversight task source and that is the frame work and you can find that in your document on tab number five. Maybe we can discuss thighs in more detail as we were saying this morning. We can look at the questions that the secretary has put forward and see what we want to add or delete from these. We can use these to see where our commonalities and to move forward and to actually look at or delete some of these.

Any comments from anybody?

If you look at our committees the task force, question number five, I think there is an issue here. I will read that for everybody. What will be the [ indiscernible ] for these solutions on the [ indiscernible ] and and the availability of the costs of the genetic test and the coon excuse meer -- consumer and health care decision. How will this help with the consumer, and the [ indiscernible ] What are the affects of leaving the system as the way it is. We were trying to look at this point of what are the consequences of these. I would like to look at these and look in the area where the secretary has had it.

Any comment from any member?

So the idea will be to -- Joe.

Joe -- I am wondering in answer and this is a question specifically -- [ Speaker/audio not clear ] Statement about the questions. There is a lot of -- lot of compound questions that you have in the terms that you were looking. So in terms of how you would get the answer in the [ indiscernible ] I would ask that you look towards your committee. Do you look [ Speaker/audio not clear ] It's going to make your practice a lot'sier, -- lot easier. If you do have questions of the [ indiscernible ] [ Speaker/audio not clear ] That's a general comment. As far as this one, mentioned earlier, there -- is there an evidence base already to answer part of this question can you review what is already written or can you get it through the sources and address that issue. I would say that -- maybe that could be something that you will do as a task work. I know that's a process that we engaged in on the large [ indiscernible ] testing issue. And the other committee that I sad -- sat on was the same thing. What can we answer and what can we not answer. So as an approach, would be to consider looking -- it's a good tet -- set of questions. One of them is to make them more discrete and second would to be look at the information to gather for yourself, and then third is to gather them as a whole for the source.

Thank you! Thank you any other comments?

Is there anything that we want to add to the serve questions that were posed to us this morning?

One of the things that [ Speaker/audio not clear ] today is the user control and the FDA clear controls so maybe when -- when we looked at the [ indiscernible ] we can also add about controls for the testing. That is something we can address some of the concerns from the comments.

I would like to comment on that. This is something that has some up on the [ indiscernible ] process quite frequently. They have indicated that 245EU have -- they have six [ indiscernible ] controls. I think the perspective is that if we are going to mauve control -- move controls to the FDA being cleared do we have a [ indiscernible ] where we are able to have the control of all of the paths even the [ indiscernible ] where we essentially had to rely on patient samples. I was just struck this was an relatively narrow view of the control issue when one looks at the broad perspective of testing.

I think that is an excellent point. At the same time there is a cost [ indiscernible ] in these controls and the [ indiscernible ] of the state it become very difficult. At the same time, I I -- I think there [ Speaker/audio not clear ]

I think that there is something we can see there and look at ways where we can look at the controls and when they are D -- FDA controls and so forth.

Doctor G I guess.

Thank you.

Just responding to your comment about is there anything else we can add [ indiscernible ] to this? And in the [ indiscernible ] question number five there's a sub part B which is investment innovation which is a fairly broad category. I don't know if [ indiscernible ] want to comment on this, you will be hearing from him tomorrow on an chick -- economic impact. If you are going to look at the [ indiscernible ] [ Speaker/audio not clear ] And the public health impact and the economics of that on the other side. [ Speaker/audio not clear ]

Thank you for your -- your comment.

Anybody else have any other comment?

Well, I guess -- [ Speaker/audio not clear ]

Is there anything -- there is no other comments that anyone wants to add to what we have or -- [Audio Cutting In and Out] [Audio Cutting In and Out] [Audio Cutting In and Out]

Do they want to add number five? THE COURT: We got the charge of the committee. We are going to respond to the secretaries question as is. You liked all of them?

All right. So here is the deal, we are going to break for dinner in about 102nds. Let me just sort of say that, hey, are you guys here?

What are you doing?

Late breaking development?


Andrea, you got to stop a minute, because I have to say thank you. You have to get your award or your applause. The committee, Cindy and you, [ LAUGHING ], put on -- first of all you clearly identified the right people to be before us. It was extraordinary. You predicted with with -- what the secretary was going to ask us and you gave us the right people.

Give a round of applause.


Let's go ahead and get the other people that we asked.

[ Speaker/audio not clear ]

Steve is joining?



Kevin can't do I did?

I dole -- I'll do it.

We got a lot of people then.

[ Speaker/audio not clear ]

And did you hear that?

Laugh laugh -- [ LAUGHING ]

Would you like to talk later?

Kevin, Steve Z Silvia, and mark and the external people that we are trying to get.

Add hocks. We have a good thing going forward. This is now a terrific issue.

The [ indiscernible ] caps force on [ indiscernible ] is meeting here tonight and everybody else, first of all you are more than welcome to join them.

They come back at eight -- KW-8. Gavel at eight clock.

Thank you very much.

[Relay Event Concluded]