Event ID: 927426
Event Started: 2/12/2008 8:20:37 AM ET
Please stand by for real-time captioned text.
Please stand by for real-time captioned text.
[Captioner present on conference line with music and awaiting beginning of event.]
Everyone, welcome to the 15th, amazingly, 15th meeting of the Secretary Advisory Committee on Genetics, Health, and Society. A couple of quick housekeeping notes, your Blackberries, when they get information the electrical pulse at 18.7 MHz -- I made that part up. It goes right into the speakers and we get that sound. So move your Blackberries away away or turn them off. The thing, by the way, is yourself on. So the first person to do that, we are going to make you feel badly. The other thing is, to turn the microphone on you push a button and see a light, and that way you will be heard. We will wait for Kevin. So you missed that part about the cellphone and the Blackberries.
I have all mine on.
The other thing is, right now the webcast video is not on yet. There are some technical issues. It is unrelated to our crack team of dedicated folks in the back there and their work really appreciated. So the idea of is on to the internet, but not the video. The public was made aware of this meeting through notices in the federal registry as well as announcements on our web site. I want to welcome members of the public to are in attendance, as well as that many listeners tune in and via the webcast. Thank you all for your interest in all our work. Before I get into the substance of my opening remarks I do want to point out to the committee's great joy and happiness that my term is ending with this meeting. The secretary has been -- the secretary has made a very wise choice, and that is that Steve will now be your new chair. We decided that it would be fitting to make the transition on day two of the region. So as of tomorrow morning if the gavel will pass to Steve. I am absolutely pleased that the secretary has made it a tremendous choice and good luck to you, Steve.
Thank you, sir.
At the beginning of this meeting at take a moment and review our [ indiscernible ] plan and the status of our project. This gives us an overview of what we have accomplished. Today I am going to really ask for your forgiveness because I will go through this in some great detail. I think it is very important that this committee and especially the fact that we have so many wonderful new members to the committee, that you have a real sense of where we are in our process because tomorrow at the end of the day we are going to have a priority setting review process which will have a much more in-depth discussion of where you are headed for the future. And so tomorrow we will kick off a process of brainstorming about the issues that may warrant the committee's attention. So with that, if you will look at the slides that are available but me just start with the vision statement. If that describes our priority issues and how we reach them which were developed in 2004 and how it has consistently guided our work since then. So one of the things you may wind up doing is revisiting that mission statement, but ultimately as you see the timeline that we began in October 2003. In March we did the priority setting of '04, the discussion, and then in December we did the report. Public concern about the misuse of genetic information has always been our highest priority issue. We have written three letters to the Secretary championing the inaction of federal legislation to prohibit discrimination based on genetic information by both health insurers and employers. In early 2005 for provided the secretary with a legal analysis of the adequacy of current law regarding genetic discrimination. We provided him with a compendium of public comment documenting public fears about genetic discrimination and a compelling 10-minute DVD of compelling testimony we received from the public in the Fall of 2004. We strongly support genetic information on discrimination and the Genetic Nondiscrimination Act of 2007, it referred to as GNA which would prefer to [ indiscernible ] from discrimination based on genetic information could in their family, by employers, and insurers. We do not have dedicated supporters on both sides and in April of '07 it passed the house by a vote of for the 20 to three. The secretary is also on record as supporting such legislation, however last July Senator Tom Tolbert placed a hold on the bill. In the last few days the leaders attempted to attach it to the fiscal '08 spending bill, but were unsuccessful. An article from the January 14th of Congressional Quarterly which is in your table quarterly's provide more background on the current situation. The dialogue is hopeful that the procedural hold will be dropped and that it will be brought to the Senate for a vote early this legislative session. In June of '04 redeveloped a resolution about the importance of educating and training health professionals and genetics, and how these efforts could be enhanced. At our last meeting we convened a round table on this topic during which it became apparent to us that there are critical means and education and training. As such we created the genetics, education, and training taskforce which is chaired by Barbara Burns McGrath. Tomorrow she will present the charge of that taskforce, and we will discuss and finalize the charge so that this important taskforce can then proceed its work. In '06 we transmitted a report on coverage and reimbursement of genetic tests and services. This affects patients access to a genetic test and services and identifies nine steps that can be taken to overcome these limitations. The recommendations cover a range of topics including evidenced decision making, a the adequacy of billing codes, billing by non-physician genetic counseling providers and genetics education of health professionals. In July of '07 CMS sent feedback back to us on our recommendations. A small group of our committee led by the terrific Mark Williams reviewed the comments and found several areas that required follow-up with CMS. In December we had a very encouraging call with CMS leadership and Dr. Barry Stroud in particular and his staff. A summary of that call can be found in your table folders. There are two important messages that we want to emphasize that we took away from that call. Number one, the eagerness on the part of CMS to learn more about and be more actively involved in various genetic initiatives within its as S and it's agencies, but particularly in the area of family history initiatives and CDC's program. Second, that we were impressed by the eagerness in taking and continuing to move forward in helping to personalize medical genomics and transforming the modern health care delivery system. Their eagerness was clear and wanting to explore how the Medicare program to take advantage of the agenda is and benefits that Javits -- genetics has to offer and are also of course being fiscally responsible. We provided his team with information that will help them pursue these goals and identified for them some areas that they should take a closer look at as they proceed. Two years have passed since we transmitted our recommendations, and while we are excited by the leadership of the team in taking action on our recommendations we have also been truly impressed that some of our recommendations in the opinion of CMS will require legislative authority that they currently do not have if they are to act on at least one of our key recommendations, particularly the one that is involved with urgent Medicare to cover services indicated by a family history of disease. If this is so important to us that I recommend that we write to the secretary calling for legislation or asking the administration to push for legislation to give them the authority to act. Also, since the coverage report was written there has been some developments management billing for genetic counseling services. These developments are technical in nature, and I will review them here. Is the sense of the effect genetic counselors options when billing. In light of these I think we should also ask the secretary to clarify if genetic counselors of at options to renew some listed action might be needed to remedy the situation dependent upon the nature of the response. Although it was not part of our support I believe this new legislation is consistent with the spirit of the report. A draft letter addressing these two issues will be distributed to you later today. I want the committee to take a look at the letter and let Susan Goodwyn know if you have any changes to suggest or if you have any issues. They will be distributed letter. You would get into that. No problem to be it good. That is why we are doing this. If you have a question about it lettuces and of that you have issues and then we well, if necessary, have a discussion about that. If it's straightforward to get it into the hands of the secretary. We all know and understand that we cannot press for legislation. Must it to the secretary and that is why we are taking this step. In '05 and '07 to letters on the issue of genetic consumer marketing. Our efforts lead to enhanced collaboration among CDC and [ indiscernible ]. And '06 a consumer alert was issued to warn consumers about using at-home genetic tests that have not been evaluated and to be wary of the claims made by companies. As part of the personalized health care initiative the secretary office is organizing an informal working group that includes various HHS agencies and the FDC to explore direct to consumer genetic testing services. This personalized health care initiative worker will be is discussing the roles and responsibilities of consumer agencies and challenges associated with communication of complex genetic information to the public and assessments of the services offered by various companies in direct to consumer marketing including the quality of information provided and confidentiality provisions. We are actually very pleased by the push that we have done and the response that has occurred. Regarding the issue of large population studies the committee's final report, policy issues associated with undertaking a new large U.S. cohort study of genes and [ indiscernible ] and disease which we need an acronym for was completed in March 2004. It was transmitted to Secretary. A downloadable PDF version is available on the website will be looking further into the status of the response to the report. In November I mentioned that there was an article on the Journal of Social Science and Medicine about the reports. We drafted a letter to the editor that clarifies the scope and goals of the report which you had an opportunity to review and comment on in the November meeting. That letter is now going, we understand, through the journals review process. A copy of the final letter is provided at your table folders. For more than two years we have been developing a report on the opportunities and challenges related to pharmacogenetics research, development of products and to their incorporation into clinical practice and public health. In March the draft report was released. These comments were carefully considered over the Summer and Fall. In November we finalize the recommendations and the file report will be delivered to the Secretary in March after copy editing and printing are complete. The report will be made available to the public 30 days after we give it to the Secretary which is provided, of course, as a courtesy to the secretary to give him and have its staff time to review it. Although the report has not been formally transmitted we do note that the American Health Information Health Community personalized health care worker is actually already reviewing our pharmacogenetics and recommendations in the area of electronic health records, clinical decision support tools, data sharing and database interoperable as it. As they begin to explore how this can be used. There is additional information on pharmacogenetics, family history, and newborn screening in your table folders. We have been monitoring the work of this group closer to our liaisons, Steve, Andrea, and Mark. Mark, is there anything specific you would like to mention about the work underway or its workgroup?
I think just to mention that it is moving very quickly. There is a lot of energy behind this, and the recommendations that have come through relating to the use case -- and they use cases are the things that the working groups to develop to basically a way out the landscape and allow the office of the National Coordinator of Health to be able to say, what do we have in terms of available standards, where the gaps are there that need to be filled with additional coding standards. That is moving very quickly, and our use case is going to -- is out for public comment for another two days. Then we will go into final form which will allow it then to move by the end of the year through the standards analysis. Those of you have read the entire report will recognize that there are references there. And it will be incumbent upon this group to work very closely with them and particularly the personalized healthcare or group because a lot of the problems and gaps we are defined are ones where potential solutions reside within that.
And of course everyone has read that report cover to cover.
I did. And I've read it about five times.
The work is absolutely transformative. And so I think everybody sort of really needs to continue to focus in on this as the committee move forward in the months and years to come. In June of '06 we decided to move forward with a study on the backs of genetic and licensing practices on patient access to genetic technologies. Since then we held a round table focusing on international perspectives. You will recall that we have been working with Dr. Bob Cook and his work at Duke on case studies on licenses to patient access, breast and colon cancer, congenital hearing loss, Alzheimer's disease, case [ indiscernible ]. These studies will illustrate lessons learned and diagnostic development, commercialization and adoption of patented versus on patented genetic tests. We expect these to be completed within the next few weeks. Once we receive them from Duke they broke be used in the development of a draft report and the recommendations on gene patents and licensing. Report development will occur during the Spring and Summer of '08. The taskforce anticipates releasing a draft report for public comment by the early fall with a final reports targeted for mid-late 2009. The chair of our patents taskforce recently presented an overview of our work on gene patents to another HHS Advisory Committee, that being called the Advisory Committee on Disorders and Genetic Diseases in Newborn and Childrens. If that committee is interested in this because many newborn screening tests are administered as panels. And intellectual property protection may limit access to these tests. Jim's presentation, as always, was well received and audience members are for advice on additional areas to move forward on. Some areas of mutual interest to our committee on disorders include informed consent, mechanisms to assess clinical utility evidence, and education of health-care workers and family. In March of '07 we were asked to respond to a series of questions posed by the Office of the Secretary on the adequacy of the oversight system for genetic testing. And extraordinary 33-member taskforce chaired by Andrea was formed to develop a report in response to the Secretary's charge. Through the dedicated effort of the oversight taskforce the draft report was released for public comment November 5th through December 21st. In response we received 64 sets of public comments that have been carefully reviewed and considered. A summary of these comments has been included under tab three in your briefing booklets. Most of our agenda today and part of tomorrow will focus on a review of the draft recommendations that have been revised in response to the comments received. Our first goal for this session -- lets me be very clear, is to finalize the recommendations for submission to the secretary by the end of February. Our second goal is to receive approval on the spirit of the final report said that it can go through final editing and be transported to the Secretary in April. Our commitment to the Secretary based upon the charge to us, his advisory committee is that we have to get this to him by April. I want to be real clear. We have been asked to do this work. We have responded as urgently as recant. We have been extremely diligent about the process, and we have to bring it in by April. And I also want to just make sure everybody also appreciates the amount of public comments that we have received. And I will tell you, the diligence with which we have gone to every stakeholder organization that we can find out there in the country to give us their comments. As we had just beaten the bush on this thing. So I just want you to understand how seriously we have taken this process. Finally, you will notice that when we start this discussion at today's meeting the public comment will be first, and that is to make sure that we get as much public comments before we start our deliberation. So there I am extremely focused on the meticulousness of the process here as we go forward. You may recall in March of '07 we decided to take up a new priority based upon two proposals. One, the economic consequences of to Numic innovation, and, second, the evaluation of a chain based applications on real world of genetics. We integrated these together into one topic that would explore what we call the turns this analysis of public health and clinical care and a viable economic model that could sustain the work. The task force was given the short and title of the evaluation taskforce. Because of potential overlap with the over such reports work on this new issue was put on hold. And so during the priority session in July you will have the opportunity to revisit this topic along with any other issues that you have identified or will identify. Finally, the cross-cutting issues of access to more public awareness and genetic exception have been integrated into all the work that we have been doing. So those have served as a foundational commonality of everything else that we have done. Well, that took a while. And quite frankly, I'm kind of proud that it took a while. This is one heck of a committee. I think that you all understand that you are not lazy. And this staff is definitely not lazy. So we have a legacy of work here. And I am also thinking, though, that it is absolutely time and appropriate to revisit where we are with this template. And I have a nice transition point for tomorrow not only do we have a new leader but so many wonderful new voices that is a nice time to take stock of what we have done and figure out where we need to be to continue to be relevant. So I'm excited. Now we will turned to Sarah about a reminder about ethics. Let me say that I often sometimes in addition to being a light-hearted about mangling names -- I actually can do this when I want to. I actually sometimes sort of joke about the theologic tone of what we want Sarah to do when it comes to the conflict. Today I will be very serious and somber. I am emphasizing to things in today's meeting. Number one is the absolute [ indiscernible ] of the public comments process and getting that input. And secondly as a meticulousness that we have always had and will continue to have around conflict of interest. So I think this is very important. At this point I will not tease her about this because I want to bring a certain [ indiscernible ] to her comments. Sarah.
Thank you. As you all know of you're special government employees, when you serve on this committee. As such you have to follow the rules that apply to regular government employees to reliable highlights to of those rules today. One rule is about conflict of interest. And because we are so close to the capital, the rule about lobbying. If before every meeting you provide us with information about your personal, professional and financial interests. If this is information we Jews to use to determine whether you have any conflicts to be objective. While we wait conflicts of interest for general matters because we believe your ability to be objective will not be affected by your interest in such matters, we also rely on you to be attentive during our meetings to the possibility that an issue could arise that could affect or could appear to affect your interest. In addition we have provided each of you with a list of your financial interests and processes that could become a conflict if they became a focal point. If this happens we ask you to recuse yourself from the discussions and leave the room. Government employees are prohibited from lobbying, and thus we may not lobby, not as individuals or as a committee. If you lobby in your professional capacity or as a private citizen is important that you keep that separate from this committee. Keep in mind that we are an advisory to the Secretary of Health and Human Services and don't advise Congress. As always I thank you for being so attentive to the rules of conduct. Thank you.
Thank you very much, Sarah. Again, the hallmark word of everything that this committee has been about and will continue to be about is transparency. If this is all extremely transparent, and we are actually going to keep to that. All right. Now, I had a schedule. I'm warning our public comments people that -- if there is anybody who thought you were on at 9:15, you are on now. It simply ran out of the room, come back. If one of our critical functions is to serve as a public forum raised by the development and use of genetic technologies. So we greatly value the input we received from the public. We set aside time each day of our meeting to hear from members and welcome and appreciate the views they share. And the interest of our special we asked but the commentors to keep remarks to five minutes. We have copies of your [ indiscernible ] segments which will be made it part of the record. As a few moments we but address the oversight recommendations. Prior to this meeting we request that those who have reference so that we can keep these in mind during our discussion. Some of our commentators unfortunately were not available today and will be speaking to us tomorrow, but we are all really pleased that we have several folks who have made it their business to travel here today to give us their input. So we are very pleased. It lets me invites to the microphone Paul Rodzinski from the Coalition for 21st Century Medicine. As Paul comes up maybe we can also, just so we don't have a loss in terms of travel time, if Jeff from the College of Merchant Pathologists is here, come on up as well. And we will start to shuttle people in. Thank you very much. Paul, we appreciate you being here and please give us your comments.
Good morning. Thank you. Can you all hear me okay? My name is Paul Rodzinski. We serve as counsel to the Coalition for 21st Century Medicine, as well as counsel to a number of the territories that are members of the coalition. The coalition was formed a little over a year ago in response to a two draft guidances. On the [ indiscernible ] in vitro diagnostics and the other for an allied specific reagents of a document. And the coalition formed including both laboratories and that area as well as manufacturers of a specific reagents to address concerns that both groups had with the contents of those two draft guidances. But the purpose of the coalition was not to say, this doesn't work or nothing works, you have to stop. The purpose was to develop workable solutions that would support public health concerns about appropriate oversight for these technologies as well as provide incentives to continue developing in this area. We submitted fairly substantial, detailed comments to the record in response to the draft a research report that came out in November, and those comments were submitted in late December. And I won't repeat the 15 pages. We tried to be constructive and respond specifically to every recommendation, particularly in these chapters dealing with clinical solidity and utility and decision support systems. What I want to focus on is something that we appended to our comments which was a proposal in response to the draft guidance that we submitted to the FDA has on that tightens and I want to explain it fell a bit about that proposal very high-level what our objectives were and why we believe that is useful for the committee to consider that on its from reports to the secretary. We identified in the draft guidance and both the September 2006 and July 2007 a number of concerns that stakeholders had as well as those that were submitted by others and the March deadline and then the August-October deadline. We were also very aware and had a number of discussion with folks at the FDA about their concerns. And that the concerns or transparency, a concern about advanced diagnostics, having equations, interpretation functions that were passed diagnostics that the folks wanted to understand better and viewed as some level as a black box. There was also the concern of the fox guarding the hen house. If you have the laboratory thing this is what our tests do. Is there some independent review work? Is FDA the right way to address that? Third, was a risk based regulation. Looking at a framework also we are looking for clear definition. There is a concern that recently the definitions and both draft were inherently subjective looking at what physicians could interpret, what are standard functions, and things of which lead to confusion by the [ indiscernible ] community. Looking for clear and predictable pathways. What will be required, what does this I need to look like in order to get various types of claims for these assays, a transition time mind because we are talking about laboratories that have been regulated by CLIA and not medical device manufacturers. If they assume those new rules it will take time for them to adapt. And lastly needing to have continued incentives toward innovation. The diagnostic life cycle is short, and if you require substantial amounts of data and substantial timeline for follow-up, by the time you finish the studies you will have new diagnostics already in place and the ones you studied will no longer be relevant. So with those principles in mind we came up with a proposal. With representatives, rather than responding to what you saw come up with a proposal about what you think would be the right approach. So we came up with a two-phased approach saying at the beginning, we don't know the number of tests we are talking about. We heard some say it is just a few and have heard others were we were able to identify a couple hundred. We don't know. We don't know what the intended use claims are. We don't know what the current state is in terms of the science to look at these. So our view is that in Phase I very much the draft report's proposed as others by the Senate and Public Policy Center, Senator Kennedy's bill have all proposed a registry to try and get information about, what are we talking about, how many tests, what does it look like. Based upon that our proposal is that that's registry would be publicly available to provide transparency and would have a role for FDA to review and comment on those claims. So we have the truthfulness and an independent review of the validity of the data to support the claims. From that period over a few years we are proposing 3-5 because it takes at least three years to get the data. If you want three years worth of data it will take five years. From that and experience based and evidence based free-market could evolve that would be one that over time to have an appropriate risk-based framework. And we encourage the advisory committee to look carefully at the proposal and to consider that. We believe is the best way to gain evidence for what appropriate cover such it should be rather than to simply [ indiscernible ].
You have made that point very well and we appreciate it. Is there any need for clarification? He has been pretty ridiculous. I think we have a good sense of what your recommendation as for is pathologist comes up and I asked David from the American Chemical Lab Association to come forward as well. Jeffrey, thank you for joining us.
Good morning. I am Professor for Pathology and Human Genetics and Director of Record Genetics at the University of Pittsburgh. I am here today on behalf of the College of American p athologists. I chair a Resources Committee that oversees programs in genetics. We are following up on written testimony the college has provided on his report on the U.S. system of setting testing, a response to the secretary's charge. I modified my remarks slightly and amidst the summary statement thinking to the time limits. At the national specialty society representing more than 17,000 pathologists. The commission of laboratory accreditation that accredits more than 6,000 laboratories here and abroad. Our members have extensive expertise providing interesting laboratory services and participate as peer inspectors in the laboratory accreditation program. The program has been a leader in developing quality improvement programs and genetics programs in testing. We have some of the strong as measures of quality. The overwhelming majority of mainstream genetic tests performed in the U. S are safe and effective. As noted in the report pop performance on multiple genetic surveys for analytic and interpretive accuracy has been excellent over a wide range of methodologies. Of note the performance of a laboratory tests on our proficiency is equivalence to assays that are FDA-approved for the same analyze. This is due in part to the nature along with a rigorous attention to quality standards and practices, along with oversight of every clinical laboratory by a physician. The accreditation program stresses of analytic and clinical [ indiscernible ]. Recognizing that tests will continue to be periodically improved after introduction with each improvement rebounded by the numbers are. As medical specialists the development and oversights of oversized cost is an important and outstanding aspect of medical practice. We therefore have a keen interest in ensuring that our ability to provide high-quality diagnostics services to patients and other physicians is not compromised by overly burdensome legislation. And we recommend that changes be made within the context. We support further enhancement of laboratory testing through educational efforts, and prevent and the quality of inspections and additional access to controls and standards. We agree that appropriate resources be directed to CMS for record of oversight and support recommendation for an expansion of sufficiency testing. Please consider that to be already require assessment of analytic validity regardless of whether these tests are in this tunnel. We are part of no evidence otherwise. Moreover we require clinical tests and stipulates responsibilities. Requiring approval for every laboratory developed test with result in numerous unintended consequences that would not benefit to patients to include delayed implementation of new tests, reduce innovation, increased cost and regimentation of access to beneficial information. Given the high quality testing is already in place different regulatory requirements for this group does not seem necessary and since not all laboratory developed tests are genetic it is difficult to implement. Finally we support the draft support on public / private partnerships for genetic tests and feel that registration of genetic tests through such partnerships could have a positive impact. Such a system should be voluntary and devised with broad [ indiscernible ]. CLIA already requires tests by laboratories. But additional information should remain within the context. New mechanisms for the collection of information should be tested before implementation to ensure the most useful information has been captured and that submission is not overly burdensome for a laboratory. If this information could then be made publicly available assuring clinicians and patients of the analytic and clinical validity of tests are not competing the medical practice of policy.
Thank you very much. Is there any inquiry on his comments? Yes?
Did I hear you say that CLIA requires evidence of clinical utility?
We interpret the requirements for the medical director oversight of the laboratory in well-run laboratories to incorporate that. Certainly that is part of our accreditation inspection process.
Thank you very much. We appreciate that. One more question.
Jeff, thank you so much. You mentioned in your letter that the FDA will have review of all the laboratory testing. I would like you to further elaborate what the impact of having to follow the regulations systems or additional inspections by the FDA on top of what we currently have to go through.
I think it would be primarily in the additional time required to generate the supporting documentation and to host the inspections. Many laboratories, as you well know, a great deal of that work is done by the laboratory director themselves. And that is clearly the last time you have to focus on developing and interpreting tests.
Thank you again. Let's ask as David comes forward from the American Clinical Laboratory Association, Suzanne from the American Academy of Nursing.
Thank you. I have had the pleasure of presenting comments to the committee more than once. I have always felt welcome, and I know the members have always felt that the comments have been well received and given full consideration. We recognize to a large degree that is because of the leadership of Dr. Tukson. We thank you for your tenure and appreciate the fact that you have made us feel welcome. Now the comments. As the community discusses the final recommendations we want you to focus your attention on one particularly important recommendation that if not carefully communicated to the Secretary to have unintended consequences. Namely the recommendation in Chapter four, recommendations four which [ indiscernible ] preferences the debate about the FDA role in regulating laboratories developed tests. That is currently written that this supports regulation in the flexible risk-based approach the agency is taking to prioritize laboratory developed test that should be robust enough to accommodate new genetic testing technologies and methodologies. We applaud and recognize the need for a flexible risk-based approach to genetic tests and the important role of laboratory developed tests to keep pace. However, if the above recommendation is interpreted to mean that FDA Food, Drug, and Cosmetic Act requirements should be applied to the leverage our develop test without interagency coordination, needless redundancies and duplications of results. Let me be more specific. Although there are many similarities between the quality validation procedures there are clear redundancies and duplications that if not coordinated, harmonized and streamlined will spike [ indiscernible ] in this area which includes separate inspections, labor requirements, additional requirements for design control, corrective action, and prevention. That's not to say that FDA does not have an extremely important role or that any of these are not important. But it is to support the regulation of LTD without recognizing the important first step of interagency coordination and requirements harmonization. Further the recommendation as written is inconsistent with the rest of the reports over arching guidance to HHS to -- and according from the draft report to enhance interagency coordination so that the agencies with regulatory roles, CMS and FDA are working synergistic with one another and other regulatory agencies and with knowledge generations businesses. We agree that it is fundamental to ensure that oversight is less burdensome, it does not place unnecessary or duplicative regulation of clinical laboratories providing genetic test services. We have proposed regulatory that build on that this answer is a [ indiscernible ], are consistent with the principles of burden, fill the regulatory gaps, and allow for a participatory approach that draws on the expertise of expertise stakeholders. CMS and FDA by invoking private partnerships they avoid significant new problems. I have provided a graphic representation of the models. We do believe we have filled the gaps, and it does in the least burdensome ways and is mindful of resources and allows for full transparency and builds on interagency coordination. We ask that you take another local and revise it. I would like you to consider. The recommendation would read adding the word answer is as he wrote for FDA and adding the word CMS. The rest of the [ indiscernible ] would stand. I appreciate the time.
Thank you very much. I really like the specificity of the comments. You are not playing around. Thank you so much, David. As Suzanne comes forward, I would to ask Peter vary from the Public Citizen's Health Research Group if he might come forward. Suzanne is an from the American Tennessee Academy of nursing.
Thank you. Thank you for the agenda to speak with you. You have a written statement that has more information than I represent. The American Academy of Nursing and the Genetic Health Care Expert Panel appreciate this opportunity to comment on the draft report, and we commend your comprehensive work and recognize that this is still a report in progress. The American Academy of Nursing comprises more than 1500 nursing leaders and is constituted to anticipate national and international transit health care and address resulting issues of health care policy. The genetics and genomics is obviously one of the significance trends impacting health care and all health-care professionals. The integration and clinical is unprecedented and the implications for health care. We want to recognize the benefits of this burgeoning technology is dependent on establishing the analytical and clinical validity of every test. And we provide the following consideration. The academy is concerned about the decision of the CMS not to create a genetic testing specialty and associated proficiency testing reversal and a previous position. We strongly support a genetic specialty and associated proficiency testing for all laboratories performed genetic tests. We encourage you strongly recommend that CMS take action to establish a minimum degree of quality required of any laboratory performing genetic tests and that further study on the issue of performance assessment should be executed while instituting genetic specific proficiency testing. The Academy commends the Committee for recognizing the need for interagency coordination and the oversight and regulation of the laboratory developed tests and strongly supports the need to convene their relevant agencies to make recommendations on further regulation of genetic tests. And an effort that should not delay instituting the genetic specific purposes the testing. We concur with your recognition that there are deficiencies in the genetic and genomic knowledge of all health-care professionals. We are concerned that the committee has not recommended that the HHS allocates assets to address this. In today's fiscal climate education efforts will be extremely hampered by the lack of funding to develop and implement innovative educating strategies and we will propose a different strategy. We recommend an adjustment to focus on the system and practice change. There is to be a shift from the traditional education approaches and schools and CE to one supporting the embedding of cinema knowledge into practice. Evidence of this being imbedded into practice should be a component of every patient records and hospital and the institute accreditation. For example, education could include the family history and patient family education materials. A successful model of this recommendation is the interdisciplinary program for Genetics Center practice at the Mayo Clinic in Rochester. When there is evidence of the application and practice our [ indiscernible ] will be influenced to include the expectation of the smallest for all health-care providers and licensing and accreditation. To facilitate the shift we may want to invite the representatives of accrediting bodies such as the Joint Commission and Health Facilities Accreditation Program to a meeting of the committee to demonstrate the significance of the application of this knowledge to practice. The Committee's recommendation on communication and clinical support will not be realized without the key foundation of an adequate base. We know that the number of health-care providers with genetic expertise is not sufficient or adequately prepared to support both genetic tests practices and the absence of a clinically competent practitioners. Many clinically available tests are supported by practitioners and one example is [ indiscernible ], a multiple gene asset performed on early stage breast cancer tumors where standards of practice for utilization support line in the domain of the [ indiscernible ] specialist. This is just one that illustrates this application the practice beyond the genetic expert. So this supports the need for the education of all health-care professionals. In summary, to reach the potential benefit to public health for all genetic testing it must be adequately regulated to ensure quality and health care providers must be prepared to incorporate these tests into there practice. The academy is poised to engage our fellows, other key stakeholders to develop and interdisciplinary initiative to increase the competency of health-care professionals and genetics and genomics as well as develop practices and standards that assure the highest level of health care to all. I will be happy to respond to any questions.
Thank you so much. I just want to make note that given not only the relevance of your comments for this report we are about to chat about, but also on the taskforce for training and education. So Barbara who is not with us today because of a pressing emergency -- but Joe, you are on the committee. If you make sure that those comments are delivered into that other process I would much appreciate it. Because there is another mechanism for dealing with it, and you have been pretty explicit. We will make sure that this gets into that committee. Mark?
I wanted to speak specifically to that point, also being on that education task force. I will take your comments to heart there. Recognize that we focus on the oversight report here. I just want to get your sign-off, if you will, that if your sense is that are devoting an entire task force to this as additional issue is sufficient size that we could leave the educational requirement alone. Otherwise I think we are trying to make this report all things to all people, and I don't see that that ultimately will serve our best interests. I would like to get your perspective if that is an appropriate way to proceed rather than trying to modify the recommendation as it currently stands.
We recognize that, and part of it is obviously if the interdependence of all of these recommendations and that the knowledge must go and is inherent on genetic testing and the reliability and validity.
In our revised recommendation for the report if we specifically articulates the fact that there is a taskforce devoted to education. So we are attempting to do that.
Thank you so much. Very well done. As Peter Larry comes forward from Public Citizen's Health Research Group, let me invite Marc Sobel from the Association of Pathology Chairs to come forward.
Good morning. My conflict of interest statement is that we take no money from either government or industry. I want to talk from the patient perspective and make clear that from the patient's perspective there is no distinction whatsoever between a genetic test or any other kind of laboratory tests. They don't understand the regulatory framework behind a genetic test, a laboratory developed test. They just get a blood test or cheek swap, and they assume that the amount of regulatory oversight that is associated with those tests article. The fact is that we have a genetic exceptionalism taking place whereby the vast majority of genetic test is barely regulated. Whereas the vast majority of other tests fall under the FDA. Very few patients if any understand that. I think that we owe patients an amount of equality and of comprehensiveness and oversize. The report itself seems to reach a similar conclusion. Genetic tests and laboratories performing them should be expected to meet the same high standards of accuracy, validity, and utilities to which other medical information is subject and that is decidedly not the case here. And I don't think that the task force current recommendations will do much rectify the situation. If the force of consumers has not really come before this task force to is significant degree despite what Dr. Tukson's describes as their efforts to reach them. All members of the taskforce come from government industry and the vast majority of comments submitted to the record, only two of those come from consumer advocacy groups. It is notable that groups with financial interest, disagreed. As we go through three of those. The first is with respect to CLIA. It throughout this report the taskforce as an excellent job of diagnosing what ails the system. It concludes the validity of genetic testing -- assuring the analytical validity is paramount, and it goes on to identify a litany of problems to the current situation. However despite their rigorous documentation of the centrality and the limits of current CMS oversight the draft report supplies no rationale for failing to endorse a genetic specialty. And as the report itself acknowledges this is contrary to congressional intent which is to generally require PT for all laboratories for all clinical tests, no exceptions. So we would like to see a much stronger endorsement of PT. And if it takes to the specialty this taskforce should be endorsing just that. With respect to FDA the problem is similar. A re-endorsement of the importance of political validity of genetic testing. Despite the well-documented reasons for expanding regulations and the problems with current oversight the draft report simply endorses status quo. It seems to endorse the efforts with regards to the [ indiscernible ] and is important. It is really a baby step in terms of reaching literally 1200 or more genetic tests that are currently available. Evidence justification for failure to endorse these genetic testing specialty, it provides only the most maker of explanations for its failure to have vigorous oversight. It talks about a backlog which you do come to have after ignoring two prior reports from committees rather similar to these dating back a decade. If you don't have one of those recommendations which recommended [ indiscernible ]. There is a good example of the ability to clear a backlog. We reviewed thousands of drugs and those were in effect taken off the market. So we have an ability to do such a thing. If there is a problem with lack of resources in this committee is in a better place than any to recommend an increase in resources rather than surrender to the problem. You should be advocating for that. It is important enough. And finally a concern that new technologies will be delayed. We often hear those kinds of concerns, but no one really provides any data. What about the dangers of allowing unregulated products on the market? What about people don't undergo a particular course of therapy? That must be considered part of the calculus as well. The third main elements in the report has to do with the registry. As the report acknowledges nobody knows the number and the number currently available genetic tests which is an unacceptable situation. Fleet recommendation is a voluntary registry. We already have a voluntary system and have had it for 14 years. It's called gene tests. And the deficiencies we currently have are deficiencies and the voluntary system. So how can it be logical that the recommendation be more of the same? Indeed that is the overall problem. It does an excellent job of identifying the problems. It lays them out clearly, but when it comes to following its own recommendations to a logical conclusion that falls short and simply endorses the status quo. Thank you.
Thank you very much. I appreciate your comments and you can't be sure people wrestle with each of those as we go forward in a very meticulous way. Does anybody have any questions to ask at this point?
Yes, thank you very much for your comment. I have a question in regard to something that is always a challenge, particularly with this kind of effort. One of the clear challenges that you have had -- and viable make it a challenge, the point about the actual diversity of the comments themselves and where they came from. The challenge is always giving input. And I know that every effort is made to do that. Maybe as a comment, what would you have suggested have been done to get more of the type that you think should have had comments knowing that a lot of effort was put in?
Let me just as an aside point out our comments are part of the record. As you point out there is diversity. There is some. The majority of people take a position in favor of genetic testing and most take a position in favor of some FDA regulation. I did hear about this report and that it was available for comment through somebody else on the task force. Nobody approached or suggested that we my testified before this committee despite the fact we had filed a petition with CMS. If any consumer group was in place to be invited, it was us and I only heard about incorrectly. There are a number of consumer groups in this town who may be interested. I can't beat so certain that I can, but I am not aware. Somebody might be able to contradict me, but whatever efforts for a mate, they did not reach me.
Actually, that was not my question. My question was a recommendation to the committee. This is only one of many reports that people be working on. If this continues to be a challenge it is, what is your recommendation on how the committee in its future efforts can begin to engage a broad base of consumer groups and organizations that you point out were not engaged, including yourself? That was my question.
I see. I have answered that in the sense that I pointed to deficiencies, but it is difficult. New news groups like the genetic alliance which have members in a large number of different organizations. Answer asking them to put the board of further. Certainly there are federal registered nurses, but nobody reads that. So I think you start with the key informant and hope that you can guess the word out. Courts are want to move this forward. I appreciate the specificity of your comments. They are very helpful to our process. I will say that the Genetic Alliance and every other major consumer organization in genetics is well aware and has been here testifying for years. It would, I think, be a matter of debate -- and I don't really have time to go through it all. There is an extraordinary legacy of involvement by this committee. And it is extremely well-known throughout that genetic consumer and professional community. This committee is no secret. Its work is well-known. We have solicited the extraordinary efforts to make sure that we -- you were told about it. You are here. So I say to you that I think what we want to take from your comments -- and I think Joe did a terrific job and making sure that we can always do it better. We both endeavor to make sure that we continue to try to do better, but I must suggest for the record that this committee's involvement with the genetic consumer community is extensive, long, and broad and that time would not want to have the record not have that comments written into it. However, I think that your comments are very helpful and we benefit from them and your presence here. Next. Marc Sobel, and then I am hoping Linda is on the telephone from 23rd. So do we have the ability to know if she is on the phone?
Can you hear me?
You are next.
Thank you.
I have a wonderful list. You are next. With that, Marc Sobel is now here from the Association of Pathology Chairs.
Good morning. I'm the managing officer of the Association of Pathology Chairs. It represents the Office of Pathology and Laboratory Medicine in all of the accredited medical schools in the United States and Canada. We submit a comprehensive statement in December and appreciate the opportunity to highlight the three most significant points in public testimony today. Those three points are that definition of genetic testing, determining under whose authority quality assurance is best managed, and identifying the best system for test registries. As for the definition of a genetic test, we see that we are using a very broad definition going beyond changes to include somatic variations and going beyond DNA and RNA to include proteins and other analites. Under this definition the test but more accurately because [ indiscernible ]. I believe that the document is to decide which [ indiscernible ] and also the difference between genetic and genomic application. So given the anticipated perhaps out there they should not be considered a significantly different tests, and we agree with this perspective which is consistent with the approach taken to not established the genetic such specialty. But if the community opted against it then it is unclear why genetic tests are proposed to require greater oversight then on genetic tests that are some of the molecular, lab developed, complex, and potentially high risk. We recognize the test for inheritable diseases are unique in several aspects. Nonetheless, at the technical level the diagnosis of genetic disease by molecular methods does not differ significantly from the same techniques that are used to diagnose infectious diseases. Therefore is not logical to establish more stringent technical and personal standards for molecular genetic testing than already exists including m olecular biology and molecular microbiology. These risks are present in all areas of health care, and we must support to minimize those. We are not aware of data that demonstrates that harm from genetic testing is greater or less than from other medical procedures performed. As to quality assurance and CLIA versus FDA, I think in the interest of time my colleague at the American Pathologists adequately express the opinion of APC that further regulation would be inappropriate given the oversights. It could be duplicative and could incorrectly have unforeseen consequences such as delaying innovation and the appropriate amount of time used to develop new tests. And finally on the system for test registration we heartedly endorse the endorsement of a private-public partnerships. We cannot necessarily retrieve the information, and the public does not necessarily have access to it. By making the information voluntarily registered more publicly available, we feel that the public will benefit and there will be no need to establish a new registry system. Thank you.
Thank you very much. Boy, this is going to be fun. So no matter what we do everybody is going to be upset with us. We will not have a friend in the world when this is over. That was extremely clear, and you were clear. I just wish you could all find some place where everybody worked agree. We are going to get yelled at everywhere. Questions?
I have a question. Using consumers that provide information available at there fingerprints as to the analytical and clinical validity in clinical utility of existing tests on genetic market and where that would come from. Personnel, I do not believe they have that rarely available. There are various sources of that information for the public. There are two websites. One is in the relationship to inheritable diseases, a test for those website called gene tests which is run out of the University of Washington which provides information not only about the background, but it has links to the laboratories which provide those tests. Understanding the unique areas of clinical analytic utility and clinical utility is difficult to access for most people. The other website that type would tell you about is the Association for Molecular Pathology Molecular Test Directory which is called [ indiscernible ] which is a listing of tests, but does not provide background information on those tests. Herein lies the distinction because the upside is not heritable. They are what I would call the somatic tests. They are infectious disease tests and test for disorders of the systems such as leukemias. There are tests related to neoplasia. Those have listings of tests and do not provide information. Here again it is really the purview of the practice of the laboratory practitioner. These are practicing physicians. I think there is a lack of understanding of the testing, certification of the laboratory directors for all laboratory tests that require an understanding and an expertise. And that is what we are trained in, to actually understand quality control, quality assurance as well as the test validity, analytical validity and clinical utility of the tests ordered.
So how do you respond to Peter Larry's comment? He is basically saying that we are being exceptional by being a more rigorous in our oversight. You are saying we are being exceptional by being overly oversightfull.
I guess my major point would be that in my opinion every single test that is performed whether it is a glucose test, my time for whether are getting the right level of Coumadin or whether it is for a cancer test that is done by the caucus system previously mentioned or for an inheritable disease condition, they all require absolute 100% accuracy in order for the public to be safe. My colleagues and pathology once noticed in the days of the multimillion-dollar contracts for baseball players that you get it batting average of 333, and you get $15 billion. As a pathologist misses one out of 1 million tests if they are wrong, their careers is over.
You're doing wonderful, but other than professional -- the question comes down to is how does the public knows that is happening? Other than the tort system why is it that the public doesn't deserve greater --
I think the public does deserve better knowledge. They need to be better educated. They need to have access to more information such as in the registry that is suggested by the report. I think that is all part of better knowledge, but this really does require expertise. Somebody needs to have the expertise to say this is clinically valid and that is what peer review systems are about and test validation. This is a daily practice of the pathologist.
I got it. At the end of the day, you are really helpful. And we have to go on. You have made your point. Because of everything you just said -- and this is the criticism that we must deal with --
This conference contains less than three participants at this time.
Of the three that are there, they are extremely important. We are okay that it is less than three. We love the ones we have. In terms of -- so that the dilemma you just presented us with is this, you just gave us compelling reason why people want us to take greater action. You said this is complicated. The whole thing is complicated. Is a real problem. People cannot possibly figure out -- let me go research -- people are just trying to live their lives and assume that the tests are fine. You just give a compelling reason why, other than this phenomenal trust -- that is all you are saying we should do.
Because systems are in place to justify that trust. We have proficiency tests. We have quality-control tests. We have inspections. The inspections very often go beyond what the regulations require. For example, there was a question about whether CLIA required clinical utility, but actually the inspections that inspect all the laboratories or most of these laboratories in United States require in their criteria for passing that inspection. So that is why having been involved in that process and seen the product because I also heard -- you think you are in trouble, you should hear what we get for our rigid we are and how unreasonable we are about what qualifications we are requiring. So that is why I have trust in the system.
Well, thank you so much, and one of the reasons I have been querying you is because you are very articulate.
I appreciate it.
I wasn't being --
I did not feel that way.
Linda, did they allow you to stay? Linda? Did you allow Linda to stay? Big brother? Linda? That is mean.
Hello?
You are there.
I thought I got cut off the call.
We can't let them.
If you did not know it you are with 23 and Me.
You have five minutes and we are here to hear you.
Great. Thank you for the opportunity to address the council. Twenty-three and Me was founded on the premise that individuals have the right to access their information and learn about themselves and a new way. We believe that they have the right to know what their bodies are made of. And that they should not have to pay for those services from a health-care professional to find out those facts. History shows that fears about how consumers will respond to information is usually overblown and inaccurate. People were able to handle being told that they had cancer in the 60's, pregnant in the 70's, HIV in the 80's, and that they may have had an increased probability of Alzheimer's in this decade as revealed studies have shown. Federal and State government as well as physicians should not impede Information Development and what ordinary people can or cannot understand or handle. We don't plan to stop that providing information to individuals about themselves. We are developing and wait for them to engage actively with new research effort, something we call consumer enabled research. We think that progress and genetic research will be greatly enhanced by the development of a large database of genetic and phenetic information contributed to it voluntarily by individuals interested in getting directly involved. I'm sorry, can you guys hear me? I am cutting out.
We hear you very well.
Yes. We do.
I would like to comment on the conversation prior to this. This is about giving people access to information that would help us understand more about these human genome. So rather than talking about diagnostic tests we want to talk about genome's and transfer that information. This is not about genetic testing and may not be the appropriate time to be debating this because it really is not about performing a test. It is more about having this information flow back and forth and as people are able to give more information about themselves we hope to gather that together, share that back with the research community, and make it a benefit. So we are talking here to about whether CLIA is applicable or FDA is applicable. We are here to say we don't have enough information and this is about a research effort. And that is what 23 and Me is going to be focusing on. I'm happy to take any questions that anyone might have.
By the way, would you remind me of what 23 and Me is. I should know it, but I don't.
It is a private-based company here in California. We are enabling people to have access to their genetic information through the use of research tools being used by laboratories across the country and across the world. We use large-scale genotyping microarrays to give people this information and [ indiscernible ] to give people an idea of what is coming out so that they have a better understanding of what these studies are turning up. You will see stories about these reports. So our mission is to give people the opportunity to learn more about what this means. We don't say that this is a diagnostic test. It is more of their way to get that information.
We have a couple of quick hands and quick questions and answers. Paul?
This is Paul billings. Do you have -- we have been hearing this morning about how consumers can judge the quality of the testing that they are provided. Does 23 and Me have a position on that issue?
It is a really good question. What we are grappling with right now is finding the right way to provide that QC. We really don't feel like CLIA is the appropriate vehicle to do that. If anything we feel like [ indiscernible ] in a wrapper of 23 and me disingenuous giving them the impression that the information is currently validated. We are providing this as an educational effort and therefore to say that this has wrapping on its gives the wrong message. With that said, we are doing everything we can to comply with CMS and feel like this is an opportunity to have a discussion with them beyond CLIA. It just sends the wrong message.
Real quick we have to Joe, Jim, and [ indiscernible ].
I will pass on my question because it is a little bit harder to answer.
For those individuals and the room who are not familiar with the offering, I was wondering if you could give any general position on what type of associations that you are providing? For example, there will be an offering soon of a company specifically designed to look at medically oriented associations. Do you have a particular overarching philosophy? Do you want to give any specific examples of the types of associations that you report to the audience here?
Absolutely. One of the components of our websites is something called Team Journal. Our scientists go through before we are willing to report on any particular finding, and they are mostly focusing on common diseases. We aren't really focusing on disorders because they are well documented and have been identified and studies, and there are genetic tests that exist for those. So with type two diabetes there are about seven genes that have been solidly established as being associated with the disorder. So we report on those and explain to people what the different versions are and give them references if they are interested. But we also break it down into everyday terms of what this means for an individual without a genetics background.
This is fascinating. Wayne, a quick question.
I am from the Center for Disease Control and Prevention. I had a call in January about the premature research tools being offered to the general public. So I appreciate your comments and the fact that you are trying to educate consumers rather than sending them a genetic test. But if these were genetic tests to be offered for preventional disease or health promotion they would not pass the test of even analytic validity and clinic utility. So as long as you appreciate that point, but it seems like you are making a distinction between an educational tool versus a tool that could be offered for health purposes. So I wanted to hear a little bit more of your perspective on this given that these are research tools and what to do you expect consumers to do with the information that is probably incomplete and changing as we speak?
That is a very good point. When we read the article in January report in very much in agreement with this. That a lot of this our mission is to continue to collect information. This has only been done in certain populations. If somebody is of a South Asian ancestry there might be a publication that came out, but it only applies to Caucasians. So the research is very limited. We hope to empower people to come back and tell us about themselves. So if somebody sees something about type two diabetes we can say, if you are Caucasian, report back to us whether or not you have it and we will continue this research together in a very prospective way. So we look at the model, and we want to do is move that concept of a prospective long-term studies where people can share that information directly.
Thank you. If you have anywhere near you your cellphone or Blackberry is on, it is receiving messages. In July and we have the benefit of having a session, a special session where people learn about companies like this, and we will have a chance to revisit it. I'm going to make sure and being the moderator i'm aware of time. I've got to make sure all issues are covered. Are you only providing information? Is it articles or information? What I think I am hearing you say is because you make no [ indiscernible ] about whether something has received this scrutiny that you just provide it with information. Therefore by definition it does not require any oversight. It so it is like, I make no pretense as to what this information is. Have at it. And how you choose to deal with it is up to your own intelligence as an individual thereby avoiding any oversight whatsoever. Is that what I'm hearing you say?
No, I would say that we welcome oversite, and that we are very eager to hear back from both the medical and research communities about what it is we are doing. Because we do want to educate people about how their genetics are impacted by the studies coming out with the caveat that it is all subject to change. We don't even know if cholesterol tests are as valid as we thought. So the public is pretty used to getting information and understanding it has a certain level. As long as we present is properly and that this information will be changing and it is more about them feeling like they're part of the process. Right now when you talk to most people they don't feel like they have a voice in where research is headed. And the autism community is a good example of that. We want people to feel they are more part of the process. It was so clear that people in training him have a sense of ownership of that process. The group wants to move that to the web in a social networking way so that people have that same feeling.
There are a couple of other answer. I think you have actually opened up an incredibly important issue here. I am going to take a little liberty and get two more questions and because I think that you have put something on the table that, quite frankly, has gotten my full attention.
Linda, I was just curious. You say that the main goal is for research purposes, and I was wondering when you provide the report back to the individual that requested the test, are you stating that this result is for researchers only.
Well, we do have said in a way to say that this is initial information. Our scientists have read these papers, and if they don't meet the criteria we established -- and those are up on our website. We explained that there are other studies out there. And because our initial response is that they want more information, and they are just hungry to know more. So we are going to have a way to sort of back up the research that is coming out and report things to people. You have to take this with many grains of salt, and people have more of a [ indiscernible ], but people seem eager and wanted to get this data in front of them.
We have to close off on this after one more.
Thank you for your comment. I think if groups like yourself have a chance to speak again it would be very helpful, to me, and very instructive when you get a chance to present again if you could map out a case to show how you carry out what you do with the information. Because right now -- I'm not sure. I just speak for myself, but there are a number of integration. You talk about the case and the process and how you think it should go. It is hard to follow so if I could make a recommendation that the next time you have a chance and present a case just walk us through how useful, what kind of questions you get, how the information itself is useful, and how you disseminate that information. I think that would be a very helpful. It sounds like what you do is a good thing. It is just hard to decipher because there is a lot there you are speaking about.
Absolutely. If we would be happy to come and give a demo. The most powerful thing we can do is to show you exactly what the customer's receive.
Any information you have, send it to the committee. Thank you for coming by phone and answer questions. Michael Watson will come up and then if Emma -- of course, you will teach me -- I did good? This is the first time.
Thank you very much for allowing me to make brief comments here today. I represent the American College of Medical Genetics, an organization on like many of the laboratory organizations that bridges both laboratory testing and clinicians who deliver genetic tests to the population. For the most part I'm going to focus on the heart of [ indiscernible ] side. I cochaired the task force on genetic testing back in 1995. I am not certain we have made tremendous amounts of progress. This is Reed's last meeting and I'm hoping he doesn't get that same funny feeling in 10 years.
It was the foundation he established that got us here.
I did not do it to spawn advisory committees. I was hoping we would make more progress than we have. There are some concrete things I think we can do, and we must look carefully at why the progress that we have hoped for has not been made there are fundamental aspects of genetic testing that get at why we have not been able to make some of the progress we hoped to have made. Genetic testing is actually highly complex. It is enormously diverse. So not any one group is really well placed to deal with it all. And there are a huge number of tests. We have recently have the entire gene test library transferred to us in the interest of project we are working on to develop a full assessment -- actually, an analysis to see what it would take to lay down the clinical validity of every genetic tests currently inching tests. People often talk about there being 1,000 or so genetic tests available. If that is so far off the mark it is sending. There are maybe 1,000 genes that we do tests on and that is a very much the way it is designed, around the genes on which we focus. We do 1,000 genes worth of testing, but from a clinical validity it is why we do tests. Every single one can be broken down to a much larger number. We've may do directed mutation testing or sequencing that does different calculation for clinical validity. That is one of the problem started end of the 4-5,000 tests we have calculated as being present the vast majority are for rare diseases. That is another problem that has been difficult for us to get a handle on. There is no incentive to invest in the development of those tests. It is left to the laboratories to develop them themselves if they want them to be accessible to the patient population, and that has made it difficult because laboratories in general are not in a strong position nor well enough resource to lay out the guidelines in a general level. The state to its specific to the tests they offer, and there is [ indiscernible ] around those tests. There is also a variation between different populations. It makes it much more complex than in many areas of genetic testing, like infectious disease. It does not suffer from huge variations among one populations of Asians versus Caucasians which leads to us being in a very clinical practice of medicine position of interpreting what these variations actually demand which is very difficult from a regulatory perspective. If this is unique it is not easy to regulate. Therefore we have become convinced that the best way to get at this is the public-private partnership. The registry is a nice idea, but it must be a bit more deep than a listing of what people are selling in their of laboratories around the country. As we look at the three primary parameters, the first one, analytical validity, CLIA should be able to manage that. It is difficult to get that otherwise because most of the variation and analytical performance of a genetic test is at the local level and the laboratory. Inspection and proficiency testing gets it. I don't think an FDA role on the analytical side will help much. It is a very powerful benefits on the manufacture test side, but I don't think it directly translates to the clinical laboratory environment. When you think about what people want, the public wants accessible tests that are accurate and have value to them for whatever clinical situation they are applying that testing. And to think about there is more information available than there was 10 years ago when we did the taskforce on genetic testing work. I think people don't really understand what they get with a different regulatory models. One of the things that is clear from an FDA evaluation is they do clinical possibility. They aren't in the position ready to say that a payer should pay for this test. They said that it can detect this, and it has a relationship to a disease. But they don't always say that it is [ indiscernible ] as of the time that this will be informative. I don't know that FDA is the answer. It definitely needs to be part of the process, but the fact that they focus on plausibility is not what the public is really looking for. They are looking for what is accurate and useful for their own situations. Clinical utility is certainly valuable. Genetic tests often don't come with the same level of statistical power that one wants in a clinical utility analysis. Clinical utility is something we all want for things that are done in a large populations. But and the rare-disease world it is difficult to get beyond the diagnosis in the test itself. So if you don't accept that the utility it will be very hard to accept that any of the tests we do are useful at all. So what we have been doing, we requested the gene tests send us their entire library. We have both said to have a complete access file of every test and seen that is available in gene test with the first goal being to see what it takes to lay down the clinical validity for the various intended uses of those tests. It is hard to do at a regulatory level because even in a diagnostic setting inheritable disease genetics, you end up in a situation where the variability is such that you may have a 90 percent chance when somebody has all the features of a disease that you will detect that analyte and it has clinical value to the patient. But as you move down to what might be a very long diagnosis you arrive at less and less likely scenarios that may still be important for that particular patient. That is what we talked about and is not something easily constrained by a regulatory perspective because certainly the regulatory perspective has lots and lots of exceptions for the practice of medicine which is how we deal with those decreasing values that might be available as one is to go down that differential diagnostic list. So our interest is really an informant that public-private partnership. Unlike the people at this table here, I did get to advise legislators and will spend the rest of the day doing that because the fundamental problem, I think, in moving towards developing a register that is not just a listing of test information about why they are clinically valid and particular situations. It will require all groups to accomplish this. We want to figure out resources and to spend a fair amount of time today doing, and then we want to figure out who the participants are.
Thank you very much. You have been clear. I think we -- you have been some specific I think everybody understands exactly what you are saying. Thank you. Don't leave to go away from us today. You should stay around for awhile. [ indiscernible ] from the National Society of Nursing and Genetics. And the last person was Michelle Schumacher from the Association of Molecular Pathology. And I want to respect these last ones. I know we are well on our break. So hopefully you guys will be able to hold off for just a second as we bring this to closure. We are pleased to give our full attention to you.
Thank you very much. My name is Emma, and I am a registered nurse to represent the International Society of Nursing and Genetics. Is a global organization dedicated to the professional growth of nurses and genetics engine damage. We congratulate the systematic efforts to regulate the oversight of the tests and results. And that the committee found significant gaps and oversight. We sure overarching concerns that it could lead to public health. Furthermore we are hopeful that the HHS health care initiative well advanced integration of technologies capable of [ indiscernible ] treatment strategies to individual needs. Overall we support the committee's recommendation to enhance interagency coordination. In particular we support development of steps to foster resources, education, and knowledge. In examining educational policy we highlight for consideration today. We take exception with the committee's conclusion that steps can be identified and addressed with the creation of a genetic testing are such specialty. The absolute value and comprehensive testing and patients are so largely unknown secondary to the highly complex and unique nature of genetic tests. Number two, we are aware of gaps to the extent at which clinical validity can be evaluated. We support the recommendation to create public resources and recognize that the American public will be best served as diverse ethnic, racial, and geographic subgroups are represented. Number three, in reducing system gaps and improving oversight we take exception with recommendations to the voluntary genetic testing. It will not be sufficient. We support strengthening federal monitoring and enforcement. Number four, we applaud the committee's concern for health related tests and agree that there is insufficient oversight of laboratories currently developing them. Given potential for misinformation and exploitation which make it taint public perception we support expansion of CLIA statutory authority. With respect to [ indiscernible ] we are acutely aware of genetic knowledge and agree that current strategies are inadequate to address them. We have further recommendations and the testimony for today. We fully support HHS collaboration. We support genetic expertise as essential when providing and interpreting every it's genetic tests. As the largest body of health-care providers purses have continual and close contact with patients and can intercede to prevent and/or [ indiscernible ] that may come from genetic tests. We repeat the need for greater visible nursing representation during the proposal and development of oversight and educational efforts. In summary, we congratulate the committee for considerable work done, and we deeply appreciative of a charity to comment on this important document.
Thank you. That is pretty straightforward. Thank you and well done. Michelle who is with the Association of molecular pathology. And I need to let you know that -- and again, I'm well aware of the break time, but the principle of trying to get as much public testimony in before we start grappling has been well served by the comments we have been seeing and all of the other ones. So from the Genetic Alliance we have a representative. And we will ask Sharon to come forward and present and then that will be our last one. But I don't want to miss the opportunity for Sharon to get her comments in.
Good morning. I am Michelle Shoemaker, and I'm speaking to you as a member of the Association for Molecular Pathology. We have provided comments to the Committee on numerous occasions in the past. We have the definition of genetic tests. Under the definition the test would more accurately be called molecular tests than genetic tests. And we encourage the committee to define which intended uses are included in the intensive oversight of genetic testing. Second, our generic tests different from other clinical laboratory tests? We recognize that tests are unique in several aspects. We are concerned that certain types of genetic testing marketed directly to consumers fall outside of the current regulatory oversight of CLIA and encourage the committee to further explore this area of genetic testing on public health and the distinction between clinical genetic testing and health related to direct to consumer market testing. Third, requirements for the laboratory personnel. CLIA already stipulates roles. It recommends that they be reemphasized. We encourage the Committee to modify recommendation 1-B to include the recommendation that CMS work with professional organizations to develop expertise of guidelines for there inspectors regarding the levels of expertise that are picked required for different kinds of genetic testing. Fourth, the role of CMS, CLIA and [ indiscernible ], we offer our expertise to promote expansion of proficiency testing programs for better oversight of director of consumer marketing of clinically dubious genetic tests. And we want to assist in the quality of genetic tests. Voluntary organizations creates detailed practice guidelines which effectively fill many holes that some individuals believe exist in the regulatory framework. The team approach in which Government Industry and practicing clinicians work together is a viable and desirable alternative to regulation for many genetic engineering tests. We are concerned that registration of genetic tests reduplicate the information already submitted as required under CLIA. We strongly support the CMS enhancement of registration for non [ indiscernible ] laboratories by enhancing the CMS infrastructure to achieve this goal. We support the proficiency survey programs currently available with additional satellites as necessary. We intend to begin publishing best practices and look forward to working with other organizations such as the CAP and ACMG. We strongly reviewed [ indiscernible ] as well as studies by CDC, other agencies and manufacturers and support integrated efforts to collect post market data. We are concerned that the current recommendation could create duplicate of systems and laboratories performing this test. And finally effective communication and decision support. We reiterate our commitments to participate not only in pursuing the success of this project, but in translating for the betterment of the public health and well-being and that we remain available to assist with or provide additional information for your thoughtful deliberation and important work. On behalf of AMP I thank the committee for your time and for listening to our concerns.
Let me just make sure -- this is very good. The key to your presentation to me is with point number four which you say again is ultimately that you will work with others to ensure the everything is okay. Are there any in those recommendations where you are calling for a material strengthening of existing recommendations, or is the essential aftertaste of your presentation that things are basically okay and you guys are going to work hard in good faith to keep making sure that everybody is doing right?
Right. We do support enhancements of CLIA where there are clearly gaps, particularly with the direct to consumer genetic marketing tests and agreed that there may be some -- FDA may be able to provide additional oversight. B. -- we do support continuing public dialogue to identify those pants to identify the intended uses. They also require additional oversight.
Okay. I think I got it pretty clear. All right. Thank you very much. Leslie is Sharon Carrie.
Thank you for the opportunity. Thank you to the taskforce for your work. It has been enormous. I speak on the order on behalf of the board of directors, and I know you received a written pages of comments. I will call out seven important concerns and more importantly move to a global view of your task. The first step is to enforce existing regulatory authority. In addition, is is important to take action on these identified interim steps. That discretion and immediately implement the necessary steps. For example, proficiency testing expansion and control training of inspectors and additions to the vest. It is clear that the mandatory test registration --
[CAPTIONER
Three, we agree the more public resources-That more public resources should fill in the gaps . We believe any such undertaking should prioritize on clinical need, and a proper resource allocation. Four in order to maximize benefits and public harm a public assertion of stakeholders should best-Including the establishment of evidence Gerry standards and increasing the number of systematic reviews. Five, --6, Director Consumer access. The testing must be carefully regulated to ensure the public safety. Seven, HHS much convene the HHS agencies as well as tickleds. In addition, HHS must take the leadership role in coordinating the activities of the federal agencies under its auspices for the benefit of public health. More important than these concrete recommendations is the overall pace of tests and testing and the integration of to necks into Madison and prevention and wellness. We recommend that HHS take a broad an enlightened view of the landscaper but we are at the dawn of a new age and innovation Development is critical to advancing human health. Genetic testing is a disruptive innovation and this is a critical time for development of new paradigmses. HHS can and must require that federal agencies work together with one another to achieve the best possible solutions. Human health is no place for politics and turf battles. Excuses such as the burden is too great or is too difficult is unacceptable in the realm of health. We, the entire testing community have achieved a great deal over the past year in understanding each other's issues of the it is time now to engage each other in meaningful and when Mark solutions and collaborative model. As a deliberate over the next two days, you are representatives of the millions of individuals who are suffering, sick and dying. Not an easy task. You must keep them before you probably are your loved ones, neighbors and friends. You cannot offer answers or opinions from your silos or of the interest today or tomorrow. You must push the boundaries for the sector company Commodore university or constituencies and represent what is best for the public but in this country and beyond. Before you speak to not think of your position of the greater good to be gained. Focus on the intended consequences rather than the unintended consequences. This is not a [ indiscernible ] game. While the status quo will be stabilized in the short term, we will all win in the long term. It has been a ticket Center Committee has made important recommendations. Regardless of the Secretary's response, we as a community, are further in mind by your work and they have a responsibility to one another and the world commodity to strive for solutions that will release the incredible potential of biomedical research. We must all remain engaged in dialogue with one another, seeking to tell the truth and discover new pathways to gather. We have a historic opportunity before us. The estimate to measure our responses, products on behalf of the better guide. Thank you.
Thank you, some much. Two quick questions, Sharon. Remind us of the genetic Alliance.
The genetic lines is a network of many, many organizations, companies, universities, etc. The go primarily, our bridges group of individuals and organizations under auspices is 650 disease-Specific organization.
Is our consumers?
Yes.
Let's take your seven points, real quick. You provided a terrific bridge to the break and discussion. As we go through your seven, essentially, in terms of the recommendations that the committee has made so far, if we go through those seven, where are you-I am trying to do the math on what you said. Are there overwhelming, profound differences with the report, the draft where we are now, as we go into this discussion that you are all concerned about? It sounds like a lot of them you are agreeing with where we are today. I want to make sure that we do not lose in the seven points some things that you are really taking the draft report to task for.
I have not seen the current draft. I believe it is different than the draft I saw. We differ in our understanding of the strength with which I believe this committee must-That CLIA be advanced and we look at proficiency testing. That is important and is not strong enough in the draft I saw. The second would be the mandatory genetic test registry along all laboratory developed tests that the House that a federal agency. I am also very clear about that in my mind. That has become very clear, not one of the first commentators hear from the 21st century medical coition talked about that. We work a lot with industry and universities and thought leaders. The mandatory registry seems to be the way to get the [ indiscernible ] on the data. If we tell our kids something it is voluntary, it does not get done. It is time to be responsible for them.
Lastly, not one of the things we keep hearing from some people who comment on over regulation, is the chilling effect on innovation, thereby, decreasing access to new knowledge and new tests. As the consumer community, are you chilled by those cautions are around, again, again greater attention to CLIA and so for the. Are you concerned, in fact,-You told us to not focus on the unintended. Focus on the intended. Are you concerned about this potential chilling affect on innovation?
If innovation is chilled, I am concerned. I come from the [ indiscernible ] committee where it is even harder to get people to innovate. I think this has to be done carefully. Our work, especially with the companies and genetic testing spaces has been very important to open our eyes and I believe enhancing CLIA and a mandatory registry does not show innovation. In fact, it brings a lot of stability to the Bill that venture-capital lists, etc. are looking for.
Thank you, so much. You are terrific. What a morning.
[ LAUGHING ].
I think we will, obviously, take our break. It is 20. We will see you. I have a reputation for starting on time. At five minutes to the hour, every minute being precious, we will start at five minutes to the hour. To go to the cafeteria, you need an armed guard.
[ LAUGHING ].
Those with visitor badges will have to be escorted by security. Are the security people out there? We will figure it out or go and see you back at five. --See you back at five of. Mac [Break until 10:55a ET].
[Captioner is on hold on audio line waiting to be joined back into meeting after break.].
Welcome back. I want to make a special note and a special hello to the 32 people who are so committed to what we are doing today. Even though the video is not on live, there are 32 people listening live to the audio. You are beyond terrific and we think you are wonderful. For those, you need to know that the video part is actually in a delayed broadcast. It will be up in a couple of hours and people will be able to watch it on a time delay the deal. We are told that tomorrow the live video will be up in the morning. There is a video to it. It will be Time delayed. We are appreciative of all of that. Now, to the discussion. We have heard a lot to. I thought that Sharon's admonition as we went into discussion is critical that we have a lot of stakeholders that have voices in says. I thought she was very passionate about thinking through and being balanced. There is also this issue of the chilling effect on over action and the harm of too much action that people have been deeply passionate about. We will work through these delivered to a fleet and thank God we have Andrea to lead us through it. I will be a traffic cop, but the floor is yours.
Thank you, Reed. Can everyone here me in the back? Okay. Great. What we want to do now is go into over you and some of the oversight sessions. Before we dive into specific discussion and specific recommendations, I am going to give you a little bit of background, when we receive the charge and what jokers' up until the point we are at today. As Reed mentioned, most of the meeting is to the discussion deliberations we need on the draft recommendations that have been developed to address the secretary at the charge to us for a genetic testing. Before we begin the process I will review our charge, the process we used to draft our report, the public comments we received on the report, some of which were just reiterated for us and the changes we have made to the report in light of the public comments and further deliberations. Although I will be reviewing comments that pertain to build, I want to emphasize that we will not be discussing the report at this time and great data put the focus of our deliberations for the next two days is to finish with the recommendations. By the end of the session tomorrow we hope to have consensus on the recommendations and approval of the transmission to the Secretary. We will also seek the committee's approval on principle. Keep that in mind. Which is what approval on the principle of the document. It will be further later edited for the month of February and then submitted at the end of April to the Secretary. About to take a moment to highlight the Secretary's charge, which received at our March 2007 meeting to remind you that our final report or recommendation should address the issues raised by the Secretary and the charge. It begins with a request to develop a comprehensive map of the steps needed for evidence development and oversight of genetics and genomics tests with health quality as the primary goal. We need to emphasize some of the decisions that we have responded to the Secretary. We have done that. The chart also tests the committee to a decidable existing path is that examine analytical ability, clinical polity and clinical utility up - -The roles and responsibilities to the government agencies and private sector organizations. We were also asked to conceive whether genetic tests are different from other tests for a purpose is to provoke the charge as several questions about proficiency testing, communication pathways to guide the use of genetic testing and approaches and models of involving the public and private sectors to demonstrate clinical validity and developed clinical Utilities. Lastly, we consider whether additional or revised government oversight would add value to our patients. As we receive the charge from the secretary, a group volunteered from SACGHS, which were six members of the committee either volunteered or [ indiscernible ] to be a part of this group, which needed to be able to deal with these issues. We call it the steering committee. The steering committee believed in looking at specifically the charge and developing from the charge a scope of what our document was going to be as we look to the charge and scope of what we're cent content intended content intended to talk to the Secretary, we decided how the document would be organized and divided into the different chapters. Add hoc members and field experts were brought in as we started to realize the scope of the charge that we needed [ indiscernible ] with different types of the expertise and material experts. I have listed all of them here. I would like two thank the steering committee and experts today devoted a lot of their personal time to look at these issues. We had a number of different meetings, conference calls two in phase meetings in July and September and worked tirelessly to come out with the document you see today. We discussed the activities in detail and previous meetings. I will not go in detail of what happened at the previous times. This briefly summarizes those activities. With the [ indiscernible ] sections in the report, they were divided into three chapters. The reason we divided it in different chapters was to tackle some of the incredible tasks we have in front of us probably worked for the summer and fall and were able to, with the conference call with the entire SACGHS committee, put out a report, a draft report for comments. Those comments took place from November 5th to December 21st. We received 64 sets of comments from a range of different stakeholders. I have listed here the difference stakeholders that we have received information from. You also have a summary. Ask you concede from the slides, the majority of the comments were from professional organizations. Some of them we already heard this morning put the toll from industry, 11 from government agencies, five from healthcare professionals, six from advocacy organizations, a and one from one individual. The steering group began analysis in late December and we receive a package and were so excited to be doing this over the holiday.
[ LAUGHING ].
I want to think that people steering committee to take the time over the holidays and January to go through the exhaustive review of all of the public comments. We met by conference calls the first three weeks in generate. Every Wednesday afternoon we had a conference call and discuss the public comments, specifically and what changes needed to be made to the recommendations and text. The revised recommendations were sent to the task force. We are getting into the task force to get a wider perspective from individuals that have already contributed. We had become its call on January 23rd. We invited task force members to present additional comments. We will have a member of the task force present them later today. On January 23rd we made some changes to the recommendations referring to some of the comments or discussions we have with the task force and presented these to the whole committee. You remember our conference call on January 38. The conference call was to not discuss the recommendations but give you an idea of where we are and for us to get a sense of what areas we need more further discussions or deliberations today and tomorrow. Of the most of the comments offered [ indiscernible ] for specific sessions for the report, the overall comments were positive. Mao's thought that the report was responsive to the Secretary's charge and provided an excellent review associated with genetic testing. Become mentors also recognize the delicate and of the report included diverse stakeholders. Some recurring themes that emerged from the public comments are listed in the slide propose several were concerned that the definition of genetic tests will sweep it under--To address this we have made changes to the text to provide further examples of what we actually considered to be a genetic/genomic tests. Genetic tests are no different from any laboratory test. They may differ in other ways such as communication or the results to the patients or even healthcare professionals. It is important to know that there was strong support for an increased proficiency tests and a large number of the comments were positive of this development. Comments for registry of genetic tests favor a mandatory approach to go there was no clear indication of--The deal, an articulate a preference for CMS and FDA. In reality most [ indiscernible ] about the registry. Those made some comments, which were the majority, provide different places where the registry should reside. Comments also had concerns about director of consumer advertisers and testing and agreed with the recommendation for regulation to cover this type of testing. In addition there was overall agreement that enhance oversight is needed for genetic testing. FDA a party to regulate laboratory tests was not questioned and the regulatory approach was reaffirmed, although there were some comments criticizing FDA guidance. Comments recognize there is adequate evidence for the clinical validity of many genetic tests and the importance to these [ indiscernible ]. Although many agree with the date for roles and accessing and supportable and favor CMS role in this particular issue. In addition to addressing gaps in clinical validity, the comments also called for more evidence and analysis of clinical utility and increased--Of healthcare providers, public health for officials, regulatory officials and actual payers. Last but not least, before increasing oversight, the benefits to patient access and cost should be considered. We changed Some of our recommendations to make sure that the state called thes are part of the recommendations that we are putting forward. We made some revisions to the report as a result of these public comments and further deliberations, not only on the steering committee but the task force and added public health surveillance as a key consideration in the Executive summary, added introductory [ indiscernible ] added methodology section to explain reports development, how do we, when and how do we get to the development of that particular report, and also revised the definition of genetic tests to include genomic tests. We are robbing to be a lot more clear about that. There were other revisions of the report and we added information about the Senate Bill [ indiscernible ] oversight of newborn screening activities of the Secretary advisory committee on genetic diseases and newborn children to roles of federal agencies in research and development and evidence and some of which is located in Chapter two of the knowledge generation agencies in Chapter four. We augmented the discussions and nanotechnology to include devices using extremely small amounts of material. We added the term reproduce ability as a key term in Chapter four probably updated and corrected information about the CAP products and performance and collected information about [ indiscernible ] biological materials and augmented the list of professional societies in Chapter four to make sure there were as many as we could list. Again, we cannot do an exhaustive list of all of the professional organizations. We have other activities that we are currently undergoing [ indiscernible ] to discussions of the clinical utility of the test. Patient access to genetic expertise. We corrected information about [ indiscernible ] and called it FDA approved or cleared what is a laboratory test. Add information about privacy concerns related to the director of consumer testing and advertising and commercially operated a [indiscernible]. We added CAP developed access sheets and examples of clinical decisions that are currently being used for newborn screening. So, the next debts, and here we go to today. As you can see, at the end of February, the final recommendations and the revised report will be submitted to the Secretary. Today we need to further discuss the recommendations and actually come to model afternoon to finalize the recommendations that will be submitted to the Secretary. We will still be receiving comments on the draft report, even though we will not be discussing the draft report. Which will ask you to approve it or not in principle part of the edits will be accepted until February 20th to make sure there is enough time to insure editing of that draft report. The final recommendations submitted to the office of the secretary by February 29. We will continue to work on the report over March until April 16th and have a final review by this entire committee done by a teleconference. April30 it will be the final report said formally submitted to the Secretary. Again, just to make sure we all understand and are on the same page, the focus is to finalize recommendations by the end of the meeting, additions to the report content can be sent to Kathy. She has been incredible in support to our efforts here.
[ APPLAUSE ].
Before we begin our discussions of the recommendations Cliff Goodman will give us a presentation of the comprehensive map. It is part of the Secretary's charge. We want to review it in some detail this morning for a two reasons. It will from our discussions and we have a very good understanding of this map of oversight. It will be a good premise for the work of reviewing the recommendations. We want the committee to weigh in on whether the map fulfills the charge of the Secretary. Remember to keep that in mind. Cliff built joining us by phone. We seem to be working with the people who get to travel to very fun places while we are here in Washington D.C.. Maybe we should ask Cliff to bring us something back.
I will do my best. In.
Staff is here that worked tirelessly to help us develop this map for the presentation. Cliff, welcome. I am pleased to continue with this review of the map.
Thank you, very much, it Andrea. Can you tell me know if this is a proper tone for my voice? Is this clear enough? Is this clear enough?
Yes.
You are very clear.
I will proceed properly should have a title slide in front of you which is as comprehensive map of genetic testing oversight. We will proceed to slide two. As you can imagine this map can be quite complicated and but I would like to do is present it at a very high level. You see in front of you five main sectors. As a matter of fact, if you want to extend the analogy of a map, you could think of five main continents of genetic testing oversight probably start out with research and development on your left. In the middle are three to 9-Except States which is New York and Washington, in particular. In the center is the main CLIA pathway. At the bottom is the FDA pathway at the far right is the sector four availability and reimbursement. Those are the five main sectors of the map. Am I still being heard clear enough at this but that?
You are very clear. You are locked into the sly. It is if you were in the room.
Thank you, Dr. Tuckson. Let's go to slide three. You've seen on the far left, the research and development sector is highlighted. What I will do now with the help of our team is described each of these individual sectors of the map, these five sectors. We will pull them all together in the final slide. Let's proceed to slide four, now part of this is the research and development sector. We will talk about this part of the map and walk you through the main parts of it. We do not have time to walk through the entire bit of it probably will talk about understanding Kathy disease interactions with basic research and a cycle of prototype, design and preclinical development. Coming out of preclinical development, we will do clinical testing, perhaps, of the device. At the top you will see test clinical development. You can arrive there directly from preclinical development, although in some cases, it might have to go from just below where it says apply from IDE which is test kits and so forth. That is the permission needed to test a device, including some tests, not all, in people. That is how you arrive at the clinical development of tests. Extended to be right back from where it says test clinical development, you can go directly up to LDTs, that his laboratory developed tests. That is one Route. You will see [ indiscernible ] and this group, of course, knows what those are. That is typically, but not always common characteristic of test kits and test systems developed by device makers and other companies that will manufacture of these. So, those are not to routes for devices. Now, you will notice quite interesting where it sells LDTs, there is a downward pointing arrow. That reminds us of that sum LDTs are IDE or [ indiscernible ] problem you will see that these are subject to FDA review as well as the CLIA oversight. It starts being a bit complicated there but it is important to understand, especially in light of more guidance that indeed, some laboratory developed tests must be subject to oversight that way. Now, going back towards the top where it says LDTs, you will see that as the exhaust into three main directions. Onewill be the CLIA-Exempt state route to protect the next is the available for use route directly part of that, by the way, the secret that you will find later on is the direct route for direct to consumer tests which end up by passing a lot of this oversight. That is a gap that the committee has noted. Then, the St. CLIA regulation is the third arrow off to the right. Before we leave this slide, I want to remind you of a couple other things. If you go back to where it says [ indiscernible ], and there is a arrow dropping down for class designation, when a company applies for FDA review, they will put it in as a Class 1A, Class A2 are Class three device. Echoes in the low right side, application for an FDA approval, it is typically for the PMA Route. Before we leave this side, notice at the bottom we have provided a pathway for code developed a therapeutic. It might be new drugs or, perhaps, biologics that might be developed and parallel to certain tests, certain genetic tests into digger. Although we will not dwell on the Therapeutics a very much at all, there is a place in the map for that code development and, indeed, the metaphase one, two and three trials, and civil is appropriate. Before we leave this slide, a discount to remind you that you will see a double asterisk at the bottom left-hand corner of this first slide that says functions of the differing quality system regulation. You will see on the slide at the FDA design controls were accounted for. Is as basic research and prototype design. You will see two other functions of the FDA Quality System regulation subsequently. That is what we are calling the research and development sector of the map. Noted that towards the top something that says G2 near LDTs G stands for gaps. The gaps were identified by the task force. Very important one says G2 refers to as sufficient clarity about the FDA wall and regulating Babbittry developed as part of the report goes into greater detail. This map shows in very short form or than 30 gaps. That is not one of the more important ones that show up on this sector. It is okay, Dr. Tuckson, I will move onto the next sector.
Please do.
Okay. Slide five conjugal see here that we have highlighted CLIA-Exempt States at the top center. Let's turn to a slide six. This is the CLIA-X and state sector and is primarily for new York and Washington State. We will start at the left middle that says tonight-Exempt. We will start with New York. This is CLIA oversight of the laboratories themselves propose that right arrow goes into a sector that has five main sections, starting with proficiency testing, Quality assurance, personal standards, a and equipment inspection. This applies to those attributes of those laboratorieses. You will notice coming out of their just below personal standards there is a right going arrow that points to analytical and clinical solidity review. If you look at this field, you know that there are some special things about the CLIA-exempt States with their examination of clinical and analytical review our good you can go up to it the New York lab approval of non-FDA approved tests, which is a very important function. Up from that is the Newark-State's licensed/CLIA-exempt. Coming out from the right of that into the right and down is the availability for clinical use. Now, in order for these tests to be available for clinical use, they need to pass through this New York State/CLIA-exempt. That is the pathway. If you look at the lower left-hand part of the inside where it says LDTs, if you remember this is not one of the pathways From our previous slide, they progress to the right and up. Those are the one subject to analytical and clinical reduce that to go to the New York lab approval and it can be provided by these New York State license/CLIA-exempt exempt Laboratories. That is the route. Weapons for the test to be available for clinical use is it has to have come from the LDTs and be subject to the oversight of these laboratories. Once the laboratory is subject to that, it can provide these tests for the that is what we are trying to show provoke the blessing to show on the slide is in the right hand corner, is by inspection per but that is another aspect of oversight and that the state's. If a laboratory does not do well, there are certain sanctions. They might lose their CLIA-exempt status in some cases or might not be able to offer a certain test. The feedback goes to the CLIA-exempt state regulation function. As a matter of fact, it can go back all the way to the LDTs in the corner because data from that inspection can be fed back even to improve test Development. So, that is the work of this one. Just imagine of a couple of the gaps program will see in the center just about proficiency testing those are gaps nine through 11 portables have to do with the exhibition resources to develop a proficiency testing for our genetic tests. Sharon refers to PT where sequencing has not been fully developed in the United States. These are some excerpted gaps from the text of the report. That is the CLIA-exempt state sector. Was moved to slide seven.
As you do that-By the way, you are doing just great propose something you just said at the end that I want to make sure-the gaps that you have so specifically identified and mapped to the map all come from the body of the report.
Yes.
You are summarizing the report. I think is important that people understand whose words you are using the. Thank you.
Dr. Tuckson, just to be more clear, we did some paraphrasing and shortening. Which I did it to the center of the discussion of the gaps to put on the accompanying she'd probably do, indeed, come from the Report. Yes. Okay. Let's move to slide seven which is the CLIA sector and slide eight, which describes in more detail. On-site eight, let's start towards the near left which is a CLIA regulation. You will see that that points to about five functions of there. Somebody should be familiar. Personal standards, quality assurance, quality control, analytical ability and proficiency testing. Outcome --To the right is denied accreditation. Another important thing to consider is the CLIA oversight of the several and functions along with inspection survey requirements--CLIA accreditation about that is not the same thing as a proving a test of a laboratory with the CLIA accreditation will be the laboratory that can provide this, the test probe of the test comes in from the upper left which we will seek LDTs from research and development. This is another pathway from that sector. It comes from the top of this sector than to deny accreditation. We are trying to portray their, the test as services become available from the CLIA-Accredited Laboratories, which have gone through those other bits of oversight, the several that I just mentioned. Off to the right back, they become available for clinical use a turbo once again, coming off the bottom of the CLIA accreditation, you will see by and allow inspection a and, again, in the analogy towards the previous slide, the biennial inspection, if it does not go well, the laboratory could lose its denied accreditation or not be able to offer some tests. That is very important feedback to the CLIA process and even to the R&D process and that you learn from the biannual inspections that can improve test and development in the future. Before leaving this one, I want to point out some of the gaps. You will see just above denied regulation gaps 3 to 8 propose correspond with the last progestin name one, Gap six, there is a lot of emphasis, which is insufficient resources to establish analytical validity, clinical validity and clinical utility to address gaps in evidence for an increasing number of genetic tests. That is an important gap to call attention to there. For example to the far right back side, and denied accreditation, a gap 12, is sufficient [ indiscernible ] laboratory tests prior to initial clinical test along the CLIA path with. That is another one that arises from the report. That is a very quick run through of the CLIA part of the map. Let's go on, if we can, to the slide nine. This is where we will highlight the FDA sector of the map. This is how it ties in and then onto a site 10. Let's start up at the upper left-hand corner. You will recall that we got to this part of the FDA sector from a couple different directions. Onecomes in from the top their brother is a downward arrow from research and development. That can be-Those can come from device makers with test kits and test Systems. Remember that some of those might be, for example [ indiscernible ] that a laboratory developed test that is LDT [ indiscernible ] and day, too, are subject to FDA oversight in this model. Towards the left where it says therapeutics, we have that parallel pathway for drugs or biologics that might be developed along or in parallel with the test provoke both of those converge on applications for FDA approval. Now, let's take the device, part of this first party to the right application you will see a of the PMA at the top which are novel devices what there is not a substantially equivalent device on the market Africa that is the steepest route to take four tests per but also see at the bottom the 510K. That is the equivalent test about that means that something has been on the market or it had a predicate as of 1976. There is also the special rights, the 513 F. as to which is to get the to know but [ indiscernible ]. That is when a device does not have a predicate on the market but does not present a high level of risk. Is trying to get a way to not have to go through the full PMA route but it is called the the novo 510K propose are to the FDA proposals and inspections are coming out of the right hand side of that, to the right and two application Review, that is when it is reviewed by the FDA. Depending on the technology, it might be analytical validity. It might be safety and effectiveness. Of course, that is a very simple way of saying the kind of things that the FDA is looking for. The one way they can get FDA approval,--Onward toward availability for clinical use. You will now does, by the way, just below and to the left of available for clinical use is the FDA Post approval inspection program that is another aspect of the FDA QSR. There is the route for the code developed or biologic therapeutic drugs or go BLA is the biologic new application. That is what you need to submit to the FDA to get review of these products to go to market. I hope you see that this is highly simplified to throw attention of these paths to go through one date --Those are the main point here insofar as the FDA routes. If it is okay-Sorry. A couple of the gaps to the far right that is below where it says FDA approval/clearance you will see G six. We have mentioned before about the insufficient resources. Gap 14 is insufficient evidence of clinical utility for most tests. Remember, even when they go through this process, it is Bradley the exception where you get good data, good evidence of clinical utilities. That is a very important gap to point out here. This is reflected in other discussions. If we might, then, let's look at slide 11. PC the 30,000-foot level. We will look at availability and reimbursement. That is the far right and fifth sector here. On slide 12, let's look at the top. You will recall that we entered this sector from four different main pathways. Onewas from the CLIA-exempt states, New York and Washington. There is a route to get here from that. Another was the special bypass, director of consumer tests. That is by not-CLIA certified labs, a typically. That is a pretty good bypass of the system. Your report has called attention to that part of the third is from CLIA regulation probably discuss that. The fourth is from the FDA approval or clearance way. There are four Midway is to get into this sector. Adjusted dancing up towards the top or is available for clinical use, that is how they become available for clinical use. Let's drop down from there and you will see that you have DTC, which is direct to consumer. It can be acquired by consumers' provoke the direct access, DAC, it should go back to a laboratory. There is clinician testing and testing by laboratories and so forth. Those are the several main ways that something becomes available for clinical use. You will see to the right of the DTC, DAC and lab that those organizations have different types and levels of oversight and other involvement in how these things are done. The FDA, the FTC, the courts, many organizations, we put a question mark after Gina. That is still pending. After we go through these gateways to become available for clinical use, you can drop down and some tests to the right are subject to clinical Review. This is a highly select number of tests at of the task force looks at some of those. EGap has looked at some of those. These are pretty good but limited efforts pro-Moscow the left-wing, been subject to another look at clinical utility carefully. Coming off the bottom of that toward reimbursement and the right. There is a arrow going to reimbursement for but that is carried out by Medicare, Medicaid, private insurance, and other. That goes into reimbursement. We do not show a bunch of other arrows to where all the money goes program that would be too complicated. I think you know where those go. Interestingly enough, also, another arrow goes to post marketing surveillance to the left. That is the market, but not entirely by FDA. When you have that, Post marketing surveillance, there is a lot of feedback information propose some post marketing surveillance is fed back to reimbursement because players are interested in what happens to the tests and how my affect their coverage to the marketing and surveillance goes to the left to the research and development sector and even the FDA development part. It might be used to resupply for a more broad indication of FDA are my change how the FDA couches its indications or labeling for marketing of tests and availability of tests. Notice, too, that at the very top four is as outcomes research, I do not want to forget that. Wants a test becomes available for clinical use, breeze organizations in the public and private sectors connect outcome research. The findings can come back to finding of a billable use and clinicians and others can use that information to reform their decision about how and when to use a test. After the right is the feedback that goes all the way back to reimbursement. Remember, the payers are also interested in outcome research. It might affect their decision. Outcome research can go all the way back with Post marketing a to the R&D sector and FDA decisions. That is the overall picture of the FDA part of the map. I want to bring attention to some, not all of the gaps. Let's go to the top where we see G 15 and 16. G 16 is a growing number of genetic tests that are offered based on genetically validated genetic association study's purpose that is not one thing that came out of the report. Let's go down to the lower right hand side which is G 32 and 33. 32 refers to inadequate outdated systems for coding, coverage and patent for genetic tests and Services. 33 raises the potential for misuse of genetic information and insurance and--That is a concern of some. That is what I know that some people are interested and Gina, for example. We are delighted to to to some of the gaps in the report provoked that is the FDA sector, real quickly. If you are brave enough to turn to slide 13, slide 13 is the big picture we put all of these five sectors to gather. I hope you realize why we did not show you this first. It would have given me an upset stomach myself this is all put together. And want to take a few things about this before turning back over to Dr. Tuckson. This map does try to represent the current system. Is a complicated? Yes. Is a simplified version of reality? Also yes. This is not a map to represent where we need to be or what would like to be or some ideal. This is a decent, high-level snapshot of where we are now out of the white is a complicated? Well, it is complicated because it needs to accommodate a great, involving the diversity of testing and testing services that evolve over time. It also has to reflect a patchwork history of legislation and regulation that have applied to tested over many, many years. It is not complicated by design. It is complicated because it has to account for an extraordinary diverse range of technology and has to be complicated in order to reflect the different historical reasons and [ indiscernible ] aggregation of types of oversight. That is where we are with this map. The map still needs some tweaking. We are welcome to more input for it probably will make it better purpose is where we are now. Back to you, Dr. Tuckson.
Thank you. I will get it back to Andrea in a second here. First of all, my God--
[ LAUGHING ].
I was looking at Kevin.
[ LAUGHING ].
First of all, what a terrific job. I think the companion code for the 33 gaps are actually terrific as well. If you have those side-by-side. Two comments that I think the report will need to make sure as we go back and look at it is number one, at one level, this coming in and of itself, could be proclaimed a problem. Just the very nature of something as awesomely complex as this could, by itself, be declared a problem. And of the things we will need to do is to say how different is this than the oversight of non-Genetic tests, which would be important. If you were to look at this in the reality of traditional medicines today, is it any less horrible than this looks? Secondly, we have to be real clear about, and we will get into the basis of our analysis, who is the person responsible for making sure for the public that all of that stuff gets dealt with? I think once you start to realize that this is complex, who is driving the train or responsible for driving the train? They will have to be fairly explicitly known so that folks will understand where the accountability is for the things that exist as we deal with the accountabilities for the things that do not exist. Andrea, take it away.
Thank you. This map is describing a very complex process. I think it looks a very complex because we have been very comprehensive in looking at the oversight of all laboratory-Developed tests. The route of clinical laboratory testing that is currently offered in this country. I would like to open the floor to see if anyone has any comments to the oversight map?
One other comment I have as people start to rise to the microphones is, not one of the things, also, that I wonder about, and tonight, I am not sure if we commissioned them to do this is a couple of illustrative vinegettes. I think it is important-Not one of the things that we should be doing as we have our debate and discussion about these recommendations is to keep in your mind-for those of you that feel strongly about certain positions, played out a scenario so that you can see how this works in real life. I think the vinegettes will be a very important thing for transmitting this report.
I think that is a very good idea. Anyone else have a comment?
Yeah, Reed mentioned the issue of genetic exceptionally some in relation to the complexity of this. We have not to other overarching issues, public awareness and whatever the other one is, access, sorry. I would say, also fostering innovation. I think that there ought to be specific comments about how this picture relates to those issues when this is portrayed.
This is a very nice complicated view of the real-world. We can all quibble about little things, but just the fact that we have been the map laid out is a very tremendous task. Might complement to the group for doing the best. By the way of clarification, I wanted to try to understand how the LDTs, 23, goes straight to the consumers, bypassing all of this. I did not quite understand how this happens right now, maybe because they do not use this for health purposes in. Basically, there is a big hole [ indiscernible ] driving from a LDT directed to the consumer through all of this complicated by Mark.
Exactly. I think that you have just identified one of the issues that the committee had in portraying the LDT, for those laboratories that are offering testing to the public without going to CLIA certification. They claim that they do not fall under CLIA statutory regulation here. That is exactly what we have here. That is a big hole that we have identified.
Isn't that because they claim not to be offering a diagnostic or medical services?
We have recommendations on that issue. We are just looking at how we are portraying that type of test. You have a comment?
Yeah. I also applaud this. It is not complicated enough.
[ LAUGHING ].
Do you want to complicate it?
It gives us a small but important line of submissions, which is the investigational device exemption. That clearly needs to be interposed provoke there are some technical corrections that I will not bother with the.
If you could give us the technical corrections, that would be greatly appreciated.
I will provide those in the Post approval products, our surveillance program [ indiscernible ] the the novo go straight for you do not break off the assignable provoke that is the whole purpose of the the novo. We would take umbrage, I believe this is hotly contested, but we would probably call LDT IDE as well. We have a variety of small [ indiscernible ].
[ OVERLAPPING SPEAKERS ].
The IDE is a patient Protection vehicle that you need to the think about when you do look at the whole thing.
It is impressive to put together a map of this scope detailing-It is and likely to become more complicated as the map evolves. My first question determines what my second question is going to be promote the audience is the audience for the report, a very high level, and hopefully other people in the field reading it to understand-the report is not to fold, and in-depth analysis of the situation with recommendations pulled out so a more casual reader can understand it. My second comment would be, not one of the most volatile parts of this at looking at everything from a 30,000-foot you is how the gaps tie in with the process. As a casual user, I would see this diagram and flip the page. So, I wonder, and I realize this is a very non-Trivial thing to be thinking about, but would it be possible to do a map of this flavor adds a more Resolution-At a higher view so that you can-and very much in the way the you have broken down easy jaunt into chunks, can the collapse of this grant of 30 into a way so that we can appreciate where the gaps are without losing the understanding of the process?
I was going to say, not one of the things that we were thinking about is actually showing the five sector [ indiscernible ]. Most of the slides you saw, the Big five pieces and each of the five pieces and finally the thing together, might be thinking about something at a slightly different level. We want to make it easier for the target audience to comprehend as, not showing the one bit complicated diagram.
I appreciate your comment. I think the value of this type of granular system is to show where some of the gaps are located. If you go to a higher level, I you might lose some of that appreciation. We can take into consideration your comment.
I just think that we have gotten into the philosophy of everything has to be on a one page executive summary and when we try to bring down horribly complex issues into something so simplistic that it does not represent reality and gives people a false sense of security. I think the issue is-It is less of the map but more the engagement of actually walking through the map. As I looked at the map and try to dissected myself while trying to do the review, I found it confusing. To have Cliff walk through the different sectors, if you could have that type of engagement which takes a relatively brief period of time, that is where the real robber can hit the road.
Okay. Steve and then [ indiscernible ].
Right thing [ indiscernible ] where the issues and ability ocher, where the clinical validity issues are so that we can begin to see that the gaps that we are dealing with in the report and trying to fix, it is not like they are in isolated places where you can put your finger directly on it. It is important to realize the problems we are grappling with our across the spectrum of this process.
I think that is a very important point that we do not want to lose, for example, the LDTs to go through the FDA and other areas. You need to see the entire picture. Maybe adding, like Mark said, at the different sides and work through. It will help whoever is reading this report down the road to understand or facilitate the understanding of what we met by this. Mark?
To be responsive to Paul's, which is right on, maybe the other thing we can add to this, but I do not think would add any more lines, we could highlight which parts of the process are currently transparent, where a sophisticated consumer can go in and find information. And those parts that are currently behind the curtain. That is a big issue in terms of our report.
I did want to build up on what Mark said. This is helpful in our deliberations and discussions later on, especially around the concept of a registry. For any intended use today, for any genetic test on the market or in this research for us here or in this diagram, for consumers and providers to get the information they need, where would they go? They can go different places. If there is a way to put out all that information together and display it to the stakeholders in a transparent way, that would be a good start in order to inform the providers and the consumers whether or not a test is ready for primetime. Just by the way, a little correction here. If you look on the right lower corner, where you have the [ indiscernible ] task force and eGap, eGap was designed not only as a clinical utility review but to review everything including analytic validity, of course with an eye toward clinical validity. We use the eGap working group for which a couple people are here.
We should put the eGap in another place too?
There is a way to try to capture this information from multiple places and feed it, whether in a central location or distributed information that is transparent [ indiscernible ] to the public through Web sites, that could actually be a good start to go through this and understand how much of it is able to be downloaded. Right now it looks like an opaque, very thick forest that you are not able to penetrate through.
That is a very good idea. They will have to figure out how to do it. Mary then James.
I would agree with the complement on this system. I do not think I have ever seen anything as comprehensive as this. I would say that is important to make the small or medium changes so that we truly have something that we can put a stake in the ground and say that this accurately reflects the system. As opposed to the last comments, I think we can use this map with the recommendations. As we go through the recommendations, we talk about gaps here but to use this literally and graphically, to say that recommendation 17, another are not 17, I did not want to prejudge it, but the recommendation 17, indeed, fills a gap that is G2 over there.
[ OVERLAPPING SPEAKERS ].
Let's make sure to use it throughout our whole process.
You have noted that you have a single page. You can still on temperate take it. As we go through the recommendation, we will go back to this map. I have James then [ indiscernible ] and try to wrap it up.
I would just suggest as a practical issue, this overview is so good. When I looked at this I almost had a tonic, clonic seizure. Cliff's walking through it, which probably took about 15 minutes, was so good, I strongly suggest having a very explicit link in the report to that presentation, which I imagine has been captured. Anyone wanting to understand this, we should say that when it would be well served by spending the 15 minutes to take them through it.
Did a great job, Cliff. I commend you and your team. In fine-tuning in the map here, when you look at the upper right hand and metal corners, the outcome research and Guidelines Development is very, very [ indiscernible ]. You could consider the same thing happening at the eGap level where research information is also used to form the recommendations. Vice versa in that line development, depending on whose guidelines you are thinking about, clinical utility is a part of their review before making the guidelines. You might want to consider taking that a little bit. Big too.
Net one other thing is that we have here, the role of the non-Regulatory oversight, such as the professional. Under the clinician we have the professional organizations and other organizations that provide guidelines propose a might need to be also reflected through the CLIA-exempt state and the CLIA regulation because they apply to how you are going to be applying it and testing it, and so forth. There is not only the regulation but also these other in but perhaps from these other professional organizations or other groups that are providing these the times. If there is a way to put them also in these other two main blocs of the CLIA-exempt and CLIA regulation. The question we have to ask, do these reflect the charge from the secretary on a map of the oversight? If you do not think so, please say so.
I certainly a vote that is responsive with the appended gaps issue, which we will go through and with the only exception, what it misses is a little bit of a commentary on accountability. If we can get a commentary on accountability at the levels at which is there, you cannot have accountability for the gaps, but assigning the accountabilities of the secretary office in general for driving the overall trade and how explicit is that accountability? The accountability for the Major government agencies, the head of the decor is accountable for-Just a sign a rational accountability for those.
I very much agree part of the accountability makes sense and what to say on the record is particularly impressive that you have added the right hand side that talks about accessibility and reimbursement. That is something that has been an undercurrent in the broadest scope of the industry for a long time. It cannot look at the left hand side without at least understanding the right.
If you notice on the map, everything is in a circle, it is inside a circle.
Patrick. Thank you.
We are doing good so far probably will see you later. Now, we will move to the next presentation--
Are we done with Rome? Big too, very much. I wanted to ask our team to make sure to not let Steve and a few others out of the room without getting their handwritten corrections on their versions of the map to make sure we capture those wonderful exceptions. We had to work in the two dimensions and could not cross lines. That is not one of the roles of go back to back for the very, very helpful suggestion.
Because you cannot see it, there are 28 of us here who are waiting from the presence from Rome.
Before you leave, Cliff, we need a round of applause.
[ APPLAUSE ].
This will be a significant contribution to our understanding of this complex issue. Thank you, Cliff.
Thank you, Andrea. to our team.
We will continue forging through.
A quick check until we have people expectations. We are scheduled for launch at 12:30 to go we will plow forward and see how we are doing and see if we can have a natural stop around 12:30. Thanks. Lunch is up here in.
Actually, lunch might be coming. It is in here.
In here?
They will be bringing it in here. Okay. Continue.
Very quickly on this launch the deal, those who followed the instructions as our staff urged to and ordered your lunch, you eat lunch here to go for those of you that did not, you go down to the cafeteria and stand in a long line.
If you go to the cafeteria, you have to go with a guard. They are right there. We begin our work to finalize the recommendations that will address those gaps. We took a poll as to where the committee was and all of the recommendations and started to identify areas that might be more discussions and further information. We decided to take the recommendations, revise the recommendations in reverse order. We will go from the back to the front. With the Chapter four, those recommendations will require a little more discussion and want to make sure we do not rush through those. We still have all of the other recommendations to go for. Will start with the five recommendations in Chapter six proceedings to the four recommendations in Chapter five and the big ones in Chapter four. We will end with the overall recommendation that appears at the end. We think Chapter four need the most time. These are the questions to consider. Keep in mind as we go through the recommendations proposed changes made to the draft recommendations are going to appear in Lima green as we go through the different text. Each recommendation will provide a summary and ask three questions. I will not read the recommendation. You will have the recommendation and any changes we have made from the original draft that was changed through the steering committee and the task force will be in lime green. First, I will ask if you have questions about the recommendation or need clarification on the intent of the recommendation. We will have the task force members seated right over there, I asked more questions, as Pacific if we need more information, what the intent of that particular it--
[ LAUGHING ].
Then, I will ask if you have any edits to the recommendations, change the wording or the specific recommendations. That, we will complete our discussions and I will ask if we can move to the next recommendation. Consider the following questions provoke does the recommendation adequately address the identified problem? Is the wording of the rat recommendation satisfactory? We will start a chapter sex part of this recommendation calls for HHS to work with relevant state calleds to identify and address deficiencies and genetic knowledge, education of three key groups, healthcare practitioners, part of health workers and consumers. We revise the preamble of the recommendation to recognize the creation of the SACGHS staff on Education. A we added educational efforts should also take into account issues of medical literacy, electronic information and efficiencies in public infrastructure. Recommendation six also has a part B. It is not new text that appears in a sections-We move this recommendation from Chapter 52 Chapter six because we thought it fit better here. This recommendation, part B calls for research and how knowledge of an analytical ballistic, chemical the liberty and clinical utility can form the development of evidence-Based clinical practice guidelines. Again, three questions we will be asking through the the. Do you have any questions about this recommendation?
Yeah. So, this is terrific. I think a lot of this will be-Is determining how to have the form and structure. This is fairly generic say that people ought to have more knowledge. We have to be attentive to saying the point of it is that people need to be able-You can talk about a lot of things with Tess. It is now whether or not, as a rational consumer, this is about protecting the consumer, not so much about-It is also about the uses, but does a rational consumer have the information and is being taught where they can go to understand the safeguards I around how-Whether or not, how they use and access a genetic tests. There is something missing in the sense that this is a little more general than getting to this notion of a ultimately saying, how do you become and aware of the consumer of a product in addition to being concerned with how you interpret the test and all of those other things to go there is something missing in terms of the focus of this activity.
I would take issue in the sense that I do not think we intended that focus or should there be-the deficiencies are across all stakeholder groups, not just the consumers, the healthcare providers ordering the tests also. Those groups are all articulated in A, the three key groups that we discussed, the healthcare practitioners, public health workers and consumers. From the perspective--
Let me try it a little differently. I agree with you there. What it is saying is that HHS should work with all of these people to identify and address. It does not say that there will be a place that you can go to get the information.
Trying to digest what was just said, I agree with him. I think the bottom line, this is about oversight of genetic testing, not about the task force. We need something, starting at chapter six this is not the place to go get information. The information they need for the implementation of use of genetic test and practice can be done in an informed fashion. Maybe we can tweak the word a little bit. A and B looks right. We need to--For the general public and providers to be aware of, not genetic information in general.
You are going ahead of what recommendations are coming. Remember we have the recommendations about clinical decision and support. Look at all the other ones too to make sure we do not have it in the other one's. I will ask what language you would recommend? What changes would you recommend to address this issue?
[CAPTIONERS TRANSITIONING].
Number two, and I'll leave this as a general comments. It does the community think about having a timeline for the implementation because while most of this -- and I very much agree this is important, but when you think about getting to all government agencies and interest of private parties that could be a process that could truly take generations. And I think putting some parameters around actions or time lines puts more teeth and that recommendation so that actions will have to be taken over a particular time period to actually in short they are implemented.
People take that into consideration.
I just want to get back to this point. To get more specificity are you actually looking for a resource, website or something, a one-site-fits-all or are we just looking for some sort of process by which we say to the public if you are looking for this kind of information this is how you go about getting?
I can make suggestions to change right now. I address deficiencies and education. I'm saying to identify deficiencies in the knowledge about genetic applications and all of these applications because this is sort of like a genetic, you know [ indiscernible ] essentially. What we are talking about is the practitioner, provider needs to know the value of this information for practice. So instead of a saying genetic knowledge and education, just say explicitly what we want people to know. That is the only change that type would make.
I can answer your question. Who knows whether a decision support --
[OVERLAPPING SPEAKERS]
This next one is recommendation number two.
Recommendation two?
Yes.
That is the regulatory one.
I guess I am sort of saying in addition to what Maria is saying, we ultimately are recommending that there be a place for guidance.
Particularly computerized tools for ordering application of genetic tests.
So maybe we can include -- expand that to include.
So I will stay with Maria on that part, and we can get more specific.
Do you want to add in language now?
Yes.
Could you repeat that first sentence?
Yes.
Deficiencies in genetic knowledge and education.
Part A.
Deficiencies in the knowledge of appropriate generic education and practice. That is probably something that captures everything we want from the oversight mechanism.
Say it one more time.
Deficiencies in the knowledge about the appropriate genomic applications of practice and genetic applications of practice.
[ speaker unclear - audio low]
Yes, slash genomic.
How about genetic tests because this is important about oversight of genetic tests?
Genetic test applications.
[ speaker unclear - audio low ]. Just take one other and.
Do we want to change the number of people while we are at it?
I would suggest that is just one of a whole series of decision-making policies. I don't know how broadly we want to make that's because there are a lot of them that are making policies that to influence this environment.
The practice and education of key groups in particular. Then we are saying this is only for -- I think that is better.
I think we could debate over Steve's point, but when you read the rest of the list they would not be included. So eliminating the number and highlighting in particular --
So we are going to have a key groups such as --
I am hearing two different things.
Such as --
And that will get to the point that Maureen and Reed had for now at least. And then there was a comment.
Perhaps this is an issue, but I thought the initial wording was describing it general gap in the knowledge. Now it is more specific to genetic tests and applications. And while that may be where we want to go it is a different thing because we are getting into these specific test and scenario and education. Are we specific, or are we going toward that's more general deficiencies?
Just to respond to that before we discuss, I think that is a good point. But I think that's the other point that Reed brought up was probably more pertinent given the focus of the report. This is appropriate. It does not mean that those other problems don't exist, and we do articulate the breadth of the problem in the language of the report. I also feel less concerned that we need to be as broad here given that we have another task force solely on this perspective. I am comfortable with the changes proposed to keep this within the context of what this report is supposed to be doing.
Now bringing back the point that Maria brought up with the time line, do we want to put a time line on this?
I would love to, but I have no idea how to set it. I really don't. I understand that these can go out and disappear. We heard talk about processes of this going around since 1995. I think probably I would defer to the education taskforce to be more descriptive about this because I am not sure I can even begin to get a handle on how to set up a time line.
It might be that we don't have a time line for every single recommendation. Just think about this. We are going to go back to the recommendations tomorrow. Keep that in mind. We can go back to specific time lines tomorrow.
I was going to say exactly that. I would like to suggest that the committee keep in mind the issue of time lines, and then come back at the end and we will be a vote likely more realistic. It may not be ideal, but I advocate that we put some parameters on around this so that we can do it as a report as a whole or major sections as opposed to A, B, one by one.
Since you brought it up we will charge you to look at that.
Just a technical question and perhaps we will be different inputs, but are we talking about payers or payors? Because it is to be consistent. How are we supposed to refer to this. Suzanne, where are you? Payors, right?
While you are here, Kevin, keep us straight. Are there any changes in B? Are there any changes?
It is not a change so much in the wording, but I think this recommendation is so broad. One issue that is inherent in the process is inherent in making guidelines based on that is very different from the issues and processes in terms of implementing those guidelines and practice and is changing practice. My only concern is this is so broad. Maybe we can split it up into two recommendations, one on making the guidelines in different domains and then a separate one on actual implementation and use and practice.
Mark, do you have any comment to that?
Yes, I am sensitive to those. I think our intent here is to try and take advantage of whatever the secretary can do to set a research agenda around these issues, whether that be through AHRQ or NIH or some other mechanism. I am not sure -- we could not really come to make a decision about how best to specifically articulates where this should go. So as a consequence we have left it broad. I would like to be more specific, and if you have some specific suggestions about what we would be able to direct the Secretary to do to give this along, that would be most welcome.
Do you have a comment to this specifically?
I appreciate what Mark just said. I think that where the specificity is, the Secretary should ensure there is adequate research resources available to advance analytical validity, clinical validity, and clinical utility for multiple purposes including so that it will be included in the clinical practice guidelines. Here I think with that danger is is -- there is no such thing as evidence based clinical guidelines without the other stuff. You don't need to conduct research on how it might be. Give us the dam research.
So are we comfortable with it?
One of the reasons we wrestle with this is, this is two separate issues. One is the critical utilities and guidelines. We could have separated them out, and we decided that probably it wasn't very helpful because they are closely linked. That is why it is sitting here in this chapter. I think that is what you are getting at, if I hear you right. There are really two separate components.
With the comments that are just made, changes to the recommendation, would address the specific issues?
Yes, I think it makes sense to me because the secretary obviously cannot conduct the research. But making the resources available --
Reed, can you go back and say where the language --
The language would be -- and by the way, I have to go back. We have a bunch of recommendations. In our gap analysis it specifically says insufficient resources to establish analytical validity. So that was a gap. There are reasons why that is important. What we ought to do is find the right place to summarize, the gap in that results in a stifling some extremely important things. One of which is not having evidence based clinical practice guidelines to inform the translation of this into clinical practice. Therefore we recommend that there be adequate resources to achieve this purpose. That is what I'm saying.
So the change would be that the Secretary provides adequate resources --
Adequate resources are provided to research.
Say that again.
We don't have to say secretary. Just sufficient resources are provided.
[ speaker unclear - audio low ]
We are going to go back. We have recommendations. We also have other recommendations. We are going to go back at the end after we have gone through all the different recommendations to make sure that we don't have overlap or where they should be broken or where they should be placed.
What I hear you saying, Madam Chairperson, is that we will except for the moment that there will be some duplicative recommendations. We can go back and smooth the stone later on.
We are going to go back to all of these.
At least we are catching redundancies as we go along and then figure out when we want to smash. We will worry about that letter.
Is this the extent of the change that is to be made? Your point about --
No. Look at the preamble.
[OVERLAPPING SPEAKERS]
I know. The following strategies.
It is not how and manage. You know all that stuff. Everybody knows that you can't do evidence based clinical practice without it. You are basically saying give us the resources to advance evidence based clinical practice.
Okay. Let's step back for just a second. Do you want to bring --
I want to speak to that issue. Chapter five actually talks about supporting a private-public partnership and getting adequate funding to do the research and surveillance and get all of this evidence right and develop guidelines. That is in Chapter five. So is may be that we can shorten that first sentence and actually get down to the second part which is the transitional piece which also needs [ indiscernible ].
We want to -- they have a $0. So the thing I don't want to do is ask them to give the agency a bunch of dollars to tell us how to translate this stuff. They know how to do that. Give me information.
No, to develop.
To develop?
Hold on. The idea is sufficient resources should be provided for the development of evidence based critical practice guidelines. Is that where we are?
No, I think what I am hearing, there are really two pieces. And this is back to dividing it out. And we may as we get -- take out that first piece have that and reflect it in Chapter five. But what Reed said is the critical issue. There aren't a lot of resources to do the translation. So what we are asking for is that they have adequate resources to be able to take the stuff that we recommend in Chapter five and create [ indiscernible ] and study how that should be translated into critical practices.
But what I am hearing is the knowledge of analytical validity is already covered in Chapter five recommendations.
Right.
So if we take that part out if we are dealing with a duplicates of the two recommendations, and we only developed this recommendations to deal with funding to develop --
Into evidence based --
But we need to look at when which as we are going to put here to reflect that. We have sufficient resources should be provided.
[ speaker unclear - audio low ]
Yes. For the development of evidence based clinical practice guidelines and how that information can be translated into clear practices that enhance the quality of care and health outcomes including dissemination and implementation of recommended genetic tests and the critical and public health practice.
I would say take out how that information can be and just say it can be translated into clinical practice guidelines that enhance the quality of care and health outcomes.
You are saying leave that, but take everything after that out?
Right.
Yes.
Wait. Hold on. Undo what you just did.
Okay. Hold on just a minute.
[ speaker unclear - audio low ]
You put this in the very beginning. So given that there are resources to enhance their knowledge about clinical validity, utility, etc. then sufficient resources be provided for the translation of that knowledge into evidence based clinical practice guidelines that enhance the quality of care and health outcomes.
Okay.
Okay. We are going to give it to him before he leaves.
We got a lot done before the lunch break.
Practice.
So with these changes that we have done -- and remember we are going to see them again tomorrow. Are we done with these recommendations?
Translated into evidence based practices.
Reed is going to work with you.
Yes.
I think we are at a good point for the break.
Does as it have to be 45? 30 minutes. If you see a member with a tag, let them in before the other people from HHS.
[Session on lunch break for 30 minutes.]
Will all of the -- has anybody noticed that there is a long line in the cafeteria? How bad is the line out of there? Can we start in your opinion? Let the record state that we have approval to start from a well-meaning soul. On the board we want to dispense with this estimate. The operative part of the recommendation is the first sentence. Is that it.
Yes.
Based upon research. Sufficient research shall be provided for the translation of this knowledge into evidence based clinical guidelines to enhance the quality of clinical care and public health outcomes. Apparently the committee's sentiment may have gone beyond that. This is what is reflected in the second sentence, which I personally believe it is not within the domain of this task force but in another task force somewhere else. But intellectual honesty prevailed upon us to put this year for the committee to tell us, no, this is what we meant. We need to ensure availability of information and its translation to ensure the adequacy meets the needs of an approved clinical care. So you want to monitor how this is actually used to be able then to have it as part of the feedback loop for oversight. I believe that it wants -- you are actually talking here about the practice of medicine and not oversight of tests. You want this information and how it is used and how are these tests being translated as a part of the oversight mechanism. You tell us if that is what you really meant and feel strongly about that.
This came out of the idea that as we discussed the testing in the report, we talked about testing as a process that does not just end with a laboratory test being done, but there is communication before the test. After there is adequate understanding of how the information should be used, and then it has an impact in appropriate care. So what we are trying to capture here is the idea that we do need to understand this. And it also reflects the sentiments that has come out and will be discussed in previous chapters about the whole idea of a post-market information gathering. Some of this will relates to the appropriate use and not just if you use is right, as it were. We thought it was reasonable to reflect this here. However, on our break there is also the possibility that this group will be proceeding with another taskforce that has been put on hold as part of our process where this would, I think, arguably fit much better.
So with that analysis -- and this is much to do -- I don't feel strongly about this point. Quickly tell us, do you want it in or out.
In? All the ins put your hand up. Okay. Now out?
The reason I think it should be an is simply that it says the secretary should assure the availability of information.
You and I are going to be overruled. We don't win this one. Andrea doesn't get a vote because she is chair.
Since when?
[OVERLAPPING SPEAKERS]
Next issue.
What did we decide?
Let's go.
Okay. Recommendation number two. It calls for FDA to engage federal agencies and advisory committees to the Secretary and other stakeholders to gather perspectives for the appropriate framework for clinical support systems. The only change we made to this recommendation was to have a preference to the Secretary committee in newborns and childrens' as another advisory committee that should be engaged and the discussion. Do you have any questions about these recommendations? Do we have any edits to these recommendations?
[OVERLAPPING SPEAKERS]
Here we go.
FDA. Okay. So let's just make sure, folks. Even though we have a lot of FDA, CLIA mishmash into you are starting with this because this is off to the side. This is not center course. You are basically saying the FDA should then prepare guidance articulating the basis of its authority to regulate critical decision support systems as opposed to actual --
Yes.
Yes.
Because the basic assumption is the FDA is the key organization here.
Well, they claim to have a statutory authority.
Yes.
That is what was brought forward in our discussion, that they have exerted statutory authority over this area. And we have thought about this probably in the smaller constructs of decision support that is associated with the interpretation of test results. So there is an algorithm that runs to be able to interpret the results. However, there are critical decision support systems that are running in clinical practice that we also have indications that the FDA may or may not choose to exert support over. This is to reflect the fact that we need clarification of exactly what their intent is.
Steve --
You need to help me a little bit. It seems to me -- and you can ask obviously as a committee, and the request will be respected. There are two different issues on the table. One is to explain the basis for authority. I think that strikes it little bit as an almost because we have been exerting authority for decades. I'm certain someone who is a great legal mind can say that it meets the definition of a device. That strikes me as legal authority. I'm not a lawyer, so I won't. If the second is more profound because we have a long history of grappling with these issues and trying to communicate to stakeholders where they are. There is -- I think there is relatively is little interest in renting a sentence saying it is a device and great interest and either an independent agency or a collaboration of stakeholders creating more clarity in terms of what a device might mean. For us for example we would characterize laboratory information systems as devices that have historically been class one. The good news is they don't require any premarket review and the bad news is if you actually have to have them work. If not we will come in and take action.
Just to make sure -- we have to move this fast.
We think this is a pretty big one.
All right. The word here is critical decision support systems in general or those that are related to drugs and devices?
I guess drugs and devices are a combination. It is both. Yes.
And is beyond this. There has been experience with and the clinical decision support community of freestanding clinical decision support specifically in our institution, glucose control in care units are we had FDA basically say cease and desist and dissemination of this article because this is a device and we are treating this as an exempt device. This has been discussed as well. If this is a very big concern because we do not understand where FDA is, in fact, are going to choose to exercise control over the range.
But what I am trying to say is -- I don't know that is easy, but I think that is something that we do owe our stakeholders.
I wish you had not chosen the example of glucose. What about how a patient or doctor worked through to treat diabetes.
And that is where the discussion line is. If a physician can reasonably do this on their own then that is considered to be low risk. But if they can't, where do you define --
The question is -- can it be sequential or simultaneous?
The FDA is going to do something. It falls off the edge of the earth.
It is in the second sentence.
That is part of this collaborative process.
Yes.
So just lose the then, and we are all right.
Okay.
Two comments. I don't think it is a big deal either way, but I thought the then was after engaging all of the others then they should do it. You could change its to make comments before they engage.
But as part of the process --
As part of the process of developing --
You are talking, but you need the FDA authority. Everybody is working together. Otherwise you have to reconvene everyone again.
I have another point. I'm not sure if this is the right time, but this sort of a broad point around this to be informed this process. But the assumption in the reports and industrywide that any regulatory authority in any way comes under device regulation. And the assumption is all over the map about within device and which part are device and which part aren't. I am going to suggest something and maybe it is bigger than we can handle in the report given the historical nature of it. I have to say, I wonder when devise regulations came down they weren't asteric and under strict regulations because regulations were first. We are not talking about regulation in an area where you believe there should be more or less, but an area in my mind that is a separate, independent industry. And while we have become accustomed to many definitions that these are truly in some way devices. There are some parts that are devices. I think the average person would have said, no, a device is something much different than a test. And so maybe we come back to this at the end, but I just wanted to mention that it is really thought-provoking. In the midst of this some of the challenges that we have is that there should be a regulation that is surely specific to diagnostics. It is not a diagnostic under a different industry, but something that is succinct and representative of the strong independent industry. And I don't mean not-for-profit research academia. And that it really is a separate area and that's classifying it as devices will never work. It is going to be piecemeal.
I think just a pragmatic response to that is, while I don't disagree, the reality is that as we raise these issues this is how it is currently working. The interpretation of the statute, which I believed dates back to 1976 which of course means we are interpreting a lot about what was really intended given that decision support really wasn't around. But that is where we are working from. We wanted to try and start from where we are, but I don't disagree that maybe as we look at a bigger picture maybe we need to go there.
And I appreciate the practical nature of it, but I don't want to completely lose this before we finish the report.
Okay. You have a specific response?
It is directly related. When you parse out diagnostics you have to realize it is not just in vitro. It is radiologic, choreographs. It is much broader. It is not the old lab.
I think that is fair. And in the broadest definition is different than devices. There are some that include it, and many that do not.
It is something to keep in the back of our mind. It has a value. Thank you.
Remember.
Did we decide to lose the then?
That is the question. Any more edits?
Where you have your cursor I would just say, as part of this process. I think that gets it -- Reed's comments that it is not sequential, but it also doesn't put the thing hanging out there. It is important to link them.
Okay. We are ready to move to the next recommendation. Recommendation number four.
Three.
Recommendation three recognizes the need for genetic expertise to support the best genetic testing practices and requests that HHS act on recommendations and the 2006 coverage and reimbursement of genetic tests and services report. We did not make any changes to these recommendations. Do we have any questions about this? Any edits? Can we move to recommendation four? Recommendation four requests that HHS allocates resources for research and development of clinical decision support tools and resources. We make no change to the wording from the draft report here. And then we revise these recommendations to include engage providers and payors to provide incentives and protection in order to ensure participation in the design, dissemination, and implementation of clinical decision support.
And just a comment, that sentence was -- the paragraph was added in response to a number of public comments that expressed concern about these issues. So this is in response to those comments.
Do we have questions about the recommendation?
Just a clarification here. In this recommendation is there a specific tight in with clinical guidelines, and if so is it the decision of the committee that they need to be [ indiscernible ] of how they are developed and have better linkage with that?
I think they are actually specifically working on those.
That is a really important point. And the critical decision support is overarching the entire -- and specifically looking at ways that guidelines can be constructed so that they are much more easily compatible. I don't know that we need to at that level of detail.
I am coming more from the perspective of having worked with other guideline developers. I know there is a great deal of [ indiscernible ]. I just wanted to bring this up to the deadline developing community.
Yes, that is true. We are trying to begin to develop that the engagement.
But remember in the report we are saying that, you know, they should be looking to other activities that the secretary is doing such as the personalized health care initiative. Do we have any other edits to this? Can we move to the next recommendation? Recommendation five requests that HHS set up an effort to assist advertising and testing and implementation of strategies to protect consumers. We would like this to include social [ indiscernible ] and privacy concerns to the potential negative impact of a director consumer testing. We also added relevant federal agencies that should be involved in issues related to direct to consumer advertising and testing. Are there any questions about this recommendation?
Just to emphasize that these are added specifically related to public comment, and there was some data that will be added into the report indicating some concerns about how the information was being collected from people, either DNA or information relating to the types of tests that were being ordered might be available for people to purchase lists. It is really compelling and to a large degree disturbing. I was not aware.
I just wonder. I'm going back to the earlier recommendations. You will have to let me know whether there will be some that will get more specific. This sounds very weak to me. At the end of the day I thought we were supposed to say, stop screwing with people. This is saying, you should step up this effort. We are not telling them how. I mean, why are we so -- don't we need to be more specific? I don't know about this, but the stuff I heard on the telephone worried me.
I will take a shot at that. I think you are right. The challenge that we have had -- and this is reflected in the gap analysis. It is not absolutely clear of the alphabetical list of agencies there, you know, who really should take ownership of this. And I think you are absolutely right. What we could probably do is to add language to indicate that this is something that really needs to have specific oversight, but the secretary has to decide which of the agencies under his or her purview is going to have the primary responsibility for this.
Now, there are differences in direct to consumer advertising and testing. And here it is geared for advertising.
And consumer initiated genetic testing.
But we have other recommendations that some of these consumer initiated are not currently under CLIA. CLIA maybe needs to be revised. So we have Chapter four, other recommendations specific to this. Well, that's actually responds to some of the concerns that you have.
So go back and put this in context with the stuff that we continue to applaud, the collaboration between FTC and FDA. Is that sufficient here? Are we saying -- which we don't preference that by the way, here. So we have been praising that collaboration as being something that deals with this problem. Do we feel -- so I think we should reference that somewhere that we recognize this is going on. And I guess by defacto we say that's a combined effort is okay. And we don't need to codify that any more.
I think the point that you made about, we should definitely include that in the report in terms of the collaboration. And maybe as I look at this what we should do is to say something more to the effect of HHS should convene relevant federal agencies, states, and consumer groups to assess the implications and decide who has oversight authority. I mean, that is a little more directive, than just saying and if necessary. I don't know if that is getting at --
I like the way Mark is going, but I would agree with Reed. I know it comes up later. I wonder if we need to be more specific and say, at a minimum to ensure that these tests are covered by CLIA and/or any future regulatory system.
[OVERLAPPING SPEAKERS]
That is a separate recommendation. Remember, that is going to be before this one, and it is Chapter four, that recommendation.
We are doing it backwards.
I just wonder whether we need both. I don't know. I can't quite harmonize them now as we are doing it this way, but I think that if that is the case, does this really say anything that is a very significant that it wouldn't just say harmonize under the one under 4? I am not sure that we need both.
My English is not always that could. But is director consumer advertising has the potential or have the potential? That is one question I have. I am not sure what the proper English is.
Can I ask the fundamental question, do we need this.
That was my trivial point. So what I don't understand about this is, this is in a study of oversight of genetic testing and is about direct to consumer advertising as it relates to genetic testing. So is this a genetic exception? Are we objecting to the right of consumer advertising on anything to do with advertising or director consumer advertising with health-care potentially? What really are we trying to get at here?
Well the committee discussed not just direct a consumer advertising. It is the advertising. You are going to do advertising for a specific test and you make claims about the test.
Okay.
Then it is under the purview of the FTC.
Okay. I guess it's the advertising costs social stigmatization and privacy concerns or is that one of the -- I'm just -- I wonder about this.
One of the reasons we got to this was Francis Collins brought and a point about this [ indiscernible ] for the millennium. It is like this really odd off-the-wall thing. Now in the collaborations between FDA and FTC do we now know based on all this [ indiscernible ] we have been describing earlier in the last two meetings --
I just wanted to point out that the Secretary is getting the agencies together to do more cooperation. They are having another meeting in a couple weeks. I think that will be participating. CDC, NIH are involved. I just want to point out.
That is helpful. So let me just ask you real quickly. Because we have given you this phrase about coming together and doing things together, is the problem solved or is there something else that needs to be done?
Addressing the problem is just beginning, of course. But I think it is important to note in the recommendations that the collaboration is working, and HHS needs to ensure that it continues to work. As far as this goes -- the advertising issue is going to be additionally addressed, not only by the FTC. Let Steve respond to this also, but if the FDA decides that it has jurisdiction and in its discretion will pursue, for example, some proprietary software is a medical device that therefore we will have jurisdiction over advertising as well and will make the collaboration even more important. So I think it is important to have something like this definitely in the report, but HHS should do what it is doing.
I hear uncertainty. I hear uncertainty about whether or not they have oversight or not.
I can't speak for the FDA.
Paul? Steve?
One of the concerns is, how is this regulated? Health related is a higher bar than normal. What we said earlier, if they don't even considered this health-related then why would the FDA regulate it? What we want to do is have them say we recognize that all of this has potential risk and need to have oversight at a higher level than you might otherwise for consumer products.
This comes under CLIA or the FDA. Some of this advertisement will be dealt with through the last avenue.
But if the manufacturer consult declare that they are just having a good time and this isn't really about --
[OVERLAPPING SPEAKERS]
Then you can't regulate me and I have decided to take myself voluntarily out. I did take myself voluntarily out of selling this.
We need to start --
My point is simply just what Reed said, to make sure that every where we do this -- and I'm not convinced we need two separate recommendations. We make it clear that these -- both the advertising and more importantly the testing itself needs to fall underneath some regulatory umbrella.
The language that I would propose given what I am hearing is that we could say, the committee recognizes the ongoing efforts of collaborations to address these issues. We ask the Secretary to explicitly add consumer -- direct to consumer advertising for genetic tests, consumer initiatives genetic testing as issues for consideration by this collaborative and would request a report and update about the issues for further deliberation or something to that effect.
Let me play devil's advocate and try to move it. The committee recommends -- the committee is concerned that the public is being preyed upon by unscrupulous people who will market their products to an unsuspecting public that is ill-prepared to understand some of the complexities and who can be harmed as a result. Therefore we recommend immediately to conclude the effort that we understand is underway to determine jurisdiction between the FTC and the FDA and anybody else and report back to this advisory committee within six months as to the answer so that the fundamental purpose by which we were convened is dealt with. Thank you. No fooling around.
Just one suggestion.
I wanted to hit you in the butt.
I think this is a really important conversation. The only thing that I would add is I think it is really important given the intensity of the feelings around this table about this issue that we come up with something that is a concrete, directed, and an action item to recommend because basically anybody who has been around the block in Washington knows any recommendations that basically says, you should convene a group and talk about it some more isn't really a recommendation. Adds to the extent that we sit here -- I liked you always from the beginning. But to the extent that we actually can come up with something concrete to say to sort of moved the secretary or move the process along that is a deliverable, I think that it is time well spent to come up with drafting was is deliverable. Reed, you came up with an idea. Maybe we can make it a little harder.
I just had a suggestion that if you do keep this recommendation that you change the word advertising to marketing because the FTC is focused on advertising. You are talking about something more broad than advertising. You are talking about bringing this test to market which involves the FDA.
What I want to do is work a little bit offline on the recommendation my wish for this. Mike.
I just have one comment, where you said and do harm. We have to have data? I don't see where the information that comes from this type of thing would potentially be any more harmful than somebody making a health decision based upon some new advertisement. You have to really support that with the data if you are going to say we think it is doing harm.
It has to be stronger than that. If you are going to break a recommendation this strongly you really have to have something? You have to say there is harm being done.
This specific issue that came up that crystallized this for me is somebody sends in a cheek swab because they want to look as diabetes testing. There is evidence that those individuals that were tested for potential diabetes are being sold to people who are marketing a diabetic devices and other things. Now, they would characterize that as providing information to consumers who really have a need for it, but I'm not sure on the front end that they have been adequately informed that this information about be used to basically target them. And while that -- it so you know, you can define that as harm or not, but there is some evidence that that does in fact happen.
If you have some information, Mark, I would certainly like to know.
Can we focus on what we need to? What are we going to do with this recommendation?
The biggest thing comes from the test is wrong, and they don't have diabetes susceptibility and go about doing high-risk behavior. I understand that is harm, but from the health perspective I think it is focused on that that piece. So I come back to what Reed put together to take a stronger stance on saying that HHS needs to take some action and that the regulatory environment that all tests that are direct to consumer must be covered by the current regulatory environment. We may not want to deal with that here, whether it is CMS or FDA or otherwise, but I think we need to take that stance. If you look at some of the public comments there were at least six of them in the my quick tallying said exactly that, that we need to have stricter regulation around Direct to consumer testing. I am not quite with the wording and maybe we can take that offline.
I think a lot of those suggestions are terrific, but in my mind they seem to apply more to our recommendation in Chapter four. I'm thinking maybe we can think about that working and apply it to that recommendation in Chapter four. And I actually have a question from Mark for this recommendation. When I read it my impression is that you are saying there is a gap in what we know [ indiscernible ]. In my mind, that is what this recommendation is trying to get that. Are there harms being done? And that will guide us going forward. What are the positive aspects of this type of testing and what are the negatives? To me the recommendations are very different, and a lot of what I heard applies to Chapter four.
I just want to say that this recommendation the way it was just expressed, that has been the committee's position for several years. In an earlier letter we called for more. CDC has been working on that. We heard last July or November an update on the work. So I do think that does seem to me to be what we are after here. There is also a role for the state. Judy can speak to this better than I in terms of who can access, and order, and receive test results. I don't think it is solely a federal matter as to what the regulatory scheme would be in this area. And then I also think we have from a regulatory standpoint addressed it more in Chapter four.
We have Paul and then Reed.
To the extent that we have gone around and around I think the issue is on the table. Where we are is to basically have an offline conversation to look at, sort of, recommendations four to see if it can be collapsed together and then maybe come back tomorrow --
We can see what is going to be covering four.
Exactly.
But we need to keep in mind some of the issues you are bringing up.
If I can say one thing. I think that is rational. Can I get two seconds of a summary of the collaboration between FTC and FDA that we have been talking about so far? What is it as you all are doing? What area are you working on?
Aside from the public advisory that we put forth actually I can't comment on anything else.
So remind us of what the advisory said.
It said that these are not substantiated. You should be aware. We've made it as public as we possibly could.
I think we can say that the FTC is looking at the area specifically to see whether there are representations being made about genetic testing services. They weren't pursued in investigations.
And you are relying on FDA.
In part.
There has been that exchange, maybe not recently, but where you were providing --
You would be surprised at how clever they are with communicating with each other.
So when we get see Section four --
We can look at recommendation four.
Just to make sure I am summarizing what I am hearing and we can get off this.
Not that we -- it is -- this is from the FDA perspective aid it wants because there are legitimate things here which are medical devices and which have implicit enough or explicit enough claims that drive you to think they are medical devices. I think in this universe there is stuff that we wouldn't under our current statutory definition by Paul medical devices. I don't know that Judy's group would call everything -- I want to mention any, but gender identification tests are not from either CMS or FDA perspective the currently medical devices.
And then the FTC point of view, you made an explicit point earlier that it is your purview to -- define the limits of your purview.
With genetic testing as with any product of their health-care religious or not is what the advertising claims are and whether they have competent and reliable scientific evidence in relation to what the clams are. It does not matter what the product or service is. It is all the same.
And when you investigate because you are concerned about the scientific validity of their statements where do you go to get that answer on the science?
I am a lawyer. I make it up. Just kidding. Just kidding. I go to Steve and his staff and private experts, and I go to everyone I can.
So at the end of the day it doesn't matter whether or not FDA has oversight over it. You can go to them and say I want to understand the science of it. Then they say, I will tell you what we understand about the science. Whether or not it is in your regulatory purview or not, you have provided an opinion. So you are good as long as it is about advertising.
Absolutely.
Thank you. Is everyone beginning to understand something about fact based --
Can I ask another question? Aside from the advisory which has been around --
Nothing public.
Our investigations that we might have are not public. So my next comment would be from a jail cell.
We need to start wrapping this up.
I guess as a place holder to come back to Steve's comment about the current regulations of the CLIA around health-related testing. Because the gender issue is a very interesting one. As I understand it is regulated, but we know families are using that to look for a link to diseases. So while gender in and of itself may not be [ indiscernible ] is being used for very much in a health-related way to make determinations around a pregnancy.
That is in Chapter four. We are going to move forward. We are going to leave it the way we are currently, the recommendation after the review. We will look at these.
[ speaker unclear - audio low ]
The concern that I heard here about public health outcomes, I don't see any mention of health or public health in that paragraph at all. And so whether it is a gender testing, whether I came from India or Africa, fertility testing, I don't know to what extent this committee or HHS will be regulating that. And to some extent I think that is part of the consideration for a person to have a determination. I think you should be careful in how you frame this and not be overstepping.
That is a very good point.
We need to be very attentive on how we define the word genetic testing as it relates to this function. What is in and what is out.
And health related testing, we might want to suggest a new definition.
We said earlier we would take a look at this. I would just say from a redrafting look at the method and which one this is supposed to be attached to.
So we are moving to a Chapter five, recommendation one. It calls for HHS to create and find a public-private entity to assist the clinical utility of the genetic tests. We rewrote this recommendation to include examples of evidenciary standards and levels of certainty for different situations, and we also added to data from electronic medical records as a source of data for research. The recommendation calls for the development and funding of research agenda that will address gaps in knowledge of analytical validity, clinical validity and clinical utility on population health impact on its genetic tests. The only change is recommendation one in Chapter six. Do we have any questions about these recommendations? Any edits? Can we move on to the next recommendation? Recommendation number two for Chapter five requests HHS to act on recommendations and the 2006 coverage and reimbursement of genetic tests and services and asks private and public health care payors to develop mechanisms such as coverage with reimbursements to facilitate the clinical utility evidence for high applications. And we rewrite this application to include whether mechanisms to collect [ indiscernible ] innovation. Do we have any questions for this recommendation?
[ speaker unclear - audio low ]
Do we have any edits?
I am just trying to understand. I'm reading it again cold now, the recommendation to continue. So public and private health-care payors should develop mechanisms such as coverage with evidence development or phase reimbursements to facilitate the collection of clinical utility evidence. I am not following the trail here. We are saying we want to collect information on clinical utility evidence through reimbursement?
This is really an extension of what CMS has proposed to allow innovative products to get on to market and that there be a process, if they agreed to get paid for, that there will be evidence along the way so that we both know about the clinical utility. And a subsequent final decision can be made. It is a way to try and get the evidence generation under way for some of these technologies. It is just a mechanism.
James.
This is also an conditional coverage. It is a potentially important mechanism to try to prevent the bar from being so high in terms of clinical utility which we don't have for 90 percent of what we do in medicine anywhere.
So basically saying we are encouraging coverage even when that evidence is not there. By the way, once you cover it you should -- we can then have a larger base of evidence upon which to make further decisions. It looks like we were saying we were going to solve the evidence problem by covering.
Because if you don't cover the test will not be offered and we can never get --
I think this is the language that will be okay.
I have Paul.
Was this meant to be a high-priority application or was this a general recommendation?
I think it is a general recommendation, but we thought that maybe starting with the high priority [ indiscernible ]. And then does the last sentence, again.
Does that sort of muddy the water?
In this recommendation who pays for the collection it is a money issue. It is something we have to attend to. It is sort of like -- we use to argue a lot for CDC being the place where you put the money for post-market surveillance. This is the same sort of deal here. You just -- it is just sort of hanging out there.
As we discussed this in the report there are some examples, and I think to get to Paul's point, there are different levels. For the ultra-rare tests, a program like the SEP program that has been brought forward through CDC has the intent that we may never get to the amount of evidence that we would like to have to me to the bar. So this is a process by which we encourage these tests coming to market with the expressed intent and funding for collection of that evidence. I think on the other end of the spectrum you have something like pharmacogenetics profiles where the impact on that is potentially for hundreds of thousands of people, or you can reason with reasonably expect utilities is to be done before the test is introduced. And then the middle ground might be something quite what has been done with the Children's oncology Group. The only way to collect sufficient data -- in the genetic from newborn screening is an example. The only way to get sufficient data is to collect it under a consortium arrangement. But all payors are covering for children's oncology knowing that data is being collected, and we are learning new things. So this should not be looked upon as a one size fits all. Maybe we need to tweak it to reflect the fact that different models may be appropriate, but the intent is that we don't want to -- you just set a high bar so that most things don't come to market or a low bar so that everything comes to market.
But at the end of the day is putting the onus on public or private payors to organize this and do something with it. I just see how this is going to happen.
I don't know that they actually have to do the evaluation. One of the examples that CMS had was for a lung volume reduction surgery for emphysema. They agreed to pay for the procedures. It was part of a clinical trial so that's at the end of the trout we would know whether that was an effective procedure. There was something learned about exactly who benefited and in that case there was a limited amount of benefits. And they continue to pay for that group. You can't do this for very many thanks. It is for a fairly selective number that you would think are likely to be of important public health or economic impacts.
They are mechanisms, but they don't have to do it.
I agree with what Steve said in terms of looking at it, but I think what Reed said, the payors -- there is no mechanism to do it now. The challenge is laboratories themselves can't do it because the fundamental piece of this is looking at the outcome data, and laboratories don't have access to outcome data. So I don't know. In the report itself that is implied in the fuller piece of the text. Maybe we can bring that out and the recommendation. It is important to ignore is that this is not just shifting the burden, but there has been discussion about laboratories doing this sort of evidence which under regulations -- otherwise laboratories can't do this. So there is a reality here that these to be at least acknowledged that this is not an optional thing. If we want to get this data they have to be part of the system. And if you believe one of the things we talked about in the pharmacogenomics report, this is not just for academic purposes. These will actually reduce inappropriate care and reduce costs. So there should be enough incentive for payors to want to do this.
I think this is a complicated issue.
We are going back to that.
Part of the current dilemma which I called the evidence dilemma into genomics is that clinical utility is the last information to be collected. Many payors won't pay until you have a clinical utility. And if you don't pay you don't get tested. There is development of new applications. So if there is a public-private stakeholder group that comes together and overseas the discussions so to speak and then sets the parameters for what is enough to meet the certain threshold beyond which you move a certain application from being researched up being conditionally covered under a controlled research and practice and trails. Obviously you cannot do it for everything and they should not pay for everything. It must be a shared burden between the public and private sector. That is part of our dilemma right now. The clinical utility piece is missing for most genomic pieces, but you need a good, at least, analytic framework. And then if there is enough possibility perhaps a few applications. If you don't do that it isn't going to be implemented. So there is a process for the rare disease environments. But for the common genetic applications we are still struggling with where to draw the bar. Where do you put the threshold? And putting it where recommendation want to work together with a recommendation two --
In recommendation one we are already recommending the funds sustainable to assist clinical utility. So this will fall within the clinical utility. We just had the evaluation by providing issues of payments with condition of payments and so forth.
I think that would be great. If we could roll this into one, that's great. I have sat on too many groups to read and every kind of group that you can think of. Everyone is sitting around trying to figure out who is going to pay for these kinds of health service research types of initiatives. We finally have a lot of effort. If we just got this compared with effectiveness. That was an enormous effort. [ speaker unclear - audio low ]. My point is that we have been through this a bunch of times. If we don't say that CDC is going to step up to pull this together then it is just -- you are not going to get it. It is just basically this whole group that actually gets funded to do some specific things, one of which is this.
Do you have any comments.
Actually in my own mind these are quite separate things. A person creates a public-private group and is going to develop a lot of information. This harkens back to the reimbursement issues and the need for evidence on utility by payors. And the question is, what do they do and how do we begin to make those things work? And that seems to me a little bit different. I don't know that we would include this reimbursement stuff in the first part of this recommendation.
That reimbursements feeds from the data that will be generated from these public-private partnership and that it developed the infrastructure to evaluate how you determine the clinical utility. So this will be maybe another component of that. Kind of the back end.
We are going to take a couple quick ones. I think we are talking about trying to see if we have the appropriate words. I will allow Steve's comment. We want to roll this into number one. You can't call for too many separate funding things.
I think we have Mara.
I agree. We can't ask for too many. I see it Steve's way. I think it should be kept separate because it is specific to the reimbursement area. We don't lose anything. We aren't asking for more, and recommendation one is particularly lengthy. It gets lost.
Then would you want to recommend the creation of a stakeholder group for this?
This is just talking about mechanisms that could vary by payor. If it does not need a stakeholder group.
I don't think so. To me it stands on it own. It is all part of number five, and it is highlighted separately. We are not asking for more or less money. I would leave it.
I think it is useful to combine the comments that have been made before. For the purpose of the public-private entity that is certainly one recommendation. This is a different recommendation which focuses on the actual implementation of research for different tests. And the question then becomes, who is going to be paying for it? So there is no need to be [ indiscernible ]. What we have been discussing is where we stand right now. The clinical labs don't have access to the outcome. But that isn't really true if you are thinking about the electronic health record being used more often. The capacity of collecting data is pretty rich and out comes as well as lab information. We aren't there yet, but there are two projects that are already funded which are looking at the clinical record based information and databases like a clinical lab prescriptions in hospitals. So in the future there will be more entities that can fund this kind of special research topics and not just focus on one group.
So your recommendations then?
My recommendation actually would be it would be useful to have this as a separate recommendation, but not just the health care payors, but other folks to make the mechanism that we are constructing.
Okay. So I think there is a sense in the committee that we will leave the recommendation and add in some of the changes that were just recommended. Do we want to work on the wording now? Do we want to add or edit?
[ speaker unclear - audio low ]
What?
We will do it during the break. So are ready to go to the next recommendation? Recommendation three requests that HHS conduct public health surveillance to assess health outcomes, surrogate outcomes, practice measures, and the public outcomes on genetic tests. We did not make any revisions to this recommendation. Do we have any questions? Do we have any edits? Do you want to go to the previous one? Let's go to that recommendation, three. The first part of recommendation three.
And guess how does this differ? Is this different than the stuff we already talked about? Have we talked about this? What is the difference here?
It is similar to the one that we stuck at the end of six before. This is using surveillance to make sure that the utility is realized. The other option is to do what you suggested and get rid of the sentence that we added in six.
Okay. The idea is to look at the one in Chapter six and this one in Chapter five.
Isn't that what you are referring to?
So if we take out our recommendation six, chapter six recommendation four and continue and take that out -- no.
The next one, I think.
Five.
This one needs to be -- which one are we on?
I think it is 6, 1.
Six, one B. We talked about this and added that.
That is right.
That is why there is redundancy. It is something with more specificity.
They don't have to be in different spaces.
Why don't we keep them together? Because you will make the reader crazy.
We are talking about deleting this part of recommendation six.
The whole recommendation?
The part that we added. Chapter 6, 1 part B, there is an overlap with Chapter five and the reason is because we added some of the language. So I think we need to decide if we keep it in six or five. Mark?
Well, to speak to Reed's point I think that what we could do here is if we keep this recommendation from five, three and then we can basically just say, you know, we reference this recommendation, the recommendation of a Chapter five, three and just say we need that information provided for transitional purposes and that is it.
Exactly.
Do you want to put the changes here first?
Yes.
And just get rid of the last sentence.
Yes. We are going to do the cross reference to this recommendation. Okay. So now we have dealt with the overlap. Going back to the recommendation of Chapter five, three.
Did you lose a little bit on the availability of data? Is that the deletion? I think that last sentence spoke to. It would almost have worked out to take that last sentence and move it as very clause. Or put in some statement about ensuring data is available.
[CAPTIONER TRANSITION]
Did the automated and voiced here may?
So, what you are saying, Steve--
I did it is there in the standard definition of surveillance. In these to be clarified. You can add something. It is there. That can go in the text, right?
Right.
We can put this into a text. Okay. Can we move to the next recommendation?
Chapter five recommendation asks HHS to advance appropriate use of interoperable patient level data for research and to enhance the quality of decision making our goal we revise the recommendation to include implementation in the efforts to advance the use of interoperable patient level data. To have any questions about this recommendation?
The only challenge we have is that AHIK is in a transition mode and will not exist under those terms, I do not think. So, by the time this comes out-Is there a AHIK two?
They are moving to a Public/Private partnership. You might want to say that SACGHS, and AHIK, and/or the successors.
Kathy, it just to fix the [ indiscernible ] problem there, lose those two parentheses and say other Workgroups addressing.
Leave the closed parentheses. Get rid of that one. Okay. That works. Move it to.
[ LAUGHING ].
I hope the camera was not on you for that. Can we retake that? Okay. Can we move now to the further recommendations? What I am going to do now before going into Chapter four, recommendation of one, we will have public comments.
Comments from Joe?
We have completed two Chapters. We have to go back. So.
My only played to the group--
After the break.
Even if we employ all of the recommendations, how far will they affect our current system?
After the break, we might go back to the map. Sherry was telling us to keep that in mind. Now, we have had earlier mention of the steering committee adding experts and [ indiscernible ] members that have specific expertise to form the task force that works through the entire document. Threat the development of the document, we have been tapping back into the knowledge of the different task force members to seek their advice, continuously. As we go through also the review of the public comments and go back to changes and added to the text and recommendations, we are also seeking advice of the task force members. Again, to give them another opportunity to give input directly to this committee, we have asked all of the task force members that might have comments to the public comment. Or any changes to the report to come to talk to ask and tell us about what they feel about the current state of these final recommendations and the draft. Oneof our task force members took us up on that offer and decided to come and address the committee. We are looking forward to Kathy Hudson to provide some comments.
In addition to those comments, we are very excited that Kathy wanted to come and present some topics. We of the areas of her comments are germane to where we are going. Therefore, it seemed to make sense to stop what we are doing here, get those comments as now we proceed through an orderly way, through the risk of our agenda. Thank you.
Does that work?
My name is Kathy Hudson. I am the director of the public and policy center at John Hopkins and was asked to serve on the oversight task force. I want to commend the committee for its expeditious work in moving through all of the issues that were included in the final recommendations. I appreciate your endurance today as you work for that. I particularly want to acknowledge the incredible work of Sarah and Kathy who have worked tirelessly to pull this together. I would like to comment on three issues that are raised in the recommendations and comment on those. First, the recommended enhancements in the CLIA, secondly, the recommendation for a registry and, third, just say a word about direct to consumers genetic testing. I recognize that the revised recommendations have not yet been discussed. This is a little bit of a challenge. In the draft report for public comment the task force recommended an expansion of proficiency testing and not the creation of a genetic testing specialty. You heard and some of the public this morning that there are still a number of people interested in the creation of a genetic specialty. It is a remark that was created by CMS in order to implement CLIA. Currently, it is the only way that CMS has of putting in place a new proficiency testing requirements per but the statute certainly does not require that the code does not the case that the creation of a specialty, necessarily, would require that laboratories perform a PT. Previous advisory committees have attempted to work within the existing and CLIA specialty structure and have made recommendations over the years to create a genetic testing specialty. I think the task force was correct in ascertaining that the thing that we really want is more proficiency testing and, therefore, let's move outside of this remark and get to what we really want, which is PT. It also has been clear over the last year that CMS does not want to create a specialty. Baker had on that the ticket for wall again might not make much sense. We support the revision to the draft recommendations that required-This is the revised recommendation. We strongly support these revised recommendation that requires that laboratories that are performing tests for which a CMS-Approved PT program exists should be required to enroll. The key issue there is going to be what PT programs does the CMS approval. Debt the Sun Devil in the details their purpose will go a long way. There will be a market to create PT programs for tests on a widespread basis. Implementing this recommendation would require changes to CLIA changes which would be subject to public comment before they are finalized. We believe these changes are straightforward. We have drafted a model regulation that would fill both requirements of the report and avoid concerns about genetic exceptional as some that have been expressed in public comments. We would be happy to share that model with the committee.
Before you go further, so we are hearing you as clearly, who is we?
The genetic Public Policy Center in.
The genetic Public Policy Center.
That is we put a I am speaking as a member of the task force and--
[ AUDIO/SPEAKER NOT CLEAR].
I will try to differentiate between me and we and they and us. The second issue of would like to address is the recommendation to have a genetic testing register. A voluntary registry, perhaps, as an extension of gene tests as the California HealthCare foundation said, there is no such thing as a voluntary universal anything. The task force and the steering committee clearly reduce those Commons where a majority of the people who made a comment about this issue recommended that the registry be mandatory. I think the task force has responded to those public comments. So, that is an important addition. Several people commented have urged that the registered be housed and managed by a federal regulatory body and in considering what agency should have the lead responsibility, a number of key issues have been raised. I think this is where if the task force had more time, we could have gone into these issues in greater detail. What functions are going to be carried out by the registry? Will they be facilitating data submission? Will they be involved in any Quality Control? Will they have a stick with which to demand that data be submitted? Will there be penalties for noncompliance? These are issues that still remain but the secretary has authority to put into place broke the other question that has and discussed is whether the various agencies or the Department has sufficient authority to require the kind of information that are envisioned to be within the registry purgative important to recognize that many of the aborted plots that the agencies have are a parties that are held by the secretary and he delegates to them down. MIB possible for him, the secretary, to use some creative read delegation of the authority to get the job done. In the discussion of the task force, of which agency would be the most appropriate home, there was lively conversation and in the one Federation, CMS was deemed to be a proper home for this registry because they already collect some information. As someone mentioned it is difficult to retrieve that information. It is certainly possible for the Secretary to figure this out and for this committee to punt to the secretary and not name a specific agency. Wherever this registry is housed, we should look for an agency that has documented experience and expertise in creating and running publicly accessible registries. So, FDA certainly has lots of experience and maintaining publicly accessible and useful data bases. CDC manages a number of registries. They allow timely and easy access to trillion of pieces of interlinked information. So, as a task force member, I might not be able to share comments on DTC, some of which to place just prior.
[ AUDIO/SPEAKER NOT CLEAR].
I will withhold my comments on DTC. I would like to make one point that in the map that was put up where it had a separate line for DTC-Non-CLIA certified, the CLIA statute applies to laboratories that are providing an assessment of help, in respect of how they are marketed. I think that might be misleading.
[ AUDIO/SPEAKER NOT CLEAR].
The line is specific and may be needed to be made more clear. Laboratories that claim they are not under the CLIA, of the regulations. They can directly to market these tests to the public.
That is a problem with enforcement. There is no permissible Pappas.
Exactly. That is why some of our recommendations deal with that specifically.
Thank you for your comments. They are very helpful. We will move right on. If you would sign up for the public testimony parts of the weekend get your DTC stuff, that would be great, Kathy. Let's move right into the next section.
Chapter four recommendation one. Recommendation one in Chapter four proposes steps to support and augment the CMS action plan in lieu of the CLIA genetic testing specialty. We revise part A of this recommendation to require proficiency testing for all high complexity tests for which PT products are available. With the now revised part B or C of this recommendation. Do we have any questions about this recommendation?
Just a very minor comment with the change of cannot be achieved immediately, there is a may before cannot. I imagine that that "may" should be deleted.
Thank you.
Back to the issue of the genetic testing specialty, everything falls on it. At the end of the day, can I make sure that I got the reason that we are not recommending the genetic testing specialty. Why did we decide not to do that?
Genetic testing, actually, covers, today is covered under CLIA. There is specific personal reply and requirements under CLIA for the testing, it falls under high complexity laboratory testing. In addition, it is a moving target. Trying to put something that is an evolving field into a specific cubbyhole might be problematic down the road. As we have already in CLIA, specific issues to deal with high complexity testing, quality control and so forth, we felt these already covered that particular group. What we saw is that the only issue that is not covered for genetic testing under the current date nine regulation was the proficiency testing. By making these changes to the proficiency testing, we actually solve some of the major concerns to the specialty and genetic testing.
Was that pretty much, again, the unanimous position of the task force? Is that we are? Given that we have some added comments critical of this, I does not to make sure that I know how to assess the public comments on this.
Mark?
I think it reflects the starting point when we were first crafting this was really to follow the direction that the SACGHS had previously given to support creation of a genetic testing specialty. Over the course of the time that we spent discussing this, with input from our representatives on the task force, at CMS and really getting out to the points that Andrea brought up, which is what is the real issue? What do we want to accomplish here? I think we recognize that if we fell back to-We just want to make a specialty it that we would once again [ indiscernible ] ourselves in the mud in. By doing this with the support of our colleagues, that we think this is the way to go, we might be able to accomplish what we want to accomplish and avoid the problems that would happen in try to create an entire new specialty. I cannot speak for everyone on the task force, but I think everyone was at least comparable with that direction going forward. We did not have-I did not recall any one that stood up and said that this is absolutely unacceptable, although you are completely correct to point out that there were a specific public comments that did go to this issue and that we did consider those. We, ultimately, decided there were not compelling enough reasons to reduce this to ask for creation of a specialty.
Another thing to keep in mind is that as I call it a moving target, we were starting to see if the genetic test, [ indiscernible ] our definition is more broad. It cuts across-the genetic testing cuts across the current specialty that are listed in CLIA. They are putting all of these different testing, genetic and genomics testing. We can then cover the majority of the issues that were brought up to us as a concern with genetic and genomics testing.
The thing that would be helpful for some of it is, and we do not have to wordsmith it here, but in general terms, the gaps that we are saying-Can we trust nail down what the gaps are? At the end of the day if you had to say that we are agreeing that there are some key gaps, those gaps are-Can we summarize the gaps?
With related to the CLIA specialty?
No. A number of years at CMS was planning to address gaps in the laboratories with genetic tests. All of the gaps in the oversight could have been done with the addition of a genetic special on the testing specialty. We are saying that CMS has changed direction and is now addressing these gaps. What are the gaps?
Not only the proficiency testing that we have identified but how they were actually revealing genetic testing laboratories. CMS has actually develop a plan to develop guidelines on how to inspect genetic testing laboratories. Maybe Judy can talk about these gaps.
I think is a very important to recognize that the majority of the issues you are dealing with here are not covered by CLIA, first of all, CLIA up 40. Secondly, to be able to craft regulations, as Andrea was indicating, for technology that is so dynamic at this point in time would clearly cause the little chilling effect that we talked about earlier and relieves limit and prevents for future development. Instead, if you step back from that spot and look at what is it as a Kathy Hudson indicated, what is it really looking for that you are looking to do with them at a party, you can get there from here. The only place you would have to do regulation is for the PT, which we have already committed and agreed to outdo. We can look at all of the PT needs, not just for genetic testing. You can get to personnel through professional standards. You can get to quality control per go there is a CDC group that is working on quality testing control. Those recommendations can go into our guidance and two laboratories. Believe me anytime replace something in there, they do it. We follow it. We have an example that we have already included a clinical and laboratory standards institute for microbiology [ indiscernible ] for antibiotics. It has become the standard of practice across the country. Everyone uses it because it is available to everyone and it works. We are trying to look at what are the needs that aren't necessary and use existing mechanisms and information to get there rather than spend six years doing a proposed and final rule on all of these different areas. Then, you do not know what the outcome will be.
The first two recommendations, we talked about some of the issues identified for the need of the clinical Genetics specialty.
So we can in Enstar drilling into these recommendations and see where they take us, the question that was confusing, [ indiscernible ] all of the problems in this space could have, by some people's recommendation be addressed by the magical creation of a genetic testing specialty or go ban, which are going through the recommendations that come forward. There are things that are well beyond just the genetic testing specialty. We set it up as if there was this magic wand. If you do not agree with the magic wand, you are a bad committee. What I want to make sure we do is say that the concern is this and that's part of the solutions that we recommend are this and this and there's probably have a false dichotomy. With that is an editorial comment. Let's go through these and see what we are saying.
Do you want us to put something into the text something like that?
Eventually we will have to organize a framework proclaims the problem that this recommendation is saying is the dissolutions are.
To that and, if you go back to the oversight map and the gaps that were identified on an oversight map, you can log off the top. They have them off of the gap three, or nine, 10 and 11 per go there is already some organization to that that will be wherever this is going to beat.
[ indiscernible ] the recommendations that we have addressed the particular issues that speak to what others are calling for the specialty to cover some of these gaps.
We are working backwards. That is find. We have been taking this big mosaic and taking it piece by piece. This piece is what? That is what I'm trying to this paper about this piece is-How do we define this pays?
If we go to the genetic testing oversight map, these recommendations in Chapter four, recommendation one and two will deal with the G, G 9 to 11-Let me get my--
The notion is, how do you describe-What is common about three, nine, 11? What is our [ indiscernible ] here?
Number three, the requirements for proficiency testing. Number nine is sufficient resources [ indiscernible ] to develop PT for all genetic tests. 10 is no doubt exists on the effectiveness of PT birds as alternative assessment.
This is almost exclusively around proficiency testing. That is what we are discussing.
Recommendation one it deals with a piece of proficiency testing. As we move forward to the other recommendations, we will deal with another piece of concern of people asking for the CLIA specialty.
All right. Let's go ahead and see what the solutions are for fixing the proficiency test and problem.
Again, you have a degree not there to call for CMS to required printers and detesting for which all PT products are available. Number two, we have also added in order to promote the development and use of PT products--To the language of that particular recommendation.
That would be everything.
Everything. It goes beyond.
If you have any high complexity tests for which [ indiscernible ] and 10 specialty tests are available, if they are available, you must use an alternative assessment methodology, as it is already required.
Is already in CLIA.
Anything that is not in CLIA now, if you have a high complexity test for which it is available if it is not available, then we have something to do.
The only place is missing is-If you have a PT available, you do not need to currently-You get a ride.
Just for a limited number.
Right now the operative word is a complexity, but we will get back to that. All I complexity tests as a result of this mess now have proficiency tests.
The way CLIA is now, for 83 specific [indiscernible]. We are taking out the 83 to talk about every high complex attest.
And the 83 state and?
No. We'd take them out.
The 83 is not a filter any more? Is that what you are saying? It was a filter that kept people out. We are not taking that filter out.
At the end of the day, no test the is the key, no high complexity test will go on regulated. We have closed the door. Oneslides.
For the purposes of PT. Nobody that is doing a complexity testing, you must do PT it is available. If not, you need to do an alternative assessment.
I do not want to get back into the other discussion but if it is a and a suitable test that is not considered high complexity--
We will deal with that problem we need to bring them back in.
We will deal with that with the definitions. The scope for the basics again. Just for the average person for whom we write our language, what is the proficiency testing on this, what does it guarantee? What does it not guarantee?
The proficiency testing will ensure that the laboratories are performing specific testing it either FDA or CLIA laboratory developed tests will have the [ indiscernible ] to check that they are getting the proper or correct results. It speaks to the analytical validity of the test.
Okay. The high complexity, is there is something important that is not been stated that is lower complexity that slides under the radar, comes out and bite me in the butt?
In the long run the analysis needs to look at all testing that is being performed and how best to describe the test that should be covered by proficiency testing. Clearly, there are not two or 3,000 different tests that a laboratory might perform. Not every laboratory does the work of the majority of labs in the country are small and maybe do a couple or 20 tests because they are Dr. Offices and do patient-Related testing for that particular visit. For the larger laboratories, they do have a huge menus that constitute that thousands of tests. You want to use the tests that are going to test the laboratory, challenge the laboratory so that if you do not want test on a machine that does 25 different tests simultaneously with the same method, you only have to do not one of those for PT to get it, whether or not the lab is doing it correctly, you do not need to do all 25 of them. You need to find a way to come up with that proficiency requirement to challenge the laboratory to insure the accuracy of its testing, but not making them do it just because.
In your answer, somewhere I need the committee to get this nailed. It sounded like you said there was a ride for someone who got a free pass.
Right now there are 83 out of those two or 3,000 tests that are currently in the regulation. Anything else that the lab does as Andrea indicated, at the lab still needs to do that alternative assessment twice a year.
You are talking about big folk and Little folk.
We have to assizes of laboratories pergola have 2, 2,000 labs in the country and most of them are very small, clinics and doctors' offices or go a lot of the tests that are currently under PT are moderate complexity. You cannot leave them out, it necessarily. They are used as a diagnostic tools and laboratories.
Is it true, from what you said that even with this recommendation that there will be in some laboratories that are performing genetic tests that will not be covered under CLIA for proficiency testing?
If a genetic test is not high complexity.
And that--
Under this phase.
Just to make sure from the committee sense, why are we comfortable that non-High complex tests do not need to be reviewed?
I think today we can say with some certainty that all genetic tests are high complexity tests.
Right now. It depends on how you define at. --How you define it.
We seem to have some uncertainty.
I need something concrete. Can I have a example of a high complexity, medium complexity and a low complexity test. Is PKU a high complexity test? What is the complexity in.
What is a low complexity it genetic test?
It goes back to the fundamental issue, which is a definition of genetic. It is not inheritable.
Let me ask CMS. Why would you be comfortable giving a pass to some category of test? Human beings get the test whether it is a complex or not a complex. It is still my life.
I did not say I was brought a what I did say was that we needed to look at the whole range of tests and determine the tests appear before PT. If you want all high complexity, maybe that is one criteria. The second might be medically useful type of tests that currently might not be listed there but are used in high volumes in laboratories.
Why wouldn't CMS just take the posture that you want the authority to evaluate tests before which PT are available and there is no alternative assessment?
That is, essentially, what the plan is to do.
We should take out the word "high complexity."
Are there tests that the committee would say we do not think they should go through PT?
What Judy is saying, we are starting with a big slot and a narrow it down to identify which tests are appropriate for proficiency testing since all in tests are currently regulated in some action on jump-and approve CLIA.
I did understand where you are at. Let me be sure. Outside of the field of genetic test labs, are there tests provided to the American people that have not been tested, that are not under some degree of oversight? Is there any laboratory tests that argument to Americans that are completely devoid of oversight? You can do whatever you want to do and put it out in the market?
There are the wave tests under CLIA. They basically require that you follow the manufacturer's instructions. And no other requirements.
[ OVERLAPPING SPEAKERS ] at.
Are you talking about tests or labs?
All laboratories are regulated as long as they meet the definition under CLIA, in some fashion. It depends on the complexity of tests that they perform ousted in the requirements are.
I am talking in this case, tests, since that is what we used.
They are FDA cleared tests.
In order for a test to be waived and for it to be a FDA approved or cleared, it has to meet the FDA standard, whether you stair and transfer by it in the sun about it has to go through a second process. That process is that--
What you said and saw a ball that I do not care.
I can assure you that that is not true.
I want to keep this as our focus, because we need to add to roll. Speak English your. Are you saying that there are some tests that you are prepared to let this committee and go forward recommending that do not get a FDA waive pass and you are not doing your number on? If you are saying that is okay, I want to know why or go to me this is straight forward and go and take out the high complexity [ indiscernible ]. You do not do it anywhere else. Why do it here? And does want to understand why. Are you making an economic problem that you do not have the manpower to do it? Of people lazy? What is? What am I missing? Tell me why it is in here.
Reed, the waive testing, the manufacturer has to go through FDA clearance and demonstrate the specific criteria that is very hard to screw up with the test. Is that correct?
Waive testing would not be a very good [ indiscernible ]. We are looking for a symbol technologies that are highly calibrated and well controlled.
So, at Steve--
That begs the issue of that is waive. I did the question you are asking is a moderate verses' high complexity. What I am not so sure is where you are mixing FDA cleared versus lab develop tests. Lab develop tests should not be cleared if it is outside of a--There are loopholes.
What about the term all non-Waived genetic tests. Is the appropriate?
Yes.
Does that cover it?
That is closer. Do we need the word "genetic"?
That is what we are talking about here.
Sort of problem we are talking about here are high complexity tests, some of which are genetic and some which are not. Many tests are where the complexity and might be genetic.
I'd like non-Waive. I do not think we need genetic or high complexity. If a test and have a PT, it should.
I think for the waive test, the way it gets approved--
The non-Waive seven.
9-Waived. Changing these recommendations so that CMS should required PT for all non-Waive tests for which--
And, if it is not available, you have to go down [ indiscernible ]. Basically, I think what we are agreed to hear is that now gets three scot-free. The FDA might decide to go through some rigamarole that decides that you get waived. They have been dealt with. Someone has a grab them by the neck and analyzed them and said that you get waived. Then, you have everything else that is left. If you are not waived, you are going through PT and PT is available. If there is no PT, you will go down Route B that no one gets to go through and just because. Is that accurate? Have we missed anything?
Yeah. Where does research use only testing come in, Steve?
Hopefully, it does not have to do with anything that anyone here is talking about.
Let's leave that out.
And so, we closed the deal on all of these things and will come back to getting into specifically about what it means-I do not know how B is an.
The idea is that we will change CMS should require a PTs for all non-Waived tests for which prior PT is available. In order to promote--HHS should on the studies on the fast-the performance. That it's to your point, Reed, in that we do not know. We do not have the data. We are asking them to fund at some studies and also to look at other ways to do PT like they do in Europe where you have PT that are based on sequencing any center specimen and have to do the right sequencing. Anything in your laboratory and sequencing phase will be covered for the PT testing.
I would modify it slightly to suggest-Determine whether, but say to ensure that they are--
You should keep in mind too, it would look at genetic testing, some of these are for rare disorders. We are not thought to have benders' going to develop PT products. It is not feasible, economically. We should have a route in which we are ensuring that the laboratory is still checking the performance that it is working well.
Is there anyone on the committee that feels-I think this is good. Are we being [ indiscernible ] on this thing clocks are we doing what we are supposed to do? Are we too timid, or are we-On the other hand-That I did not think we are timid. I did we are very aggressive. Again, at Reed, Reed, I think the issue, it is very important here that if there is the PT product available, there is other [ indiscernible ]. We are not hampered the innovation of testing. If you bring in a test that you have shown clinical validity, you can develop alternative assessment and continue to offer the test. We make sure that the laboratories are checking it--
We are going to get to the FDA part later and the root B part. We are giving to these B part right now. It is not some little jive thing, but it is a real. Will come to the risk in a minute. Okay.
On your previous slide, the third sentence, immediately following it says in principle genetic tests and/or all other high complexity test should be required to go under PT. That should be changed in light of the change we just made.
Again, we change things here and there and then they get out of sync. Tonight, that is what we will be doing is reading this. Everyone has homer tonight is to read these. So, continuation of what recommendations--
Is there a way-and see what you are getting at with these studies of the effectiveness. As someplace-There is an implied aspiration here. I would like to make it more explicit. Do you know what I am saying? Will want to study to see-They should be as robust. Therefore, I want to study to make sure they get to that level of being robust. It is a little weak. It could be that the alternative assessment is the robust.
Just as a suggestion in terms of timing, may be getting through it all and going back. We have to go back in terms of timing and put it on the map.
Keep in mind.
We also have to have different volumes and different testing. It has to be answerable the evaluation--
I understand.
Let's go to part B and deal with some of the issues specific to the specialty produce 14 should consult or get with experts in the--Training by such experts will enhance the understanding of the technology, processes and procedures utilized by genetic testing laboratories to assess compliance with the CLIA requirements. In addition to 14 should identify alternative mechanisms to inspect genetic testing laboratories. This is to the point that CMS had already put in place where they will hire more inspectors and train them to do about.
[ indiscernible ] says that everything is fine now. We are saying to go further.
No, we are saying to continue to implement. We are behind CMS in the implementation of the specific changes to the process of educating the Inspectors and getting more Inspectors. Even though they have already undergone the process of doing this, we want to make sure it is in the recommendation that they really do move forward. It is a reaffirmation of what they are doing. Number waive is the government about contract accountability report of clinical laboratory, CMS should use revenues generated by the CLIA program to hire sufficient staff to fulfill it CLIA responsibilities. It should be exempted from any hiring constraints imposed by any other agencies.
Back to B, [ indiscernible ] that reached some level of standard. The question is, what is the standard? What B does not say to me, I am trying to push your. What B does not say here, the bar right now for inspections, we are okay with. Are we okay with the bar now? Are we saying that the current inspecting the process is A okay and therefore--
We are saying that inspectors require additional training to deal with genetic testing laboratories.
All right. We are saying that they need more training that the bar should go up and that they should all also evaluate--That meet a higher standard.
Not a higher standard. Today, there is no training on the Inspectors to inspect genetic testing laboratories.
Sort of a CME idea is that it is working reasonably well now but we want to make sure that those in this field are to date with new and evolving science about it as CME. Make sure that these folks are continuously trained and up to date without fundamentally changing the whole system.
I am really appreciative for that articulation. That is what I want to make sure I understand what I am signing on to. Are we saying that the CME, the status quo today is pretty okay, that we are okay with that, but we want more of it, or are we saying that in these to go up a notch and if you find alternative mechanisms you want to find things that are at least as good if not better than today. The bottom line is, are you okay Today? Of our public comments, in any way, challenging that assumption. I am not sure that I understand what they are saying.
I think there are concerns about the lack of knowledge of some of the inspectors for a genetic testing. This will solve some of the issues brought we will have a CMS work force that is knowledgeable and to inspect the genetic testing laboratories. It is the same bar. We are just adding more education to the current inspection process.
Let me please speak in defense. These are all experienced laboratory [ indiscernible ] with multiple years of experience before they become Inspectors. We teach them about the regulations. Which each and how to interpret the regulations, what to look for in the laboratories to insure that the laboratory is meeting the regulations. We teach them how to interview. We teach them how to go through these laboratory and observed testing and gather information, analyze that information to determine whether the laboratory is in compliance. We teach them on very broadbased levels so they can go into a toxicology laboratory and to a psychology laboratory and to a histology of laboratory and be able to identify, does that laboratory have qualified--
And with you--
It is a specific knowledge that we are asked to share.
Okay.
We have already started the process.
You are doing fine work or go you are working Rabat's off.
Yes, we are.
I appreciate that you are saying what you need to say. I am asking and will let it go from this. I am trying to get absolute clarity here. The very proud government official and she should be very proud of per agency. Have we heard said the kit testimony from this committee that said the status quo and needs to be, even though this terrific, it needs to be better. All I am asking is, have we heard people say that it has to get better than it is today? If so, are we dealing with it? I have seen people shake their heads that testing from the external people-We do not have any critical people screaming mad about today. They just want more of it and so forth. Is that what we are hearing?
Yeah.
I have a little summary of the comments and looking at four A, IDE and C. Most positive or neutral. Very few were negative.
To make it better, we will add training and some things, all of the wonderful things of that Judy has said. Let's move on.
I did not hear that CMS should be exempt from the [ indiscernible ] to make sure there are enough Inspectors.
We have a recommendation to add more?
We are telling them--
Why don't they Do it now?
They are in a hiring freeze.
We got exempted from the hiring freeze.
Got it.
Remove from the normal--
Done.
[ indiscernible ] and Performance assessment along with other steps to address gaps and analytical and clinical validity date the. We did not revise part A or B of these recommendationses. We revised part C to enhance public reference databases should encourage robust participation and need to consider mechanisms of four anonymous reporting and protection from liability. Do we have any questions about these recommendations?
Do we want to stick on this first? I have a specific comment on A.
Okay. Go back to A.
One of the things that needs to be clear is that there are really two type of Standards. There are standards the [ indiscernible ] for specific tests. There are also platform standards for microarrays. Those are being developed to. What I recommend is that we change the wording after the last line where it says for assay. Falling assay it should save for assay and a and platform validation quality-control Performance assessment and standardization. That emphasizes the point that there are two different types of Standards. It should be assay, [ indiscernible ] and platform validation, quality control, Performance assessment and standardization.
Did I miss something? I feel like I missed something.
No, I think it is fine.
Your next comment plucks do you say that you have another comment?
That is it.
Any other comments? The next one, part D, I am just wondering. It says genotype should support the development of dissemination by professional organizations of additional standards and guidance for applying genetic testing and clinical practice. The intention of this part D of the recommendation was to encourage professional organizations to also develop professional guidance with respect to personnel personal training in interpreting the genetic testing. Maybe we can either adhere a recommendation or maybe have to go back to recommendation number one That CMS can draw from these professional organizations recommendations to develop into operative guidelines for the Inspectors so they have a better understanding of who, actually, is properly trained to be [ indiscernible ] this type of testing in this country.
We would love to do that. We would love to have all of your help to do that.
Would you say all our help--
We need your expertise.
Looking for professional societies to develop these professional guidance.
We will be happy to incorporate them.
I think this is an absolutely critical recommendation. We know that if you look at the adoption whatsoever of CAP, it is only after professional societies recommend them. Can we be more-Can we be more specific as opposed to what we have and there is an D that says we should support it, how can we be more specific and give that more teeth to ensure that it happen.
We have a recommendation that HHS should support the development and dissemination of professional organization of professional standards. We have been asking HHS to do that. We need to ask CMS to use the professional guidance to develop interpretive guidelines for their Inspectors.
[CAPTIONERS TRANSITIONING]
The problem is we don't have enough resources to develop that process. And so money for these professional organizations, but I think working with this, members of the different agencies in coordination with the Professional Association and development of these guidelines could be very important and have a major impact.
We need to provide the necessary support. I want to get to a level of specificity that doesn't just say that HHS -- I mean they've met with the societies and say we would really like to do that. They are still stuck with the inability.
There are two changes. One is that HHS should provide the necessary support for the development and dissemination of professional organizations for a standards. And the other change -- and I guess we can do the change back and recommendation one. So if we look back to 1-B we can say -- and 1-B we are talking about the inspection process and enhancing the inspector. Maybe we can move that here. We can say work with a professional organization to develop and interpret guidance regarding personal requirements for the interpretation of a different genetic testing.
I guess I was thinking that -- just focus on the inspectors and that is broadens it too much in terms of that. I guess I was thinking of just deal with it. I thought B stood well on its own.
I have it in either place. The idea is to help CMS to use these standards. So we can put it in.
Maybe that is the way to put it in there that either HHS or CMS, maybe if they have specific tasks that they actually asked specific organizations to provide guidance within X amount of time.
If you give a CMS that means -- that is what I saw.
I think that is right. I just think that was the issue about turning the inspectors. I would not put it in B. I believe in D.
Okay. But I think we need to have a better understanding of what interpretation guidelines. That is more explanation to how you interpret the CLIA regulation for the inspectors to use.
Looking at it in a narrow context I think that it could go in either B or D, but in the is much broader. Because if you are really just looking at guidance to help both laboratories and surveyors be able to meet CLIA requirements or come into compliance and it is ensuring equality as the bottom line. Wherever you think that fits better --
I kind of a sound that is in B. This is a broader context we aren't going there for purposes of clinical practice.
All right. That is it. Next.
I just want it in.
Okay.
So do we put that same phrase in D?
Yes.
The interpreting guidelines is to provide information to the inspector.
[OVERLAPPING SPEAKERS]
We have broadened our scope.
Maybe that is the issue. D allows it to be more than that.
So you have a good sense of it. Why don't you tweak it a bit. This is not a major issue. Let's move on.
So do we have any other edits or recommendations? Okay. We will move on to the next.
[ speaker unclear - audio low ]
No, go back. Go back to C. For example. A need for mechanisms. Do you see what I am saying? It is just an editorial -- the last line is C. Such an issue should be structured to encourage robust participation. I would question what robust participation is. But for example --
It may be a need.
Whatever. Whatever it is.
Let's go.
Okay. Shall we go back to recommendation number three, supports the mandatory system of registration? Wait. Wait.
Maybe. We aren't talking major league policy here.
Let's fix the grammar. Remember we are going back to this tomorrow.
I want to get the big issues.
Do you want to have a break now?
No, no break.
Okay. I'll tell you what we do. When are we supposed to have a break?
Right now.
I am worried about the time. Ten minutes. Go.
While we are on break, is the webcast working?
There is no video. It is audio only.
Are they getting the audio? There is no video until tomorrow.
Okay.
Can you find out if they are getting the audio?
Okay.
[Session on break for 10 minutes.]
If you could come back in from the hallway I think we are ready. All the loyal CMS inspectors are eating cake. [ speaker unclear - audio low ]. Despite repeated questioning on the part of the chairman she held firm. Is anybody in the hallway? Can't do anything without Steve. Mike. All right. We are going to press on. We are going to press on to the really hard stuff.
We are going to go to recommendation four first and then come back to recommendation three. Recommendation for asks HHS to convene relevant stakeholders to provide further input on FDA with state regulatory framework for laboratory develop tests and considered models for the laboratory developed tests that would be subject to FDA review. We revised parts A to expand the least of it stakeholders and include laboratory developed tests and consumers. We also added that the FDA should use laboratory developed tests and the likelihood of harm to patients are consumers and test results being subject to interpretation or extended beyond the proposed intended use. We also revised part B to offer alternative models for the laboratory developed test. So do we have any questions about these recommendations? No? This is a recommendation that actually received a lot of comment. And we have different points of view from the different -- mainly the taskforce has different views on this issue. Furthermore the public comment has provided different views on this particular recommendation. From everything regulated under FDA to actually leave it as it is during the current model, and some have it in between.
I know there will be much comment, but I will open it up with one issue on the addition. For infrequently performed LCD I don't think we should have the statements such as those for rare diseases.
Weekend but rare diseases.
No, I actually think infrequently performed is better than rare diseases because there are many rare diseases that are tested very frequently. The issue is the intricacy of testing that is relevant. Is not the disease itself. So I would delete that phrase.
Before we get going with the debate, can I make sure that we all have the same background as to why we say -- basically why is it infeasible?
I was not getting to infeasible. I think there is a different issue. I think the purpose of that is infrequently performed. The disease itself is not relevant. It is about tests that are only done at a dozen times a year.
I am back to Department's recommendation number four preamble. The whole launching for this is that we agree that applying the same framework to every test is unfeasible given the number of tests in use and in development and the costs that would be needed to support such a structure. So we are basically saying you can't do everything because it is infeasible practically to do it. Therefore you have to make some trade-offs. So we are going to start now. And also if you try to make everything fit you are going to delay patients' access to important new technology. So therefore we have something else. We are basically accepting and saying, public, you can't do everything and we agree to that. I want to make sure that we agree. Now the issue is as you go forward to decide what things it is okay not to have the highest level of scrutiny on, right? Is that's what this argument basically is?
I have another comment, too. It is now very, very clear. This has to do with some of that language as we have in the second sentence of the preamble. We are in support of the FTC and be flexible with their prioritization. Now, if we go back to the genetic testing oversight's map you can see that for the laboratory developed test we will go through the FDA. Laboratories have to comply with FDA manufacturing control and pre-approval inspections and quality system regulation. At the same time the laboratory also will have to go through inspection for CLIA where some of the same issues will be inspected by the laboratory. So it seems to have an overlap that is very onerous for the laboratory.
That is one of the things that we have to figure out. If you go back to the map question you are saying that we need to be clear. Are we saying that there is an insufficient rigor or a gap problem or a duplicative problem? There are three different things that could be going on here, and we must be disciplined on how we think through these. You have two systems regulating the same thing. Sometimes you are saying that there is nobody regulating either one. And then sometimes you say we are making a judgment about the sufficiency of the review by saying that not everything goes through the highest level of scrutiny and some things triage out. So let me make sure I understand. Some of these recommendations that are coming in, and are they speaking to all of those scenarios?
There is one speaking to this scenario. The testing will go directly to the consumer without any CLIA our site. We have a separate specific recommendation to deal with those particular ones. So take it out of this equation.
So what are we going to be able to do is to sort of declare which one we are speaking to. Can I make sure when we look at this whole thing, is there any sense within the totality of these recommendations in number four that -- again, I come back to my one-note song here. Are there any free passes? Is there any whole where somebody gets to drive a truck untouched in this group?
Well, it seems to me that as we look at the subgroups after the preamble that we end up with a situation similar to the waived versus non-waived test. Here we have tests that's FDA exerts premarket review on and those that it chooses not to we then recommend an alternative halfway for those that the FDA declined to apply pre-market. So there would be oversight for those tests that would avoid that premarket review. So the sense I have is that we don't have -- they have to go A or B. There is no way to get around those two.
And there may be a C where you get somehow with the FDA and CLIA.
No.
I think one of the things we should articulate in that recommendation is that we specifically say to avoid duplicative --
I think Mary and Steve have comments to this.
I completely agree with Mark that there is no C. And a lot of the public comments say that we cannot have duplicative overlapping and non consistent regulation. That would make it difficult. But are we going to get -- do you think that the FDA is taking the important step forward through the IBDMIA, are we going to talk about whether we agree or disagree with that as a piece of the pre market -- it does premarket review in the way that it has been articulated in the guidance?
I think what we have here in the preamble is that there was a lot of discussion in our task force regarding how the risk has been allocated. And a part of the preamble is saying that we have to bring the stakeholders together to further elaborate in that particular concept of what constitutes [ indiscernible ] and how much which we give to technology. Is there anything specific you want to discuss?
Well, I guess we have heard in the comment and discussion here everything from agreement to tweak to fundamental rethinking of the pre-market review. So I think that we need to have a recommendation one way or another that says that we agree with the guidance as stated today or we don't or rethink that the philosophy of the guidance is correct, but needs to be implemented over a period of years or period of X. And not just have it as a preamble because it is not clear to me whether that says we agree or disagree. I may give you my opinion, but I wanted to start with the process.
Can I ask for clarification? When you say, do we agree with the pre-market review are you saying -- does the committee agree with that nature of the review?
The deficiency.
Or is it what they have chosen to subject to pre market. The overall question is do we require pre-market review.
Yes.
To be fair I have been involved in some of the discussion about that, but for the clarification of the report itself given this is one of the absolute key issues that is fundamental we should clarify whether we answer your question. Do we agree that this should have premarket review as stated? Should it be different?
Well the discussion and outcome was that the tests that had a high risk should have some premarket review. And that is through the FDA. And that is according to the FDA building forward. You move forward under this other partnership and actually do a pre-market review. Said the recommendation is there is a need for premarket review.
But you are defining that as a public-private partnership and a way that the FDA --
No, it is according to the risk. It will be one or the other.
The way I understand it -- maybe this is incorrect, but I think what we are saying is we agree that there need to be a risk-based strategy. There was a lot of concern and discussion about how we interpreted the FDA assessment of the risk and we thought that 30 to be input from other stakeholders to basically take more time around the risk issue to make sure that we are doing the issue properly with the appropriate input. I see that as being appropriate and appropriately represented in the preamble and that is basically a of the recommendation. This is a group we need to pull together to really look at getting inputs from to decide how to do there risk and how to decide who does decide for which one gets premarket and which ones don't. This is our response to say from public comments that these are the groups that say we think we need to have input. So I think this reflects the ongoing process. Steve wants to comment.
Well, I want to chime in. Sure. Even within the subgroup there are risks. It is not all Class three, Class two. Because we aren't driven particularly by technology. Certainly the transparency issue is important, but it was as the technology per say. If you want to look at our web page we are in multiplex assays. So I would argue that even in the construct it can be parsed with some difference of opinion, but some subtlety. In terms of the issue that we've raised a couple of iterations ago there are differences in that document, we are working with the duty to try and resolve any differences or build off of the strengths or minimize redundancy. And I view that as a red herring. I think there are more similarities than differences, and they just need to be explained in a user-friendly way. That is what I would characterize them as doing. You might want to have design control for things that a regular lab might not need to have. I think the most important thing to me, frankly as a regulator, but maybe not as a regulator, as a patient, the most important thing to me is what Reed said which is, is there A? And what is it? Is it a free pass? Is it three-quarters and let me tell you, they have these things like informed consent and IRB's and things like an actual submission to either the IRB or to the FDA so it has that investigation protection. You need discreet clinical performance and I would think that was a possibility, but I argue it is correct. So we don't require that we demonstrate what the impact will be in 10 years on the health-care system. And then we have all kinds of interesting parts market controls. One is a requirement that they make products consistently and if they don't they notified players using the products. And they are reporting so that when something goes wrong you have to report it. Usually companies are anxious to work with the FDA and fix what has gone wrong. Sometimes they aren't so anxious. They are trying to bury it under the rug, and we get into very interesting disputes. And I say that's fine. I'm going to put out a press release and let everyone know what is going on. Usually that works. That is the A. That comes with research, pre-market, quality during production, and it comes with postmark. Your job -- or your job to give to a HHS is to figure out what B is. And I, as a patient, was hoping that it would at least be $0.50 on the dollar.
Okay. I'm confused.
I had you and tell the $0.50 versus $0.10.
I'm talking about something that is an alternative. It doesn't have the [ indiscernible ]. It can be just like FDA and you can simply create an FDA. It is what we wanted to cut it can be substantially equivalent and have the same functions or it can be an awfully different, but I would hope at the end for the patients -- and that is the most important thing. Our obsession with labeling the truth. I can assure you our truth and the manufacturers truth are not the same. Label the truth and put the whole damn review in a place where every person can swear at it or buy it. But they can swear by it because it is in the public domain. And it is quality control. Every company has pristine data and the best clams, and of course that is a business.
Remind us again of which things and that scenario you just gave --
You have to choose. That is your job.
I think they are all important.
You aren't listening to my question. Which things are outside of the FDA? That is what I don't understand.
Cost for sure. A letter with my name on it does not guarantee the company will make a dime. So reimbursement is outside. Actual use because I think you said earlier practice standards and information articles will drive use. Off label use.
I'm talking about -- in other words, if you have the FDA process and you said there is another process.
[OVERLAPPING SPEAKERS]
The question I would ask is, how do you know that the registry has correct information? And of course what they are leveling at us is how will the FDA be nimble and quickly make changes to products? Well, the same question applies to the registry. How do you about it to make quick and legitimate changes.
I'm sorry, Steve. You are still [ indiscernible ]. I'm not sure how we got you to jump to the registry train.
I thought that was B.
Yes, but what I'm trying to say is --
That was before that.
FDA is doing -- you write a process for the FDA.
They are behind it.
I am just asking a very stupid question. Why isn't everything in the FDA?
I am asking the same question.
It's clarified very easily. The language has only been subject to review. That is not what we heard and that's not what happened.
And lots of people have said that things that aren't FDA today have been under CLIA and CMS. And we heard people say that regulation is sufficient and we heard other people say that it isn't. I think that is very much the heart.
And that is my question.
And FDA has to be careful what it wishes for.
In light of some of the current reports on the infrastructure and their current ability to review this type of application what is realistic from the agency. And that is what we propose and these other balls to be able to offload some of these. Courts so where I am starting from everybody is really precise that. First of all, at one level our job is to be practical and not ridiculous. However, our job is also, as I understand it, to define the optimal state and then work backwards from there. So it seems to me that I'd love for us to be able to make one statement in our chapter for recommendation for mother, God, and country table setting, the optimal situation would be that's -- this is what will occur. That is what we want. However, after doing meticulous homework the FDA says, ain't no way in hell you are ever going to get enough money to be able to actually do this in real life. For every test, the same thing. And we were impressed by that. Although, you know, we are scared to recommend what is important to the American people, but we are practical. Everything gets something. The rules of hierarchal go as follows. That is what we are trying to say. Thank you.
I actually think that we don't have enough information to make a recommendation on this just yet. Because we have not done a thorough economic assessment of the impact to market to innovation. The group that we have is not qualified to do that.
Great point. That hypothesis doesn't exist for us. We are in the position of having thought about it as best we can and making recommendations. So what you said is maybe what you are doing is tempering the degree of zeal or certainty and so forth. But at the end of the day we can't avoid it. We have to make that choice. We have to make the call based on best input. So back to this. Can we at least just simply to find the optimal state? Can --
I think we also have to have in mind you have the laboratory, but you also have the laboratory of [ indiscernible ]. And it seems to me there are two different sets of regulations and some of them are overlapping that could be overburdensome to the laboratory. And we could actually may be stifle some of these by over regulating these systems.
I understand. I guess what I am asking the committee is, we can get caught up in 8 million machinations of everybody's special interests and every reason why the FDA people are going to get pissed, the libertarians are going to pissed. At the end of the day can't we just clean this slate and say we aren't worried. I'm not worried about everybody's special interests. I'm worried about the people. This is the optimal situation, and from there you work backwards.
I think [ speaker unclear - audio low ]. Okay. What do we want? Put our public hat on. We want good tests that pass a certain amount of standards with analytical validity. The challenge is, is to design a plan B where you have $0.50 for the dollar or $0.10 for the dollar. That is what we need to think about. People are telling us of that is invalidated. From here down to the consumer. You don't even have to go through CLIA. You could just go this way. This committee could make that recommendation and describe what the ideal is. [ speaker unclear - audio low ].
The public deserves a threshold that you can't drive a truck through. If you have to close the store and that door and that is what this committee is saying we may not be able to get to the level of specificity that you absolutely wants. But there for here is what you have to do. That isn't the optimal report. It is a pretty damn good report. But above all let's clarify.
I agree with everything that was just said, but there is another piece to its. If we want people to continue to develop the new test and new technology. You have to balance the regulatory zeal with the commercial reality. And --
I'm glad you did that. That is a sober analysis. I have enormous private sector interest and sympathies for myself. I wonder, does anybody believe from the private sector that unless you get a free pass of no oversight that is the only way you are going to be innovative. I believe in innovation so strongly that I should never have to pass any scrutiny. That doesn't exist either.
It doesn't exist either because today we have CLIA.
So everybody -- there is nobody who will ever stand up in public and to save you should never looked at me.
Didn't we hear that from one of our public commenters? I think we heard exactly that.
No.
Other than one.
[OVERLAPPING SPEAKERS]
They claim they don't fold within the current one.
Okay.
[OVERLAPPING SPEAKERS]
I heard them say that today they don't know where they fit in the system, but I thought she specifically said we welcome appropriate oversight.
The rules don't apply to them.
But we were saying --
Anyway, the bottom line is I think it is very important that we get a sense. And I think the balance does not mean that the committee is to be scared into apoplexy that says you stifle innovation the moment you say oversight.
But your question was, what is the optimal state. And you have to consider the whole -- you really have to consider both sides of the equation.
We at least -- can we all acknowledge the general points -- now that we are moving towards that basic sense that everybody should have it should be reviewed. Now the question is, what is the nature of that review, and by whom?
What I see here, the minimum threshold is a risk-based threshold that should go to FDA. That is where we have come to as a committee. We need a group to decide what level that is. We need to have another system which will be the one that oversees the LDT. We have that first level of review in here. That is my sense.
And that is okay?
We are going to convene a group to get a risk to figure out what the level of risk of test -- I'm sorry, given a certain level of risk of test. Above that level it should go to FDA review.
Let me just ask you, if FDA is doing it today why do we need to restudy and why are we unsure of the adequacy of the review that we are doing today?
There have been some concerns.
They aren't. They are just moving it.
It should not be based on the mechanism of the test. It should be based on the risk of the test.
[ speaker unclear - audio low ]
We are doing risk assessment. But we are doing risk assessment in general for commercially distributed tests. The classification is actually a matter of public record. You can go in and look at our databases and see where virtually all of the contests, whether class one, class two, or class three -- most new will class two or class three. So we are doing it, but we are doing it only for commercial tests. We did say that --
So for the commercial test there is no risk stratification?
Yes. There is a class one.
Why can't you just roll that over and say -- in other words, what I am just -- I think it is pretty obvious. If this report calls for 18 commissions, 43 studies, the secretaries to allocate money to Bob, Joe, and Sue to study something or another, at the end of the day what are you left with? I am just trying to take out as much uncertainty as you can and get to --
[OVERLAPPING SPEAKERS]
It would certainly be our preference as we do have a risk based program that we will be operating for 32 years now, it would be our preference not to scrap that and start with a new one. The program has been refined and and I'm not suggesting that it couldn't be refined further. But the idea of starting over again strikes me as novel.
I won't disagreed. I think in a clarification to your question what we are talking about are LDT. Limited LDT. [ speaker unclear - audio low ]. But what we are talking about are laboratory developed tasks which are not commercially distributed in this same way that Steve is talking about. There are typically looked at as more of a service than a product. I think it is very critical for us to recognize the difference both in terms of time, effort, money to create it, the work that is behind it, not the technology itself because I agree that it cannot be technology based because I also think we cannot predict technology five years from now. But the regulating service is very different then regulating products. And the difference between CLIA and FDA is that CLIA for the most part -- some may argue with this, regulates but the laboratory. Because there are a number of different LDT's going through that laboratory as opposed to the FDA is regulating on the other side of the tests themselves. So that was the issue of about fundamental overlap, but not quite equal in terms of how this regulatory scheme is. But I would say we need to recognize that a laboratory develops test is not the same as a commercial kits with instruction. And that is relatively simple to do going forward, and we need to in the same way have regulation that makes sense over all. And I would say not genetic versus not genetic. And at the same time recognize the need for innovation because laboratory developed tests have been the engine of many new tests. Many of these the laboratory developed ones start out and gets to market relatively quickly and then with the adoption and sometimes the innovation and lowering of costs eventually becomes the commercialized tests that Steve was talking about. And I think it is absolutely essential that we maintain that system because that is the engine of many of these new tests and technologies, particularly in the field of personalized medicine becoming available to patients.
So as you said that I recognize that there is a difference between the two. The issue then becomes is that difference so distinctive that it demands different assessments rigor? I appreciate not stifling. The genetic alignment was in question. And they were sort of -- I remember what Sharon guts to with this answer. It is making me think about this again. At the end of the day what we are recommending is that somebody else to figure out what is the optimal level of scrutiny for the laboratory test? Even though there is a difference I am still struggling with why that would be different in terms of its oversight?
That is the fundamental piece of debate. I think we should take a stand and not say it is then yet another committee to do that. But I've wanted to clarify the issue.
[OVERLAPPING SPEAKERS]
I would say there is a difference in the oversight, the need for oversight, the timing of oversight, and the access of information that is available to the lab doing it.
But the process that you use now for the MIA -- whatever, the thing that you use now, describe the process so everybody has the same knowledge base.
Well, we have actually there's only one. It went through a class one. So it was viewed as a moderate device that had a [ indiscernible ] claim which would have also made it moderate risk device. We respected the fact that it was a very complex device. So rather than doing analytical studies, we use the signature itself as the signal by which to determine performance characteristics. We did insist that the signal the reproducible and robust overtime. We felt that if you got the signal you would always be getting the same signal. We have no way to analytically credential this. So we did it, and the clinical outcomes. It is a very unusual submission.
It costs the manufacturers a billion dollars to go through your process.
The company -- again, I would argue that it would cost the companies the most money to do the studies that will demonstrate that they had a value and will make CMS happy. So I think those trials are the more expensive, but I can't say it is a no cost deal because we do ask annoying analytical questions.
I think it is important to realize that there are laboratories that don't have the resources of the private sector that could develop these types of tests just because they have to go through these processes. We might be hampering some of that innovation because of this.
So -- I'm sorry.
I've just wanted to go back to your comments about the million dollars. We don't want to stifle innovation, but if you put something prematurely out there I think that might make sense or not. Just going through the recommendations that came out in September, we have working groups going through six or seven. Many of them are established genetic tests. There are some missing information and both analytical and technical validity that if you had to do it all over again you would want that information about your innovating because at the end of the day when you review things as the FDA level or in a working group or at the task force level, the data has to be there. So just the fact there is no data, one can say there is no data. That would be a premature release of technology.
So at the end of the day you would not -- so you also -- because you make a good point. The opposite of that point is a law meeting something in the laboratory to create something that hurts people. I didn't have the money to figure out whether it would hurt anybody, but I have a terrific intentions and therefore I release it. You would want to stop me, would you? Yes, we would. I guess I'll just try to try this on you all. It's the best that this recommendation can do is taking the earlier comments about all [ indiscernible ] and there is a minimum threshold, that is the ideal state. Number two, we believe that the FDA model for reviewing is good template that may not be able to be applied. But a high level of review assures the following -- for the test it meets the following criteria. This is something that you really want to apply. For the things that don't reach that level of scrutiny but recognize that everybody has to get through something, we do call for some process in an urgent way that at least accomplishes the threshold to five a minimum threshold defined as [ indiscernible ]. That is what we are at least coming out of this thing with. Maybe we can go further than that and maybe our recommendations based to how you play that out. I am pulling a straw out for you to hit.
Given that, I think what would be important is to put out the data that currently exists. That is how we get back to this. [ indiscernible ] when we get there. That is basically part of the process. It is time to put the data out.
And I think that is exactly right because the Devils then becomes and the details. So the FDA should exert some authority in this area. But not do it in a way that stifles innovation is where the registry -- I think it is spread to say the committee moved from voluntary registry to where the overall my public support was in terms of mandatory registration to ensure that registry and some of the proposals -- and I was involved in one talk about having that for at least a period of time before there was any more formal FDA premarket review just given the massive change that this is for the industry.
Now, are you recommending that in lieu of, for example, some of these moderate and lower go through review and just use the registry to convey that information?
Well, understanding Steve's comment about ensuring that the registry itself was accurate today which is an important issue, both of which have to be the -- the same way it is now. The burden of the company is to put that information out. The way the FDA today can say we have a problem with what you are saying -- and we talked about the FTC in terms of inappropriate advertising. I think that is a very important at a minimum a relatively immediate like month-year process. We can put up a registry and have full transparency with an industry which is critical. And then from there we can evaluate where I go because the other piece I heard is some folks saying there are a dozen or two tests that would fit. And a few hundred that would fit LTD. I heard other people say the opposite. Everyone has a legitimate arguments that says why their position is right. So I am concerned today to put in a pre-market review because it stifles innovation. And I don't know what we are getting into in terms of the number of tasks. So having an aggressive mandatory registry, all information the companies put in is the basic of the people who are putting it in needing to sign off to say that I agree with this and is truthful. We recommend a very narrow -- not narrow meaning small, but a very prescribed registry for which every piece of information is the same. And use that as the baseline. Put that in very quickly. That's where we have that full transparency. And with that we will have the data to then potentially go on to have a more aggressive FDA process.
[ speaker unclear - audio low ]
[ speaker unclear - audio low ]
I have heard a number of people say a registry is something that is doable. Not every group, but --
Let me make sure we put this stretch. The registry occurs -- they registry is a set of information that describes whether or not -- the registry describes the status of the review.
[ speaker unclear - audio low ]
Okay. Now that is -- you described your ideal state. Everybody gets something.
I would say virtually everybody has something today. But under this system everyone will absolutely have something. But there are very few loopholes.
Let me make this clear. We are recommending that we create this registry with the specific data elements to allow us to get a handle on what the current section is and from there move forward to decide what model for premarket review.
I heard Mark said earlier that the committee talked about the principle of ensuring a complete review and the principle of having the FDA involved. It is a very important one. But how to implement, to me, is where innovation and practicality of whether the FDA can do it over the [ indiscernible ]. That allows us to move forward but does not cut off.
Let's go back to the recommendations. I think there is some tweaking needed of the preamble on a slide four. Let's skip that for now. I don't want to wordsmith it.
Maybe as we go through this registry there could be a role for FDA and CMS to work together.
[OVERLAPPING SPEAKERS]
I think that's --
In your mind's describe the relationship between the registry and the review. I don't think you mean if the registry is a substitute for review. The registry is an assistant review. It is also an assist. But the registry in and of itself does not protect you.
[ indiscernible ]
How?
You start putting information out there.
Right. But the information has to be analyzed by someone.
Someone has to vouch for the information being correct on an analytical validity and what we know about the clinical validity that's where it's being used at all. And right now we don't even have that.
So that is essential for review, but that you can't say say Ms. Jones, the average citizen, go to the registry. Now they have a conversation with your doctor about whether or not --
The problem is with conical validity.
Exactly.
Now if we put the registry where we have all this testing and we also heard from [ indiscernible ] about this database. And he just left unfortunately about this database that is developing this kind of publicity information. It can be linked or both together within the registry. It will get to a place where [ indiscernible ]. If there is no sufficient clinical validity. They can go back and say to the laboratory that it doesn't have the validity.
Let's put the pieces together.
Today many of the pieces are available. If I, the consumer, wanted to get 23 and Me it is very hard for me, as a consumer, to get all these pieces. I know I can get them if I work very hard. I come back to these because they have quite a bit of wealth of experience from these reviews that are ongoing. It takes a long time to assemble existing information. These are sort of low hanging truth. So by acquiring that formal registration in one place, FDA, or CMS, or some kind of virtual place. It doesn't matter. If you can develop the registration process where people put in that information for people to evaluate. Now evaluators can evaluate at any point in time. It can become part of the collection that will help the assessment of the validity of that information. This is helping the developers say this is the kind of data we want. But we are also helping them sort of invest in the research that is needed to get that data. And they are also helping NIH and other funding bodies to do that research. So this could be done under the auspices of the public-private partnership if we want the tie in from the private sector to kind of feel the registry. This has a strong feeling from private and professional organizations. We can all work together to try to begin to populate this so that we can achieve that idea.
That is the key thing. The registry is information necessary for people to make the evaluation. I want to make sure I understand this. The committee is saying that it is okay. That you -- the public is protected because there is a registry. Go look it up. At some point the registry is information that is used. But there is some agency protecting the public that is saying, it's okay. And that is what I am trying to get to. Am I missing the sense of the committee?
[ speaker unclear - audio low ]
From my sense it's actually is a mix. To be fair I think that many who have advocated for registry -- and I won't say it again, but I have been involved in some of those efforts. They would say it is best suited for virtually most of the tasks that go through physicians. So it is not Mrs. Jones who goes to the registry, although she could. So I think that this works best in those circumstances and that the level I would imagine of scientific rigor here is not necessarily based for a consumer but for a physician. So we have more complete information on analytical and clinical validity in that area. And I think the concept behind that is kept it up and get it done because that doesn't exist now. So at an absolute minimum when we talk about professional groups or other organizations, you just can't get that situation.
And one sense you are arguing against the sense of the registry. [ speaker unclear - audio low ]
[OVERLAPPING SPEAKERS]
[ speaker unclear - audio low ]
If you have not read the study please read that's because it is a very sobering. That is the deal. You have crystallized it. FDA is not supposed to have moderately higher or may be high or low risk put into a registry. In fact that would be the only way that we could survive. What I was trying to say about the dime on the dollar is exactly what I think Reed is struggling with. I have seen too many bads datasets either inadvertently bad or deliberately bad or something in between. You pull them together, and you have a statistical goldmine. I have seen major exchanges. Can you send the data, and I said house sends you the 14 samples right away. I'm telling you got that is what makes it credible. The professional society, the public-private partnership steps up and acts in a pseudo FDA way and you can say to Ms. Jones or Dr. Smith that this is a credible registry. And the audit them to make sure they know what they are doing, and they have no stock -- and that is tricky. I'm not sure that this committee needs to resolve that, but I certainly hope that there is a desire for is the quality control the material entering that registry. I don't give a damn how it is done. I would just like to see it done.
The quality control of the registry is under CMS. Quality control is already checked by CLIA.
But CLIA doesn't look at every single test. They come in and they will look at a lab with a dozen, and they will look at one or two and they sample. They look at quality assurance and environmental -- how can that possibly be?
I just want to point out that an excellent registry is wonderful, but that doesn't make it safe. Just like a scalpel is the -- even if you're not a good surgeon, you can certainly get cut.
I like Steve's idea in terms of having a registry with key organizations that are also putting their reputation on the line. And they are saying what is and this registry means something. So I think having a registry like that, not immediately going to premarket review, but having a process that leverages the FDA time and CMS time and has some key organizations that work together to do that. Again, one of the groups suggested something like that. But I love the idea to do that because that may at the least, as we learned more about this industry, might be able to fill the gap of getting the transparency and having all the tests together which I think we all recognize is a valuable, but on the other hand making it a registry that if we know it is on that registry with a checkmark that some groups of professional organizations has gone through it. It is very similar to the inspection system.
Why can this be that -- Steve, tell me why this can't be again. This is the last time I am going to ask this. You have in some definition to a high priority set of tests for which there must be premarket review. FDA says, okay. I have to review this thing. I am going to turn to the registry. Look at all of this terrific stuff. My job is so much easier now. And I'm here to make an ascertainment about this test. Terrific. Plan B is the FDA makes some decisions and says because of the nature of the test it doesn't need FDA. It needs an alternative method. Something is there. They go, this has lots of information. This makes our job so much easier. We will do what we do. If you are interested in learning a lot more information beyond the fact that is passed judgment of whatever that judgment is to unleash on the American people. Go look at the registry. And I don't understand why the discussion keeps going through the registry and stops. FDA is off the hook. Everybody is off the hook. All you need to do is do a registry and everyone is safe. I am missing that leap.
I am a very transparent guy. I played poker by putting all my cards on the table. I think whoever gets this registry is going to have a job that is hard as hell. We are starting to discuss with the sponsors that this precision said it wasn't done right. They have entertainment.
Reed, my problem is I have not heard anyone assumed the authority for reviewing the LDT's and taking action.
I haven't heard anyone assume that authority.
[OVERLAPPING SPEAKERS]
If you have authority --
[OVERLAPPING SPEAKERS]
You know, I am simply a midlevel official. I probably should not say this, but the agency has a long history of being in discernible. So the idea of looking at risk -- I am not ducking. I certainly don't want all of these tests because it is not possible. I think the high-risk tests belong at FDA.
The devil is in the detail. But if it becomes part of the registry it gets mandated somehow. People start submitting data according to specific formats. There has to be some process before it goes into the registry. Or at least a check for initial [ indiscernible ]. People who are doing systematic reviews to see whether or not the cumulative data makes sense, that is what we have been trying to do for the last 10 years. That could be done by an independent group or an FDA process, but I could envision a situation that requires a lot of thinking and a lot of groups coming together under this public-private partnership umbrella. But we cannot just take anything that people sent to the registry. Then they say to Ms. Jones, go check the registry.
But like you say, the devil is in the details. If we are going to say you have to put everything in the registry it has to be reviewed. You are going to completely stifle everything. There has to be some kind of process were reports of and the registry. If there is this public-private partnership that starts looking at these. It has to be funded. But we have to be cautious when the devil is in the details.
There is a difference between what NIH now requires and the sequences for the genome. Not everyone is funded by NIH. That is sort of the raw material from which people can do [ indiscernible ]. The problem with genetic test development is you have data that is surprising and competition between many groups. The way we did this was everybody needs this data. And this is Gene acts in relation to Jane Wyatt. So could we construct a similar situation where instead of doing Test A for Company A and Test B for Company B to develop an overarching datapoint on analytical levity and conical validity for these tests for this group.
Well, this is similar.
[OVERLAPPING SPEAKERS]
[OVERLAPPING SPEAKERS]
At [ speaker unclear - audio low ]
Let's start making these comments. How do we get to the actual [ indiscernible ]? We need to have people put on the table what they want.
I think I am getting there. First comment, why don't we suggest the registry has a user fee. Many registries have. Many companies have. And if there are -- I think it will work out that we recommend a user fee based registry for which it takes away the issue of enough funding to get this done with the public-private partnership that approves of things going into the registry with various organizations and maybe then the FDA has the ability to look at that registry and say, you know, we still have a question over what went into this registry. But the FDA has been working with four or five professional organizations and has the ability to say these are the things we want you to ask and 82 checkoff.
[OVERLAPPING SPEAKERS]
[OVERLAPPING SPEAKERS]
[ speaker unclear - audio low ]
[ speaker unclear - audio low ]
[OVERLAPPING SPEAKERS]
What you are saying is the FDA can reduce some of these tests. So it has regulatory authority over the average for developed tests. That is the fundamental issues that. They don't have that authority, but maybe you have to have kind of an interagency. That is the question we need to answer. Now we can say after that that the FDA can review high risk and anything that isn't high risk -- and they can let the registry develop. And as it develops that can work from the registry because we built up these data elements. Work from the registry to actually exercise the authority over a number of these things that they have questions about.
Mark?
I am reluctant because I think we are so far out to sea I fear of ever getting back to shore. We spent a lot of time talking about the registry which I see as a means and not an end. The fundamental question was very well stated by my colleague whose name I cannot recall. Who has ownership of saying yea or nay. This is a report on oversight. The issue we have heard is we have one test that has gone through an FDA clearance process. We know that there are hundreds, if -- we have a whole with people who are brought articulates it with gaps and oversight. Establishing a registry does nothing to do with this. I think the critical issue here relates to the ownership of who has the authority to say, we've looked at this or we don't look at that. And as I look at the recommendation, the purpose that I saw of pulling the consortium together is to try and see who is going to step up to the plate. Maybe that won't do it. Maybe that would just end up with more cost, but I don't see a registry doing that either. And I think that ultimately if we don't come down with some --
[OVERLAPPING SPEAKERS]
[ speaker unclear - audio low ]
[OVERLAPPING SPEAKERS]
I just think we are completely lost at the present time.
Any other comments?
Would you say that today CLIA owns -- an answer to that question, does CLIA own oversight of LCD?
No, they would not say that. That is the gap. That is the elephant in the room that we aren't addressing.
We may go either way.
That is and the report. 200 pages explaining exactly why we have this. The first role in Quality Improvement is systems are perfectly designed to give you the results that you have. Our system is perfectly designed to give us the results that we have.
[OVERLAPPING SPEAKERS]
We need to have a tangible solutions come out of the room. We don't have any right answers that we can impose. That's we can at least say, here are the players that we think are important and the secretary should ask them to say what is the system that you propose to fix this gap which currently exists.
You are asking to have -- do away with the current recommendation and say this is what we have identified in the report. These are the three agencies that have some kind of overlap. They need to get together and figure out how or who is going to go about following with them.
I would say it is getting away from there recommendations.
We have articulated that.
It is in there.
We can tweak it.
We have suddenly become focused on something that isn't the recommendations, but is only a part of the whole picture. If we focus on that solely people lose what is really important.
What we have focused on is very important to the entire recommendation. The devil is in the details. Are there any other comments?
I always defer to my colleague.
Sure. At the end.
[OVERLAPPING SPEAKERS]
[OVERLAPPING SPEAKERS]
Now, I agree very much with Mark. It's fine. I agree, the registry is going to be key. This other part is also key. When you started to say, let's just pull the three, I thought we would try to make sure that in order not to stifle innovation and not to leave anybody out of everybody is supposed to be there. We want to make sure that those forces are there so that nobody can come back and say you didn't listen to.
But you are assuming that the FDA has the authority.
But what we have here is HHS convenes these agencies. I don't think we claim necessarily in that.
[OVERLAPPING SPEAKERS]
In the preamble we do.
In the preamble we do.
Kevin and Mark, I guess I have a question. I appreciate what you said, but if we have a lot of different is as listed what worries me is that will make it less likely that one would step up because it then becomes a very large committee it takes such a long period of time to come to clarity with having a lot of lists of people.
If the secretary says sit in a room and then in a month I want an answer, that is what they are going to do. We have to say this is really important. We can't create a solution as an advisory committee. At least we can say we didn't pass the buck.
Let's try to get to some consensus here. We may have to have Mark, who has a good grasp of this, draft something.
[ speaker unclear - audio low ]
[ speaker unclear - audio low ]
Here is the deal. Let's meet try this and just see where we get. We say in our preamble something to the effect that, dear Mr. Secretary, it is clear that there is a major gap in the oversight of the genetic tests when it comes to the assignment evaluation of clinical validity. That is a major, a huge problem. There is a truck that can drive through that hole all the way through to the end. Therefore we find that to be unacceptable. And our recommendation is that reality is clearly determined to be unacceptable. It needs to be fixed. This involves a combination of approaches. Risk-based assessment that goes through an FDA-like process that is used for [ indiscernible ]. And potentially a separate process for less risky things that still need the public -- it meets the hurdle of protection of the public with legitimate oversight. Redefine risky as attributes such as -- and we have a few attributes. To accomplish this we urge you and the strongest terms [ speaker unclear - audio low ]
[OVERLAPPING SPEAKERS]
[OVERLAPPING SPEAKERS]
[OVERLAPPING SPEAKERS]
They don't want me to continue.
[OVERLAPPING SPEAKERS]
We in the strongest -- we say, you fix this urgently through a process of convening the appropriate agencies and in an expeditious way assign this accountability for this issue. In making this recommendation we are cognizant of the concern around innovation and not stifling it. We are also cognizant of the differential data requirements between different kinds of products manufacturers. However, with that cognizants in mind we still cannot avoid the recommendation. Every PT test has to pass some test. And lastly companion recommendation is to facilitate that process. That registry must have the following attributes. That registry will then make it much easier for the FDA review and the alternate pathways review as well as other public [ indiscernible ].
What is FDA-like?
[OVERLAPPING SPEAKERS]
[OVERLAPPING SPEAKERS]
[OVERLAPPING SPEAKERS]
[OVERLAPPING SPEAKERS]
[OVERLAPPING SPEAKERS]
[OVERLAPPING SPEAKERS]
I would be happy to have more courage.
[OVERLAPPING SPEAKERS]
Okay. There it is.
I am granted be a broken record. You have to have the evidence to make such a strong statement. You have to have that data.
I do.
Okay.
We have 10 minutes. I've thrown out a recommendation. Now I want to get people who disagree, and be specific. They've already changed its to my FDA-like. What other modifications do you want to make?
I think we have to write it down. We should come back tomorrow with it.
We can do that.
[OVERLAPPING SPEAKERS]
[OVERLAPPING SPEAKERS]
This has already been turned out.
I just have one clarification because I agree with the comment that says we shouldn't pass the buck. So what I was concerned about was the first paragraph of 4-A was passing the buck back to make the decision.
[OVERLAPPING SPEAKERS]
With its first attempt which is the guidance that is what the preamble says. We are agreeing that the FDA is the agency that has the authority and has the right mechanisms to review laboratory developed tests and get at the clinical validity issue. What we also say is they did not quite get it right. Convene a group of all agencies and stakeholders to help the FDA get it right. And the reason they did not get it right is because in our understanding they did not rely on what they say they always do which is risk. Rather they relied on technology. That is what the taskforce decided on. So we want to provide further input. Although we got a lot of input from the public. But --
I was confused about having the --
[OVERLAPPING SPEAKERS]
What I want to do is this. We are going to redo this tonight right now. Lucky Mark is off the hook with his one dangling like a participle. You will have it as soon as you walk in tomorrow.
Take a look at recommendation three. Maybe you can work on that.
I appreciate that. Here is the deal. He guys have worked hard. So apparently you get to eat at one of the greatest restaurants in the universe. If you have not been [ indiscernible ]. [ speaker unclear - audio low ]. You have to be able to make this transition.
Reconvene at the restaurant at 7:15.
A block from the hotel.
So you are in the lobby?
No, at the restaurant.
In the lobby --
No.
7:15.
Read this letter.
[Session adjourned for the day]